Eli Lilly Canada Inc. v. Apotex Inc. et al., 2015 FC 1016

• Judge: Gleason, J.
• Court: Federal Court (Canada)
• Case Date: August 26, 2015
• Jurisdiction: Canada (Federal)
• Citations: 2015 FC 1016;[2015] F.T.R. TBEd. SE.029

Eli Lilly Can. Inc. v. Apotex Inc., [2015] F.T.R. TBEd. SE.029

MLB being edited

Currently being edited for F.T.R. - judgment temporarily in rough form.

Temp. Cite: [2015] F.T.R. TBEd. SE.029

Eli Lilly Canada Inc. (applicant) v. Apotex Inc. and The Minister of Health (respondents) and Icos Corporation (respondent patentee)

(T-1599-13; 2015 FC 1016)

Indexed As: Eli Lilly Canada Inc. v. Apotex Inc. et al.

Federal Court

Gleason, J.

September 11, 2015.

Summary:

Eli Lilly Canada Inc. applied for an order under s. 6 of the Patented Medicines (Notice of Compliance) Regulations, to prohibit the Minister of Health from issuing Notices of Compliance (NOCs) to Apotex Inc. for approval to sell generic versions of CIALIS and ADCIRCA until after the expiry of the Canadian Patent 2,379,948 (the '948 Patent) on April 26, 2020. Eli Lilly marketed CIALIS principally for the treatment of erectile dysfunction and ADCIRCA for the treatment of pulmonary arterial hypertension. The '948 Patent was a formulation patent for tadalafil, the active pharmaceutical ingredient in both CIALIS and ADCIRCA, that claimed formulations with a reduced particle size and certain excipients to address tadalafil's poor water solubility. At issue was whether Apotex's products infringed the '948 Patent and whether the '948 Patent was invalid for obviousness or lack of utility.

The Federal Court dismissed the application. Apotex's allegation of non-infringement was justified. The court also concluded that Apotex's allegation of obviousness was justified, but that its allegation of non-utility was not justified.

Courts - Topic 2015

Jurisdiction - General principles - Controlling abuse of its process - [See first Food and Drug Control - Topic 1108.2 ].

Food and Drug Control - Topic 1108.2

Drugs - New drugs - Notice of compliance - Prohibition order - Eli Lilly applied for an order under s. 6 of the Patented Medicines (Notice of Compliance) Regulations, to prohibit the Minister of Health from issuing Notices of Compliance to Apotex Inc. for approval to sell generic versions of CIALIS and ADCIRCA - Apotex argued that the proceedings were an abuse of process because another Federal Court judge had ruled against Eli Lilly in a similar case involving another generic company (i.e., the Mylan case) - The Federal Court held that in the rather unique circumstances of this case, the application was not an abuse of process and fairness required that Eli Lilly be allowed to pursue the application - The Mylan decision was still pending appeal - Elily Lilly would be more severely prejudiced than Apotex if the application was dismissed summarily and would lose its ability to have the application heard on the merits - That would be to its severe prejudice if it was successful on the Mylan appeal - See paragraphs 11 to 28.

Food and Drug Control - Topic 1108.2

Drugs - New drugs - Notice of compliance - Prohibition order - Section 6(5)(b) of the Patented Medicines (Notice of Compliance) Regulations (PMNOC Regulations) gave the court the discretion to stay prohibition applications brought under s. 6 of the Regulations where they were "redundant, scandalous, frivolous or vexatious" or "otherwise an abuse of process in respect of one or more patents" - The Federal Court, per Gleason, J., in deciding whether to dismiss an application under s. 6(5)(b) stated that: "... the decision on whether to dismiss an application like the present as being abusive is a discretionary one: paragraph 6(5)(b) of the PMNOC Regulations confirms that I may dismiss this application if I find it to be an abuse of process. In exercising my discretion in this case, I believe the key issue for consideration involves determination of which party will be more severely prejudiced by a negative determination on the dismissal request" - See paragraph 19.

Food and Drug Control - Topic 1108.2

Drugs - New drugs - Notice of compliance - Prohibition order - [See Patents of Invention - Topic 2926 ].

Patents of Invention - Topic 1582

Grounds of invalidity - Lack of "inventive ingenuity" (obviousness) - Test for obviousness - The Federal Court reviewed the principles applicable in determining whether a patent was invalid on the ground of obviousness - See paragraphs 74 to 77.

Patents of Invention - Topic 1589

Grounds of invalidity - Lack of "inventive ingenuity" (obviousness) - Particular patents - In the context of Notice of Compliance proceedings, an issue arose as to whether Apotex's generic products infringed a patent owned by Eli Lilly (i.e., the '948 patent) respecting tadalafil, the active ingredient in CIALIS (an erectile dysfunction drug) and ADCIRCA (a pulmonary arterial hypertension drug) - The '948 Patent was a formulation patent for tadalafil that claimed formulations with a reduced particle size and certain excipients to address tadalafil's poor water solubility - Apotex also claimed that the '948 Patent was invalid for obviousness - The Federal Court dismissed the prohibition application because Apotex's allegation of non-infringement was justified - The court opined, however, that Apotex's allegation of obviousness was justified - The court concluded that the use of of tadalafil in free drug form, reducing its particle size and formulating it with the excipients claimed in the '948 Patent were obvious steps to try in order to achieve a stable and more rapidly-dissolving formulation of tadalafil - See paragraphs 78 to 114.

Patents of Invention - Topic 1721

Grounds of invalidity - Lack of utility and operability - General (incl. "promise of the patent") - The Federal Court reviewed the principles applicable in determining whether a patent was invalid for inutility - See paragraphs 115 to 122.

Patents of Invention - Topic 1721

Grounds of invalidity - Lack of utility and operability - General (incl. "promise of the patent") - In the context of Notice of Compliance proceedings, an issue arose as to whether Apotex's generic products infringed a patent owned by Eli Lilly (i.e., the '948 patent) respecting tadalafil, the active ingredient in CIALIS (an erectile dysfunction drug) and ADCIRCA (a pulmonary arterial hypertension drug) - Apotex also alleged that the patent was invalid for lack of utility - The Federal Court stated that "... the parties disagree on whether a patent must reference the studies or data demonstrating utility. In my view, the data demonstrating utility need not be referenced in a patent and, therefore, Lilly may rely on the studies appended to the affidavits of Drs. Kral and Pullman in support of its demonstration of the 948 Patent's utility. In this regard, the traditional rule was that while there may well be a disclosure requirement for the factual basis for sound prediction, there is no disclosure requirement for demonstrated utility which may be met if the patentee can defend demonstrated utility on a challenge. This demonstration usually requires evidence beyond what is in the patent ..." - See paragraphs 138 to 142.

Patents of Invention - Topic 1723

Grounds of invalidity - Lack of utility and operability - Chemical products and substances intended for food and medicine - In the context of Notice of Compliance proceedings, an issue arose as to whether Apotex's generic products infringed a patent owned by Eli Lilly (i.e., the '948 patent) respecting tadalafil, the active ingredient in CIALIS (an erectile dysfunction drug) and ADCIRCA (a pulmonary arterial hypertension drug) - The '948 Patent was a formulation patent for tadalafil that claimed formulations with a reduced particle size and certain excipients to address tadalafil's poor water solubility - Apotex also alleged that the patent was invalid for lack of utility - Eli Lilly relied on demonstrated utility to uphold the patent as opposed to the doctrine of sound prediction - The Federal Court dismissed the prohibition application because Apotex's allegation of non-infringement was justified - The court opined also that Apotex's allegation on inutility was not justified - See paragraphs 123 to 142.

Patents of Invention - Topic 1725

Grounds of invalidity - Lack of utility and operability - Particular patents - [See Patents of Invention - Topic 1723 ].

Patents of Invention - Topic 2926

Infringement of patent - Acts not constituting an infringement - Of particular patents - In the context of Notice of Compliance proceedings, an issue arose as to whether Apotex's generic products infringed a patent owned by Eli Lilly (i.e., the '948 patent) respecting tadalafil, the active ingredient in CIALIS (an erectile dysfunction drug) and ADCIRCA (a pulmonary arterial hypertension drug) - The '948 Patent was a formulation patent for tadalafil that claimed formulations with a reduced particle size and certain excipients to address tadalafil's poor water solubility - Apotex alleged non-infringement because it used a different binder in the composition of its tablets - That is, the generic versions did not contain approximately 50 to 85% by weight of a water-soluble diluent nor approximately 1 to 5% by weight of a hydrophilic binder selected from the group consisting of a cellulose derivative, povidone, or a mixture thereof and thus fell below the amounts required by the '948 Patent - The Federal Court held that Apotex's non-infringement allegation was justified and, therefore, dismissed Eli Lilly's prohibition application - See paragraphs 47 to 72.

Patents of Invention - Topic 2945

Infringement of patent - Chemical products and substances intended for food and medicine - Particular patents - [See Patents of Invention - Topic 2926 ].

Counsel:

Jamie Mills, Beverley Moore and Chantal Saunders, for the applicant and respondent Patentee;

Harry Radomski, Jordan Scopa and Sandon Shogilev, for the respondent, Apotex Inc.

Solicitors of Record:

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

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

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

This application was heard in Ottawa, Ontario, from May 25 to 28, 2015, before Gleason, J., who released confidential reasons on August 26, 2015, followed by the release of a public redacted version of the decision on September 11, 2015.