Pfizer Canada Inc. v. Canada (Health)

Pfizer Canada Inc. v. Canada (Health)
Court (s) Database
Federal Court Decisions
Date
2008-04-17
Neutral citation
2008 FC 500
File numbers
T-899-06
Decision Content
Date: 20080417
Docket: T-899-06
Citation: 2008 FC 500
Toronto, Ontario, April 17, 2008
PRESENT: The Honourable Mr. Justice Hughes
BETWEEN:
PFIZER CANADA INC., PFIZER INC.
and PFIZER LIMITED
Applicants
and
THE MINISTER OF HEALTH
and PHARMASCIENCE INC.
Respondents
REASONS FOR JUDGMENT AND JUDGMENT
[1] This application has been brought by Pfizer Canada Inc. et al. under the provisions of the Patented Medicines (Notice of Compliance) Regulations, SOR/93-133, as amended, seeking to prohibit the Minister of Health from issuing a Notice of Compliance to the Respondent Pharmascience Inc. in respect of its generic version of a drug containing a medicine known as amlodipine besylate, 5 mg and 10 mg tablet form, until the expiry of Canadian Letters Patent 1,321,393 (’393 patent). For the reasons that follow, I find that the application is allowed.
[2] The drug in question is one containing amlodipine besylate. It acts as a calcium channel blocker used to lower blood pressure and reduce angina and is sold by Pfizer in Canada under the name NORVASC. Pfizer has previously received patents for a group of compounds which include amlodipine used for these purposes. These patents claim such compounds in their free base state as well as “pharmaceutically acceptable acid addition salts” of the compounds and include the patent that issued from European Patent Application 0089167 and Canadian Letters Patent 1,253,865. The issues in this application have to do with one particular salt form, besylate, of amlodipine, as claimed in the ’393 patent.
[3] The ’393 patent is no stranger to litigation in the context of NOC proceedings. Justice von Finckenstein of this Court in a decision dated February 17, 2006, cited as 2006 FC 220, determined that the allegation made by Ratiopharm, the generic in that proceeding, as to invalidity of the ’393 patent, was justified. The Federal Court of Appeal, in a decision cited as 2006 FCA 214, reversed this decision (the “Ratiopharm” decisions). Presently, in a case involving Cobalt Pharmaceuticals Inc., Justice Heneghan of this Court is considering the validity of the ’393 patent in the context of NOC allegations raised by Cobalt.
[4] In the United States, the Court of Appeals for the Federal Circuit (CAFC) on March 22, 2007 decided that an equivalent United States Patent, 4,879,303, claiming amlodipine besylate was invalid in the context of drug approval proceedings (cited as 480 F.3d 1348; 82 U.S.P.Q 2D (BNA) 1321), thereby reversing an earlier Trial Court decision.
THE ISSUES IN THIS PROCEEDING
[5] Counsel for the Respondent Pharmascience, who by agreement presented argument first, limited the matters to be dealt with in this proceeding to three, all dealing with Pharmascience’s allegations of invalidity of the ’393 patent. These matters respecting invalidity are:
1. Sufficiency: Is the specification of the ’393 patent sufficient having regard to the provisions of section 27(3) of the Patent Act, R.S.C. 1985, c. P-4 as amended, so as to enable a person skilled in the art to put the alleged invention into practice?
2. Utility: This is a two pronged attack on validity. First it is argued that the data presented in the ’393 patent fails to demonstrate the asserted utility, namely that the besylate salt of amlodipine provides an unexpectedly better level of features desirable in a commercial pharmaceutical product. Second it is argued that the underlying data which was revealed through the evidence provided by Pfizer of Davison, one of the named inventors of the ’393 patent, demonstrates that the besylate salt fails to achieve that stated utility. This argument is supplemented by evidence provided by Pharmascience of the approval for sale in the United Kingdom of a maleate salt version of amlodipine and manufacturing data provided by Pharmascience’s supplier of its own intended amlodipine mesylate product.
3. Obviousness. Pharmascience argues that earlier patents issued to Pfizer, the previously mentioned patent arising from European Application 0089167 and Canadian Letters Patent 1,253,865 disclose amlodipine together with “pharmaceutically acceptable addition salts” and that besylate was one such salt that would easily have been selected by a person skilled in the art at the relevant time, for that purpose. Pharmascience points to a scientific paper by Berge et al. that lists approximately fifty such salts, including besylate, and argues that the list would have been quickly narrowed to only a few candidates of which besylate was one. It supplements this argument by referencing three other United States Patents which illustrate the suitability of a besylate salt, not with amlodipine but in arguably like circumstances.
This is an argument that prevailed in the United States Court of Appeals (CAFC) decision previously referred to.
[6] Pfizer readily agreed to the narrowing of issues and argues that each of these issues, save perhaps some arguments as to utility, are precluded by the previous decision of the Federal Court of Appeal in “Ratiopharm” or failure by Pharmascience to raise the issue properly in its Notice of Allegation or both or other reasons.
THE EVIDENCE
[7] Each of Pfizer and Pharmascience provided affidavit evidence, upon some of which there was cross-examination. The Minister did not participate in providing evidence nor in argument in this proceeding.
[8] As to the evidence:
Pfizer
Pfizer tendered the affidavit evidence of four expert witnesses, all of whom were cross-examined:
i. Dr. Gerald S. Brenner: is a retired pharmaceutical chemist with experience in drug synthesis, formulation development and solid state chemistry. He was employed by Merck Research Laboratories for thirty-three years, where he held various positions including Senior Director of Pharmaceutical Research and Development.
ii. Dr. Stephen Byrn: is a Professor of Medicinal Chemistry at Purdue University. His research interests include medicinal chemistry and pharmaceutics with an emphasis on salt functions and salt properties.
iii. Dr. Peter Chen: is a Professor of Physical Organic Chemistry in the Institute of Organic Chemistry at the Swiss Federal Institute of Technology. His research involves the study of structure-activity relationships of chemical compounds and the reaction mechanisms of organic reactions.
iv. Dr. James W. McGinity: is a Professor of Pharmacy at the College of Pharmacy at the University of Texas at Austin. His research interests include pharmaceutical formulation, preformulation, immediate release and sustained release systems, novel drug delivery systems, materials science and pharmaceutical processing.
Pfizer also tendered the affidavit evidence of three fact witnesses, Edward Davison one of the named inventors of the ’393 patent, Madeline Pesant (a Pfizer employee), and Dianne Zimmerman (a law clerk). Davison and Pesant only were cross-examined.
v. Edward Davison: is a former employee of Pfizer Limited and one of the named inventors of the ‘393 patent. His affidavit describes Pfizer’s research efforts relating to amlodipine besylate.
vi. Madeline Pesant: is employed by Pfizer Canada Inc. as a Senior Advisor, Regulatory Policy & Intelligence, Medical Division. Her affidavit discusses Pfizer’s new drug submissions to Health Canada in respect of amlodipine besylate and the Form IV patent lists that included the ‘393 patent.
vii. Dianne Zimmerman: is a law clerk at Pfizer’s counsel’s law firm. Her affidavit introduces correspondence between Pfizer, Pharmascience and the Minister. She also includes as exhibits Pfizer and Ratiopharm’s written submissions in Court File No. A-75-06, a letter from Apotex to Pfizer Canada, and an Order of Madam Justice Heneghan in Pfizer Canada Inc. v. Canada (Minister of Health) (T-1255-04) dated March 26, 2007.
Pharmascience
Pharmascience has filed the evidence of four expert witnesses, all of whom were cross-examined:
i. Dr. Robert Joseph Zamboni: is an organic chemist who was employed by Merck Frosst from 1980 to 2005 where he held various positions including Vice-President of the Medicinal Chemistry Department. Since 1993 he has taught graduate-level medicinal chemistry classes at McGill University.
ii. Dr. Christopher T. Rhodes: is a Professor Emeritus at the University of Rhode Island. During his career as a research scientist he investigated the formulation and fabrication of compressed tablets, including stability and bioavailability studies.
iii. Dr. Robert Miller: is the President of MPD Consulting, a company that provides consulting services to the pharmaceutical industry. He holds a Ph.D. degree in pharmaceutics and has over twenty years experience in the pharmaceutical industry. From 1994 to 2002 Dr. Miller was an Associate Professor of Pharmaceutics at the University of British Columbia where he taught various courses on pharmaceutical formulation.
iv. Paul J. Larocque: is the President of Acerna Incorporated, a consulting firm specializing in pharmaceutical regulatory affairs. He holds a B.Sc. degree in chemistry and has held senior positions in the Quality Control and Regulatory Affairs Departments of large Canadian pharmaceutical companies. Since 1994, Mr. Larocque has worked as a consultant.
Pharmascience also filed the affidavit of Rebecca Seath, a law clerk with Pharmascience’s counsel’s law firm. Her nine-volume affidavit serves to introduce the Notice of Allegation and the prior art referred to in the Notice of Allegation. Ms. Seath was not cross-examined.
Further, Pharmascience filed the affidavit evidence of Gaetano Gallo, a graduate chemist engaged in regulatory affairs with Pharmascience. He provided, as exhibits, certain technical data respecting amlodipine mesylate products produced abroad.
[9] Pfizer took objection to the admissibility of three pieces of evidence namely:
1. A document identified as “Exhibit A” tendered by Pharmascience’s counsel during the cross-examination of the inventor Davison;
2. All exhibits attached to the affidavit of Gallo;
3. Exhibits E and F to the affidavit of Larocque.
[10] Turning to each of these objections:
1. Exhibit A purports to be a copy of a memorandum dated 23 March 1990 from Platt, a colleague of the inventor Davison, to Davidson (not Davison) their boss. This document had not previously been put in evidence either by Pfizer or Pharmascience but was put to Davison on cross-examination, by Pharmascience’s counsel. Davison (in answer to question 141 at page 54 of the transcript) said he had never seen the document before and could not identify it. In reply examination, at pages 78 and 79 of the transcript, he reiterated that he had never seen the document before but offered a brief commentary as to what it appears to contain.
I rule this document to be inadmissible. The witness could not identify it, the brief commentary in Reply is simply a comment as to what, on its face, part of the document appears to say. This is not a concession as to the admissibility of the document or verification as to its contents.
Even if I had held this document to be admissible, I would have given it little weight as it is of no assistance in determining the matters in issue.
2. The exhibits to the Gallo affidavit comprise a number of technical documents prepared by third party manufacturers abroad respecting amlodipine mesylate. These documents are apparently of the type submitted to public authorities such as Health Canada for the purpose of demonstrating safety and efficacy of a product in seeking approval from such authorities. As such, they can constitute business records however they are not the records of Pharmascience nor were they prepared by or with the involvement of Gallo or anyone at Pharmascience. Gallo says that they are documents that “can and will” be submitted to Health Canada.
No mention is made of these documents in Pharmascience’s Notice of Allegation, nor is any mention made in that Notice of any of the testing reflected in these documents. Pharmascience says that the documents were not prepared until after it submitted its Notice of Allegation. Pfizer says that at least a reasonable portion of the testing reflected in the documents took place before the Notice of Allegation was submitted. Both parties refer to the decision of Justice von Finckenstein in “Ratiopharm”, supra, at paragraphs 26 to 29 where he said that he would disregard evidence respecting certain “Dalton testing” because that testing preceded the submission of the Notice of Allegation and was not mentioned in that Notice.
I rule that the exhibits to the Gallo affidavit are inadmissible for two reasons. First, at least some of the testing reflected in the documents preceded the Notice of Allegation and, if relevant, should have been mentioned in the Notice. Second, the documents are of no assistance. While the documents taken at their highest show that some kind of formulation of amlodipine mesylate salt can apparently be made in a commercially satisfactory way, we do not know what that formulation is, or the way in which the product is made.
The Gallo documents, therefore, even if admissible, would be of no assistance in determining the issues in this matter.
3. Exhibits E and F to the affidavit of Larocque are said to be public documents available from the United Kingdom health authorities relating to amlodipine maleate products approved for sale there. Larocque is a consultant specializing in pharmaceutical regulatory affairs. He can identify these Exhibits sufficiently and I accept them into evidence since they are public documents.
However, just as with the Gallo exhibits, the Larocque exhibits are of little probative value. They do not tell us enough about the formulation, method of manufacture or any other information that may assist in determining whether “problems” with amlodipine maleate salts have been solved by other techniques. The evidence of Dr. Chen at paragraphs 64 to 67 of his affidavit for instance shows that in the last several years there have been a number of developments alleging to solve the maleate “problem”. Therefore, while admissible, I give these documents little weight.
BURDEN OF PROOF
[11] The parties, thankfully, have spent little time in oral argument on the question as to which party has what level of burden of proof on what issue. I have said all that I can really say about this matter at this time, not having further assistance from a higher court, in the cases if Eli Lilly Canada Inc. v. Apotex Inc., 2008 FC 142 at para. 58 and Pfizer Canada Inc. v. Canada (Minister of Health), 2008 FC 11 at paras. 28-33.
[12] Here the only issue is validity. Pharmascience has raised three arguments in that respect. Each of Pfizer and Pharmascience have led evidence and made submissions as to those matters. At the end of the day, I must decide the matter on the balance of probabilities on the evidence that I have and the law as it presently stands. If, on the evidence, I find that the matter is evenly balanced, I must conclude that Pfizer has not demonstrated that Pharmascience’s allegation is not justified.
CONSTRUCTION OF THE CLAIMS
[13] As we have been instructed by the Supreme Court of Canada in Whirlpool Corp. v. Camco Inc., [2000] 2 S.C.R. 1067 at paragraph 43, and often repeated in proceedings such as this, the Court must first construe the claims at issue before considering issues such as validity or infringement. The application for the ‘393 patent was filed in Canada before October 1989 thus the “old” provisions of the Patent Act, R.S.C. 1985, c. P-4 apply. The patent is to be construed as of its date of grant, August 19, 1993.
[14] Here claims 11, 12 and 13 represent the claims at issue:
11. The besylate salt of amlodipine.
12. A pharmaceutical composition for use as an anti-ischaemic or anti-hypertensive agent, comprising a therapeutically effective amount of the besylate salt of amlodipine together with a pharmaceutically acceptable diluent or carrier.
13. A tablet formulation for use as an anti-ischaemic or anti-hypertensive agent, comprising a therapeutically effective amount of besylate salt of amlodipine in admixture with excipients.
[15] These claims are simple and clear on their face and need no further analysis save for one issue raised by Pharmascience, that of hydration.
[16] A sample of a compound such as amlodipine besylate salt may contain water. This can occur because the sample is put into a water-containing solution or because a dry tablet or dry mixture for use, for instance, in a capsule, is exposed to humid conditions, or because a dry tablet or dry mixture contains other ingredients (excipients) which contain water. Some of this water simply sticks to the surface of the sample (adsorbs). Some of the water molecules may become very closely associated with the amlodipine molecules and may integrate into the crystal lattice structure of the compound in which case the molecule is considered to be a hydrate. In this latter instance, the term monohydrate or dihydrate or trihydrate etc. is used to identify the sample, depending on the number of water molecules associated with each molecule of amlodipine besylate. A dry sample that does not contain any water molecules that are closely associated with the amlodipine besylate is called an anhydrate.
[17] The claims, exemplified by 11, 12 and 13 and all others make no distinction as to whether the amlodipine besylate exists as an anhydrate, monohydrate or other hydrate form. The specification is of no assistance. Pfizer’s expert Dr. McGinity, at pages 69-70 of his cross-examination said that he would understand that all forms of amlodipine besylate would be included. I so find as well, all forms of amlodipine besylate, anhydrous and hydrated are included in the claims.
[18] I point out that the word besylate is used in the claims. That is a short form used by chemists to refer to a benzene sulphonate salt as pointed out on the first page, fourth paragraph, of the ’393 patent. Some of the other references considered in this proceeding will use the term benzene sulphonate, benzene sulfonate or benzenesulfonate. It is all the same thing.
THE NOC MINEFIELD
[19] It has been pointed out by the Supreme Court of Canada in Merck Frosst Canada Inc. v. Canada (Minister of National Health and Welfare), [1998] 2 S.C.R. 193 at 214, and repeated by many Courts since, that the NOC Regulations are draconian. They are an imperfect and partial implementation of similar provisions instituted in the United States under the “Hatch Waxman” Act, 21 U.S.C. §355 and, while revised in part from time to time, the Canadian NOC Regulations have not been revised in a way so as to rectify or even address the numerous procedural complexities and absurdities occasioned by and developed in the jurisprudence under these Regulations. Parties, seeking advantages, eagerly exploit the procedural difficulties and disadvantages that may be visited upon their adversaries.
[20] There are ways to avoid the NOC Regulations by instituting proper actions in the Court to address the validity or infringement of a patent and this Court is endeavouring to make this option more viable by setting early trial dates and imposing case management.
[21] In dealing with NOC proceedings, the first minefield is the Notice of Allegation. It is a document prepared by a generic and served upon the innovator who has listed one or more patents in respect of a drug that the generic wishes to copy. The Notice of Allegation is provided for in section 5(3) of the NOC Regulations. It is not a document provided for in the Federal Courts Act, R.S.C. 1985, c. F-7 or Federal Courts Rules, SOR/98-106 but, to all extent and purposes, serves as a statement of claim whereby the generic alleges the issues which it wishes to raise with respect to a patent, such as validity and infringement, and the “legal and factual” basis for its allegations. The jurisprudence has held that:
1. The Notice of Allegation cannot be amended, while a generic may take things out or not rely on certain things in the Notice, it cannot add to what is said or amend what is said. An innovator may say to a generic, rather too glibly, simply serve a fresh Notice. However each fresh Notice gives the innovator an opportunity to obtain, without anything more than instituting an application in this Court, a fresh 24 month injunction to restrain approval being given to the generic.
2. The requirement to state the “legal and factual basis” for the allegations for instance as to invalidity or infringement have grown very stringent. The underlying criterion is that the innovator should not be taken by surprise. The practical manifestation is that the Notice must go into great detail as to each argument to be raised and stipulate each important piece of evidence upon which it relies. A good example of the application of this principle is set out in Justice Gauthier’s reasons in Eli Lilly Canada Inc. v. Apotex Inc., 2007 FC 455 at paragraphs 103 to 125.
[22] There are many fine points as to what must be raised in a Notice of Allegation and a review of one such a point will be made later in these Reasons.
[23] The Court system has been overwhelmed by NOC proceedings, many involving different generics addressing the same patent in one proceeding after another, or by the same innovator asserting the same patent time after time, even when the patent was declared in a NOC proceeding to be invalid. The United States legislation makes provision for joinder of several proceedings and interested parties. In Sanofi-Aventis Canada Inc. v. Novopharm Limited, 2007 FCA 163 (application for leave to Supreme Court dismissed [2007] S.C.C.A. No. 311) the Federal Court of Appeal stated at paragraph 50 that relitigation in an NOC context of the same patent, even if different generics are involved, is not to be permitted unless a subsequent party is apprised of “better evidence or a more appropriate legal argument”.
[24] Thus parties involved in NOC proceedings engage in a “screening out” procedure:
1. Is the matter sufficiently raised in the Notice of Allegation;
2. Has the matter been previously determined even if the generic is different, if so, does the present generic have “better evidence or a more appropriate legal argument”.
[25] The question of “better evidence or a more appropriate legal argument” is often confounded because it is not readily apparent what the evidence or argument was in the earlier case. The record there is not of record here. The evidence and argument there is sometimes cloaked in secrecy by a confidentiality order. Usually all that one has is the Reasons of the earlier Court(s) and possibly memoranda of argument filed there.
[26] Not unexpectedly, Pfizer puts the three validity matters raised by Pharmascience through the “screening out” process and argues that all that is left is some portion of the utility argument. Pharmascience disagrees. Therefore I will approach each argument by looking at the “screen” and, regardless of my determination, provide my views as to the substantive arguments.
THE “RATIOPHARM” DECISION
[27] The first time that the ’393 patent came before this Court was in the NOC proceeding decided by Justice von Finckenstein supra, 2006 FC 220. At paragraph 6 of his Reasons he said that Ratiopharm alleged that the patent was invalid by reason of:
a) anticipation
b) obviousness, and
c) being an improper selection patent.
[28] He noted at paragraph 13 that Pfizer’s experts included Dr. Gerald Brenner and Dr. Stephen Byrn. These two persons are also Pfizer witnesses in the present application. Only one witness put forward by Ratiopharm, Dr. Robert Miller, is common to the witnesses put forward by Pharmascience in the present proceeding (see paragraphs 16 and 17 of Justice von Finckenstein’s Reasons).
[29] Justice von Finckenstein held at paragraph 20 of his Reasons that:
[20] This case does not turn on expert evidence. On all the key points, the experts are in agreement. Their evidence only differs on what a person skilled in the art would have anticipated or considered obvious. Ultimately, these are questions for the court to decide. Therefore, although the expert evidence is useful, it is not determinative.
[30] He held, at paragraph 22 that the only claim he needed to consider was claim 11, supra. That is equally appropriate in considering the issues in the present application.
[31] On the first matter, anticipation, Justice von Finckenstein, at paragraphs 35 to 42 held that the allegation of anticipation failed. The Federal Court of Appeal (2006 FCA 214) at paragraphs 34 to 36 agreed. There is no allegation as to anticipation by Pharmascience in the present proceeding and nothing more needs to be said about it.
[32] On the second matter, obviousness, Justice von Finckenstein held at paragraph 58 of his Reasons that he did not need to address the matter:
[58] In light of the foregoing finding, there is no need to address Ratiopharm's allegation of obviousness.
[33] The Federal Court of Appeal did not use the world “obviousness” anywhere in their Reasons. I will return to this subject.
[34] Justice von Finckenstein and the Federal Court of Appeal gave considerable consideration in their Reasons to the question of a “selection patent”. There is controversy as to whether in the arcane field of patent law, one must create yet another niche category for something called a “selection patent” and create a cluster of jurisprudence around that category. This question is currently under consideration by the Supreme Court of Canada in the appeal from the decision of the Federal Court of Appeal in Apotex Inc. v. Sanofi-Synthelabo Canada Inc., 2006 FCA 421. I invited the parties to postpone the present hearing until the disposition by the Supreme Court of the matter. They declined.
[35] Justice von Finckenstein conducted his analysis of selection patents at paragraph 43 of his Reasons by incorporating the concepts of obviousness and double patenting into that of selection patents:
[43] Ratiopharm contends that the 393 Patent is invalid for obviousness double patenting and is an improper selection patent. It contends that:
(a) the selection of amlodipine besylate over the prior disclosed class of pharmaceutically acceptable acid addition salts of amlodipine does not meet the criteria of a valid selection patent; and
(b) that the disclosure of the 393 Patent is insufficient to support the selection of amlodipine besylate over the other acid addition salts based on a combination of solubility, hygroscopicity, processability and stability characteristics.
[36] He incorporated obviousness into his analysis of selection patents again at paragraph 46:
[46] Unless the patent can be characterized as a selection patent, the concept of obviousness double patenting as enunciated by Justice Binnie in Whirlpool, supra prohibits the issuance of a second patent with claims that are not patentably distinct from a prior patent.
[37] He reviewed the evidence and the law and concluded that all that Pfizer had done was to verify the existing properties of besylate and that this was not “inventing”. He said at paragraphs 54, 55 and 57:
[54] The purpose of selection patents is to reward the inventor for discovering hitherto unknown characteristics peculiar to the members of the selection. The purpose is not to permit the creation of valid selection patents simply by allowing an 'inventor' to test the degree of known characteristics, setting unexplained minimum thresholds without any justification, and then claiming any product that meets the combination of these characteristics is unique.
[55] What Pfizer did in this case, in essence, amounts to no more than verifying that besylate has the following degree of:
a) solubility: 4.6 mg ml-1, pH 6.6;
b) stability: it is most stable amongst Hydrochloride, Acetate, Maleate, Salicylate, Succinate, Tosylate, Mesylate and Besylate;
c) Non-hygroscopicity: it remains non-hygroscopic when exposed to 90oC for three days; and
d) Processability: 1.17 µg Amlodipine cm-2, i.e. 58% relative to maleate.
…
[57] Accordingly, the 393 Patent is not a valid selection patent, and Pfizer has failed to disprove Ratiopharm's allegation that the 393 Patent is invalid for obviousness double patenting.
[38] It was for these reasons that he concluded, at paragraph 58 previously cited, that he did not need to consider obviousness. He had already done so in the context of discussing selection patents.
[39] The Federal Court of Appeal gave considerable consideration to the question of selection patents as well in their Reasons. At paragraph 14 of the Reasons they acknowledged that Justice von Finckenstein had done likewise.
[40] In the Analysis portion of their Reasons, the Federal Court of Appeal distinguished between “empirical research” and “verification”. At paragraphs 21 to 24 they said:
[21] It is important at the outset to establish that empirical research for the purpose of making a selection from a class is not verification. Lord Wilberforce in Beecham noted that the selection of some from a larger number of possible components and the exploration of their appropriateness by empirical investigation is a different thing from verification and leads to different results (at page 568).
[22] The empirical investigation leading to an invention protected by a selection patent must involve "at the least the discovery that the selected members possess qualities hitherto undiscovered, particular to themselves and not attributable to them by virtue of the fact of their belonging to a class specified by an earlier inventor" (see In the Matter of an Application for a Patent by Henry Dreyfus, Robert Wighton Moncrieff and Charles William Sammons (1945), 62 R.P.C. 125, at page 133 per Evershed J.).
[23] In Pope Appliance Corp. v. Spanish River Pulp & Paper Mills, Ltd., [1929] 1 D.L.R. 209 (P.C.), Viscount Dunedin, at page 216 noted that invention is merely "finding out something which has not been found out by other people." An inventor is entitled to a patent where he can show that his efforts led to a discovery of [page146] certain knowledge central to his invention. It is no answer that others by experiment might have also found it (see also T. A. Blanco White, Patents for Inventions and the Protection of Industrial Designs, 5th ed., (London: Stevens, 1983), at page 99).
[24] On the other hand, verification means confirming predicted or predictable qualities of known compounds; i.e. components that have already been discovered and made. No one can claim a selection patent merely for ascertaining the properties of a known substance (see SmithKline Beecham Pharma Inc. v. Apotex Inc., [2003] 1 F.C. 118 (C.A.), at paragraph 21).
[41] At paragraph 27 they said that Justice von Finckenstein had erred “when he concluded that the investigation conducted by Pfizer amounted to mere verification”.
[42] The Federal Court of Appeal considered that there were two “legal” errors, one dealt with threshold which is not an issue in the present proceeding. The second dealt with section 34(1) of the Patent Act and “special advantages”. They said at paragraphs 30 to 33 of their Reasons:
[30] According to Pfizer, this analysis contains two legal errors. In considering thresholds, it sets the bar too high on what constitutes special advantage, and in any event, thresholds were not put in issue by ratiopharm's NOA.
[31] To meet the statutory requirement in subsection 34(1) of the Patent Act, R.S.C., 1985, c. P-4 (old Act) that a patent be "useful", the selected species must have an advantage over the class as a whole (see Consolboard Inc. v. MacMillan Bloedel (Sask.), [1981] 1 S.C.R. 504, at pages 525-526). That case broadly defined the utility required for valid patent as discussed in Halsbury's Laws of England (3rd ed.), Vol. 29, at page 59:
... it is sufficient utility to support a patent that the invention gives either a new article, or a better article or a cheaper article, or affords the public a useful choice.
However, there are no special legal requirements regarding what particular type of advantage is required. The test for advantage is understood to include a disadvantage to be avoided, as is the case here (see I.G. Farbenindustrie, at page 322).
[32] The applications Judge was also concerned that the thresholds could be manipulated, and commented that there was no evidence offered by Pfizer to justify them. However, he failed to recognize that there was little evidence on the issue of thresholds because Ratiopharm never objected to them in its NOA. Threshold issues had to be raised in the NOA so that Pfizer could know the case it had to meet (see Pfizer Canada Inc. v. Novopharm Ltd.). Deciding a case on a theory not raised by parties may give rise to an argument [page150] for procedural unfairness.
[33] In summary, the applications Judge's erroneous application of the principle of verification caused him to conclude that besylate had no "special advantage" or "quality of a special character" capable of supporting a selection patent. In my analysis, based on the uncontested facts and the findings of the applications Judge, besylate has, in terms of stability, solubility, non-hygroscopicity and processability, both a special advantage and quality of a special character, thus giving rise to a valid claim for a selection patent.
[43] Ratiopharm, following release of the Reasons by the Federal Court of Appeal applied for a re-hearing on the question of obviousness. Ratiopharm’s Memorandum of Argument on the appeal is in evidence as Exhibit H to the Zimmerman affidavit. It is clear that the issue of obviousness is raised in its Memorandum and was before the Court when it made its original decision. This Court was provided by Pfizer without objection by Pharmascience, with Ratiopharm’s Notice of Motion as to the re-hearing where the issue was clearly as to whether obviousness had been considered in the original decision. In dismissing the motion to re-hear the matter, Linden J.A. said in brief Reasons:
The motion for reconsideration pursuant to rule 397(1)(b) is dismissed. The rule is intended to give the Court the power to correct slips and oversights in the preparation of the judgment document. The purpose of the rule 397 is not to substantively amend the reasons for judgment, but merely to ensure that the judgment accords with the reasons (see Halford v. Seed Hawk Inc. (2004), 31 C.P.R. (4th) 569 at paragraph 11 (F.C.)). The judgment in this case properly reflected the Court’s unanimous intention to allow the appeal, as evidenced in both the Court’s reasons and its judgment prohibiting the Minister from issuing a notice of compliance to ratiopharm until after the expiry of the 393 patent. Furthermore, rule 397 does not require that the Court give reasons in respect of every matter raised (see Balasingham v. Canada (Minister of Citizenship and Immigration) (1994), 77 F.T.R. 79 at paragraph 5 (F.C.T.D.)).
[44] I am satisfied, therefore, that both Justice von Finckenstein and the Federal Court of Appeal gave consideration to the issue of obviousness and subsumed that question in their consideration as to validity of a “selection patent”. Justice von Finckenstein in effect, held the ’393 patent to be obvious. The Federal Court of Appeal reversed that finding holding the patent not to be obvious.
[45] Pfizer also argued that the Federal Court of Appeal had found that the disclosure of the ’393 patent was sufficient. They rely on that Court’s Reasons, paragraphs 28 and 29 and the disposition of the Court in reversing the Hearing Judge:
[28] According to Ratiopharm, the Applications Judge was also correct to question the lack of certain essential details surrounding its discovery of Besylate's 'unique combination' of properties. Ratiopharm urges that if Pfizer need only assert that the 'unique combination' of Besylate's Formulation Properties cannot be predicted and therefore possess an unexpected advantage, then any amlodipine salt selected could be tested against any number of properties which could theoretically support a claim to 'unique properties' that could not be predicted. They argue that this is absurd and that more disclosure details of selection of comparator salts, Formulation Properties and fully explained thresholds for acceptable results are essential to support Besylate's special advantage over the class.
[29] In rejecting Pfizer's claim that Besylate was unexpectedly found to have a 'unique combination" of good formulative properties the Applications Judge wrote at paragraphs 52 through 54:
...all four factors had a totally unexplained minimum threshold. No evidence was presented to show that any of the four characteristics were not known beforehand. Similarly, no evidence was provided to justify the minimum threshold in terms of regulatory requirements, industry standards, ease of production or minimization of costs.
...
Any combination of the four characteristics in the nine salts can qualify as unique, and as being particularly suitable for pharmaceutical preparations of amlodipine, so long as no rationale is given for choosing the minimum threshold. Any alteration of these thresholds could result in another salt having 'a unique combination of good formulation properties which make it particularly suitable for the preparations of pharmaceutical formulations of amlodipine. In effect, these thresholds can be manipulated to get the outcome one desires.
...
The purpose of selection patents is to reward the inventor for discovering hitherto unknown characteristics peculiar to the members of the selection. The purpose is not to permit the creation of valid selection patents simply by allowing an 'inventor' to test the degree of known characteristics, setting unexplained minimum thresholds without any justification, and then claiming any product that meets the combination of these characteristics is unique.
[46] I reject this argument. Sufficiency may have been an argument put to the Hearing Judge, however that is unclear having regard to paragraph 46 of his reasons 2006 FC 220:
Unless the patent can be characterized as a selection patent, the concept of obviousness double patenting as enunciated by Justice Binnie in Whirlpool, supra prohibits the issuance of a second patent with claims that are not patentably distinct from a prior patent.
The Court of Appeal did not appear to consider the matter. The decisions of both Courts did not turn on that question. The disposition made was in respect of “verification” versus “invention” and not on the sufficiency of the disclosure.
[47] As to utility, this is not an attack on the validity of the ’393 patent that appears to have been raised by Ratiopharm. It is not listed as one of the attacks in paragraph 8 of the Reasons of Justice von Finckenstein supra. To some extent, there was a discussion using the world “utility” in a quote from Professor Blanco White’s text appearing at paragraph 49 of Justice von Finckenstein’s Reasons:
[49] An excellent summary of the state of the law is found in the British text by T.A. Blanco White, Patents for Inventors [sic] and the Protection of Industrial Designs, 5th ed. (London: Stevens & Sons, 1983) at p 62, para 14-110 where it states:
The current view is, that disclosure of a class, even a very small class, whether the disclosure is in general terms or by enumeration of the members, is not disclosure of the individual members so as to make them no longer new. In particular, mere recital of the systematic name of a chemical compound is not a publication of it: a compound is not an old compound until it has actually been made. Furthermore, an invention involving knowledge of the properties of a compound has not been made, and so cannot be publ