Biotechnology & Pharmaceutical Practice Group Newsletter

Health Canada Attempts to Bring Clarity to Pharma Patents & Litigation

Health Canada has published a draft guidance document for interpretation of the Patented Medicines (Notice of Compliance) Regulations (“NOC Regulations”). Comments must be provided to Health Canada no later than March 27, 2007. Background on the NOC Regulations is provided at the end of this article.

Please contact Bereskin & Parr for a copy of the draft guidance document or further information about providing comments to Health Canada.

The guidance document was developed following amendments to the NOC Regulations that came into force in October 2006. The amendments were largely intended to reduce the opportunities provided to brand name companies to use NOC Regulations to block generic drugs from Canadian market entry.

The guidance document outlines Health Canada’s relationship with brand name companies and generic companies under the NOC Regulations.

Among the topics addressed in the guidance document are:

• Eligibility of patents for listing on the Health Canada Patent Register via a drug submission;
• Health Canada auditing of the Patent Register;
• Circumstances where patents on the Patent Register can trigger the NOC Regulations;
• Notice of Allegation requirements for generic companies;
• ‘Freezing’ of the Health Canada Patent Register after a generic drug submission is received by Health Canada;
• Procedure for Health Canada issuance of a Notice of Compliance to a generic company; and Complaint mechanisms

The guidance document also provides Health Canada’s position on when the NOC Regulations are triggered in view of the Supreme Court of Canada decision in AstraZeneca Canada Inc. v. Canada, [2006] SCC 49. That case involved the unusual issue of whether a generic company had to address a newly submitted patent list for a drug that was no longer marketed.

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The NOC Regulations - Background

The Food and Drugs Act Regulations deal with health and safety requirements for brand name and generic drug approval. The NOC Regulations create a unique system that can link the Food and Drugs Act approval to patent status. We emphasize that the NOC Regulations do not affect the scope or validity of pharmaceutical patent claims or the ability to bring a patent infringement action. The purpose of the NOC Regulations is to prevent patent infringement. The NOC Regulations create a specialized system that allows patent owners to try to delay government marketing approval (called an “NOC”) for a generic drug until expiry of the relevant “listed” patent. This system is in sharp contrast to conventional patent enforcement that usually involves a patent owner suing for patent infringement after a generic company receives its NOC.

Under the NOC Regulations, patent owners have the option to list certain pharmaceutical patents on a Health Canada Patent Register, which is the Canadian equivalent of the US FDA Orange Book. Before a generic company can get government marketing approval for its generic drug, it has to allege that it would not infringe a valid claim of a patent listed on the Patent Register. If a generic company makes such an allegation, the patent owner has the right to trigger a court proceeding (“NOC Proceeding”) by stating that the generic allegations are not justified and requesting an order prohibiting the government from issuing an NOC to the generic company. The NOC Proceeding typically involves court consideration of evidence on issues such as infringement and validity. The NOC Proceeding can last up to 24 months, during which time the generic company cannot get its NOC. If the generic company wins, it gets its NOC and the patent owner has to sue for patent infringement. If the brand name company wins, the government is prohibited from issuing the NOC to the generic drug until after patent expiry.

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Generic Levofloxacin Infringes Patent

Court orders removal from market - no stay of judgment pending appeal

Last Fall, the Federal Court found that generic drug manufacturer Novopharm infringed a patent for the antimicrobial drug LEVAQUIN (levofloxacin). The patent is owned by Daiichi Pharmaceutical Co., Ltd. and is licensed in Canada to Janssen-Ortho Inc. Mr. Justice Hughes rejected Novopharm’s arguments that the patent was invalid. He awarded the plaintiffs damages and a permanent injunction.

More recently, the Federal Court of Appeal denied Novopharm’s request to stay the trial judgment pending appeal.

Michael Charles, Andrew McIntosh, and Joshua Spicer of Bereskin & Parr acted for Daiichi in the case.

Novopharm Limited v. Janssen-Ortho Inc. and Daiichi Pharmaceutical Co., Ltd., [2006] FC 1234.

Edited by Noel Courage. Please send feedback and suggestions to Noel at
ncourage@bereskinparr.com.

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Last Modified:Thursday, March 29, 2007