Aventis Pharma Inc. v. Pharmascience Inc.

Aventis Pharma Inc. v. Pharmascience Inc.
Court (s) Database
Federal Court Decisions
Date
2005-03-11
Neutral citation
2005 FC 340
File numbers
T-482-03
Notes
Reported Decision
Decision Content
Date: 20050311
Docket: T-482-03
Citation: 2005 FC 340
Ottawa, Ontario, this 11th day of March, 2005
PRESENT: THE HONOURABLE MADAM JUSTICE SNIDER
BETWEEN:
AVENTIS PHARMA INC. and AVENTIS
PHARMA DEUTSCHLAND GmbH
Applicants
- and -
PHARMASCIENCE INC. and THE MINISTER OF HEALTH
Respondents
- and -
SCHERING CORPORATION
Respondent/Patentee
REASONS FOR ORDER
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)
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Regulations(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 Pharm 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 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 1,187,087 (the "'087 patent") which covered the use of ramipril for the treatment of hypertension and which expired November 4, 2002.
_ Canadian Patent 1,246,457 (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.
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_ Canadian Patent 1,341,206 (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 s. 5(1) 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.
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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.
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Canadian Patent 1,341,206 ("'206 patent")
[8] The '206 patent is entitled "Carboxyalkyl Dipeptides, Processes for Their Production and Pharmaceutical Compositions Containing Them". The patent relates to compounds (carboxyalkyldipeptides) which are useful as angiotensin-converting enzyme ("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 carboxyalkyldipeptides 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.
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_ 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.
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[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
EVENT
October 20, 1981
Application filed.
March 1, 1984
First office Action issued.
May 16, 1984
Response to first office Action.
Between 1985 and 1990
Schering filed five requests for status.
May 2, 1990
Second office Action issued.
August 2 and 3, 1990
Schering filed response (August 2) and supplementary (August 3).
December 27, 1990
Third office Action issued.
April 24, 1991
Response to third office Action.
January 21, 1992
Schering filed a sixth request for status.
January 22, 1993
Commissioner declared a conflict with 4 other applications (including one by Hoechst, the owner of the now expired '087 patent).
May 5, 1993
Commissioner reissued conflict notice.
August 8, 1996
Commissioner declared Schering to be the first to invent all the conflict claims to which it was a party.
January 10, 1997
The parties in conflict with Schering filed an appeal.
December 2000
The matter is settled shortly before the trial in Federal Court.
March 20, 2001
'206 patent issued.
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[11] While the conflict proceedings placed thirteen 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 1,187,087 ("'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.
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_ 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
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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 the 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.
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Canadian Patent 1,246,457 ("'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 lead to the conclusion that the compounds of the '457 patent would be useful in the treatment of heart failure".
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[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 (the "Act") as it read immediately before the October 1, 1989 amendments. Section 27(1)(a) of the Act provided that:
27.1 (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.
27.1 (1) Sous réserve des autres dispositions du présent article, l'auteur de toute invention ou le représentant légal de l'auteur d'une invention peut, sur présentation au commissaire d'une pétition exposant les faits, appelée dans la présente loi le « dépôt de la demande » , et en se conformant à toutes les autres prescriptions de la présente loi, obtenir un brevet qui lui accorde l'exclusivité propriété d'une invention qui n'était pas:
a) connue ou utilisée par une autre personne avant que lui-même l'ait faite;
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[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, s. 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 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.
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ISSUE #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.
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General
[29] Section 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.
5.(1) Lorsqu'une personne dépose ou a déposé une demande d'avis de conformité pour une drogue et la compare, ou fait référence, à une autre drogue pour en démontrer la bioéquivalence d'après les caractéristiques pharmaceutiques et, le cas échéant, les caractéristiques en matière de biodisponibilité, cette autre drogue ayant été commercialisée au Canada aux termes d'un avis de conformité délivré à la première personne et à l'égard de laquelle une liste de brevets a été soumise, elle doit inclure dans la demande, à l'égard de chaque brevet inscrit au registre qui se rapporte à cette autre drogue :
a) soit une déclaration portant qu'elle accepte que l'avis de conformité ne sera pas délivré avant l'expiration du brevet;
b) soit une allégation portant que, selon le cas :
(i) la déclaration faite par la première personne aux termes de l'alinéa 4(2)c) est fausse,
(ii) le brevet est expiré,
(iii) le brevet n'est pas valide,
(iv) aucune revendication pour le médicament en soi ni aucune revendication pour l'utilisation du médicament ne seraient contrefaites advenant l'utilisation, la fabrication, la construction ou la vente par elle de la drogue faisant l'objet de la demande d'avis de conformité.
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[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] F.C.J. No. 855, at paras. 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, [2003] F.C.J. No. 1910 at para. 189).
[32] As I stated in Pfizer Canada Inc. v. Apotex Inc. [2004] F.C.J. No. 326, at para. 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 at 81 (F.C.T.D.), aff'd (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.
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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. Jeanette 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:
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¼ 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 where 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.
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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.
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[41] There is no dispute that ramipril metabolizes to ramiprilat when administered to patients. As indicated in Pharmascience's Product Monograph, ramipril is rapidly hydrolzed 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 s. 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
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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 #2: DOUBLE PATENTING
[44] As Justice Binnie for the Supreme Court of Canada stated in Apotex Inc. v. Wellcome Foundations Ltd. (2002), 21 C.P.R. (4th) 499 at para. 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 para. 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
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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 para. 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" must be the claims 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. v. Procter & Gamble Co. (1982), 61 C.P.R. (2d) 1, at p. 22. He referred to this as "same invention" double patenting.
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[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 paras. 66 to 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, 41 C.P.R. 9, 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.]
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In Consolboard, supra, Dickson J. referred to Farbwerke Hoechst as "the main authority on double 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 para. 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
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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 para. 37, Justice Binnie stated the following:
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[T]he 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 the statutory 17 years from the date of the filing of the patent grant (now 20 years from the date of the filing 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" (Camco, at para. 37); he would have received "something for nothing" (Free World Trust v. Électro Santé, Inc. [2000] 2 S.C.R. 1024, at para. 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 Canada (Commissioner of Patents) v. Farbwerke Hoechst Aktien - Gesellschaft Vormals Meister Lucius & Bruning, [1964] S.C.R. 49; 41 C.P.R. 9. 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.
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[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 v. Apotex (1997) 77 C.P.R. (3d) 547. That case involved an allegation by Apotex that Pfizer's patent for flucanazole, 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
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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:
The ICI patent is an originating patent while the Pfizer patent is a selection ¼ 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);
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_ the '087 patent involves claims to ramipril only (similar to the Pfizer (a 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