ratiopharm inc. v. Pfizer Ltd., (2009) 350 F.T.R. 250 (FC)

• Judge: Hughes, J.
• Court: Federal Court (Canada)
• Case Date: July 08, 2009
• Jurisdiction: Canada (Federal)
• Citations: (2009), 350 F.T.R. 250 (FC);2009 FC 711

ratiopharm inc. v. Pfizer Ltd. (2009), 350 F.T.R. 250 (FC)

MLB headnote and full text

Temp. Cite: [2009] F.T.R. TBEd. AU.024

Ratiopharm Inc. (plaintiff) v. Pfizer Limited (defendant)

(T-1712-07; 2009 FC 711)

Indexed As: ratiopharm inc. v. Pfizer Ltd.

Federal Court

Hughes, J.

July 8, 2009.

Summary:

Pfizer Ltd. was the named owner of Canada Patent 1,321,393 (the '393 patent). The patent was based on an application filed in Canada on April 2, 1987, and claimed priority from a U.K. patent application filed on April 4, 1986. The '393 patent was issued on August 17, 1993. Ratiopharm Inc. sought a declaration that the patent was invalid and a direction under that an entry in the records of the Canada Patent Office be made to that effect. The parties agreed that the validity of the patent would be determined on the basis of Claim 11, directed to a particular salt form of a pharmaceutical, amlodopine besylate.

The Federal Court found that the patent was invalid on a number of legal bases and gave the requested declaration and direction.

Editor's Note: The patent had been the subject of previous litigation in the context of the Patented Medicines (Notice of Compliance) Regulations. And a related United States patent, put in evidence in this case, had been the subject of litigation in that country.

Evidence - Topic 252

Inferences and weight of evidence - Weight - Expert evidence - The plaintiff, a generic pharmaceutical company, sought a declaration that the defendant's patent was invalid - It led the evidence of five expert witnesses who were examined in chief and cross-examined, including Dr. Cunningham, an independent consultant to the pharmaceutical industry, and Dr. Cappucino, who had over 30 years experience in the pharmaceutical industry - The Federal Court accepted Dr. Cunnigham's evidence, as "he was not shaken nor did he retreat from his evidence on Cross-Examination ... He was forthright and honest. I am particularly impressed with his depth of actual experience in the pharmaceutical industry during the relevant period" - On the other hand, the court gave little weight to Dr. Cappucino's evidence - Although he gave his evidence "in a clear and straightforward manner, it is evident that he is closely associated with the generic pharmaceutical industry in many ways ... I treat his evidence cautiously for that reason" - - See paragraphs 21, 25.

Evidence - Topic 7002

Opinion evidence - Acceptance, rejection and weight to be given to expert opinion - Ratiopharm Inc. sought a declaration that Pfizer Ltd.'s '393 patent (a besylate product) was invalid - Pfizer's expert witnesses included Dr. McGinity, who had testified previously in Canada and the United States in respect of the '393 patent and the related U.S. patent - He was confronted in cross-examination with several contradictions between his evidence given in the U.S. litigation and his evidence given in this case - The Federal Court stated that it had difficulty in having any confidence in his evidence - Further his evidence in chief by way of a report gave the incorrect impression that he was giving factual first hand evidence - "Taking the tenor of his evidence as a whole I view it as containing much that is hearsay, prepared in conjunction with counsel for Pfizer, under the guise of giving expert evidence, while in reality providing a narrative of a Pfizer-biased view as to the development of the besylate product. In so doing Dr. McGinity overstepped the role of an expert and became an advocate. I will treat his evidence with great caution" - See paragraphs 22, 25.

Evidence - Topic 8001

Trial practice - General - The plaintiff sought a declaration that the defendant's patent was invalid - The plaintiff called five witnesses at trial, all as expert witnesses - The defendant called eight witnesses; five were fact witnesses and three were expert witnesses - There was no evidence in conflict from a factual point of view although there were many gaps - As to the experts, there were conflicting opinions - The Federal Court stated that, "in cases such as this, the Court must accept factual witnesses as they are, weighing their evidence based on the Court's findings as to credibility and, where the evidence conflicts, weighing the evidence on the balance of probabilities" - The court also expressed reservations concerning some of the evidence of some of the experts, including those whose evidence was "seriously discredited" during cross-examination - Further, the court contrasted the evidence given "in proceedings such as this action where witnesses can be observed live in the stand as opposed to the simple reading of affidavits and cross-examination transcripts as in [Notice of Compliance] Proceedings. Live witness are much more valuable in seeking out the truth of a matter and sound opinions" - See paragraphs 19 to 26.

Patents of Invention - Topic 700

Application for grant - General - The Federal Court observed that the courts have discussed in various decisions what was required of a person who, believing they had made an invention, must do in order to obtain a valid patent - "They must 1. Have made an invention, something that would not have been obvious to a person skilled in the art (Obviousness and Invention); 2. The invention must be new. If it has been previously disclosed in such a way as to enable a person skilled in the art to understand the invention as previously disclosed, no valid patent can be granted (Novelty); 3. The invention as promised in the specification must live up to that promise. It must have the promised utility (Utility); 4. The invention must be fully and correctly disclosed as contemplated by the inventors in a way that a person skilled in the art could read the patent and put the invention into practice (Disclosure); and 5. The patent specification cannot mislead a person skilled in the art (Section 53)" - See paragraph 156.

Patents of Invention - Topic 770

Application for grant - Conflicting applications - Date of invention - The plaintiff sought a declaration under the Patent Act that the defendant's '393 patent was invalid - The patent was based on an application filed in Canada on April 2, 1987, and claimed priority from a U.K. patent application filed on April 4, 1986 - The Federal Court stated that the "'date of invention' for an 'old' Act patent such as the '393 Patent at issue is initially accepted as being the date of filing the application for the patent in the Canadian Patent Office, here April 2, 1987. However, where priority is claimed from an application filed elsewhere, here Great Britain, it is presumed to be the filing date of that application, here April 4, 1986. An even earlier date may be established if the evidence shows that the inventors formulated orally or in writing a description which affords a means of making that which was invented ... Usually if a date earlier than the priority date is relevant, it should be pleaded. There is no such pleading here" - However, from the evidence of the inventors and of some of their colleagues, the court found it was reasonable to state that the "date of invention" was November 25, 1985, the date of the patent memorandum written by one of the inventors for the purpose of instructing the defendant's patent department to prepare a patent application - See paragraphs 32 to 34.

Patents of Invention - Topic 1026

The specification and claims - Construction of a patent - General - The plaintiff sought a declaration that the defendant's '393 patent was invalid - The patent was based on an application filed in Canada on April 2, 1987, and claimed priority from a U.K. patent application filed on April 4, 1986 - The Federal Court accepted the identification of the notional person skilled in the art or person of ordinary skill in the art to whom the patent was addressed as described by one of the plaintiff's experts; the description accorded essentially with that expressed by two of the defendant's experts - The court stated that the person skilled in the art "plays a role as of different dates. For purposes of construction of the patent, that person plays a role as of the date the patent was granted, here August 17, 1993, since the '393 Patent is an 'old' Act patent ... For the purposes of considering a question of 'obviousness,' "since this is an 'old' Act patent, the relevant date is the 'date of invention'" - See paragraphs 29 to 31.

Patents of Invention - Topic 1026

The specification and claims - Construction of a patent - General - Validity of the defendant's patent was determined having regard to Claim 11, which read "The besylate salt of amlodipine" - The Federal Court found that the Claim was to be read as it was, unrestricted as to any particular use, and unrestricted as to any particular form of the compound - "The jurisprudence directs that a court, before dealing with issues as to validity of a patent, or infringement, must first construe the claim(s) at issue. Such a construction in the case of an 'old' Patent Act patent, such as the one at issue here, is to be made by the Court as of the date it was granted ... through the eyes of a person skilled in the art to which the patent pertains. The Court is to look at the claims in the context of the entire patent specification, being neither benevolent nor harsh, to give meaning to the claim ... by reading the document as a whole. Experts may assist as to the meaning of technical terms and as to the state of the art at the relevant time but construction is for the Court, not experts" - In the result, the claim's essential feature was that a particular salt form, besylate, of a known pharmaceutical compound, amlodipine, was the claimed invention - See paragraphs 35 to 40.

Patents of Invention - Topic 1032

The specification and claims - Construction of a patent - Particular patents - [See second Patents of Invention - Topic 1026 ].

Patents of Invention - Topic 1128.1

The specification and claims - The description - Sufficiency of description of invention - [See Patents of Invention - Topic 1779 ].

Patents of Invention - Topic 1130

The specification and claims - The description - Claims for more than what was invented - The plaintiff sought a declaration that the defendant's patent was invalid on several grounds - The patent described the claimed invention in terms of superlatives - The Federal Court had the "rare opportunity" to compare what was said in the patent to what was actually known to the inventors, and concluded that the claim was not an accurate reflection of the understanding of the inventors - "Great technical skill is required to get it [drafting a patent] right. There is, however, an overriding duty as imposed by section 34(1) (now 27(3)) of the Patent Act) to correctly and fully describe the invention and by section 53(1) not to wilfully provide in the specifications more or less than is necessary so as to mislead. These are statutory continuations of earlier common law obligations" - The defendant objected to any reliance by the plaintiff on a lack of good faith or failure of living up to common law disclosure obligations, saying that it had not been pleaded - However, the court stated that it was not necessary to rely on a generalized lack of good faith or common law disclosure argument, as the issues were squarely before the court, namely, selection, obviousness, insufficiency, utility and validity under s. 53(1) - See paragraphs 108 to 115.

Patents of Invention - Topic 1136

The specification and claims - The description - Chemicals (incl. selection patents) - [See Patents of Invention - Topic 1130 ].

Patents of Invention - Topic 1507

Grounds of invalidity - General - Untrue material allegations in petition, specification or drawings - The Federal Court stated that, in considering whether a specification was misleading, "the Court must look at the specification, the nature of the alleged misleading material to determine if it would be likely to mislead a person skilled in the art, and whether, taking the evidence as a whole, whether an intention to mislead can be determined directly or by reasonable inference" - See paragraph 157.

Patents of Invention - Topic 1507

Grounds of invalidity - General - Untrue material allegations in petition, specification or drawings - Section 53 of the Patent Act read that "A patent is void if any material allegation in the petition of the applicant in respect of the patent is untrue, or if the specification and drawings contain more or less than is necessary for obtaining the end for which they purport to be made, and the omission or addition is wilfully made for the purpose of misleading" - The Federal Court stated that "Canada, unlike other jurisdictions such as the United States, does not have an explicit statutory provision directed to issues of fraud. However, Section 53 comes close" - Allegations directed to s. 53 "must be pleaded with particularity and a party alleged to have breached the provisions of that section should have ample opportunity to know what is alleged and prepare its defences - See paragraph 196.

Patents of Invention - Topic 1507

Grounds of invalidity - General - Untrue material allegations in petition, specification or drawings - Ratiopharm alleged that Pfizer had breached s. 53 of the Patent Act in three aspects - The Federal Court found that the three pleaded matters were misstatements, they were misleading and, sufficient intent to make such statements has been made out in the evidence - The patent was invalid for that reason, as well as others, and it could not be saved under s. 53(2) - The evidence had shown that the misstatements were made, that they were misstatements and that they served to enhance the alleged uniqueness and outstanding characteristics of the besylate salt, which characteristics were not true - These misstatements and the selection of words such as "unique", "outstanding" and "particularly suitable" were the work of patent draftsmanship not of the inventors - In their evidence, the inventors distanced themselves from the patent drafting; a factual witness placed blame on a trainee who now could not be found - The court was left with the "clear impression" that Pfizer knew that there were problems with the patent as drafted - Proper disclosure was essential and intent to mislead could be inferred - See paragraphs 197 to 204.

Patents of Invention - Topic 1582

Grounds of invalidity - Lack of "inventive ingenuity" (obviousness) - Test for obviousness - The plaintiff sought a declaration that the defendant's '393 patent was invalid on a number of legal bases, including obviousness - Since this was an "old" Patent Act patent, the relevant date was the "date of invention - see paragraph 35 - The Federal Court stated that "In considering obviousness and novelty the Court must look at the invention as claimed " - Here, the court had construed the claim as the besylate salt of amlodipine - The court was presented with a situation where the inventors looked at amlodipine maleate to see if they could make it work sufficiently so as to pass it on for final formulation for regulatory approval - They determined that there were two problems, stability and stickiness; only stability was mentioned in the patent - A suitable formulation for maleate was eventually found but not mentioned in the patent except as a besylate formulation - In the first set of salts screened the inventors found a few salts, including besylate, good enough, so they stopped there - The court agreed with the plaintiff's expert (Cunningham) in his conclusion that a person skilled in the art would be motivated to test the besylate salt as this had already been shown to offer advantages over other salts in terms of stability - The court found, in applying the "Sanofi" test, that the claimed invention was obvious, hence the '393 patent was invalid - See paragraphs 157 to 172.

Patents of Invention - Topic 1584

Grounds of invalidity - Lack of "inventive ingenuity" (obviousness) - Chemical processes - [See Patents of Invention - Topic 1582 ].

Patents of Invention - Topic 1587

Grounds of invalidity - Lack of "inventive ingenuity" (obviousness) - Selection patents - The Federal Court addressed the question of selection patents; i.e., patents based on a selection of compounds from those described in general terms and claimed in the originating patent - The court stated the issue as "Given that a person skilled in the art already knows that amlodipine exists and already knows that several pharmaceutically acceptable salts of amlodipine exist, can a valid patent be obtained for the besylate salt, particularly where that particular salt has not been previously developed?" - In other cases, the court had already expressed the view that "an attempt to create a special category for 'selection' patents is really nothing more than a way of approaching an issue of obviousness. The question generally stated is, if a class of compounds has been discovered, is it obvious that a particular member or group within that class will have the same or different properties, and, if different, how different?" - See paragraphs 174 and 175.

Patents of Invention - Topic 1587

Grounds of invalidity - Lack of "inventive ingenuity" (obviousness) - Selection patents - The plaintiff sought a declaration that the defendant's '393 patent (a pharmacuetical compound, besylate salt of amlodipine) was invalid on a number of legal bases, including obviousness - The person(s) who drafted the application that resulted in the patent used the words "unexpectedly" and "unique" and "outstandingly suitable" - The Federal Court held that, if a category of "selection" patent existed, besylate salt of amlodipine did not merit being a member of that category - The court addressed the three conditions that must be satisfied for a selection patent to be valid and determined that the besylate salt of amlodipine did not have a "special advantage" in respect of a "quality of special character" unique to besylate - "Adjectives and adverbs without solid foundation cannot create a 'selection patent' where none in fact exists" - As reviewed in the evidence, it was difficult from the face of the patent and unsupportable from the evidence to state that besylate was sufficiently superior to the other salts so as to make it "unique" or "outstanding" or "particularly suitable" - See paragraphs 174 to 180.

Patents of Invention - Topic 1723

Grounds of invalidity - Lack of utility and operability - Chemical products and substances intended for food and medicine - The plaintiff sought a declaration that the defendant's '393 patent was invalid on a number of legal bases, including lack of utility - The Federal Court stated that in considering utility, "the Court must look at the usefulness of the invention as promised in the specification" - Through evidence presented at trial, the court had evidence beyond the patent - The invention disclosed in the patent was that the besylate salt of amlodipine had a "unique" combination of features which made it "outstandingly suitable" for pharmaceutical formulations of that drug - That was, on the evidence, not the case - The evidence beyond the patent showed that the promise of the invention as being "unique" and "outstanding", was not fulfilled - In the result, the '393 patent was invalid for lack of utility, among other legal bases - See paragraphs 181 to 186.

Patents of Invention - Topic 1776

Grounds of invalidity - Insufficiency - General - The Federal Court stated that in considering sufficiency of the disclosure required under the Patent Act, "the Court must look at the entire specification to determine if it adequately instructs a person skilled in the art, however , in a case such as this where we have much evidence from the inventors themselves, their colleagues and contemporaneous documents, the Court cannot assume that the patent specification is an accurate reflection of the understanding of the inventors " - See paragraph 157.

Patents of Invention - Topic 1779

Grounds of invalidity - Insufficiency - Particular cases - The plaintiff sought a declaration that the defendant's '393 patent was invalid on a number of grounds, including insufficiency - Sections 34(1)(a) and (b) of the "old" Patent Act (s. 27(3) of "new" Patent Act) described the "sufficiency" requirements, including that in the specification, an applicant "correctly and fully describe the invention and its operation or use as contemplated by the inventor" - The Federal Court stated that the courts had focused "on whether the patent itself describes sufficient information so as to enable a person skilled in the art to put it into practice ... [T]he question is not whether there is enough data in the patent to substantiate the promise of the patent but rather whether sufficient information has been disclosed so as to enable a person skilled in the art to make use of the invention" - In the present case, the court had not only the underlying data presented, but also the evidence of the two inventors, given in the witness box - Accordingly, attention was given, "where it has not been given before in decisions of the Court", to the concluding words "as contemplated by the inventor" in s. 34(1)(a) - There were many serious errors, omissions, insertions and departures in the patent in comparison with what the inventors contemplated - "Rarely has the Court had the opportunity to look into such matters" - The evidence showed that the specification did not disclose what the invention was as contemplated by the inventors - The patent was also invalid for that reason - See paragraphs 187 to 194.

Cases Noticed:

Pfizer Canada Inc. et al. v. Canada (Minister of Health) et al. (2006), 288 F.T.R. 215; 46 C.P.R.(4th) 281; 2006 FC 220, revd. (2007), 351 N.R. 189; 52 C.P.R.(4th) 241; 2006 FCA 214, affd. (2007), 371 N.R. 174; 2007 FCA 407, refd to. [para. 14].

Pfizer Canada Inc. et al. v. Canada (Minister of Health) et al. (2008), 326 F.T.R. 88; 2008 FC 500, refd to. [para. 15].

Pfizer Inc. v. Synthon Holdings BV et al., 1:05CV39 (D. Middle Dist. N.C.), revd. 480 F.3d 1348; U.S. App. Lexis 6623; 82 U.S.P.Q. 2D (BNA) 1321 (Cir., D.C. Cir.), refd to. [para. 16].

Whirlpool Corp. et al. v. Camco Inc. et al., [2000] 2 S.C.R. 1067; 263 N.R. 88, refd to. [para. 30].

Windsurfing International Inc. v. Bic Sports Inc. (1985), 63 N.R. 218; 8 C.P.R.(3d) 241 (F.C.A.), refd to. [para. 31].

Johnson & Johnson Inc. et al. v. Boston Scientific Ltd. (2008), 327 F.T.R. 49; 2008 FC 552, refd to. [para. 31].

Apotex Inc. and Novopharm Ltd. v. Wellcome Foundation Ltd., [2002] 4 S.C.R. 153; 296 N.R. 130; 2002 SCC 77, refd to. [para. 32].

Janssen-Ortho Inc. et al. v. Novopharm Ltd. (2007), 366 N.R. 290; 59 C.P.R.(4th) 116 (F.C.A.), refd to. [para. 35].

Minerals Separation North American Corp. v. Noranda Mines Ltd., [1947] Ex. C.R. 306, revd. [1950] S.C.R. 36, refd to. [para. 114].

Sanofi-Synthelabo Canada Inc. et al. v. Apotex Inc. et al., [2008] 3 S.C.R. 265; 381 N.R. 125; 2008 SCC 61, appld. [para. 159].

Windsurfing International Inc. v. Tabur Marine (Great Britain) Ltd., [1985] R.P.C. 59 (C.A.), refd to. [para. 159].

Sanofi-Synthelabo Canada Inc. et al. v. Apotex Inc. et al. (2005), 271 F.T.R. 159; 2005 FC 390, refd to. [para. 162].

Pfizer Canada Inc. et al. v. Apotex Inc. et al. (2009), 385 N.R. 148; 2009 FCA 8, refd to. [para. 163].

Pfizer Canada Inc. et al. v. Canada (Minister of Health) et al. (2008), 377 N.R. 9; 2008 FCA 108, consd. [para. 188].

Searle (G.D.) & Co. et al. v. Novopharm Ltd. et al., [2008] 1 F.C.R. 477; 296 F.T.R. 254; 2007 FC 81, revd. [2008] 1 F.C.R. 529; 361 N.R. 290; 2007 FCA 173, refd to. [para. 203].

Statutes Noticed:

Patent Act, R.S.C. 1985, c. P-4, sect. 27(3) [para. 189]; sect. 34(1)(a), sect. 34(1)(b) [paras. 56, 187]; sect. 53(1) [paras. 114, 195]; sect. 60(1), sect. 62 [para. 1].

Authors and Works Noticed:

Berge, Stephen M., Bighley, L.D., and Monkhouse, D.C., Pharmaceutical Salts (1977), 66(1) J. Pharm. Sci. 1, pp. 1 to 19 [para. 37].

Fox, Harold George, The Canadian Law and Practice Relating to Letters Patent for Inventions (4th Ed. 1969), p. 178 [para. 114].

Gould, P.L., Salt Selection for Basic Drugs (1986), 33 Int. J. Pharm. 201, pp. 201 to 217 [para. 48].

Counsel:

David W. Aitken and Marcus Klee, for the plaintiff;

John B. Laskin, Kamleh J. Nicola, W. Grant Worden and Asma Faizi, for the defendant.

Solicitors of Record:

Osler Hoskin and Harcourt, LLP, Ottawa, Ontario, for the plaintiff;

Torys, LLP, Toronto, Ontario, for the defendant.

This action was heard at Toronto, Ontario, on June 1-4, 8-10, 12, 16-18, 23, 25 and 26, 2009, before Hughes, J., of the Federal Court, who delivered the following judgment and reasons for judgment, dated July 8, 2009.