snIP/ITs Insights on Canadian Technology and Intellectual Property Law

Tag Archives: Patented Medicines (Notice of Compliance) Regulations

Revised NOC Regulations to Come Into Force on September 21, 2017

Posted in Intellectual Property, Patents

The Government of Canada has announced that the amended NOC regulations will come into force on September 21, 2017. These amendments will implement sweeping changes to pharmaceutical patent litigation in Canada pursuant to obligations imposed under CETA. The changes will apply to proceedings commenced in respect of NOAs served on or after September 21, 2017.

The final text of the amended NOC Regulations does not differ from the initial draft published on July 15, 2017, as summarized by our previous blog here.… Continue Reading

Supreme Court of Canada to Hear Landmark Pharmaceutical Section 8 Damages Case

Posted in Intellectual Property, Patents

On October 30, 2014, the Supreme Court of Canada granted leave to Sanofi-Aventis’ (“Sanofi”) application for leave to appeal a decision of the Federal Court of Appeal (2014 FCA 68). By granting leave to Sanofi, the Supreme Court will now consider for the first time the correct interpretation of, and the correct legal framework applicable to quantifying section 8 damages under the Patented Medicines (Notice of Compliance) Regulations (“PM(NOC) Regulations”).

The PM(NOC) Regulations strike a balance between the interests of innovative pharmaceutical companies and generic manufacturers, by requiring generic manufacturers to address innovators’ patents before receiving … Continue Reading

Ontario Court Grants Summary Judgment Dismissing Apotex’s Claim for Unjust Enrichment

Posted in Patents

On January 15, 2013, the Honourable Justice Michael G. Quigley of the Ontario Superior Court granted summary judgment to Abbott and Takeda, denying Apotex’s claim for disgorgement of profits on the basis of unjust enrichment.

The case involved a claim for damages arising from Abbott’s invocation of the Patented Medicines (Notice of Compliance) Regulations. The PM(NOC) proceedings were ultimately discontinued by Abbott and Apotex thereafter brought an action, in the Ontario Court, for (a) damages under section 8 of the PM(NOC) Regulations; and (b) disgorgement of Abbott’s profits on the basis of unjust enrichment.

In the Federal Court, … Continue Reading

Responding to Canadian Patent Office Objections: Proof of Utility

Section 2 of the Patent Act

Posted in Patents

This is part of a series of posts reviewing common Canadian Patent Office objections to patent applications and claimed inventions and providing some insight into how these objections may be addressed.

The Objection

In a typical objection, the patent examiner asserts that the claimed composition of matter, while novel and non-obvious, cannot be patented because the application’s description fails to prove the utility of all claimed embodiments. The examiner usually will rely on:

  • the definition of “invention” in section 2 of the Patent Act as the statutory basis for the objection.
  • recent case law, mainly from abbreviated proceedings under the
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Recent Pair of Rampiril Decisions Clarifies Limits on s. 8 Damages in Patent Law

Posted in Intellectual Property, Patents

When a generic drug claims damages against a brand name drug, what limits should be put on calculating compensation? Section 8 of the Patented Medicines (Notice of Compliance) Regulations was designed to answer just that question, but it left some questions unanswered. A pair of twin judgments by Justice Snider, Teva Canada Ltd. v. Sanofi-Aventis Canada Inc., and Apotex Inc. v. Sanofi-Aventis Canada Inc. released at the end of May 2012, provided insight into some of the issues.

Damages under Section 8

Under section 8 of the Regulations, if a brand name’s patent claim falls through, the brand … Continue Reading