Date: 20090130
Docket: T-1934-07
Citation: 2009 FC 102
Ottawa, Ontario, January 30,
2009
PRESENT: The Honourable Mr. Justice Lemieux
BETWEEN:
SOLVAY
PHARMA INC.
Applicant
and
ATTORNEY GENERAL OF CANADA
and THE MINISTER OF HEALTH
Respondents
REASONS FOR JUDGMENT AND JUDGMENT
I. Introduction
[1]
This
judicial review application is a challenge by Solvay Pharma Inc. (Solvay or the
innovator) to the October 10, 2007 decision by the Minister of Health
(the Minister) who refused Solvay’s application to list its Canadian Patent
No. 2,240,895 (the ‘895 patent) on the Patent Register (the Register)
maintained by the Minister pursuant to the Patented Medicines (Notice of
Compliance) Regulations (the NOC Regulations).
[2]
The
Minister was of the view Solvay’s ‘895 patent did not meet the eligibility
requirements for the listing of a patent on the Register set out in paragraph
4(3)(c) of the Regulations. Subsection 4(3) of the Regulations
dealing with the eligibility requirements for listing of a patent on the Register
had been substantially amended on October 5, 2006. Subsection 4(3) of the Regulations,
incorporating the October 5, 2006 amendments, reads:
|
Patented Medicines (Notice of Compliance) Regulations,
SOR/93-133
4.(3) A patent on a patent list in relation to a
supplement to a new drug submission is eligible to be added to the register
if the supplement is for a change in formulation, a change in dosage form
or a change in use of the medicinal ingredient, and
(a) in the case of a change in formulation, the patent
contains a claim for the changed formulation that has been approved through
the issuance of a notice of compliance in respect of the supplement;
(b) in the case of a change in dosage form, the patent
contains a claim for the changed dosage form that has been approved through
the issuance of a notice of compliance in respect of the supplement; or
(c) in the case of a change in use of the medicinal
ingredient, the patent contains a claim for the changed use of the medicinal
ingredient that has been approved through the issuance of a notice of
compliance in respect of the supplement. [Emphasis mine.]
|
|
Règlement sur les médicaments brevetés
(avis de conformité), DORS/93-133
4.(3) Est
admissible à l’adjonction au registre tout brevet, inscrit sur une liste de
brevets, qui se rattache au supplément à une présentation de drogue nouvelle
visant une modification de la formulation, une modification de la forme
posologique ou une modification de l’utilisation de l’ingrédient médicinal,
s’il contient, selon le cas :
a) dans le cas d’une modification de
formulation, une revendication de la formulation modifiée, la formulation
ayant été approuvée par la délivrance d’un avis de conformité à l’égard du
supplément;
b) dans le cas d’une modification de la
forme posologique, une revendication de la forme posologique modifiée, la
forme posologique ayant été approuvée par la délivrance d’un avis de
conformité à l’égard du supplément;
c) dans le cas d’une modification
d’utilisation de l’ingrédient médicinal, une revendication de l’utilisation
modifiée de l’ingrédient médicinal, l’utilisation ayant été approuvée par la
délivrance d’un avis de conformité à l’égard du supplément.
[Non souligné dans
l’original.]
|
[3]
As
a matter of convenience at this point, I also set out the definition of “claim
for the use of the medicinal ingredient” added to section 2 of the NOC Regulations
by the October 5, 2006 amendments:
|
"claim
for the use of the medicinal ingredient" means a claim for the use of
the medicinal ingredient for the diagnosis, treatment, mitigation or
prevention of a disease, disorder or abnormal physical state, or its
symptoms; [Emphasis
mine.]
|
|
«revendication
de l’utilisation de l’ingrédient médicinal» Revendication de l’utilisation de
l’ingrédient médicinal aux fins du diagnostic, du traitement, de
l’atténuation ou de la prévention d’une maladie, d’un désordre, d’un état
physique anormal, ou de leurs symptômes. [Non souligné dans
l’original.]
|
[4]
Specifically,
the Minister’s refusal was based on two grounds. First, Solvay’s Supplementary
New Drug Submission (SNDS) dated March 11, 2005 to which the ‘895 patent
was connected or related for listing on the Register was not a submission
for a change in use of the medicinal ingredient – testosterone – (in the
form of topical gel) as set out in the product monograph approved by Health
Canada for ANDROGEL, namely, hormone replacement therapy in males suffering
from conditions associated with a testosterone deficiency. According to Health Canada, all that Solvay’s
SNDS did was to update the product monograph to reflect its safety and efficacy
for treatment beyond 180 days as a result of recent clinical studies on long
term usage of ANDROGEL. Second, according to the Minister, the ‘895 patent does
not contain a claim for the changed use introduced in the monograph by Solvay’s
relevant SNDS of March 11, 2005 for which an NOC issued.
[5]
Two
regulatory schemes provide the framework for the Minister’s decision. First,
there is the regulatory scheme set out in the relevant provisions of Part C,
Division 8 of the Food and Drug Regulations (the F&D Regulations)
which state that no drug shall be marketed in Canada unless the
manufacturer has obtained from the Minister a Notice of Compliance (NOC) for
that drug, by filing a drug submission. The F&D Regulations provide
for different types of drug submissions appropriate to different circumstances.
Typically, a drug innovator such as Solvay, seeking its first approval to
market a new drug in Canada, files with Health Canada a new drug submission
(NDS) which normally contains a vast amount of data by way of clinical trials
and other studies which enables the Minister to be satisfied as to the safety
and efficacy of the new drug before authorizing its sale in Canada. After a
drug has been approved for sale, a wide range of changes may be made in respect
of the drug or its backup document such as to the approved product monograph or
label for that drug which requires the filing of an SNDS or another type of
submission depending on the nature of the change.
[6]
The
second regulatory prong underpinning the Minister’s decision are the NOC
Regulations first enacted by the Governor-in-Council in 1993, pursuant to
the provisions of section 55 of the Patent Act. These regulations call
for the maintenance of a Patent Register listing Canadian patents held by innovator
drug manufacturers. If a generic drug manufacturer wishes to market a generic
drug in Canada, it must
obtain an NOC from the Minister by the filing of an Abbreviated New Drug
Submission (ANDS) which typically compares the generic’s drug with the equivalent
drug of an innovator who is already on the market via an NOC issued by the
Minister. This ANDS by a generic drug manufacturer triggers the procedure set
out in the NOC Regulations if an innovator’s drug is listed on the
Patent Register. In such a case, the generic drug manufacture must notify the
innovator through a Notice of Allegation (NOA) stating the marketing of
its drug would not infringe the listed patent or that the listed patent is
invalid. Once an NOA has been served, the innovator drug company may launch
prohibition proceedings to determine whether the NOA is justified. Generally,
until those proceedings are determined, the Minister cannot for a certain
period of time issue an NOC to the generic under the F&D Regulations.
However, if the patent for that drug is not listed on the Register, no NOA
needs to be served and filed and the process under the NOC Regulations
is closed to the innovator drug manufacturer albeit an action for patent infringement
is not. In other words, the Minister’s action to issue an NOC to the generic
manufacturer is not constrained if the Minister is otherwise satisfied under
the F&D Regulations.
II. Facts and context
[7]
On
August 6, 2000, Solvay filed with the Minister, pursuant to the F&D
Regulations, a NDS for the purpose of obtaining a NOC which would
authorize it to market its ANDROGEL product on the Canadian market. Solvay was
issued that NOC on February 6, 2002. That NOC also approved the product
monograph for ANDROGEL dated January 28, 2002. The Indications and Clinical
Use section of that product monograph reads:
AndroGelTM (testosterone gel)
is indicated for replacement therapy in males for conditions associated with a
deficiency or absence of endogenous testosterone:
1. Primary hypogonadism (congenital or
acquired) – testicular failure including cryptorchidism, bilateral torsion,
orchitis, vanishing testis syndrome, orchiectomy, Klinefelter’s syndrome,
chemotherapy, or toxic damage from alcohol or heavy metals. These men usually
have low serum testosterone levels but have high gonadotropins (FSH, LH) above
the normal range.
2.
Hypogonadotropic
hypogonadism (congenital or acquired) – idiopathic gonadotropin or luteinizing
hormone-releasing hormone (LHRH) deficiency or pituitary-hypothalamic injury
from tumors, trauma, or radiation. These men have low testosterone serum levels
but have gonadotropins in the normal or low range.
3.
In sexual
dysfunction or for male climacteric symptoms when the conditions are due to a
measured or documented testosterone deficiency.
[8]
On
August 29, 2001, Solvay filed its application for the ‘895 patent which was
laid open for public inspection on March 9, 2002. This patent issued six
years later on March 13, 2007. Pursuant to subsection 4(6) of the NOC
Regulations, Solvay had 30 days from the grant of the ‘895 patent to submit
the patent for listing against an eligible drug submission. Solvay made that
application on March 13, 2007 which was refused by the Minister on October
10, 2007 for the reasons previously stated herein.
[9]
After
it obtained its NOC in February 2002 to sell ANDROGEL, Solvay sought in
March 2000, by way of a notifiable change submission, approval for certain
updates to its ANDROGEL product monograph in order to reflect the most current medical
terminology. That update was accepted with the product monograph revised as
of July 16, 2002.
[10]
In
late 2004,
Solvay obtained the results of a long term extension study entitled “A Long-term
Study of the Safety and Effectiveness of Testosterone Gel for hormonal
replacement in hypogonadal men”. Solvay’s NDS had been based on an initial six
month pivotal study which contained the clinical results for the treatment of
males with ANDROGEL for a treatment period of up to 180 days. The extension
study continued the patient treatment with ANDROGEL for periods of up to 42
months. Solvay wanted to reflect the extension study results in its product
monograph for ANDROGEL and, for this purpose, its Regulatory Affairs Associate
contacted Health and Welfare Canada to determine what kind of submission was
required: could the changes to the product monograph be made by way of a
notifiable change submission or was an SNDS required? Her inquiry
enclosed draft changes to the product monograph. Her e-mail identified its
subject as “Product Monograph Revisions”.
[11]
On
December 31, 2004, Solvay’s Regulatory Affairs Associate was advised by
Adam Gibson, the A/Senior Regulatory Project Manager for the Bureau of
Metabolism, Oncology and Reproductive Sciences (BMORS) in the Therapeutics
Products Directorate (TPD) of Health Canada as follows:
In response to your inquiry below, the
proposed changes and inclusion of results from your extended study would be
considered an SNDS.
The primary reasons for this classification
are as follows:
- A change has occurred to the Dosage and
Administration Section.
- References to the long term study
results in other sections, such as “Adverse Reactions” and “Action and Clinical
Pharmacology” imply a long-term usage of Androgel beyond the timeframes
outlined in the original clinical data. Although this is not an explicit change
to the indication section of the Androgel Product Monograph, the Reproduction
and Urology Division (RUD) considers the inclusion of long-term study results
to directly influence the implied use of the product. You may wish to note
that the latter consideration is applicable to all sponsors of steroid products
making similar changes.
For the reasons above and in accordance
with our Changes to Marketed New Drug Products Policy, this submission will
be considered an SNDS. [Emphasis mine.]
[12]
The
Applicant’s record contains a copy of Health and Welfare Canada’s Policy on Changes
to Marketed New Drug Products dated April 1994 which suggested that an SNDS was
required for a change:
5. in the
labelling including package inserts, product brochures, file cards, and product
monographs of the drug product respecting, either explicitly or implicitly:
i)
the recommended route of administration of the drug product,
ii)
the dosage of the drug product, and
iii)
the claims, including indications, made for the drug product.
[13]
Solvay’s
SNDS for ANDROGEL was submitted on March 10, 2005. In a covering letter,
the Regulatory Affairs Associate explained the SNDS had two purposes, the first
being “to update the Product Monograph based on the results of the open-label,
long-term extension study”.
[14]
The
NOC which was issued in connection with the SNDS is dated January 25, 2006
and indicated the reason for the SNDS to be “Update PM with long term extension
study results”.
[15]
The
Applicant’s record (Volume I, at page 69) contains the ANDROGEL Product
Monograph (ANDROGEL PM) updated in accordance with the SNDS. Its indications
and clinical use section is substantially the same in wording to the ANDROGEL
PM dated January 2002; taking into account the wording update as a
result of the notifiable change which occurred in March 2002. As counsel for
Solvay demonstrated ANDROGEL PM contained some wording changes to the
contra-indications, the warnings and precautions, adverse reactions,
administration, pharmacokinetics and clinical
trial sections of the product monograph. The Applicant’s record also contains
the affidavit of Dr. Alvaro Morales sworn December 7, 2007. Solvay relies on it
to support its argument the 2006 NOC represents a change in the use of
ANDROGEL. The Minister objected to its receipt because it was not before the
Minister and cites jurisprudence as settled law. I will deal with this
objection later.
[16]
The
Respondents’ record contains several documents introduced through the affidavit
of Waleed Jubran who is a Patent Officer – Science in the Office of the
Patented Medicines and Liaison (OPML) in the TPD. His duties include the
administration of the NOC Regulations which primarily involves ensuring
that notices of compliance are issued in accordance with the NOC Regulations
which requires knowledge of the drug submission and the NOC Regulations.
According to him, Solvay’s SNDS “was approved for an update to the safety
information in the product monograph for ANDROGEL and not for a change in the
formulation, a change in dosage form or a change in the use of the medicinal ingredient
as required by subsection 4(3) of the NOC Regulations” concluding “the ‘895
patent … is not eligible for listing on the Patent Register in respect of the SNDS
097485.” He was cross-examined on his affidavit.
[17]
He
states at paragraph 9 of his affidavit “the indications (the approved uses), are
described in the “Indications and Clinical Use Section …” He adds: “Only those indications
approved by Health Canada can be included.”
[18]
Paragraph
12 of his affidavit reads:
12. The rationale underlying
the listing of “use patents” on the Patent Register is described at page 1517
of the Regulatory Impact Analysis Statement (“RIAS”) accompanying the October 5th
amendments to the NOC Regulations, attached as Exhibit “C”. In respect
of an NDS, the NOC Regulations seek to “limit the eligibility of use
patents to those which contain a claim to an approved method of using the
medicinal ingredient, for an approved indication. This link should be apparent
from a comparison of the claims in the patent with the relevant portions of the
product monograph and labelling for the approved drug.” In respect of an SNDS,
as described at page 1518 of the RIAS, the purpose of the SNDS must be a change
in use of the medicinal ingredient (i.e. a new method of use or new indication)
and the patent must contain a claim to the use so changed.
[19]
At
paragraph 19 of his affidavit, he describes the update of the language in the ANGROGEL
PM which was authorized by the Notifiable Change submission in March 2002.
[20]
At
paragraph 21 of his affidavit, he analyses all of the changes proposed by
Solvay through its March 10, 2005 SNDS as noted in the TD’s Pharmaceutical Safety
and Efficacy Assessment Template (PSEAT) which was prepared by the BMORS
responsible for reviewing and approving drugs such as ANDROGEL. In that
process, BMORS recommend a number of other revisions to the ANDROGEL PM.
[21]
Mr.
Jubran asserts that overall BMORS concluded SNDS 097485 “sought an update to
the safety information of the product monograph” as reflected in the PSEAT but
also in the Executive Summary for Submission Review dated December 9, 2005 which
was considered by the Director General of the TPD for decision as to whether an
NOC should be issued for SNDS 907485.
[22]
On
March 13, 2007, as noted, Solvay submitted to the OPML a form IV patent list
for the ‘895 patent in respect of its ANDROGEL product which indicated the uses
of the medicinal ingredient (testosterone) were:
1. Primary hypogonadism;
2. Secondary hypogonadism;
3. Sexual dysfunction or andropause.
[23]
The
record indicates that on March 20, 2007, Mr. Jubran consulted Mr.
Randall, the Regulatory Project Manager, Oncology Division of BMORS who advised
him: “It does not appear that the indications changed under this submission.”
[24]
On
March 26, 2007, the Associate Director, OPML, wrote to Solvay’s Vice
President, Medical and Regulatory Affairs to advise the SNDS of March 10, 2005 was
submitted “for approval of a Product Monograph update based on the results of a
long term extension study” and was therefore not eligible because the SNDS
contained no change in formulation, dosage or in the use of testosterone, the medicinal
ingredient in ANDROGEL.
[25]
The
Associate Director, OPML, asked for Solvay’s written representations, which
were provided by letter dated April 25, 2007 from Solvay’s outside legal
counsel, Anita Nador from McCarthy Tétrault, who
submitted that
the changes identified in the product monograph were not simply an update but
reflected a change in the use of testosterone, the medicinal ingredient
based on the results of the long range safety and efficacy study “that examined
the use of the drug well beyond the six month studies performed to support the
original NDS”. The crux of Ms. Nador’s submissions are contained in the
following two paragraphs:
On the basis of these data, the SNDS
amends the Product Monograph by extending the period in which the safety and
efficacy of the drug has been demonstrated from 6 months to three years. Solvay
regards this as a change to the use described in the Product Monograph.
Fundamentally, the supplement pertains to
a change in the length of the demonstrated period of time during which the drug
can be used safely and effectively. The changes include reference to safety in
the extended period of use and to benefits, or efficacy in that period of use.
As such, the SNDS does relate to a change in the use of the medicinal
ingredient, namely the use of the drug to achieve such desired effects as
“hormonal steady state levels of testosterone”, safely, over a longer time
frame for treatment.
[26]
She
then identified the numerous changes in the ANDROGEL PM and provided the
following examples about safety in longer term use:
·
Under
the “Warning and Precaution” section which described the prolonged use of methyltestosterone
may cause peliosis hepatis, the following statement was inserted: “ANDROGEL is not
known to produce these adverse effects”. Ms. Nador argued this phrase was a key
addition to the product monograph and is an assertion that in the long term
study conducted over 36 months, ANDROGEL does not produce the adverse effects
associated with “prolonged use” and that it was a claim about the relative
safety of using ANDROGEL in a longer duration than had been approved by the
original NOC;
·
The
addition of the sentence: “Similar trends were observed in patients followed
up to 3 years” in a section of the product monograph dealing with the
maintenance of serum testosterone concentration in follow up measurements 30, 90 and
180 days. Ms. Nador submitted the added sentence in the SNDS demonstrated “that
concentrations may be maintained for longer periods than originally stated
which again indicates the extended use of the product”;
·
Under the “Clinical Trials” section, the added reference in the SNDS
“to the implied duration of safe and effective use which had previously
been based on a 6 month study and is now based on 42 months of data”. Ms. Nador
submitted “this change shows that the implied duration of safe and effective
use is now based on a much longer period than originally stated”;
·
Under the “Action and Clinical Pharmacology section”, the
reference to additional symptoms of hypogonadism; Ms. Nador argued: “the
addition of those to the Product Monograph based on the data presented in the
longer term study is clearly related to the implied use of the drug to address
such symptoms”.
[27]
Solvay’s
counsel concluded:
It is clear that the SNDS seeks approval
of changes to the Product Monograph that relate directly to a change in “use”
of the drug. The safe and effective duration of use is extended and
important changes to the implied use of the product, as authorized to be
described in the Product Monograph, are clearly the essential subject of the
SNDS. [Emphasis mine.]
[28]
She
also pointed out that Health Canada “clearly shares Solvay’s view of the nature
and import of the changes to the use of ANDROGEL, as effected by the SNDS
pointing to and quoting the December 31, 2004 e-mail from Adam Gibson”.
[29]
By
letter dated June 11, 2007, from its Director David Lee, the OPML commented on
Ms. Nador submissions of April 25, 2007. Mr. Lee pointed out the amended NOC
Regulations as at October 5, 2006 applied because Solvay’s patent list for
the ‘895 patent was received by OPML on March 13, 2007. He characterized
Solvay’s submissions in these terms:
In your representations,
you indicate that supplemental new drug submission (“SNDS”) 097485 seeks a
notice of compliance for a change in use of the medicinal ingredient. You take
the position that SNDS 097485 pertains to a change in the period of time during
which ANDROGEL can be used safely and effectively. More specifically, you
indicate that the period in which the safety and efficacy of the drug has been
demonstrated has been extended from six months to three years.
Even if the OPML were
to accept your position that SNDS 097485 seeks a notice of compliance for a
change in use of the medicinal ingredient, the fact remains that there is no claim
within the ‘895 patent for the specific changes that have been approved through
the issuance of a notice of compliance in respect of the above-noted supplement.
More specifically, the ‘895 patent does not contain a claim for the change in
duration of use, or a claim for the relative safety of using ANDROGEL for a
longer duration. As indicated in paragraph 4(3)(c) of the NOC
Regulations, a patent on patent list in relation to a SNDS is eligible to
be added to the Patent Register if the supplement is for a change in use of the
medicinal ingredient and the patent contains a claim for the changed use
of the medicinal ingredient that has been approved through the issuance
of a notice of compliance in respect of the supplement.
[30]
Mr.
Lee then referred to the Regulatory Impact Analysis Statement (RIAS) which
accompanied the October 5, 2006 amendments. He indicated that “product
specificity is the key consideration required of the Minister in applying the listing
requirements under section 4 of the NOC Regulations”. He wrote: “the
amended language of section 4 more precisely reflects the intended link between
the subject matter of a patent on a patent list and the content of the
underlying submission for the notice of compliance in relation to which it is
submitted”.
[31]
Ms.
Nador wrote to Mr. Lee on June 15, 2007 pointing out that OPML had
advanced a new ground for not listing the ‘895 patent on the Register. She
asked for additional time to address this new ground. Those additional
submissions are contained in her letter of July 20, 2007 to Mr. Lee
which she submitted the ‘895 patent contained claims that are specific to the
changes that form the basis of the SNDS; that is the ‘895 patent contains a
claim for the changed use of the medicinal ingredient.
[32]
She
referred Mr. Lee to her letter of April 25, 2007 and noted one of these changes
was the addition of the symptom “erectile dysfunction” to the “Action and
Clinical Pharmacology” section. She noted the addition of this symptom to the
Product Monograph, based on data from the longer term study, is clearly a
change in the use of the drug to address this symptom. She referred to claims 25,
63, 87, 91 and 95 in the ‘895 patent as directed to the treatment of this
function.
[33]
She
also observed: “Additionally, the long term efficacy data included in the
Product Monograph indicates that serum testosterone concentrations are
generally maintained within the eugonadal range,
and can be maintained for at least a period of three years.” She stated the
‘895 patent had claims for this changed use mentioning claims 30, 59 and 91
which in her view “contemplate maintenance of testosterone levels for
extended periods as they are directed to the use of testosterone to achieve
hormonal steady state levels of testosterone”, adding “claims for the daily use
without an upper limitation on duration of use are also claims for the changed
use of ANDROGEL for instance claims 27, 56 and 88”.
[34]
She
advanced an additional point stating “further claims for use in the treatment
of conditions that are chronic conditions in which change in duration in use
and change in the safety of using ANDROGEL for a longer period is beneficial,
including, but not limited to hypogonadism (claims 23, 24, 53, 54, 85 and 86)
are inherently claims for the changed use which was approved through the
issuance of the NOC for the SNDS. These are directly related to the subject of
the SNDS and the longer term duration of use and safety of ANDROGEL”.
[35]
Finally,
she concluded by submitting the addition of data relating “to duration of use
and a change in safety are a change in the use of the product ANDROGEL for the spectrum
of indications/conditions outlined in the product monograph”, stating “the ‘895
patent had claims for the use of the medicinal ingredient for the treatment of
said indications/conditions. As such, those changed uses are claimed in the
‘895 patent (e.g. claims 1 – 95)”. She concluded:
Because the SNDS relates to a change in
the use of ANDROGEL in the treatment of said indications/conditions, and
because the claims in the ‘895 patent are claims for a changed “use” of
ANDROGEL in the treatment of these indications/conditions, they are all claims
that render the ‘895 patent listable on the Patent Register with respect to
said SNDS.
[36]
She
closed off the issue by drawing Mr. Lee’s attention, by letter dated August 3,
2007 to the Federal Court’s recent decision in Abbott Laboratories Ltd. et
al v. the Attorney General of Canada, 2007 FC 797 (Abbott/PREVACID)
which Ms. Nador submitted supported Solvay’s position.
[37]
On
October 10, 2007, the OPML conveyed its views to Ms. Nador that she and
Solvay’s solicitors had not persuaded it the relevant SNDS was for a change in
the use of the medicinal ingredient for ANDROGEL – testosterone.
[38]
Anne
Bowes, the Associate Director of OPML reviewed the submissions made by Ms.
Nador and legal counsel. She expressed the view that OPML’s June 11, 2007
response did not raise a new ground for rejection – lack of a claim in the ‘895
patent for the alleged changed use. OPML did, however, respond to Solvay’s
submissions that the ‘895 patent did claim the changed use namely (a) the use
of testosterone to treat erectile dysfunction and (b) the long term use of
testosterone as related to the submission for the new use for the treatment of
erectile dysfunction.
[39]
Anne
Bowes then wrote:
After reviewing your representations
of July 20, 2007 and August 3, 2007, the OPML remains of the view that the
‘895 patent does not reflect the intended link between S/NDS 097485 and the
‘895 patent. As outlined further below, the ‘895 patent does not include a
claim for the changed use of the medicinal ingredient, for the long term use
and relative safety of ANDROGEL, as required in subsection 4(3)(c) of the PM(NOC)
Regulations. [Emphasis mine.]
[40]
She
proceeded to analyse Solvay’s submissions under the heading treatment for
erectile dysfunction and she confirmed OPML’s view the relevant SNDS “relates
to an update to the product monograph for ANDROGEL with long term extension study
results” stating “the approved use of ANDROGEL remains unchanged as a result of
S/NDS 097485”. She referred to relevant extracts at page 3 what was the medical
indication for ANDROGEL and at page 13 of that same product monograph
indicating which symptoms were associated with male hypogonadism which included
erectile dysfunction. She then concluded:
The above change in description
of the symptoms of male hypogonadism are not changed uses of ANDROGEL. The uses
of ANDROGEL are the same uses that were approved in the NDS 068080 for which an
NOC issued on February 6, 2002. Since the ‘895 patent application was filed
on August 29, 2001 and NDS 068080 was filed on August 28, 2000, the ‘895
patent is ineligible for listing on the Patent Register in accordance with
section 4(6) of the PM(NOC) Regulations. The changes introduced in S/NDS
097485 were not changes to the use of the medicinal ingredient as contemplated
by subsection 4(3) of PM(NOC) Regulations. Instead, the NOC is an
update to the product monograph for treatment of symptoms of known uses of
testosterone. [Emphasis mine.]
[41]
Anne
Bowes then discussed the subject matter of “long term use and chronic use
treatments”. She referred to Solvay’s letter of July 20, 2007 which pointed to
several claims in the ‘895 patent “that you state relate to the safe and long
term use of testosterone” and to the addition to the ANDROGEL product monograph
of the statement: “Similar trends were observed in patients followed up to 3
years.” Anne Bowes then wrote:
The addition of this sentence does not
constitute a new use of ANDROGEL. Further, if the addition could be considered
as a new use, the OPML is unable to conclude that the ‘895 patent contains a
claim for that changed use of the medicinal ingredient that has been approved
through the issuance of an NOC in respect of S/NDS 097485. Claims within the
‘895 patent pertaining to achieving a “hormonal steady state”, for use “without
an upper limit” and “chronic use treatment” must be read in light of the
disclosure of the ‘895 patent. The disclosure does not provide for a duration of three
years since the studies in the disclosure are limited to 180 days. [Emphasis
mine.]
[42]
She
concluded her letter by referring to the Federal Court’s decision in Abbott/PREVACID.
She noted in that case the SNDS was for a new use unlike the case at hand and
that moreover it was an appeal on the issue whether the patent in Abbott/PREVACID
contained a claim for the changed use.
[43]
As
will be seen, the Federal Court of Appeal issued its decision in Abbott/PREVACID
on July 25, 2008. Justice Pelletier, writing for that Court, ruled the patent
reference to “ulcers” was not sufficient to support an argument that it covered
the approved new use of “NSAID ulcers”.
Analysis
(a) The Standard of Review
[44]
In
Dunsmuir v. New Brunswick, 2008 SCC 9, the Supreme Court of Canada
reformed the standard of review analysis which had prevailed up to that time
by, in particular, reducing from three to two the standards of review, namely
correctness and reasonableness.
[45]
The
Supreme Court also said at paragraphs 57 and 62 “an exhaustive
review is not required in every case to determine the proper standard of review”
which will be the case where “the jurisprudence has already determined in a
satisfactory manner the degree of deference to be accorded with regard to a particular
category of question”.
[46]
The most recent case dealing with the standard of review of the
Minister’s decision on the listing requirements found in section 4 of the NOC
Regulations as amended on October 5, 2006 is the Federal Court of
Appeal’s decision in Abbott Laboratories v. Attorney General of Canada and
the Minister of Health (Abbott/MERIDIA), delivered on November 17,
2008, cited 2008 FCA 354, reasons for judgment written by Justice Sharlow who dismissed
an appeal from the decision of my colleague Justice Hughes, reported at 2008 FC
700, who had determined Abbott’s drug MERIDIA was not eligible for listing on
the Register not having met the eligibility requirements of subsection 4(1) and
paragraph 4(2)(d) of the NOC Regulations which stipulate a patent on a patent list
in relation to a NDS is eligible to be added to the Register if the patent
contains:
|
(d) a claim for the use of the medicinal ingredient,
and the use has been approved through the issuance of a notice of
compliance in respect of the submission.
[Emphasis mine.]
|
|
d) une revendication de l’utilisation
de l’ingrédient médicinal, l’utilisation ayant été approuvée
par la délivrance d’un avis de conformité à l’égard de la présentation.
[Non souligné dans l’original.]
|
[47]
Justice
Hughes had stated at paragraph 4 of his reasons to determine whether a patent should be
added to an existing NOC under the provisions of paragraph 4(2)(d) of the NOC
Regulations required the Minister to make a three step determination:
1. What use does the patent claim?
2. What is the use approved by the NOC?
3. Is the use claimed by the patent
that which is approved by the existing NOC?
[48]
In
the case before him, the Minister had decided the use claimed in the patent was
not the use approved by the NOC and, as a consequence, the patent could not be
listed as against the NOC. Specifically, the Minister determined the approved
use of Meridia as indicated in
the drug’s product monograph is an
antiobesity agent/anorexiant for the use in adjunctive therapy within a weight
management program to treat obese patients. Meridia
was not indicated for the treatment of hypertension, type 2 diabetes,
dyslipidemia, and visceral fat. In contrast, the relevant patent claimed the use of the medicinal ingredient (sibutramine)
for improving the glucose tolerance of humans having pre-type 2 diabetes or for
type 2 diabetes. The Minister found that the claims in the relevant patent were
not directed towards the treatment of obesity. The conclusion of OPML in that
case was that the uses claimed in the patent had not been approved by the NOC
for MERIDIA.
[49]
On
the standard of review, Justice Hughes, citing Justice Gauthier in GD Searle & Co. v. Canada (Minister of Health), 2008
FC 437 ruled:
1. The construction of the NOC Regulations and patent claim
construction are questions of law to be reviewed on a standard of correctness;
2. The uses approved by the existing NOC are questions of fact
and are to be reviewed on the basis of reasonableness with considerable
deference given to the Minister's decision; and
3. The consideration as to how the uses claimed in the patent
compare with those approved by the NOC for the purposes of section 4(2)(d)
involves mixed fact and law and considerable deference should be given to
the Minister's decision.
[50]
Justice
Sharlow’s analysis on the standard of review is contained at paragraphs 26 to
34 of her reasons. She agreed the answer to the question: “What use does the patent
claim?” is a question of law to be reviewed on the standard of correctness.
[51]
She
also agreed reasonableness was the proper standard to apply to the question: “What is the use approved by the existing notice of compliance?” but she
arrived at this determination for different reasons. She wrote at paragraph 31:
31 The
determination of the approved use of a drug requires an interpretation of the
notice of compliance and the product monograph. Generally, the interpretation
of a document that defines legal rights and obligations is a question of law,
and on that basis it is arguable that the interpretation of a product monograph
is a question of law, rather than a question of fact as Justice Hughes found.
Even so, it is an interpretative exercise that must necessarily be informed by
a particular expertise in matters of the safety and efficacy of drugs. Those
are matters on which the Minister is more expert than the Court. Further,
it results in a determination that relates to a single case, rather than a
principle of general application. Based on those considerations, I conclude
that in a judicial review of the Minister's decision to accept or reject a
patent for listing, the Minister's determination of the approved use of a drug
should be reviewed on the standard of reasonableness, even if it is a question
of law. [Emphasis mine.]
[52]
She
also confirmed the standard of reasonableness applied to the answer to the
question: "Is the use claimed by the patent that which is approved by
the existing notice of compliance?" Justice Sharlow found that this
question posed one of mixed fact and law because “it requires an application of
the law to the facts”. She was of the view the factual component to this
question must be reviewed on a standard of reasonableness but the legal
component on a standard of correctness because the component to that question
was the meaning of paragraph 4(2)(d) of the NOC Regulations.
[53]
She
summarized her views at paragraph 34 of her reasons:
34 In
summary, the Minister's decision not to list the 620 patent must stand unless
it is based on an incorrect construction of claim 6 of the 620 patent, an
incorrect interpretation of paragraph 4(2)(d) of the NOC Regulations, an
unreasonable conclusion as to the approved use of Meridia, or an unreasonable
conclusion as to whether the use of the sibutramine claimed in the 620 patent
is an approved use of Meridia.
[54]
Applying
Abbott/MERIDIA to the application in this case of paragraph 4(3) of the NOC
Regulations, I conclude:
1)
The
construction of the NOC Regulations and the construction of the ‘895
patent are questions of law to be reviewed on a standard of correctness.
2)
The
uses of the medicinal ingredient claimed by Solvay’s SNDS and subsequent
approval in the NOC are questions of fact and are to be reviewed on the basis
of reasonableness with considerable deference given to the Minister’s decision
on the question.
3)
The
question is the use claimed in the ‘895 patent, the changed use contained in
the SNDS and approved by the NOC is one of mixed fact and law where the factual
component is reviewed on the standard of reasonableness but the legal component
on a standard of correctness.
(b) Discussion
(1) The Federal Court of Appeal’s
decision in Abbott/PREVACID
[55]
Counsel
for the Minister drew the Court’s attention to another Abbott case
recently decided by the Federal Court of Appeal in Abbott Laboratories Ltd. v.
Canada (Attorney
General),
dated July 25, 2008 and cited 2008 FCA 244 (Abbott/PREVACID). He argued
this case was dispositive of the case before me because it involved the very
subsection and paragraph which are before me, namely, paragraph 4(3)(c) of the NOC
Regulations.
[56]
The
Appeal Court’s reasons were penned by Justice Pelletier who overturned the
Federal Court’s decision reported at 2007 FC 797, the case relied upon by
Solvay in its letter of August 3, 2007 to Mr. Lee. It is important to note that
in Abbott/PREVACID, the Minister and Abbott agreed, before the
applications judge, Abbott had satisfied the first element of eligibility under
paragraph 4(3)(c) of the NOC Regulations, namely Abbott had shown that
in its SNDS there had been a change in the use of the medicinal ingredient
because it contained a new indication for PREVACID, i.e. healing of
NSAID-associated gastric ulcer and reduction of risk.
[57]
As a result, the focus of the Federal Court of Appeal’s decision
in Abbott/PREVACID was on the
second element required for determination under the paragraph, that is, whether
the patent at issue contained a claim for the changed use of the medicinal
ingredient. The Minister had ruled the patent did not contain such a claim and,
as a result, he deleted the patent from the Register. The applications judge
found the Minister had erred in deleting the patent from the Register but, as
noted, that decision was reversed by the Federal Court of Appeal.
[58]
In
the Abbott/PREVACID case, just as in the situation before me, the NDS
upon which the NOC issued authorizing the marketing of the drug PREVACID preceded
the filing of the relevant patent: (1) on May 12, 1995, the Minister
issued the NOC for PREVACID for use in the treatment of duodenal ulcers, gastric
ulcers, and reflux esophagitis; (2) on November 13, 1997, an application
was filed in the Canadian Patent Office for the relevant patent, the '053
patent, which issued only on July 18, 2006; and (3) on April 2, 2000,
Abbott filed its SNDS seeking approval for the new indication for PREVACID
relating to the healing of non steroidal anti-inflammatory drug (NSAID)
associated gastric ulcer and its reduction.
[59]
The
Federal Court of Appeal’s decision in Abbott/PREVACID was its first
consideration of the amendments which came into force on October 5, 2006.
Justice Pelletier made two observations as to why those amendments had been
made.
[60]
First,
he said the redrafting to section 4 of the NOC Regulations into its
current form came in response to “a running debate about the relevance of
patents in relation to the submissions against which drug manufacturers seek to
list them”, referring to the Federal Court of Appeal’s decision in Eli Lilly Canada Inc. v. Canada (Minister of Health), 2003 FCA 24, in which that Court
quashed a decision by the Minister to remove the '969 patent from the Register.
Justice Pelletier wrote the following at paragraphs 46 and 47 of his reasons:
46 That
controversy was resolved by amendments which specified the characteristics of
patents which could be listed against specific types of SNDS's. Thus, where a
manufacturer submitted an SNDS with respect to a new dosage form, the Regulations
now require any patent sought to be filed against that submission to contain
"a claim for the changed dosage form...": see paragraph 4(3)(b)
of the Regulations. In the present case, the SNDS in question is with
respect to a new indication for an existing drug PREVACID. That drug was
originally approved for use in the treatment of "duodenal ulcers, gastric
ulcers, and reflux esophagitis". The SNDS relevant to these proceedings
claims as a new indication for the drug "Healing of NSAID-associated
gastric ulcer and reduction of risk of NSAID-associated gastric ulcer". Paragraph
4(3)(c) of the Regulations requires that any patent sought to be listed
on the Patent Register against that submission must contain "a claim for
the changed use of the medicinal ingredient".
47 It stands to
reason that if a patent must contain a claim for the changed use identified in
Abbott's SNDS, that patent cannot simply claim the use which formed the basis
of the original submission. Such a patent does not specifically claim the
changed use, even though the changed use may come within the claims of the
patent. In other words, the Regulations envisage as a condition of
listing a patent in respect of a change in the use of a medicinal ingredient
that the patent specifically claims the changed use as opposed to non-specific
claims which are wide enough to include the changed use. [Emphasis mine.]
[61]
Second, he was of the
view that “it was the distinction between specific claims and broad
non-specific claims which led to the discussion in the jurisprudence about the
nature of the patented invention”, citing Wyeth Canada v.
Ratiopharm Inc., 2007 FCA 264 (Wyeth), at
paragraph 29. He continued by writing: “That discussion has now been overtaken
by the amendments to the Regulations.” For convenience, I reproduce
paragraphs 29 and 30 of Justice Sharlow’s reasons in Wyeth:
29 This
appeal deals with the propriety of a patent listing. The part of AstraZeneca
that is most relevant to that issue is the part explaining that the listing of
a patent on the basis of a SNDS requires a certain link between the change
reflected in the SNDS, the NOC issued in response to that SNDS, and the patent
sought to be listed. On this point I agree with the Judge (see paragraph 22 of
his reasons).
30 I
also agree with the Judge that AstraZeneca reverses part of the
reasoning for the decision of this Court in Eli Lilly Canada Inc. v. Canada
(Minister of Health) (C.A.), [2003] 3 F.C. 140. The part of the Eli
Lilly reasoning that cannot stand with AstraZeneca is the proposition that
a patent containing a claim for the medicine in a drug is listed generally against
the drug, rather than against a specific NOC issued in response to the NDS or
SNDS upon which the patent listing is based.
[62]
The
applications judge in Wyeth was Justice Hughes and the paragraph she
approved was his paragraph 22 reported at 2007 FC 340, which I also reproduce
for completeness:
22 Given AstraZeneca
and Biolyse it can be seen that what the Minister must do under section
3(1) of the pre-October 5, 2006 NOC Regulations for purposes of
determining whether a patent is to be listed as against a particular NOC is to
look at the "patented invention" and determine if there is a
"relationship" between that "patented invention" so as to
make it "relevant" to the particular NOC against which it is sought
to be listed or, if listed, to be de-listed.
[63]
Justice
Pelletier expressed his conclusions at paragraphs 49 and 50 of his reasons:
49 Even if one were
inclined to look to the nature of the invention, the difficulty is that the
language of the Regulations speaks only of "a claim for the changed
use of the medicinal ingredient". I conclude that paragraph 4(3)(c) of the
Regulations requires, as a condition of listing a patent on the Patent
Register, that the patent must specifically claim the very change in use which
was approved by the issuance of a Notice of Compliance with respect to an SNDS.
50 As a result, I am
of the view that Simpson J. erred in accepting the expert opinions which were
placed before her as evidence that the '053 patent contained a claim for the
changed use of the medicinal ingredient in PREVACID. That evidence went no
further than showing that the '053 patent would have been eligible for listing
against the original submission for PREVACID, had it not been for the fact that
the date of the submission preceded the date of the patent application. To
allow registration of the '053 patent against the SNDS for a changed use which
was not the subject of a specific claim would be to undo the reform which the
amended regulations seek to introduce. For that reason, I would allow the
appeal with costs and set aside the decision of the Federal Court. I would
dismiss with costs the respondent's application for judicial review.
(2) Statutory Interpretation Principles
[64]
The
Supreme Court of Canada in Rizzo &Rizzo Shoes Ltd. (Re), [1998]
1 S.C.R. 27 settled the issue of the proper approach to be taken in matters of
statutory interpretation – in essence it is the search for the intention of the
law-maker or regulation-maker. Justice Iacobucci, writing on behalf of
the Court, stated as follows at paragraph 21 of his reasons:
21 Although much has been written about
the interpretation of legislation (see, e.g., Ruth Sullivan, Statutory
Interpretation (1997); Ruth Sullivan, Driedger on the Construction of Statutes
(3rd ed. 1994) (hereinafter "Construction of Statutes"); Pierre-André
Côté, The Interpretation of Legislation in Canada (2nd ed. 1991)), Elmer
Driedger in Construction of Statutes (2nd ed. 1983) best encapsulates the
approach upon which I prefer to rely. He recognizes that statutory
interpretation cannot be founded on the wording of the legislation alone. At p.
87 he states:
Today
there is only one principle or approach, namely, the words of an Act are to be
read in their entire context and in their grammatical and ordinary sense
harmoniously with the scheme of the Act, the object of the Act, and the
intention of Parliament.
…
[65]
In
the case at hand, there are three relevant aids to the intention behind the
changes to the NOC Regulations made on October 5, 2006: (1) A discussion
in the jurisprudence what was the mischief sought to be cured in making the regulatory
changes. Justice Pelletier’s decision in Abbott/PREVACID discusses, as
has already been noted, what the effect of the previous jurisprudence was and
what problems were sought to be cured by making the regulatory changes; (2) A
comparison between the scheme provided under the old provision with those set
out under the new provisions; and, (3) The light shed on the issue as outlined
in the Regulatory Impact Analysis Statement (RIAS), which in this case is quite
extensive, addresses the previous jurisprudence and points to the intent behind
the October 5, 2006 changes.
[66]
It
becomes apparent how profound the October 5, 2006 amendments were in terms of
eligibility to list patents on the Register when a comparison is made between
the patent listing regime now in place and the scheme under the old regime
which existed since 1999 under SOR/99-379. I set out in the Annex to these
reasons the old and new regimes as set out in section 4 of each applicable
regulation. It is obvious that the current regime is much more precise in
spelling out the eligibility criteria for the listing of patents on the NOC
Regulations Register.
[67]
In
terms of the RIAS, Justice Sharlow, in Abbott/MERIDIA, referred to the RIAS
to provide an understanding of the October 5, 2006 amendments of the NOC
Regulations in these terms at paragraph 54:
54 As
I read paragraph 4(2)(d), it asks whether claim 6 of the 620 patent claims a
use of the sibutramine that is an approved use of Meridia. That question was
deliberately chosen for the current version of paragraph 4(2)(d) of the NOC
Regulations to avoid the broad interpretation given to the more general
provision it replaced (compare, Eli Lilly (cited above) at paragraphs 34
and 35, and the Regulatory Impact Analysis Statement, Canada Gazette
Part II, Vol. 140, No. 21 (October 18, 2006), at page 1514). To accept the
broader infringement question posed by Abbott as a permissible means of
interpreting paragraph 4(2)(d) would not be consistent with its current
language, or the purpose for which it was enacted. [Emphasis mine.]
[68]
She
appears to endorse the principle found in the jurisprudence that a RIAS
indicates the Government’s purpose and intention in promulgating regulations
including the NOC Regulations (see paragraphs 68 to 74 of Chief
Justice’s reasons in Eli Lilly cited above).
[69]
Turning
to the relevant RIAS, its very first paragraph states: “These amendments are
intended to restore the balanced policy underlying the NOC Regulations by
reaffirming the rules for listing patents on the Register and clarifying when
listed patents must be addressed.” Under the heading “Patent
Listing Requirements”, the RIAS states, at page 1511, that the NOC
Regulations “are intended to operate as a very potent patent enforcement
mechanism”, citing the 24 month automatic stay when an innovator launches a
prohibition application, adding that “it is this very potency which calls for
moderation in the application” with the result that “only those patents which
meet the current timing, subject matter and relevance requirements set out in
section 4 of the Regulations are entitled to be added to … the Register
and to the concurrent protection of the 24-month stay”.
[70]
Throughout the RIAS, examples are given of the problems
caused as the government perceived them arising from the jurisprudence on the
interpretation of the NOC Regulations. I cite a few examples:
·
The impression in the previous wording in the regulations
that the patent filing date precede the date of the submission for a notice of
compliance without specifying if this meant and NDS or a subsequent SNDS coupled
with a Court decision (Apotex v. Minister of Health, 11 C.P.R. (4th) 538
(F.C.A.)) that a subsequently filed SNDS could revive patents which were out of
time in relation to an NDS noting that SNDSs could be filed “virtually any time
for any number of reasons, ranging from the mundane, such as a change in drug
name, to the substantive, such as a change in its indications or formulation”.
·
That same decision also expressly sanctioned the listing of
new formulation patents that “do not claim the specific product the innovator
is approved to sell”, citing the Eli Lilly case, reported at 2003 FCA 24,
as a decision where the Federal Court of Appeal rendered “a precedent-setting
decision … which reaffirmed the right of innovator companies to list
formulation patents that do not claim the formulation approved for sale”.
[71]
The
RIAS at page 1514 expressed the Government concern “that
the combined effect of the above described in the jurisprudence is a weakening
of the listing requirements to the point of redundancy”, citing with approval two
Federal Court of Appeal decisions in Ferring Inc. v. Canada
(Attorney General), 2003 FCA 274 and Hoffmann-La Roche Ltd. v. Canada
(Minister of Health), 2005 FCA 140, where the Court refused to list a
patent in relation to SNDSs involving a change to a drug’s name or one in
relation to a change in the manufacturer’s site, its reasoning being that such
changes could not possibly be relevant to any potential claim for infringement
of a patent and were therefore outside the scope of section 4.
[72]
The
RIAS expressed the Government’s view that regulatory change was a better
mechanism to redress the situation rather than proceeding through the Courts on
a case by case basis. In its view stated at the bottom of page 1514:
To date, these unintended consequences include the
possibility that an innovator company may delay generic market entry by listing
new and sometimes irrelevant patents on the basis of minor product revisions.
The result is a blurring of the lines between the original product, as approved
via the NDS, and the “changed” version, as approved via the SNDS, such that
generic manufacturers may be prevented from entering the market with a
competing version of the original innovator product even when the original patents
have long since expired or been addressed.
[73]
The
RIAS contained at page 1515 the following description of the purpose of the
amendments:
The primary purpose of these amendments is to pre-empt
further such behaviour by restoring the original policy intent of the NOC
Regulations. This entails reaffirming the requirements innovators must meet
to list patents on the register and clarifying when these patents must be
addressed by their generic competitors. In addition, a number of ancillary
amendments are being made with a view to reducing unnecessary litigation and improving
the overall effectiveness of the regime. These were developed in response to
specific concerns expressed by stakeholders following pre-publication of an
earlier round of proposed amendments in the Canada Gazette, Part I, on
December 11, 2004.
[74]
According
to the RIAS, in order to qualify for protection under the regulations,
a patent must be “relevant to the drug product the innovator is approved to
sell”. [Emphasis mine.] and “in making that determination the Minister can
only be called upon to assess the relationship between the patent and the drug
described in the innovator’s submission for a NOC.” The RIAS goes on to say “the
amendments reflect this by further entrenching the concept of product
specificity as the key consideration required of the Minister in applying the
listing requirements under section 4 … They do so through more precise
language respecting the intended link between the subject matter of the patent
and the content of the underlying submission for a NOC in relation to which it
is submitted. In addition, only certain clearly defined submission types will
provide an opportunity to submit a new patent list.” [Emphasis mine.]
[75]
The
document went on to explain that according to the amendment only a patent filed
prior to an NDS which contains one of four claims may be listed; one of those
claims is “a claim for an approved use of the medicinal ingredient.”
[76]
The
document went on to elaborate on some of the new definitions in the amended
regulation and stated as follows at page 1517 with respect to the definition of
“claim for the use of the medicinal ingredient”:
Although the
definition for “claim for the use of the medicinal ingredient” in these
amendments is unchanged from the current definition for “claim for the use of
the medicine”, a point of clarification regarding the intention underlying this
aspect of the NOC Regulations is in order. It is acknowledged that the regulatory
language employed in the health and safety context to describe the use for
which a medicinal ingredient in a drug is sometimes at odds with the manner in
which claims are drafted in the many different kinds of so-called “use patents”
which exist in the pharmaceutical realm. Examples of the latter include kit claims,
“Swiss-type” claims and claims for dosing regimens. However, the combined
effect of the definition under this part and the requirement that the claimed
use be one described in the underlying NDS should be to limit the eligibility
of use patents to those which contain a claim to an approved method of using
the medicinal ingredient, for an approved indication. This link should be
apparent from a comparison of the claims in the patent with the relevant
portions of the product monograph and labelling for the approved drug.
[77]
The
RIAS concluded on the issue of the linkage between the patent to be listed and
the underlying submission for an NOC by stating the “amendments
formally confirm the right to list new patents on the basis of SNDS filings and
introduce listing requirements governing that right”. In this connection, it
stated:
Under these
requirements, a patent which had been applied for prior to the filing of an
SNDS may be submitted in relation to that SNDS provided the purpose of the
latter is to obtain approval for a change in use of the medicinal ingredient
(i.e. a new method of use or new indication), a change in formulation or a
change in dosage form and the patent contains a claim to the formulation,
dosage form or use so changed. This will protect and encourage legitimate and
substantive incremental innovation of direct therapeutic application. New patents
claiming novel physical forms of the approved medicinal ingredient will not be
eligible for listing in this manner.
(c) Conclusions
[78]
This judicial review application must be dismissed. The
evidence before me supports the Minister’s conclusions that Solvay did not meet
the relevant requirements of the Regulations for the listing of the ‘895
on the Register both in terms of: (1) that the SNDS represents a change in use
of the medicinal ingredient in Androgel,
namely testosterone; and, (2) the ‘895 patent claims a limitation as to
duration in the use of ANDROGEL which was the principal basis upon which
the SNDS to which the 2006 NOC relates was advanced.
[79]
The evidence in the record satisfies me the SNDS, filed on
March 11, 2005, did not represent a change in use of the medicinal ingredient
of ANDROGEL – testosterone in the form of topical gel. The jurisprudence
supports the proposition that “change in use” as that term is used in
subsection 4(3) of the Regulations is measured by the approved use in
ANGROGEL’s product monograph, as approved by Health Canada, which is described
in the Indications and Clinical Use Section of that document. ANDROGEL is
indicated for hormone replacement therapy in men suffering from conditions
associated with a testosterone deficiency. No change of indication and
use was made to Solvay’s ANDROGEL product monograph as a result of the 2006
NOC.
[80]
Counsel for Solvay referred to Mr. Gibson’s advice the
proposed changes to its ANDROGEL product monograph would have to be by way of
an SNDS as an indicator of change in use which met the requirements of section
4(3). This argument fails on two points. First, that advice was given in 2004
before the amendment to section 4(3) was in place in October of 2006. Second,
the advice was only as to the form by which approval to the product
monograph updates would take place. It did not purport to rule on the nature of
those changes.
[81]
I deal with a second argument put forward by counsel for
Solvay that there was a clash between the experts in Health Canada in
the BMORS section with those in the OPML section. I cannot accept this
submission. OPML has expertise in the administration of the Regulations
and coordinates the views of Health Canada in
specific cases. In 2007, when the ANDROGEL issue was on the table, OPML sought
the advice of BMORS experts who indicated “it did not appear the indications
changed under this submission”.
[82]
It is evident Solvay fails on the second requirement that
the ‘895 patent claims the changed use. I am prepared to accept Dr.
Morales’ affidavit because, taken as a whole, it does not represent substantial
new evidence not before the Minister. On the other hand, it provides clear
evidence that the ‘895 patent claims contain no limitation as to duration of
use. As put by the Minister’s counsel, the ‘895 patent does not address the
issue of the duration of testosterone therapy.
[83]
For these reasons, this judicial review application is
dismissed with costs taxed at the middle of column IV.
JUDGMENT
THIS COURT
ORDERS AND ADJUDGES that this application
for judicial review is dismissed with costs to be taxed at the middle of column
IV.
“François
Lemieux”
_____________________________
Judge
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