Eli Lilly Canada Inc. v. Mylan Pharmaceuticals ULC et al., (2015) 475 F.T.R. 267 (FC)

• Judge: de Montigny, J.
• Court: Federal Court (Canada)
• Case Date: February 23, 2015
• Jurisdiction: Canada (Federal)
• Citations: (2015), 475 F.T.R. 267 (FC);2015 FC 178

Eli Lilly Can. v. Mylan Pharmaceuticals (2015), 475 F.T.R. 267 (FC)

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Temp. Cite: [2015] F.T.R. TBEd. MR.026

Eli Lilly Canada Inc. (applicant) v. Mylan Pharmaceuticals ULC and The Minister of Health (respondents) and ICOS Corporation (respondent patentee)

(T-299-13; 2015 FC 178)

Indexed As: Eli Lilly Canada Inc. v. Mylan Pharmaceuticals ULC et al.

Federal Court

de Montigny, J.

February 23, 2015.

Summary:

Eli Lilly Canada Inc. (Lilly) applied for an order to prohibit the issuance of a Notice of Compliance to Mylan Pharmaceuticals ULC (Mylan) for a generic version of tadalafil, sold by Lily under the brand name CIALIS, until after the expiration of the Canadian Patent 2,379,948 (the '948 Patent). The '948 Patent was directed to a pharmaceutical formulation of reduced particle size of tadalafil with particular excipients (components) for the treatment of erectile dysfunction. Mylan alleged in its Notice of Allegation that the '948 Patent would not be infringed because its product would not contain the particle size of tadalafil and the quantities of excipients claimed in the Patent. Mylan further alleged that the '948 Patent was invalid because it was obvious.

The Federal Court found that Mylan's allegations as to the invalidity of the '948 Patent and as to non-infringement were justified, and dismissed Lilly's application.

Evidence - Topic 7002

Opinion evidence - Expert evidence - General - Acceptance, rejection and weight to be given to expert opinion - [See first Patents of Invention - Topic 2926 ].

Food and Drug Control - Topic 1108.2

Drugs - New drugs - Notice of compliance - Prohibition order (incl. compensation by first person) - Eli Lilly Canada Inc. (Lilly) applied for an order to prohibit the issuance of a Notice of Compliance to Mylan Pharmaceuticals ULC (Mylan) for a generic version of tadalafil, sold by Lily under the brand name CIALIS, until after the expiration of the Canadian Patent 2,379,948 (the '948 Patent) - The '948 Patent was directed to a pharmaceutical formulation of reduced particle size of tadalafil with particular excipients (components) for the treatment of erectile dysfunction - Mylan alleged in its Notice of Allegation that the '948 Patent would not be infringed because its product would not contain the particle size of tadalafil and the quantities of excipients claimed in the '948 Patent - Mylan further alleged that the '948 Patent was invalid because it was obvious - The Federal Court dismissed Lilly's prohibition application - Mylan's allegations as to the invalidity of the '948 Patent and as to non-infringement were justified.

Patents of Invention - Topic 1032

The specification and claims - Construction of a patent - Particular patents - "Lilly" applied for an order to prohibit the issuance of a Notice of Compliance to "Mylan" for a generic version of tadalafil, sold by Lily under the brand name CIALIS, until after the expiration of the Canadian Patent 2,379,948 - Tadalafil, first discovered at Glaxo, was poorly soluble - Glaxo and ICOS worked to find a suitable formulation - When the collaboration between ICOS and Glaxo ended, their studies were transferred to Dr. Kral, the co-inventor of the invention claimed in the patent - Dr. Kral was a fact witness for Lilly - Mylan argued that the Court should give no weight to Dr. Kral's evidence - The Federal Court held that the fact that Dr. Kral was not personally involved with the early studies did not prevent her from introducing those studies into evidence - "As an inventor, she used those studies to take the formulation process to its final stage, and the portion of her testimony devoted to the early formulation work on tadalafil at Glaxo is really confined to a description of that work on the basis of these studies. I fail to see anything improper in her doing so; she refrained from offering her own views of these studies, as she was not called as an expert witness, and she did not give evidence on Glaxo's work on tadalafil beyond the four corners of the studies that were transferred to her" - See paragraphs 41 and 42.

Patents of Invention - Topic 1032

The specification and claims - Construction of a patent - Particular patents - Claim 1 of the Canadian Patent 2,379,948 (the '948 Patent) claimed a formulation of tadalafil "wherein said [tadalafil] is provided as free drug comprising particles wherein at least 90% of the particles of the compound have a particle size less than about 40 microns" - In its Notice of Allegation, "Mylan" alleged that its generic product would not contain the particle size of tadalafil and the excipients claimed in the '948 Patent - The most critical issue that divided the parties and the experts was the moment at which particle size should be measured - Lilly argued that a purposive construction led to the conclusion that particle size must be measured after formulation - The Federal Court rejected the argument as "[d]isregarding completely the wording of the Patent. ... The problem with this construction is that it is neither supported by the language of the Patent itself nor by the experts. Claim 1 defines the pharmaceutical formulation 'wherein said compound [tadalafil] is provided as free drug comprising particles' of the defined sizes. That language clearly indicates that the particle size claimed is of the tadalafil particles going into the formulation. ... It can hardly be clearer, therefore, that the particles to be measured are the tadalafil particles before they are combined with the excipients." - See paragraphs 102 to 106.

Patents of Invention - Topic 1589

Grounds of invalidity - Lack of "inventive ingenuity" (obviousness) - Particular patents - "Lilly" applied for an order to prohibit the issuance of a Notice of Compliance to "Mylan" for a generic version of tadalafil, sold by Lily under the brand name CIALIS, until after the expiration of the Canadian Patent 2,379,948 (the '948 Patent) - The Federal Court found that Mylan's allegation that the '948 Patent was invalid for obviousness was justified - There was nothing inventive about using the common excipients used in the formulation of tadalafil found in the '948 Patent - The Court agreed with Mylan's expert witness (Dr. Brittain) that the preferred excipients disclosed in the '948 Patent were among the most commonly available and used at the relevant time - Moreover, the weight percentage rates for those excipients in the '948 Patent were virtually identical to those disclosed in the leading treatises - The choice of the excipients and of their specific amounts was well within the common general knowledge of the skilled person - Moreover, "the test is not whether a skilled person would know for certain that a formulation would work or whether there is a guarantee that particular formulations would work ... . The test, rather, is whether the skilled person had good reason to pursue predictable solutions or solutions that provide a 'fair expectation of success'. ... [E]ven if the standard is not 'fair expectation of success', I find that the invention was 'obvious to try' ... . In a field where routine trials are carried out, it cannot be said that the extent, nature and amount of effort required to select the excipients and their percentage is such that it would bring it beyond the realm of the 'obvious to try' analysis." - See paragraphs 149 to 151.

Patents of Invention - Topic 1589

Grounds of invalidity - Lack of "inventive ingenuity" (obviousness) - Particular patents - "Lilly" applied for an order to prohibit the issuance of a Notice of Compliance to "Mylan" for a generic version of tadalafil, sold by Lily under the brand name CIALIS, until after the expiration of the Canadian Patent 2,379,948 (the '948 Patent) - The Federal Court found that Mylan's allegation that the '948 Patent was invalid for obviousness was justified - With respect to the particle size, "the reduction of the particle size was an obvious route to try, even if it was not possible to be sure that taking this route would produce success. ... [T]he test is not whether a skilled person could have predicted the result with certainty, but rather whether there could be a fair expectation of success. Once prior art is taken into consideration, there was a finite number of approaches to improving solubility, and two of the most obvious were ruled out either because they were not available or because they had been tried without success." - See paragraphs 152 to 159.

Patents of Invention - Topic 2926

Infringement of patent - Acts not constituting an infringement - Of particular patents -"Lilly" applied for an order to prohibit the issuance of a Notice of Compliance to "Mylan" for a generic version of tadalafil, sold by Lily under the brand name CIALIS, until after the expiration of the Canadian Patent 2,379,948 (the '948 Patent) - "Mylan" alleged non-infringement; specifically, that its formulation would not use the claimed amount of hydrophilic binder - Counsel for Lilly stated that "a lot of it just comes down to which expert the Court is going to go with" and submitted that the opinion of its expert witness (Dr. Bodmeier) should be preferred because he was the real expert in the field, while the expertise of Mylan's expert witness (Dr. Brittain) was limited to being the "analytical guy" - The Federal Court rejected the argument - "First of all, even if the Court was left only with Dr. Bodmeier's opinion, it would be far from sufficient to discharge the burden of moving beyond speculation and hypothesis, and therefore does not meet the balance of probabilities standard. Moreover, I find that Dr. Brittain has significant expertise both academically and in industry with the design and development of drug formulations. ... [I]t would be unfair to characterize Dr. Brittain as an 'analytical guy' with little or no practical experience with formulation. If anything, Dr. Bodmeier would better fit that profile" - See paragraphs 92 and 93.

Patents of Invention - Topic 2926

Infringement of patent - Acts not constituting an infringement - Of particular patents - "Lilly" applied for an order to prohibit the issuance of a Notice of Compliance to "Mylan" for a generic version of tadalafil, sold by Lily under the brand name CIALIS, until after the expiration of the Canadian Patent 2,379,948 (the '948 Patent) - Mylan made two allegations of non-infringement: (1) Mylan-Tadalafil would not contain tadalafil whereby at least 90% of the tadalafil particles were less than about 40 microns in size, less than about 30 microns in size, less than about 25 microns in size, less than about 15 microns in size or less than about 10 microns in size, and thus would not infringe claims 1 to 33; and (2) Mylan-Tadalafil would not contain about 1% to about 5% by weight of a hydrophilic binder, and thus would not infringe claims 1 to 33 - The Federal Court held that Lilly had not met its burden to establish that Mylan's allegations of non-infringement were not justified - Lilly had failed to meet its burden of proving on a balance of probabilities that Mylan-Tadalafil would contain "about 1% to about 5%, by weight, of a hydrophilic binder" - See paragraphs 83 to 95 - Lilly had submitted no evidence to show that it was more likely than not that Mylan's milling process would not only reduce the tadalafil particle size, but would do so significantly enough to bring it within the claims of the '948 Patent - See paragraphs 96 to 133.

Cases Noticed:

Apotex v. Cephalon, 2012 WL 1080148 (Dist. Co. PA), refd to. [para. 72].

Free World Trust v. Électro Santé Inc. et al., [2000] 2 S.C.R. 1024; 263 N.R. 150; 2000 SCC 66, refd to. [para. 78].

Pfizer Canada Inc. et al. v. Novopharm Ltd. et al. (2005), 341 N.R. 330; 2005 FCA 270, refd to. [para. 82].

Eli Lilly Canada Inc. v. Apotex Inc. et al. (2009), 346 F.T.R. 78; 2009 FC 320, refd to. [para. 82].

Glaxo Group Ltd. v. Canada (Minister of National Health and Welfare) (1998), 147 F.T.R. 298; 80 C.P.R.(3d) 424 (T.D.), refd to. [para. 82].

Sanofi-Aventis Canada Inc. v. ratiopharm Inc. et al. (2010), 367 F.T.R. 307; 2010 FC 230, refd to. [para. 88].

AB Hassle et al. v. Apotex et al. (2001), 204 F.T.R. 248; 2001 FCT 530, refd to. [para. 99].

Fournier Pharma Inc. et al. v. Canada (Minister of Health) et al. (2012), 413 F.T.R. 239; 2012 FC 740, refd to. [para. 112].

Takeda Pharmaceutical Co. v. Zydus Pharmaceuticals USA Inc. (2014), 743 F(3d) 1359 (Fed. Cir.), refd to. [para. 112].

Eli Lilly Canada Inc. v. Mylan Pharmaceuticals ULC et al. (2015), 474 F.T.R. 256; 2015 FC 125, refd to. [para. 134].

AB Hassle et al. v. Canada (Minister of National Health and Welfare) et al. (2000), 256 N.R. 172; 7 C.P.R.(4th) 272 (F.C.A.), refd to. [para. 137].

Beloit Canada Ltd. v. Valmet Oy (1986), 64 N.R. 287; 8 C.P.R.(3d) 289 (Fed. C.A.), refd to. [para. 141].

Pfizer Canada Inc. et al. v. Apotex Inc. et al. (2009), 385 N.R. 148; 2009 FCA 8, refd to. [para. 150].

AstraZeneca Canada Inc. et al. v. Teva Canada Ltd. et al. (2013), 428 F.T.R. 269; 2013 FC 245, refd to. [para. 150].

Shire Biochem Inc. et al. v. Canada (Minister of Health) et al. (2008), 328 F.T.R. 123; 2008 FC 538, refd to. [para. 150].

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. 151].

Statutes Noticed:

Patent Act, R.S.C. 1985, c. P-4, sect. 28.3 [para. 134].

Counsel:

Jamie Mills, Beverley Moore and Ryan Steeves, for the applicant and the respondent patentee;

Tim Gilbert, Maxwell Morgan and Zarya Cynader, for the respondent, Mylan Pharmaceuticals ULC.

Solicitors of Record:

Borden Ladner Gervais LLP, Ottawa, Ontario, for the applicant and the respondent patentee;

Gilbert's LLP, Toronto, Ontario, for the respondent, Mylan Pharmaceuticals ULC;

William F. Pentney, Deputy Attorney General of Canada, Toronto, Ontario, for the respondent, The Minister of Health.

This application was heard at Ottawa, Ontario, on October 27-30, 2014, before de Montigny, J., of the Federal Court. The Court delivered the following public judgment and reasons, dated February 23, 2015.