Date: 20070611
Docket: T-773-06
Citation: 2007
FC 622
Vancouver, British Columbia, June
11, 2007
PRESENT: Roger R. Lafrenière, Esquire
Prothonotary
BETWEEN:
ABBOTT LABORATORIES LIMITED
and TAP PHARMACEUTICALS INC.
Applicants
and
THE MINISTER OF HEALTH, NOVOPHARM
LIMITED
and TAKEDA PHARMACEUTICAL COMPANY LIMITED
Respondents
REASONS FOR ORDER AND ORDER
[1]
The Respondent, Novopharm
Limited (“Novopharm”), is a Canadian corporation engaged in the business of
manufacturing off-patent pharmaceutical preparations, commonly called generic
drugs. On August 10, 2006, Novopharm moved for an order pursuant to subsection
6(5) of the Patented Medicines (Notice of Compliance) Regulations,
SOR/93-133, as amended (the Regulations), dismissing the
prohibition application brought against it by the Applicants, Abbott
Laboratories Limited (“Abbott”) and Tap Pharmaceuticals Inc. (“TAP”), based on three distinct
grounds.
[2]
The
first ground advanced by Novopharm is that the patent in issue in the application,
Canadian Patent No. 2,286,753 (the “’753 Patent”), is irrelevant to the dosage
form of its capsules (“Novopharm Capsules”) and the reference product (the
“relevance” argument). The second ground is that the ‘753 Patent is not
eligible for inclusion on the Register because it does not contain a claim for
the medicine itself or a claim for the use of the medicine (the “eligibility”
argument). The third ground is that the application is redundant, scandalous,
frivolous, vexatious and otherwise an abuse of process (the “abuse of process”
argument).
[3]
Before
addressing the issues raised by the parties at the hearing of the motion,
including recent developments in the law and the appropriate standard to apply
on this motion, a brief review of the facts and a summary of the claims of the
‘753 Patent is in order.
Facts
[4]
The Respondent,
Takeda Pharmaceutical Company Limited (“Takeda”), is a Japanese corporation
that distributes its drug products around the world directly and through
arrangements with other drug companies. It is the patentee of both the ‘753
Patent and the now expired Canadian patent for the compound lansoprazole,
Canadian Patent No. 1,255,314 (the “’314 Patent”), which was issued on June 6,
1989. During the 17 years that the ‘314 Patent was effective, Takeda and those
claiming under it enjoyed a monopoly over lansoprazole as a compound.
[5]
TAP
is a joint venture between Takeda and Abbott through which lansoprazole is sold
in Canada. Abbott and TAP are
“first persons” under the Food and Drug Regulations in relation to the
medicine lansoprazole.
[6]
Lansoprazole
is a proton pump inhibitor or “PPI” which reduces gastric acid secretion. After
ingestion it is absorbed in the small intestine and enters the blood stream.
Once absorbed in this way, lansoprazole has the effect of inactivating or
inhibiting the hydrogen pumps in parietal cells. These are the cells in the
stomach lining that secrete hydrochloric acid into the stomach. However,
lansoprazole's effectiveness is reduced or destroyed by the presence of acid.
Therefore, lansoprazole must be protected from acid while it moves through the
stomach to its point of absorption in the intestine. The usual way to do this
is to coat the lansoprazole in an enteric coating.
[7]
Abbott
and TAP (the “Applicants”) have been selling lansoprazole delayed release
capsules (the “Applicants’ Capsules”) in Canada under the brand name PREVACID®
since they received their first Notice of Compliance (“NOC”) from Health Canada
in 1995. These capsules are comprised of a gelatine capsule shell filled with
enterically coated granules. The sale of the Applicants’ Capsules predates the
Relevant Date by approximately 3 years.
[8]
Novopharm
sought approval from Health Canada through an Abbreviated New Drug Submission (“ANDS”) in which
it compared the Novopharm Capsules to the Applicants’ Capsules as they existed
in 2004. This ANDS referred to the three patents then registered against the
reference product, being the ‘314 Patent, Canadian Patent no. 1,312,548 (the “’548
Patent”) and Canadian Patent no. 2,009,741 (the ‘741 Patent).
[9]
On
December 21, 2004, Novopharm served Abbott with a Notice of Allegation (the
“First NOA”) in which Novopharm alleged that its Novopharm Capsules would not
infringe the ‘548 Patent or the ‘741 Patent. The First NOA did not address the
‘314 Patent, since Novopharm was waiting for the expiry of the ‘314 Patent
before bringing the Novopharm Capsules to market.
[10]
Abbott
responded to the First NOA by commencing an application (Court No. T-214-05),
seeking an order prohibiting the Minister of Health from issuing a NOC to
Novopharm. This application was heard by Justice Konrad von Finckenstein in Toronto in October 2006. By
Order dated November 21, 2006, the application was allowed. This order is
currently under appeal (Court No. A-580-06) and is scheduled to be heard by the
Federal Court of Appeal on June 27, 2007.
[11]
On
May 17, 2006, Health Canada responded to
Novopharm's ANDS by approving the submission (subject to the outcome of
T-214-05 and Novopharm's response to the subsequently listed patents) and
issuing a Drug Identification Number (“DIN”) for the Novopharm Capsules. In
doing so, Health Canada accepted that the
Novopharm Capsules are bioequivalent to and have the same dosage form, strength
and route of administration as the Reference Product.
[12]
On
February 13, 2006, after Novopharm had provided Health Canada with its ANDS and
after Novopharm had served Abbott with the First NOA, the Applicants caused the
‘753 Patent to be added to the Register for the Reference Product. Abbott has
since caused three other patents to be added to the Register in relation to the
Reference Product.
[13]
On
March 23, 2006, Novopharm responded to the newly listed ‘753 Patent by
providing the Applicants with another Notice of Allegation in which it alleged,
among other things, that its Novopharm Capsules would not infringe the ‘753
Patent. In response, the Applicants commenced the present application on May 5,
2006.
[14]
As
indicated as the beginning of these reasons, Novopharm now moves pursuant to
ss. 6(5) of the Regulations to have this application dismissed.
Claims of the ‘753 Patent
[15]
The
‘753 Patent contains 29 claims. Claims 1, 10, 11 and 22-26 are independent
claims. There are 16 claims which list an active pharmaceutical ingredient, including
11 that relate to lansoprazole (claims 7, 13, 14, 15, 16, 17, 22, 23, 24, 25
and 26).
[16]
Claim
1 is the broadest independent claim and describes a solid preparation
comprising: i) a pharmaceutically active ingredient; ii) one or more
water-soluble sugar alcohols from the group consisting of sorbitol, maltitol,
reduced starch saccharide, xylitol, reduced palatinose and erythritol; and iii)
low-substituted hydroxypropylcellulose having hydroxypropoxyl group contents of
7.0 to 9.9 percent by weight.
[17]
Claims
5, 6, and 7 read as follows:
- The solid
preparation according to any one of the claims 1 to 4, which is capable of
buccal disintegration or dissolution.
- The solid
pharmaceutical preparation according to any one of the claims 1 to 5,
which is a tablet.
- The solid
preparation according to any one of claims 1 to 6, wherein the
pharmaceutically active ingredient is lansoprazole.
[18]
Claim
10 relates to the “use of L-HPC” having a hydroxypropoxyl group content of 7.0
to 9.9 percent by weight for the manufacture of a pharmaceutical preparation
capable of buccal disintegration or dissolution. Similarly, claim 11 describes
a method of improving buccal disintegration or dissolution of a solid
pharmaceutical preparation by “using L-HPC” having hydroxypropoxyl group contents
of 7.0 to 9.9 percent by weight. These claims require both: i) L-HPC having
hydroxypropoxyl group contents of 7.0 to 9.9 percent by weight; and ii) the
capability of buccal disintegration or dissolution as that term is used in the
‘753 Patent.
[19]
Claim
12 describes the use of claim 10 where the Active Ingredient is an anti-ulcer
agent.
[20]
Claims
20 and 21 are dependent claims that refer solely to tablets.
[21]
Claims
22 to 26 describe uses of “...preparations containing lansoprazole and low-
substituted hydroxypropylcellulose [i.e. L-HPC] having hydroxypropoxyl group
content of 7.0 to 9.9 percent by weight, capable of buccal disintegration or
dissolution” to treat various conditions.
Recent developments in the law
[22]
Since
the date on which Novopharm’s notice of motion was filed, there have been two
significant developments in the law. On November 3, 2006, the Supreme Court of
Canada released its decision in AstraZeneca Canada Inc. v. Canada (Minister
of Health), 2006 S.C.C. 49 (“AstraZeneca”). In addition, effective
October 5, 2006, the Regulations were amended to, among other things,
change the wording of ss. 6(5). The impact of these recent developments
on this motion is addressed below.
The AstraZeneca decision
[23]
In
its written and oral submissions, Novopharm advanced additional arguments based
on the AstraZeneca decision. In that case, AstraZeneca, the innovator
manufacturer, obtained from the Minister of Health a NOC enabling it to market
its drug omeprazole for use in the treatment of acidic stomach conditions. The
drug was sold as Losec 20 in Canada from 1989 until 1996, when AstraZeneca decided to remove it
from the market and replace it with another formulation. AstraZeneca’s patent
for omeprazole expired in 1999. In 2002, despite the absence of Losec 20 from
the market, AstraZeneca obtained and registered with the Minister of Health two
more patents associated with Losec 20, but did not incorporate this new
technology into any of its products. In 1993, Apotex filed an abbreviated new
drug submission for a NOC for its generic version of omeprazole, comparing its
product to AstraZeneca’s 1989 version of Losec 20. The Minister determined that
Apotex was not required to address the after-issued patents and granted Apotex
the NOC in 2004. AstraZeneca applied for judicial review of this decision, and
the motions judge upheld the Minister’s decision. The Federal Court of Appeal
overturned this judgment and quashed Apotex’s NOC.
[24]
In allowing Apotex’s appeal
and restoring the motions judge’s decision, the Supreme Court of Canada
referred to a principled approach to determining which patents must be
addressed pursuant to the Regulations. Under this approach, the
obligations incurred by a generic manufacturer under the Regulations are
based upon the generic manufacturer's “early working” of a patent listed on the
Register. These obligations only arise where the invention of the “early worked”
patent is embodied in the specific reference product used by the generic
manufacturer as the basis for its ANDS. The AstraZeneca decision
clarifies that if the invention of the patent is not embodied in the reference
product, the patent is irrelevant and need not be addressed.
[25]
Novopharm
submits that the invention patented by the ‘753 Patent is not embodied in the
specific PREVACID® delayed release capsules to which Novopharm makes reference
in its ANDS. According to Novopharm, the ‘753 Patent is not relevant to TAP’s
PREVACID® capsules because the Patent refers to a rapidly disintegrating oral
form, whereas PREVACID® is a non-disintegrating gelatin capsule containing
enterically coated granules, neither of which are designed to disintegrate.
Novopharm submits that the ‘753 Patent is therefore irrelevant and need not be
addressed by Novopharm, and that the application ought to be dismissed as
frivolous, vexatious and an abuse of the process of this Court.
[26]
The
arguments based on AstraZeneca, although compelling, are beyond the
scope of the present motion and the application itself. Novopharm should have
sought leave to amend its notice of motion, or brought a separate motion to
obtain relief on this additional ground. However, Novopharm gave no notice to
the Applicants that it planned to advance an argument based on the AstraZeneca
decision prior to filing its written representations. Due process requires
that a party be given an opportunity to adduce evidence with respect
substantive issues and that the evidence be considered in the adjudication of
the issues. The Applicants have been deprived of this opportunity, and have
been prejudiced as a result. In the circumstances, it would be inappropriate to
entertain Novopharm’s argument in a factual vacuum or based on an incomplete
evidentiary record.
Impact of amendments to the Regulations to the
relevance argument
[27]
Novopharm’s
argument on the grounds of relevance has been overtaken by recent amendments to
the Patented Medicines (Notice of Compliance) Regulations. Where
necessary, the previous regulations will be referred to as the “Old
Regulations”, while the amended regulations will be called the “New
Regulations”.
[28]
Under
the Old Regulations, there were two alternative bases for granting a
motion to dismiss pursuant to par. 6(5)(a); namely, if the Court was satisfied
that (1) the patents were not eligible for inclusion, or (2) the patents were
irrelevant to the dosage form, strength and route of administration of the drug
for which the second person has filed a submission for a notice of compliance.
The old grounds were therefore ineligibility and irrelevance to the generic’s
product.
[29]
The New
Regulations maintain s. 6(5) as a means by which generic manufacturers can
effectively deal with improperly listed patents. However, where the old s. 6(5)
provided explicit grounds for attacking the listing of a patent on the basis of
irrelevance to the dosage form, strength and route of administration of the
product, the New Regulations have moved that requirement to section 4.
[30]
However,
in a strange twist, the transitional provisions of the New Regulations provide
that s. 4 of the New Regulations does not apply to patents on a patent
list submitted prior to June 17, 2006. In other words, patents on the register
as of the date of the coming into force of the amendments remain subject to the
listing requirements as they were interpreted and applied prior to that date.
Given that the ‘753 Patent was included on the Register as of February 2006,
Novopharm properly concedes that s. 4 of the New Regulations do not
apply.
[31]
Novopharm
submits, however, that since s. 4 of the Old Regulations continues to apply
to the ‘753 Patent, s. 6(5) of the Old Regulations must, by extension,
also apply. Novopharm has cited no case law in support of this proposition. In
my view, it would also be completely arbitrary to assume that the Old
Regulations apply simply because Novopharm’s notice of motion was brought
before the New Regulations were proclaimed into force. As a general
rule, when a law repeals a previous law, the repealed legislation no longer
applies to the situations it once did, even if such situations arose before the
law was repealed. In the absence of any grandfathering provisions, and taking
into account the plain and obvious effect of the amending legislation, I
conclude that section 6 of the Old Regulations has ceased to exist, and
with it, Novopharm’s ground for dismissal based on relevance.
Standard to apply in paragraph 6(5)(a) motions
[32]
Paragraph
(6)(5)(a) provides that “the court may, on the motion of a second person,
dismiss the application in whole or in part …in respect of those patents that
are not eligible for inclusion on the register”. The parties disagree on the
standard or test to be applied in assessing the merits of a motion brought
pursuant to par. 6(5)(a). The Applicants submit that the burden of proof is on
Novopharm and that the standard in very high. Novopharm responds that the
purpose of par. 6(5)(a) is to summarily dismiss groundless notices of
application and there is therefore no reason to adopt a restrictive standard.
[33]
In Procter
& Gamble Pharmaceuticals Canada, Inc. v. Canada (Minister of Health), 2003
FCT 583, [2003] 4 F.C. 445, Madam Justice Johanne Gauthier had an opportunity
to consider whether or not the restrictive standard enunciated in the Supreme
Court of Canada case of Hunt v. Carey should apply to motions to dismiss
under par. 6(5)(a). However, she declined to decide the question because she
would have reached the same conclusion applying even the more restrictive
standard.
[34]
In Sanofi-Aventis
Canada Inc. v. Novopharm Limited, 2006 FC 1547, Justice Roger Hughes
was dealing with a motion to dismiss a prohibition application pursuant to par.
6(5)(b) of the Old Regulations on the grounds that the reasons of the
Supreme Court of Canada in AstraZeneca resulted in the patents at issue
being irrelevant. He concluded that such motions are to be determined on the
same basis as a motion to strike a pleading, and that an application should not
be dismissed pursuant to this provision unless clearly futile. At paragraph 11 of
his decision, Justice Hughes wrote:
Taking section 6(5)(b) on an equal
footing with old Rule 419 or present Rule 221 we must start with the well
entrenched proposition as stated by the Supreme Court in Hunt v. Carey
Canada Inc., [1990] 2 S.C.R. 959 that a party should not be driven from the
judgment seat at an early stage before trial unless it is “plain and obvious”
that the matter cannot succeed. In dealing with an application not an action,
the Federal Court of Appeal in Norton v. Via Rail Canada (2005), 255
D.L.R. (4th) 311, at paragraph 15, states that striking out an application
before hearing is an extraordinary remedy, granted only in narrowly defined
circumstances.
[35]
The
question of whether the same high standard applies equally to motions brought
pursuant to paragraph 6(5)(a) was subsequently considered by Justice Hughes in
the recent decision in Pfizer Canada Inc. v. Canada (Health), 2007 FC
188. He concluded that the Court has a duty to decide if a determination can be
made based on the law and “uncontroverted relevant evidence or admissions or
plain and obvious findings on the evidence”.
[15]
The balance that a Court must consider in this matter
concerning section 6(5)(a) of the NOC Regulations is whether, on the one hand,
an application should continue where at least one of the patents should not have
been on the register in the first place. It would be a waste of judicial
resources and those of the parties to do so. On the other hand, a party
should not be deprived of its opportunity to make full argument based on all
the evidence that would ultimately be before the Court. This latter point
is tempered however in cases such as this where the application is to proceed
in a summary fashion based on affidavit evidence and written transcripts of
cross-examination alone and, at the end of the day, a decision has no binding
effect should the parties proceed to an ordinary infringement and validity
action.
[16]
Taking these matters into consideration I find
that a section 6(5)(a) motion should be considered on the basis that if a
determination can be made based on law and the application of uncontroverted
relevant evidence or admissions or plain and obvious findings on the evidence,
then the Court should proceed to make a determination. Section 6(5)(a)
must have a purpose that is not trivial. However, if the Court finds
itself determining the matter on disputed relevant evidence or having to weight
the merits of competing expert opinion, the matter should be left to the
hearing at trial. It is difficult to sum this up as simply “plain and
obvious”, it goes beyond that, but where the law can be applied to admissions
and relevant evidence that is quite reasonably found to be undisputed or “plain
and obvious” then the Court has a duty to make a determination.
[36]
The
administrative scheme set out in section 6 provides a specific procedure and a
judicial forum for a generic manufacturer to short-circuit the prohibition
application: Apotex v. Canada (2000), 3 C.P.R. (4th) 1
(F.C.A.) at para. 22-24. A second person may, by discrete and interlocutory application,
move to dismiss the application on the grounds that the patent is not eligible
for inclusion on the register.
[37]
In
the case at bar, both the Applicants and Novopharm have been given an
opportunity to adduce evidence, to conduct cross-examinations, to make written
submissions, and to be fully heard on the issue of non-eligibility of the ‘753
Patent for inclusion on the Register. Since the issue of eligibility of the
patent will not be adjudged in this case otherwise than on the current motion,
I see no reason to apply a stricter test than would generally apply to
application itself. I conclude therefore that although Novopharm bears the
burden of proof of establishing that the patent is not eligible for inclusion
on the Patent Register, the balance of probabilities standard applies. It
remains that the evidence must be viewed in the light most favorable to the
Applicants and all reasonable inferences must be drawn in their favour.
The eligibility argument
[38]
Under
the Regulations, the Minister of Health maintains a Patent Register. The
Register consists of patent lists submitted in respect of drugs for which a NOC
has been issued. Patent lists filed for inclusion on the Patent Register are
subject to the eligibility requirements under Regulations. Paragraph
6(5)(a) of the Regulations has been described as an important mechanism
available to generic drug manufacturers to have applications dismissed at an
early stage where ineligible patents are on the Register.
[39]
Pursuant
to par. 4(2)(b) of the Regulations, a patent may only be added to the
Register if it contains a claim to the medicine or the use of the medicine.
4(2) A patent list submitted in respect
of a drug must
(b) set out any Canadian patent that is
owned by the person, or in respect of which the person has an exclusive licence
or has obtained the consent of the owner of the patent for the inclusion of the
patent on the patent list, that contains a claim for the medicine itself or a
claim for the use of the medicine and that the person wishes to have included
on the register;
[40]
Novopharm
submits that neither lansoprazole nor its use form part of the “invention” of
the ‘753 Patent. According to Novopharm, the invention of the ‘753 Patent is a
rapidly disintegrating oral dosage form; in short, a delivery system. The
Applicants submit that the ‘753 Patent relates to a lansoprazole composition or
preparation, and that, properly construed, the relevant claims of the Patent
cover a lansoprazole composition that can include granules. The eligibility argument
comes down to whether the claim in the Patent is a claim to a delivery system
or to a payload.
[41]
The
Federal Court of Appeal has held that a patent is not eligible for listing when
it is directed to a delivery system rather than a payload: GlaxoSmithKline
Inc. v. Canada (Attorney General) (2005), 40 C.P.R. (4th) 193 (FCA)
at para. 42-44 (“GlaxoSmithKline”); Biovail Corp. v. Canada (Minister of National
Health and WeIfare) (2006),
46 C.P.R. (4th) 321 (FCA) at para. 6-7 (“Biovail”); Proctor & Gamble
Pharmaceuticals Canada Inc. v. Canada (Minister of Health), 2007 FCA 31 at para. 4.
[42]
Where
the patent involves a combination of an Active Ingredient and a device whose
purpose is to administer that ingredient to a patient, the patent is not
eligible for protection under the Regulations, as such a patent does not
contain a claim for a medicine or the use of a medicine. In Biovail, the
Federal Court of Appeal held that where a patent contains claims that can be
either the medicine itself or a delivery system, the question is one of
construing the patent and that the claims must not be construed in isolation
from one another and the rest of the patent.
[43]
In GlaxoSmithKline
above, the Federal Court of Appeal concluded that a patent for a
controlled release capsule was not covered by the Regulations. According
to Justice Desjardins, the patent did not even refer to a particular medicine
contained in the capsule. It simply referred to an “active substance”, and
therefore, the patent could not be said to claim protection for a medicine. In
concluding that the patent was ineligible for listing on the Register, Justice
Pelletier, who concurred in the result with Justice Desjardins, applied the
following reasoning:
If one reviews the “medical devices”
cases referred to above, one notes that the theme which runs though them all is
the dichotomy between the delivery system and its payload. The attempts to
define “claim for the use of the medicine itself” on the basis of whether the
ingredients are mixed, or the presence of physical devices, all point to a more
fundamental distinction between a delivery system and that which is delivered
by that system. The distinction articulated in Glaxo Group Ltd (C.A.) between devices for the administration of medicaments and
the medicaments which are themselves administered is another way of expressing
the difference between delivery system and payload. But, as this case shows,
the distinction is more difficult to make when a tablet is both the thing
administered and that which administers the drug. The distinction between
delivery system and payload bridges both types of tests by focussing on the
substance of the patent. Does the patent protect the delivery system or does it
protect the payload?
If the patent protects the delivery
system, then it does not contain a claim for the medicine itself, or the use of
the medicine, even if it contains a reference to the medicine as payload.
[44]
Novopharm
submits that the proper approach in determining eligibility for listing under
s. 6(5) of the Regulations is to examine the “nature of the invention”
(also referred to as the “purpose of the patent”, “nature of the patent” and “essence
of the invention”) in determining whether a patent constitutes a “delivery
system” or a “payload”. In doing so, the Court examines the claims of the
patents, but also looks to the disclosure to identify the “substance of the
patent”, even where there are specific claims to a particular payload. Thus,
the determination of the “nature of the invention” (the land) is critical on
this motion while the scope of the monopoly (the fence posts) is merely a
component of the larger analysis. Biovail Corp. (c.o. b. Biovail
Pharmaceuticals Canada) v. Canada (Minister of National Health and Welfare),
[2005]
F.C.J. No. 1402 ; aff’d (2006), 46 C.P.R. 4th 321 (F.C.A.) ("Biovail");
GlaxoSmithKlineInc. v. Canada (Attorney General), [2006] F.C.J. No. 1620
(CA) (GSK1), Proctor & Gamble Pharmaceuticals Canada Inc. v. Canada (Minister of Health), [2006] F.C.J. No. 515
(P&G1); aff’d (2006) (F.C.A.) 347; Pfizer Canada Inc. v. Canada (Attorney General) 7 2004 F.C. 370.
[45]
The
Applicants disagree that a determination of whether a patent claims the
medicine itself involves a determination of the “nature of the invention”.
According to the Applicants, the issue is one of claims construction and
requires a consideration of each claim. They submit that a patent must be given
a purposive construction in accordance with the decision of the Supreme Court
of Canada in Free World Trust v. Électro Santé Inc. (2000), 9 C.P.R. (4th)
168 at para 30, rather than relying on vague notions like the “essence” or the
“spirit” of the invention.
[46]
Even
applying the purposive construction proposed by the Applicants, the result
would be the same. Without having to refer to the abstract, I am satisfied on a
plain reading of ‘753 Patent as a whole that it protects a delivery system in
which seemingly any active compound can be packaged and delivered in a rapidly
dissolving oral form.
[47]
Lansoprazole
is not mentioned in claim 1 or dependent claims 2-6, 8 or 9. Therefore, these
claims are not claims for lansoprazole itself or the use of lansoprazole.
Further, claims 1-6 relate solely to a delivery system that can be used with
the 190 or more Active Ingredients described in the disclosure. They are
therefore solely directed to a means of administering any medicine. Claims 7-9
relate to lansoprazole, voglibose and candesartan cilexetil respectively.
Claims 10 or 11 do not mention lansoprazole or its use. Both claims relate
solely to the delivery system applicable to the numerous Active Ingredients
mentioned in the disclosure. The only “use” described in these claims is the “use
of L-HPC having hydroxypropoxyl group contents of 7.0 to 9.9 percent by weight.”
This is not a use of lansoprazole.
[48]
As
lansoprazole is not mentioned in claim 12, this is not a claim for the medicine
lansoprazole or its use. Depending from claim 10, it too is related solely to
the aspects of a delivery system applicable to the numerous Active Ingredients
mentioned in the disclosure. While claims 13-17 mention lansoprazole, they are
not claims to the medicine lansoprazole itself. The uses referred to in claims
13-20, are not uses of lansoprazole but uses of L-HPC. Specifically, they are
uses of L-HPC having a hydroxypropoxyl group content of 7.0 to 9.9 percent by
weight for the manufacture of a pharmaceutical preparation capable of buccal
disintegration or dissolution. Depending from claim 10, these claims are
related solely to the patented delivery system which can be used to deliver the
numerous Active Ingredients mentioned in the disclosure.
[49]
I am
not satisfied that the experts put forward by the Applicants took a proper
approach to the claims construction of the ‘753 patent. Instead, they
incorrectly focused on lansoprazole to the exclusion of all the other medicines
covered by this patent. I prefer the evidence of David Graham who asserts that
the ‘753 Patent does not seek to protect the medicine lansoprazole any more
than it protects the other 189 Active Ingredients described in the disclosure.
The use of lansoprazole, and indeed any other Active Ingredient in the ‘753
Patent, is included in the patent simply to show how an Active Ingredient, with
its known uses, can be delivered by the patented invention. In fact, the uses
of the Active Ingredients appear to be included merely to explain the rather
obvious point that the appropriate dosing of even a single Active Ingredient
will vary depending on the disease state and the subject being treated. I
concur that the claims referring to specific active ingredients are merely
narrow expressions of the patented delivery system and do not constitute claims
to those medicines or their use.
[50]
Lansoprazole,
enteric coatings, enterically coated lansoprazole, delayed release enterically
coated granules of lansoprazole and the uses for all of these were known for
many years prior to May 26, 1997, the earliest relevant date for the ‘753
Patent. Lansoprazole and its uses were known long before the Relevant Date. Therefore,
the invention of the ‘753 Patent cannot subsist in describing this particular
Active Ingredient and its known uses. Instead, the ‘753 Patent explains that
various medicines can be used with the delivery system invention.
[51]
Lansoprazole
is merely one of several “payloads” which can be used in the delivery system.
The claims mentioning lansoprazole are no more than a narrow expression or
embodiment of the delivery system which is the patented invention, applied to 1
of at least 190 possible Active Ingredients.
[52]
Based
on the above, it is clear that the ‘753 Patent does not contain a “claim for
the medicine itself” or a “claim for the use of the medicine” and is therefore
not eligible for listing on the Register. Pursuant to the first portion of par.
6(5)(a), this application should be dismissed.
The abuse of process argument
[53]
Inclusion
of patents on the Patent Register is significant to an innovator, providing it
with an opportunity to delay, for up to 24 months, a generic from entering the
market where the patent may be infringed. Novopharm maintains that Abbott’s
litigation strategy in this application and two other related applications is
intended to delaying the entry of the Novopharm Capsules into the Canadian
marketplace through an abuse of the Regulations, improperly taking
advantage of the availability of successive 24-month stays and listing patents
against unrelated products. In light my conclusion that the application should
be dismissed pursuant to par. 6(5)(a), I need not determine this issue.
[54]
Takeda
appeared on this motion to counter certain allegations of abuse of process levelled against them by
Novopharm. At paragraphs 15 to 17, and 36 to 40 of his affidavit sworn August
11, 2006, Brian Des Islet, Executive Director of Research and Development at
Novopharm, states that Takeda added 18 new claims to the ‘753 Patent
application in August 2005, within 12 days of Novopharm’s disclosure of its
formulation to the Applicants and Takeda in Court No. T-214-05, and began
“vigorously prosecuting” its patent application that had laid dormant in the
Patent Office for two years. Takeda views the allegations as serious since
they insinuate that Takeda misused confidential information received from a
different proceeding during the prosecution of the ‘753 Patent, and abused the Regulations
in an attempt to delay Novopharm’s entry in the workplace.
[55]
Novopharm
did not pursue the allegations in its written submissions and abandoned them at
the start the hearing of the motion. Although I disagree with Takeda’s
characterization of Mr. Des Islet’s evidence as tantamount to charges of
“dishonesty, fraud, breach of a Court Order, and conspiracy”, the allegations
were serious and needed to be rebutted. In the circumstances, I conclude that
Takeda should be entitled to its costs and disbursements associate in defending
its reputation.
ORDER
THIS COURT ORDERS that
1.
The
application is dismissed.
2.
The
Applicants’ motion for disclosure will not be dealt with.
3.
Novopharm’s
costs of the motion and the application are to be paid by the Applicants.
Novopharm shall provide written submissions of no more than three pages
concerning the appropriate scale and amount of its fees and disbursements, the
Applicants shall provide a response on the same issues not exceeding five
pages, and Novopharm shall provide a reply not exceeding three pages.
Takeda’s
costs of the motion, with fees assessed based on the middle of Column III of
Tariff B, and reasonable disbursements, shall be paid by Novopharm. Takeda is
entitled to claim costs for two counsel, including the costs related to attend
the motion to dismiss in Toronto, the cross-examination of Mr. Goto in Osaka, and the
cross-examination of Mr. Des Islet in Toronto. If the parties cannot agree on quantum, Takeda
shall provide written submissions of no more that three pages explaining its
claimed fees and disbursements and Novopharm shall provide a response not
exceeding three pages.
“Roger
R. Lafrenière”
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