Eli Lilly Canada Inc. et al. v. Novopharm Ltd., (2011) 399 F.T.R. 221 (FC)

• Judge: O'Reilly, J.
• Court: Federal Court (Canada)
• Case Date: November 10, 2011
• Jurisdiction: Canada (Federal)
• Citations: (2011), 399 F.T.R. 221 (FC);2011 FC 1288

Eli Lilly Can. Inc. v. Novopharm Ltd. (2011), 399 F.T.R. 221 (FC)

MLB headnote and full text

Temp. Cite: [2011] F.T.R. TBEd. NO.042

Eli Lilly Canada Inc., Eli Lilly and Company, Eli Lilly and Company Limited and Eli Lilly SA (plaintiffs/defendants by counterclaim) v. Novopharm Limited (defendant/plaintiff by counterclaim)

(T-1048-07; 2011 FC 1288)

Indexed As: Eli Lilly Canada Inc. et al. v. Novopharm Ltd.

Federal Court

O'Reilly, J.

November 10, 2011.

Summary:

The plaintiffs (collectively Lilly) sued Novopharm Ltd. for infringement of a patent for a medicine called olanzapine, prescribed primarily for the treatment of schizophrenia. Novopharm marketed a generic version of olanzapine. Olanzapine was the subject of a Canadian patent (No 2,041,113) (the '113 patent). Lilly applied for the '113 patent in 1991 and was granted it in 1998. Olanzapine was also included within an earlier Lilly patent (No 1,075,687) (the '687 patent). The '687 patent was a "genus patent". The '113 patent, therefore, was a "selection patent". Lilly sued Novopharm, alleging that Novopharm's generic version of olanzapine infringed the '113 patent. Novopharm alleged that the '113 patent was invalid on numerous grounds.

The Federal Court, per O'Reilly, J., in a decision reported at 353 F.T.R. 35, dismissed Lilly's action for infringement of the '113 patent, primarily on the basis that Lilly was not entitled to a second patent for olanzapine. Lilly appealed.

The Federal Court of Appeal, in a decision reported at 405 N.R. 1, allowed the appeal. O'Reilly, J., had erred in the approach to selection patents. The '113 patent was not invalid for anticipation, double patenting or obviousness. The court referred the issues of utility and sufficiency of disclosure back to O'Reilly, J. The parties agreed that the issues could be determined on the basis of the evidentiary record generated by the first trial. The main controversies related to the inferences and conclusions that could be drawn from that evidence.

The Federal Court, per O'Reilly, J., dismissed Lilly's action for infringement. In relation to the issue of utility, Novopharm had established that the '113 patent's promise had not been demonstrated and could not have been soundly predicted on the basis of the evidence available to the inventors in 1991. Accordingly, the '113 patent was not a valid selection patent. Novopharm's attack on the sufficiency of the '113 patent failed. The patent described the compound of the invention, its advantages, how to make it and the range within which it could be dosed.

Patents of Invention - Topic 1128

The specification and claims - The description - Sufficiency of disclosure - The Federal Court stated that "A selection patent must set out clearly what is better and different about the selected compound as compared to the genus from which it derives. The patent must give enough detail that a person skilled in the art would know what the advantages of the selected compound are ... Not only must the selected compound have special advantages, those advantages must be spelled out with adequate precision in the patent" - See paragraph 270.

Patents of Invention - Topic 1128

The specification and claims - The description - Sufficiency of disclosure - The plaintiffs (collectively Lilly) sued Novopharm Ltd. for infringement of a patent for a medicine called olanzapine - Novopharm marketed a generic version of olanzapine - Olanzapine was the subject of a Canadian patent (No 2,041,113) (the '113 patent) - Lilly applied for the '113 patent in 1991 - Olanzapine was also included within an earlier Lilly patent (No 1,075,687) (the '687 patent) - The '687 patent was a "genus patent" - The question of the '113's validity as a selection patent was at the forefront of the action - Novopharm argued that s. 27(3) of the Patent Act required Lilly to disclose in clear terms the substantial advantages of olanzapine over the '687 genus - Lilly maintained that to meet the requirements of s. 27(3), it must simply state in the patent what the invention was and how it worked - The Federal Court, in its second judgment, concluded that Novopharm's attack on the sufficiency of the '113 patent failed - Lilly's position was supported by the jurisprudence - The '113 patent described the compound of the invention, its advantages, how to make it, and the range within which it could be dosed - To require more, such as disclosure of the basis for the assertion that olanzapine had certain advantages, would have led the court to repeat the error in its original judgment - See paragraphs 271 and 272.

Patents of Invention - Topic 1514

Grounds of invalidity - General - Selection patents - The plaintiffs (collectively Lilly) sued Novopharm Ltd. for infringement of a patent for a medicine called olanzapine - Novopharm marketed a generic version of olanzapine - Olanzapine was the subject of a Canadian patent (No 2,041,113) (the '113 patent) - Lilly applied for the '113 patent in 1991 - Olanzapine was also included within an earlier Lilly patent (No 1,075,687) (the '687 patent) - The '687 patent was a "genus patent" - The question of the '113's validity as a selection patent was at the forefront of the action - The Federal Court, in its second judgment, stated that the main problem with Lilly's submissions on sound prediction was that they were based on a reading-down of the promise of the '113 patent to the same utility that had been relied on for the '687 patent - The argument was not in keeping with the prevailing jurisprudence, which required a selection patent to set out a specific promise of a substantial advantage over the genus compounds - See paragraph 228.

Patents of Invention - Topic 1514

Grounds of invalidity - General - Selection patents - The plaintiffs (collectively Lilly) sued Novopharm Ltd. for infringement of a patent for a medicine called olanzapine, prescribed primarily for the treatment of schizophrenia - Novopharm marketed a generic version of olanzapine - Olanzapine was the subject of a Canadian patent (No 2,041,113) (the '113 patent) - Lilly applied for the '113 patent in April 1991 - Olanzapine was also included within an earlier Lilly patent (No 1,075,687) (the '687 patent) - The '687 patent was a "genus patent" - The question of the '113's validity as a selection patent was at the forefront of the action - The Federal Court, in its second judgment, held that the preponderance of the evidence did not support a sound prediction of the '113 patent's promise - Therefore, the '113 was not a valid patent - The evidence suggested that Lilly filed the '113 patent before it had a basis on which to found a sound prediction of olanzapine's advantages, if any, over the '687 compounds or other antipsychotics - In sum, at the time the patent was filed, Lilly had not found any special qualities of olanzapine that would justify a fresh monopoly - "There must be an invention. And, in the context of a selection patent, the invention is the discovery of a substantial advantage over the genus compounds" - There was no sound and articulable line of reasoning, or a prima facie reasonable inference, that would have led the inventors from the evidence available at the relevant time to the explicit promise of the substantial advantage set out in the '113 patent relating to clinical-superiority and a better side-effects profile - See paragraphs 264 to 268.

Patents of Invention - Topic 1723

Grounds of invalidity - Lack of utility and operability - Chemical products and substances intended for food and medicine - [See both Patents of Invention - Topic 1514 ].

Patents of Invention - Topic 1724

Grounds of invalidity - Lack of utility and operability - Doctrine of sound prediction - [See both Patents of Invention - Topic 1514 ].

Cases Noticed:

Eli Lilly Canada Inc. v. Apotex Inc. et al. (2007), 311 F.T.R. 21; 2007 FC 455, refd to. [para. 50].

Eli Lilly Canada Inc. v. Apotex Inc. et al. (2008), 375 N.R. 381; 2008 FCA 44, refd to. [para. 52].

Eli Lilly Canada Inc. v. Novopharm Ltd. et al., [2007] F.T.R. Uned. 828; 2007 FC 596, refd to. [para. 54].

Eli Lilly Canada Inc. v. Novopharm Ltd. et al. (2007), 370 N.R. 140; 2007 FCA 359, refd to. [para. 54].

Sanofi-Synthelabo Canada Inc. et al. v. Apotex Inc. et al., [2008] 3 S.C.R. 265; 381 N.R. 125; 2008 SCC 61, refd to. [para. 65].

Farbenindustrie (I.G.) AG's Patents, Re (1930), 47 R.P.C. 289 (Ch. D.), refd to. [para. 65].

Apotex Inc. and Novopharm Ltd. v. Wellcome Foundation Ltd., [2002] 4 S.C.R. 153; 296 N.R. 130, refd to. [para. 72].

Consolboard Inc. v. MacMillan Bloedel (Sask.) Ltd., [1981] 1 S.C.R. 504; 35 N.R. 390, refd to. [para. 84].

Pfizer Canada Inc. et al. v. Canada (Minister of Health) et al. (2009), 377 N.R. 9; 2008 FCA 108, refd to. [para. 84].

Pfizer Canada Inc. et al. v. Canada (Minister of Health) et al. (2007), 351 N.R. 189; 2006 FCA 214, refd to. [para. 111].

Dreyfus and Other Applications (1945), 62 R.P.C. 125, refd to. [para. 111].

Pfizer Canada Inc. et al. v. Canada (Minister of Health) et al. (2011), 423 N.R. 180; 2011 FCA 236, refd to. [para. 210].

Pfizer Canada Inc. et al. v. Novopharm Ltd. et al. (2009), 352 F.T.R. 35; 2009 FC 638, affd. (2010), 408 N.R. 166; 2010 FCA 242, refd to. [para. 221].

Olin Mathieson Chemical Corp. v. Biorex Laboratories Ltd., [1970] R.P.C. 157 (Ch. Div.), refd to. [para. 221].

Monsanto Co. v. Commissioner of Patents, [1979] 2 S.C.R. 1108; 28 N.R. 181, refd to. [para. 221].

Laboratoires Servier et al. v. Apotex Inc. et al. (2008), 332 F.T.R. 193; 2008 FC 825, affd. (2009), 392 N.R. 96; 2009 FCA 222, refd to. [para. 221].

Lundbeck Canada Inc. v. Canada (Minister of Health) et al. (2009), 343 F.T.R. 53; 2009 FC 146, affd. (2010), 409 N.R. 322; 2010 FCA 320, refd to. [para. 221].

Pfizer Canada Inc. et al. v. Apotex Inc. et al. (2007), 306 F.T.R. 254; 2007 FC 26, refd to. [para. 224].

GlaxoSmithKline Inc. et al. v. Pharmascience Inc. et al. (2008), 328 F.T.R. 241; 2008 FC 593, refd to. [para. 227].

Novopharm Ltd. v. Eli Lilly & Co. (2011), 420 N.R. 188; 2011 FCA 220, consd. [para. 234].

Eli Lilly & Co. v. Teva Canada Ltd. - see Novopharm Ltd. v. Eli Lilly & Co.

Counsel:

Anthony G. Creber, Cristin Wagner and John Norman, for the plaintiffs/defendants by counterclaim;

Jonathan Stainsby, Andrew Skodyn, Andrew Radhakant and Neil Fineberg, for the defendant/plaintiff by counterclaim.

Solicitors of Record:

Gowling Lafleur Henderson LLP, Ottawa, Ontario, for the plaintiffs/defendants by counterclaim;

Heenan Blaikie LLP, Toronto, Ontario, for the defendant/plaintiff by counterclaim.

This action for patent infringement was heard at Toronto, Ontario, on January 19-21, 2011, before O'Reilly, J., of the Federal Court, who delivered the following reasons for judgment and judgment, dated November 10, 2011.