Aventis Pharma Inc. v. Apotex Inc.

Aventis Pharma Inc. v. Apotex Inc.
Court (s) Database
Federal Court Decisions
Date
2005-11-04
Neutral citation
2005 FC 1504
File numbers
T-2459-03
Notes
Digest
Decision Content
Date: 20051104
Docket: T-2459-03
Citation: 2005 FC 1504
Ottawa, Ontario, November 4, 2005
PRESENT: MADAM JUSTICE TREMBLAY-LAMER
BETWEEN:
AVENTIS PHARMA INC. and
AVENTIS PHARMA DEUTSCHLAND GmbH
Applicants
and
APOTEX INC. and
THE MINISTER OF HEALTH
Respondents
REASONS FOR ORDER AND ORDER
INTRODUCTION
[1] This is an application by Aventis Pharma Inc. and Aventis Pharma Deutschland GmbH (collectively "Aventis") pursuant to the Patented Medicines (Notice of Compliance) Regulations, SOR/93-133 (the "Regulations") for (i) a declaration that a letter dated November 10, 2003 from Apotex Inc. ("Apotex") is not a Notice of Allegation ("NOA") as contemplated by the Regulations and (ii), in the alternative, an Order prohibiting the Minister of Health (the "Minister") from issuing a Notice of Compliance ("NOC") to Apotex in respect of ramipril oral capsules 1.25, 2.5, 5 and 10 mg until after the expiration of Canadian Patent 1,246,457 (the "'457" patent).
BACKGROUND
a) Previous Proceeding with Respect to the '457 Patent
[2] This is not the first time that Apotex has delivered an NOA in respect of the '457 patent. Approximately three months prior to the delivery of the putative NOA that gave rise to the present proceeding, Apotex served an NOA in August 2003, which became the subject of Court File T-1851-03 and was argued in April 2005 before Simpson J. That decision was released on October 11, 2005.
[3] Whereas the previous proceeding was based on Apotex's allegation that it would not infringe the claims of the '457 patent because its capsules would be made, used and sold solely for the treatment of hypertension, which use is not within the scope of the patent's claims, the within proceeding is based on Apotex's allegation that the claims in issue of the '457 (use to treat cardiac insufficiency) patent are invalid due to anticipation, obviousness and double patenting.
b) Overview of the scientific background
[4] Two conditions are relevant to this proceeding: heart failure and hypertension.
[5] Heart failure (and congestive heart failure), also known as cardiac insufficiency, is the inability of the heart to adequately pump enough oxygenated blood to meet the demands of the body. Heart failure is not a single disease, but rather a syndrome with a variety of origins and manifestations. It can occur in patients with normal blood pressure as well as those exhibiting high blood pressure, i.e. hypertension.
[6] One of the body's systems, the renin-angiotensin ("RAS") system, is known to be important for the treatment of both heart failure and hypertension because the RAS system plays a role in controlling the volume of fluid in the body, maintaining the volume and pressure of blood, and also maintaining arterial blood pressure.
[7] In simple terms, the kidneys are stimulated to produce renin, an enzyme which converts the peptide angiotensinogen (a substance found in the body) into the decapeptide (ten peptide units) angiotensin I ("Ang I"). Another particular enzyme known as angiotensin converting enzyme ("ACE") is responsible for converting Ang I into angiotensin II ("Ang II") (an octapeptide) by cleaving two peptide units. Ang II causes blood vessels to constrict or shrink, thereby raising blood pressure. ACE inhibitors inhibit or prevent the conversion of Ang I to Ang II.
EXPERT EVIDENCE
[8] Aventis filed expert evidence from the following witnesses:
[9] Dr. Gilles Dagenais, a cardiologist at the Québec Heart and Lung Institute Laval Hospital, previously professor and chairman, Department of Medicine, University of Montreal. Dr. Dagenais was co-chair of the HOPE and HOPE II Steering Committees, studies which considered the effects of ramipril in the prevention of heart attacks, stroke and cardiovascular death, heart failure and vascular revascularization.
[10] Dr. Morris Karmazyn, a professor at the University of Western Ontario and Career Investigator, Heart and Stroke Foundation of Ontario. He is also the Director of the Heart and Stroke Foundation of Ontario Program in heart failure.
[11] Dr. Reinhard Becker, a physician-pharmacologist employed by Aventis who introduced the Becker declaration described infra.
[12] Apotex filed expert evidence from the following witnesses:
[13] Dr. Robert McClelland, a professor in the Department of Chemistry at the University of Toronto. He is considered an international expert on Physical Organic Chemistry and Biological Chemistry and has received numerous prestigious awards for his accomplishments in this area. His affidavit served as a primer for the chemical nomenclature and structures in this case.
[14] Dr. Haralambos Gavras, a professor of medicine at Boston University School of Medicine, Boston, M.A. He is also Chief of the Hypertension and Atherosclerosis Section at Boston Medical Center, Director of the Specialized Center of Research in Molecular Genetics of Hypertension, and the immediate-past President of the American Society of Hypertension. He has been involved in a wide range of research related to hypertension, angiotensin, blood pressure maintenance and congestive cardiac failure and has received numerous awards throughout his career for his success. In particular, in February 2004, Dr. Gavras was awarded the Franz Volhard Award from the International Society of Hypertension for his research on the renin-angiotensin system, which award is the highest honour bestowed by the society. He is clearly an expert in the treatment of cardiovascular conditions, including both hypertension and chronic heart failure, the use of ACE inhibitors and the pharmacology of ACE inhibitors.
[15] Dr. John Parker, a professor emeritus of Medicine at Queen's University in Kingston, Ontario and a cardiologist at Kingston General Hospital in Kingston, Ontario (a former Chief Resident in medicine at the Kingston General Hospital). In addition, he was a research fellow in the cardiopulmonary laboratory of the Department of Medicine at Columbia University, New York, New York and a McLaughlin traveling fellow at Broussais Hospital, Paris, France and at the National Heart Hospital, London, England. In 1995, Dr. Parker was awarded the Research Achievement Award from the Canadian Cardiovascular Society for his research in cardiovascular disease. He is thus qualified as an expert in all aspects of the management of cardiac insufficiency (cardiac failure or congestive heart failure).
[16] Both Aventis and Apotex have tried to cast doubt on the credibility of one another's experts. However, I am satisfied that they are all experts in their respective fields and have assigned weight to their evidence according to the appropriate context and not with regard to their possible relationship with the party for whom they are testifying. In my view, if an expert's opinion is properly limited to his area of expertise, it is not appropriate to discount his evidence as self-serving or bias solely on the basis that the expert is an employee of one of the parties. While they may have different views on certain issues, I have found their evidence to be helpful and I see no reason to question their overall credibility.
CONSTRUCTION OF THE PATENT
[17] Construction of patent claims is a matter of law (see: Whirlpool Corp. v. Camco Inc., [2000] 2 S.C.R. 1067. As articulated by Binnie J. in Whirlpool, claims are to be construed in an informed and "purposive" way, read by a person skilled in the art at the date when the patent first became public. This involves an identification by the Court of what the inventor considered to be the "essential" elements of the invention (Whirlpool, ibid., at para. 45).
[18] The patent is not addressed to an ordinary member of the public, but to a worker skilled in the art described by Dr. Harold Fox as:
a hypothetical person possessing the ordinary skill and knowledge of the particular art to which the invention relates, and a mind willing to understand a specification that is addressed to him.
(H.G. Fox, The Canadian Law and Practice Relating to Letters Patent for Inventions, 4th Ed. (Toronto: Carswell Co. Ltd., 1969), cited in Free World Trust v. Électro Santé Inc., [2000] 2 S.C.R. 1024 at para. 44.)
[19] A patent filed under the pre-1989 Patent Act, R.S.C. 1985, c. P-4 (the "old Patent Act") must be construed as of the date of issue: Free World Trust, ibid., at para. 54. The '457 patent was issued on December 13, 1988.
[20] The '457 patent is entitled "Method of Treating Cardiac Insufficiency". The invention relates to compositions for treating cardiac insufficiency by peroral or parenteral use of angiotensin-converting enzyme inhibitors of a general formula ("formula I").
[21] The '457 patent comprises 13 claims. The claims include within their scope pharmaceutical compositions containing ACE inhibitors selected from a class of compounds defined by formula I for treating cardiac insufficiency.
[22] Ramipril is one such ACE inhibitor, amongst others belonging to the class of compounds defined by formula I, covered by claims 1 through 3 of the '457 patent. These ACE inhibitors are also covered by claims 4 through 10 of the patent, with claim 8 specifically claiming pharmaceutical compositions containing ramipril for the treatment of cardiac insufficiency. Claims 11 through 13 relate to the corresponding metabolites of the ACE inhibitors described within claims 4 through 10 (e.g. ramiprilat).
[23] The issue around construction focuses on claim 8 of the '457 patent, which reads:
The composition as claimed in claim 1 containing (S,S,S,S,S)-N-(1-carbethoxy-3-phenyl-propyl)-alanyl-2-azabicyclo[3.3.0]octane-3-carboxylic acid or a pharmaceutically acceptable salt thereof.
[24] While Aventis submits that the invention contained with the '457 patent is the use of ramipril for the treatment of heart failure, it is clear that the patent is not limited to the use of ramipril to treat heart failure. Rather, the patent claims a class of ACE inhibitor compounds useful in the treatment of heart failure, ramipril being one of a number of preferred compounds of the class.
[25] In my view, a person skilled in the art as of the date of issue would read the '457 patent as relating to a new use for known compounds, namely, the use of a class of ACE inhibitor compounds, including ramipril, for the treatment of heart failure.
ISSUES
(a) Abuse of process
(b) Sufficiency of the NOA
(c) Burden and Standard of Proof
(d) Invalidity of the '457 patent
i) Anticipation
ii) Obviousness
iii) Double patenting
ANALYSIS
(a) Abuse of process
[26] Aventis submits that the allegation made by Apotex relates to the same product and the same patent at issue in a proceeding before Simpson J., therefore the present proceeding constitutes an abuse of process.[1]
[27] The doctrine of abuse of process has been recently considered by the Supreme Court of Canada (see Danyluk v. Ainsworth Technologies Inc., [2001] 2 S.C.R. 460; Toronto (City) v. Canadian Union of Public Employees (C.U.P.E.), Local 79, [2003] 3 S.C.R. 77), as well as by this Court in the context of a proceeding under the Regulations (see AB Hassle et al v. Apotex Inc. et al (2005), 38 C.P.R. (4th) 216 (F.C.)).
[28] The doctrine provides the Court with an inherent and residual discretion to prevent the misuse of its procedure. The doctrine is flexible and is "unencumbered by the specific requirements of res judicata": C.U.P.E., supra, at para. 42. Whereas issue estoppel focuses "on the motive or status of the parties, the doctrine of abuse of process concentrates on the integrity of the adjudicate process": C.U.P.E., supra, at para. 51. As explained by Layden-Stevenson J. in AB Hassle, supra, at para. 94:
While critics have argued that when the doctrine of abuse of process is used as proxy for issue estoppel it obscures the true question, while adding nothing but a vague sense of discretion, that is not so. In all of its applications, the primary focus of the doctrine of abuse of process is the integrity of the adjudicative function of courts. The focus is less on the interests of the parties and more on the integrity of judicial decision making as a branch of the administration of justice. When the focus is properly on the integrity of the adjudicative process, the motive of the party who seeks to relitigate cannot be a decisive factor. [emphasis added]
[29] Abuse of process has a strong public policy dimension. Arbour J. in C.U.P.E., supra, stated that the policy grounds for both issue estoppel and abuse of process are essentially the same. At pages 103-104, she quoted from D. J. Lange, The Doctrine of Res Judicata in Canada (2000) at pp. 347-48:
The two policy grounds, namely, that there be an end to litigation and that no one should be twice vexed by the same cause, have been cited as policies in the application of abuse of process by relitigation. Other policy grounds have also been cited, namely, to preserve the courts' and the litigants' resources, to uphold the integrity of the legal system in order to avoid inconsistent results, and to protect the principle of finality so crucial to the proper administration of justice.
[30] In arguing that the current proceeding constitutes an abuse of process, counsel for Aventis relies on Layden-Stevenson J.'s decision in AB Hassle, supra. I find it helpful to review the facts of that case in detail.
[31] In that case, Apotex informed AstraZeneca Canada, by way of a notice of allegation, that it had filed a new drug submission with the Minister of Health for magnesium omeprazole tablets for oral administration in strengths of 10 mg and 20 mg. The patents referred to were owned by AB Hassle and AstraZeneca (collectively, "AstraZeneca"). By application, AstraZeneca sought, inter alia, an order prohibiting the Minister from issuing a notice of compliance until the expiration of the Canadian patent. Only claim 1 of the '693 patent was in issue.
[32] This was not Apotex's first NOA in respect of the '693 patent. Apotex first alleged non-infringement in April 1993. AstraZeneca's application in respect of that allegation was dismissed in May 1996. On December 18, 1997, an Apotex NOA alleged non-infringement of the same Canadian patents in the proceeding before Layden-Stevenson J. By an order dated May 18, 1999, the NOA was deemed to be withdrawn and the application was deemed to be discontinued. Finally, on August 1, 2000, an Apotex NOA with respect to the same Canadian patents as those in the proceeding alleged non-infringement. Kelen J. declared that the NOA did not constitute an NOA under the Regulations and granted an order prohibiting the Minister from issuing a NOC. Apotex appealed. In dismissing the appeal, Rothstein J.A. construed claim 1 of the '693 patent.
[33] On September 26, 2002, Apotex forwarded the NOA at issue in the proceedings before Layden-Stevenson J. to AstraZeneca and alleged both non-infringement and invalidity with respect to the '693 patent.
[34] AstraZeneca submitted that Apotex was precluded from bringing the allegation because it gave rise to issue estoppel. AstraZeneca alleged that the allegation of non-infringement in its NOA in that proceeding turned on the construction of claim 1 as did Apotex's allegation of non-infringement in the previous proceeding. The Federal Court of Appeal had determined the construction issue and Apotex could not relitigate it.
[35] On the issue of whether non-infringement was previously decided on Layden-Stevenson J. concluded that in the previous proceeding, Apotex had alleged non-infringement and could not allege it in the second case.
[36] Insofar as validity was concerned, she accepted AstraZeneca's argument that by alleging only non-infringement in the previous proceeding, Apotex necessarily accepted the validity of the '693 patent because if the patent was not valid, Apotex's formulation could not infringe the patent. She found that Apotex may have been "hiding in the weeds" and splitting its case in two parts. On this, she found issue estoppel to apply.
[37] Ultimately, she decided not to exercise her discretion in Apotex's favour not to apply the doctrine of issue estoppel.
[38] She also held that, if she were wrong in her determination that issue estoppel applied, then Apotex's NOA constituted an abuse of process for substantially the same reasons as the issue estoppel section of her reasons.
[39] With respect, I cannot accept that by alleging only non-infringement in the previous proceeding, Apotex necessarily accepted the validity of the '457 patent because if the patent was not valid, Apotex could not infringe.
[40] The regulatory scheme under the Regulations provides that allegations may be brought on a number of grounds. Subparagraph 5(1)(b)(iv) contemplates allegations that the patent will not be infringed by the second person. Subparagraph 5(1)(b)(iii) contemplates allegations that the patent is not valid.
[41] It is well-established law that multiple allegations are permissible provided that the legal and factual bases underlying each allegation are separate and distinct (see for example: Apotex Inc. v. Canada (Minister of National Health and Welfare) (1997), 76 C.P.R. (3d) 1 (F.C.A.), leave to appeal ref'd, [1998] 1 S.C.R. viii; Bayer AG v. Canada (Minister of National Health and Welfare) (1997), 77 C.P.R. (3d) 129 (F.C.T.D.) at paras. 12-15; Bayer AG et al v. Apotex Inc. et al (1998), 84 C.P.R. (3d) 23 (F.C.T.D.) at paras. 27-28, aff'd., (2001) 14 C.P.R. (4th) 263 (F.C.A.); Bayer Inc. et al v. Canada (Minister of National Health and Welfare) et al (1998), 82 C.P.R. (3d) 359 at paras. 9-14 (F.C.T.D.); AstraZeneca AB v. Apotex Inc. (2005), 335 N.R. 1 (F.C.A.) at para. 21.).
[42] Aventis argues that the second allegation - that of invalidity - could have and should have been raised in the previous proceeding and cites Procter and Gamble Pharmaceuticals Canada, Inc. v. Canada(Minister of Health) (2003), 33 C.P.R. (4th) 193 (F.C.A.). I do not find this argument to be persuasive. That case dealt with the question of whether a patent was eligible for inclusion on the patent register whereas in the present matter, the Court must determine patent validity pursuant to a regulatory scheme where multiple allegations, and consequently multiple proceedings, are provided for as long as the legal and factual bases underlying each are separate and distinct. Moreover, that case was decided on the doctrine of issue estoppel whereas this matter is only concerned with abuse of process.
[43] While the authorities are clear that the second person is not required to make separate and distinct allegations in the same notice, I believe the interest of the adjudicative function of the Court would be better served to proceed as such. If the second person knows of multiple grounds under which they intend to bring an NOA, it would be, in my opinion, more efficient to bring those grounds in a single NOA. While the Regulations do not require this, the Federal Court Rules, 1998, SOR/98-106, indicate that proceedings should be conducted in a just and expeditious manner. To do otherwise undermines the efficiency of the judicial system and the administration of justice.
[44] However, as I have stated above, the decisions of the Federal Court of Appeal have repeatedly held that the distinctive nature of the proceedings contemplated by the Regulations do not preclude a second person from advancing a subsequent allegation that is factually and legally distinct from any prior allegations.
[45] Is then the legal and factual basis underlying the present NOA separate and distinct from the legal and factual basis underlying the NOA in Court File T-1851-03?
[46] The allegation of invalidity in the former proceeding (Court file T-1851-03) was raised only on the conditional basis that if Aventis asserted the use of ramipril to treat hypertension was within the '457 patent, such construction could not be correct as it would invalidate the patent as claiming an old use. Aventis did not adopt that position, thus the conditional allegation of invalidity was not pursued any further. The former proceeding was therefore solely with regard to the issue of infringement of the '457 patent. This allegation is premised on separate and distinct factual and legal issues that have never been determined in a prior proceeding, namely that the '457 patent is invalid based on anticipation, obviousness and double patenting. The Regulations contemplate separate proceedings for multiple allegations.
[47] Thus, Apotex was entitled to serve the second NOA because the second allegation is separate and distinct from the first one. While the first dealt with non-infringement, the second alleges that the patents are invalid based on anticipation, obviousness and double-patenting. The issue of invalidity of the '457 patent is therefore properly before this Court and does not give rise to the doctrine of abuse of process.
(b) Sufficiency of the NOA
[48] The test for determining the sufficiency of an NOA has recently been formulated as follows: "whether [the second person] provided [the first person] with a sufficient understanding of the case it had to meet": Pfizer Canada Inc. v. Novopharm Ltd., [2005] F.C.J. 1318 (C.A.)(QL) at para. 16. Stated differently, "a detailed statement of the bases of an allegation must be sufficiently complete to enable a patentee to make an informed decision as to whether to respond to the allegation by instituting proceedings for an order of prohibition": AstraZeneca AB v. Apotex Inc. (2005), 335 N.R. 1 (F.C.A.) at para. 12, citing AB Hassle v. Canada(Minister of National Health and Welfare) (2000), 7 C.P.R. (4th) 272 (F.C.A ) at para. 21.
[49] Whether an NOA may be deficient due to a lack of particularity of the art is perhaps an open question. However, the fundamental inquiry - whether the first person is informed of the case it has to meet and is not left guessing at the bases for the second person's allegations - remains unchanged.
[50] In the present case, as in AstraZeneca AB, supra, there is no evidence to suggest that Aventis was unable to respond to Apotex's NOA because it lacked particulars. Therefore, in my view, Aventis had a sufficient understanding of the case it had to meet. The NOA is not deficient.
(c) Burden and standard of proof
[51] The burden of proof as to validity in proceedings under the Regulations has been discussed at length. It is well-established that the legal burden or persuasive burden rests with the applicant to refute the allegations set forth by the second person in its NOA. Aventis must establish on a balance of probabilities, that Apotex's allegations are not justified. However, while Aventis bears the overall legal burden of establishing its entitlement to the order sought, Apotex has an evidentiary burden to put the allegations set out in its NOA "in play": see Merck Frosst Canada Inc. v. Canada (Minister of National Health and Welfare) (1994), 55 C.P.R. (3d) 302 (F.C.A.) at pages 319-20, and the recent commentaries thereon in SmithKline Beecham Pharma Inc. v. Apotex Inc., [2001] 4 F.C. 518 (T.D.), aff'd. [2003] 1 F.C. 118 (F.C.A.) and in Janssen-Ortho Inc. v. Novopharm Ltd. (2004), 264 F.T.R. 202.
[52] In discharging its burden, Aventis is entitled to the rebuttable presumption that a patent is valid: see section 45 of the old Patent Act, subsection 43(2) of the new Patent Act, R.S.C. 1985, c. P-4. In Proctor & Gamble Pharmaceuticals Canada Inc. v. Canada (Minister of Health), [2005] 2 F.C.R. 269, Rothstein J.A., relying on the decision in Bayer Inc. v. Canada (Minister of National Health and Welfare) (2000), 6 C.P.R. (4th) 285 as the governing authority with regard to burden and standard of proof, stated at paragraphs 15 and 16:
[15] [...] in Bayer v. Canada(Minister of National Health and Welfare) (2000), 6 C.P.R. (4th) 285 (F.C.A.) which, on this point, is the governing authority. In Bayer, Sharlow J.A. dealt with the burdens of proof on the patentee and the generic in proceedings under the Regulations. She explained that the patentee, being the applicant for the order of prohibition, bears the burden of establishing its entitlement to the order sought. Subsection 43(2) of the Patent Act, R.S., c. P-4, s. 1, as amended, provides that "After the patent is issued, it shall, in the absence of any evidence to the contrary, be valid and avail the patentee..." Sharlow J.A. observed that because of that presumption of validity, the generic, as the party responding to the application for a prohibition order, has the burden of proof to displace the presumption.
[16] As to the standard of proof, at paragraph 9, she wrote:
The operation of the statutory presumption in the face of evidence of invalidity depends upon the strength of the evidence. If the evidence proves, on a balance of probabilities that the patent is invalid, the presumption is rebutted and is no longer relevant
Therefore, the standard of proof applicable to proving invalidity has been found to be proof on a balance of probabilities. [...]
[53] Aventis accepts that it bears the ultimate legal burden to convince the Court that it is entitled to the order sought. However, it relies on the Supreme Court of Canada's decision in Apotex Inc. v. Wellcome Foundation Ltd., [2002] 4 S.C.R. 153 in support of its argument that, in a proceeding under the Regulations, I should apply a higher threshold and find that the burden of showing invalidity lies on the person challenging the patent. The Supreme Court, in that case, found that the appropriate standard of review with regard to a finding of invalidity in a patent infringement action was reasonableness simpliciter, i.e. that the Commissioner's decision must withstand a somewhat probing examination. Aventis argues that this standard applies equally to NOC proceedings.
[54] In Pfizer Canada Inc. v. Canada(Minister of Health), [2005] F.C.J. No. 1607 (F.C.)(QL), Heneghan J. rejected a similar argument at paragraph 57:
¶ 57 In my opinion, the Applicants' reliance on Apotex v. Wellcome, supra, in relation to the question of the burden of proof is not well-founded. That decision came from an action involving issues of patent impeachment and infringement. The present proceeding is a summary proceeding pursuant to the NOC Regulations and the Federal Court Rules, 1998, supra governing application for judicial review. Again, a finding of invalidity or infringement, for the purposes of this kind of proceeding is not determinative of that issue in any subsequent action; see Pharmacia Inc. v. Canada (Minister of National Health and Welfare) (1994), 58 C.P.R. (3d) 209 (F.C.A.) at page 216 where the Court said as follows:
...these proceedings are not actions for determining validity or infringement: rather they are proceedings to determine whether the Minister may issue a notice of compliance. That decision must turn on whether there are allegations by the generic company sufficiently substantiated to support a conclusion for administrative purposes (the issue of a notice of compliance) that the applicant's patent would not be infringed if the generic's product is put on the market....
[55] I agree with this reasoning. Thus, in my opinion, it would be inappropriate to apply a standard used for actions involving patent infringement to proceedings under the Regulations.
[56] In conclusion, while the legal burden rests with Aventis, Apotex must prove, on a balance of probabilities, by the evidence supporting its allegations in the NOA, that the '457 patent is invalid. Having determined the burden and standard of proof, I now turn to consider the issue of invalidity of the '457 patent.
(d) Invalidity of the '457 Patent
(i) Anticipation
[57] In alleging that the claim is invalid based on anticipation, Apotex submits that the invention embodied by the '457 patent was anticipated by four pieces of prior art: European Patent Application No. 50 800 A1 (the "'800 application"); the Journal of Cardiovascular Pharmacology (1983) 5: 643-654; European Patent Application No. 49 658 A1 (the "'658 application"); and a presentation to the American Society for Pharmacology and Experimental Therapeutics ("ASPET presentation").
[58] With respect to the '800 application, Apotex highlights the phrase that compounds covered by the invention are "useful in the treatment of cardiovascular
disorders and particularly mammalian hypertension". Apotex submits that a person skilled in the relevant art at the relevant time would have known that the term "cardiovascular disorders" included heart failure. While the '800 application does not specifically disclose ramipril per se, ramipril is included within the class of compounds claimed in the '800 application. As such, the '800 application taught that the use of the compounds of its invention, including ramipril, would be useful in the treatment of heart failure.
[59] The other anticipating documents, Apotex submits, each teach and disclose compounds that fall within the scope of the claims of the '457 patent and indicate that ACE inhibitor compounds are useful for the treatment of cardiac insufficiency. Claim 8 of the '457 patent, which specifically claims ramipril, is also anticipated in Apotex's view in that inventive ingenuity is not required to recognize that the ACE inhibitor compound ramipril can be functionally substituted for any of the other members of the class of compounds of formula I.
[60] Regarding the lack of clinical data, Apotex submits that by demanding human clinical trials, Aventis is attempting to elevate the standard to a regulatory approval standard. That is not the standard of patentability or anticipation, however, as borne out by the fact that the '457 patent itself does not include a reference to clinical testing in humans.
[61] Aventis submits that Apotex's approach to anticipation is plainly wrong in law. Apotex relies upon a class effect theory, and attempts to ascribe to ramipril the effects seen with other ACE inhibitors as disclosed in the prior art even though ramipril is neither disclosed nor claimed in that prior art (apart from the "'800 application"). In effect, Apotex argues that another compound was known for that use, ramipril is a member of that class and therefore anticipation is established. This approach, if sanctioned, would allow Apotex to broaden anticipation into an obviousness analysis.
[62] Insofar as the '800 application is concerned, Aventis submits that, according to its experts, the phrase "cardiovascular disorders" would not be understood by the person skilled in the art as meaning cardiac insufficiency. Moreover, Apotex's reliance on this statement conveniently ignores the particular reference to hypertension and the fact that cardiovascular disorders encompass a broad range of conditions. In short, ramipril is not specifically disclosed or claimed in the '800 application, nor is the use of heart failure disclosed or supported by data.
[63] Finally, Aventis contends thatthe '658 application and the Journal of Cardiovascular Pharmacology referenced by Apotex also lack testing data, and the ASPET presentation pertained to a hemodynamic study (a preclinical heart failure model in a dog) as opposed to a clinical trial with humans.
[64] Having set out the positions of the parties, I will now review the principles underlying the law of anticipation before turning to consider the application of those principles to the facts in the case at bar.
[65] Anticipation is a statutory doctrine which provides that that which is claimed lacks novelty. Subsections 27(1) and 61(1) of the old Patent Act, supra, are relevant to the issue of anticipation. They provide as follows:
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,
(b) not described in any patent or in any publication printed in Canada or in any other country more than two years before presentation of the petition hereunder mentioned, and
(c) not in public use or on sale in Canada for more than two years prior to his application in Canada,
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.
61. (1) No patent or claim in a patent shall be declared invalid or void on the ground that, before the invention therein defined was made by the inventor by whom the patent was applied for, it had already been known or used by some other person, unless it is established that
(a) that other person had, before the date of the application for the patent, disclosed or used the invention in such manner that it had become available to the public;
(b) that other person had, before the issue of the patent, made an application for patent in Canada on which conflict proceedings should have been directed; or
(c) that other person had at any time made an application in Canada which, by virtue of section 28, had the same force and effect as if it had been filed in Canada before the issue of the patent and on which conflict proceedings should properly have been directed had it been so filed.
27. (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'exclusive propriété d'une invention qui n'était pas :
a) connue ou utilisée par une autre personne avant que lui-même l'ait faite;
b) décrite dans un brevet ou dans une publication imprimée au Canada ou dans tout autre pays plus de deux ans avant la présentation de la pétition ci-après mentionnée;
c) en usage public ou en vente au Canada plus de deux ans avant le dépôt de sa demande au Canada.
61. (1) Aucun brevet ou aucune revendication dans un brevet ne peut être déclaré invalide ou nul pour la raison que l'invention qui y est décrite était déjà connue ou exploitée par une autre personne avant d'être faite par l'inventeur qui en a demandé le brevet, à moins qu'il ne soit établi que, selon le cas :
a) cette autre personne avait, avant la date de la demande du brevet, divulgué ou exploité l'invention de telle manière qu'elle était devenue accessible au public;
b) cette autre personne avait, avant la délivrance du brevet, fait une demande pour obtenir au Canada un brevet qui aurait du donner lieu à des procédures en cas de conflit;
c) cette autre personne avait à quelque époque fait au Canada une demande ayant, en vertu de l'article 28, la même force et le même effet que si elle avait été enregistrée au Canada avant la délivrance du brevet et pour laquelle des procédures en cas de conflit auraient dû être régulièrement prises si elle avait été ainsi enregistrée.
[66] The test for anticipation is difficult to meet. As Binnie J., reiterated in Free World Trust v. Électro Santé Inc., supra at para. 26, quoting from General Tire & Rubber Co. v. Firestone Tyre & Rubber Co., [1972] R.P.C. 457 (Eng. C.A.), at p. 486:
A signpost, however clear, upon the road to the patentee's invention will not suffice. The prior inventor must be clearly shown to have planted his flag at the precise destination before the patentee.
[67] The prior disclosure must clearly and unmistakably lead the skilled person to the patent-in-suit, as Hugessen J.A. remarked in Beloit Canada Ltd. et al v. Valmet OY (1986), 8 C.P.R. (3d) 289 (F.C.A.) at paragraph 30:
[...] One must, in effect, be able to look at a prior single publication and find in it all the information which, for practical purposes, is needed to produce the claimed invention without the exercise of any inventive skill. The prior publication must contain so clear a direction that a skilled person reading and following it would in every case without possibility of error be led to the claimed invention. [...]
This test was cited with approval by the Supreme Court in Free World Trust, supra.
[68] It is not enough to select portions from more than one document to form a mosaic of information. Anticipation is not directed to the state of the art and common general knowledge at the time (see Beloit, supra). Additionally, when more than one result is possible, it cannot be said that the skilled person would arrive at the invention "in every case" or that the result is "inevitable" (see Reeves Brothers Inc. v. Toronto Quilting & Embroidery Ltd. (1978), 43 C.P.R. (2d) 145 (F.C.T.D.)).
[69] In the present matter, does any one of the documents of prior art contain so clear a direction that a skilled person would in every case and without possibility of error be led to the claimed invention?
[70] As stated above, Apotex relies on four documents to show anticipation: the '800 application; the Journal of Cardiovascular Pharmacology; the '658 application; and the ASPET presentation.
[71] In my opinion, Apotex has failed to show that any one of the four documents that it refers to satisfies the test for anticipation.
[72] Apotex argues that another compound of a class was known to treat heart failure, ramipril is a member of the class, and therefore anticipation is established. This argument, while it may be applicable to the test for obviousness, is irrelevant to the anticipation inquiry. I agree with Aventis that Apotex cannot rely on the Journal of Cardiovascular Pharmacology; the '658 application; and the ASPET presentation, which involved different compounds, albeit of the same class as ramipril (i.e. ACE inhibitors), to show anticipation. To do so would effectively nullify the distinction between anticipation, which asks whether a skilled person would be able to perform the invention based upon a single prior publication, and obviousness, which asks whether a skilled person would have known how to arrive at the invention based upon the state of the art and of common general knowledge at the relevant time (see Beloit, supra).
[73] To allow an anticipation argument based on these three documents would require the skilled person reading them, and following each in isolation, to assume that ramipril could have been substituted for the compounds used therein. This assumption may constitute the common general knowledge at the relevant time (i.e. the obviousness inquiry) but none of these three documents, on its own, would lead the skilled person, inevitably and in every instance, to perform the invention. Where more than one result is possible, anticipation has not been established.
[74] I found that Apotex's experts based their opinions on whether one could predict that ramipril would be useful in treating heart failure given the general state of the prior art, an obviousness inquiry, as opposed to whether such use was specifically disclosed in a single reference. In this regard, I assign weight to Dr. Parker's admission that he looked to multiple documents to form his opinion on anticipation. Dr. Parker, when cross-examined on anticipation, answered:
I am looking at the rather healthy file of data prior to 1984 about such drugs as captopril and enalapril, and some of ramipril, showed that this class of drugs was effective in improving symptoms, and also we reviewed a patent, Canadian patent '500, I think it is, 1980, and the European patent, which identified in those documents the role of ACE inhibitors in cardiac insufficiency, heart failure.
It would seem to me, as a non-lawyer, that there was anticipation; from the data there in the literature, plus these two previously existing patents, that there was anticipation in terms of bene