Sanofi-Aventis Inc. v. Laboratoire Riva Inc.

Sanofi-Aventis Inc. v. Laboratoire Riva Inc.
Court (s) Database
Federal Court Decisions
Date
2007-05-17
Neutral citation
2007 FC 532
File numbers
T-1384-04
Notes
Digest
Decision Content
Date: 20070528
Citation: 2007 FC 532
Ottawa, Ontario, May 28, 2007
PRESENT: The Honourable Mr. Justice Harrington
Docket: T-1384-04
BETWEEN:
SANOFI-AVENTIS INC. and
SANOFI-AVENTIS DEUTSCHLAND GmbH
Applicants
and
LABORATOIRE RIVA INC. and
THE MINISTER OF HEALTH
Respondents
and
SCHERING CORPORATION
Respondent/Patentee
Docket: T-1888-04
AND BETWEEN:
SANOFI-AVENTIS INC. and
AVENTIS PHARMA DEUTSCHLAND GmbH
Applicants
and
LABORATOIRE RIVA INC. and
THE MINISTER OF HEALTH
Respondents
AMENDED REASONS FOR ORDERS
[1] In these two applications taken pursuant to the Patented Medicines (Notice of Compliance) Regulations, Sanofi-Aventis seeks orders prohibiting the Minister from approving, in the form of a Notice of Compliance (NOC), Laboratoire Riva’s version of Ramipril for use in the treatment of high blood pressure (hypertension).
[2] Sanofi-Aventis was the first to obtain the Minister’s approval and has successfully marketed Ramipril under the name Altace for many years. Indeed it holds Canadian patent 1,187,087 (‘087) for a process for the preparation of Ramipril and other compounds and their use in the treatment of high blood pressure. The monopoly granted by that patent expired in 2002.
[3] Laboratoire Riva has persuaded the Minister that its version of Ramipril is pharmaceutically equivalent and bioequivalent to Altace. However, the Minister has put Riva-Ramipril on “patent hold” because Sanofi-Aventis submitted four patents to the Minister which are maintained on his patent list. Riva is blocked from marketing “Riva-Ramipril” until the expiry of the last of the four patents in 2018, unless it avails itself of the recourses available to it under the PM (NOC) Regulations, or otherwise disposes of the patents in a patent action.
[4] These regulations have been intensely litigated and have been considered by the Supreme Court in such cases as Bristol-Myers Squibb Co. v. Canada (Attorney General), [2005] 1 S.C.R. 533, 39 C.P.R. (4th) 449 [Biolyse] and Merck Frosst Canada Inc. v. Canada (Minister of National Health and Welfare), [1998] 2 S.C.R. 193, 80 C.P.R. (3d) 368. More recently, Mr. Justice Hughes recapitulated their history in Ferring Inc. v. Canada (Minister of Health), 2007 FC 300, [2007] F.C.J. No. 420 (QL).
[5] Not content to wait until the patents expire, Riva served a Notice of Allegation on Sanofi-Aventis. Insofar as patent 1,341,206 (‘206) (which is owned by the respondent Schering Corporation but listed by Sanofi-Aventis with its consent), Riva alleged it to be invalid for a number of reasons, including that there was no sound basis for predicting it would actually work i.e. fulfil its promise, when the patent application was filed.
[6] The three other patents, all held by Sanofi-Aventis, relate to other uses of Ramipril:
a. Cardiac insufficiency – patent 1, 246,457 (‘457);
b. Cardiac and vascular hypertrophy and hyperplasia – patent 2,023,089 (‘089); and
c. Prevention and therapy of proteinuria, a kidney ailment – patent 2,055,948 (‘948).
Riva alleged that it will not infringe these patents as it is only seeking approval for and will limit its marketing efforts to the treatment of high blood pressure.
[7] Sanofi-Aventis took up the challenge by applying for the prohibition orders which are before me. It asserts that the allegations that patent ‘206 is invalid for lack of sound prediction and other reasons are not justified. With respect to the three “use” patents, it submits that the Notices of Allegation are insufficiently detailed or that Riva will infringe by inducing or procuring others to do so at its behest.
[8] Sanofi-Aventis (earlier known as Aventis-Pharma) also alleges that Riva is a privy of Pharmascience Inc. Pharmascience has unsuccessfully alleged in prior NOC proceedings that patent ‘206 was invalid on the grounds of double patenting (Aventis Pharma Inc. v. Pharmascience Inc., 2005 FC 340, [2005] 4 F.C.R. 301, 38 C.P.R. (4th) 441, Madam Justice Snider [Aventis]; appeal dismissed, 2006 FCA 229, [2007] 2 F.C.R. 103, 53 C.P.R. (4th) 453, application for leave denied, [2006] S.C.C.A. No. 362 (QL)). Since Pharmascience could not relitigate the issue by adding a new ground of invalidity, i.e. lack of sound prediction, neither can Riva.
[9] Riva joined issue with the allegations set out in the applications, and denied that it was Pharmascience’s privy. In its responding material, and for good measure by way of a separate motion, it further submitted that since another generic drug company, Apotex Inc., had alleged in its NOC proceedings that patent ‘206 was invalid for lack of sound prediction, and that that allegation had been found to be justified, it would be an abuse of process for Sanofi-Aventis to relitigate the point in these proceedings, even though the parties are not the same (Aventis Pharma Inc. v. Apotex Inc., 2005 FC 1283, 278 F.T.R. 1, 43 C.P.R. (4th) 161, Madam Justice Mactavish [Apotex]; appeal dismissed, 2006 FCA 64, 265 D.L.R. (4th) 308, 46 C.P.R. (4th) 401 application for leave denied, [2006] S.C.C.A. No. 136 (QL)).
[10] After five days of hearing on the patents, as well as on the privy and abuse of process issues, and having reviewed the record and the written and oral submissions of counsel, I find:
a. Riva is not privy to Pharmascience and was entitled to allege that patent ‘206 was invalid for lack of sound prediction;
b. The allegation that patent ‘206 is invalid for lack of sound prediction, or otherwise, is not justified;
c. The Notices of Allegation with respect to non-infringement are sufficiently detailed to satisfy the requirements of the PM (NOC) Regulations;
d. The allegations of non-infringement of the cardiac and vascular hypertrophy and hyperplasia, and the prevention and therapy of proteinuria patents are justified; and
e. The application as regards cardiac insufficiency is now moot as that patent has expired and cannot serve as a basis to prohibit the Minister from issuing an NOC to Riva.
[11] I would have dismissed Riva’s abuse of process motion. It follows that I would have granted an order prohibiting the Minister from issuing Laboratoire Riva an NOC until the expiry of patent ‘206 in 2018.
[12] However, after I had taken these matters under reserve, the Federal Court of Appeal handed down its decision in Sanofi-Aventis Canada Inc. v. Novopharm Ltd., 2007 FCA 163 [Novopharm]. Mr. Justice Sexton found it to be an abuse of process within the meaning of the PM (NOC) Regulations for a patent holder to relitigate an allegation of invalidity against a generic, if the allegation had been held to be well founded in an earlier proceeding against a different generic. Madam Justice Sharlow concurred, but Mr. Justice Nadon dissented. The patent at issue was the very same as in this case – patent ‘206.
[13] I am bound by that decision, and in light thereof, I will maintain Riva’s motion and dismiss Sanofi-Aventis’ applications without issuing prohibition orders.
[14] However, given that an application for leave to appeal Mr. Justice Sexton’s decision to the Supreme Court is pending, or that I may have misunderstood the decision or unduly fettered my discretion, I will set out my reasoning on all issues under the following headings:
Paragraphs
a. History of the proceedings
15-20
b. Are Pharmascience and Riva privies?
21-30
c. Patent ‘206 – Allegations of invalidity
31-65
i. Treatment of High Blood Pressure
34-37
ii. Patent Claim Construction
38-39
iii. Skilled Addressee
40-46
iv. Sound Prediction and Lack of Utility
47-59
v. “Evergreening”
60-65
d. Abuse of process
66-86
e. Allegations of non-infringement
87-104
f. Expired patent ‘457
105-106
g. Costs
107
h. Afterward
108
HISTORY OF THE PROCEEDINGS
[15] In June 2004, Riva served Sanofi-Aventis with a Notice of Allegation relating to the ‘457, ‘206 and the ‘089 patents. Sanofi-Aventis responded by filing Federal Court application T-1384-04 the following month. Laboratoire Riva’s Notice of Allegation with respect to patent ‘948 was only served in September 2004. Sanofi-Aventis’ responding Notice of Application to this Court was filed the next month, under docket number T-1884-04. Subsequently, the cases were ordered to be heard one after the other.
[16] The PM (NOC) Regulations statutorily prohibit the Minister from issuing an NOC for 24 months, or such lesser time as it takes the Court to render a decision. The matters were set down for hearing in May 2006 before Mr. Justice von Finckenstein. However, on consent, as reflected in his orders of 5 June 2006, the hearing was adjourned sine die. The 24-month statutory prohibition was extended “until a decision [wa]s rendered on the merits in this proceeding or until a further order of this Court.” The Court adjourned the proceedings so the parties could wait for the Federal Court of Appeal’s ruling in Pharmascience’s appeal of the decision of Madam Justice Snider in Aventis, above. Upon that decision being rendered, a case management conference was held on 14 July 2006. As a result, the applications were referred to the Office of the Judicial Administrator for rescheduling. The minutes record that Riva was also authorized to bring on a motion with respect to abuse of process.
[17] The two applications were set down for hearing, one following the other, for five days in Toronto from April 16 to 20, 2007.
[18] In the week preceding the hearing, Riva, out of what it termed an “overabundance of caution”, filed its abuse of process motion with respect to Sanofi-Aventis’ contention that patent ‘206 was valid because there was a sound basis for prediction. Since the same point had been raised in Riva’s responding material in any event, I did not give effect to Sanofi-Aventis’ faint-hearted protest.
[19] Counsel pointed out that I could deal with the applications, and the motion, without having to consider the merits of the invalidity, lack of detailed notice and non-infringement allegations. If I was satisfied that Riva was Pharmascience’s privy, then Riva had no standing whatsoever. The applications would be maintained and the abuse of process motion dismissed. On the other hand, a decision granting the abuse of process motion would, at the very least, relieve me of the need to consider the thorny issue of sound prediction.
[20] It seemed to me then, and it seems to me now, that I could not have heard the privy issue and immediately delivered a decision from the bench, or in like manner, dealt with the abuse of process issue. I would have had to reserve judgment on both, the net effect being that three or four days which had been set aside for hearing would have been wasted. I therefore decided to hear all matters at once.
ARE PHARMASCIENCE AND RIVA PRIVIES?
[21] The concept of parties being privy to each other is an offshoot of the principle of res judicata. The authorities, as they then were, were reviewed by Mr. Justice Richard, as he then was, in Hoffman-La Roche Ltd. v. Canada (Minister of National Health and Welfare), [1997] 2 F.C. 681, 72 C.P.R. (3d) 362. Mr. Justice Richard, deciding in the context of the PM (NOC) Regulations, referred to the decision of Mr. Justice Dickson, as he was, in Angle v. Minister of National Revenue, [1975] 2 S.C.R. 248, 47 D.L.R. (3d) 544, a tax case, wherein he said that res judicata, a form of estoppel, had two species. The first, “cause of action estoppel”, precludes a person from bringing an action against another when that cause of action has already been decided. The second, “estoppel per rem judicatam”, or “issue estoppel”, is where, although the cause of action is different, the same point or issue of fact has already been decided.
[22] There are three identities that must be present in res judicata: the object, the action and the parties. The notion of “privies” deals with identity of parties. The question is whether two persons legally distinct should be treated as one. Call one the alter ego or “prête nom” of the other, or call it piercing the corporate veil; for two corporations to be treated as one there must be a relevant community or privity of interest between them.
[23] Riva filed its Abbreviated New Drug Submission (ANDS) with Health Canada in the spring of 2004. It cross-referenced its regulatory submission to an earlier one submitted by Pharmascience, who neither then nor even now has received an NOC (see the decision of Madam Justice Snider in Aventis, above). Since Pharmascience did not have an NOC it follows that its version of Ramipril and the product monograph were not publicly available. This means, as was admitted on cross-examination, that Riva and Pharmascience had a trade relationship.
[24] Mostafa Akbarieh, Riva’s vice-president of Research and Development and Regulatory Affairs, admitted that its ANDS for Ramipril was not the first submission it filed which cross-referenced Pharmascience’s submissions. Riva relies on the information found in the Pharmascience submission and its product monograph was, and had to be, identical.
[25] Although Riva obviously had to have Pharmascience’s permission, Mr. Akbarieh was not involved in negotiations. He did not know if there was a written agreement in place with respect to the cross-reference. Although he knew the two corporations did not have any common employees, he knew nothing of common shareholding or any other matter which might make the companies related. Riva’s solicitor refused to undertake to make that information available.
[26] It is clear that if the respondent in these applications were Pharmascience, it would be precluded by “issue estoppel” from relying on the allegations in its NOA. Indeed, Pharmascience unsuccessfully sought an order that it would be an abuse of process for Sanofi-Aventis to continue to argue that the ‘206 patent was valid in the light of the decision of Madam Justice Mactavish in Apotex, above. In Pharmascience Inc. v. Sanofi-Aventis Canada Inc., 2006 FCA 210, [2006] F.C.J. No. 933 (QL), Madam Justice Sharlow gave short shrift to that argument. She pointed out that all Madam Justice Mactavish did was dismiss Sanofi-Aventis’ application for a prohibition order. That was not a final determination as to the validity of the’206 patent. Pharmascience had not made an allegation of invalidity on the basis of lack of sound prediction and so Sanofi-Aventis could hardly be faulted for failing to respond to an allegation which had not been made. See also the recent decision of the Federal Court of Appeal in Abbott Laboratories v. Canada (Minister of Health), 2007 FCA 140.
[27] However, I am not satisfied that the facts above and the fact that Riva’s expert, Dr. Christensen, was first approached by Pharmascience establish that the two parties were privies. All that has been established is that they have a trade relationship, and that is not enough (Hoffman-La Roche, above).
[28] Sanofi-Aventis has invited the Court to draw an adverse inference from the fact that Mr. Akbarieh, who signed an affidavit for Riva, was not knowledgeable in that area and that undertakings were not provided. Mr. Akbarieh was not all-knowing, but certainly had knowledge with respect to regulatory matters and non-infringement issues. Cross-examination on an affidavit does not give rise to undertakings. This was not a discovery of documents and examination for discovery of a corporation within the meaning of Rules 222 and following of the Federal Courts Rules.
[29] The point seems to have been lost that applications, as opposed to actions, are supposed to be summary in nature. There is nothing summary about proceedings which take up five days of legal argument! Sanofi-Aventis’ plea of hopelessness and helplessness does not sit well. Even in applications, Rule 313 provides that where the Court considers the record of a party to be incomplete, it may order that more material be filed. If truly relevant, and if so minded, Sanofi-Aventis could have moved for an order for the production of additional material in the possession of Riva.
[30] Sanofi-Aventis also argues that these proceedings are abusive in that it is the Minister’s policy not to issue an NOC where a submission cross-references an earlier submission, unless and until that earlier submission is successful. The application by Pharmascience was unsuccessful. However, I am not concerned with whatever policy the Minister may have. What are before me are allegations of invalidity and non-infringement, no more and no less. If the Minister decides not to issue an NOC on other grounds, then that decision might be the subject of a separate judicial review.
PATENT ‘206 – ALLEGATIONS OF INVALIDITY
[31] Canadian patent ‘206 has had somewhat of a peculiar history. Schering Corporation applied for a Canadian patent in October 1981, based on United States priority dates in 1980 and 1981. It covered a genus of compounds known as Angiotensin Converting Enzyme (ACE) inhibitors that actually included Ramipril, although there was no specific disclosure of or claim to it. Innovative pharmaceutical companies were carrying out a great deal of research at that time with respect to ACE inhibiting compounds, which go to preventing the constriction of blood vessels, and thereby help to relax blood vessels and lower blood pressure. Due to protracted conflict proceedings in the patent office, patent ‘206 was only issued in 2001. Under the Patent Act, as it was before being amended in 1989, and as applicable to patent ‘206, patent ‘206 only expires in 2018, 17 years after issuance.
[32] Sanofi-Aventis’ patent ‘087 for the preparation of Ramipril and other compounds and their use in the treatment of high blood pressure was in essence a selection patent, or an improvement on patent ‘206. The application was filed in November 1982 based on German priority dates in 1981 and 1982. It was issued in May 1985, and so expired in 2002.
[33] Although the invention covered by patent ‘206 was tied up in the Canadian Patent Office, it was granted in other jurisdictions, as was Sanofi-Aventis’ Ramipril. The result was a stand-off in that in those jurisdictions, Schering could not manufacture Ramipril for fear of infringing patent ‘087, and Sanofi-Aventis could not manufacture Ramipril for fear of infringing genus patent ‘206. They had to accommodate each other, which was done by Schering granting Sanofi-Aventis a worldwide licence to use patent ‘206 insofar as it related to Ramipril.
a. Treatment of High Blood Pressure
[34] Angiotensin is a substance which naturally occurs in the body in two forms. Angiotensin I does not directly affect blood pressure. However, Angiotensin II is a potent vasoconstrictor, which constricts blood vessels, thereby increasing blood pressure. Angiotensin II is produced by the action of Angiotensin converting enzyme on Angiotensin I. It follows that ways and means of inhibiting this conversion reduce the production of Angiotensin II, thereby reducing blood pressure.
[35] ACE is a member of the class of enzymes known as “Peptidase” which leads to the cleavage of a peptide or protein into smaller fragments. ACE cleaves Angiotensin I in such a way that produces Angiotensin II, which is a potent up-regulator of blood pressure. The value of ACE inhibitors is that they block the cleavage of Angiotensin I, thus reducing the amount of Angiotensin II in the body.
[36] In essence, this is what patent ‘206 is all about. It claims “carboxyalkyl dipeptides, processes for their production and pharmaceutical compositions containing them.” According to the Abstract, “disclosed are novel carboxyalkyl dipeptides which are useful as inhibitors of angiotensinconverting enzyme and as anti-hypertensive agents… having a particular formula.” Riva also emphasizes page 24 of the patent which says, “the compounds of this invention has useful pharmaceutical properties. They are useful in the treatment of high blood pressure.” The patent makes 13 claims. It is common ground that some, but not all, could be construed to cover Ramipril. The claim which is narrowest in scope and which includes Ramipril, and on which validity stands or fails, is claim 12 which reads:
The compound 1- [N- (1 – carboethoxy-3-phenylpropyl) – (S) – alanyl] octahydrocyclopenta [b] pyrrole-2 (S) – carboxylic acid and its pharmaceutically acceptable salts thereof.
[37] This claim, of course, is incomprehensible to one unskilled in the art. Those who offered advice to the Court were professors in biochemical pharmacology, professors of chemistry specialising in the general principles of stereochemistry and synthesis of compounds containing centres of asymmetry, professors of medicine and pharmacology, professors in departments of medical chemistry, and those holding doctorates in the field of organic chemistry and active in human and animal research.
b. Patent Claim Construction
[38] Although much of their focus was on the principle of “sound prediction”, what the experts said also explained some of the terminology used in the patent.
[39] The first step is to determine what the patent discloses and what it promises. Drawing upon the decisions of the Supreme Court in Free World Trust v. Électro Santé Inc., [2000] 2 S.C.R. 1024, 9 C.P.R. (4th) 168 and Whirlpool Corp. v. Camco Inc., [2000] 2 S.C.R. 1067, 9 C.P.R. (4th) 129, I set forth my own understanding of what is claimed in a patent in Biovail Pharmaceuticals Inc. v. Canada (Minister of National Health and Welfare) (2005), 267 F.T.R. 243, 37 C.P.R. (4th) 487. Not all I said there need be repeated, but quoting from paragraph 15 thereof:
[…]
a It is a statutory requirement that the patent contain a specification and end with a claim or claims "defining distinctly and in explicit terms the subject-matter of the invention for which an exclusive privilege or property is claimed". The specification must be sufficiently full, clear, concise and exact "as to enable any person skilled in the art or science to which it pertains, or to which it is most closely connected, to make, construct, compound or use it". (Patent Act, R.S.C. 1985, c. P-4, as amended, s. 27)
b The patent is notionally addressed to a person skilled in the art or science of the subject-matter and is to be read as such a person would have read it when it first became public.
[…]
c The claims are to be read in an informed and purposive way to permit fairness and predictability and to define the limits of the monopoly "[I]ngenuity of the patent lies not in the identification of the desired result but in teaching one particular means to achieve it. The claims cannot be stretched to allow the patentee to monopolize anything that achieves the desired result" (Free World Trust, paras. 31, 32).
[…]
d Yet a patent is not an ordinary writing. It meets the definition of a "regulation" in the Interpretation Act, and must be read to assure the attainment of its objects. "Claims construction is a matter of law for the judge, and he was quite entitled to adopt a construction of the claims that differed from that put forward by the parties." (Whirlpool, para. 61.)
c. Skilled Addressee
[40] There was surprisingly little debate as to the qualifications of the experts. None was actually challenged.
[41] I found the evidence of Dr. Paul Bartlett, called by Schering, to be particularly useful. Dr. Bartlett is professor of chemistry emeritus, at the University of California, Berkley. In addition to teaching, he leads a research group in the field of bio-organic chemistry and synthetic organic chemistry, the focus of which has been the design, synthesis and evaluation of biologically active compounds. He has published many articles and is the inventor or co-inventor of a number of United States patent applications.
[42] I also considered the evidence of Dr. Burton Christensen, called by Riva, to be helpful. Unlike the other experts who spent most of their careers in academia, after obtaining his Ph.D. in 1956 in the field of organic chemistry from Harvard, he joined Merck & Co. Inc. in 1956, and was employed in various positions, including Senior Vice-President chemistry, until his retirement in 1992. More recently, he has acted as a consultant and co-founded a research company. He brought to the Court more than 48 years of practical experience in drug development.
[43] Although the principles of stereochemistry must be taken into account in determining whether claim 12 of patent ‘206 claims anything that is useful, which is a prerequisite of a patent, Schering points out that the broadest claim, claim 1, has no stereochemistry aspects whatsoever.
[44] After having benefited from a tutorial on ACE inhibitors, I find I am able to construe the patent without any further extrinsic aid, while remaining mindful of the following words of Mr. Justice Pigeon in Burton Parsons v. Hewlett-Packard, [1976] 1 S.C.R. 555 at page 563, 17 C.P.R. (2d) 97 at page 104:
While the construction of a patent is for the Court, like that of any other legal document, it is however to be done on the basis that the addressee is a man skilled in the art and the knowledge such a man is expected to possess is to be taken into consideration.
I find that as long as there would be any ACE inhibition or activity, then the promise of the patent is fulfilled. Dr. Christensen was of the view that what was disclosed and claimed in the patent had to have some “therapeutic” use. That word does not appear at page 24 of the patent.
[45] The promise was simply that the compounds claimed by the patent would have utility as both ACE inhibitors and anti-hypertensive agents. More particularly, as regards claim 12, there was no claim that the compounds would be so effective as to warrant the issuance of an NOC, or otherwise be commercially viable. As a practical matter, Dr. Christensen said that he would not waste research time and money trying to develop something that was not the “best in class”. In other words, he looked for an improvement on what had already been developed. I have no doubt that that attitude served him very well in industry, but all the law requires is that there be some utility. He raised the bar too high.
[46] Thus, I have come to the same conclusion as did Madam Justice Mactavish in the Apotex decision referred to in paragraph 9 hereof. I refer particularly to paragraph 61 and following and paragraph 276 and following of her reasons. Judicial comity calls for one judge of the same Court to follow another on points of law, unless of the view that the earlier decision was clearly wrong. My passing concern was that since we benefited from the advice of different experts, we might have been reading the patent through different glasses.
d. Sound Prediction and Lack of Utility
[47] When Schering applied for the Canadian patent in 1981, it had not actually laboratory tested the efficacy of any of the eight compounds set out in claim 12. Patent law did not require it to do so. The Commissioner was entitled to issue a patent if satisfied there was a sound basis for predicting that each of the compounds claimed would be useful for the promised purposes. Put another way, was the promise of the invention a reasonable inference from what the inventors knew, or should have known, or was it based on mere speculation?
[48] Claim 12 is presumed to be valid until it is either proved that at least one of the eight compounds is not useful, or the Court is satisfied that there was no sound basis for making the prediction in the first place. Even if it were established today that all eight compounds fulfilled the promise of the invention, the patent would still fall if the invention was merely a lucky guess.
[49] Today we know that one of the eight compounds, Ramipril, works very well indeed. No laboratory evidence was properly put before me as to whether the other seven compounds work or not.
[50] Although much of the evidence before me was similar to that before Madam Justice Mactavish in the Apotex case, the evidence differed sufficiently so that although she found as a fact that there was no sound basis for predicting the compounds in claim 12 would be useful, I have come to the opposite conclusion. The facts relate to stereochemistry. One is not entitled to expect that the Court knows anything about stereochemistry, so that findings of fact in that regard come from reliance on expert advice. Madam Justice Mactavish relied on the opinion of a Dr. Marshall. Dr. Marshall was not before me. I rely particularly on the evidence of Dr. Bartlett and Dr. Christensen, whose evidence was not before her.
[51] The parties, who are in the pharmaceutical business, know a great deal about stereochemistry, and the fundamental principles were not in dispute. What was in dispute was what might be described as “fine tuning”.
[52] As to relevant principles of stereochemistry, I can do no better than to refer to paragraphs 25 through 52 of Madam Justice Mactavish’s reasons for judgment.
[53] I need only mention that organic molecules are three dimensional. At the heart of the stereochemistry in this case is the carbon atom, which to be stable must take four bonds. This linkage may be called a ring. In addition to simple rings constructed from carbon and hydrogen, organic molecules may also have chains of atoms connected by double or triple bonds, and additional elements such as hydrogen, oxygen and sulphur.
[54] These three dimensional organic molecules take on different forms. As Dr. Bartlett explains it, a carbon atom that is substituted with four different groups can exist in two different forms. These carbon atoms may be called stereocentres or chiral centres, from the Greek word for hand. As set out in Madam Justice Mactavish’s decision, these chiral centres may either have an “S” configuration or an “R” configuration. The importance of the “S” and “R” configurations as explained by Dr. Bartlett is:
Enzymes are proteins that catalyze chemical reactions in the living cell, plant, or animal. They do so by binding the substrate to their active site, catalyzing the conversion of the substrate to the products of the reaction, and then allowing the products to dissociate from the active site. An inhibitor is a molecule that prevents this reaction from occurring, usually by competing with the substrate for binding to the active site. Inhibitors often bear some structural resemblance to the substrates with which they compete, but are themselves incapable of reacting.
[Emphasis in original]
[55] He went on to say that long before 1980 it was well known in the field of medical chemistry that there are distinct subsites of the active sites of peptidase enzymes; each subsite interacting with a particular segment of the peptide substrate or part of the inhibitor. It was generally known that for ACE, chiral centres in the “S” position were more effective than those in the “R” position. In fact, as mentioned by Madam Justice Mactavish, a paper published by Merck scientists in 1980 showed that in this context, chiral centres in the “S” position were 700 times more active (A.A. Patchett et al., “A new class of angiotensin-converting enzyme inhibitors” (1980) 288 Nature 280 [Merck article]).
[56] Following up on earlier works by Squibb and Merck, the Schering inventors, including Dr. Elizabeth Smith who filed an affidavit in these proceedings, were exploring structural variations of the bridgehead rings at the right hand side of the molecule, as it is usually depicted in diagram form.
[57] This is where the evidence before Madam Justice Mactavish and before me diverges. Claim 12 of Schering’s patent has three backbone chiral centres and two bridgehead chiral centres. It requires two of the three backbone chiral centres to be in the “S” position. The other three chiral centres may be in either the “S” or the “R” position.
[58] Dr. Marshall, in the affidavit and cross-examination put before Madam Justice Mactavish, was of the opinion that there would be no activity in the bridgehead chiral centres invented by Schering, and therefore no sound basis for making a prediction. However Dr. Christensen admitted that there would be “promiscuity” or activity in those centres. While Dr. Marshall thought there would be no activity, Dr. Christensen thought there would not be enough activity. However, since I, as had Madam Justice Mactavish, construe the patent as only claiming some activity, the promise was fulfilled.
[59] In addition to Dr. Christensen’s admission that there would be activity in the bridgehead chiral centres, Dr. Bartlett pointed out that although the Merck article simply reported facts, Merck made promises of activity in its own patent applications, promises which were very similar to those made by Dr. Smith and her colleagues. Since the people at Merck were pre-eminent in the field at that time, I have come to the conclusion that the claims made by Dr. Smith and her colleagues were not shots in the dark. There was a sound basis for their prediction. Indeed, patent ‘206 contemplates a 3000-fold difference in dosages, which more than covers the 700-fold range of activity reported in the Merck article. The patent also contemplates both oral administration and injection. Injection may not be popular, but it is a more effective way of getting medicine into the bloodstream.
e. “Evergreening”
[60] By the time the matter came up for hearing, Riva had abandoned some of the grounds it alleged that patent ‘206 was invalid. However it maintained its allegation with respect to “evergreening”. Sanofi-Aventis submitted that this was simply a new term for double patenting. Although I do not think that was Riva’s intent, call it what you will, it does not justify its allegation that the patent is invalid.
[61] Riva’s argument is that the ‘087 patent claimed Ramipril when made by certain processes. It was issued in 1985 and expired in 2002. The issuance of patent ‘206 in 2001 in effect perpetuated the monopoly on Ramipril without any new benefit flowing to the public. The combined effect of the two patents is that a duopoly beginning in 1985 will run until 2018, some 33 years. The Patent Act as it was before 1989 only gave a monopoly for 17 years from date of issuance, while the current version gives a 20-year monopoly from the date of application.
[62] Thus there is, Riva argues, a disproportionate unfairness to the public in that no one else may make Ramipril under the expired ‘087 patent without infringing patent ‘206. Expired monopolies should not be perpetuated.
[63] The delay in granting patent ‘206 in Canada, but not in other jurisdictions, worked to Schering’s initial disadvantage. Although Sanofi-Aventis started paying it a license fee in 1986, it certainly did not have to do so as far as Canada was concerned. It did so because it wanted to market Ramipril worldwide, and had to come to grips with patent ‘206 as granted in other jurisdictions.
[64] This is not a case of attempting to patent the same invention twice, or the same patent holder attempting to add “bells and whistles” onto an existing patent in an effort to perpetuate the patent list contemplated by the PM (NOC) Regulations. Ramipril was a “selection” patent out of a known genus.
[65] The decision of the Supreme Court in Consolboard Inc. v. MacMillan Bloedel (Sask.) Ltd., [1981] 1 S.C.R. 504, 56 C.P.R. (2d) 145 is on point. That was a situation where the Commissioner took the position that a patent had to be divided in two. The Court held that the patentee could not be prejudiced by what had happened in the Patent Office. The same applies in this case.
ABUSE OF PROCESS
[66] Having found that Riva’s allegations that patent ‘206 was invalid were not justified, more particularly its allegation with respect to a lack of sound prediction, I have to consider whether Sanofi-Aventis is precluded from arguing this point in virtue of the legal doctrine of abuse of process. Like the doctrine of privies, abuse of process, in this context, is closely related to res judicata.
[67] Section 6(5)(b) of the PM (NOC) Regulations provides:
6(5) In a proceeding in respect of an application under subsection (1), the court may, on the motion of a second person, dismiss the application
[…]
(b) on the ground that the application is redundant, scandalous, frivolous or vexatious or is otherwise an abuse of process
6(5) Lors de l'instance relative à la demande visée au paragraphe (1), le tribunal peut, sur requête de la seconde personne, rejeter la demande si, selon le cas :
[…]
b) il conclut qu'elle est inutile, scandaleuse, frivole ou vexatoire ou constitue autrement un abus de procédure.
[68] Mr. Justice Sexton’s decision in Novopharm, above, dismissing the appeal from Madam Justice Tremblay-Lamer’s decision, 2006 FC 1135, drives home the point that mere litigation, with another party, of a point already decided, can constitute, without more, an abuse of process, even if it is not clear and obvious that the application would have failed on the merits. This decision marks a clear development in the law as applicable in NOC proceedings.
[69] I mentioned earlier that were it not for this decision, I would not have found Sanofi-Aventis’ litigation with respect to sound prediction to be abusive. It is not necessary to set out those reasons in any detail, as Mr. Justice Sexton fully addressed the concerns I had, which were that the purpose of NOC applications is simply to decide whether the Minister should be prohibited from issuing an NOC, not whether a patent is invalid or would be infringed. An NOC decision does not even determine the validity of the patent as between the immediate parties. The jurisprudence, in the main, made it a constituent element of abuse of process that there be little or no likelihood of success. The issue of sound prediction is largely one of fact, and the evidence before two judges can well differ.
[70] In addition, I had failed to sufficiently distill the principles of abuse of process from the facts in the leading case of Toronto (City) v. C.U.P.E., [2003] 3 S.C.R. 77 [C.U.P.E.]. The city fired a recreation instructor after he had been convicted of sexually assaulting a boy under his supervision. The employee, with the support of his union, grieved the dismissal. The arbitrator ruled that the criminal conviction, which had been affirmed on appeal, was not conclusive as to whether he had actually sexually assaulted the boy. As a matter of public policy it simply will not do for an arbitrator to question the final decision of a court of competent jurisdiction. The city would have been put in an impossible position if it had to rehire a convicted sex felon. Here, there is no possibility of moral outrage on the part of an informed public.
[71] In applying C.U.P.E., above, to NOC proceedings, Mr. Justice Sexton declared that the old authorities had to be reassessed. He said at paragraphs 35 and 38:
[35] Despite these authorities, this Court's analysis with respect to abuse of process must now be informed by the principles enunciated by the Supreme Court of Canada in Toronto (City) v. C.U.P.E., Local 79, [2003] 3 S.C.R. 77, 2003 SCC 63 ("C.U.P.E."). In C.U.P.E., Arbour J. provided a thorough explanation of the doctrine of abuse of process as it relates to attempts by parties to relitigate issues already adjudicated. She held that relitigation of an issue can constitute abuse of process and stressed that the key concern motivating the doctrine of abuse of process is preserving the integrity of the adjudicative process …
[…]
[38] Therefore, despite the fact that Mactavish J.'s decision would not dictate the outcome of the present application and consequently, that it is not possible to say that Sanofi-Aventis has no chance of success, I nevertheless am compelled to hold that the application in respect of the Novopharm NOA is an abuse of process and therefore should