Date: 20061114
Docket: T-1408-02
Citation: 2006 FC 1373
Ottawa, Ontario, November
14, 2006
PRESENT: The
Honourable Mr. Justice Mosley
BETWEEN:
CALGON CARBON
CORPORATION
Plaintiff
and
THE
CORPORATION OF THE CITY OF NORTH BAY and
TROJAN
TECHNOLOGIES INC.
Defendants
REASONS FOR JUDGMENT AND JUDGMENT
INTRODUCTION
[1]
“We don't have to kill
the little buggers, we only have to give them a vasectomy”. That is how Dr. Sam Stevens described the effects of irradiating Cryptosporidium parvum
with low doses of ultraviolet light, in his testimony at the trial of this
action for patent infringement. The plaintiff, Calgon Carbon Corporation ("Calgon")
obtained Canadian Patent No. 2,331,525 (the '525 patent) for that method. That the method is useful is beyond question.
But was it new? For the reasons that follow, I find that the patent was
anticipated by the prior art and is invalid.
[2]
The plaintiff alleges direct infringment by the
Corporation of the City of North Bay ("North
Bay"). Trojan Technologies Inc.
("Trojan") is alleged to have induced or procured North Bay’s
infringement.
[3]
The relief sought by the plaintiff
includes a declaration of infringement, a permanent injunction and damages against
Trojan and damages or an accounting of profits against North Bay. Calgon
does not seek an injunction against North
Bay. The defendants by counterclaim seek
a declaration that the patent is invalid.
The
Parties:
[4]
Calgon is a Delaware corporation based in Pittsburgh, Pennsylvania.
It is primarily in the business of making and selling activated carbon products
and systems for purifying water, air and food products. Calgon began to
manufacture and sell its own line of ultraviolet (UV) water treatment systems
under the Sentinel brand in the late 1990’s. Calgon owns the ‘525 patent and licenses
water treatment facilities to use the ‘525 technology at a fee of 1.5 cents per thousand gallons of water treated.
[5]
North Bay is an Ontario municipal corporation. Among other things
it owns water treatment facilities operated by the Ontario Clean Water Agency,
and it provides drinking water for the residents and businesses of the city. The
costs of water treatment and supply are borne by the ratepayers. The city’s
primary source for drinking water is Trout Lake, a large, deep and normally
pristine lake adjacent to the municipality. North Bay contracted with Trojan
in 2001 to supply a UV drinking water disinfection system for its water
treatment plant.
[6]
Trojan, based in London, Ontario is the wholly owned subsidiary
of an American corporation. It has been in the business of designing,
manufacturing and selling UV disinfection systems since the 1970’s. Initially,
its drinking water systems were designed for residential applications. Trojan
has more recently expanded however into municipal and industrial drinking water
and waste water treatment. Trojan supplied the ultraviolet radiation system to North
Bay that is alleged to infringe Calgon’s patent. In the course of completing
that deal, Trojan agreed to indemnify North Bay against any claim of patent
infringement arising from the use of the system.
The Patent
[7]
The ‘525 patent
application, entitled “Method for Preventing Replication In Cryptosporidium
Parvum Using Ultra Violet Light” was filed on May 5, 1999 claiming priority
from U.S. Application No. 09/078116 filed in the United States on May 13,
1998. The claim date for present purposes is, therefore, the date of the U.S. filing. The ‘525 application was laid open for public
inspection on November 18, 1999 and the patent was issued February 19, 2002.
[8]
There are just four
claims found in the ‘525 patent:
1. A method for the prevention of
Cryptosporidium oocysts comprising irradiating water with a continuous broad
band of ultraviolet light in doses of from about 10 mJ/cm2 to about
175 mJ/cm2.
2. A method as set forth in claim 1 wherein
said broad band is a frequency of 200 to 300 nm using a UV lamp.
3. A method as set forth in claim 1 or 2
wherein said dose is from about 20 mJ/cm2 to about 30 mJ/cm2.
4. A method as set forth in claim 1 wherein
said broad band is a frequency of 200 to 300 nm using a medium pressure UV
light.
PROCEDURAL
HISTORY
[9]
The statement of claim in this
action was issued on August 29, 2002. Particulars were ordered and delivered in
response to a motion to strike portions of the claim. North Bay then brought a motion seeking summary judgment on the ground that the ‘525
patent was anticipated. North Bay further argued that the ‘525 patent
did not disclose an invention, but rather the mere discovery of an advantage of
an old invention.
[10]
In Calgon Carbon Corp. v. North Bay (City), 2005 FC 838, 41 C.P.R. (4th) 78, Justice
James Hugessen allowed North Bay’s motion
for summary judgment and dismissed the action as against that defendant. For
the purposes of the motion, North Bay had abandoned its own expert evidence and relied upon
that of the plaintiff’s expert, a Dr. Huffman. Dr. Huffman, whom Calgon did not
call at trial, admitted on discovery that if the phrase "for the
prevention of Cryptosporidium oocysts" was removed from claims 1-4, then the
method could otherwise be described as well-known prior to the claim date. The
prior art put into evidence by affidavit on the motion was that of the UV
system installed at Fort Benton, Montana and point of entry systems installed
at North Bay.
[11]
On the strength of that evidence,
Justice Hugessen held that the use of an old invention to prevent Cryptosporidium
oocyst replication was a mere discovery and not a new invention even if the
advantage was previously unknown. Accordingly, that use was not patentable
subject matter.
[12]
Calgon appealed the dismissal of its action. In a
decision dated December 6, 2005, the Court of Appeal allowed the appeal and set
aside the summary judgment decision: Calgon Carbon Corp. v. North Bay
(City), 2005 FCA 410, 262 D.L.R.
(4th) 476. Citing Shell
Oil Co. v. Canada (Commissioner of Patents), [1982] 2 S.C.R. 536 (Shell
Oil), and Hickton’s Patent Syndicate v. Patents and Machined
Improvements Co. (1909), 26 R.P.C. 339, Justice Marshall Rothstein held for
the Court that irradiating water for Cryptosporidium using low doses of UV
light, while not a new method itself, constituted a newly discovered use for
that method and was therefore a new and useful art. At paragraph 17 of the
decision, Justice Rothstein stated:
…Here, what is useful is the
method of using UV light at particular levels for preventing Crypto oocyst
replication. What is new and was
not previously known is that using UV light at particular levels adequately
treats water to prevent Crypto infection. Because of this, a more
costly means of producing that desired result can be avoided. That meets the
definition of "invention". [Emphasis added]
[13]
The Court of Appeal
declined to deal with the issue of anticipation as it was not addressed in
Justice Hugessen’s decision and was only “argued cursorily” by the parties.
Leave to appeal to the Supreme Court of Canada from the Court of Appeal’s
decision was dismissed without reasons: Calgon Carbon Corp. v. North
Bay (City), [2006] S.C.C.A. No. 39.
[14]
In the present case, the
plaintiff asserts that the question of whether the subject matter of the ‘525
patent is patentable is now res judicata. North Bay and Trojan submit that the issues in the present trial case are not the
same as those which were before the Court of Appeal. There is new fact evidence
on the prior art, new expert testimony, and new constructions of the claims put
forward by the experts. Thus I am free, the defendants submit, to arrive at a
different conclusion from that of the Court of Appeal as to the validity of the
‘525 patent.
[15]
The defendants urge me
to revisit the issue of whether there is a mere discovery or a patentable new
use of an old method based on the evidence at trial. This evidence establishes,
the defendants submit, that the use was not new and that UV light in doses that
fall within the claimed range of 10 to 175 mJ/cm² had been used to disinfect Cryptosporidium
in drinking water prior to the patent application.
[16]
I am clearly bound by
the ratio of the Court of Appeal decision which I take to be the
principle taught by Shell Oil applied to the limited evidence which the
Court had before it. As the Court of Appeal expressly left open the question of
anticipation, its decision does not preclude a finding that using UV
light at the claimed levels was known to treat water to prevent Cryptosporidium
prior to the date of the patent application. Moreover, the evidence to be
addressed with respect to anticipation includes new evidence that was not
before Justice Hugessen or in the record before the Court of Appeal.
[17]
As the opening
paragraph of these reasons indicates, I have concluded from the evidence that it
was known prior to the date of the patent application that using UV light at
particular levels adequately treats water to prevent Crypto infection, and that
the invention was therefore not new.
[18]
The following summary of the facts is drawn from the testimony
and documentary evidence at trial.
FACTUAL B ACKGROUND
Cryptosporidium parvum
[19]
There are several species of Cryptosporidium
protozoa (i.e., single-celled)
parasites. As parasites they can only reproduce within another organism (the “host”). Cryptosporidium parvum can cause a gastroenteritic
disease, Cryptosporidiosis, when ingested by an animal or human host. Cryptosporidium parvum appears to be the predominant
species responsible for Cryptosporidiosis in humans and animals and is known to
spread through contaminated drinking water, contaminated foods and by close
contact.
[20]
In one stage of its
life cycle, the oocyst or spore phase, the parasite is enclosed in a protective
cyst-like membrane which may be thick or thin walled. Thick walled oocysts are
highly resistant to environmental stresses and to common disinfectants such as
chlorine.
[21]
The oocysts are about
4-6 micrometers (4-6 µm or millionths of a meter) in diameter and will pass
through many filtration systems. When ingested, stomach acids and enzymes cause
the oocyst to open, a process called excystation, and to release up to four
sporozoites. The sporozoites attach to intestinal cells and re-start the life
cycle, replicating the protozoa within the host. Thin walled oocysts can remain
within the intestinal tract and multiply, producing symptoms such as fever and
diarrhoea.
[22]
Both the disease and
the parasite are commonly known as "Crypto" and that is the term that
I will use unless it is necessary to distinguish between the two in a
particular context.
[23]
Thick walled Crypto
oocysts are shed in the feces of infected hosts, where they can then be washed
by rain, snow, or through sewage discharge into lakes, ponds, rivers and
streams. The oocysts may therefore be present in water taken from above ground
sources (“surface water”) or from shallow wells (“ground water under the
influence of surface water”), where there are infected hosts in the watershed
feeding that source. Typically Crypto is not found in deep wells due to natural
filtration through the aquifer sediments.
[24]
Crypto oocysts may appear only sporadically in a
water source; typically after a heavy rain or following spring snow melt. It is difficult to determine whether a
water source is contaminated as any given sample of water taken for analysis
may contain no oocysts. Thus, in testing for the risk of the presence of Crypto,
analysts rely on the presence of other contaminants such as E. coli bacteria which indicate the presence of
fecal matter in the water.
[25]
For healthy individuals, Cryptosporidiosis may be self-limiting
within a few days. For others, particularly the very young or elderly or those
with depressed immune systems such as persons with AIDS, the results can be
severe including death. There is no specific treatment. Consequently it is a
major public health concern.
[26]
The first outbreak of Cryptosporidiosis linked to contaminated
water was reported in a groundwater system in Texas in 1984. Two major
outbreaks followed in Georgia, U.S.A. and in Swindon, U.K. in the late 1980’s.
What captured attention, however, was the outbreak in Milwaukee, Wisconsin in
1993 in which some 400,000 people reportedly became infected. That incident in
particular appears to have focused interest on the use of alternative methods
to prevent Crypto infection. In Canada, an outbreak occurred in Waterloo,
Ontario in 1993 and in Cranbrook B.C. in 1996.
[27]
Conventional water treatment uses several
steps to produce potable or “finished
water” including screening, coagulation,
flocculation, and filtration. Under
optimal conditions, coagulation and filtration can effectively remove Cryptosporidium
oocysts. However, a substantial number of outbreaks of Cryptosporidiosis prior
to 1998 were related to such water treatment systems. That was the case in Waterloo, Ontario which operated a
conventional system to treat water taken from the Grand
River, from groundwater wells, and from infiltration
wells adjacent to the river.
[28]
Following filtration, the
practice in North America at least, has been to add a chemical disinfectant,
typically chlorine. North American regulations typically
require that a constant amount of chlorine remain in the water pipes to the
point of use. The presence of that residual chlorine in the water prevents
bacterial infiltration and microbial growth in the pipes but is also the source
of concerns about health effects and aesthetic objections. Chlorine produces
Trihalomethanes which are known to be carcinogenic. In the concentrations used
for water treatment, chlorine does not “kill” or inactivate Crypto.
[29]
Chemical ozone is considered to be very
effective against Crypto but it is costly and difficult to use. Ozone was employed by Milwaukee following the 1993 outbreak. Lesser amounts of ozone
may be used for odour and taste control. Modern filtration systems employing
fine membrane filters can also be effective at removing protozoa, including Crypto,
if the pores in the membrane are small enough. Micro-filtration systems are
also expensive to install and maintain.
[30]
Pathogen removal is measured in logarithms or
“logs”. One log reduction is
equivalent to the removal of 90% of all pathogens present, two equals 99%
removal, three 99.9% removal, four would be 99.99%, 5 is 99.999% and so on. This
means of calculating efficiency of treatment depends on input. Removing 99.9% may
still leave a considerable number of oocysts capable of replicating if a large
number were initially present. Moreover, it is difficult to know whether the
parasite is present or not. It is comparable to searching for a grain of sand
in a swimming pool. One oocyst may be capable of infecting in a person with a
weakened immune system. The adequacy of preventive measures may in some cases depend
on a combination of barriers with different log reductions attributed to each,
to ensure a sufficient reduction is reached.
Ultraviolet Irradiation
[31]
The limitations
inherent in conventional water treatment systems and the costs and other
negative factors associated with ozone and membrane filtration led to increased
interest in North America in the use of ultraviolet light
irradiation as a solution for Giardia and Crypto protozoa in the early to mid 1990’s.
[32]
Ultraviolet light operates to disrupt
replication in an organism by cross-linking its DNA or RNA double helix strands
preventing their separation into two strands. This effect of UV light was known
in the prior art, and the use of low levels of UV light as a disinfectant for
bacteria and viruses in drinking water and waste water treatment was well
established prior to the mid-1990’s.
[33]
The standard units of measurement of UV energy
are milliwatts per square centimetre (mW/sq cm). Doses are expressed in terms
of intensity, time and area as milliwatt seconds per square centimetre or millijoules
per square centimetre (mJ/cm²). A dose is the actual amount of energy delivered
multiplied by the time taken to deliver it. The effect is the same whether the
energy is transmitted intermittently or continuously.
[34]
In a typical medium pressure UV lamp, mercury
vapour is maintained at a pressure of about 1000 mm, a pressure at which it produces
a continuous broadband of ultraviolet light at wavelengths below 254 nm. In a
typical low pressure UV lamp, the mercury pressure is about 10 mm of mercury or
less, a pressure at which it produces ultraviolet light primarily at a single
wavelength of 254 nanometers (nm) with smaller emissions at other wavelengths
within the UV spectrum. UV may also be delivered by pulsed light systems which
deliver bursts of high intensity UV light intermittently.
[35]
It was believed by many
persons in the water treatment field in the early 1990s that a high dose of UV
light, in the range of 3, 000 to 5, 000 mJ/cm², was necessary to “kill” or
inactivate Crypto in the oocyst life-cycle stage. It was believed that it was
difficult to penetrate the oocysts’ membranes with UV light. The in vitro methods
used in laboratories for assessing and measuring the effectiveness of UV light
were excystation and vital dye staining. These tests were considered as
reliable surrogates for the more lengthy and expensive in vivo method, mouse
infectivity - described in the evidence as the
"gold standard" of microbiological assays. The U.S. Environmental Protection Agency required
animal infectivity studies to demonstrate the efficacy of inactivation technologies.
[36]
In assessing test
results, it is important to remember that suspended solids in natural water can
interfere with the absorption of UV light by organisms. Clarity is measured in
nephelometric turbidity units (NTU). A turbidimeter estimates how light is scattered by suspended particulate
material in the water.
[37]
As of 1996-1997, there were several thousand
known UV installations using doses in the range of 10 to 40 mJ/cm² to treat
water. UV disinfection was more widely practised in Europe than in North
America. For example, Germany
had developed a standard by 1997 and accredited eight manufacturers
[38]
The North American market for municipal UV
systems pre-1998 was small due to the reliance upon chlorine to disinfect for
bacteria and viruses. Calgon’s research into the effectiveness of low doses of
UV was a positive factor in the development of the municipal market. Prior to
then, the bulk of Trojan’s market was in waste water treatment and UV
applications for residences and cottages.
[39]
As noted above, Waterloo suffered an outbreak of Cryptosporidiosis in
1993. Among other sources, the Regional Municipality of Waterloo takes water
from infiltration wells adjacent to the Grand River. Under current Ontario
regulations, those wells are potentially considered sources of “groundwater
under the direct influence of surface water” or GUDI wells. For wells in that
category, Waterloo uses UV as the primary disinfectant supported by residual
chlorine. It has about ten of these wells and uses UV equipment manufactured by
Calgon, Trojan and Wedeco.
[40]
UV systems for two Waterloo wells, one GUDI and one not, were
commissioned and installed in October of 1996. At that time the provincial
Ministry required extended contact time for the chlorine in the system and to
provide that would have been extraordinarily costly. With the W-10 well, a GUDI
well, Waterloo operates a Trojan 8000 UV reactor run in the 40- 60 mJ/cm²
range. It was installed for bacteria and viruses. The Region has not tested for
Crypto at that well as it would be difficult to establish whether it is present
or not.
[41]
Log “credits” are
assigned by regulatory agencies for the use of various disinfection methods. Waterloo currently receives a credit of 2.5
log for natural filtration in wells under the direct influence of surface water
(“GUDI wells) and just .5 log for UV treatment. The minimum standard it needs
to meet is 2 log. Waterloo also operates a Calgon Sentinel reactor at
its Mannheim treatment facility which takes water directly from the Grand
River. Given that the presence of Crypto in that river is well known, the
targeted log reduction from the multiple barriers employed there is in the
range of 5-7 logs. The plaintiff’s witness Dr. Stanley, of the Edmonton water
utility corporation Epcor, testified that any log reduction would be valuable
to a water producer.
The North Bay UV System
[42]
In August of 2000, Ontario introduced stricter water protection regulations
following the contamination of the drinking water system in Walkerton, Ontario. North Bay’s water at
that time received no treatment other than chlorine. Its source, Trout Lake,
was considered to be pristine apart from spring and fall inversion which
produced increased turbidity (particulates) and colliform levels. In the
aftermath of Walkerton, the Ontario Ministry of the Environment (MOE) advised
the city that its treatment process must be capable of handling a higher risk
of microbiological contamination including 99% (2 log) removal of Giardia.
Crypto was not referenced at that time, but it was expected by the city to be included
in the near future. There is no evidence that Crypto was in the lake or that it
was expected to be present. The city had never had a Crypto outbreak and they
had not tested for its presence.
[43]
North Bay retained the
services of an environmental consultant to conduct a risk assessment of its Trout Lake
water supply. That assessment indicated that Giardia was likely present in the
lake from time to time and that there was “some chance” Crypto may also be
present.
[44]
Further to the
regulatory requirements, an engineering firm CH2M Hill Canada (CH2M) was hired
to assess the available options. Four were considered:
a new membrane filtration facility; adding an ozone contact tank; adding a
chlorine contact tank; and ultraviolet irradiation. Membrane filtration was the
preferred option but, at that time, it was very expensive. Additional chlorine
would have had no effect on Crypto. Ozone was costly and complex to install and
dangerous to operate. The UV option did not then have MOE approval. However,
Trojan was prepared to install a pilot system to verify the log reduction at
its own cost and CH2M recommended the city pursue that opportunity which it did. The
testing was conducted over three months and was evaluated as successful.
[45]
North Bay officials
sought to avoid having to adopt membrane filtration because of the major
capital expenditures involved and because the lake source was normally pristine
and within provincial turbidity guidelines. However, in April 2001 the lake
experienced a significant “turbidity event” or inversion which led to a boil
water advisory by the Medical Officer of Health. The conclusion reached by city
officials as a result of that event was that they would have to seek funding
for construction of a new filtration system. They have since done that and a
new system is scheduled to come on line in 2008. They were advised that UV
disinfection would not be effective at high turbidity levels. In the interim,
city officials were under pressure to install additional protection and, on the
advice of their consultants, considered UV disinfection to be the best
temporary solution.
[46]
CH2M had a working
relationship with Trojan. Trojan provided CH2M with research, test equipment
and lab facilities. CH2M evaluated competing systems on the market for the city
including Calgon’s but recommended Trojan’s system as best overall. It was open
to the City to accept the recommendation to adopt UV irradiation through
another company’s products but clearly Trojan had the advantage of an
established presence in the field and its relationship with CH2M. Calgon was a
late arrival. It entered the market in 1996 and made its first sale of the
Sentinel system in 1999. Trojan had made UV disinfection systems for waste
water treatment and point of entry or point of use drinking water systems for
over a decade.
[47]
The City Engineer, John Simmonds, recommended to
Council that it accept CH2M’s recommendation. Given the time pressures, there
was no bidding process. City Council passed resolutions on July 9, 2001 to
install UV equipment purchased from Trojan. In a document dated July 13, 2001
Trojan undertook to indemnify North Bay against any damages or costs incurred as a result of any legal
action arising from a patent infringement claim. It appears that this was
requested by CH2M on the city’s behalf but there is no evidence that it was
made known to the city before the purchase decision was made. In September 2001
Calgon had written to inform the city that the proposed UV treatment process
was covered by its patent and that it was prepared to license use of the
technology by the city. Mr. Simmonds testimony that he learned of the
indemnity in October, 2001 following receipt of the Calgon letter is supported
by a memorandum dated at that time.
[48]
Notwithstanding notice of the ‘525 patent, North
Bay chose to proceed with the implementation of the Trojan system without
seeking a license from Calgon or paying the fee. On the assumption that the
city treats roughly 20 million gallons a day, the cost would be about $100,000
annually. In Mr. Simmonds words, they considered the patent “bonkers” and
without validity.
[49]
In June 2002 the North
Bay municipal plant began to process drinking water
with UV irradiation. The Trojan Swift system employed by North Bay uses medium pressure lamps in
continuous operation at a wavelength of 200-300 nm producing doses in the range
of 40-50 mJ/cm². The city has now undertaken construction of an entirely new
water treatment facility which will employ micro-filtration (2-3 microns), chlorination
and UV irradiation in a multi-barrier system with built in redundancies.
Background to the Patent Application
[50]
Dr. Stevens testified that he had been working
with ultraviolet light in various applications for about 30 years. At a
previous employer, Solarchem, acquired by Calgon in 1996, he had considered the
use of UV to inactivate Crypto in 1993-94 but lacked the resources to develop
the concept. Stevens stated that he and his colleagues were perplexed by the
literature which indicated that very high doses were required in the range of
many thousands of mJ/cm2 as the dosages required to inactivate bacteria
and viruses were a thousand times lower. He said they could not understand why Crypto,
another living thing with DNA, would behave differently. I take that to be an
indication of what others with similar expertise would have thought at the same
time.
[51]
Prior to acquiring Solarchem, Calgon had
undertaken a literature review of UV applications for preventing Crypto
infection. This review was conducted by a Dr. Bertrand Dussert, one of the
three named inventors of the ‘525 patent. Dr. Stevens and Dr. James Bolton of
the University of Western
Ontario are the other two named inventors. Calgon then sponsored research by a
Dr. Gerba of the University of Arizona to attempt to “bracket” the range of UV doses required to
inactivate Crypto. They were not satisfied with Dr. Gerba’s progress and in
June of 1997, assembled a number of people active in the water treatment field
to discuss research that was underway at that time. Included was Dr. Jennifer
Clancy of a Vermont based firm,
Clancy Environmental Consultants (CEC). Dr. Dussert had attended a
presentation by Dr. Clancy earlier in 1997 that discussed the use of UV
technologies for the inactivation of Crypto.
[52]
Following the June meeting, Calgon sought to
engage Clancy to train Gerba’s staff to carry out the research they wanted done.
Clancy declined but offered to develop her own protocol if they wanted the work
done by her firm. Stevens sent Clancy a request to budget a particular scope of
work (Ex. D-51). That document appears to be the research protocol for which
they had engaged Gerba as it refers to the use of Tucson and Phoenix tap water. Clancy preferred to
develop her own proposal which she sent Calgon in July, 1997.
[53]
The object of the Gerba research, as disclosed
by Ex.D-51, was to determine the dose necessary to inactivate Crypto up to 2
logs using both low and medium pressure lamps, to be measured by in vitro
excystation tests for viability. Some animal infectivity assays were to
be conducted with high pressure lamps at doses expected to kill 99% and
99.9% of the oocysts (my emphasis). It does not appear, therefore, that Stevens
and others at Calgon were at that time pursuing the idea that irradiation at
low doses would render oocysts incapable of replication. They were interested
in finding out what range of dose would “kill the little buggers”.
[54]
Dr. Clancy is a highly respected microbiologist
with long experience in the drinking water field. She had managed water quality
for a large municipal utility before opening her own firm and had been working
on Crypto in water since the late 1980’s. She also has a Masters degree in
Environmental Law.
[55]
Clancy and her team had done research in 1995
and 1996 for a U.K. firm on
Crypto inactivation with a UV device which the firm wished to market in the U.S. The research involved tests at flow
rates of 100-400 gpm and verification of inactivation by excystation and mouse
infectivity studies to meet EPA standards. This was described at trial as a
“trap and zap” system as filters were employed to capture the oocysts whereupon
they would be subjected to a dose of UV. The results of that study were published
in the November 1997 proceedings of the Water Quality Technology Conference.
[56]
Clancy had also been conducting research under
the auspices of the American Water Works Association Research Foundation (AWWARF)
on methods for detecting Crypto in water and at the effectiveness of various
disinfectants. That had led to a project, AWWARF 282, which involved research
using a pulsed UV system supplied by INNOVOTECH, a company owned by Dr. Bob LaFrenz
and also with a low pressure UV system. A subsequent project, AWWARF 395, which
began in 1997 was co-funded by the United Kingdom Drinking Water Inspectorate
and led by Dr, Clancy. The goal of AWWARF 395 was to compare animal infectivity
with in vitro surrogate tests for Crypto inactivation. This project also
involved the use of a pulsed UV system supplied by Dr. LaFrenz. Dr. Clancy gave
a presentation on this research at the June 1997 meeting with Calgon.
[57]
The proposal Dr. Clancy submitted in July 1997 led
to an agreement with Calgon in September 1997 to test the inactivation of Crypto
oocysts with UV light over a broad range of doses from 100 to 10,000 mJ/cm². Under
that agreement, CEC was to conduct in vitro excystation and vital dyes assays.
Mouse infectivity studies were to be used to verify the results of the in vitro
surrogates to satisfy EPA requirements. That part of that work was to be done by
Dr. Marilyn Marshall of the University of Arizona who was also involved with the AWWARF research. Dr.
Marshall was also under contract to Calgon.
[58]
Clancy and her team knew from their 1995-96
project that doses in the range of 4000 to 8000 mJs/cm² would inactivate Crypto
oocysts to a greater than 4 log level but they did not know what the lower
limits were. The object of the study plan developed for Calgon was to prepare a
response curve showing the lowest doses required to be effective for 1 to 3 log
reduction. The results were to be determined by in vitro assays and some would
be verified by mouse infectivity studies.
[59]
As part of AWWARF 395, in September 1997 doses
of 14, 40, 80 and 120 mJ/cm² were administered to viable oocysts with Dr.
LaFrenz’ pulsed UV system and the results were subjected to in vitro assays by
CEC and to mouse infectivity tests by Dr. Marshall. As recorded in a fax from
Dr. LaFrenz dated November 5, 1997 (Ex.D-55), none of the mice given the doses
of UV irradiation at 14 and 40 mJ/cm² were infected while the control group
given untreated oocysts were infected as expected. In my opinion, this was the
source of the discovery that low levels of UV radiation could prevent Crypto
replication and infection.
[60]
Dr. LaFrenz disclosed these results in a paper
(Ex. D-56) presented at the Water Quality Technology Conference
("WQTC") held from November 9-12, 1997 along with similar results he
had obtained in parallel research funded by the Electric Power Research
Institute (EPRI) which dealt with the irradiation of flowing water. While the
LaFrenz work was conducted with pulsed UV, the evidence is that a dose of UV
light is the same whether the energy is delivered in pulses or continuously
over time. Dosage is a factor of intensity and time. Dr. Stevens agreed with
this on cross examination.
[61]
Upon learning of these mouse infectivity results
from Dr. Marshall, Dr. Clancy concluded that the in vitro surrogates and mouse
infectivity were measuring different things: the in vitro surrogates were
measuring cell activity, not infection, and could not therefore correlate with
mouse infectivity.
[62]
Dr. Clancy disclosed the AWWARF 395 results to
Drs. Bolton, Stevens and Dussert by letter dated December 10, 1997 (Ex. D-1).
The purpose of the letter was to report on the in vitro studies conducted for
Calgon but Dr. Clancy went on to advise them of her conclusions about the lack
of correlation between the in vitro surrogates and mouse infectivity drawn from
the AWWARF 395 results. She described how at UV doses of 14 and 40 mJ/cm² the
in vitro surrogates demonstrated only a 50% reduction in viability while the
mouse data showed no infection. At that stage, the Calgon mouse infectivity
data was not yet in. This was AWWARF data. In an accompanying draft report (Ex.D-58),
Dr. Clancy indicated that the difference between the in vitro and the in vivo
results was not a new phenomenon as it occurs in bacteria. The organism appears
alive when looked at in the surrogate tests but is not infective because it
cannot divide.
[63]
A reasonable inference is that it was this correspondence
that taught Drs. Stevens, Bolton and Dussert that “you don’t have to kill the little buggers”, you
just have to render them non-infectious by altering their DNA. Apart from Dr.
Stevens’ testimony, there is no evidence that they had the idea that this could
be done previously.
[64]
As of December 10, 1997 CEC’s Tom Hargy had
performed UV exposures of Crypto oocysts for Calgon but the results of the
mouse studies had not yet been obtained. This work was done in a petri dish using
low and medium pressure lamps and a collimated beam apparatus supplied by the
company. Hargy was trained by Dr. Jim Bolton in the use of the apparatus. Filters
were used to diminish the radiance of the medium pressure lamp as the light
would otherwise have been too intense. The low pressure doses administered ranged
from 125 to 750 mJ/cm² and the medium from 150 to 1000 mJ/cm². Bolton subsequently
recalculated the doses downward. The in vitro assay results from those doses were
not consistent with the AWWARF 395 mouse infectivity results.
[65]
Dr. Marshall provided the mouse study data from
the Calgon exposures to Dr. Clancy's team in a report dated January 26, 1998
(Ex. D-59). The samples sent to Marshall had been exposed to UV irradiation at doses of 300, 600 and 1000
mJ/cm². At those doses, no infection occurred in the treated mice but neither
was there much infection in the control sample. The tests had to be repeated
with a different oocyst isolate to achieve more consistent results. Marshall
reported again on March 10, 1998 that the results from bench doses of 100, 200,
300 and 600 mJ/cm² were that no mice were infected, except for one anomaly in
the 300 exposure group, while the expected proportion in the control group were
infected. This translates into at least a 4 log reduction given the number of
oocysts injected per mouse. If more had been used, the log reduction would have
been higher.
[66]
To satisfy the verification requirements of the
US Environmental Protection Agency which would determine whether Calgon
received any log credits for its UV equipment, Calgon undertook a pilot challenge
study at the Mannheim water
treatment plant in Waterloo,
Ontario in February-March of 1998. This was done by injecting oocysts into
water which flowed from the plant through a Calgon Rayox UV reactor. Filters
collected the post-treatment oocysts which were then assayed either in vitro or
in vivo. CEC’s Hargy also did the oocyst exposures for this pilot.
[67]
In an e-mail dated March 9, 1998 from Dr. Bolton
to a number of people including Mr. Hargy, Bolton discusses the data from the field tests. He stated:
We now have
preliminary data on the lab mouse infectivity experiments. Amazingly, even at
the lowest UV dose applied (100 mWs/cm2) no mice got sick!!! This means that
the doses we had planned for the field trip were too high…
[68]
Mr. Hargy’s evidence, supported by the
documentary evidence, was that the field trials were conducted with doses of
100 to 300 mJ/cm². Bolton recalculated the lowest dose amounts down to
approximately 19 mJ/cm². That resulted in a EPA verification statement that
3.9 logs of Crypto inactivation can be obtained with 20 mJ/cm. Hargy’s
uncontradicted evidence is that the lowest dose that can be directly attributed
to the bench tests at the CEC lab or to the pilot tests at Waterloo was 50
mJ/cm². It is this data that was submitted as part of the patent specification
in support of the claims.
[69]
It appears that Bolton recalculated the dosages administered in the bench and pilot tests several
times before the patent claim date for two reasons. First, he had miscalculated
correction factors for the filters employed in the bench tests. Secondly, the
effect of light absorption in the water used in the pilot tests had not been
taken into account. The mathematical model employed by Dr. Bolton to arrive at
the claimed doses was not put into evidence by the plaintiff. Defendant’s
expert, Dr. Linden testified that a skilled person would not be able to
determine how the dose was calculated from the specification. It also appears
that there was no verification of the actual doses administered at the Mannheim plant.
[70]
I find from the evidence that exposures
confirming the efficacy of a dose as low as 10 mJ/cm², as claimed in the
patent, were not performed until after the May 13, 1998 claim date. I arrive at
this conclusion from the testimony of Dr. Clancy and Mr. Hargy and the
supporting pre-May 13, 1998 documentation. A report by Dr. Bolton dated April
6, 1999 and marked for identification as Ex. D-65 was not properly identified
by a witness at trial and was, therefore, inadmissible.
[71]
In my view, the tests conducted for Calgon merely
confirmed what had already been discovered through the AWWARF and EPRI research
with LaFrenz’ pulsed UV system. Low UV doses inactivated Crypto and that could
only be verified with mouse infectivity studies as the in vitro surrogates did
not correlate.
[72]
Bolton and Stevens sought to have Clancy and her
associate, Dr. Bukhari, listed as inventors on Calgon’s patent application
submitted in May, 1998 in the U.S.. They declined. Dr. Clancy gave two reasons in her testimony. She
did not want to be seen as aligned with one of the several firms employing UV
technology and secondly, she did not believe that the research had disclosed a
patentable invention. She conveyed only the first reason to Calgon at the time
and cooperated to some extent in the preparation of the patent application.
[73]
Dr. Clancy candidly acknowledged that she was
extremely upset when she learned that Calgon was asking for a licensing fee for
using UV to treat drinking water as in her view, “UV was not a new technology. It
had been used for treating drinking water for decades, since the turn of the
previous century.” Subsequent to the issuance of the patent, both Dr. Clancy and
Mr. Hargy participated in discussions within the industry to find a way to neutralize
its effects. Several strategies were considered, including litigation and attempts
to persuade Calgon to put it in the public domain or to agree not to enforce
it. Dr. Clancy went so far as to seek informal legal advice as to whether she
could, at that stage, claim inventorship. This does not appear to have affected
Clancy or Hargy’s relationship with Calgon as CEC has continued to do work for
the company until recently.
[74]
While it is clear that they were adverse in
interest to Calgon, I did not find that Dr. Clancy’s or Mr. Hargy’s testimony
on the facts was any less credible as a consequence of their views about the
patent. To the contrary, they were straightforward, clear and precise witnesses.
[75]
It is clear from the considerable amount of
evidence tendered by both sides on this subject, that Calgon’s decision to
exploit proprietary rights to the technology did not sit well with many in the
water treatment field. Some felt that it should be made available at no cost in
the interests of public health, particularly as much of the underlying research
was funded by public bodies. There were also concerns that Calgon officials had
participated in discussions about regulatory changes respecting the use of UV
disinfection without disclosing their commercial strategy. In short, Calgon
seems to have made a great many people angry over this patent. All this is
irrelevant however if the patent is valid. Calgon would then be entitled to the
full enjoyment of the monopoly granted by the patent including the right to
license the use of the technology.
ISSUES
[76]
On the consent of the parties, the issues to be
determined at trial were fixed by the case management judge as follows:
1. Infringement by North Bay and inducement or procuring of infringement
by Trojan in respect of the North Bay installation;
2. Validity of the patent;
3. The plaintiff’s entitlement to make an election between its damages
and an accounting of the defendants’ profits;
4. The plaintiff’s entitlement to injunctive relief and delivery up;
and
5. The plaintiff’s entitlement to punitive or exemplary damages.
[77]
During the course of the trial and in closing
argument, North Bay did not
seriously contest that if the ‘525
patent is found to be valid, infringement by the City would be established.
[78]
If the patent is valid and infringement is
found, North Bay acknowledges
that the plaintiff is entitled to damages but disputes that an accounting of
profits is appropriate in the circumstances. Trojan contests any finding of
inducement or procuring.
[79]
With regard to validity, while obviousness was
pleaded the defendants advised during the trial that they were no longer
relying upon that allegation. The defendants also advanced a number of other
challenges to the patent including inventorship, overbreadth, sufficiency of
the specification and ambiguity.
[80]
This case turns on anticipation. That is the
issue I propose to address in some detail. In the event that I may be found to
have erred in my findings on validity, I will also indicate the findings I
would have otherwise made on infringement and remedies.
CLAIM
CONSTRUCTION
[81]
The first task of the Court,
before considering whether or not a patent is valid or infringed, is to
construe the patent. Claim construction is a matter of law and the claim
language must be read in an informed and purposive way. The key to purposive
construction is the identification by the Court, with the assistance of the
skilled reader, of the particular words or phrases in the claims that describe
what the inventor considered to be the “essential” elements of the invention: Whirlpool Corp. v. Camco Inc., [2000] 2 S.C.R. 1067, 2000 SCC 67 at
para. 45 (Whirlpool); Free
World Trust v. Électro Santé Inc.,
[2000] 2 S.C.R. 1024, 2000 SCC 66 (Free World Trust).
[82]
Patent
specifications are not addressed to specialists or the public generally; they
are addressed to skilled individuals sufficiently versed in the art to which
the patent relates to enable
them on a technical level to appreciate the nature and description of the
invention: Whirlpool, above at para. 53.
[83]
The words chosen by the patentee
are read in the sense the inventor is presumed to have intended, and in a way
that is sympathetic to accomplish the inventor’s purpose expressed or implicit
in the text of the claims. In addition, the involvement in claims construction
of the skilled addressee holds out to the patentee the comfort that the claims
will be read in light of the knowledge provided to the court by expert evidence
on the technical meaning of the terms and concepts used in the claims: Free
World Trust, above at para. 51.
[84]
Expert evidence is admissible at trial to determine what the
common knowledge was at the time of the patent. Expert evidence may also be
presented as to the meaning of words used in the claims: Airseal
Controls Inc. v. M & I Heat Transfer Products Ltd. (1997), 77 C.P.R.
(3d) 126 at 127 (F.C.A.). The role of the expert is not to interpret the
patent claims but to put the trial judge in the position of being able to do so
in a knowledgeable way: Whirlpool at para. 57; Unilever PLC v. Procter & Gamble Inc. (1995),
61 C.P.R. (3d) 499 at 506-07 (F.C.A.). Claims must also be read in context. The
question is therefore what, at the date the patent was issued, a person skilled
in the art at issue would have understood from a reading of the claims,
together with any definitional assistance from the rest of the specification: Whirlpool,
above at para. 54.
The ‘525 Patent:
[85]
The field of the invention is
described as follows:
The present invention relates to
a method for preventing the replication of Cryptosporidium Parvum in water and
in particular to a method for the prevention of cryptosporidium oocyst and
similar organism infections in water using low levels of ultraviolet light.
[86]
I note in passing that the method
disclosed does not prevent replication of Crypto or infections in water
but this description should be understood as referring to replication and
infection after ingestion of the water by a suitable host. The background
indicates that the prior art generally recognized that it is necessary to kill
or inactivate Crypto oocysts so that they don’t infect and reference is made to
several patents and publications which disclosed methods for “killing” the
oocysts using high doses in excess of 3000 mJ/cm². As I will discuss further
below with respect to the sufficiency of the specification, this discussion was
neither accurate nor complete.
[87]
The advantages of the invention
are said in the summary of the invention to be significantly lower power levels
needed to achieve the desired results and substantial increases in the cost
effectiveness of UV. The preferred embodiment was described in terms of the
pilot test challenges carried out at Mannheim on a 111 litre (29.4 gal) UV reactor
containing 6 one kilowatt
Rayox medium pressure UV lamps mounted horizontally
across a tower. The organisms were introduced upstream and collected on 1
micron filters after the reactor. Flow rate during the test was about 215
gallons per minute. The description of how the doses were calculated is as
follows.
The UV doses were calculated from
the average irradiance (determined from a sophisticated mathematical model of
the reactor) times the residence time in the reactor (about 8.3s). The dose was
varied by turning one or two lamps on and at low or high power.
[88]
No explanation is provided for
the meaning of the “sophisticated mathematical model”. A description of the in
vitro assays conducted is followed by tables outlining the viability factors
for those tests and the log reductions achieved by the mouse infectivity tests
for doses in the range of 20 - 167 mJ/cm². Figure 1 is a chart of log reduction
levels achieved for doses from approximately 10 to approximately 170 mJ/cm² as
measured by in vitro assays and mouse infectivity studies. Figure 2 does
the same for viability as measured by pilot and bench in vitro assays. As
noted above, there appears to have been no verification of the actual doses
administered and the evidence does not establish that the bench or pilot bio
assays produced results for doses as low as 10 mJ/cm² prior to the claim date.
[89]
For convenience, I will
reproduce the claims again with the construction issues highlighted:
1. A method for the prevention of Cryptosporidium oocysts comprising
irradiating water with a continuous broad band of ultraviolet light in
doses of from about 10 mJ/cm2 to about 175 mJ/cm2.
2. A method as set forth in claim 1 wherein
said broad band is a frequency of 200 to 300 nm using a UV lamp.
3. A method as set forth in claim 1 or 2
wherein said dose is from about 20 mJ/cm2 to about 30 mJ/cm2.
4. A method as set forth in claim 1 wherein
said broad band is a frequency of 200 to 300 nm using a medium
pressure UV light.
[Emphasis added to highlight the
construction issues]
[90]
To assist the Court in construing
the claims, the plaintiff tendered the opinion evidence of Dr. Christian Chauret, Associate Professor of Microbiology at Indiana University, Kokomo and Mr.
Joseph Dinkel, Assistant Executive Director and Plant Manager for the West View
Water Authority in Pittsburgh, Pennsylvania.
[91]
Dr. Chauret’s qualifications as an
expert in environmental matters related to water treatment were not disputed. While
he has had no direct experience in the design and engineering of apparatus for
UV disinfection he has conducted extensive research into water born
contaminants including Crypto, has published on that subject and on UV
disinfection and has been retained as a consultant on water treatment
projects. Dr. Chauret was most helpful to the Court in explaining the nature
of Crypto and the effects of UV water treatment on the protozoa, as summarized
in the background above.
[92]
The defendants relied on the
opinion evidence of Dr. Karl Linden, Associate Professor of Civil and
Environmental Engineering at Duke University. Dr.
Linden’s PhD dissertation was in UV disinfection. He teaches a course in that
field, is a founding member of the International Ultraviolet Association
(“IUVA”), has published extensively in the field, advises the U.S.
Environmental Protection Agency on its UV Disinfection Guidance Manual and is
regularly consulted by water treatment operations in the US and abroad,
including in Canada.
[93]
Dr. Linden’s qualifications to
provide expert opinion evidence were unquestioned. However,
it was put to Dr. Linden that he had had discussions
with Dr. Clancy and Mr. Hargy to “work towards attacking or invalidating the
plaintiff “. He denied that but acknowledged that the question had come up at
meetings of IUVA. The organization decided to take no position on the issue
until the facts of the case had been settled. Dr. Linden stated that he was not
offended by the patent but concerned that as it read, it would be very
difficult for water utilities to determine whether they would infringe it if
they employed UV. I was satisfied that Dr. Linden did not lack objectivity in
giving his testimony and I found his opinion evidence to be particularly clear
and helpful.
[94]
Dr. Chauret described the “person
skilled in the art” of potable water treatment to whom the patent is notionally
addressed as being the holder of a Master’s degree in
civil or environmental engineering, microbiology or chemistry, and having an
understanding of water treatment systems or at least a Bachelor’s degree in
those fields and several years of practical experience in water treatment. Dr.
Linden’s evidence was that he expected that such a person would have received formal
university education but he would also require practical experience in water treatment
by UV processes.
[95]
Mr. Dinkel was tendered as an
expert in the operation of water treatment systems and was described by
plaintiff’s counsel as the prototypical person skilled in the art based on his
long experience in the field, initially as an enlisted man trained by the U.S.
Army and latterly with public water utilities. Mr. Dinkel lacks formal
education in any of the fields described by the two professors – he has a
degree in Industrial Management - but otherwise fits the profile of the “competent, skilled workman”. Mr.
Dinkel’s knowledge and understanding at the relevant time was effectively
challenged on cross-examination by the defense. For example, he had no
knowledge or experience of UV systems prior to November 1999 and then gained
much of his knowledge through personal research on the Internet. With some
reservations, Mr. Dinkel was accepted as qualified to provide opinion evidence.
[96]
Having heard his evidence, I doubt
that Mr. Dinkel understood that as an expert he was expected to be entirely
objective. It appears that Mr. Dinkel was instrumental in persuading his board of
directors to choose a Calgon UV reactor for his plant. Calgon waived the
license fee for that installation because Mr. Dinkel, as part of the deal, agreed
to provide tours to prospective Calgon customers. The manner in which Mr. Dinkel
testified did not inspire confidence either. He appeared to seek reassurance on
cross-examination by looking to Plaintiff’s counsel after each answer and his
grasp of the science involved was shaky. If the Court erred in admitting his
expert opinion evidence, the result I think was more helpful to the defendants
than to the plaintiff. His evidence was more consistent with that of Dr. Linden
than that of Dr. Chauret.
[97]
I am not persuaded that
the ordinary person skilled in the art in the context of this case would be a
person without the formal education required to understand the science
underlying the disinfectant effects of UV radiation. I find that such a person
would require at least a basic university degree in engineering, biology or
chemistry and an understanding of UV technology as well as several years
experience with drinking water treatment systems.
[98]
Approaching the
construction of the claims with a mind willing to understand and to give effect
to the specifications, I note first that the claims do not contain any limitation
that the water irradiated must be flowing. That could be inferred from the
description of the preferred embodiment which describes the manner in which the
pilot tests were carried out and appears to be a practical application of the
invention but as I read the claims, it is not an essential element. The method
could be practised with water in a static container.
[99]
There is no indication
that dose is to be determined by the average irradiance and the resident time
of the water in the UV reactor. However, that would be understood by the
ordinary person skilled in the art applying the equation: intensity x time.
[100]
There is no dispute between the parties that
the patent is directed at potable water and not waste water treatment. It is also
common ground that the word "frequency" was likely used in error and
should be read as "wavelength". Claim 3 narrows the range of dose
claimed and, in any event, does not apply to the North Bay system as the dose
of ultraviolet light used there is in the range of 40 to 50 mJ/cm2.
[101]
Claim 4 adds the
limitation that the UV lamp of the prior claims is limited to a medium pressure
lamp. Dr. Chauret acknowledged on cross-examination that in claims 1, 2 and 3
you could use either a low pressure or a medium pressure lamp for the UV
source, both were known in the prior art and use of a medium pressure lamp was
not inventive. What was inventive, in his view, was the use of a low dose.
While the preferred embodiment refers to the medium pressure lamp used in the
pilot tests, there is no indication that that is the only way in which they
could have been conducted. I conclude that the reference to a medium pressure
lamp is not an essential element of the claims.
[102]
There was some variation in the expert evidence on the meaning to
be given to the phrase "a method for the prevention of Cryptosporidium
oocysts" and the parties differ as to the meaning of the word
"continuous".
“A method for the prevention of Cryptosporidium
oocysts”
[103]
I note that this phrase does not expressly refer
to the prevention of Cryptosporidiosis but rather to prevention of the oocysts
themselves. However, each of the experts construed it in reference to infection.
In his report, Dr. Charest stated that this phrase indicates
that the purpose of the method is to prevent infection which is achieved by
rendering the oocysts incapable of reproduction. In his view, the method claimed by the patent was only complete when
irradiated protozoa had been ingested and failed to replicate in the intestines
by reason of their DNA having been cross-linked. On cross-examination Dr.
Chauret agreed with the suggestion that the mechanism that renders Crypto
non-infectious occurs when the Crypto passes through a curtain of UV light
outside the host. That is also the plaintiff’s position - the method is
complete when oocysts are irradiated and DNA cross-linking occurs.
[104]
Dr. Linden’s evidence was that a person skilled
in the art would understand the phrase to mean a method that stops Crypto in
the oocyst life-cycle stage from replicating, thereby eliminating the
potential for parasitic infection resulting from the ingestion of water
containing Crypto oocysts. For Mr. Dinkel the meaning was that of a
method of preventing the oocysts from infecting humans or animals. These
constructions are, in my view, consistent.
[105] Dr.Chauret
stated on cross-examination that the method is being practised if Crypto could be expected to
be in the water even where the use of UV disinfection in the prescribed doses is
being used to deal with another infectious agent such as bacteria or viruses. The
method is being practised in
a stand-by mode awaiting the possible arrival of Crypto oocysts if it is being
used to irradiate water for any purpose. On further cross-examination, Dr.
Chauret agreed with the suggestion that Crypto must be present in the
irradiated water in order for the claimed method to be practised.
[106]
Mr. Dinkel took a different view on cross-examination.
On his reading of the claims, Crypto did not have to be in the water or
expected to be in the water to practice the claimed method so long as UV
irradiation was used in the prescribed doses. That is consistent with Dr.
Linden’s evidence. In Dr. Linden’s opinion, the claims do not indicate the
presence or the expectation of the presence of Crypto in the water. Whether it
appears once a day, once a year or never, the method is being practised as the
barrier is there. That appears to me to be the correct construction.
[107]
No minimum level of log
reduction is provided for the range of doses claimed. The patent specification
indicates what results were achieved by the bench and pilot tests performed but
does not disclose that the practical effectiveness of the invention correlates
to a particular log reduction level. I can’t see how the test results serve as
a limitation on the scope of the claims, as the plaintiff suggests. The experts
all appear to agree that any level of log reduction will prevent replication of
Crypto oocysts and infection. Factors such as the clarity of the water and the concentration
of oocysts will affect this. In some cases, less than 1 log will be effective.
In others, more than 5 log reduction may not be enough to prevent infection if
sufficient oocysts escape irradiation.
“A continuous broad band of ultraviolet
light”
[108]
In Dr. Chauret’s
opinion, the term “continuous” would be understood to mean a lamp which is
turned on constantly during the relevant time period as distinct from a pulsed
lamp that would emit high doses intermittently. The
term “broad band of ultraviolet light” means emissions of multiple wavelengths
within a defined range of wavelengths. Claims 2 and 4 define that range as 200
to 300 nm. As noted above, the unit of measurement used is in wavelength not
frequency and the parties agree that the use of the latter term in the claims
was in error.
[109]
Dr. Linden’s evidence
was that the term “continuous” in this context was ambiguous and could be
understood by the person skilled in the art as meaning either continuous in
time or continuous in spectrum. The latter interpretation could include both
low and medium pressure non-pulsed lamps and pulsed lamps. When pressed in
cross-examination as to how that was consistent with the patent specification,
he noted that the disclosure included a pulsed UV system and the only use of the
term ‘continuous’ was as part of the phrase “a continuous ultraviolet
spectrum”. However, that was in reference to a medium pressure lamp which emits
UV continuously in time. The pulsed system disclosed was based on a high
intensity lamp. I agree with the plaintiff and Dr. Chauret that the
specification makes it clear that the reference in the claims to a continuous
broad band of ultraviolet light means continuous in time and not pulsed.
Conclusion on Construction:
[110]
The essential elements
of the ‘525 patent in my opinion are:
- the irradiation of drinking water,
- with continuous in time ultraviolet
light,
- in wavelengths of 200 to 300 nm,
- generating doses in the range of 10
mJ/cm² to 175 mJ/cm,
- to prevent infection by Cryptosporidium oocysts.
VALIDITY
[111]
An issued subsisting Canadian patent is presumed to be valid
during its full term of 20 years from the date of filing, pursuant to section
43(2) of the Patent Act, R.S.C. 1985, c. P- 4.
[112]
The statutory presumption imposes an onus on the party attacking
the patent to prove invalidity. The party attacking a patent must prove its
invalidity on a balance of probabilities, failing which, the presumption
prevails: Diversified Products Corp. v. Tye-Sil
Corp. (1991), 35 C.P.R. (3d) 350 (F.C.A.) (Diversified Products); Bayer
Inc. v. Canada (Minister of National Health and Welfare) (2000), 6 C.P.R. (4th) 285, [2000] F.C.J. No. 464
(C.A.) (QL); Almecon Industries Ltd.. v.
Anchortek Ltd., 2001 FCT 1404, [2001] F.C.J. No. 1956 aff’d 2003 FCA 168, [2003]
F.C.J. No. 536 (QL).
[113] An “invention”, as defined by s.2 of the
Act, means any “new and useful
art, process, machine, manufacture or composition of matter, or any new and
useful improvement in any art, process, machine, manufacture or composition of
matter”. For a patent to be valid,
the claimed invention must be new, useful and inventive: Apotex Inc. v.
Syntex Pharmaceuticals International Ltd., [1999] F.C.J. No. 548 at para.
62 (T.D.)(Q.L.)(Apotex). As noted by the Supreme Court, as a general
rule, if the patent holder obtains a monopoly for something which does not
fulfill the statutory requirements of novelty, ingenuity and utility, then the
public is short-changed: Bristol-Myers Squibb Co. v. Canada
(Attorney General), [2005]
1 S.C.R. 533, 2005 SCC 26 at para.1. The question of whether a patent claim is
novel, is often addressed by the courts in terms of its antithesis, wherein it
is asked whether the claimed invention was "anticipated".
Anticipation
[114]
To determine whether a
patent claim is “new” is to consider whether it has been anticipated, that is
whether it was already known to the public and thus cannot be the subject of a
monopoly. Section 28.2 of the Act requires that the subject matter of a claim
must not have been disclosed prior to the claim date
in such a manner that it became available to the public in Canada or elsewhere. The
claim date is the filing date of the patent application. In this case,
it is the date of the filing of the U.S. application on May 13, 1998.
[115]
Prior disclosure of the claimed invention can be in the form of a
prior publication, oral disclosure, sale, or use, provided the invention is
made available to the public. This
case raises issues of anticipation by disclosure through publication and use. The
test for anticipation by publication was described by Hugessen J.A., as he then was, in Beloit Canada Ltd. v. Valmet Oy (1986), 8 C.P.R. (3d) 289, at 294 (Beloit):
One must, in
effect, be able to look at a prior, single publication and find in it all the
information which, for practical purposes, is needed to produce the claimed
invention without the exercise of any inventive skill. The prior publication
must contain so clear a direction that a skilled person reading and following
it would in every case and without possibility of error be led to the claimed
invention. Where, as here, the invention consists of a combination of several
known elements, any publication which does not teach the combination of all the
elements claimed cannot possibly be anticipatory.
[116]
This was echoed in Free World Trust, above, by Binnie J.
who explained, at para. 25, that anticipation by publication is a difficult
test to meet because, after an invention has been disclosed, it is all too easy
to find its antecedents in bits and pieces of earlier learning. Evidence of
prior use should also be given close scrutiny when viewed retrospectively: Diversified
Products above at 363.
[117]
For a prior public use to anticipate an invention, it must amount
to enabling disclosure, that is, the disclosure has to be such as to enable the
public to make or obtain the invention: Baker Petrolite Corp. v. Canwell
Enviro-Industries Ltd. (2002), 17 C.P.R. (4th) 478, 2002 FCA 158 at para.
42, (Baker Petrolite) drawing upon
Merrell Dow Pharmaceuticals v. H.N. Norton & Co., [1996] R.P.C. 76
(H.L.) (Merrell Dow).
[118]
For the purpose of analysing anticipation in the context of disclosure by prior sale or use, the
principles addressed in Beloit and Free
World Trust, above in relation to anticipation by prior publication,
may need to be "tailored to fit the particular circumstances": Baker
Petrolite at para. 35. At paragraph 35 of Baker Petrolite, Justice
Rothstein notes by way of example that anticipation by publication involves the
skilled person reading the prior art. With anticipation by sale or use, reading
may not be relevant.
[119] In Merrell Dow, Lord Hoffman
referred to what he described as a gap between the tests for anticipation and
infringement arising from implementation of the European Patent Convention
through the UK Patent Act 1977. He concluded that the 1977
statute introduced a substantial qualification into the old principle that a
patent cannot be used to stop someone doing what he has done before. This principle
has frequently been expressed as “what amounts to infringement, if posterior,
should, as a general rule, amount to anticipation, if anterior”: Lightning
Fastener Co. v. Colonial Fastener Co. [1933] S.C.R. 377 at 381 (Lightning
Fastener). Lord Hoffman concluded that this is no longer the case, hence
the gap, subject to section 64 of the 1977 Act (which is similar to section 56
of the Canadian Patent Act) which provides to some extent for situations
where a person was, before the priority date, doing an act which would have
been an infringement if the patent was in force.
[120] Section
2 of the 1977 U.K. Act provides that an invention shall be taken to be new if
it does not form part of the state of the art. The state of the art is “all
matter (whether a product, a process, information about either, or anything
else) which has at any time before the priority date of that invention been
made available to the public … by written or oral description, by use or in any
other way”. This is similar to the test in s. 28.2 of the Canadian Act. The
gap described by Lord Hoffman appears to have been imported into Canadian law.
[121] Applying
these definitions, Lord Hoffman observed that making available to the public
requires the communication of information and that the use of a product makes
the invention part of the state of the art only so far as that use makes
available the necessary information. Acts done secretly or without knowledge of
the relevant facts, which would amount to infringement after the grant of the
patent, will not count as anticipation. The
question to be decided is what has been 'made available' to the public: the
question is not what may have been 'inherent' in what has previously been used.
The intuitive response to that question would be wrong: Merrell Dow at
pp.86-87.
[122] Lord
Hoffman more recently described enabling disclosure as being “concerned with
teaching the public how the invention works, not with devising the invention in
the first place…the question is no longer what the skilled person would think
the disclosure meant but whether he would be able to work the invention which
the court has held it to disclose: Synthon BV v. Smithkline
Beecham plc, [2005] UKHL 59 at para. 28 & 32, [2006]
R.P.C.10 (Synthon).
[123] Disclosure
means that the matter relied upon as prior art must disclose subject matter
which if performed would necessarily result in an infringement of the patent.
It is not necessary that such disclosure be apparent to anyone at the time.
Enabling means that the ordinary skilled person would have been able to perform
the invention which satisfies the requirement of disclosure: Synthon, at
para.26. The invention that must be enabled is the one disclosed by the prior
art. As stated by Lord Hoffman at paragraph 33 of Synthon:
It makes no sense to inquire as to whether the prior
disclosure enables the skilled person to perform the patented invention, since
ex hypothesi in such a case the skilled person will not even realise that he is doing so.
[124]
In Baker Petrolite, Justice Rothstein noted that in Canada
amendments made effective on October 1, 1989, and continued in the 1996 Patent
Act eliminated use or sale of the invention per se as sufficient evidence
of anticipation. The test for anticipation by any means became disclosure of
"the subject matter defined by a patent claim"…”in such a manner that
the subject matter became available to the public in Canada or elsewhere".
[125]
Justice Rothstein’s analysis in Baker Petrolite has not,
in my view, been altered by the recent decision of the Federal Court of Appeal
in Abbott Laboratories v. Canada (Minister of Health), 2006 FCA 187 (Abbott
Laboratories), drawn to my attention by counsel for the defendants
following the trial. In Abbott Laboratories, which concerned proceedings
under the Patented Medecines (Notice of Compliance Regulations), SOR/93-133,
the Court of Appeal found that a product claim was anticipated by
a prior reference. In the course of her reasons for the Court, Justice Sharlow
noted that the use of the term inherent in the notice of allegation was
synonymous with anticipation and cited Rinfret J.’s adage from Lightning
Fastener, above, that what would infringe if later, anticipates if earlier.
She further quoted from Lord Hoffman’s opinion in Synthon, above, at
paragraph 22:
[...] the matter relied upon as prior art must
disclose subject-matter which, if performed, would necessarily result in an
infringement of the patent. That may be because the prior art discloses the
same invention. In that case there will be no question that performance of the
earlier invention would infringe and usually it will be apparent to someone who
is aware of both the prior art and the patent that it will do so. But patent
infringement does not require that one should be aware that one is infringing:
"whether or not a person is working [an] ... invention is an objective
fact independent of what he knows or thinks about what he is doing": Merrell
Dow Pharmaceuticals Inc v N.H. Norton & Co. Ltd. [1996] R.P.C. 76, 90. It
follows that, whether or not it would be apparent to anyone at the time,
whenever subject-matter described in the prior disclosure is capable of being
performed and is such that, if performed, it must result in the patent being
infringed, the disclosure condition is satisfied. The flag has been planted,
even though the author or maker of the prior art was not aware that he was
doing so. [Emphasis added here - not by the Court of Appeal]
[126] In
my view, Synthon and Abbott Laboratories reinforce the conclusion
reached in Merrell Dow and Baker Petrolite that use alone is
insufficient to qualify as anticipation. Enabling disclosure is required. It is
not however necessary for the defendants to demonstrate that anyone was aware
of the implications of the disclosure at the time to establish anticipation.
[127] Following
the trial, counsel for the defendants also brought to my attention the decision
of the United States District Court for the District of New Jersey in Wedeco
UV Technologies, Inc. v. Calgon Carbon Corporation, 2006 U.S. Dist. LEXIS 48657 (Wedeco). This was a decision on three
motions for summary judgment concerning the validity of U.S. ‘803
patent, the claims of which are equivalent to the ‘525 patent at issue in these
proceedings, and a related patent for the inactivation of Giardia in drinking
water (the ‘893 patent).
[128] At issue in Wedeco was whether use
of the prior art, a UV disinfection process, was patentably new when applied to
the inactivation of Crypto and Giardia. U.S.C.
§ 102 precludes patents for inventions that had been in use in the U.S. more than
a year prior to the claim date. The evidence was that UV light had been in use
in the U.S. to disinfect drinking water since 1916. Calgon’s experts conceded that
if UV treatment within the scope of the claims was being employed to deal with
bacteria, Crypto was also inactivated. Judge Greenaway found that the patent was
invalid as anticipated by the publication of a 1993 scientific paper by Ransome
and others, and by public use at Fort
Benton, Montana, both of which will be discussed further below.
[129] As described in Wedeco, under U.S. law anticipation may
be express or inherent. A prior art reference may anticipate without disclosing
a feature of the claimed invention if that missing characteristic is necessarily
present in the single anticipating reference: SmithKline Beecham Corp. v.
Apotex Corp., 403 F.3d 1331 at 1343 (Fed. Cir. 2005) (SmithKline).
Alternatively, “[a] reference includes an inherent characteristic if that characteristic
is the 'natural result' flowing from the reference's explicitly explicated
limitations”: Eli Lilly & Co. v. Barr Labs., 251 F.3d 955 at 970
(Fed. Cir. 2001). It appears that reduction to actual practice is not required
so long as the requirement for disclosure is satisfied: Wedeco, above at
16 citing SmithKline, above at 1344.
[130] The U.S. Federal Circuit Court of Appeal has held that the
inherent anticipation principle applies to method or process patents:
"[n]ewly discovered results of known
processes directed to the same purpose are not patentable because such results
are inherent."… Wedeco, above at 25 citing Bristol-Myers
Squibb Co. v. Ben Venue Labs., Inc., 246 F.3d 1368 at 1374 (Fed. Cir. 2001).
[131] Counsel for the plaintiff submitted by correspondence that
I should disregard Judge Greenaway’s decision as being of “no assistance” for
several reasons: it is not a final judgment and is currently under appeal; it
is limited to the context of a summary judgment motion; it was based on an incomplete
evidentiary record which was not the same record before this Court; and, it is
premised on legal reasoning that has no application in Canada, notably with
respect to claim construction and anticipation.
[132] There are significant differences between U.S. and Canadian
patent law and procedure which make it dangerous to rely upon the U.S. authorities. I note,
for example, that the court in Wedeco relied in part upon the U.S.
prosecution history (“file wrapper” evidence) which is, generally, not the
practice in Canada: Free World Trust, above at para.66. Moreover, the “gap” described by Lord Hoffman does not appear to
be part of U.S. patent law.
[133] As outlined in Merrell Dow and Baker
Petrolite above, the focus under Canadian law in determining whether the
patented process or method is new, must be on whether the prior disclosure,
sale or use amounts to an enabling disclosure of the method and not
whether it was necessarily present or a natural result of the process.
[134] Judge
Greenaway found that what Calgon discovered was not a “new use” of a known
process, which is patentable under U.S. Code § 101, but rather a newly
discovered result of an old process. He concluded:
The UV treatment of water is a known process. The
inactivation of Crypto and Giardia are newly discovered results of the known
process: the old UV water disinfection method inactivates Crypto and Giardia
along with bacteria and viruses. As such…the newly discovered results are
unpatentable because they are inherently anticipated. Wedeco, p.25.
[135] In
contrast, in the summary judgment appeal decision in this case, Justice
Rothstein concluded, at para.19:
[I]rradiating
water for Crypto using low doses of UV light, while not a new method itself,
constitutes a newly discovered use for that method and therefore is a new and
useful art.
[136] On
the evidence heard at trial, I am unable to reach the same finding. In my view,
the defendants have established on a balance of probabilities that there were enabling
disclosures of the invention by use and by publication prior to the claim date
and that the use, therefore, was not new.
The Prior Use
at Fort Benton, Montana
[137] The
City of Fort Benton sits on the banks of the muddy Missouri River. It is
downstream from cities and towns that discharge their sewage into the river.
There is abundant wildlife and livestock in the watershed. Tailings from mining
operations wash into the river. At Fort Benton, the Missouri is meandering and
slow except during spring run off or heavy rains. There is high turbidity in
the water from suspended solids.
[138] Prior
to 1987 the City had been treating surface water from the Missouri with
conventional slow sand filtration which had to be periodically backwashed into
the river. The State of Montana insisted that the town, at considerable cost,
filter that backwash before discharging it back into the river. Fort Benton
decided to install an “induced infiltration radial well system” known as the
Ranney Method. This involved sinking a concrete caisson next to the river from
which five horizontal perforated pipes were pushed underneath the riverbed. The
pipes absorb water from the surrounding material. Four of the pipes draw water
directly from the river through the silt and gravel in the riverbed. The silt
and gravel acts as a filtration system removing particulates much as a
conventional filtration system would. The water thus obtained from these
horizontal pipes collects in the caisson and is piped from there into the town’s
water system.
[139] The
fifth pipe was installed too close to the river bank and draws groundwater
which is considerably harder than that in the river. If the groundwater was
allowed to mix with the river water it caused problems. That groundwater is pumped
out of the system and discharged into the river downstream.
[140] In
Montana in the late 1980’s deep wells extracting pure groundwater were not
required to be chlorinated. The State required Fort Benton to chlorinate
the water collected by the Ranney system. The City’s distribution system
did not allow for sufficient contact time with the chlorine to satisfy the
State authorities. Reconstruction of the system would have been very expensive.
Fort Benton looked for an alternative and found one in the UV systems used in Europe.
In 1987 it bought and installed an Aquionics brand system made in England, but
not without a fight with the State regulators.
[141] As
described in a September 1996 U.S. Environmental Protection Agency publication
(Ex. D-20-H), Fort Benton uses medium pressure mercury arc tubes generating UV
radiation including radiation at 253.7 nm. The initial dosage delivered is 41
mWs/cm² (=mJ/cm²) and the minimum at the end of a lamp’s working life is 25
mWs/cm². Lower doses could be experienced if the lamp were dirty and higher if
the flow were reduced for any reason. In 1999, the water system was upgraded
somewhat and dose meters were installed. The dose meters confirm the prior
understanding of dose ranges.
[142] As
witness Tim Farwick put it, Fort Benton has a “very shallow well that is right
out of a river” and the state would not initially allow UV disinfection as an
alternative to residual chlorine until extensive testing was conducted at the
site. Test samples taken from the caisson in 1987 upstream from the UV chamber
showed a high colliform count. Samples taken from the water after UV
irradiation repeatedly showed no colliform. As a result, the State decided to
treat the water at Fort Benton as ground water relieving the City of regulatory
requirements applicable to surface water sources. Had the source been true
ground water, chlorination would not have been required. As it was, Fort Benton
had to chlorinate but did not have to maintain the contact levels to each point
of use which the State required of surface water sources. In effect, a
compromise was reached.
[143] The
State’s designation of the source at Fort Benton as groundwater may be
charitably characterized as an easy way out of a regulatory dilemma. The good
citizens of Fort Benton were not about to accept a designation that would force
them to install a needless and expensive chlorine contact tank and additional
pipes to their storage facility. It is clear from the Engineer’s Report
describing the 1987 installation (Ex.D-21) that the only source of water of
reasonable quality in the area was the Missouri River as the groundwater was
highly mineralized thus precluding conventional wells. A 1996 EPA document
surveying UV systems in operation classified the water source at Fort Benton as
surface water “from the Missouri River” (Ex. D-69-E).
[144] Dr.
Linden testified that the EPA currently allows only half a log credit for
Crypto removal from horizontal infiltration wells with laterals 25 feet under
the river bed. The fine silt on the river bottom which can act as an effective
filter may be displaced during high flows. The underlying gravel is more porous
allowing micro-organisms such as Crypto into the wells.
[145] In
the performance guarantee provided to Fort Benton in August 1987 (Ex.P-13),
Aquionics specifically excluded “deactivation of cysts such as Giardia” from
its warranty. There is no direct evidence as to why that was done. Mr.
Farwick testified that Giardia was not found when tests were conducted in the
late 80’s. In any event, notwithstanding the disclaimer, Mr. Farwick was
confident from what he was told by the Aquionics personnel who installed the
system that it could deal with Giardia. I note that in the material provided by
Aquionics to Fort Benton to explain UV disinfection (Ex. D-20(f)) is the
following statement:
The ultraviolet
wavelengths of 200 -- 290 nm penetrate cell membranes to disrupt the DNA
molecules preventing cell replication with a maximum effectiveness around 260
nm, depending on the organism.... there are no micro organisms known to be
resistant to UV which, unlike chlorination, is highly effective against
bacteria, viruses, algae, molds and yeasts. In practice bacteria and viruses
are the cause of the major waterborne pathogenic diseases. [Emphasis added]
[146] In
special samples taken in 1993, colliform was found in the caisson water prior
to the UV chamber. From time to time, Mr. Farwick testified, he would find
other elements in the caisson water, such as algae and microorganisms, and
would have to shock the system with a heavy dose of chlorine to disinfect it.
This indicates that notwithstanding the filtering effects of the silt and
gravel in the river bottom, surface water contaminants entered the caisson
through the Ranney laterals, particularly when there had been a heavy run-off
in the watershed. Dr. Chauret agreed with that assessment on cross-examination.
I note that Mr. Dinkel understood that this would happen when the river bottom
was scoured during high flow periods. As a result, he stated, “no one could
place any great credence in the filtration capacity of the river bottom at the
Ranney collector.”
[147] The
Fort Benton system was publicly disclosed in Aquionics publicity materials and
EPA documents and attracted attention as the first example of a municipal UV
water treatment facility in the U.S. Mr. Farwick gave interviews and tours and
responded to telephone calls and correspondence about the facility well before
the claim date. The system was open and available to the public for inspection,
at least prior to September 11, 2001.
[148] As
noted above, Crypto became an issue for water system operators following the Milwaukee
outbreak in 1993. Mr. Farwick testified that he attended a training program put
on by the State in 1995 that instructed operators on how to make a preliminary
assessment as to whether their water source was groundwater under the direct
influence of surface water, and thereby at risk of contamination. By his
calculation, using the index factors provided by the State (Ex. D-38), the Fort
Benton source fell into that category by a wide margin. Mr. Farwick then
contacted an Aquionics engineer to tell him of his concerns about Crypto and
was assured that the UV system at Fort Benton “could easily handle that
situation”.
[149] Despite
efforts to impeach Mr. Farwick’s recollection about these events, I am
satisfied that he sought and obtained assurances that the UV system he was
operating at Fort Benton could cope with the threat if Crypto appeared in the
Missouri and made its way through the silt and gravel of the river bottom and
into the Ranney collectors.
[150] I
am satisfied from Mr. Farwick’s evidence that the conversation in question took
place well before the claim date and that this was an enabling disclosure of
the fact that the Fort Benton system prevents infection from Crypto by irradiating
the water flowing through its pipes with a continuous broadband of UV light
from medium pressure lamps within wavelengths of 200 to 300 nm in doses that
can vary from about 10 mJ/cm² to about 175 mJ/cm².
[151] In
the alternative, I note that in Dr. Linden’s opinion, the September 1996 U.S.
EPA publication describing the UV system used at Fort Benton would have
provided the skilled person with the information to practise
the method claimed in the ‘525 patent. A skilled person would also know from
Dr. Clancy’s 1997 paper (D-69-J) that Crypto infectivity in a flow through
system such as at Fort Benton could be determined by performing a challenge
study using neonatal mice. This is, in effect, what the pilot tests at Mannheim
accomplished in the spring of 1998 to provide the EPA with verification that
the Calgon Rayox (later Sentinel) UV reactor would perform as claimed. But what
they verified then was already being done at Fort Benton.
The NSF-ETV
Disclosure:
[152]
Dr. Clancy prepared a presentation for the April
20, 1998 meeting of the National Sanitation Foundation, Environmental
Technology Verification Steering Committee (NSF-ETV) entitled “The Use of
Animal Infectivity for Demonstrating Cryptosporidium parvum Oocyst
Inactivation”. The NSF-ETV serves as a national verification process in the U.S. for evaluating drinking water
technologies and the committee meeting was attended by a broad range of
interested parties. The paper prepared for that meeting (Ex.D-60) bears Dr.
Clancy’s name and that of Dr. Marshall, in addition to Thomas Hargy of CEC and
Frank Schaefer of the US E.P.A., all of whom were part of the AWWARF project
team. It was described as the Marshall paper at trial. The object of presenting the paper, as described by
Dr. Clancy and Mr. Hargy in their testimony, was to advocate for mouse
infectivity as the standard to evaluate UV systems rather than merely as
verification of in vitro findings.
[153]
The NSF-ETV paper describes the AWWARF 282 and
395 findings and those from “Study III - Medium Pressure UV Inactivation of
Cryptosporidium parvum”, the work conducted under the Calgon contract. The last
page of the paper contains a chart referencing exposures of 81, 163, 244 and
488 mWs/cm² and the results obtained with in vitro surrogates and animal
infectivity assays. Dr. Clancy testified that these exposures did not reflect
the actual doses administered but Dr. Bolton’s initial recalculation. In the
final publication of this work, as disclosed in the patent, the doses are about
half these values. A dose of 100 was recalculated as 81 and then again
recalculated to about 40 mJ/cm². But the lower doses disclosed on the chart are
within the range claimed.
[154]
Under the terms of the letter contract signed on
September 22, 1997, Dr. Clancy and her staff were bound to hold any information
acquired as a result confidential for the term of the agreement, specified as
being for the period from September 29, 1997 to December 31, 1997. As the work
continued beyond the latter date, the confidentiality agreement may have been
at least implicitly extended but no record of that was tendered in evidence.
Under the agreement, information in the public domain was excluded. The
confidentiality agreement also did not apply to research conducted by Clancy’s
firm under other arrangements including the AWWARF 395 project which was still
underway at that time.
[155] In
an e-mail to Dr. Clancy dated April 2, 1998 Dr Stevens stated:
Jenn, Thanks for
the update and the info on the upcoming meeting. I have discussed your
suggestion regarding publication of the lab data with Jim, and we both feel
that it’s a good idea. He will be in touch with you to co-ordinate our input.
[156] Dr.
Clancy testified on direct examination that she understood that message to refer
to the April NSF-ETV meeting. On cross-examination she acknowledged that it may
have been meant to refer to the June AWWA meeting in Dallas. In any event, it
is not at all clear that Dr. Clancy and her staff remained bound by the
confidentiality agreement in April, 1998. I note that Calgon has taken no
action against Dr. Clancy for breach of confidence. To the contrary, it
continued to offer her more work.
[157] Clancy
did not attend the April 20, 1998 meeting in Cincinnati. Dr. Marshall and Tom
Hargy were present. Hargy testified that the paper prepared by Dr. Clancy was
printed and copied before he left for Cincinnati and that he took the copies
with him and did not bring them home. He could not recall who handed them out
at the meeting. The minutes of the meeting (Ex. P-31) indicate that a
discussion respecting methods for determining Crypto viability took place and
that both Hargy and Marshall spoke to the issue. I have no difficulty in
finding that the paper was distributed at the meeting and constitutes a public
disclosure of the Calgon test results from March 1998.
[158] The
plaintiff attempted to impeach Mr. Hargy’s recollection of these events by
tendering a document from the file of an EPA official who also attended the
meeting. The official did not testify but provided a certified true copy of
what he had in his meeting file by statutory declaration. That document
(Ex.P-32) consists of two pages of charts which are similar to the charts at
the end of the Marshall paper (D-60). The font is larger and Mr. Hargy
speculated that it may have been a printed copy of the overhead transparencies
used by Dr. Marshall to explain the results of the mouse infectivity studies.
Dr. Marshall did not testify at the trial. In my view, Ex. P-32 does not
contradict Mr. Hargy’s account as to what transpired at the meeting. I am
satisfied that there was an enabling disclosure of information sufficient to practise the invention at that meeting.
[159] There
are some slight differences between the last chart in P-32 and that in D-60 which
I do not find to be material. Both indicate that the chart presents a
comparison of log inactivation of Crypto by UV irradiance as indicated by in
vitro surrogates and animal infectivity and contain the same data. D-60 is
headed by a line which states “Summary of Medium Pressure UV Data” which does
not appear in P-32. Dr. Linden stated in his evidence that this difference
would not matter to the skilled person who would come to exactly the same
conclusions as from D-60. As indicated above, I do not consider medium pressure
to be an essential element of the claims. Assuming that P-32 was shown in the
form of overheads and distributed at the meeting as the plaintiff suggests, I
am satisfied that it also constitutes a public disclosure of the Calgon findings.
[160] I
note that Mr. Dinkel agreed on cross-examination that the Marshall paper
provides the same information that is in claim 1 of the ‘525 patent (transcript
p.1881).
[161] It
was also suggested that the Marshall paper (D-60) teaches away from the claimed
invention as it contains a section on “Conclusions and Recommendations” that is
incompatible with the disclosure of the Calgon results, specifically that the
“conventional type UV system was shown to be ineffective in reducing [Crypto] viability”. A “conventional type UV system” was
interpreted by witnesses to mean a continuous in time medium or low pressure
system. As explained by Dr. Clancy and as read by Dr. Linden, this paper was a
summary of the three
studies disclosed: AWWARF 282,
AWWARF 395 and the Calgon medium pressure studies. That is also clear to the
Court on the face of the document. One cannot read the conclusions of one study
as applying to the document as a whole. The purpose of the Marshall paper was
to present all of the results from these projects ending with the most recent.
[162] It
is evident from the document itself that the section on “Conclusions and
Recommendations” does not apply to the three studies presented but was cut and
pasted from the AWWARF 282 report and applies only to the description of that
study in the paper. The section is identical to the corresponding part of that
report (Ex. P-19). AWWARF 282 dealt with viability as determined by in
vitro assays and not with the infectivity results obtained from the
mouse studies. Those results were clearly disclosed in the paper as having been
obtained by the third study and not from AWWARF 282. I am satisfied from the
evidence, including the document itself, that the point of referring to the
AWWARF 282 results was to contrast them with what was found later.
[163] I
find that the results of the in vitro and animal infectivity studies conducted
for Calgon from September, 1997 through March, 1998 showing nil infection rates
for continuous medium pressure UV doses within the range claimed by the patent
were publicly disclosed at the NSF-ETV meeting. This was an enabling disclosure
prior to the claim date.
The
Weerseloseweg Prior Use and Publication:
[164] The
East Twente Waterworks Corporation uses water from the Twentekanaal in the Netherlands
as a source of drinking water. In 1994 the Corporation began a project to
increase the amount of water taken from the canal and to do that it was
required to extract surface water through a drain below a sandbed. The amount
of filtration time through the underlying soil would be considerably reduced
and options were considered for additional treatment steps. A microbiological
study was commissioned from the Laboratory for Water and Food Microbiology of
the National Institute for Public Health and the Environment in the Netherlands.
The planned expansion was undertaken concurrently with the study.
[165] The
report from the study which is dated February 1996 and entitled "Load and
inactivation of the protozoa Cryptosporidium and Giardia at the Weerseloseweg
pumping station of the East Twente Waterworks Corp.”, was put into evidence in the
original Dutch and via the certified English translation (Ex.D-66). One of the
co-authors, Dr. Gertjan Medema, testified as to the content of the report and
to the UV system installed at Weerseloseweg, which he is personally familiar
with.
[166] Dr.
Medema did his Ph.D. on Cryptosporidium and Giardia in drinking water but
testified as a fact witness. He currently works for the Water Research
Institute owned by the public water companies in the Netherlands as the manager
of water quality and health with particular responsibility for microbiological
issues. His February 1996 report was broadly distributed and is available to
anyone at the National Library of the Netherlands. The water treatment facility
at Weerseloseweg is open to the public through guided tours.
[167] The
primary concern of the microbiological study conducted by Dr.Medema was with
Cryptosporidium and Giardia contamination. The source of water was open
surface water and as such it was subject to animal fecal waste. In the spring
of 1995, weekly samples were taken from the canal and from a reservoir storage
site. The canal was found to contain 1.6 Crypto oocysts and 2.9 Giardia oocysts
per litre. Water stored in the reservoir after conventional treatment including
filtration and flocculation was found to contain 0.6 Crypto oocysts and 0.2
Giardia per litre. The water in the reservoir was subject to re-contamination
from birds and other sources.
[168] The
primary barrier for pathogens had been sand filtration for a minimum of two
weeks. In the new system, the water would be in the sandbags for only a few
hours thus reducing the removal capacity of the soil. The operators of the
system also wished to increase the microbial safety of the water in light of
the by then well-known effects of cyst contamination. What they built and put
into operation by February 1996 might be described as a “belt and suspenders”
water treatment facility employing a multi-barrier approach including UV. The
UV system put in place was a Wedeco low-pressure reactor employing an initial
dose of 36 mJ/cm² and with aged lamps, 25 mJ/cm².
[169] Part
of Dr. Medema's job was to estimate the log reduction which would be achieved
by each barrier in the new system to ensure that the total would minimize the
risks of contamination and infection. For that purpose he used the minimum
dose, the measurements of crypto taken from the reservoir, and the existing
literature on the results achieved by each method. They used a conservative
estimation selecting the studies on the lowest dosage treatments that resulted
in the least removal.
[170] With
respect to the results that could be expected to be achieved from irradiation
with a low dose of ultraviolet light, Dr. Medema and his co-author relied on
the Ransome paper discussed below. Extrapolating from Ransom's finding that an
exposure of 120 mJ/cm² would result in a two log reduction for Cryptosporidium,
Medema concluded that a dosage of 80 mJ/cm² would be required for a one log
inactivation. The water facility did not need that much to achieve its overall
log targets given the other barriers hence the lower reduction actually
claimed. Using 23 mJ/cm², they needed and claimed no more than .3 log removal
of Crypto or about 50%.
[171] For
the purpose of an anticipation analysis, prior use and prior publication have
to be considered separately. I find that the UV system put into operation by
February, 1996 at Weerseloseweg was an enabling and public disclosure of the
method claimed by the ‘525 patent to prevent infection from Cryptosporidium
oocysts.
[172] In
my view, Dr. Medema’s 1996 report also anticipated the disclosure in the ‘525
patent as it teaches everything that a person skilled in the art would require
to put the method into practice.
The Ransome
Publication
[173] This
publication is a 1993 survey paper by M.E.Ransom and others (Ex. P-33),
published in the journal Water Supply, wherein it was entitled
“Effective Disinfectants on the Viability of Cryptosporidium Parvum Oocysts”.
The authors reported on the reduction of Crypto oocysts observed with UV,
ozone, chlorine, hydrogen peroxide, and peroxone using excystation as the assay
method.
[174] Oocysts
in open petri dishes were exposed under a low pressure UV lamp that, as
reported, gave an intensity of 25 mW/cm²
at a distance of 5 cm. The UV doses, as reported, were 42, 63, 90 and 120
mJ/cm².
[175] The
Ransome paper concluded that ozone was the one disinfectant that showed
promise. However, that conclusion has to be read in context. Of the methods
tested by Ransome and her colleagues, UV provided the greatest log reduction
observed at 2 log or 99% at the highest dose of 120 mJ/cm². Ransome was reporting on the
efficacity of the doses typically used at that time; for UV it was 30 mJ/cm² and as recommended by the US
Public Health Service, just 16 mJ/cm².
The doses commonly used for ozone at that time were more effective in the
authors’ view based on the excystation assay. But that did not teach away from
Dr. Ransome’s conclusions about UV. Dr. Medema and the East Twente
Waterworks Corporation took the
Ransome conclusions about UV and relied upon them for their study and
installation at Weerseloseweg.
[176] Dr. Linden was of the opinion that
Ransome provided the skilled person with sufficient information to reproduce
their experiment, in other words an enabling disclosure. Dr. Chauret disagreed
because it was not clear whether the water in the petri dish was stirred, the
depth of the water and the concentration of Crypto were not specified and the
exposure time must have been brief. The use of “bore-hole water” was not
explained. I did not find Dr. Chauret’s opinion convincing. The Ransome authors
described the procedure followed and the method employed with reference to a
1981 paper that would have been known to a person of ordinary skill in the art.
Bore-hole water, as Dr. Linden explained, is simply an English term for well
water.
[177] On cross-examination Dr. Chauret agreed
that the doses cited in the Ransome paper, assuming they were correct, would
prevent replication of the irradiated oocysts (transcript p.1983).
[178]
The excystation assay employed by Ransome disclosed that UV
rendered Crypto oocysts inactive or non-viable at doses within the range
claimed. Organisms that are no longer viable are incapable of replicating and
causing infection. In my view, the Ransome paper provides the skilled person
with the information required to carry out the method provided in Claims 1, 2
and 4 of the ‘525 patent. Claim 3 is excluded as it defines the dose range as
20-30 mJ/cm². A skilled
person would understand, however, that a dose below those tested by Ransome
would still prevent Crypto replication, albeit at a lower level of log
reduction. Any log reduction of Crypto is effective at preventing replication
and infection.
The Erickson
Improvement District Prior Use
[179] Erickson
is a rural area adjacent to Creston, B.C. The Erickson Improvement District
(EID) was created in 1930 to provide water for irrigation, for the household
uses of the residents of the District and, more recently, for the Town of Creston.
Elwin Masuch was a trustee for the District for 32 years and chairman of the
Board for 28 years. His son in law, Robin Douville, was the works
superintendent for the EID and currently holds that position for the Central
Kootenay Erickson Water Service. I found both Mr. Masuch and Mr. Douville
credible and careful witnesses. I was particularly impressed with Mr. Masuch’s
evidence. He had a clear recollection of events, a thorough understanding of
the conditions in his watershed and a sound grasp of the scientific principles
involved in water disinfection in general and UV irradiation in particular.
[180] At
the material times, the system supplied water to the 5000 residents of Creston
and 2000 residents of Erickson as well as for irrigation needs. For many years,
little was done to treat the water distributed by the EID apart from screening.
The source was surface water from two creeks. They had Giardiasis outbreaks in
1985 and 1990. In 1992 the province adopted Safe Drinking Water Guidelines and
insisted on chlorination to deal with the risk of contamination from bacteria
and other pathogens. That did not sit well with the people of Erickson. They
were determined to avoid having to chlorinate, Mr. Masuch testified, as they
considered it an obsolete and ineffective method of disinfection, it made the
water taste and smell bad – unfit to drink in his view - and it produced cancer
related trihalomethanes.
[181] Crypto was a concern. In 1996 there was an outbreak of
Cryptosporidiosis in Cranbrook, just 60 miles away and in other B.C.
communities. Samples taken from the Creston reservoir in January 1997 tested
positive for Crypto and Giardia. The trustees were aware that chlorine was
ineffective against Crypto and limited against Giardia. They conducted
extensive research for an alternative and their research convinced them that UV
was effective against both Crypto and Giardia. The EID had prior experience
using UV disinfection against bacteria. UV had been used by the EID in
the late 1970’s, on the Health Ministry’s recommendation, to disinfect water
taken from another surface water source to meet additional summer demand.
[182] Early
in 1996, the trustees approached the Culligan water treatment company and asked
the firm to install two systems employing filtration and UV in two homes as a
pilot project. The pilot was begun in May-June 1996. The system installed in
Mr. Douville’s home, a Trojan Advantage 5 low pressure unit, treated all of the
water that was used in his house. The Trojan Advantage 5 lamps are on
continuously and deliver doses within the range claimed by the ‘525 patent when
water is flowing to opened fixtures. The other unit was installed in a
neighbour’s home as a point-of-use system to supply disinfected water to one
faucet for drinking water.
[183] The
Trojan residential UV products date from the late 1980’s and evolved over time.
As described by Stewart Hayes, a Trojan design engineer from
1993, the Advantage series was developed from1994 and introduced in 1996. The
residential and industrial units marketed pre-1998 used medium or low pressure
lamps housed in a stainless steel reactor. The Advantage 8 series was
designed for an 8 gallon per minute nominal flow and the Advantage 5 for 5 gpm.
There was also an Advantage 2, point of use system (single faucet) at 2 gpm and
an Advantage 12 (12 gpm) in the series. These rates were tested using city
water line pressures between 40 and 45 pounds per square inch and standard
household ½ inch copper pipe. Transmittance of UV light was tested at 74% water
clarity, much dirtier than normal drinking water. The doses claimed for these
systems were validated by bioassay.
[184] The
UV lamps in these systems operating continuously at wavelengths within 200-300
nm would deliver a dose of 20-30 mJ/cm²
at normal flow rates. Changing the flow rate or UV transmittance would alter
the dose. This was illustrated by Ex. D-74, a chart prepared for the State of Wisconsin
dated October 31, 1996. The revised doses remained within the range of 10 to
175 mJ/cm² claimed by the ‘525 patent. Higher doses would be delivered to
the contents of the unit when there is no flow to the fixtures. But
these systems were designed as flow through applications at a rated gallonage
per minute and would continuously treat the water as showers were run, toilets
were flushed and glasses were filled. Mr. Hayes’ evidence on this was
unchallenged.
[185] There
were some differences in the evidence about the size of the filters installed
in the EID pilot project. Mr. Masuch testified that the filters were installed
to control turbidity prior to irradiation of the water. For most of the year
turbidity was low but it would spike in the spring. He recalled that 5 micron
filters were initially installed but they were replaced by 20 micron filters as
the finer screens were being clogged too frequently. Neither would serve as a
barrier to Crypto. Masuch and Douville understood that Crypto oocysts were
smaller than 5 microns. A contemporaneous letter written by Mr. Douville
states that 20 micron filters were installed in June 1996. Mr. Douville
testified that they never installed a 5 or 1 micron filter in his house. 20
microns was the only size they used. Photographs of the unit in his home
support that statement. A 1 micron filter was installed at his neighbour’s home
but was replaced with the 20 micron version because of clogging.
[186] Samples
were taken regularly of the treated water at the two homes, they were tested
and the resulting records were kept for a year. The results exceeded provincial
guidelines.
[187] The
plaintiff submits that this can’t be considered an enabling disclosure as the
units were installed and operated inside private homes and thus were not
accessible to the public. It was not sufficient that the trustees discussed it
amongst themselves. But Mr. Masuch testified that the results were reported to
the ratepayers in June 1997 at the annual general meeting. In my view, that was
an enabling public disclosure of a method falling within the essential elements
of the claims of the ‘525 patent.
[188] The
trustees were forced to resile from the confidence they placed in UV as the
province continued to insist on other barriers. EID submitted a proposal to the
regional health unit to allow installation of point of entry treatment units in
all residences and businesses in the district. A Culligan document,
prepared for submission to the health unit in April 1997, indicates that the
proposed system would use 1, 5 and 25 micron filters. According to the
document, the 25 and 5 micron filters would be used to clarify the water and
the 1 micron filters would completely remove cysts. In a 1999 affidavit,
prepared for litigation with the province, Mr. Masuch indicated that the EID
was prepared to install this system if it were approved by the province. The
plaintiff submits that this is evidence of abandonment of the prior use.
[189] This
is not a case where an effort to put the prior use into practical operation was
abandoned because it was concluded that it could not work. To the contrary, Mr.
Masuch and his fellow trustees were convinced that the “main component of that
system was the UV for control of Giardia and Cryptosporidium”. However, at the
time the submission was being made, UV had been given no log credits for cyst
removal in B.C. It wasn’t the failure of practical application that defeated
them but bureaucracy. The province continued to insist upon chlorination. The
EID was dissolved and a considerably more expensive disinfection system has
since been installed.
[190] I
am satisfied from this evidence that the method disclosed by the ‘525 patent
was being publicly practised at Erickson prior to the claim date.
The Trout
Lake Point of Entry Systems
[191] Mr.
Brian Kelly testified that he had been selling and installing Trojan UV systems
from the late 1980’s for residences and cottages with wells or lake water
systems in the North Bay area. He described several typical installations in
1997 prior to the claim date. Brochures for the Trojan Advantage 5 and 8 series
systems installed in 1997 describe the specifications of the units and refer to
the benefits of UV disinfection for dealing with waterborne disease-causing
microorganisms. Specifically mentioned are bacteria, viruses, algae, fungi and protozoa.
The brochures were distributed by Mr. Kelly to prospective customers from his
shop. The systems Mr. Kelly installed typically included a 50 micron filter
which would not serve as a barrier to Crypto. Later brochures published by
Trojan clearly state that these systems are effective against Crypto, but that
was not the case for the pre-1998 brochures.
[192] The
environmental study subsequently prepared for the City of North Bay determined
that there was a risk of Crypto in the waters of Trout Lake but it was not
established by the evidence that Mr. Kelly was installing these systems for
that reason prior to the claim date. While it is evident from hindsight that they
would prevent any Crypto in the water from replicating and infecting, they were
installed and operated to deal with other pathogens in the water. Accordingly,
I find that there was no enabling disclosure of the method by the
installation of the point of use systems at Trout Lake.
CONCLUSION ON VALIDITY
[193] I am
satisfied on all of the evidence submitted at trial that the presumption of
validity of the ‘525 patent has been overcome and that the defendants have
established on a balance of probabilities that the patent was anticipated by
both prior use and publication.
[194] To satisfy the test of anticipation, just one of the applications of
prior art described in the evidence would suffice if the principles stated in Beloit and Baker Petrolite,
above are satisfied. The notional person skilled in the art, using
available analytical techniques, must be able to find the invention without the
exercise of inventive skill.
[195] In
this case, the installations at Fort Benton, Weerseloseweg and Erickson, the
Weerseloseweg Report and the Ransome paper, would each inform the skilled
person that using UV light at particular levels would adequately treat water to
prevent Crypto oocyst replication and infection. These were disclosures that were
made before the claim date in such a manner that the subject matter became
available to the public in Canada or elsewhere within the requirements of
paragraph 28.2 (1) (b) of the Patent Act.
[196] I find
further that the presentation of the Marshall paper in April 1998 at the
NSF-ETV meeting constituted prior disclosure by a person who obtained knowledge
from the applicant more than one year prior to the filing date within the
meaning of paragraph 28.2(1)(a) of the Act.
Other
Validity Issues
[197] In light of
my findings on anticipation, I do not find it necessary to deal in any detail
with the other defences advanced by the defendants, which include:
inventorship; overbreadth; sufficiency of the specification; and ambiguity. As
noted above, in my construction of the claims I found no ambiguity in the use
of the term “continuous”.
[198] Had I found
there to be an invention in the discovery claimed by the ‘525 patent, I would
have concluded that while Dr. Clancy appears to have contributed more to it
than Drs. Stevens, Bolton and Dussert on the evidence before me, failure to
name her as an inventor would not have invalidated the patent.
[199] It is clear
from the evidence that the patent claims more than what had been established as
of the date of application in that the effectiveness of doses as low as 10
mJ/cm² had not been determined by the research. The plaintiff submits that
this was acceptable on the sound prediction of utility principle and was
subsequently confirmed by further research. The prediction was also supported
by the LaFrenz data and Dr. Linden concluded that a 10 mJ/cm² dose would
provide at least a 2 log removal. I would not have found the patent invalid on
this ground.
[200] The
defendants have raised valid concerns about the sufficiency of the
specification. As already noted, the failure to disclose “the sophisticated
mathematical model” used to calculate the doses would have made it difficult
for a skilled person to reproduce the invention in Dr. Linden’s expert opinion.
After all of the evidence heard at trial, it remains unclear how Dr. Bolton
arrived at the final values claimed based on the test results that he
recalculated several times.
[201] Among the prior art
cited in the specification as illustrating the understanding that high doses
were required is a 1993 study by Lorenzo-Lorenzo et al.. Dr. Clancy provided
information obtained from personal communication with those authors that their
UV experiments may have resulted in greater than 3 log inactivation using doses
between 100 and 300 mJ/cm². An e-mailed letter (Ex. D-2) from Dr. Dussert to Dr
Clancy states that that information should be reworded or deleted as “[t]he
doses given would hurt our patent claims and therefore Calgon Carbon’s
business, and are therefore unacceptable”. The letter goes on to indicate that
Bolton’s attempt to calculate doses from Lorenzo-Lorenzo’s work led to higher
doses than the range predicted.
[202] Also cited is the
LaFrenz paper (Ex.D-56) referred to above which was submitted to the AWWA
conference at Denver in November, 1997. It
was distinguished on the basis that the pulsed UV doses applied to achieve 6
log inactivation were 200 mJ/cm² and greater. That is not a complete
description of the disclosure of Dr. LaFrenz’ findings at the Denver conference. In
paragraph 2.3.1 of the paper Dr. LaFrenz states that “[t]est results to date
for Cryptosporidium indicate that a Pulsed UV treatment level of approximately
100 mWs/sq.cm provides 3-4 logs of inactivation. Six logs of inactivation have
been achieved for irradiation levels of less than 200 mWs/sq.cm.” Figure 5 of
his paper illustrates those findings.
[203] These examples raise
questions about the accuracy and sufficiency of the specification.
INFRINGEMENT
[204] As indicated
above, I find that the ‘525 patent is invalid for anticipation. It follows that
I find that North
Bay
has not infringed the patent and that Trojan has not induced or procured
infringement.
[205] In the event
that I am found to have erred on the question of validity, I will indicate the
findings that I would have reached on infringement. As stated by the Supreme
Court in Monsanto Canada Inc. v. Schmeiser, [2004] 1 S.C.R. 902 at 918 (Monsanto),
infringement is generally a question of fact and will be clear on the facts
once the claim has been construed.
[206] The city uses
its Trojan Swift system to irradiate its drinking water with a broadband of UV
light in wavelengths between 200 and 300 nm generating doses of 40-50 mJ/cm² to
prevent infection from Crypto oocysts. Those are the essential elements as I
have found them of the method claimed by the patent. I would find, if the
patent were valid, that the City of North Bay directly infringed
claims 1, 2 and 4. Claim 3 is not infringed as the dosage range claimed is not
practised by the City.
[207] The evidence
of procurement or inducement on the part of Trojan is less clear and turns on
the question of whether the city was led to the decision to perform the
infringing act by Trojan’s indemnity.
[208] To establish
inducement there must be an act of infringement completed by the direct
infringer, the completion of that act must have been influenced by the acts of
the inducer to the point that without that influence the infringement would not
otherwise have taken place and the influence must be knowingly exercised by the
inducer so that the inducer knows that the influence will result in the
completion of the act of infringement: Dableh v. Ontario Hydro, [1996] 3
F.C. 751, 68 C.P.R. (3d) 129 at 148-49 (F.C.A.), leave to appeal to S.C.C.
ref’d [1996] S.C.C.A. No. 441 (Dableh).
[209] The plaintiff
does not rest its case entirely on the indemnity provided by Trojan to North Bay. The
plaintiff takes the position that inducement would be established with or
without the indemnity merely by Trojan’s offer for sale and sale of its UV
Swift system to municipalities who have not taken a license from Calgon. But
that is, in my view, overstating the matter.
[210] Calgon also
relies upon the relationship between Trojan and CH2M Hill, the engineering firm
which provided consulting advice to North Bay. CH2M, described by
Trojan’s President as a “client” of the firm, received research and analytical
support for its water treatment consulting practice. The inference is that in
return for that support CH2M exercised undue influence on its “client”, North Bay to choose
the Trojan system. That does not explain why North Bay chose not to
take a license from Calgon.
[211] The
uncontradicted evidence is that in the circumstances described by the City
Engineer, Mr Simmonds, North Bay officials felt
compelled to install more effective barriers to pathogens without delay. Trojan
stood to gain solely from the sale of its equipment and would likely have
obtained the contract whether the City took the license or not. Calgon did not
tie licensing to the sale of its equipment. Trojan’s system had been in
development for over a decade. Calgon had just recently entered the field. CH2M
provided information about other systems on the market.
[212] Evidence was
tendered by the plaintiff concerning the arrangement reached by the Edmonton water
utility, Epcor, with Calgon. Epcor installed Calgon equipment and took a
license. It receives a commission from Calgon for acting as its Western
Canada
agent promoting the technology which offsets the license fee. I note that Waterloo which
operates Trojan, Calgon and Wedeco UV systems does not pay the license fee. It
appears from the evidence that the majority of the municipalities in North
America that have acquired Calgon UV reactors or those supplied by its
competitors do not pay the license fee. Just six, three in Canada and three in
the U.S. have agreed
to pay. The Pittsburgh utility pays
but has a special arrangement with Calgon, as described by Mr. Dinkel. Calgon
may have been prepared to negotiate with North Bay.
[213] This is not a
case similar to those in which the defendants induced infringement by selling
products that could only be used by infringing the plaintiff’s patent such as Procter
& Gamble Co. v. Bristol-Myers Canada Ltd. (1978), 39 C.P.R. (2d) 145
(F.C.T.D.), affirmed (1979), 42 C.P.R. (2d) 33 (F.C.A.); Windsurfing
International Inc. v. Triatlantic Corporation (1984), 8 C.P.R. (3d) 241
(F.C.A.). The products sold by Trojan can and are being used for purposes which
would not infringe such as for the prevention of infection by bacteria and
viruses.
[214] The indemnity
was dated and signed by Trojan several days after the decision was made by the
North Bay Council to choose Trojan and UV light to treat its drinking water. It
appears to have been provided to CH2M and not to the city. Mr. Simmonds
testified that he first became aware of it several months later when the city
solicitor requested a copy from CH2M following the receipt of correspondence
from Calgon. CH2M may have acted as an agent of the City in requesting the indemnity
from Trojan but the evidence does not establish that but for that inducement
the deal would not have been made. Plaintiff’s counsel fairly conceded that
point in final argument.
[215] However, the
infringing act occurred not when the Trojan contract was issued but when North Bay put its UV
system into operation and practised the patented method without a license from
Calgon. It is clear that the City officials knew of the Calgon patent by that
stage and knew that Calgon would offer a license even where a competitor was
supplying the system. Mr. Simmonds said they considered the patent to be, in
his English idiom, “bonkers”. But the officials also knew that the City would
be saved harmless from any damages for infringing the patent by reason of the
Trojan indemnity. They had nothing to lose by ignoring it. A reasonable
inference is that the indemnity was the deciding factor in the decision to
proceed without a license.
[216] The
defendants submit that there had to be an issued patent as of the time of the
inducement to satisfy the first leg of the Dableh test, i.e., that there
must be an act of infringement completed by the direct infringer. In this
instance, the indemnity was provided in July 2001, after the claim date but
before the patent was issued in Canada. The infringing act
began in 2002 when the UV system was put into operation by North Bay after the
patent was issued. The indemnity was not withdrawn by Trojan and continued to
operate at that time.
[217] If I had
found the patent valid, I would have found that Trojan induced infringement of
the patent by providing the indemnity. That inducement did not go to North Bay’s decision
to award the system contract to Trojan but to the City’s decision to infringe
by refusing the license offered by Calgon. I would have referred the quantum of
damages for subsequent determination but would have limited entitlement to the
royalties lost and excluded damages for any potential sale of the equipment. I
would have found that entitlement to aggravated, punitive or exemplary damages
was not justified in this matter as the evidence did not establish high-handed,
oppressive or egregious conduct on the part of the defendants. In the
particular circumstances of this case, the validity of the patent, while
presumed in law, was in doubt. I would have been reluctant to grant a broadly
framed permanent injunction against Trojan as requested by the plaintiff in its
prayer for relief but would have granted one limited to the scope of the
infringing use.
[218] The plaintiff
submits that if infringement by North Bay is established it
should have the option of electing between damages and lost profits. Damages
represent the patentee's loss, which may include lost profits from sales or
lost royalty payments. An accounting of profits, by contrast, is measured by
the profits made by the infringer, rather than the amount lost by the patentee.
If the patentee elects to seek an accounting of profits, the patent holder is
only entitled to that portion of the infringer’s profit which is causally
attributable to the invention: Monsanto, above at paras.100-102.
[219] In this case,
had I found the patent valid I would have held that the plaintiff was entitled
to damages with interest but not to an accounting of profits. The plaintiff
submits that the City should be liable for the savings achieved by the choice
of a more cost-effective technology than that presented by the other available
options. I do not see those savings as profits accruing to the benefit of the
Corporation of the City of North Bay. The evidence is that
the water utility operates on a user pay basis with the costs for water
treatment charged directly to the ratepayer. The city receives no revenue from
the operation of the water system.
[220] I don’t think
that this is what the Supreme Court had in mind when it discussed the
“value-based approach” to calculating profit at paragraph 102 of Monsanto.
At the heart of the equitable remedy is the notion that the infringer should
not be entitled to benefit by his wrongdoing. I accept that a municipal corporation
may make a profit from the use of infringing technology and there will be
circumstances in which it should be held accountable for those profits. In Baker
Petrolite Corp. v. Canwell Enviro-Industries Ltd., 2001 FCT 889, 210 F.T.R.
161, 13 C.P.R. (4th) 193 rev’d on other grounds [2003] 1 F.C. 49,
2002 FCA 158, Justice Frederick
Gibson found the City of Medecine Hat accountable for the sale of sour gas
“sweetened” by the patented product. But that was a case in which the City was
selling the gas to a commercial distributor for profit and the use of the
infringing technology enhanced the value of the product.
[221] In this case,
the City has not gained a profit in providing the product to its ratepayers at
cost and no additional value can be causally attributed by the use of the
infringing technology. The quality of the water remained exactly the same. At
best, the ratepayers avoided the risk of infection and the burden of some
additional cost. Moreover, they took no direct part in the decision by the
Corporation to employ the technology. The fact that Trojan would be liable to
cover these “profits” by virtue of its indemnity agreement is inconsequential.
COSTS
[222] The
defendants shall be entitled to their costs to be assessed on the normal scale.
JUDGMENT
IT IS THE JUDGMENT OF
THIS COURT that:
- The plaintiff’s claim for a declaration
that Canadian Patent No. 2,331,525 has been infringed by the defendants
and claims for an injunction, compensation, damages, interest and costs
are dismissed;
- The defendants’ counterclaim is allowed and
it is declared that Canadian Patent No. 2,331,525 is invalid;
- The defendants are
entitled to their costs to be assessed on the ordinary scale.
“Richard
G. Mosley”