Canada: Appeal Relating To Olanzapine Patent Dismissed (Intellectual Property Weekly Abstracts Bulletin: Week Of September 24, 2012)

Last Updated: September 27 2012

Edited by Chantal Saunders and Beverley Moore

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Appeal Relating to Olanzapine Patent Dismissed

Eli Lilly Canada Inc. v. Novopharm Limited

Drug: ZYPREXA®

The Court heard this patent infringement action relating to olanzapine in 2009 and found that the patent was invalid. The Court of Appeal held that the Court erred in finding that the conditions for a valid selection patent can be an independent allegation of invalidity. The Court of Appeal found that the patent at issue was not invalid for anticipation, double patenting or obviousness, and referred the issues of utility and sufficiency back to the Court. Upon reconsideration, the Federal Court held that there was no demonstration of utility and no sound prediction for the promise found by the Court. The patent contained the results of human clinical trials on patients suffering from schizophrenia, and information relating to olanzapine's side effect profile.

The Court of Appeal dismissed the appeal, finding no error of law or principle or any palpable and overriding error of fact.

Other Cases of Interest

Injunction Issued to Prevent Use of Copies of Tests to Prepare Students

Canada (Attorney General) v. Rundle (Nec Plus Ultra)

This is an application in the Ontario Superior Court of Justice for an injunction, in which the Attorney General is seeking to prevent Rundle from continuing to use copies of the Public Service Commission's (PSC) Second Language (French) Evaluation Test (SLE) in her courses to prepare students for the SLE Test. The SLE Tests were developed using taxpayer money to assess applicants for bilingual positions with the Federal Government and are stamped "Subject to Copyright Protection".

The Attorney General established that there is a serious issue to be tried. With respect to irreparable harm, the Court found that the individuals taking Rundle's course that have access to materials that are substantially the same as the official SLE Test have an unfair advantage compared to other test takers. The Court found that access to test questions causes the PSC irreparable harm in that the PSC cannot ensure compliance with the Official Languages Act. Rundle argued that her business would suffer irreparable harm if she was not allowed to continue to use a copy of the test to prepare her students. The Court found that this was not the case because she never had permission to use a copy of the SLE Tests in the first place. Finally, the Court found that the balance of convenience favours allowing Rundle to continue to operate her teaching business but without use of the official SLE Test questions.

Accordingly, Rundle was enjoined from copying, reproducing, distributing, making available to the public or any clients questions that are substantially similar to the SLE Tests.

No Reviewable Error in Rejection of SNDS

Duchesnay Inc. v. Canada (Attorney General)

Drug: DICLECTIN®

This is an application for judicial review of a decision issuing a Notice of Deficiency-Withdrawal (NOD-W) in response to a Supplemental New Drug Submission (SNDS). The decision under review related to the inclusion of two clinical studies. Health Canada refused to include the studies in the Product Monograph.

The Court considered a preliminary issue of whether additional evidence could be filed before the Court. The Court refused to allow the additional evidence, which consisted of an affidavit attaching a transcript of an examination for discovery on the basis that discovery is confidential.

The Court held that there was no reviewable error by the Minister of Health in rejecting the SNDS. Further, the Court held that the Minister of Health did not commit a breach of procedural fairness.

Court Holds Reasonable Finding Relating to Safety and Efficacy of Ingredient

North American Nutriceutical Inc v. Canada (Attorney General)

Drug: TherapeutxTM "Maori Miracle" Joint Health Companion

This is an application pursuant to Section 18.1(1) of the Federal Courts Act, in which the Applicant is seeking judicial review of a decision made by the Natural Health Products Directorate (NHPD) refusing a product licence application.

The Court first noted that the decision by the NHPD is reviewable on a reasonableness standard but a standard of correctness for issues of procedural fairness applies. The Court found that the NHPD came to a reasonable finding that the evidence relating to the safety and efficacy of one of the ingredients of the product was deficient and there was no breach of procedural fairness. The Court found that the NHPD continually noted its concern with respect to the lack of information about the safety of the ingredient in the Applicant's product.

Dismissal of Copyright Infringement Action for Computer Programs Dismissed

Harmony Consulting Ltd. v. G.A. Foss Transport Ltd.

This is an appeal from a decision of the Federal Court, in which the Court dismissed an action for copyright infringement. The Court of Appeal considered grounds of appeal relating to originality, ownership and infringement, and dismissed the appeal.

Patent Appeal Board Finds Sound Prediction and Definite Claims

Commissioner's Decision No. 1329

This decision relates to a patent application entitled "Viruses for the Treatment of Cellular Proliferative Disorders". The Examiner rejected the application on the basis of anticipation, obviousness, lack of support, and/or indefiniteness. The Patent Appeal Board (PAB) found certain claims to be anticipated by the cited prior art. The PAB also found a number of claims obvious.

The Examiner found that the claimed use is not soundly predicted because there was no demonstration of the use of any of the specific viruses recited in the proposed claims and because there was no factual basis nor an enabling specification as undue experimentation would have been required to practice the invention. The PAB found that the claims are based on a properly supported sound prediction and the disclosure was adequately enabled. Finally, the PAB found that the person of skill in the art "would have no difficulty understanding and predicting what modified viruses fall with the scope of the proposed claims and thus, the proposed claims are definite and comply with subsection 27(4) of the Patent Act."

The Commissioner of Patents concurred with the recommendations of the PAB that certain amendments be made to the remaining claims and the application issued.

Other Industry News

CIPO has posted an Update re Amazon.com, indicating that it is still reviewing the feedback from the consultation period for its Practice Notice and will provide a further update at the beginning of October 2012.

The Competition Bureau announced that it has released its final Enforcement Guidelines on the Abuse of Dominance Provisions (Sections 78 and 79 of the Competition Act). The updated guidelines are now available on the Bureau's website.

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