Canadian Biotechnology & Pharmaceutical Law Bulletin

Volume 4 - January, 1997

This newsletter is not intended to constitute a legal opinion on any of the issues discussed. Readers should seek professional legal advice on issues of concern to them - we would be pleased to elaborate on any of the articles herein and discuss how it might apply to specific problems. Contact us for more information.

Extinguishment of compulsory license affecting sub-licensee:

Janssen Pharmaceutica Inc. v. Nu-Pharm Inc. (1996), 68 C.P.R. (3d) 243, Federal Court Trial Division

HELD: The statutory extinguishment of an interim compulsory license held by one company completely terminated any rights of the second company to tablet and sell the medicine, which rights had been acquired under a license from the first company.

Definition of medicine for notice of compliance provisions:

Eli Lilly & Co. v. Apotex Inc. (1996), 68 C.P.R. (3d) 126, Federal Court of Appeal

HELD: In order to be defined as a medicine, as defined in the Notice of Compliance Regulations, a substance must be intended for or capable of one of the precise medical uses enumerated in those Regulations. If the substance in question does not fit into those categories it will fall outside of the scope of those Regulations.

Relevance of patent file histories in patent infringement actions:

Richter Gedeon Vegyeszeti RT v. Merck & Co. (1996), 68 C.P.R. (3d) 8, Federal Court Trial Division

In patent infringement action, issue arose as to whether or not witnesses needed to answer questions surrounding the patent file histories of a Canadian patent and a corresponding Hungarian patent to illuminate the state of the prior art.

HELD: Where prosecution file history is useful, certain portions may need to be disclosed. The witnesses were required to answer questions regarding the experience of the witnesses along with their exposure to any relevant materials prior to the priority date.

Nature of evidence required on injunctive relief applications in patent infringement cases:

Plastichange International Inc. v. 2964-9004 Quebec Inc. (1996), 68 C.P.R. (3d) 102, Federal Court Trial Division

Plaintiff applied for an injunction restraining the defendant throughout the completion of a patent infringement lawsuit surrounding patent for a coin container.

HELD: The amount of lost sales to potentially be suffered by the plaintiff were quantifiable and therefore compensable by damages - this did not form a solid ground upon which to grant the injunction. The Court refused to grant an injunction on the basis that evidence of irreparable harm filed by plaintiff was speculative and not clear. In order to succeed in an application for injunctive relief, clear non-speculative evidence of irreparable harm must be shown, along with the balance of convenience favoring the applicant.

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