Eli Lilly Canada Inc. et al. v. Novopharm Ltd., 2009 FC 1018

• Jurisdiction: Federal Jurisdiction (Canada)
• Court: Federal Court (Canada)
• Judge: O'Reilly, J.
• Citation: 2009 FC 1018,(2009), 353 F.T.R. 35 (FC)
• Date: 17 November 2008
• Subject Matter: PATENTS OF INVENTION

Eli Lilly Can. Inc. v. Novopharm Ltd. (2009), 353 F.T.R. 35 (FC)

MLB headnote and full text

Temp. Cite: [2009] F.T.R. TBEd. OC.018

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; 2009 FC 1018)

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

Federal Court

O'Reilly, J.

October 5, 2009.

Summary:

The plaintiffs ("Lilly") sued Novopharm for infringement of a patent for a medicine called olanzapine, which was used for treating schizophrenia. Olanzapine was the subject of a Canadian patent (the '113 patent) which was granted to Lilly in 1998. Olanzapine was included within an earlier Lilly patent (the '687 patent). The '687 patent was a "genus patent" which covered olanzapine as well as a large number of other related compounds. The '113 patent was a "selection patent". Novopharm challenged the validity of the '113 patent on the ground, inter alia, that it was not a valid selection patent.

The Federal Court held that the '113 patent was not a valid selection patent and the claims of the '113 patent in issue were invalid. Lilly's action for infringement was therefore dismissed. Novopharm was entitled to relief under s. 8 of the Patented Medicines (Notice of Compliance) Regulations to be determined in a separate proceeding.

Patents of Invention - Topic 705

Application for grant - Disclosure and examination (incl. duty of candour) - The plaintiffs ("Lilly") sued Novopharm for infringement of a patent for a medicine called olanzapine - Olanzapine was the subject of a Canadian patent (the '113 patent) which was granted to Lilly in 1998 - Novopharm argued that Lilly should be deemed to have abandoned its patent application because it failed to respond in good faith, and within six months, to a requisition by the patent examiner (Patent Act, s. 73(a)) - The Federal Court stated that "I do not have sufficient evidence supporting Novopharm's position. Mr. Frank Pole, the patent agent who prosecuted the '113, now retired, testified that Lilly's communication with the patent examiner was intended to be a good faith response to the examiner's queries. The patent examiner accepted them as such. That conclusion merits some deference on my part. As I have found above, some of the assertions in the '113 were hopeful. They were based on too little evidence to be factual contentions or even sound predictions of olanzapine's alleged advantages. But, to my mind, that does not mean that they were misleading or made in bad faith" - The court found no basis under s. 73 to invalidate the '113 patent - See paragraphs 152 to 153.

Patents of Invention - Topic 710

Application for grant - General - Abandonment - [See Patents of Invention - Topic 705 ].

Patents of Invention - Topic 1136

The specification and claims - The description - Chemicals (incl. selection patents) - [See second Patents of Invention - Topic 1514 ].

Patents of Invention - Topic 1504

Grounds of invalidity - General - What constitutes an invention - [See second Patents of Invention - Topic 1514 and Patents of Invention - Topic 1587 ].

Patents of Invention - Topic 1507

Grounds of invalidity - General - Untrue material allegations in petition, specification or drawings - The plaintiffs ("Lilly") sued Novopharm for infringement of a patent for a medicine called olanzapine - Olanzapine was the subject of a Canadian patent (the '113 patent) which was granted to Lilly in 1998 - Olanzapine was included within an earlier Lilly patent (the '687 patent) - The '687 patent was a "genus patent" which covered olanzapine as well as a large number of other related compounds - The '113 patent was a "selection patent" - Novopharm argued that the '113 patent was invalid because Lilly wilfully made a misleading, material allegation in its patent application (Patent Act, s. 53(1)) - Alternatively, if the misrepresentation was involuntary (not wilful), then the parts of the patent containing false statements should be severed from the remainder (s. 53(2)) - The Federal Court stated that despite its finding that the '113 patent was not valid because it was not a valid selection patent, it did not necessarily follow that Lilly intended to mislead anyone - Novopharm had not presented any evidence to that effect - Nor did the court have before it sufficient evidence from which to infer that intention - As for unintentional misstatements or omissions, Novopharm had not persuaded the court that Lilly made any false statements - The court found no basis under s. 53 to invalidate the '113 patent - See paragraphs 150 to 151.

Patents of Invention - Topic 1514

Grounds of invalidity - General - Selection patents - The plaintiffs ("Lilly") sued Novopharm for infringement of a patent for a medicine called olanzapine, which was used for treating schizophrenia - Olanzapine was the subject of a Canadian patent (the '113 patent) which was granted to Lilly in 1998 - Olanzapine was included within an earlier Lilly patent (the '687 patent) - The '687 patent was a "genus patent" which covered olanzapine as well as a large number of other related compounds - The '113 patent was a "selection patent" - Novopharm challenged the validity of the '113 patent on the ground that it was not a valid selection patent - The Federal Court stated that "in order to uphold the '113 patent as a valid selection patent, I must be satisfied that olanzapine has an advantage over the other compounds of the '687 patent. Further, that advantage must be substantial and somewhat peculiar to olanzapine. Finally, the patent must clearly describe olanzapine's substantial and special advantage" - The court further stated that "the first step I must take is to decide whether one or more of the asserted advantages of olanzapine was known to exist, or was soundly predicted, at the time the '113 patent was filed in 1991. Second, I must decide whether at least one of them could be considered a substantial advantage over the '687 compounds and somewhat peculiar to olanzapine. And, if so, the third question is whether the disclosure of that substantial and special advantage in the '113 patent was adequate. If I decide any one of them in the negative, I must find the '113 patent to be invalid" - See paragraphs 49 and 55.

Patents of Invention - Topic 1514

Grounds of invalidity - General - Selection patents - Olanzapine, a medicine used for treating schizophrenia, was the subject of a Canadian patent (the '113 patent) which was granted to the plaintiffs ("Lilly") in 1998 - Olanzapine was included within an earlier Lilly patent (the '687 patent) - The '687 patent was a "genus patent" which covered olanzapine as well as a large number of other related compounds - The '113 patent was a "selection patent" - The Federal Court held that the '113 patent was not a valid selection patent - There was an insufficient basis for the '113 patent's assertion of an advantage for olanzapine over the '687 compounds and other antipsychotic agents - The '113 patent did not describe an invention over and above what was disclosed in the '687 patent and it therefore was not a valid selection patent - See paragraphs 47 to 139.

Patents of Invention - Topic 1587

Grounds of invalidity - Lack of "inventive ingenuity" (obviousness) - Selection patents - Olanzapine, a medicine used for treating schizophrenia, was the subject of a Canadian patent (the '113 patent) which was granted to the plaintiffs ("Lilly") in 1998 - Olanzapine was included within an earlier Lilly patent (the '687 patent) - The '687 patent was a "genus patent" which covered olanzapine as well as a large number of other related compounds - The '113 patent was a "selection patent" - The Federal Court considered the issue of whether the '113 patent was invalid on the ground of obviousness - The court stated that the test for obviousness assumed an inventive step in arriving at the subject matter of the patent in issue and that it could not find an inventive step in Lilly's decision to develop olanzapine - The court also could not conclude that the selection of olanzapine as a development compound was an obvious choice - It was not "more or less self-evident" that olanzapine would work - The court stated that the best way to characterize olanzapine in 1991 was that it was an "almost invention" - It was neither obvious nor a genuine invention - It was a compound that showed promise and, later, some of the early positive indications were borne out - The court concluded that the development of olanzapine was neither obvious nor an invention - The court emphasized that it was using the term "invention" strictly in the legal sense, as the law applied to selection patents - See paragraphs 143 to 149.

Cases Noticed:

Eli Lilly Canada Inc. v. Apotex Inc. et al. (2007), 311 F.T.R. 21; 2007 FC 455, refd to. [para. 5].

Eli Lilly Canada Inc. v. Apotex Inc. et al. (2008), 375 N.R. 381; 2008 FCA 44, refd to. [para. 5].

Eli Lilly Canada Inc. v. Novopharm Ltd. et al., [2007] F.T.R. Uned. 828; 2007 FC 596, refd to. [para. 6].

Eli Lilly Canada Inc. v. Novopharm Ltd. et al. (2007), 370 N.R. 140; 2007 FCA 359, refd to. [para. 6].

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. 12].

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. 48].

I.G. Farbenindustrie A-G's Patents, Re (1930), 47 R.P.C. 289 (Ch. Div.), refd to. [para. 48].

Eli Lilly Canada Inc. v. Apotex Inc. et al. (2009), 392 N.R. 243; 2009 FCA 97, refd to. [para. 90].

Pfizer Canada Inc. et al. v. Canada (Minister of Health) et al. (2006), 351 N.R. 189; 2006 FCA 214, refd to. [para. 119].

Dreyfus and Other Applications, Re (1945), 62 R.P.C. 125, refd to. [para. 119].

GlaxoSmithKline Inc. et al. v. Pharmascience Inc. et al. (2008), 328 F.T.R. 241; 2008 FC 593, refd to. [para. 120].

Sanofi-Synthelabo Canada Inc. et al. v. Apotex Inc. et al. (2005), 271 F.T.R. 159; 2005 FC 390, refd to. [para. 123].

Ratiopharm Inc. v. Pfizer Ltd. (2009), 350 F.T.R. 250; 2009 FC 711, refd to. [para. 151].

Statutes Noticed:

Patent Act, R.S.C. 1985, c. P-4, sect. 53, sect. 73 [para. 150].

Counsel:

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

Jonathan Stainsby, Andrew Skodyn, Andy Radhakant, Neil Fineberg and Trent Morris, 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 was heard on various dates between November 17, 2008, and April 3, 2009, at Toronto and Ottawa, Ontario, before O'Reilly, J., of the Federal Court, who delivered the following judgment on October 5, 2009.