Sanofi-Aventis Canada Inc. et al. v. Apotex Inc., 2009 FC 676

• Judge: Snider, J.
• Court: Federal Court (Canada)
• Case Date: April 15, 2009
• Jurisdiction: Canada (Federal)
• Citations: 2009 FC 676;(2009), 350 F.T.R. 165 (FC)

Sanofi-Aventis Can. v. Apotex Inc. (2009), 350 F.T.R. 165 (FC)

MLB headnote and full text

Temp. Cite: [2009] F.T.R. TBEd. AU.035

Sanofi-Aventis Canada Inc., Sanofi-Aventis Deutschland GmbH and Schering Corporation (plaintiffs) v. Apotex Inc. (defendant)

Apotex Inc. (plaintiff by counterclaim) v. Sanofi-Aventis Canada Inc. and Schering Corporation, Sanofi-Aventis Deutschland GmbH and Ratiopharm Inc. (defendants by counterclaim)

Sanofi-Aventis Canada Inc., Schering Corporation and Sanofi-Aventis Deutschland GmbH (plaintiffs) v. Novopharm Limited (defendant)

Novopharm Limited (plaintiff by counterclaim) v. Sanofi-Aventis Canada Inc., Schering Corporation and Sanofi-Aventis Deutschland GmbH (defendants by counterclaim)

(T-161-07; T-1161-07; 2009 FC 676)

Indexed As: Sanofi-Aventis Canada Inc. et al. v. Apotex Inc.

Federal Court

Snider, J.

June 29, 2009.

Summary:

The plaintiffs were the owner and a licensee of Canadian Patent No. 1,341,206 (the '206 patent). The plaintiffs sued Apotex Inc. and Novopharm Ltd. (the defendants) for infringement of the patent. The defendants defended and counterclaimed, asserting that the '206 patent was invalid on a number of grounds.

The Federal Court dismissed the action and allowed the counterclaim. The defendants had infringed certain claims of the '206 patent. However, the court found that claims 1, 2, 3, 6 and 12 of the '206 patent were invalid.

Patents of Invention - Topic 1002

The specification and claims - General - Scope of - The plaintiffs were the owner and a licensee of Canadian Patent No. 1,341,206 (the '206 patent) - The plaintiffs sued Apotex Inc. and Novopharm Ltd. (the defendants) for infringement of the patent - The defendants defended and counterclaimed, asserting that the '206 patent was invalid on a number of grounds - The defendants submitted that the inventors failed to disclose the best (and only) method known to them to actually make the 5,5 bicyclic compounds when they filed the patent application - They argued that the inventors' failure to disclose the "best mode" of putting the invention into practice was a breach of its obligations under s. 34(1) of the Patent Act - The Federal Court rejected the argument - The first problem with the defendants' argument was with the use of the "best mode" requirement in respect of a patent to a medicinal compound - Section 34 of the Patent Act set out the requirements for the specification in a patent - The "best mode" obligation only arose in the case of a patent to a machine - Neither the words nor the underlying concept that a patentee had to set out the best available manner of putting the invention into practice were used elsewhere in s. 34(1) or in the Patent Act - Reading such a requirement into non-machine patents would be contrary to the principles of statutory interpretation - Further, even if the notion of "best mode" was applicable, the jurisprudence raised another difficulty - The best mode obligation, even if it applied, would not have required the inventors to disclose the better synthesis method in its specification - See paragraphs 321 to 333.

Patents of Invention - Topic 1026

The specification and claims - Construction of a patent - General - The plaintiffs were the owner and a licensee of Canadian Patent No. 1,341,206 (the '206 patent) - The plaintiffs sued Apotex Inc. and Novopharm Ltd. (the defendants) for infringement of the patent - The defendants defended and counterclaimed, asserting that the '206 patent was invalid on a number of grounds - The Federal Court stated that "[c]onstruction of the claims is a matter for the court to determine. The court is called on to determine, on an objective basis, what a hypothetical skilled person would have understood the inventor to mean ... Where a patent is of a highly technical nature, the person skilled in the art will be someone possessing a high degree of expert scientific knowledge and skill in the particular branch of the science to which the patent relates ... The court should construe the claims in light of the description in the specification, assisted, where necessary, by experts as to the meaning of technical terms, if they cannot be understood by the court from reading the specification ... It is also important to recognize that purposive construction should be directed at the points at issue between the parties ... Lastly, as the '206 patent was issued under the old Patent Act, all claims at issue are to be construed as of the date of issue and grant of the patent" - See paragraphs 79 to 83.

Patents of Invention - Topic 1582

Grounds of invalidity - Lack of "inventive ingenuity" (obviousness) - Test for obviousness - The plaintiffs were the owner and a licensee of Canadian Patent No. 1,341,206 (the '206 patent) for ramipril (an ACE inhibitor), used in the drug ALTACE, which was used primarily in the treatment of high blood pressure and cardiac insufficiency - The plaintiffs sued Apotex Inc. and Novopharm Ltd. (the defendants) for infringement of the patent - The defendants defended and counterclaimed, asserting that the '206 patent was invalid on the ground of, inter alia, obviousness - The Federal Court held that the '206 patent was invalid for obviousness - Firstly, the work done by others, as disclosed in a series of scientific papers would have been part of the common general knowledge - Secondly, the skilled worker would also look to work done by others in respect of enalapril - Thirdly, a person of ordinary skill in the art would have been aware of a publication by Fisher and Ryan which suggested that there might be an advantage, in terms of potency, to making the proline ring at the C-terminus more conformationally rigid rather than more flexible - Fourthly, the skilled person could be presumed to be aware of patent applications filed in the same area of research - Fifthly, the literature of the day included a series of work, which taught that there was sufficient volume for groups larger than the proline ring at the ACE active site, including bicyclic rings - Consequently, based on the general knowledge available to the skilled person, it would have been more or less self-evident that a 5,5-bicyclic ring substituted for the proline moiety of the enalapril molecule ought to work, particularly where the molecule is in an all-S configuration - The 5,5 ring would be one of a relatively small class of choices that would be predictable to a person skilled in the art - The effort, nature and amount of effort required to achieve the invention would not be insignificant - However, there were known methods of synthesis available to the skilled person to make, separate and test the targeted compounds - See paragraphs 288 to 320.

Patents of Invention - Topic 1584

Grounds of invalidity - Lack of "inventive ingenuity" (obviousness) - Chemical processes - [See Patents of Invention - Topic 1582 ].

Patents of Invention - Topic 1589

Grounds of invalidity - Lack of "inventive ingenuity" (obviousness) - Particular patents - [See Patents of Invention - Topic 1582 ].

Patents of Invention - Topic 1591

Grounds of invalidity - Lack of "inventive ingenuity" (obviousness) - Time to determine obviousness (incl. date of invention) - The plaintiffs were the owner and a licensee of Canadian Patent No. 1,341,206 (the '206 patent) - The plaintiffs sued Apotex Inc. and Novopharm Ltd. (the defendants) for infringement of the patent - The defendants defended and counterclaimed, asserting that the '206 patent was invalid on the ground of, inter alia, obviousness - The Federal Court held that "[o]bviousness must be assessed as of the date of the invention. In the absence of proof of an earlier invention date, the date of invention is presumed to be the first priority date ... Should a party wish to assert an earlier date, that party bears the burden of establishing that the date of invention was different than the first priority date ... the date of invention will be the date on which the inventor can demonstrate three things: 1. the invention is identified; 2. the invention has been reduced to writing: and 3. the invention is 'practical' in that it will do the job that is claimed; in other words, it will have utility." - In this case, the court held that it was appropriate to address the question of obviousness as of the first priority date, i.e., October 23, 1980, when the U.S. patent application was filed - See paragraphs 269 to 287.

Patents of Invention - Topic 1621

Grounds of invalidity - Not true or first inventor - General - The plaintiffs were the owner and a licensee of Canadian Patent No. 1,341,206 (the '206 patent) for ramipril (an ACE inhibitor), used in the drug ALTACE, which was used primarily in the treatment of high blood pressure and cardiac insufficiency - The plaintiffs sued Apotex Inc. and Novopharm Ltd. (the defendants) for infringement of the patent - The defendants defended and counterclaimed, asserting that the '206 patent was invalid on the ground that, inter alia, the inventors were not the first to invent ramipril - The defendants argued that because the inventors did not isolate and test ramipril before Hoeschst (the '087 patent), scientists at Hoeschst were the first inventors of ramipril - The Federal Court rejected the assertion - The defendants' proposition required an interpretation of the jurisprudence that was not sustainable - Further, assuming, for purposes of this issue, that the requirements of sound prediction had been met by the inventors, the date of invention was either August 8, 1980 or October 23, 1980 - The only evidence that the court had of an invention date for the subject matter of the '087 patent was that the Canadian filing date of the application was November 4, 1982, a date well after the invention disclosed in the '206 patent - On these facts, the court found that the invention of the compounds of the invention included in the '206 patent, including ramipril, was invented prior to the date of invention of the subject matter of the '087 patent - See paragraphs 350 to 354.

Patents of Invention - Topic 1674

Grounds of invalidity - Lack of novelty - Prior invention (incl. double patenting) - The plaintiffs were the owner and a licensee of Canadian Patent No. 1,341,206 (the '206 patent) - The plaintiffs sued Apotex Inc. and Novopharm Ltd. (the defendants) for infringement of the patent - The defendants defended and counterclaimed, asserting that the '206 patent was invalid on the ground of, inter alia, double patenting over the invention described and claimed in claims 2 and 4 of the '087 patent issued to Hoeschst, a predecessor to one of the plaintiffs - The Federal Court noted that the jurisprudence identified two categories of double patenting - The court stated that "in the first category, 'same invention double patenting', two patents are the same or have an identical or conterminous claim. The second category, 'obviousness double patenting', is somewhat broader. In obviousness double patenting, the claims of the patents are not identical or conterminous, but the later patent has claims that are not patentably distinct from the other patent, or involve no novelty or ingenuity. Since the claims of the '206 patent are not identical or conterminous with the claims of the '087 Patent, the invalidity allegation in this case must be understood as an allegation of obviousness double patenting" - See paragraph 337.

Patents of Invention - Topic 1674

Grounds of invalidity - Lack of novelty - Prior invention (incl. double patenting) - The plaintiffs were the owner and a licensee of Canadian Patent No. 1,341,206 (the '206 patent) - The plaintiffs sued Apotex Inc. and Novopharm Ltd. (the defendants) for infringement of the patent - The defendants defended and counterclaimed, asserting that the '206 patent was invalid on the ground of, inter alia, double patenting over the invention described and claimed in claims 2 and 4 of the '087 patent issued to Hoeschst, a predecessor to one of the plaintiffs - The Federal Court rejected the argument - The specific question of double patenting with respect to the '206 patent and the '087 patent was considered and rejected in a number of cases - It was undisputed that the priority filing date of the '206 patent was earlier than that of the '087 patent - Finally, the inventors and owners of the '087 patent were different from the inventors and owner of the '206 patent - There was no corporate relationship between the owners of the respective patents - Although the court previously considered and rejected the notion that double patenting could only exist where patents were owned by the same parties, subsequent jurisprudence had consistently assumed that double patenting could only arise where the two patents were held by the same parties - See paragraphs 334 to 343.

Patents of Invention - Topic 1721

Grounds of invalidity - Lack of utility and operability - General - The plaintiffs were the owner and a licensee of Canadian Patent No. 1,341,206 (the '206 patent) - The plaintiffs sued Apotex Inc. and Novopharm Ltd. (the defendants) for infringement of the patent - The defendants defended and counterclaimed, asserting that the '206 patent was invalid on the ground of, inter alia, lack of utility - The Federal Court discussed the general principles of the concept of utility and stated that "To begin, the overarching concept is that, as of the relevant date, there must have been a demonstration of utility of the invention or, lacking that, a sound prediction of utility based on the information and science available at the time of the prediction ... the defendants bear the burden. To demonstrate lack of utility, the defendants must show 'that the invention will not work, either in the sense that it will not operate at all or, more broadly, that it will not do what the specification promises that it will do' ... there are a number of other guiding posts: Where the specification does not promise a specific result, no particular level of utility is required - a 'mere scintilla' of utility will suffice ... where the specification sets out an explicit 'promise', utility must be measured against that promise ... Utility does not depend upon marketability ... The relevant date has been held to be the filing of the Canadian patent application ... Where a claim is to a class of compounds, lack of utility of one or more of the compounds will invalidate all of the compounds of that particular claim" - See paragraphs 142 to 145.

Patents of Invention - Topic 1723

Grounds of invalidity - Lack of utility and operability - Chemical products and substances intended for food and medicine - [See second, third and fourth Patents of Invention - Topic 1724 ].

Patents of Invention - Topic 1724

Grounds of invalidity - Lack of utility and operability - Doctrine of sound prediction - The plaintiffs were the owner and a licensee of Canadian Patent No. 1,341,206 (the '206 patent) - The plaintiffs sued Apotex Inc. and Novopharm Ltd. (the defendants) for infringement of the patent - The defendants defended and counterclaimed, asserting that the '206 patent was invalid on the ground of, inter alia, lack of utility - The Federal Court discussed the general principles of the concept of utility and stated that "The doctrine of sound prediction can be relied upon by an inventor to justify patent claims whose utility has not actually been demonstrated, but can be soundly predicted based upon the information and expertise available ... a three-part test ... must be satisfied in order to establish that a sound prediction has been made by the inventor. The three elements of the test are: 1. There must be a factual basis for the prediction; 2. The inventor must have an articulable and 'sound' line of reasoning from which the desired result can be inferred from the factual basis; and 3. There must be proper disclosure. To be sound, a prediction does not need to amount to a certainty, as it does not exclude the risk that some compounds within the area claimed may, at some later time, prove to be devoid of utility" - See paragraphs 146 and 147.

Patents of Invention - Topic 1724

Grounds of invalidity - Lack of utility and operability - Doctrine of sound prediction - The plaintiffs were the owner and a licensee of Canadian Patent No. 1,341,206 (the '206 patent) for ramipril (an ACE inhibitor), used in the drug ALTACE, which was used primarily in the treatment of high blood pressure and cardiac insufficiency - At issue were promises in claims 1, 2, 3, 6 and 12 - The '206 patent promised that all of the compounds would have utility as both ACE inhibitors and antihypertensives - The plaintiffs sued Apotex Inc. and Novopharm Ltd. (the defendants) for infringement of the patent - The defendants defended and counterclaimed, asserting that the '206 patent was invalid on the ground of, inter alia, lack of utility - The Federal Court held that claims 1, 2, 3, 6 and 12 of the '206 patent were invalid - On a balance of probabilities, the inventors of the '206 patent could not soundly predict, as of October 20, 1981 (patent filing date), that all of the eight compounds of claim 12 of the '206 patent would have the utility promised by the patent - Claims 1, 2, 3 and 6 included the same compounds as were covered by claim 12 - Accordingly, it followed that claims 1, 2, 3, 6 and 12 of the '206 patent were invalid - See paragraphs 148 to 212.

Patents of Invention - Topic 1724

Grounds of invalidity - Lack of utility and operability - Doctrine of sound prediction - The plaintiffs were the owner and a licensee of Canadian Patent No. 1,341,206 (the '206 patent) for ramipril (an ACE inhibitor), used in the drug ALTACE, which was used primarily in the treatment of high blood pressure and cardiac insufficiency - At issue were promises in claims 1, 2, 3, 6 and 12 - The '206 patent promised that all of the compounds will have utility as both ACE inhibitors and antihypertensives - The plaintiffs sued Apotex Inc. and Novopharm Ltd. (the defendants) for infringement of the patent - The defendants defended and counterclaimed, asserting that the '206 patent was invalid on the ground of, inter alia, lack of utility - The Federal Court held that claims 1, 2, 3, 6 and 12 of the '206 patent were invalid - The disclosure provided by the inventors in the '206 patent was insufficient for several reasons - First, there was no test data included in the specification of the patent - Second, nowhere in the patent was there any discussion that the active site of the ACE inhibitor had sufficient volume to fit all stereoisomers of the bicyclic rings disclosed in the '206 patent - Third, the '206 patent also made no reference to the Troy conference or any publications - There was also no evidence that the inventors relied on those disclosures to predict that all of the various permutations of the side chain claimed in the '206 patent would have utility - Fourth, no reference to any of the work the inventors did on captopril analogues, including the analogues where the proline ring was substituted with one or more substituents, was set out - The lack of information in the '206 patent made it very hard for a person skilled in the art to make a decision about exactly which of the compounds disclosed were active, and which were not active - As a result, if the invention of the '206 patent included a promise that some of the compounds would be active as antihypertensives, the patent failed to teach what was the invention and how it worked; there was no enabling disclosure across the breadth of the claimed invention - There was inadequate disclosure in the '206 patent - The '206 patent disclosed neither the underlying facts (their test data) nor a sound line of reasoning - The underlying factual basis and line of reasoning that grounded the inventors' alleged prediction were not disclosed - See paragraphs 213 to 228.

Patents of Invention - Topic 1724

Grounds of invalidity - Lack of utility and operability - Doctrine of sound prediction - The plaintiffs were the owner and a licensee of Canadian Patent No. 1,341,206 (the '206 patent) for ramipril (an ACE inhibitor), used in the drug ALTACE, which was used primarily in the treatment of high blood pressure and cardiac insufficiency - At issue were promises in claims 1, 2, 3, 6 and 12 - The '206 patent promised that all of the compounds will have utility as both ACE inhibitors and antihypertensives - The plaintiffs sued Apotex Inc. and Novopharm Ltd. (the defendants) for infringement of the patent - The defendants defended and counterclaimed, asserting that the '206 patent was invalid on the ground of, inter alia, lack of utility - In addition to arguing that the claims in issue should be held to be invalid on the grounds of no sound prediction of the subject matter, the defendants also submitted that the inventors had no sound basis to predict that it would be able to make and isolate each of the stereoisomers of claim 12 - The Federal Court rejected the argument - First, the doctrine of sound prediction did not extend as far as proposed by the defendants; rather, the sufficiency requirement set out in the Patent Act protected a third party from patents that provided inadequate disclosure of how the patent was to be practiced - Second, the evidence demonstrated that the claim 12 compounds could be made and separated either by the methods set out in Example 20 or by methods known as of the Canadian filing date - See paragraphs 232 to 259.

Patents of Invention - Topic 1725

Grounds of invalidity - Lack of utility and operability - Particular patents - [See second, third and fourth Patents of Invention - Topic 1724 ].

Patents of Invention - Topic 3006

Infringement of patent - Defences - Patent indistinguishable from prior art (Gillette defence) - The plaintiffs were the owner and a licensee of Canadian Patent No. 1,341,206 (the '206 patent) for ramipril (an ACE inhibitor), used in the drug ALTACE, which was used primarily in the treatment of high blood pressure and cardiac insufficiency - The plaintiffs sued Apotex Inc. and Novopharm Ltd. (the defendants) for infringement of the patent - The defendants pointed out that the uncontradicted evidence was that the ramipril used in Apo-Ramipril (the defendants' generic drug) was made in accordance with the process for making ramipril set out in the '087 patent - The '087 patent was issued in May 1985 and expired in November 2002, whereas the '206 patent did not issue until 2001 - Thus, the defendants argued, since Apo-Ramipril was made using ramipril that was made in accordance with teachings of the '087 patent, the existence of the '206 patent could not possibly interfere with the defendants' right to manufacture, use and sell Apo-Ramipri1 and there was no infringement of the '206 patent - The Federal Court rejected the assertion - The application for the '087 patent was filed after that for the '206 patent - Given the unusual timing that arose because of the conflict proceedings under the old Patent Act, the court could not look at the issue date of the respective patents - Rather, the court had to consider the subject matter - Even though the '206 patent issued later, its subject matter was in the public domain prior to the filing of the '087 patent - The Gillette defence was not available to the defendants - Further, the defendants had not made a claim of invalidity due to anticipation by the '087 patent - It followed that the Gillette defence could not be sustained, in isolation, as a defence to the plaintiffs' claims of infringement - See paragraphs 344 to 349.

Patents of Invention - Topic 3781

Infringement actions - Evidence - General - The plaintiffs were the owner and a licensee of Canadian Patent No. 1,341,206 (the '206 patent) - The plaintiffs sued Apotex Inc. and Novopharm Ltd. (the defendants) for infringement of the patent - The defendants defended and counterclaimed, asserting that the '206 patent was invalid on a number of grounds - The Federal Court held that "the plaintiffs bear the burden of demonstrating that the defendants have infringed the '206 Patent. Once infringement has been established, the burden shifts. Under s. 43(2) of the Patent Act, a patent is presumed valid in the absence of evidence to the contrary. The defendants have the onus of demonstrating that the '206 patent is not valid ... The evidentiary burden is that of a civil burden of proof. The defendants can meet their burden if they can persuade me, on a balance of probabilities, either that: (a) they have not infringed the '206 Patent; or (b) the claims at issue are invalid on any one of the grounds advanced by them." - See paragraphs 74 to 78.

Cases Noticed:

Bull (David) Laboratories (Canada) Inc. v. Pharmacia Inc. et al., [1995] 1 F.C. 588; 176 N.R. 48; 58 C.P.R.(3d) 209 (F.C.A.), refd to. [para. 66].

AB Hassle et al. v. Apotex Inc. et al., [2006] 4 F.C.R. 513; 350 N.R. 219; 2006 FCA 51, refd to. [para. 66].

Aventis Pharma Inc. et al. v. Pharmascience Inc. et al., [2005] 4 F.C.R. 301; 270 F.T.R. 187; 38 C.P.R.(4th) 441; 2005 FC 340, refd to. [para. 69].

Aventis Pharma Inc. et al. v. Pharmascience Inc. et al., [2007] 2 F.C.R. 103; 352 N.R. 99; 53 C.P.R.(4th) 453; 2006 FCA 229, refd to. [para. 70].

Aventis Pharma Inc. v. Apotex Inc. et al. (2005), 278 F.T.R. 1; 43 C.P.R.(4th) 161; 2005 FC 1283, refd to. [para. 71].

Aventis Pharma Inc. v. Apotex Inc. et al. (2006), 349 N.R. 183; 265 D.L.R.(4th) 308; 46 C.P.R.(4th) 401; 2006 FCA 64, refd to. [para. 71].

Sanofi-Aventis Canada Inc. v. Novopharm Ltd. et al., [2007] 1 F.C.R. 174; 364 N.R. 325; 59 C.P.R.(4th) 416; 2007 FCA 163, refd to. [para. 72].

Sanofi-Aventis Inc. et al. v. Laboratoire Riva Inc. et al. (2007), 315 F.T.R. 59; 58 C.P.R.(4th) 109; 2007 FC 532, refd to. [para. 72].

Monsanto Canada Inc. et al. v. Schmeiser et al., [2004] 1 S.C.R. 902; 320 N.R. 201; 2004 SCC 34, refd to. [para. 75].

Apotex Inc. and Novopharm Ltd. v. Wellcome Foundation Ltd., [2002] 4 S.C.R. 153; 296 N.R. 130; 2002 SCC 77, refd to. [para. 75].

Whirlpool Corp. et al. v. Camco Inc. et al., [2000] 2 S.C.R. 1067; 263 N.R. 88; 2000 SCC 67, refd to. [para. 79].

Dimplex North America Ltd. v. CFM Corp. (2006), 292 F.T.R. 38; 54 C.P.R.(4th) 435; 2006 FC 586, affd. (2007), 370 N.R. 316; 60 C.P.R.(4th) 277; 2007 FCA 278, refd to. [para. 79].

Eli Lilly Canada Inc. v. Apotex Inc. et al. (2008), 323 F.T.R. 56; 63 C.P.R.(4th) 406; 2008 FC 142, refd to. [para. 79].

Eli Lilly Canada Inc. v. Novopharm Ltd. et al., [2007] F.T.R. Uned. 828; 58 C.P.R.(4th) 214; 2007 FC 596, refd to. [para. 79].

Apotex Inc. v. Syntex Pharmaceuticals International Ltd. et al. (1999), 166 F.T.R. 161 (T.D.), refd to. [para. 80].

Shire Biochem Inc. et al. v. Canada (Minister of Health) et al. (2008), 328 F.T.R. 123; 2008 FC 538, refd to. [para. 81].

Pfizer Canada Inc. et al. v. Canada (Minister of Health) et al. (2005), 285 F.T.R. 1; 2005 FC 1725, refd to. [para. 83].

Markush, Ex parte (1924), 1925 Dec. Comm'r. Pat. 126 (U.S.), refd to. [para. 100].

Monsanto Co. v. Commissioner of Patents, [1979] 2 S.C.R. 1108; 28 N.R. 181; 42 C.P.R.(2d) 161, refd to. [para. 128].

Laboratoires Servier et al. v. Apotex Inc. et al. (2008), 332 F.T.R. 193; 2008 FC 825, refd to. [para. 129].

Pfizer Canada Inc. et al. v. Canada (Minister of Health) et al. (2005), 279 F.T.R. 164; 43 C.P.R.(4th) 241; 2005 FC 1205, refd to. [para.135].

Pfizer Canada Inc. et al. v. Canada (Minister of Health) et al. (2007), 366 N.R. 347; 60 C.P.R.(4th) 81; 2007 FCA 209, reving. (2005), 279 F.T.R. 164; 43 C.P.R.(4th) 241; 2005 FC 1205, refd to. [para. 136].

Merck & Co. et al. v. Apotex Inc. et al. (2005), 274 F.T.R. 113; 41 C.P.R.(4th) 35; 2005 FC 755, refd to. [para. 143].

Pfizer Canada Inc. et al. v. Apotex Inc. et al. (2007), 306 F.T.R. 254; 2007 FC 26, affd. (2007), 367 N.R. 98; 2007 FCA 195, leave to appeal refused (2007), 381 N.R. 399 (S.C.C.), refd to. [para. 143].

Consolboard Inc. v. MacMillan Bloedel (Saskatchewan) Ltd., [1981] 1 S.C.R. 504; 35 N.R. 390; 122 D.L.R.(3d) 203, refd to. [para. 144].

Pfizer Canada Inc. et al. v. Canada (Minister of Health) et al. (2008), 377 N.R. 9; 67 C.P.R.(4th) 23; 2008 FCA 108, refd to. [para. 145].

Eli Lilly Canada Inc. v. Apotex Inc. et al. (2009), 392 N.R. 243; 2009 FCA 97, refd to. [para. 214].

Pfizer Canada Inc. et al. v. Apotex Inc. et al. (2007), 367 N.R. 98; 60 C.P.R.(4th) 177; 2007 FCA 195, refd to. [para. 216].

American Home Products Corp. v. Novartis Pharmaceuticals, [2001] R.P.C. 8 (C.A.), refd to. [para. 223].

Free World Trust v. Electro Santé Inc. et al., [2000] 2 S.C.R. 1024; 263 N.R. 150; 9 C.P.R.(4th) 168; 2000 SCC 66, refd to. [para. 224].

Sanofi-Synthelabo Canada Inc. et al. v. Apotex Inc. et al., [2008] 3 S.C.R. 265; 381 N.R. 125; 69 C.P.R.(4th) 251; 2008 SCC 61, refd to. [para. 261].

Pfizer Canada Inc. et al. v. Apotex Inc. et al. (2009), 385 N.R. 148; 2009 FCA 8, refd to. [para. 264].

Westaim Corp. v. Royal Canadian Mint (2002), 224 F.T.R. 184; 23 C.P.R.(4th) 9 (T.D.), refd to. [para. 270].

Christiani & Nielsen v. Rice, [1931] 4 D.L.R. 273 (P.C.), affd. [1930] S.C.R. 443, refd to. [para. 272].

Permutit Co. v. Borrowman, [1926] 4 D.L.R. 285; 43 R.P.C. 356 (P.C.), refd to. [para. 272].

TRW Inc. v. Walbar of Canada Inc. (1992), 132 N.R. 161; 39 C.P.R.(3d) 176 (F.C.A.), refd to. [para. 321].

Minerals Separation North American Corp. v. Noranda Mines, [1947] Ex. C.R. 306, refd to. [para. 324].

Teledyne Industries Inc. and Teledyne Industrial Canada Ltd. v. Lido Industries Products Ltd. (1981), 39 N.R. 561; 57 C.P.R.(2d) 29 (F.C.A.), refd to. [para. 331].

Merck & Co. et al. v. Apotex Inc. (2006), 282 F.T.R. 161; 53 C.P.R.(4th) 1; 2006 FC 524, refd to. [para. 341].

Sanofi-Synthelabo Canada Inc. et al. v. Apotex Inc. et al. (2006), 358 N.R. 135; 59 C.P.R.(4th) 46; 2006 FCA 421, affd. [2008] 3 S.C.R. 265; 381 N.R. 125; 2008 SCC 61, refd to. [para. 341].

Bristol-Myers Squibb Canada Co. et al. v. Apotex Inc. et al. (2009), 342 F.T.R. 161; 2009 FC 137, refd to. [para. 341].

Gillette Safety Razor Co. v. Anglo-American Trading Co. (1913), 30 R.P.C. 465 (H.L.), consd. [para. 344].

Eli Lilly Canada Inc. v. Apotex Inc. et al. (2009), 346 F.T.R. 78; 2009 FC 320, refd to. [para. 346].

Pfizer Canada Inc. et al. v. Apotex Inc. et al. (2005), 282 F.T.R. 8; 2005 FC 1421, refd to. [para. 346].

Laboratoires Servier et al. v. Apotex Inc. et al. (2008), 332 F.T.R. 314; 70 C.P.R.(4th) 347; 2008 FC 1070, refd to. [para. 361].

Adir v. Apotex Inc. - see Laboratoires Servier et al. v. Apotex Inc. et al.

Statutes Noticed:

Patent Act, R.S.C. 1985, c. P-4, sect. 27(a) [para. 350 et seq.]; sect. 34(1) [para. 328].

Authors and Works Noticed:

Cheung, H.S., Wang, F.L., Ondetti, M.A., Sabo, E.F., and Cushman, D.W., Binding of Peptide Substrates and Inhibitors of Angiotensin-Converting Enzyme (1980), 225(2) J. of Biological Chemistry, pp. 401 to 407 [paras. 205, 296].

Cushman, D.W., Cheung, H.S., Sabo, E.F., and Ondetti, A., Design of New Antihypertensive Drugs: Potent and Specific Inhibitors of Angiotensin-Converting Enzyme (1978), 21(3) Progress in Cardiovascular Diseases 176, pp. 176 to 182 [para. 190].

Cushman, D.W., Cheung, H.S., Sabo, E.F., and Ondetti, A., Design of Potent Competitive Inhibitors of Angiotensin-Converting Enzyme, Carboxyalkanoyl and Mercaptoalkan Amino Acids (1977), 16(25) Biochemistry 5484, generally [paras. 199, 203]; pp. 5485 to 5491 [paras. 189, 292].

Cushman, D.W., Cheung, H.S., Sabo, E.F., Rubin, B., and Ondetti, A., Development of Specific Inhibitors of Angiotensin I Converting Enzymes (Kininase II) (1979), 38(13) Federal Proceedings, pp. 2778 to 2782 [para. 203]; 2780 [para. 292].

Farkas, E., Lavignino, E.R., and Rapala, R.T., Preparation of 3-Dehydroeserpic Acid Lactone and Its Conversion to Reserpic Acid Lactone (1957), 22(10) J. of Organic Chemistry, pp. 1261 to 1263 [para. 255].

Fisher, G.H., and Ryan, J.W., Superactive Inhibitors of Angiotensin Converting Enzyme: Analogs of BPP9a containing dehydroproline (1979), 107 FEBS Letters, No. 2, pp. 273 to 276 [para. 294].

Fox, Harold George, The Canadian Law and Practice Relating to Letters Patent for Inventions (4th Ed. 1969), p. 153 [para. 145].

Funae, Y., Romori, T., Sasaki, D., and Yamamoto, K., Effects of N-mercaptoacylamino acids on inhibition of angiotensin I converting enzyme (1978), 28 Jap. J. of Pharmacology, No. 6, pp. 925 to 927 [para. 296].

Holmquist, B., and Vallee, B.L., Metal-coordinating substrate analogs as inhibitors of metalloenzymes, (1979), 76(1) Proceedings of the National Academy of Sciences of the United States of America, pp. 6216 to 6220 [para. 296].

Iso, T., and Iwao, J., Pharmacological studies on SA 446, a new angiotensin I-converting enzyme inhibitor (1979), 30 Jap. J. of Pharmacology (Supp.), p. 136P [para. 296].

Iso, T., Nishimura, K., and Oya, M., Potentiating mechanism of bradykinin action on smooth muscle by sulfhydryl compounds (1979), 54 Eur. J. of Pharmacology, No. 3, pp. 303 to 305 [para. 296].

Maycock, A.L., DeSousa, D.M., Payne, L.G., Broeke, J.T., Wu, M.T., and Patchett, A.A., Inhibition of Thermolysin by N-Carboxymethyl Dipeptides (1981), 102(3) Biochemical and Biphysical Research Communications, pp. 963 to 969 [para. 197].

Mita, I., Iwao, J., Oya, M., Chiba, T., and Iso, T., New sulfhydryl compounds with potent antihypertenive activities (1978), 26 Chemical & Pharmaceutical Bulletin, No. 4, pp. 1333 to 1335 [para. 296].

Ondetti, M.A., Rubin, B., and Cushman, D.W., Design of Specific Inhibitors of Angiotensin-Converting Enzyme: New Class of Orally Active Antihypertensive Agents (1977), 196 Science, No. 4288, pp. 441 to 444 [para. 292].

Patchett, A.A., Harris, E., Tristram, E.W., Wyvratt, M.J., Wu, M.T., Taub, D., and Peterson, E.R., A New Class of Angiotensin-Converting Enzyme Inhibitors (1980), 288 Nature, No. 5788, generally [para. 197]; pp. 280 to 283 [para. 192].

Counsel:

Gunars Gaikis, Sheldon Hamilton, Jeremy Want, Jeffrey Coles and Junyi Chen, for the plaintiffs, Sanofi-Aventis Canada Inc. et al. (in T-161-07 & T-1161-07);

Anthony Creber and Marc Richard, for the plaintiff, Schering Corp. (in T-161-07 & T-1161-07);

Harry Radomski, Nando Deluca, Jerry Topolski, Benjamin Hackett and Karen Murdoch, for the defendant, Apotex Inc. (in T-161-07);

Jonathan Stainsby, Mark Davis, Bill Mayo, Lesley Caswell and Keya Dasgupta, for the defendant, Novopharm Ltd. (in T-1161-07).

Solicitors of Record:

Smart and Biggar, Toronto, Ontario, for the plaintiffs, Sanofi-Aventis Canada et al.;

Gowlings Lafleur Henderson, LLP, Ottawa, Ontario, for the plaintiff, Schering Corp.;

Goodmans, LLP, Toronto, Ontario, for the defendant, Apotex Inc.;

Heenan, Blaikie, LLP, Toronto, Ontario, for the defendant, Novopharm Ltd.

This action and counterclaim were heard between January 12 and April 15, 2009, at Toronto, Ontario, by Snider, J., of the Federal Court, who delivered the following judgment on June 29, 2009.