Date:
20121009
Docket:
A-44-12
Citation: 2012 FCA 254
CORAM: SHARLOW
J.A.
TRUDEL J.A.
MAINVILLE
J.A.
BETWEEN:
GILEAD
SCIENCES CANADA INC.
Appellant
and
THE MINISTER OF HEALTH
and
THE ATTORNEY GENERAL OF CANADA
Respondents
REASONS
FOR JUDGMENT
TRUDEL
J.A.
Introduction
[1]
The
main issue in this appeal is whether Canadian Patent No. 2,512,475 (the ‘475
Patent) is eligible for listing on the patent register in respect of new drug
submission 140115 (the NDS) where the medicinal ingredients claimed in the ‘475
Patent do not match up with those in the NDS.
[2]
The
Minister of Health (the Minister) refused to list the ‘475 Patent on the patent
register as, in his view, it did not meet the requirements of paragraph 4(2)(b)
of the Patented Medicines (Notice of Compliance) Regulations (SOR/93-133)
(the PM (NOC) Regulations). A Judge of the Federal Court accepted the
Minister’s position and dismissed Gilead Sciences Canada Inc.’s (Gilead or the appellant) application for judicial review. This is an appeal from the
Federal Court’s decision reported at 2012 FC 2.
[3]
I
propose to dismiss Gilead’s appeal, but for reasons different than those
expressed by the Judge in dismissing the application for judicial review.
Contrary to what he found, I conclude that the claims at issue in the ‘475
Patent are for a new combination of medicinal ingredients so that eligibility
of the ‘475 Patent for listing depends upon the requirements of paragraph 4(2)(a)
of the PM (NOC) Regulations, not paragraph 4(2)(b). This said, the relevant
claims in the ‘475 Patent do not meet the requirements of paragraphs 4(2)(a)
as they lack strict product specificity with regards to the three medicinal
ingredients listed in the NDS.
[4]
Paragraphs
4(2)(a) and 4(2)(b) of the PM (NOC) Regulations read:
|
4. (2) A patent
on a patent list in
relation to
a new drug submission is
eligible to
be added to the register if
the patent
contains
(a) a claim
for the medicinal
ingredient
and the medicinal
ingredient
has been approved through
the issuance
of a notice of compliance
in respect
of the submission;
(b) a claim
for the formulation that
contains the
medicinal ingredient and
the
formulation has been approved
through the
issuance of a notice of
compliance
in respect of the
Submission;
|
4.
(2) Est admissible à l’adjonction au
registre
tout brevet, inscrit sur une
liste
de brevets, qui se rattache à la
présentation
de drogue nouvelle, s’il
contient,
selon le cas :
a)
une revendication de l’ingrédient
médicinal,
l’ingrédient ayant été
approuvé
par la délivrance d’un avis
de
conformité à l’égard de la
présentation;
b)
une revendication de la formulation
contenant
l’ingrédient médicinal, la
formulation
ayant été approuvée par la
délivrance
d’un avis de conformité à
l’égard de
la presentation;
|
The relevant
facts
[5]
The
relevant facts are uncontested. On October 4, 2010, Gilead filed an NDS with
the Minister seeking approval of a drug for the treatment of
human immunodeficiency virus (HIV) infection. The NDS states that
the drug, known as Complera, contained the following medicinal ingredients: 1)
tenofovir disoproxil fumarate (tenofovir), 2) emtricitabine, and 3) rilpivirine
(Judge’s reasons at paragraph 3). Rilpivirine is one of a class of agents known
as non-nucleoside reverse transcriptase inhibitors (NNRTIs). On October 20,
2011, after the evidence was filed in the application below but before issuance
of the decision under appeal, a Notice of Compliance (NOC) was issued for
Complera. From this point on, I shall refer to NDS or NOC depending on the
context.
[6]
At
the same time Gilead filed its NDS, it also submitted eight patents for listing
on the patent register in relation to Complera, including Patent ’475. By
letter of October 26, 2010, the Office of Patented Medicines and Liaison
advised Gilead of the Minister’s preliminary view that Patent ‘475 was not
eligible for listing because it did not contain a claim for all of the
medicinal ingredients contained in the NDS, that is, tenofovir, emtricitabine and
rilpivirine, as required by the PM (NOC) Regulations. Rather, the ‘475 Patent
contains claims combining the medicinal ingredients tenofovir and
emtricitabine, together with a third unnamed antiviral agent selected from,
amongst other classes of agents, NNRTIs. It is admitted that rilpivirine is not
mentioned in any of the’475 Patent claims. Gilead was provided 30 days to
respond to the Minister.
[7]
It
did so on November 26, 2010, and submitted that the claims in the ‘475 Patent
were directed to chemically stable combinations of ingredients and thus
fell within paragraph 4(2)(a) of the PM (NOC) Regulations (emphasis
added). Alternatively, Gilead submitted that the ‘475 Patent did make formulation
claims which provided for sufficient product specificity because rilpivirine
was a drug within one of the specified classes of drugs, i.e., NNRTIs (emphasis
added). Therefore, the ‘475 Patent also met the requirements of paragraph 4(2)(b)
of the PM (NOC) Regulations.
[8]
The
Minister issued a final decision letter on January 13, 2011 confirming that the
‘475 Patent was not eligible for listing. The Minister found that “a
patent containing claims for a formulation cannot “match” the approved
formulation [in the NDS or NOC] unless both formulations explicitly contain all
of the same medicinal ingredients” (Minister’s final decision letter, appeal
book, volume I, tab 4E). Consequently, reference only to classes of ingredients
in the ‘475 Patent did not meet the “matching requirement” for lack of product
specificity.
The standard of
review
[9]
The
role of this Court in the case at bar is to determine whether the reviewing
Judge has chosen and applied the correct standard of review and, if not, to
assess the Minister’s decision in light of the correct standard of review (Dr.
Q. v. College of Physicians and Surgeons of British Columbia, 2003 SCC 19,
[2003] 1 S.C.R. 226 at paragraphs 43-44).
[10]
In
this instance, the standard of review is tied to the three part analytical
framework for analyzing questions relating to section 4 of the PM (NOC)
Regulations, which was adopted by this Court in Abbott Laboratories Ltd. v.
Canada (Attorney General), 2008 FCA 354, [2009] 3 F.C.R. 547 at paragraphs
29-33, and cited most recently in Purdue Pharma v. Canada (Attorney General),
2011 FCA 132 at paragraphs 11-13 [Purdue].
[11]
At
paragraph 12 of his reasons, the Judge adopted this framework, which consists
of the following questions:
a.
What
is the correct construction of the ‘475 Patent? This question is reviewed on a
standard of correctness;
b.
What
is the nature of the drug approved in the NDS or in the NOC? This question is
reviewed on a standard of correctness;
c.
Is
the subject matter claimed in the patent that for which approval is sought
under the NDS or NOC?
[12]
The
first step in answering the third question requires interpreting the PM (NOC)
Regulations. This is a question of law reviewable on a standard of correctness.
The second step consists of applying the law to the facts, an exercise reviewed
on a standard of reasonableness.
[13]
The
Judge correctly noted that question 2 of the analytical framework was not at issue,
as the parties agreed that the NDS referred to a drug containing tenofovir,
emtricitabine and rilpivirine.
Issues
[14]
The
Judge therefore framed the remaining issues as follows:
a.
What
is the correct construction of the ‘475 Patent?
b.
What
is the correct interpretation of paragraphs 4(2)(a) and (b) of
the PM (NOC) Regulations; and,
c.
Was
the Minister’s decision to exclude the ‘475 Patent from the Register
reasonable? (reasons for judgment at paragraph 14).
[15]
I
will deal with the Judge’s reasons on each of these questions in the course of
my analysis.
Analysis
Issue 1) The
construction of the ‘475 Patent
[16]
The
‘475 Patent is entitled “Compositions and Methods for Combination Antiviral
Therapy”. It contains 53 claims consisting of claims for ingredients and claims
for formulations, as well as claims for dosages and uses, the latter of which
are not relevant to the within appeal. Of relevance are claims 15, 31, 32 and
34, as well as claims 42, 45, 46 and 48 which are reproduced in annex to these
reasons.
[17]
At
the hearing of this appeal, Gilead focused on claims 42, 45, 46 and 48, arguing
that these are claims to the medicinal ingredients in Complera. In Gilead’s
view, once considered separate and apart from the formulation claims, those
claims are eligible for listing pursuant to paragraph 4(2)(a) of the PM
(NOC) Regulations (appellant’s memorandum of fact and law at paragraphs 79-80).
[18]
Having
reviewed the approach to patent construction set out in the case law, the Judge
first held that the object of the invention was to take advantage of the
chemically stable characteristics of tenofovir and emtricitabine in combination
and sometimes with a third medicinal ingredient (reasons at paragraph 25). He
had previously found that claims 42, 45, 46 and 48 refer to the combination of
two or more anti-viral agents while claims 15, 31, 32 and 34 refer to a
formulation containing two or more anti-viral agents.
[19]
Ultimately,
at paragraph 26 of his reasons, the Judge construed the relevant claims as
… combinations and formulations
of two medicinal ingredients plus a third one of the NNRTI class that could
possibly include but is not specifically rilpivirine.
[20]
The
parties do not take issue with the Judge’s construction of the relevant claims per
se.
As a result, the crux of this
dispute is over the Judge’s conclusions on the second and third issues, more
specifically the Minister and the Judge’s interpretation of paragraphs 4(2)(a)
and (b) of the PM (NOC) Regulations, and their application of these to
the facts.
Issue 2:
The interpretation of paragraphs 4(2)(a) and 4(2)(b) of the PM
(NOC) Regulations
The Regulatory
framework
[21]
Drug
manufacturers wishing to sell a new drug in Canada must submit a new drug
submission to the Minister and obtain a notice of compliance. These documents
set out basic information regarding the drug in question. Although most new
drugs are covered by patents which protect them from being copied, generic drug
producers may work patents without infringing them in order to seek the
necessary approvals from the Minister to release generic equivalents of drugs
as soon as the patents expire. This is known as the “early working exception”
of the Patent Act (R.S.C., 1985, c. P-4) [Patent Act].
[22]
To
ensure that this exception is not abused, the Patent Act also provides
for the PM (NOC) Regulations to manage this exception. To benefit from the
protections of the PM (NOC) Regulations, drug companies must apply to the
Minister to have the patents related to their drugs listed on a patent
register.
[23]
Thus
the Patent Act and the PM (NOC) Regulations seek to balance “effective
patent enforcement” over new and innovative drugs with the “timely market
entry” of lower priced generic versions once the patents have expired (Regulatory
Impact Analysis Statement, (2006) Canada Gazette Part II., Vol. 140,
1510-1525) [RIAS].
[24]
According
to the Minister, deficiencies in the language of the PM (NOC) Regulations led
to court decisions which made it too easy to list patents on the register and
thus tilted the balance too far in favour of patent protection. To correct
this, the Minister introduced revisions to the PM (NOC) Regulations in 2006.
Among the key features of these revisions is the concept of “product
specificity,” whereby the subject matter of the patent must reflect the subject
matter of the approved drug submission to qualify for listing on the patent
register (respondent’s memorandum of fact and law at paragraph 7).
The meaning of
paragraphs 4(2)(a) and (b)
[25]
After
construing the relevant claims, the Judge went on to describe these claims in
comparison with the three ingredients contained in Complera (reasons at
paragraph 28). In my respectful view, this is where the Judge erred in law in
applying the three part framework. He moved directly from the question of
claims construction to the question of whether the claims matched the
description of Complera as set out in the NDS, without interpreting paragraphs
4(2)(a) and (b) to assess whether the claims fell more
appropriately under (a) or (b). In the end, the Judge adopted the
Minister’s position without much explanation as to why he did so.
[26]
As
mentioned above, paragraphs 4(2)(a) and (b) refer to claims “for
the medicinal ingredient” and “for the formulations”. Section 2 of the PM (NOC)
Regulations defines these expressions:
|
2. In these Regulations,
…
“claim for the formulation” means a claim for a substance that is a mixture
of medicinal and non-medicinal ingredients in a drug and that is administered
to a patient in a particular dosage form; (revendication de la
formulation)
“claim for the medicinal ingredient”
includes a claim in the patent for the medicinal ingredient, whether chemical
or biological in nature, when prepared or produced by the methods or
processes of manufacture particularly described and claimed in the patent, or
by their obvious chemical equivalents, and also includes a claim for
different polymorphs of the medicinal ingredient, but does not include
different chemical forms of the medicinal ingredient; (revendication de
l’ingrédient médicinal)
|
2. Les définitions qui suivent s’appliquent au présent
règlement.
[…]
« revendication de la formulation » Revendication à l’égard d’une substance qui est
un mélange des ingrédients médicinaux et non médicinaux d’une drogue et qui
est administrée à un patient sous une forme posologique donnée. (claim for the
formulation)
« revendication de l’ingrédient médicinal » S’entend, d’une part, d’une revendication, dans
le brevet, de l’ingrédient médicinal — chimique ou biologique — préparé ou
produit selon les modes ou procédés de fabrication décrits en détail et
revendiqués dans le brevet ou selon leurs équivalents chimiques manifestes,
et, d’autre part, d’une revendication pour différents polymorphes de
celui-ci, à l’exclusion de ses différentes formes chimiques. (claim for the
medicinal ingredient)
|
[27]
In
my view, both the Minister and the Judge failed to give sufficient weight to
the requirement that formulations contain non-medicinal ingredients and set out
a particular dosage form, which is administered to the patient. At the hearing
of this appeal, counsel for the respondent readily conceded that on a plain
reading of section 2, the relevant claims do not meet the definition of
formulation, because they do not contain non-medicinal ingredients. Yet, the
respondent argues that the inventive step here is the “formulation of the
separate medicinal ingredients into the new combination product” (respondent’s
memorandum of fact and law at paragraph 35).
[28]
I
conclude that these arguments have no basis in law. The first rule in interpreting
statutes is that words “must be read in their entire context and in their
grammatical and ordinary sense, harmoniously with the scheme of the PM (NOC)
Regulations, their object, and the intention of Parliament. Where regulations
are concerned, the purpose of the enabling statute must also be considered” Apotex
v. Merck & Co. Inc., 2009 FCA 187 at paragraph 83.
[29]
As
mentioned above, the definition of formulation in the PM (NOC) Regulations is
clear. It must contain both medicinal and non-medicinal ingredients.
[30]
In
addition, the PM (NOC) Regulations are subject to the Interpretation Act,
R.S.C. 1985, c. I-21 [Interpretation Act]. The term medicinal ingredient
is to be read in both the singular and the plural, and thus allows for more
than one medicinal ingredient in an eligible claim under paragraph 4(2)(a)
(Interpretation Act at section 33(2)).
[31]
Finally,
the overall inventive step of the ‘475 Patent, as found by the Judge, is the
combination of chemically stable medicinal ingredients. The ‘475 Patent
emphasizes the beneficial effects of combining chemically stable combinations
of medicinal ingredients.
[32]
Thus,
I conclude that the ‘475 Patent falls under paragraph 4(2)(a), as the
relevant claims consist of chemically stable combinations of medicinal ingredients.
The product
specificity requirement
[33]
As
stated previously, the current version of the PM (NOC) Regulations makes
product specificity between the patent claims and the NOC for the approved drug
a key requirement for a patent to be considered eligible for listing on the
register. The parties agree on this point.
[34]
However,
Gilead argues for a low threshold of connection between the wording of the NDS
and the patent claim. It cites the case of Nowegijick v. The Queen,
[1983] 1 S.C.R. 29, at page 39 [Nowegijick] for the proposal that the
words “in relation to” found in section 4 of the PM (NOC) Regulations are to be
given wide scope in conveying a connection between two related subject matters.
As well, it argues that the PM (NOC) Regulations must be given a broad
interpretation, consistent with the interpretation given by this Court to
subsection 55.2(1) of the Patent Act, which sets out the exemption from
patent protection which gives rise to the PM (NOC) Regulations , in Merck
& Co., Inc. v. Apotex Inc., 2006 FCA 323 at paragraphs 100-104.
[35]
Finally,
Gilead points to the Minister’s Health Canada Guidance Document:
Patented Medicines (Notice of Compliance) Regulations [Guidance Document],
and the commentary it sets out regarding section 4 of the PM (NOC) Regulations.
The Guidance Document states that under paragraph 4(2)(a), a claim to
one medicinal ingredient is eligible for listing in respect of a product which
contains the said medicinal ingredient in combination with other medicinal
ingredients (Guidance Document, appeal book, volume II, tab 6C, page 343).
[36]
These
arguments cannot succeed. First, the case of Nowegijick concerned
whether tax imposed upon the income of Mr. Nowegijick, a registered Indian,
could be said to be “in respect of” personal property situated upon a reserve.
The case is of little value to resolve the issue in the within appeal. I prefer
to rely on the case of Purdue where the current version of the PM (NOC)
Regulations was at play.
[37]
In
Purdue, this Court considered whether a patent, whose relevant claim for
a dosage form contained only one medicinal ingredient, was eligible for listing
on the patent register under paragraph 4(2)(c) of the PM (NOC)
Regulations when the approved dosage form consisted of two medicinal
ingredients. This Court held that absent precise and specific matching between
the patent claims and the approved NOC, the patent was not eligible for
listing. Writing for the Court, Layden-Stevenson J.A., stated:
In my view, the requirement for
this level of specificity is consistent with the text, the object and the
purpose of the Regulations. It is also consistent with the interpretation of
the other classes of claims in section 4 of the Regulations as determined by
the jurisprudence of this Court (at paragraph 44).
[38]
I
adopt here Layden-Stevenson J.A.’s comments and apply them to the within
appeal, with the result that her reasoning extends to paragraph 4(2)(a).
[39]
There
is no sound reason to adopt different legislative requirements for the
paragraphs set out in subsection 4(2). Each paragraph uses the definitive form
in referring to both the substance of the claim and the substance in the notice
of compliance: “the medicinal ingredient”, “the formulation”, “the
dosage” and “the use” (in French, “l’ingrédient,” “la
formulation”, “la forme posologique”, “l’utilisation”). The
content of each paragraph is otherwise completely consistent.
[40]
The
wording of the PM (NOC) Regulations, as well as their object and purpose,
suggest that the product specificity requirement sets a high threshold of
consistency. Thus, in the case at bar, “the” medicinal ingredients, i.e.,
tenofovir, emtricitabine, and rilpirivine, must be set out in the patent claims
and the NOC for the patent to be eligible on the register.
[41]
Second,
the 2006 revisions to the PM (NOC) Regulations clearly establish that not all
patents relating to an NDS will necessarily be listed on the patent register.
Under the 1993 version of the Regulations, section 4 provided that persons
could submit a list of patents that they wished to have included on the patent
list provided the patents met certain general criteria. Section 4 now states
that patents are “eligible” for listing if they meet a more specific and
detailed set of criteria. The revised section 3 provides new powers to the
Minister to manage the patent register, including the ability to refuse to list
patents, to remove patents from the register, and to consult with the Patent
Office to determine whether to accept or remove a patent.
[42]
Further,
according to the RIAS, the government’s view was that where the patent failed
to meet the requirements, policy considerations tip the balance in favour of
the generic manufacturer, and the matter is better left to the alternative (and
traditional) judicial recourse of an infringement action.
[43]
The
2006 revisions also clearly introduced the requirement for product specificity.
A plain reading of the version in force prior to the 2006 revisions establishes
that if the patent claims were shown to be “relevant to” the approved drug, the
submitted patents were generally accepted for listing. In contrast, the revised
version introduces a requirement for more detailed information on the product
against which the patent is to be listed, including the medicinal ingredient,
the brand name, the dosage form, the strength, the route of administration and
the use as set out in the NDS. In addition, the categories set out in section 4
are now more detailed and precisely defined. These changes, combined with the
greater emphasis on meeting eligibility criteria and being subject to the
Minister’s determination as noted above, lead to a clear rejection of Gilead’s argument for a wide scope of connection between the patent claims and the NOC.
[44]
Finally,
the Guidance Document cited by the appellant is useful to clarify the roles of
the different actors in the patented medicine system, notably innovators,
generic manufacturers, and the Minister. However, it is not a legally binding
document. More significantly, where the Guidance Document is inconsistent with,
or in conflict with, the PM (NOC) Regulations, the latter takes precedence over
the former (Guidance Document, section 1.2, appeal book, volume II, tab 6C). At
the hearing, the Minister conceded that only the PM (NOC) Regulations are a
binding statement of law.
[45]
I
note also that the PM (NOC) Regulations provide no support for the
interpretation suggested in the Guidance Document. As noted above, the wording
of section 4 is consistent across the four subsections and requires a high
degree of specificity between the wording of the claim and the NOC. It would be
necessary to read an interpretation into paragraph 4(2)(a) to allow the
paragraph to support claims which contain only some of the medicinal
ingredients. Such an interpretation goes against the ordinary meaning of the
words, the purpose and object of the PM (NOC) Regulations, and the government’s
position that product specificity is the key consideration in interpreting
section 4. As a result, I would not attribute this interpretation to the PM (NOC)
Regulations.
Issue 3: The
decision to exclude the ‘475 Patent from the Register
[46]
The
Judge was tasked with assessing the reasonableness of the Minister’s decision
to exclude the ‘475 Patent under paragraph 4(2)(b) of the PM (NOC)
Regulations. As I find that both the Minister and the Judge erred in applying
this paragraph to the claims at issue, the Minister’s decision cannot stand.
[47]
As
set out above, the claims should have been considered under paragraph 4(2)(a).
That said, the Judge did not err in his reasoning under the product specificity
analysis. He adopted the comments set out by Layden-Stevenson J.A. in Purdue
and determined that, as set out in paragraph 48 of his reasons, “the
claimed formulation and the approved formulation do not match precisely and the
requirement of product specificity is not met”.
[48]
I
agree with the Judge and conclude that his reasoning regarding product
specificity is equally applicable under paragraph 4(2)(a) of the PM
(NOC) Regulations.
Conclusion
[49]
I
would therefore uphold the Judge’s conclusion that the patent claims fail the
requirement for product specificity because they do not make specific reference
to the medicinal ingredient rilpirivine, but only the broad class of compounds.
However, as set out above, I would do so under paragraph 4(2)(a) rather
than 4(2)(b).
[50]
As
success was divided, and the interests of both parties are served by clarifying
the interpretation of paragraphs 4(2)(a) and (b), as well as by
setting out a consistent approach to product specificity under subsection 4(2),
I propose that both parties bear their own costs in the present appeal.
“Johanne Trudel”
“I
agree,
K. Sharlow J.A.”
“I
agree
Robert M. Mainville J.A.”
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