Pfizer Canada Inc. v. Canada (Santé), 2007 CAF 209 (2007)

Date: 20070531

Docket: A-457-05

Citation: 2007 FCA 209

CORAM: LINDEN J.A.

NADON J.A.

SEXTON J.A.

BETWEEN:

PFIZER CANADA INC., WARNER-LAMBERT COMPANY LLC

and PARKE, DAVIS & COMPANY LLC

Appellants

and

THE MINISTER OF HEALTH

and APOTEX INC.

Respondents

Heard at Toronto, Ontario , on September 27 and 28, 2006.

Judgment delivered at Ottawa, Ontario , on May 31,, 2007.

REASONS FOR JUDGMENT BY: NADON J.A.

CONCURRED IN BY: LINDEN J.A.

SEXTON J.A.

Date: 20070531

Docket: A-457-05

Citation: 2007 FCA 209

CORAM: LINDEN J.A.

NADON J.A.

SEXTON J.A.

BETWEEN:

PFIZER CANADA INC., WARNER-LAMBERT COMPANY LLC

and PARKE, DAVIS & COMPANY LLC

Appellants

and

THE MINISTER OF HEALTH

and APOTEX INC.

Respondents

REASONS FOR JUDGMENT

NADON J.A.

[1] We are once again, but certainly not for the last time, called upon to determine a dispute between a patentee and a generic competitor which arises pursuant to the Patented Medicines (Notice of Compliance) Regulations , SOR/93-133, March 12, 1993 (the “Regulations”).

[2] More particularly, the matter before us arises from an application brought by the appellants (“Pfizer”) pursuant to section 6 of the Regulations for an order prohibiting the Minister of Health (the “Minister”) from issuing a notice of compliance (a “NOC”) to the respondent Apotex in respect of its drug product apo-quinapril until the expiration of Canadian letters patent numbers 1,341,330 (the “ ‘330 patent ”) and 1,331,615 (the “ ‘615 patent ”).

[3] Pfizer’s application was heard by Heneghan J. of the Federal Court who, on September 28, 2005, dismissed it (2005 FC 1205). By its appeal, Pfizer seeks an order setting aside the Federal Court’s decision and declaring that the Minister is prohibited from issuing a NOC to Apotex until the expiration of the ‘330 and ‘615 patents.

[4] For a proper understanding of the questions which this appeal raises, the following review of the facts will be helpful.

THE FACTS

[5] Not surprisingly, the ‘330 patent, a genus patent for a novel group of compounds, including quinapril, and the ‘615 patent, a species patent for quinapril hydrochloride in various solid forms, are at the heart of this appeal.

[6] Quinapril-hydrochloride is an angiotensin-converting enzyme (ACE inhibitor). By inhibiting the transformation of angiotensin I to angiotensin II (the form which raises blood pressure), quinapril hydrochloride is useful in the treatment of high blood pressure, congestive heart failure and the prevention of kidney failure. Pfizer markets quinapril-hydrochloride in tablet form under the trade name Accupril .

[7] The ‘330 patent, entitled “Substituted Acyl Derivatives of 1,2,3,4- tetrahydroisoquinoline-3-Carboxylic Acids”, was applied for in the Canadian Patent Office on September 30, 1981, with a priority date of October 3, 1980. Because of conflict proceedings which were initiated in respect of the ‘330 patent and a patent involving a German patent owned by Hoechst Aktiengessellschaft (Hoechst), the patent was not issued until January 1, 2002. This followed a consent judgment entered on December 22, 1999 which allowed the claims of the patent to issue in Canada . The patent was issued to Parke, Davis & Company LLC. The ‘330 patent is a genus patent which claims a novel group or family of chemical compounds, including quinapril and other ACE inhibitors. All of the compounds claimed share a common structure consisting of a THIQ head and an enalapril tail.

[8] The ‘615 patent, entitled “Substituted Acyl Derivatives of 1,2,3,4,-Tetrahydroisoquinoline-3-Carboxylic Acids” was applied for, as a divisional application derived from the ‘330 patent, on June 23, 1992, by the assignee, Warner-Lambert Company LLC. The patent, which issued on August 23, 1994 claims a narrow subclass of the compounds claimed in the ‘330 patent, including the hydrochloride salt of quinapril.

[9] On July 18, 2003, pursuant to subsection 5(3) of the Regulations, Apotex filed and served a Notice of Allegation (“NOA”) which says that the ‘615 patent would not be infringed by the manufacturing and marketing of its drug product apo-quinapril in tablet form, on the grounds that its tablets would not comprise any of the compounds covered by the ‘615 patent, nor would such compounds be made, constructed or used in the manufacture of its tablets. As a result, Apotex says that the claims of the ‘615 patent would not be infringed.

[10] On July 24, 2003, Apotex filed a second NOA which says that the ‘330 patent is invalid for lack of utility, lack of sound prediction, anticipation, obviousness, overly-broad claims and double patenting.

[11] On September 5, 2003, Pfizer filed its application for an order of prohibition before the Federal Court, asserting that Apotex’s allegations of non-infringement and of in...

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