Pfizer Canada Inc. v. Canada (Health)

Pfizer Canada Inc. v. Canada (Health)
Court (s) Database
Federal Court Decisions
Date
2010-04-26
Neutral citation
2010 FC 447
File numbers
T-124-08
Decision Content
Federal Court
Cour fédérale
Date: 20100426
Docket: T-124-08
Citation: 2010 FC 447
Ottawa, Ontario, April 26, 2010
PRESENT: The Honourable Madam Justice Heneghan
BETWEEN:
PFIZER CANADA INC. and
PHARMACIA ATKIEBOLAG
Applicants
and
THE MINISTER OF HEALTH and
APOTEX INC.
Respondents
REASONS FOR JUDGMENT AND JUDGMENT
I. Introduction
[1] Pfizer Canada Inc. and Pharmacia Atkiebolag (the “Applicants”) apply pursuant to the Patented Medicines (Notice of Compliance) Regulations, SOR/93-133 (the “NOC Regulations”)
for an order prohibiting the Minister of Health from issuing a Notice of Compliance (“NOC”) to Apotex Inc. (“Apotex” or the “Respondent”), pursuant to section C.08.004 of the Food and Drug Regulations, C.R.C. 1978, c. 870, until the expiry of Canadian letters patent 1,339,132 (the “ ‘132 Patent”). The ‘132 Patent is entitled “Prostaglandin Derivatives for the treatment of glaucoma or Ocular Hypertension”. A patent list pertaining to 50 microgram/ml ophthalmic solution of Latanoprost and referencing the ‘132 Patent was submitted to the Minister of Health (the “Minister”). The Minister issued Notices of Compliance to Pfizer for the 50 microgram/ml ophthalmic solution of Latanoprost on various dates, including October 6, 2003. The 50 microgram/ml ophthalmic solution of Latanoprost is marketed in Canada under the registered trade-mark Xalatan®.
[2] This application was commenced following service of a Notice of Allegation (the “NOA”) dated March 4, 2008 upon the Applicants. In its NOA, the Respondent alleged that the ‘132 Patent is invalid on several grounds including anticipation, obviousness, lack of utility, lack of sound prediction, overbreadth, double patenting and lack of sufficiency. The Respondent also alleged that it would not infringe the ‘132 Patent by producing its version of Latanoprost ophthalmic solution, 50 microgram/ml, hereinafter referred to as “APO-latanoprost”.
[3] The Minister of Health (the “Minister”), although a party to this proceeding, is not actively participating in it.
[4] Further to an Order made on April 9, 2010, the statutory injunction granted by the NOC Regulations was extended until April 26, 2010.
A. The Patent
[5] The ‘132 Patent application was filed on September 12, 1989. It issued on July 29, 1997. The Patent addresses the use of certain prostaglandin derivatives in the treatment of glaucoma or ocular hypertension.
[6] Prostaglandins are naturally occurring substances found in human and animal tissues that contain 20 carbon atoms and have a molecular structure called “prostanoic acid”. The PGF2α is a naturally occurring compound that can be esterified into PGF2α isopropyl ester, also referred to as PGF2α –IE. The chemical composition of PGF2α is as follows:
[7] The Latanoprost compound is a prostaglandin derivative that has the chemical formulation of 13,14-dihydro-17-phenyl-18,19,20-trinor PGF2α isopropyl ester or 13,14-dihydro-17-phenyl-18,19,20-trinor PGF2α -IE. Its chemical structure is as follows:
[8] Latanoprost is made by modifying PGF2α as follows:
i. removing the last 3 carbons of the omega chain (“18,19,20-trinor”);
ii. attaching a phenyl ring to carbon 17 (“17-phenyl”);
iii. changing the double bond to a single bond between carbon 13 and carbon 14 (“13,14-dihydro”); and
iv. esterifying the carboxylic acid to an isopropyl ester.
[9] The ‘132 Patent contains 38 claims; however, only Claims 12, 19, 31, 37 and 38 are at issue in this proceeding. Broadly speaking, Claim 19 is a compound per se claim that is dependent on Claim 18. Claims 31, 37 and 38 are use claims. Claim 12 is a narrower use claim and is dependent on Claim 1. The relevant claims read as follows:
i. A therapeutic composition for topical treatment of glaucoma or ocular hypertension, containing a prostaglandin PGA, PGB, PGD, PGE or PGF in an amount sufficient to reduce intraocular pressure without causing substantial ocular irritation and an ophthalmologically compatible vehicle, which the omega chain of the prostaglandin has the formula:
(13) (14) (15-24)
C - B - C - D - R2
wherein
C is a carbon atom (the number is indicated within parenthesis);
B is a single bond, a double bond or a triple bond;
D is a chain with 1-10 carbon atoms, optionally interrupted by hetero atoms O, S, or N, the substituents on each carbon atom being H, alkyl groups, lower alkyl groups with 1 – 5 carbon atoms, an oxo functionality or a hydroxyl group;
R2 is a ring structure selected from the group consisting of phenyl and phenyl having at least one substituent, said substituent being selected from C1-C5 alkyl groups, C1-C4 alkoxy groups, trifluoromethyl groups, C1-C3 aliphatic acylamino groups, nitro groups, halogen atoms, and phenyl group; or an aromatic heterocyclic group having 5-6 ring atoms, selected from the group consisting of thiazol, imidazole, pyrrolidine, thiopene and oxazole; or a cycloalkane or a cycloalkene with 3-7 carbon atoms in the ring, optionally substituted with lower alkyl groups with 1-5 carbon atoms.
12. An ophthalmological composition according to claim 1, wherein the prostaglandin derivative is 13,14-dihydro-17-phenyl-18,19,20-trinor-PGF2α -isopropylester.
18. 13,14-dihydro-17-phenyl-18,19,20-trinor-PGF2α -alkyl-ester, in which the alkyl group has 1-10 carbon atoms.
19. Compound of claim 18, wherein the alkyl group is isopropyl.
31. The use of 13,14-dihydro-17-phenyl-18, 19,20-trinor-PGF2α -isopropylester in the treatment of glaucoma or ocular hypertension.
37. The use of 13,14-dihydro-17-phenyl-18,19,20-trinor- PGF2α -alkyl-ester, in which the alkyl group has 1-10 carbon atoms for the treatment of glaucoma or ocular hypertension.
38. The use of 13,14-dihydro-17-phenyl-18,19,20-trinor- PGF2α -isopropyl-ester in the treatment of glaucoma or ocular hypertension.
B. The Evidence
[10] Each party submitted affidavit evidence from several witnesses, some of whom provided factual evidence and others who addressed matters of opinion.
i) Applicants’ Witnesses
[11] Dr. Wolff is a registered U.S. patent agent and a registered pharmacist in the State of California, United States of America. He obtained a Ph.D. degree in Medicinal Chemistry from the University of California, Berkeley in 1955 and worked as Adjunct Professor of Medicinal Chemistry at the University of Southern California from 1982 to 2002. He was also a member of the faculty of the Residential School of Medicinal Chemistry of Drew University in Madison, New Jersey from 1996 to 2008. He has worked and taught in the fields of medicinal chemistry drug discovery and drug development, both in the pharmaceutical industry and the academic world, for more than 40 years.
[12] Dr. Wolff’s mandate was to describe the person of skill in the art (“POSITA”), provide an opinion on the ‘132 Patent, and to review the opinions expressed by the Respondent’s expert witnesses. He said that around September 12, 1989 there were over 40,000 articles published on prostaglandins. Dr. Wolff said that most of the articles provided by the Respondent as prior art have nothing to do with the eye and any teachings on metabolism found in those articles cannot be transferred to the eye field. He also said that Canadian Patent No. 1,208,560 entitled “Use of Eicosanoids and Their Derivatives for Treatment of Ocular Hypertension and Glaucoma” (the “ ‘560 patent”), does not give the POSITA enough directions to make chemical modifications needed to get to Latanoprost.
[13] Discussing the data found in the ‘132 Patent, he said that using healthy humans gives a sound basis to expect that the drug would work in glaucoma patients because there is no reason to expect substantial differences in the side effects seen between these two groups. He concluded that animal and normal human testing has been and continues to be the standard step-wise process used to evaluate almost all drugs.
[14] Dr. Robert D. Fechtner is a clinical ophthalmologist practising in New Jersey. He is also a professor in the Department of Ophthalmology and Visual Science, New Jersey Medical School, University of Medicine and Dentistry of New Jersey. He has held this position since 2002. He was asked to provide a basic tutorial on the eye and intraocular pressure (“IOP”), glaucoma, ocular hypertension and the treatment of those conditions and to describe the common general knowledge relative to the treatment of ocular hypertension, glaucoma and prostaglandins as of September 12, 1989.
[15] Dr. Fechtner was also asked to describe the qualifications of the POSITA to whom the ‘132 Patent is addressed and to state his understanding of the ‘132 Patent, with reference to Claims 12, 19, 31, 37 and 38 as of July 29, 1997. He was also asked to describe the utility taught by the ‘132 Patent and whether Latanoprost has utility. He was asked to describe the utility of the ‘132 Patent and whether Latanoprost exhibits that utility. As well, he was asked to consider whether the specification of the ‘132 Patent, including Claims 12, 19, 31, 37 and 38 correctly and fully describe, as of July 29, 1997, to the POSITA, the subject matter of the invention and its operation or use as contemplated by the inventor. In addition to reviewing relevant documents, including the ‘132 Patent, Dr. Fechtner was asked to review certain affidavits filed by the Respondent.
[16] Dr. Johan W. Stjernschantz of Uppsala, Sweden is one of the inventors of the ‘132 Patent. He addressed the factual background to the discovery of Latanoprost, including the history of other efforts that were made by competitors, seeking the discovery of a drug that would treat glaucoma and ocular hypertension.
[17] As well, Dr. Stjernschantz tendered opinion evidence as to the POSITA as of September 12, 1989, the concept of obviousness of the invention claimed in the ‘132 Patent having regard to the prior art, the sufficiency of the ‘132 Patent having regard to the test data in the patent and the evidence tendered by the Respondent, and the utility of the ‘132 Patent.
[18] I note that Dr. Stjernschantz, as one of the inventors of the ‘132 Patent, is uniquely situated to give evidence about the invention. However, in my opinion, his evidence is to be cautiously treated in respect of issues of claim construction and validity since it is almost impossible for a person with an “interest”, even an intellectual one, to be wholly objective about his own work. In this regard, I refer to the decision in Emmanuel Simard & Fils (1983) Inc. v. Raydan Manufacturing Ltd. (2005), 41 C.P.R. (4th) 385 (F.C.).
[19] Dr. Kirk M. Maxey is a medicinal chemist with expertise in the area of prostaglandins with almost 30 years experience in the study and synthesis of prostaglandins. Although he holds a medical degree, he has never practiced as a medical doctor. He is the founder and Chairman of the Board of the Cayman Biomedical Research Institute, a non-profit institute that conducts research in the areas of rare diseases and genetic defects.
[20] Dr. Maxey was asked to give a brief tutorial on prostaglandins. He was also asked to describe the qualifications of the POSITA and to give his understanding of the ‘132 Patent, particularly with regard to Claims 12, 19, 31, 37 and 38 as of July 29, 1997.
[21] Dr. Maxey was also asked to consider whether Latanoprost had been disclosed in the prior art, whether the POSITA would have been led to Latanoprost having regard to the state of the art as of September 12, 1989 and July 29, 1997 and whether the claims in issue are broader than the invention made or disclosed in the ‘132 Patent.
[22] The affidavit of Dr. Maxey disclosed that not only did his company supply the raw prostaglandins used by Dr. Stjernschantz’ group, but that no one else had ever requested the compounds that went into the development of Latanoprost and that these base chemicals were not in the main catalogue and were difficult to manufacture.
[23] Dr. Maxey said that he was unaware of any company selling modified 17-phenyl substituted PGF2α as of September 12, 1989. The only people looking for this product were Dr. Stjernschantz and his team at Pharmacia.
[24] Dr. Maxey gave the opinion that Latanoprost was not anticipated by the ‘560 patent or by NOA Document No. 6 entitled “Effect of Chemical Modifications On The Metabolic Transformation of Prostaglandins”. This article was published on December 1, 1976.
[25] Dr. Maxey addressed the issue of esterification of the carboxylic acid of PGF2α and said, in agreement with Dr. Bodor, an expert witness put forward by the Respondent, that this esterification was known as of September 12, 1989. However, he testified that it was also known that other positions could be esterified and sterification was not the solution to the problem of side effects. He concluded that the choice of the four chemical modifications that were made by the inventors was “brilliant”.
[26] Dr. Arthur H. Neufeld is a Professor of Ophthalmology and the Head of Laboratory for the Investigation of the Aging Retina at the Northwestern University School of Medicine. He submitted two affidavits on behalf of the Applicants, the first sworn on September 11, 2008 and the second sworn on January 15, 2009.
[27] In his first affidavit, Dr. Neufeld addressed his mandate to give his interpretation on the ‘132 Patent and whether the Respondent’s product APO-latanoprost infringes Claims 12, 19, 31, 37 and 38 of the ‘132 Patent. In his opinion, the Respondent’s product would infringe the specified claims of the ‘132 Patent.
[28] In his second affidavit, Dr. Neufeld said that he had been asked to explain glaucoma and ocular hypertension and to describe the common general knowledge, as of September 12, 1989, based on his expertise relative to prostaglandins. He was also asked to give his “interpretation” of the ‘132 Patent as of July 29, 1997 and to describe the qualifications of the POSITA.
[29] The Applicants filed one affidavit of fact, that is the affidavit of Ms. Arshia Ghani, Regulatory Affairs Associate of Pfizer Canada. She deposed to the ownership of the ‘132 Patent and the issuance of NOCs over a number of years, beginning in 1997.
ii) Respondent’s Witnesses
[30] The Respondent filed the affidavits of Dr. Nicholas Bodor, Dr. Cheryl Cullen, Dr. Allan Flach, Dr. Howard Leibowitz, Chrystal Yorke and Ines Ferreira.
[31] Dr. Bodor holds a Ph.D. in organic chemistry and has worked in the fields of pharmochemical research and medical chemistry. He was asked to provide a summary of prostaglandin development and chemistry as of September 12, 1989, as well as his opinion as to whether claims of the ‘132 Patent here in issue are anticipated, by the ‘560 patent and if those claims are obvious.
[32] Dr. Bodor summarized the development of prostaglandins as of September 12, 1989. He also gave a definition of the POSITA. He concluded that that the claims are obvious and anticipated, in light of the ‘560 patent which he observed would direct a person skilled in the art to Latanoprost.
[33] Dr. Cheryl Cullen is an Associate Professor in the Faculty of Veterinary Medicine at the University of Calgary, in Calgary, Alberta. She was asked to provide comments on the animal models and testing described in the ‘132 Patent, and whether these models and tests were sufficient to permit the inventors to predict the behaviour of a new prostaglandin in the treatment of glaucoma in humans.
[34] Dr. Cullen found both the animals and testing insufficient for the purposes of predicting the behaviour of a new prostaglandin in the treatment of glaucoma in humans. Her affidavit sets out various criticisms, including criticism of the sample size and the alleged lack of data.
[35] Dr. Allan J. Flach holds a doctorate in pharmacy and a medical degree. He is an American Board of Ophthalmology certified ophthalmologist and has worked in the field of ophthalmology for more than 30 years. He has been a tenured professor within the Department of Ophthalmology at the USCF Medical Center for 23 years. He was asked to provide a history of prostaglandins, to describe the POSITA and to give his opinion on the animal models and test data found in the ‘132 Patent.
[36] He concluded that the animal models used were not sufficiently reliable to predict the efficacy and toxicity of prostaglandins in humans. He found that the results of the animal testing could “only provide a general indication of how the prostaglandins will behave in humans”. He also concluded that the small number of humans tested was insufficient to support a prediction as to whether the human response to efficacy or toxicity would be favourable or otherwise.
[37] Dr. Howard Leibowitz is a medical doctor with specialized training in ophthalmology. From 1971 to 2002, he served as the Chairman, Department of Ophthalmology, Boston University School of Medicine. He has been recognized by his peers as an expert in external ophthalmic diseases and other diseases. Dr. Leibowitz was asked to provide his opinion on the POSITA, background information on glaucoma, the claims of the ‘560 patent, whether the ‘132 Patent discloses sufficient data and information to support a prediction that Latanoprost reduces IOP without causing substantial ocular irritation in humans and whether Latanoprost meets the promise of the patent.
[38] In Dr. Leibowitz’ opinion, the ‘132 Patent claims a treatment for glaucoma and ocular hypertension without substantial ocular irritation and hyperemia. He expressed the opinion that the ‘560 patent describes and claims “a class of PGE2 and PGF2α eicosanoid (prostaglandin) derivatives, for the treatment of ocular hypertension without tachyphylaxis”. He expressed the opinion that the ‘132 Patent did not disclose data or results that show that Latanoprost has “surprising or unexpected properties” in light of the teachings of the ‘560 patent. Finally, he rejected the idea that there was a sound prediction that Latanoprost would “lack” ocular irritation and hyperemia, as side effects in humans.
[39] Finally, the Respondent filed the affidavits of Ms. Chrystal Yorke and Ms. Ines Ferreira.
[40] Ms. Yorke, at the time of swearing her affidavit, was an articling law clerk. She deposed that she attended at the Office of Patented Medicines and Liaison, Health Canada Therapeutic Products Directorate and obtained documents relating to the listing of the ‘560 patent on the Patent Register. These documents, being copies of Form IV Patent List relating to the ‘560 patent, are attached as exhibits to her affidavit.
[41] Ms. Ferreira is a legal assistant with the Solicitors for the Respondent. She attached, as exhibit “A” to her affidavit, a copy of a “Patent Expiry Report” for the period January 2003 to December 2003, obtained from the Canadian Patent Register website. This report notes that the Canadian Patent ‘560 under the brand name “Xalatan”, using the medicinal ingredient Latanoprost, expired in July 2003.
[42] Ms. Ferreira also attached a copy of the Respondent’s NOA and its Schedules as exhibit “B”. The Schedules to the NOA include, in Schedule “B", the documents cited by the Respondent as prior art.
C. The Eye, Glaucoma and Ocular Hypertension
[43] The ‘132 Patent deals with an ophthalmic solution for treatment of glaucoma and ocular hypertension. The eye is a closed sphere that produces a clear fluid called aqueous humor. Aqueous humor is essential to the functioning of the eye. It conveys nutrients to the eye and removes waste products and contaminants from the eye. Drainage of aqueous humor assists in avoiding an increase in intraocular pressure. Elevated IOP is one of the strongest risk factors for disorders of the eye, including glaucoma and ocular hypertension.
[44] Ocular hypertension means elevated intraocular hypertension in the absence of damage to the optic nerve, according to Dr. Fechtner. Glaucoma, according to Dr. Fechtner, describes a group of disorders that are characterized by damage to the optic nerve that results in loss of vision if the condition is left untreated. Elevated intraocular pressure is one of the strongest risk factors for the development and progression of glaucoma.
[45] There is no cure for glaucoma but both this disease and ocular hypertension can be managed by the reduction of intraocular pressure. According to Dr. Fechtner, this is the only risk factor of these disorders that can be modified by treatment.
[46] Two possible ways of reducing intraocular pressure by the use of drugs are the reduction in the production of aqueous humor and second, an increase in the outflow of aqueous humor.
[47] Successful treatment of glaucoma by the use of drugs requires a high level of patient compliance. Therapies with less frequent dosages are preferred by patients and contribute to patient compliance.
[48] Tolerance of the drug regime is another factor that affects patient compliance. Tolerability of drugs refers to the existence of side effects. Side effects may be systemic, that is occurring throughout the body or local, that is adverse effects occurring in and around the eye. Systemic effects of drugs used to treat glaucoma include worsening of asthma or emphysema. Local side effects include ocular inflammation, that is within the eye, and irritation, that is side effects occurring outside the wall of the eye.
[49] Conjunctival hyperemia, that is redness of the eye, may also be a local side effect. Conjunctival hyperemia can be experienced with or without irritation.
[50] Prior to the advent of Latanoprost, other drugs were on the market for the treatment of glaucoma and ocular hypertension. According to the evidence of Dr. Neufeld and Dr. Fechtner, these drugs included timolol maleate, epinephrine and acetazolamide which caused side effects, including burning, hyperemia, tingling, and stomach upset. Further, more serious systemic effects of these drugs were blood disorders, cardiac arrhythmia, asthma, emphysema and death.
II. Issues
[51] The following issues arise from this application:
i. How should the claims in issue be construed?
ii. Will the Respondent’s drug infringe the ‘132 Patent?
iii. Are any of the Respondent’s allegations of invalidity justified, as follows:
(a) double patenting
(b) anticipation;
(c) obviousness;
(d) lack of utility;
(e) lack of sound prediction;
(f) overbreadth.
III. Discussion and Disposition
[52] The parties filed a considerable amount of evidence in relation to this proceeding. I will not refer to all of the evidence contained within the record but instead will base my conclusions upon that evidence which I found to be most relevant, credible and reliable. I have not ignored evidence which is not specifically mentioned.
A. Nature of This Proceeding
[53] This application seeks to prohibit the issuance of a NOC to the Respondent for its product which contains Latanoprost. The Applicants challenge the Respondent’s NOA on the grounds that the allegations of invalidity of the ‘132 Patent are not justified.
[54] A NOC grants marketing approval for drugs in Canada. It is issued by the Federal Government, indicating that all requirements have been met pursuant to the Food and Drug Regulations for the protection of public health and safety. The NOC Regulations authorize owners of existing patents for pharmaceutical products to file a “patent list” relative to those products for which they hold a NOC. The NOC Regulations refer to the person filing such a list as the “first person”. In this case, the Applicants are the “first person”.
[55] The framework of the NOC Regulations allows generic drug manufacturers to rely on prior approval of related pharmaceutical products in applying for marketing approval of their generic form of the products. Manufacturers who produce the same drug may file an application for a NOC that refers to and relies on the fact that prior approval has been granted for the brand-name version of the drug. Such a manufacturer is known as the “second person” and that is the Respondent’s status.
[56] The NOC Regulations prohibit the Minister of Health from issuing a NOC until all relevant product and use patents in the earlier approved medicine, as described in the patent list, have expired. Consequently, a second person must either wait until patent expiry before receiving a NOC or it may submit a NOA to the Minister with its new drug submission.
[57] The NOC Regulations require service of the NOA upon the first person. Section 5 sets out the grounds upon which a NOA is to be based. Briefly, the NOA must assert either that the first person is not the patentee, that the patent is expired or invalid, or that it would not be infringed if a NOC were issued.
[58] Following service of the NOA, the Minister may issue a NOC to the second person, unless the first person avails of its right, pursuant to section 6(1) of the NOC Regulations, to seek an order from the Federal Court prohibiting the Minister from issuing the NOC. Any such step must be taken by the first person within 45 days after receipt of the NOA and once such a proceeding is commenced, the issuance of a NOC to the second person is stayed for a maximum period of 24 months.
B. Burden of Proof
[59] Before addressing the specific aspects of this case, I will briefly address the jurisprudence applicable to the burden of proof and the question that must be answered in a NOC proceeding. It is well-established that the burden of proving that the second person’s, that is, Apotex’s, allegations are not justified is on the person seeking the Prohibition Order, Pfizer. Pfizer must establish, on a balance of probabilities, that Apotex’s allegations are not justified. Apotex must put its allegations “in play” through its NOA. However, once that has been done, Pfizer bears the burden of proving that such allegations are not justified, on a balance of probabilities: see Eli Lilly and Co. v. Nu-Pharm Inc. (1996), 69 C.P.R. (3d) 1 (F.C.A.), Merck Frosst Canada Inc. v. Canada (Minister of National Health and Welfare) (1994), 55 C.P.R. (3d) 302 (F.C.A.) and SmithKline Beecham Pharma Inc. v. Apotex Inc., [2001] 4 F.C. 518 (T.D.), aff’d (2002), 291 N.R. 168 (F.C.A.).
[60] Second, the Court must determine whether Apotex’s allegations of invalidity are justified or not. In Pharmacia Inc. v. Canada (Minister of National Health and Welfare) (1994), 58 C.P.R. (3d) 209 (F.C.A.) (“Pharmacia”) the Federal Court of Appeal commented upon the standard to be applied to this type of proceeding, at page 216:
...these proceedings are not actions for determining validity or infringement: rather they are proceedings to determine whether the Minister may issue a notice of compliance. That decision must turn on whether there are allegations by the generic company sufficiently substantiated to support a conclusion for administrative purposes (the issue of a notice of compliance) that the applicant’s patent would not be infringed if the generic’s product is put on the market…
[61] In SmithKline, Justice Gibson considered the evidentiary burden in proceedings under the NOC Regulations where invalidity of a patent is alleged. At paragraphs 14 to15 he wrote the following:
Against the foregoing, I conclude that while an “evidential burden” lies on Apotex to put each of the issues raised in its notice of allegation “in play”, if it is successful in doing so, the “persuasive burden” or “legal burden” then lies with SmithKline. Assuming Apotex to be successful in putting the issue of validity of the ‘637 patent “in play”, SmithKline is entitled to rely on the presumption of validity of the patent created by subsection 43(2) of the Act.
The “persuasive burden” or “legal burden” that lies with SmithKline in the circumstances described in the preceding paragraph is, however, impacted by the nature of the proceeding here before the Court. In Merck Frosst Canada Inc. v. Canada (Minister of National Health and Welfare), [(1994), 55 C.P.R. (3d) 302 (F.C.A.)] Mr. Justice Hugessen, for the Court, wrote at pages 319-20:
As I understand the scheme of the regulations, it is the party moving under s. 6, in this case Merck, which, as the initiator of the proceedings, has the carriage of the litigation and bears the initial burden of proof. That burden, as it seems to me, is a difficult one since it must be to disprove some or all of the allegations in the notice of allegation which, if left unchallenged, would allow the Minister to issue a notice of compliance…
…
In this connection, it may be noted that, while s. 7(2)(b) [of the Regulations] seems to envisage the court making a declaration of invalidity or non-infringement, it is clear to me that such declaration could not be given in the course of the s. 6 proceedings themselves. Those proceedings, after all, are instituted by the patentee and seek a prohibition against the Minister; since they take the form of a summary application for judicial review, it is impossible to conceive of them giving rise to a counterclaim by the respondent seeking such a declaration. Patent invalidity, like patent infringement, cannot be litigated in this kind of proceeding.
Thus, the burden on SmithKline is only to disprove the allegations in the notice of allegation, not to justify declarations of validity and infringement or conversely to negative claims for declarations of invalidity and non-infringement.
[62] The burden lies on Pfizer, as the Applicants, to refute the allegations set forth by Apotex in its NOA dated March 4, 2008. Like any plaintiff or applicant, Pfizer has the overall legal burden of proof. Apotex, as the Respondent, has an obligation to put the allegations set out in its NOA in play.
[63] The present proceeding is a summary proceeding pursuant to the NOC Regulations and the Federal Court Rules, SOR/98-106 (the “Rules”) governing applications for judicial review. A finding of invalidity or infringement in the context of this type of proceeding is not determinative of that issue in any subsequent action; see Pharmacia at page 216.
Issue 1: Construction of the ‘132 Patent
[64] According to the direction given by the Supreme Court of Canada in its decisions in Whirlpool Corp. v. Camco Inc. (2000), 9 C.P.R. (4th) 129 (S.C.C.) and Free World Trust v. Électro Santé Inc. (2000), 9 C.P.R. (4th) 168 (S.C.C.), before addressing the issues of infringement and invalidity, the Court must first construe the patent.
[65] Claims construction must be approached in an informed and purposive manner, with close regard to the purpose and intent of the authors. Information is to be gained from the patent as a whole in order to determine the context in which the claims are to be considered. The role of experts is to provide assistance, if necessary, relative to the technical meaning of the words and concepts used in the claims; see Whirlpool at paragraphs 51 and 52. In construing the claim, the Court should be neither harsh nor benevolent but approach the claim with a mind willing to understand.
[66] The ‘132 Patent specification gives an overview of disorders of the eye derived from elevated IOP, discloses the results if the eye disorder is left untreated, and defines the formulae to determine IOP levels. The specification goes on to discuss the current state of the art available at the time the patent application was filed as well as the available research activity undertaken in the use of prostaglandins. Finally, the specification discloses the solution that the invention solves as well as some of the preferred derivatives and preferred methods of preparing, testing, using and applying the invention.
[67] The ‘132 Patent is governed by the provisions of the Patent Act, R.S.C. 1985, c. P-4, (the “Act”). The provisions of the Act that pertain to patents applied for prior to October 1, 1989, are called “Old Act Patent”. The claims are to be construed from the date of issue, that is July 29, 1997. The ‘132 is an “Old Act Patent”.
[68] The Applicants and the Respondent made submissions on the issue of claims construction. The Applicants argued that claims construction should follow the steps outlined by the Supreme Court of Canada recently in its decision in Sanofi-Synthelabo Canada Inc. v. Apotex Inc. (2008), 298 D.L.R (4th) 385 (S.C.C.) at para. 76.
[69] The Respondent submits that the claim in issue should be construed as addressing the abolition of side effects in the chronic treatment of glaucoma by the use of the compound described in Claim 19 of the ‘132 Patent. Further, it argues that the promise of the patent is chronic use of the compound.
[70] As noted earlier, Claims 12, 19, 31, 37 and 38 are in issue in this proceeding. Broadly speaking, Claim 19 is a compound per se claim. Claims 12, 31, 37 and 38 are use claims, with Claim 12 limited by reference to Claim 1.
[71] In Pfizer Canada Inc. v. Canada (Minister of Health), [2009] F.C.J. No. 1659 (F.C.) (Q.L.), I construed Claims 12, 19, 31, 37 and 38 of the ‘132 Patent, the same claims that are in issue here. I am not persuaded by the evidence submitted by the Respondent nor by its arguments that the construction of these claims should differ from what I have already said and my prior construction will apply here, too.
[72] Claim 19 reads as follow:
19. Compound of claim 18, wherein the alkyl group is isopropyl.
[73] This claim is for the chemical compound described in Claim 18. Claim 18 reads as follows:
18. 13,14-dihydro-17-phenyl-18,19,20-trinor-PGF2α -alkyl-ester, in which the alkyl group has 1-10 carbon atoms.
[74] I construe Claim 19, having regard to Claim 18 as being a chemical compound with isopropyl as the alkyl group. The isopropyl used as the alkyl group has three carbon atoms.
[75] Claims 12, 31, 37 and 38 are use claims and I construe them as such. Claim 12 refers to Claim 1 and accordingly, can be read as follows:
i. A therapeutic composition for topical treatment of glaucoma or ocular hypertension, containing a prostaglandin PGA, PGB, PGD, PGE or PGF in an amount sufficient to reduce intraocular pressure without causing substantial ocular irritation and an ophthalmologically compatible vehicle, which the omega chain of the prostaglandin has the formula:
(13) (14) (15-24)
C - B - C - D - R2
wherein
C is a carbon atom (the number is indicated within parenthesis);
B is a single bond, a double bond or a triple bond;
D is a chain with 1-10 carbon atoms, optionally interrupted by hetero atoms O, S, or N, the substituents on each carbon atom being H, alkyl groups, lower alkyl groups with 1 – 5 carbon atoms, an oxo functionality or a hydroxyl group;
R2 is a ring structure selected from the group consisting of phenyl and phenyl having at least one substituent, said substituent being selected from C1-C5 alkyl groups, C1-C4 alkoxy groups, trifluoromethyl groups, C1-C3 aliphatic acylamino groups, nitro groups, halogen atoms, and phenyl group; or an aromatic heterocyclic group having 5-6 ring atoms, selected from the group consisting of thiazol, imidazole, pyrrolidine, thiopene and oxazole; or a cycloalkane or a cycloalkene with 3-7 carbon atoms in the ring, optionally substituted with lower alkyl groups with 1-5 carbon atoms.
12. An ophthalmological composition according to claim 1, wherein the prostaglandin derivative is 13,14-dihydro-17-phenyl-18,19,20-trinor-PGF2α -isopropylester.
[76] The claim for use in Claim 12 is limited by the reference in Claim 1 to the reduction of intraocular pressure “without causing substantial ocular irritation”.
[77] Claim 31 provides as follows:
31. The use of 13,14-dihydro-17-phenyl-18, 19,20-trinor-PGF2α -isopropylester in the treatment of glaucoma or ocular hypertension.
[78] I construe this to be a claim for the use of the compound in Claim 19 in the treatment of glaucoma or ocular hypertension. Glaucoma and ocular hypertension are disorders of the eye, according to the evidence of the expert witnesses.
[79] Claim 37 provides as follows:
37. The use of 13,14-dihydro-17-phenyl-18,19,20-trinor- PGF2α -alkyl-ester, in which the alkyl group has 1-10 carbon atoms for the treatment of glaucoma or ocular hypertension.
[80] I construe this to be a claim for the use of the compound claimed in Claim 19 for the treatment of glaucoma or ocular hypertension.
[81] Claim 38 provides as follows:
38. The use of 13,14-dihydro-17-phenyl-18,19,20-trinor- PGF2α -isopropyl-ester in the treatment of glaucoma or ocular hypertension.
[82] I construe this to be another claim for the use of the compound claimed in Claim 19 in the treatment of glaucoma or ocular hypertension. It is identical to Claim 37 with a difference in the spelling of “isopropylester”, a hyphen is included in Claim 38.
[83] Since this is an Old Act Patent, the operative date for claims construction is the date of issuance of the ‘132 Patent, that is July 29, 1997. In this regard, I refer to the decision in Janssen-Ortho Inc. v. Novopharm Ltd. (2006), 57 C.P.R. (4th) 6 (F.C.), aff’d (2007), 59 C.P.R. (4th) 116 (F.C.A.), leave to appeal to S.C.C. refused, [2007] 3 S.C.R. xii.
Issue 2: Infringement
[84] The Respondent alleges that its product will not infringe the ‘132 Patent because the ‘132 Patent claims an old use for an old compound. This kind of allegation is known as the “Gillette Defence” on the basis of the decision in Gillette Safety Razor Co. v. Anglo-American Trading Co. Ltd. (1913), 30 R.P.C. 465 (H.L.) at 480 to 481 where the House of Lords said the following:
…The defence that “the alleged infringement was not novel at the date of the plaintiff’s Letters Patent” is a good defence in law, and it would sometimes obviate the great length and expense of Patent cases if the defendant could and would put forth his case in this form, and thus spare himself the trouble of demonstrating on which horn of the well-known dilemma the plaintiff had impaled himself, invalidity or non-infringement.
[85] The Gillette Defence has been raised in many cases in Canada but has rarely been successful. One exception to that trend is the decision in Eli Lilly Canada Inc. v. Apotex Inc.(2009), 75 C.P.R. (4th) 165 (F.C.), at paras. 60 to 64, where the Court, per Justice Hughes, found that the product to be produced by the respondent would not be different from that produced by the process of a prior art patent and in theory, the respondent would infringe the patent in issue in the proceedings before him. However, he found that the product of that earlier patent anticipates the product of the patent in issue and consequently, the claims in issue were invalid.
[86] In my opinion, the availability of the “Gillette Defence” depends upon the determination of the many allegations of invalidity raised by the Respondent. This means that if the allegations of anticipation and obviousness fail, this Gillette Defence must also fail.
[87] Dr. Neufeld addressed the issues of infringement on behalf of the Applicants. He referred to the description of the Respondent’s product as set out in the NOA as follows:
APO-latanoprost (latanoprost) is an ophthalmic solution that is meant to be used topically as eyedrops for the reduction or treatment of IOP in patients that have open-angle glaucoma or ocular hypertension.
[88] In his affidavit, he said that the active pharmacological ingredient in APO-latanoprost is 13, 14-dihydro-17-phenyl-18,19,20-trinor-PGF2α-isopropyl ester which is Latanoprost as set out in Claim 19 of the ‘132 Patent.
[89] Dr. Neufeld reviewed the five claims of the ‘132 Patent that are in issue and tendered the opinion that the Respondent’s product will infringe each claim. Claim 12 of the ‘132 Patent claims an ophthalmological composition containing Latanoprost as described in Claim 19. He also reviewed the use claim in Claims 31, 37 and 38, in comparison with APO-latanoprost, and concluded that the use claim will be infringed by the Respondent’s product.
[90] The disposition of the allegation of non-infring