T-482-03
2005 FC 340
Aventis Pharma Inc. and Aventis Pharma Deutschland GmbH (Applicants)
v.
Pharmascience Inc. and The Minister of Health (Respondents)
and
Schering Corporation (Respondent/Patentee)
Indexed as: Aventis Pharma Inc. v. Pharmascience Inc. (F.C.)
Federal Court, Snider J.--Vancouver, December 7, 8 and 9, 2004; Ottawa, March 11, 2005.
Patents -- Infringement -- Pharmascience seeking Notice of Compliance (NOC) for angiotensin-converting enzyme (ACE) inhibitor, ramipril -- Aventis seeking to prohibit Minister from granting NOC -- Overarching issue: whether non-infringement allegation in notice of allegation (NOA) justified -- Questions for determination: (1) adequacy of NOA; (2) whether certain patent claims amount to double patenting; (3) justification of allegation Pharmascience will not infringe claims to use drug for cardiac insufficiency -- Relevant patents, patent laws considered -- Purpose of NOA -- NOA inadequate for failure to assert adequate facts to justify non-infringement allegation -- Lengthy obiter analysis, discussion of double patenting -- Whether double patenting where different patentees -- Concept of "evergreening" discussed -- Determination of priority dates -- Effect of licence agreement -- Expert evidence considered as to date for assessing obviousness double patenting argument -- Date of invention versus date of patent -- In absence of Canadian case law on point, Court applying American case In re Braat, 937 F. 2d 589 -- Prohibition order granted.
This was an application to prohibit the Minister from issuing a notice of compliance (NOC) to Pharmascience to market the angiotensin-converting enzyme (ACE) inhibitor, ramipril, for treatment of hypertension. Applicant, Aventis Pharma Inc. held a patent on ramipril for the treatment of hypertension, but it has expired. It still holds a patent on this drug to treat cardiac insufficiency. Schering Corporation, which owns a genus patent for ramipril and other ACE inhibitors, was joined as a respondent. In its notice of allegation (NOA), Pharmascience alleged that its product was not to be used or sold as a treatment for cardiac insufficiency. It further alleged that certain claims of Schering's 206 patent were invalid for double patenting.
The 206 patent relates to compounds useful as ACE inhibitors in hypertension treatment. Its claims were broad and would cover ramipril but the patent made no specific disclosure of the compound ramipril. A number of major obstacles had to be overcome before the patent for this invention was secured. The 087 patent was issued to Hoechst AG, predecessor to Aventis; it contained a claim of a process for making only the compound ramipril. The 087 patent is a selection patent of a compound also covered by the genus 206 patent. In 1986, Hoechst and Schering entered into a licence agreement, pursuant to which Aventis, as successor to Hoechst, holds a worldwide, exclusive licence to manufacture and sell ramipril. While the 087 patent has expired, it was relevant herein due to the double patenting allegation. The submission advanced by Pharmascience was that Aventis seeks to extend its monopoly beyond expiry of the 087 patent by claiming infringement of its 457 patent. That patent, issued to Aventis in 1988, claims compositions for the treatment of cardiac insufficiency, containing a compound of the genus of ACE inhibitor compounds including ramipril; claim 8 specifically claimed a composition containing ramipril or pharmaceutically acceptable salts thereof for the treatment of cardiac insufficiency (heart failure). That is a distinct therapeutic indication from hypertension and there was expert evidence that one would not have expected that a drug which was useful for the treatment of hypertension would also be useful for the treatment of heart failure. It was said that a skilled person reading either the 206 or 087 patents would not have been led to the conclusion that the compounds of the 457 patent could be used for heart failure.
The 206 patent issued from an application filed prior to October 1, 1989. It was accordingly governed by the pre-1989 Patent Act. The 206 patent was filed October 20, 1981 but did not issue until March, 2001, when the conflict proceedings concluded. There was no provision for "back dating" the patent or for shortening the patent's term. Had the application for the Schering patent been made after the October 1, 1989 amendments, the situation would have been otherwise since, under the current legislative scheme, conflicts are decided according to who filed first.
Held, the application should be allowed.
The first issue for consideration was the adequacy of the NOA. The case law has described the purpose of the NOA as well as the matters to be considered in assessing the adequacy thereof. It was urged by Aventis that Pharmascience ought to have disclosed the manner by which its marketing of ramipril was to be restricted to hypertension treatment. The medicine that Pharmascience intends to produce will be bioequivalent to and identical in appearance to "Altace", the subject of the expired 087 patent and the extant 457 patent. Furthermore, it would have therapeutic effect equivalent to "Altace". The NOA failed to disclose the employment of a limited interchangeability listing on the Ontario Drug Benefit formulary. Thus Pharmascience could only avoid infringement of the 457 patent by taking active steps to limit marketing. Such active steps should have been disclosed in the NOA. Pharmascience's allegation in this regard was nothing but a bald assertion of non-infringement.
The NOA was not inadequate on the double patenting issue. Pharmascience had described, at some length, the basis for this allegation of invalidity and this had allowed Aventis to assemble affidavit evidence and to make argument on this predominantly legal issue.
Aventis submitted that Pharmascience should have addressed claim 13 of the 206 patent. That submission would be correct only if Pharmascience had to address not only ramipril but any metabolite of that compound. But, under subparagraph 5(1)(b)(iv) of the Patented Medicines (Notice of Compliance) Regulations, the second person need only address issues of infringement of claims for the medicine. Here, the medicine was ramipril, not ramiprilat. What happens to ramipril once ingested was irrelevant in determining the adequacy of the NOA. But, since the NOA failed to assert adequate facts to justify the allegation that Pharmascience's marketing would not infringe the 457 patent, the NOA did not satisfy the Regulations and so Aventis was entitled to the relief sought.
In the event that this conclusion might be wrong, the double patenting allegation was dealt with. The Supreme Court of Canada has made it clear that previous inventions are not to be "evergreened" by the expedient of uninventive additions. Pharmascience argued that Aventis was attempting, by the backdoor, to extend its expired ramipril patent. Simply by filing this application, Aventis automatically obtained a two-year extension of its 087 patent. If the effect of this Court's decision is that an expired patent appears to maintain a continued monopoly, this should not be viewed as evergreening. It is simply a recognition that patents, other than the expired patent continue and that the rights of those patent holders must be recognized. The claims of the 206 patent are not identical or conterminous with those of the 087 or 457 patents: 206 is a genus patent covering a huge number of compounds, the 087 is a selection patent covering only a portion of the chemicals claimed in the genus patent and 457 is a use patent, claiming ramipril as a cardiac insufficiency treatment. This was not "same invention" double patenting. A second type of double patenting is termed "obviousness" double patenting. This refers to a second patent, the claims for which are not "patentably distinct" from those of the earlier patent. A second patent is not justified unless the claims reveal novelty or ingenuity over the earlier patent. This is the type of double patenting here at issue. Aventis and Schering submitted that obviousness double patenting had no application where the inventors or patentees are different. There was no case law directly on point. The inventors or patentees should not be the focus of the analysis, but rather basic principles and the claims. A patent represents a bargain between the patentee and the public and if a patent is granted for an invention that is not new, the patentee would receive a benefit without having paid the "hard coinage" of an ingenious disclosure. In other words, he would receive something for nothing. The public would have received no consideration for the bargain regardless of whether the patentees were different or the same. The concept of obviousness double patenting should not be limited to the same patentees or inventors. The focus must always be on the claims that form the invention and not on the parties advancing them. While Canadian case law on "evergreening" has yet to deal with a situation of different patentees, an invalidity allegation should not be rejected just because existing case law had not settled the issue.
Thus the question was whether the claims to one of the patents in issue was patentably distinct over the claims of the other. Considering the relationship between the 206 and 087 patents, the 087 ramipril patent covered an invention that added something of a substantial character to existing knowledge.
However, Schering has "enjoyed" the benefits of its patent through royalties received since 1986, pursuant to its licence agreement with Hoescht. The problem with the argument that having benefited from its 206 claim to a patent, Schering should not have recognition for a further period of time, was that the rights under a licence agreement are limited and not comparable to the protection afforded by a patent under the statutory scheme. Schering could enforce the rights acquired under its licence agreement with Hoescht only against the other party to the agreement i.e. Hoechst or its successor in interest, Aventis. At the time the licence agreement was entered into, there remained a significant risk to Schering that the 206 patent might never issue. Little weight was assigned to the agreement as evidence that Schering had had any benefit from the patent since 1986. And even if Schering and Aventis were considered as the same patentees, nothing in the Act prevented the same patentees from developing a novel invention that could be patented.
In determining the date for assessing the obviousness double patenting argument, the Court considered the evidence of the expert witnesses. The allegation of Pharmascience, that the 206 claims were invalid for double patenting, was founded on an assessment of obviousness using the patent issue date of March, 2001. But, if the correct reference date was 1981, the double patenting argument would collapse. In this case, the date of invention rather than that of the patent should be used to determine obviousness because the 206 patent issued under the pre-1982 patent scheme. The claims arise from an invention, not from the grant. The problem herein could not arise under the Act now in force. Assessing the issue of obviousness double patenting as of the date of invention appears to result in an inequity, but Schering's situation if 2001 were selected as the correct reference date had also to be considered. In that case, Schering would not have had the benefit of a patent from 1981 to 2001 and would also be stripped of its side of the "bargain" as of 2001. That would mean that the patentee got nothing for its invention in respect of the claims that cover ramipril.
There was no Canadian case on point, but the Court was referred to an American case, In re Braat, 937 F.2d 589. An application of the logic of Braat required an assessment of whether the claims of the 087 patent were obvious over the claims to ramipril in the 206 patent. The only expert evidence on this was that it would not have been obvious that ramipril would have significantly increased activity relative to its stereoisomers. Based on that uncontested evidence, the claims of the 087 patent were not obvious over the claims of the 206 patent and, according to the logic of Braat, the obviousness double patenting argument could not succeed.
The situation here was not one of evergreening the 087 patent. It was rather described as a recognition of the rights of the 206 patent holder. The Pharmascience allegation that its ramipril will not infringe the `206 patent was not justified and this was a sufficient basis upon which to grant Schering's application.
statutes and regulations judicially
considered
Federal Courts Rules, SOR/98-106, rr. 1 (as am. by SOR/2004-283, s. 2), 400(3), Tariff B, Column III.
| Patent Act, R.S.C., 1985, c. P-4, ss. 27(1), 43. |
| Patented Medicines (Notice of Compliance) Regulations, SOR/93-133, ss. 5(1) (as am. by SOR/98-166, s. 4; 99-379, s. 2). |
cases judicially considered
applied:
Pfizer Canada Inc. v. Apotex Inc. (2004), 31 C.P.R. (4th) 214; 245 F.T.R. 243; 2003 FC 1428; Apotex Inc. v. Wellcome Foundation Ltd., [2002] 4 S.C.R. 153; (2002), 219 D.L.R. (4th) 660; 21 C.P.R. (4th) 499; 296 N.R. 130; 2002 SCC 77; Pfizer Canada Inc. v. Apotex Inc. (1997), 77 C.P.R. (3d) 547 (F.C.T.D.); In re Braat, 937 F.2d 589 (Fed. Cir. 1991).
considered:
AB Hassle v. Canada (Minister of National Health and Welfare) (2000), 7 C.P.R. (4th) 272; 256 N.R. 172 (F.C.A.); Whirlpool Corp. v. Camco Inc., [2000] 2 S.C.R. 1067; (2000), 194 D.L.R. (4th) 193; 9 C.P.R. (4th) 129; 263 N.R. 88; 2000 SCC 67; Commissioner of Patents v. Farbwerke Hoechst Aktiengesellschaft Vormals Meister Lucius & Bruning, [1964] S.C.R. 49; (1963), 41 C.P.R. 9; 25 Fox Pat C. 99.
referred to:
AB Hassle v. Genpharm Inc. (2003), 243 F.T.R. 6; 2003 FC 1443; Beecham Canada Ltd. et al. v. Procter & Gamble Co. (1982), 61 C.P.R. (2d) 1; 40 N.R. 313 (F.C.A.); Free World Trust v. Électro Santé Inc., [2000] 2 S.C.R. 1024; (2000), 194 D.L.R. (4th) 232; 9 C.P.R. (4th) 168; 263 N.R. 150; 2000 SCC 66; In re I.G. Farbenindustrie A.G.'s Patents (1930), 47 R.P.C. 289 (Ch. D.).
APPLICATION for an order prohibiting the Minister of Health from issuing a notice of compliance, under Patented Medicines (Notice of Compliance) Regulations, for the marketing of the drug ramipril as a treatment for hypertension. Application granted.
appearances:
Gunars A. Gaikis, A. David Morrow and J. Sheldon Hamilton for applicants.
Donald H. MacOdrum and Mark S. Mitchell for respondent Pharmascience Inc.
Anthony George Creber for respondent Schering Corporation.
Eric Petersen for respondent Minister of Health.
solicitors of record:
Smart & Biggar, Toronto, for applicants.
Lang Michener LLP, Toronto, for respondent Pharmascience Inc.
Gowling Lafleur Henderson LLP, Ottawa, for respondent Schering Corporation.
Deputy Attorney General of Canada for respondent Minister of Health.
The following are the reasons for order rendered in English by
Snider J.:
INTRODUCTION
[1]Pharmascience Inc. (Pharmascience), on August 31, 2001, made a submission to the Minister of Health (Minister), pursuant to the Patented Medicines (Notice of Compliance) Regulations [SOR/93-133] (the Regulations), for the issuance of a notice of compliance (NOC) to market capsules of ramipril for the treatment of hypertension. In this application, commenced by notice of application filed March 28, 2003, Aventis Pharma Inc. and Aventis Pharma Deutschland GmbH (Aventis) seek an order of prohibition preventing the Minister from granting the NOC to Pharmascience. Schering Corporation (Schering), as owner of one of the relevant patents, has been joined as a respondent in this application and supports Aventis.
[2]The drug ramipril, known as an angiotensin-converting enzyme (ACE) inhibitor, has been used for the treatment of both cardiac insufficiency (also referred to as heart failure) and hypertension (or high blood pressure). In this proceeding, there are three relevant patents related to this drug:
· Aventis held Canadian Patent 1187087 (the 087 patent) which covered the use of ramipril for the treatment of hypertension and which expired November 4, 2002.
· Canadian Patent 1246457 (the 457 patent) is held by Aventis for the use of ramipril for cardiac insufficiency; the 457 patent was issued December 13, 1988 and expires in December 2005.
· Canadian Patent 1341206 (the 206 patent), held by Schering, is a genus patent that includes ramipril and other ACE inhibitors. Although application for the patent was filed in October 1981, the patent did not issue until March 20, 2001.
[3]Aventis markets ramipril under the trade name "Altace".
[4]In connection with its NOC submission and as required by subsection 5(1) [as am. by SOR/98-166, s. 4; 99-379, s. 2] of the Regulations, Pharmascience, on February 7, 2003, served Aventis with a notice of allegation (NOA) accompanied by a "detailed statement of the legal and factual basis for each such allegation." In brief, the NOA made the following allegations:
· Pharmascience's ramipril "will not be made, constructed, used or sold for treating cardiac insufficiency as claimed in the claims of the `457 patent."
· Claims 1, 2, 3, 6 and 12 of the 206 patent, which cover ramipril, "are invalid on the basis that they cover subject matter that is not patently distinct from subject matter covered by claims of the . . . `087 patent and the . . . `457 patent."
· None of the other claims of the `206 patent (claims 4, 5, 7, 8, 9, 10, 11, and 13), which do not cover ramipril, will be infringed.
ISSUES
[5]The overarching issue in this application is whether the allegation of non-infringement made by Pharmascience in its NOA submitted to the Minister is justified. In making this determination, the following questions must be answered:
(1) Is the NOA adequate?
(2) In light of the earlier granted 087 and 457 patents, is Pharmascience justified in alleging that those claims of the 206 patent that cover ramipril, are invalid on the basis of double patenting?
(3) Is the allegation that Pharmascience will not infringe the claims to the use of ramipril to treat cardiac insufficiency in the 457 patent justified?
[6]If the answer to any of these questions is "no", Aventis will be successful in this application.
THE RELEVANT PATENTS
[7]Some of the claims of each of the 206, 087, and 457 patents are relevant to this application. It would be helpful to commence with a description of the pertinent claims and the background of the three patents.
Canadian Patent 1341206 (206 patent)
[8]The 206 patent is entitled "Carboxyalkyl Dipeptides, Processes for Their Production and Pharmaceutical Compositions Containing Them." The patent relates to compounds (carboxyalkyl dipeptides) which are useful as ACE inhibitors for the treatment of hypertension. The claims of the 206 patent are broad and cover a genus of compounds that include ramipril but, nowhere in the patent is there a specific disclosure of the compound ramipril. The claims relevant to this application are as follows:
· Claim 1 of the 206 patent claims a genus of carboxyalkyl dipeptides of a general formula consisting of three main units: (a) the bicyclic rings; (b) the central alanyl unit; and (c) the end chain unit. It is not limited to a specific stereochemistry. Where certain substitutions are made to the general formula, the resulting formula describes ramipril and its stereoisomers (the different configurations possible in three-dimensional organic molecules).
· Claim 2 also covers compounds with a specified general formula and is not limited to specific stereoisomers. With certain substitutions, ramipril is covered by this claim.
· Claim 3, in a similar fashion, covers ramipril.
· Claim 6 claims compounds having a general formula. When certain substitutions are made, the general formula of claim 6 describes 32 stereoisomers, one of which is ramipril.
· The formula of claim 12 describes 8 different stereoisomers, one of which is ramipril.
· Claim 13 covers the compound ramiprilate which is the metabolite formed in the body of patients who take ramipril.
[9]Dr. Elizabeth Smith, who has been employed by Schering-Plough Research Institute and its predecessors for 30 years, was one of the co-inventors of the invention embodied in the 206 patent. As she stated in her affidavit, "The patent arose out of work . . . which recognized that a number of different compounds with related structures have utility as ACE inhibitors and anti-hypertensives." As she notes, claim 1 of the 206 patent covers, in addition to ramipril, a number of compounds that have been commercialized, including spirapril and, trandolapril. Attached to her affidavit were a report dated June 20, 1980 and lab notes dated August 1, 1980, indicating the work that was being done on this invention at that time. Certain compounds were tested in February 1981. All of this led to a filing in Canada of an application for patent on October 20, 1981.
[10]From the date of filing to the issuance of the 206 patent on March 20, 2001, the road to obtaining a patent on this invention contained a number of major obstacles. Mr. Edward H. Mazer, a patent attorney with Schering-Plough Corporation for the 17 years preceding this application, included, in his affidavit, a chronology of events culminating, after almost 20 years, in the issuance of the 206 patent. The major milestones in this time line are the following:
| DATE October 20, 1981 March 1, 1984 May 16, 1984 Between 1985 and 1990 May 2, 1990 August 2 and 3, 1990 December 27, 1990 April 24, 1991 January 21, 1992 January 22, 1993 May 5, 1993 August 8, 1996 January 10, 1997 December 2000 March 20, 2001 |
EVENT Application filed. First office Action issued. Response to first office Action. Schering filed five requests for status. Second office Action issued. Schering filed response (August 2) and supplementary (August 3). Third office Action issued. Response to third office Action. Schering filed a sixth request for status. Commissioner declared a conflict with 4 other applications (including one by Hoechst, the owner of the now expired 087 patent). Commissioner reissued conflict notice. Commissioner declared Schering to be the first to invent all the conflict claims to which it was a party. The parties in conflict with Schering filed an appeal. The matter is settled shortly before the trial in Federal Court. 206 patent issued. |
|
[11]While the conflict proceedings placed 13 separate claims in conflict with Schering's patent application, neither the 087 nor the 457 patents were among the claims in conflict.
[12]As discussed below, Pharmascience takes the position that this patent is invalid for double patenting.
Canadian Patent 1187087 (087 patent)
[13]The 087 patent issued May 14, 1985 to Hoechst AG, predecessor to Aventis, from an application filed November 4, 1982. It is entitled "Derivatives of Cis, Endo-2-Azabicyclo- {3.3.0}-Octane-3-Carboxylic Acid, a Process For Their Preparation, Agents Containing These Compounds and Their Use". The 087 patent expired on November 4, 2002.
· Claim 1 of the 087 patent claims a process for the preparation of a compound of formula I and the physiologically acceptable salts thereof.
· Claim 2 claims the compound of formula I and the physiologically acceptable salts thereof when made according to the process of claim 1 or an obvious chemical equivalent.
· Claims 3 and 4 place limitations on the process and compounds claimed including ramipril.
· Claim 5 claims a process for making only the compound ramipril.
· Claim 6 claims ramipril when made by a process claimed in claim 5 or obvious equivalent.
[14]Both claims 1 and 2 specify that hydrogen atoms attached to the two carbon atoms in the middle of the bicyclic ring are "cis" or on the same side of the ring. In contrast, the claims of the 206 patent place no restriction on the stereospecificity of the hydrogens; stereochemistry being the means by which the locations of atoms or groups of atoms are described.
[15]Dr. Richard Becker, who has been a clinical pharmacologist with Aventis or its predecessors since 1998, is a named inventor on the 087 patent and an affiant in these proceedings. He confirmed that the developmental work by Hoechst (predecessor to Aventis) on ramipril and similar compounds was conducted independently from the work of Schering. During in vivo testing, he discovered that ramipril was at least 18 times more potent than the most potent of the structurally analogous comparative test compounds. In his words, ramipril was "markedly more active in inhibiting ACE than any of the other tested stereoisomers of ramipril"; that ramipril was "significantly more potent." He also confirmed that Hoechst did not make ramipril before April 28, 1981, the latest claimed priority date for the 206 patent.
[16]Briefly put, the 087 patent is a selection patent of a compound that is also covered by the genus 206 patent. The indicated use for the drug covered by this expired patent is hypertension.
[17]Hoechst and Schering entered into a license agreement, effective December 15, 1986, pursuant to which Aventis, as successor to Hoechst, holds a "worldwide, exclusive license to make, use and/or sell" ramipril. Mr. Edward Mazer, in his affidavit, stated that Hoechst obtained a licence from Schering as a result of a dispute between the parties.
[18]Since this patent has expired, there is no question in these proceedings of infringement of the 087 patent. The 087 patent is, however, brought into play because of the allegation of double patenting. Pharmascience is arguing that Aventis, in opposing the issuance of a NOC to Pharmascience, is seeking to extend its monopoly on ramipril beyond the expiry of the 087 patent by claiming infringement of its 457 patent.
Canadian Patent 1246457 (457 patent)
[19]The final patent involved in this application is the 457 patent entitled "Method of Treating Cardiac Insufficiency." Application was filed for the patent on April 10, 1985 and the patent was issued to Aventis on December 13, 1988. This patent relates to the use of ACE inhibitors, including ramipril, for treating cardiac insufficiency.
· Claim 1 claims pharmaceutical compositions for treating cardiac insufficiency, containing a compound of the genus of ACE inhibitor compounds described in claim 1, which includes ramipril.
· Claim 8 specifically claims a composition containing ramipril or pharmaceutically acceptable salts thereof for the treatment of cardiac insufficiency.
[20]The term cardiac insufficiency describes heart failure. Cardiac insufficiency is a distinct therapeutic indication from hypertension. As pointed out by Dr. Becker, "It would not be expected that ramipril, which is useful for the treatment of hypertension, would also be useful for the treatment of heart failure." Further, he stated that "[a] skilled person reading either the 206 or the 087 patents would not have been led to the conclusion that the compounds of the 457 patent would be useful in the treatment of heart failure."
[21]As discussed below, Pharmascience submits that the sale of its generic ramipril will not infringe this patent since it will be marketed solely for the treatment of hypertension and not cardiac insufficiency.
THE RELEVANT PATENT LAWS
[22]Since the critical issue in this proceeding deals with the priority of patents, it is important to understand the statutory framework that applies to the dates of the relevant patents.
[23]The 206 patent issued from an application filed before October 1, 1989. Accordingly, the patent is, for most purposes, governed by the pre-1989 Patent Act [R.S.C., 1985, c. P-4] (the "Act") as it read immediately before the October 1, 1989 amendments. Paragraph 27(1)(a) of the Act provided that:
27. (1) Subject to this section, any inventor or legal representative of an inventor of an invention that was
(a) not known or used by any other person before he invented it,
. . .
may, on presentation to the Commissioner of a petition setting out the facts, in this Act termed the filing of the application, and on compliance with all other requirements of this Act, obtain a patent granting to him an exclusive property in the invention.
[24]When pending applications contain one or more claims defining substantially the same invention or one or more claims of one application describe the invention disclosed in another application, section 43 of the Act provided a conflict procedure to determine which of the applicants is the prior inventor to whom the Commissioner will allow the claims. Pursuant to the scheme outlined in the Act, no patent could be issued until the conflict proceedings were resolved. The 206 patent, caught under this scheme, was filed October 20, 1981 but did not issue until March 20, 2001, almost 20 years later when the conflict proceedings concluded. In circumstances such as those encountered here, there is no provision for "back dating" the patent or for shortening the term of the patent. Accordingly, the patent issued and became effective on March 20, 2001 for 17 years from that date.
[25]It is interesting to note that, had the application for the Schering patent been made after the October 1, 1989 amendments, the situation would have been far different. Under the present legislative scheme, conflicts are decided on the basis of who filed first. Thus, if the current scheme had been in place when Schering had filed its application, the 206 patent would have issued on October 21, 1981 and the protection of that patent would have expired by now.
[26]With this background, I turn to an analysis of the issues in these proceedings.
ISSUE No. 1: ADEQUACY OF NOTICE OF ALLEGATION
[27]Aventis submits that the NOA of Pharmascience is deficient and is not a notice of allegation and detailed statement contemplated by the Regulations. The company bases this submission on three arguments:
· Pharmascience has stated only that it is not seeking approval for the treatment of cardiac insufficiency (which would be an infringement of the 457 patent), but failed to make any mention in its NOA of how it would achieve that assertion.
· Pharmascience fails to provide any legal or factual basis that demonstrates that the claims 1, 2, 3, 6 and 12 of the 206 patent are invalid for double patenting.
· Ramiprilate, which is covered by claim 13 of the 206 patent, is an active metabolite that is produced when ramipril is administered to patients. Pharmascience has not provided facts in its NOA that would justify its allegations that claim 13 is not infringed.
[28]I will consider each in turn.
General
[29]Subsection 5(1) of the Regulations establishes the legal basis for a notice of allegation as follows:
5. (1) Where a person files or has filed a submission for a notice of compliance in respect of a drug and compares that drug with, or makes reference to, another drug for the purpose of demonstrating bioequivalence on the basis of pharmaceutical and, where applicable, bioavailability characteristics and that other drug has been marketed in Canada pursuant to a notice of compliance issued to a first person and in respect of which a patent list has been submitted, the person shall, in the submission, with respect to each patent on the register in respect of the other drug,
(a) state that the person accepts that the notice of compliance will not issue until the patent expires; or
(b) allege that
(i) the statement made by the first person pursuant to paragraph 4(2)(c) is false,
(ii) the patent has expired,
(iii) the patent is not valid, or
(iv) no claim for the medicine itself and no claim for the use of the medicine would be infringed by the making, constructing, using or selling by that person of the drug for which the submission for the notice of compliance is filed.
[30]What is the purpose of a notice of allegation? As described by Justice Stone in AB Hassle v. Canada (Minister of National Health and Welfare) (2000), 7 C.P.R. (4th) 272 (F.C.A.), at paragraphs 16-17, the NOA is provided so that the patentee may decide whether to commence an application under the Regulations to prevent the issuance of an NOC. The NOA, therefore, must be sufficiently detailed to make the patentee fully aware of the grounds upon which the second person (here Pharmascience) claims that there will be no infringement.
[31]The second party, for example, cannot ignore patent claims that describe the basic invention; each of the relevant claims must be referenced in either the NOA itself or the detailed statement that accompanies the NOA (AB Hassle v. Genpharm Inc. (2003), 243 F.T.R. 6 (F.C.), at paragraph 189).
[32]As I stated in Pfizer Canada Inc. v. Apotex Inc. (2004), 31 C.P.R. (4th) 214 (F.C.), at paragraph 32:
In assessing the adequacy of the NOA, the following guidance can be taken from a number of decisions of the Federal Court of Appeal, including Bayer AG v. Canada (Minister of National Health and Welfare) (1993), 51 C.P.R. (3d) 329 (F.C.A.); Glaxo Group Ltd. v. Canada (Minister of National Health and Welfare) (2000), 6 C.P.R. (4th) 73 (F.C.T.D.), at 81, affirmed (2001), 11 C.P.R. (4th) 417 (F.C.A.):
A bald assertion of non-infringement is insufficient.
It is permissible for the second person to withhold certain information regarding its formulation until subsequent to a confidentiality order being in place.
The NOA will be adequate if further disclosure elaborates on the basis for which the allegation of non-infringement was made such that there is sufficient evidence upon which to evaluate the allegation.
Failure to set out the basis upon which marketing would not include marketing for the treatment of cardiac insufficiency.
[33]As noted, Pharmascience stated in its NOA that its ramipril "will not be made, constructed, used or sold by Pharmascience for treating cardiac insufficiency and will not be a composition for treating cardiac insufficiency as claimed in the claims of the 457 patent. "Neither the NOA nor the detailed statement that accompanied the notice contain any other reference to this allegation. Aventis submits that Pharmascience was required to disclose how it would restrict its marketing of ramipril to the treatment of hypertension.
[34]The medicine that Pharmascience intends to produce will be bioequivalent to and identical in appearance to the "Altace" that is the subject of the expired 087 patent and the extant 457 patent. There can be no dispute that the Pharmascience product would provide a therapeutic effect equivalent to "Altace", whether the drug is used to treat cardiac insufficiency (the 457 patent) or hypertension (the 087 patent).
[35]It was not until Aventis was presented with the affidavits of Ms. Jeannette Echenberg, Director of Regulatory Affairs for Pharmascience, and of Mr. Ronald Nefsky, a licensed pharmacist in Ontario, that Aventis was able to determine what steps Pharmascience intended to take to limit its marketing of ramipril. Mr. Nefsky was asked by Pharmascience to:
. . . explain what I would do and in my professional opinion, what should happen if an Ontario pharmacist is presented with a prescription for Ramipril which does not specify the condition being treated, in circumstances wher e Pharmascience has obtained an NOC for use of Ramipril to treat hypertension only and consequently has only sought and obtained a listing on the Ontario Drug Benefit Formulary/Comparative Drug Index ("the DBF/CDI or Formulary") where interchangeability is limited to hypertension.
[36]Simply stated, Mr. Nefsky was asked to provide his opinion based on the assumption of a limited interchangeability listing on the Ontario formulary, a fact that was not disclosed in the NOA. Ms. Echenberg described how Pharmascience would apply for a limited formulary listing. Thus, it appears that Pharmascience can only avoid infringement of the 457 patent by taking active steps to limit marketing. These active steps ought to have been disclosed in the NOA.
[37]In my view, Pharmascience's allegation in this respect amounts to a "bald assertion of non- infringement." The subsequent evidence regarding the limited listing went far beyond evidence that "elaborates on the basis for which the allegation of non-infringement was made." This is because, absent the subsequent affidavits and information, there was nothing whatsoever in the NOA that would enable Aventis to understand why a pill that looks and acts identically to its patented cardiac insufficiency medicine would not be used for such purpose.
Failure to provide any legal or factual basis that demonstrates that the claims 1, 2, 3, 6 and 12 of the 206 patent are invalid for double patenting
[38]On the issue of the 206 patent and double patenting, Pharmascience asserts, in its NOA, that claims 1, 2, 3, 6, and 12, which cover ramipril are invalid "on the basis that they cover subject matter that is not patently distinct from subject matter covered by claims of the [087 and 457 patents]." Aventis argues that the NOA is inadequate on this issue, even when taking the detailed statement into consideration. I do not agree.
[39]In the detailed statement that accompanied the NOA, Pharmascience describes, at some length, the basis upon which it makes this allegation of invalidity. It sets out its view of the facts related to the issuance of the relevant patents and its assessment of the law on double patenting. From this information, Aventis was able to put together affidavit evidence and legal argument that addressed this predominantly legal issue. I cannot conclude that Aventis was not fully aware of the grounds that Pharmascience was putting forward for its allegation of invalidity.
Failure to address claim 13
[40]The NOA must address each and every patent claim describing the basic invention. In this case, it is obvious that Pharmascience was required to address all of the claims of the three patents that cover ramipril. That was done. Aventis argues that Pharmascience should also have addressed claim 13 of the 206 patent.
[41]There is no dispute that ramipril metabolizes to ramiprilat when administered to patients. As indicated in Pharmascience's Product Monograph, ramipril is rapidly hydrolyzed to ramiprilat upon being swallowed. Ramiprilat is covered in claim 13 of the 206 patent. In its NOA, Pharmascience states that it will not infringe claim 13. Aventis submits that, because of the transformation of ramipril after being administered, Pharmascience's allegation of non-infringement of claim 13 is not justified.
[42]To find that the allegation is not justified with respect to claim 13, I would have to conclude that Pharmascience was required to address not only the compound ramipril but any metabolite of ramipril. A plain reading of the Regulations does not support this conclusion. Pursuant to subparagraph 5(1)(b)(iv) of the Regulations, the second person need only address issues of infringement of claims for the medicine. In this case, the medicine is ramipril and not ramiprilat. Thus, in my view, what happens to ramipril once it is ingested is irrelevant to the determination of the adequacy of the NOA.
Conclusion
[43]Since Pharmascience's NOA failed to assert adequate facts to justify the allegation that the marketing of its product will not infringe the 457 patent, I conclude that the NOA is not a notice of allegation and detailed statement as contemplated by the Regulations. On this basis, the application of Aventis should succeed. However, in the event that I am wrong on this issue, I will continue with an analysis of the double patenting allegation.
ISSUE No. 2: DOUBLE PATENTING
[44]As Justice Binnie for the Supreme Court of Canada stated in Apotex Inc. v. Wellcome Foundation Ltd., [2002] 4 S.C.R. 153, at paragraph 37, "The patent monopoly should be purchased with the hard coinage of new, ingenious, useful and unobvious disclosures." Thus, a monopoly should not be granted, nor should previous inventions be "evergreened", by the expedient of obvious or uninventive additions (Whirlpool Corp. v. Camco Inc., [2000] 2 S.C.R. 1067, at paragraph 37 (referred to as Camco)).
[45]Pharmascience argues that this case is simply a question of evergreening; that Aventis is trying, through the back door, to extend its expired patent for ramipril. The rule against double patenting prevents this. Simply by filing this application, Aventis has automatically obtained, in effect, a two-year extension of its 087 patent that expired on November 4, 2002. Now that the 087 patent has expired, the patentee should not be entitled, through another related patent, to extend its monopoly.
[46]That is certainly one side of the equation. However, upon considering all of the possibly relevant patents, it may be that the effect of a decision of this Court is that an expired patent appears to maintain a continued monopoly. This should not be viewed as evergreening; it is simply a recognition that patents, other than the expired patent, continue and that the rights of those patent holders must be recognized. The continued monopoly applies, as it properly should, to the valid and subsisting patent until its expiry. Such is the situation involving genus and selection patents to be discussed further below.
What does Camco teach us about double patenting?
[47]Both parties referred extensively to the comments of Justice Binnie in Camco. In Camco, Justice Binnie discussed the law related to double patenting. Commencing at paragraph 63, he stated that the prohibition against double patenting relates to the "evergreen" problem, adding:
The inventor is only entitled to "a" patent for each invention: Patent Act , s. 36(1). If a subsequent patent issues with identical claims, there is an improper extension of the monopoly. It is clear that the prohibition against double patenting involves a comparison of the claims rather than the disclosure, because it is the claims that define the monopoly. The question is how "identical" the claims must be in the subsequent patent to justify invalidation.
[48]Justice Binnie outlined two types of double patenting. The first type, where the claims are "identical or conterminous", is discussed in the Federal Court of Appeal decision in Beecham Canada Ltd. et al. v. Procter & Gamble Co. (1982), 61 C.P.R. (2d) 1, at page 22. He referred to this as "same invention" double patenting.
[49]Just as in Camco, it cannot be said that the claims of the 206 patent are "identical or conterminous" with those of the 087 or 457 patents. The 206 patent is a genus patent that covers a huge number of compounds, while the 087 patent covering ramipril was a selection patent covering only a portion or a selection of the chemicals claimed in the genus patent. The 457 patent is a use patent, specifically claiming ramipril in the treatment of cardiac insufficiency. The issue before me is not one of "same invention" double patenting.
[50]The second type of double patenting discussed by Justice Binnie is the "obviousness" double patenting. On this type of double patenting, Justice Binnie had the following to say, at paragraphs 66-67:
There is, however, a second branch of the prohibition which is sometimes called "obviousness" double patenting. This is a more flexible and less literal test that prohibits the issuance of a second patent with claims that are not "patentably distinct" from those of the earlier patent. In Commissioner of Patents v. Farbwerke Hoechst Aktiengesellschaft Vormals Meister Lucius & Bruning, [1964] S.C.R. 49, the issue was whether Farbwerke Hoechst could obtain a patent for a medicine that was a diluted version of a medicine for which it had already obtained a patent. The claims were neither identical nor conterminous. Judson J. nevertheless held the subsequent patent to be invalid, explaining at p. 53:
| A person is entitled to a patent for a new, useful and inventive medicinal substance but to dilute that new substance once its medical uses are established does not result in further invention. The diluted and undiluted substance are but two aspects of exactly the same invention. In this case, the addition of an inert carrier, which is a common expedient to increase bulk, and so facilitate measurement and administration, is nothing more than dilution and does not result in a further invention over and above that of the medicinal itself. [Emphasis added.] |
In Consolboard, supra, Dickson J. referred to Farbwerke Hoechst as "the main authority on d ouble patenting" (p. 536) which stood for the proposition that a second patent could not be justified unless the claims exhibited "novelty or ingenuity" over the first patent:
| Judson J. for the Court said that the second process involved no novelty or ingenuity, and hence the second patent was unwarranted. |
[51]This second type of double patenting is what is in issue in these proceedings.
Can obviousness double patenting apply where the inventors or patentees are different?
[52]Aventis and Schering submit that obviousness double patenting cannot apply where there are different inventors. Aventis argues that the words of Justice Binnie, in Camco, at paragraph 63, where he states that "[t]he inventor is only entitled to `a' patent for each invention", are a clear indication that the concept of double patenting can only arise where you have the same inventor. Here, Dr. Smith and her team are the named inventors of the 206 patent and Dr. Becker and his group were the inventors on the 087 patent. Further, Aventis points out that the patentees are different in this case.
[53]There is no Canadian jurisprudence that is directly on point to assist me in determining whether double patenting can apply where the inventors or patentees are different. While Justice Binnie speaks of flexibility in the context of obviousness double patenting, he was doing so in a case where the defendant, Whirlpool, was the holder of both patents in question. That is, Camco was alleging that the claims of one of the Whirlpool patents (the `734 patent) were not patentably distinct over the claims of another Whirlpool patent (the `803 patent). Although the inventors appear to have been different, they were all Whirlpool researchers. In contrast, in the case before me, the parties who applied for the original patents were clearly different and the inventors worked separately to develop their inventions.
[54]Finally, with respect to the Camco case, I note that Camco's argument of double patenting was rejected on the basis that Camco had failed to provide a sufficient factual basis to invalidate the 734 claim. In other words, Camco failed to discharge the evidentiary burden on it to prove, on a balance of probabilities, that the patent was invalid.
[55]In conclusion, I do not think that Camco should be cited as determinative of either position of the parties before me. The issue simply did not arise on the facts of that case with sufficient clarity to be a binding precedent.
[56]So, where does that leave us?
[57]In my view, it does not help to focus on the inventors or the patentees. As the jurisprudence tells us, basic principles and the claims are what matters. As has been pointed out by the Supreme Court of Canada, a patent is a "bargain". In Camco, at paragraph 37, Justice Binnie stated the following:
. . . the bargain between the patentee and the public is in the interest of both sides only if the patent owner acquires real protection in exchange for disclosure, and the public does not for its part surrender a more extended monopoly than t he statutory 17 years from the date of the patent grant (now 20 years from the date of the patent application).
[58]Using the language of a "bargain", each party, both the patentee and the public, must receive something. If an invention is not new, the patentee would receive a term of protection for which he has not paid the "hard coinage of new, ingenious, useful and unobvious disclosures" (Wellcome Foundation, at paragraph 37); he would have received "something for nothing" (Free World Trust v. Électro Santé Inc., [2000] 2 S.C.R. 1024, at paragraph 13). The public, in such a situation, receives no consideration for the bargain. This would be true regardless of whether the inventors or the patentees are different or the same. If the claims of the two patents are not patentably distinct, the effect would be an extension of the original patent as was considered by the Supreme Court in Commissioner of Patents v. Farbwerke Hoechst Aktiengesellschaft Vormals Meister Lucius & Bruning, [1964] S.C.R. 49. In that case, the Supreme Court refused to recognize a new patent for a substance that was, in fact, a simple dilution of a medicine covered by an already existing patent.
[59]Thus, I would not limit the operation of the concept of obviousness double patenting to the same patentees or inventors. In reviewing the facts of each case, the focus must be the claims that form the invention and not the persons or parties that advance them. If the claims to one patent are not patentably distinct over those in another patent, an allegation of invalidity may have merit.
[60]It is true that the Canadian cases discussing the concept of "evergreening" have used the term "monopoly" to describe the situation that the principle seeks to avoid. It is also the case that no Canadian jurisprudence has ever considered or found the concept to apply to situations of different patentees. However, I do not believe that this should lead inextricably to the conclusion, as argued by Aventis and Schering, that such a finding is only possible if I have the same patentees or the same inventors. Given the diligence of the Commissioner of patents and the provisions in the Patent Act that prohibit the issuance of patents to claims that are not patentably distinct, the situation of double patenting rarely arises. Once it arises--as it has in the application before me--I see no reason to dismiss the allegation of invalidity simply because there is no existing case law settling the issue.
[61]Thus, the question that must be addressed is whether the claims to one of the patents in issue are patentably distinct over the claims of the other. In answering this question, the relationship between the claims to ramipril in the two patents must be examined.
What is the relationship between the 206 patent and the `087 patent?
[62]In my view, the relationship between the 206 patent and 087 patent is very similar to that described in the case of Pfizer Canada Inc. v. Apotex Inc. (1997), 77 C.P.R. (3d) 547 (F.C.T.D.). That case involved an allegation by Apotex that Pfizer's patent for fluconazole, an anti-fungal drug for the treatment of serious systemic and superficial infections, was obvious in light of the ICI patent. The claims of the ICI patent were directed generally to a broad class of compounds described as fungicidal triazoles and imidazoles. The ICI 263 patent issued on July 3, 1984, well after the filing date of the Pfizer patent on June 4, 1982. It was not disputed that fluconazole is encompassed within the broad generic scope of the claims of the ICI patent. Justice Richard (as he then was) considered the relationship between the two patents as follows [at paragraphs 34 and 53]:
The ICI Patent is an originating patent while the Pfizer Patent is a selection The former claims the genus; the second claims the species. ICI's 263 Patent is directed generally to fungicidal triazoles and imidazoles. Fluconazole is not specifically described and neither were its superior and previously unknown efficacy described or known. The ICI Patent did not include the fluconazole compound. ICI was not the first inventor of this compound and never made it.
. . .
I find that fluconazole, the subject matter of the Pfizer Patent, has unexpected and valuable properties which are not possessed by the structurally closest compounds disclosed in the ICI Patent . . . .
[63]Accordingly, Justice Richard found that Apotex's allegation of invalidity because of obviousness failed.
[64]As I stated, the situation before me is similar in that:
· the 206 patent involves claims to a broad range of compounds some of which encompass ramipril (similar to the ICI originating patent);
· the 087 patent involves claims to ramipril only (similar to the Pfizer selection patent);
· the 087 and 206 patents have different inventors; and,
· ramipril is significantly more active in inhibiting ACE than any of the stereoisomers of the 206 patent.
Each of the 087 patent for ramipril and the Pfizer patent considered by Justice Richard involve an invention that add "something of a substantial character to existing knowledge" (In re I.G. Farbenindustrie A.G.'s Patents (1930), 47 R.P.C. 289 (Ch. D.), at page 322). Thus, as in the case before Justice Richard, I have a genus patent (the 206 patent) and a selection patent (the 087 patent).
[65]Based on the record before me, I am satisfied that the date of invention of the 206 patent was before the date of invention of either the 457 or the 087 patent. The relevant priority dates are as follows:
· 206 patent--October 23, 1980
· 087 patent--November 5, 1981
· 457 patent--April 12, 1984
[66]The facts of the application before me are not materially different from those considered by Justice Richard. Accordingly, on its face, a claim of obviousness fails.
[67]There are two differences in the case before me that should be examined before I make a conclusive finding. The first is the licence agreement between the patentees; the second, the relative dates of the inventions versus the dates of the issuances.
What is the effect of the licence agreement?
[68]Pharmascience argues that Schering has "enjoyed" the benefits of its patent through the royalties it has received since 1986, the effective date of its licence agreement with Hoescht. The thrust of the submission appears to be that Schering, having benefited from its 206 claim to a patent, should not have recognition for a further period of time.
[69]The problem with this argument is that the rights under a licence agreement are limited and in no way can be compared to the range of protection afforded by a patent and the provisions of the patent legislative scheme. The rights acquired under its agreement by Schering were only enforceable against the other party to the agreement--in this case, Hoechst or its successor in interest, Aventis.
[70]I also note that there was, in 1986, no certainty that the patent would ever issue. The conflict proceedings were still in the future and could have had a different outcome. There was significant risk to Schering, at that time, that the 206 patent might never issue.
[71]While I have evidence that the licence agreement bears an effective date of 1986, I know very little more about it. I do not know when it was entered into. I do not know the consideration. I do not know if other side agreements exist that covered the possibility that the patent would never issue.
[72]In short, I put little weight on the licence agreement as evidence that Schering has had any benefit of the patent since 1986. Whatever benefit it had was limited to one party only and did not alleviate the concern that the patent might never issue.
[73]However, even if the effect of the licence agreement is that Schering and Aventis should be considered as the same patentees, I would attach little significance to that conclusion. As pointed out earlier, the focus is on the inventions making up the claims. There is nothing in the Act to prevent the same patentees from developing new and novel inventions that may then be patented.
What is the date for assessing the obviousness double patenting argument?
[74]An analysis of the Pharmascience argument begins with claims 1, 2, 3, 6 and 12 of the 206 patent. There is no dispute that these claims cover ramipril. Both Professor Ronald H. Kluger, an affiant for Pharmascience, and Dr. David J. Triggle, affiant for Aventis, stated this conclusion.
Evidence of Drs. Kluger and Triggle
[75]Dr. Kluger holds a Ph. D. in organic chemistry and a post-doctoral fellowship in biochemistry. He is currently Associate Chair and Director of Graduate Studies in Chemistry at the University of Toronto. He was asked by Pharmascience to determine if the chemical compound named ramipril was included in the 206, the 087 and the 457 patents and to identify which claims included ramipril. His conclusions can be summarized as follows:
· Claims 1, 2, 3, 6 and 12 of the 206 patent cover ramipril and, since they are not limited to products made by a particular process, they cover ramipril made by any process.
· With respect to the 087 patent, ramipril is included in claims 1, 2, 3, 4, 5 and 6.
· For the 457 patent, claims 1 (subject to the correction of an apparent error), 2, 3 and 8 include ramipril.
· As of March 2001, the date of the grant of the 206 patent, it would have been obvious to any chemist familiar with the chemical structure of ramipril, that claims 1, 2, 3, 6, and 12 of the 206 patent obviously cover the compounds claimed in claims 2, 4 and 6 of the 087 patent.
· As of March 2001, it would have been obvious to any chemist familiar with the chemical structure of ramipril that claims 1, 2, 3, 6 and 12 of the 206 patent obviously cover the composition containing ramipril claimed in claims 1 (if corrected as he suggests), 2, 3 and 8 of the 457 patent.
[76]Dr. Kluger was not cross-examined on his affidavit.
[77]Dr. Triggle holds a Ph. D. in chemistry and is currently a professor at the School of Pharmacy and Pharmaceutical Sciences, State University of New York at Buffalo. He was asked by Aventis to review Pharmascience's NOA and to review the 206 and 087 patents. The significant highlights of his affidavit are as follows:
· While claims 1, 2, 3, 6 and 12 claim a general formula which, with specific substitutions would include ramipril, nowhere in the disclosure or the claims of the 206 patent is there a specific disclosure of the compound ramipril.
· The 206 patent provides no suggestion to a skilled person that the claimed compounds would be useful in the treatment of heart failure.
· The `087 patent provides no suggestion to a skilled person that the claimed compounds are useful in the treatment of heart failure.
· In the case of ramipril, a skilled person could not have predicted in the early 1980s that ramipril would exhibit enhanced biological activity relative to its stereoisomers, including those covered by the 206 patent; nor could a skilled person have predicted the magnitude of any increased activity. Accordingly, while the ramipril stereoisomer falls within the claims of the 206 patent, a skilled person could not have predicted and it would not have been obvious that ramipril would have significantly increased activity relative to its stereoisomers.
[78]Dr. Triggle was not cross-examined on his affidavit.
[79]At first blush, there appears to be a conflict between the findings of Drs. Triggle and Kluger. Dr. Kluger says that it would have been obvious to any chemist familiar with the chemical structure of ramipril, that claims 1, 2, 3, 6, and 12 of the 206 patent obviously cover the compounds claimed in claims 2, 4 and 6 of the 087 patent. On the other hand, Dr. Triggle states that, while the ramipril stereoisomer falls within the claims of the 206 patent, a skilled person could not have predicted, and it would not have been obvious, that ramipril would have significantly increased activity relative to its stereoisomers (the 087 patent) or that the claimed compounds would be useful in the treatment of heart failure (the 457 patent).
[80]This apparent conflict can be easily explained. Dr. Kluger was evaluating the obviousness as of March 2001, the date of the issuance of the 206 patent. In 2001, the claims of the 457 and 087 patents had been known and recognized for over 15 years. What Dr. Kluger has told us is that, if a chemist had the ramipril drug and the information of the two specific patents for ramipril, the chemist could easily come up with the claims of the 206 patent that cover ramipril. His conclusion is not illogical given that the evidence demonstrates that the 087 patent and the 457 patent claims overlap with those of the 206 patent. Dr. Kluger was not asked to express his view of whether the claims of the 206 patent would have been obvious to a chemist in 1981, when the application for the 206 patent was made and when, as the evidence demonstrates, the invention of the genus claims was made. We do not know what opinion he would have expressed on obviousness under that assumption. He may well have agreed with Dr. Triggle.
[81]Dr. Triggle was asked to look at a reference date of 1981. We do not know what opinion he would have expressed on obviousness under the assumption that the relevant date was 2001. He may well have agreed with Dr. Kluger.
[82]What date should be used? Pharmascience's allegation that the 206 claims are invalid on the basis of double patenting is founded on an assessment of obviousness using the patent issue date of March 2001. During oral argument, Pharmascience acknowledged the importance of the 2001 date to its position. If I conclude that the correct reference date is 1981 and not 2001, its argument of double patenting collapses.
[83]Let me try to outline the Pharmascience view of the order of events and the applicability of the double patent argument.
· First, we have the 087 patent that was issued on May 15, 1985.
· Secondly, we have the 457 patent issued on August 15, 1985.
· Finally, we have the 206 patent issued in March 2001, with its claims to compounds that include ramipril which, in 2001 (according to Dr. Kluger), were obvious.
[84]Thus, in Pharmascience's view, we have a situation where Schering is caught in an obviousness double patent bind. The effect, according to Pharmascience, is that Schering, through this evergreening, is keeping generic companies from benefiting from the expired 087 patent to market ramipril for the treatment of hypertension. This situation, in Pharmascience's view, is exactly what Justice Binniehad in mind when he made his comments in Camco.
Date of invention vs. date of patent
[85]In my view, in this case the date of invention and not the date of the patent should be the date used for determining obviousness. The reason for this is that the 206 patent issued under the old patent scheme pre-1982. When faced with a question of obviousness, the Court is required to examine the claims. The claims arise from an invention and not from the grant of the patent. While the patent affirms the claims and provides the patentee with certain rights, it is a statutory mechanism and not one that creates the invention. Thus, it appears logical to analyse the situation based on the relative dates of the invention.
[86]As the Patent Act now operates the problem before me would not arise. However, that is not the scheme under which these patents are operating and I must consider whether there is any argument that would warrant varying the logical unfolding of events.
[87]The most significant of these arguments is that Schering's protection under the 206 patent extends well beyond 17 years after the date of the invention. Assessing the issue of obviousness double patenting as of the date of invention does appear to result in an inequity. As I noted earlier, had the 206 patent issued on or close to the date of invention, it would have expired long ago and Pharmascience would not need to allege non-infringement of the 206 patent.
[88]While recognizing this apparent inequity, I must also consider the situation of Schering in the event that I determine that the correct reference date is 2001. In that case, Schering would not have had the benefit of a patent during the period 1981 to 2001 and would also be stripped of its side of the "bargain" as of 2001. The result would be that the patentee would receive nothing for its invention in respect of the claims that cover ramipril. This would be unfair, particularly when the delays in the issuance of the patent cannot, in any significant way, be attributed to Schering. Schering, unfortunately, was caught by an application of the old rules governing conflict procedures.
In re Braat
[89]The situation before me, where the dates against which obviousness must be assessed are in dispute, has not been considered by Canadian courts. Aventis, however, referred me to an American case of In re Braat, 937 F.2d 589 (Fed. Cir. 1991) which is helpful. Contrary to the assertion of Pharmascience, some guidance may be taken from jurisprudence from another common law jurisdiction even though it is not binding.
[90]The Court of Appeal, in Braat, considered an appeal from a decision of the U.S. Patent and Trademark Office (PTO). The Board of the PTO had rejected the patent claims of Braat on the grounds of obviousness double patenting. The two patent claims in question were the Dil patent which issued June 24, 1980 on an application filed January 31, 1979 and the Braat application, filed July 17, 1978, which claimed priority from a Netherlands patent application filed April 3, 1978.
[91]The PTO examiner and, subsequently, the Board rejected certain of the claims of the Braat application on the basis that the claims of Braat were not patently distinct over relevant claims of the Dil patent.
[92]The Court, in Braat, reversed the decision of the Board. In doing so, they held that a double patenting rejection was sustainable only if the claims of the Dil patent are not patently distinct from the claims of the Braat application. The Court held that a "two-way" determination was required. Not only was the Board obligated to look at whether the claims of Braat were obvious over those of the Dil patent, it had to determine whether the claims of the Dil patent were obvious over the claims of Braat. On the evidence before it, the Court held that the claims of the Dil patent were patentably distinct from the claims of the Braat application and that the double patenting allegation failed. In so concluding, the Court took note of the fact that, it was not the fault of the claimant to the Braat rights that the claims in the Dil patent issued first.
[93]The Court in Braat also acknowledged the fact that the allowance of the Braat application would result in some timewise extension of patent protection for the Dil claims. The Court viewed this as a situation where the extension was justified.
[94]The reasoning of the Court in requiring an analysis of whether the Dil patent claims were obvious over the Braat claims is, in my view, logical. In the application before me, the 087 and 206 patents are in a similar situation in that:
(a) The 087 patent issued before the 206 patent even though the 206 application was filed first; and,
(b) The delay in issuance of the 206 patent was not the fault of Schering.
The application of logic of Braat to this application requires that I assess whether the claims of the 087 patent are obvious over the claims to ramipril in the 206 patent. Dr. Kluger did not carry out this analysis. Only Dr. Triggle addressed this question and concluded that "it would not have been obvious that ramipril would have significantly increased activity relative to its stereoisomers." Neither his qualifications nor his conclusions were contested. Based on his evidence, I conclude that the claims of the 087 patent are not obvious over the claims of the 206 patent. Following the logic of Braat, the argument of obviousness double patenting cannot be sustained.
SUMMARY ON ISSUE No. 2
[95]On this issue, I conclude that the claims of the 206 patent are not invalid on the basis of double patenting. The situation before me is not one of evergreening of the 087 patent. It can more correctly be described as a recognition of the rights of the holder of the 206 patent. Briefly stated, although the concept of double patenting is not necessarily limited to same patentees or inventors, on the facts of this case:
· as of the date of the invention encompassed by the 206 patent claims that cover ramipril, the claims of the 087 patent were not obvious;
· the 087 patent is a selection patent from the 206 patent and is, thus, patentably distinct from the 206 patent;
· the delay in issuance of the 206 patent was not the fault of Schering, the patentee, whose rights to the patent were not fully protected until the patent issued in 2001;
· the extension of the patent rights of Schering for the entire 17-year period of its patent is justified; and
· the licence agreement between Schering and Aventis is of little relevance since the rights held by Schering pursuant to the licence agreement are not equivalent to the patent rights.
[96]Accordingly, the allegation of Pharmascience that its ramipril will not infringe the claims 1, 2, 3, 6 and 12 of the 206 patent is not justified. This is a sufficient basis upon which to allow the application of Schering.
ISSUE No. 3 INFRINGEMENT BY USE OF PHARMASCIENCE'S RAMIPRIL TO TREAT CARDIAC INSUFFICIENCY
[97]As noted above, Pharmascience alleges non-infringement of the 457 patent on the basis that it is not seeking approval for the treatment of cardiac insufficiency. Aventis submits that the generic drug will be used by patients for the treatment of cardiac insufficiency, thereby infringing the 457 patent.
[98]In light of my conclusions that the NOA is inadequate and that the allegation of non-infringement of the 206 patent is not justified, the prohibition sought by Aventis will be granted irrespective of any decision related to the 457 patent. While the question is not moot, it is certainly not determinative of the application before me. The prohibition to be granted will be in effect whatever the decision might be on the merits of Aventis' submissions on this particular issue.
[99]I note that the 457 patent expires in December 2005--long before the expiry of the 206 patent. Thus, any determination of this secondary issue would have applicability for a very short time. Accordingly, there is no need for me to consider this issue.
CONCLUSION
[100]For the above reasons, the application for prohibition will be granted. The Minister will be prohibited from issuing the notice of compliance.
[101]The issue of costs was addressed by the parties at the commencement of the hearing. Having taken into account the submissions of the parties, having regard to the fact that costs should be awarded in favour of the successful parties (Aventis and Schering) and upon considering the factors in awarding costs set out in subsection 400(3) of the Federal Courts Rules [SOR/98-106, r. 1 (as am. by SOR/2004-283, s. 2)], in my discretion I will order that costs be awarded to Aventis and Schering to be assessed in accordance with the following directions:
(1) Costs are to be assessed on the basis of the middle of column III of Tariff B;
(2) Aventis is entitled to costs for second counsel;
(3) Schering is not entitled to costs for second counsel; and
(4) Aventis and Schering are entitled to reasonable disbursements.
[102]In issuing these directions as to costs, I recognize Pharmascience's submission that Aventis and Schering should not both be entitled to costs. However, I have rejected this position on the basis that both parties made substantial contributions to this application. I was assisted greatly by both Aventis and Schering.