BETWEEN:
BIOVAIL CORPORATION (d.b.a. BIOVAIL PHARMACEUTICALS CANADA)
and
THE MINISTER OF NATIONAL HEALTH AND WELFARE
Heard at Toronto, Ontario, on March 9, 2006.
Judgment delivered at Ottawa, Ontario, on March 13, 2006.
REASONS FOR JUDGMENT BY: EVANS J.A.
CONCURRED IN BY: DÉCARY J.A.
MALONE J.A.
Docket: A-427-05
Citation: 2006 FCA 105
CORAM: DÉCARY J.A.
EVANS J.A.
MALONE J.A.
BETWEEN:
BIOVAIL CORPORATION (d.b.a. BIOVAIL PHARMACEUTICALS CANADA)
Appellant
and
THE MINISTER OF NATIONAL HEALTH AND WELFARE
Respondent
REASONS FOR JUDGMENT
[1] This is an appeal from a decision of O'Reilly J. of the Federal Court dismissing an application for judicial review by Biovail Corporation of the refusal by the Minister of National Health and Welfare to include on the patent register its patent for "Controlled Release Formulations Using Intelligent Polymers" (Canadian Patent No. 2,286,684) ("the '684 patent"). Biovail had asked that the patent be included on the patent register in respect of two drugs, WELLBUTRIN SR and TIAZAC XC, in accordance with the Patented Medicines (Notice of Compliance) Regulations, SOR/93-133.
[2] The Applications Judge held that the Minister had correctly concluded that the '684 patent was not eligible to be listed on the register since it did not "contain a claim for the medicine itself" as required by paragraph 4(2)(b) of the Regulations. The Judge agreed that, properly construed, the invention claimed in the patent was for a system for delivering the named active ingredients to the patient, not for the medicine itself.
[3] The decision under appeal is reported as Biovail Corporation (d.b.a. Biovail Pharmaceuticals Canada) v. Canada(Minister of National Health and Welfare), 2005 FC 1135.
[4] Despite the very able submissions of Mr Deeth, counsel for Biovail, I would dismiss the appeal for substantially the reasons given by the Judge.
[5] Counsel for Biovail submitted that claim 30 of the patent is manifestly "a claim for the medicine itself" within the meaning of paragraph 4(2)(b). Claim 30 states:
30. The composition of claim 1, 13 or 18, wherein the pharmaceutically active substance is selected from the group consisting of glipizide, diltiazem hydrochloride, bupropion, buspirone hydrochloride, tramadol hydrochloride and verapamil. [emphasis added]
The active ingredients underlined are contained in the appellants' drugs, WELLBUTRIN SR and TIAZAC XC.
[6] Counsel argued that claim 30 was for a composition of the named active ingredients, including those found in the tablets in question, and two "intelligent polymers" which ensured the slow release of the active ingredients into the patient's body. He submitted that, since the active ingredients were uniformly and intimately mixed with the polymers, and were not separated by any structure, the tablets were not a "delivery system", but the medicine itself.
[7] I do not agree. Whether a patent claims a composition, which can be "the medicine itself", or a delivery system for medicine, is a question of construing the patent. While each claim of the patent must be considered individually, they must not be construed in isolation from the other claims and the rest of the patent. In my view, when considered in the context of the '684 patent as a whole, claim 30 should be construed as a claim for the use of the polymers to achieve the slow release of six of the 40 or so active ingredients mentioned in the patent. The claimed invention is thus not the medicine itself.
[8] It is important to reiterate that this decision does not cast doubt on the validity of the patent, but merely denies Biovail the extraordinary remedial advantage provided by the Regulations to the holders of patents falling within their scope.
[9] For these reasons, I would dismiss the appeal with costs.
"I agree
Robert Décary J.A."
"I agree
B. Malone J.A."
FEDERAL COURT OF APPEAL
NAME OF COUNSEL AND SOLICITORS OF RECORD
DOCKET: A-427-05
STYLE OF CAUSE: BIOVAIL CORPORATION v. THE MINISTER OF NATIONAL HEALTH & WELFARE
PLACE OF HEARING: TORONTO, ONTARIO
DATE OF HEARING: THURSDAY, MARCH 9, 2006
REASONS FOR JUDGMENT BY: EVANS J.A.
CONCURRED IN BY: DÉCARY AND MALONE J.A.
APPEARANCES:
Douglas Deeth
Heather Watts FOR APPELLANT
Rick Woyiwada FOR RESPONDENT
Mr. John Pro
SOLICITORS OF RECORD:
Deeth Williams Wall LLP
Barristers & Solicitors
Toronto, Ontario FOR APPELLANT
John H. Sims, Q.C.