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.
On July 15, 2017, the Canadian government published (link) its proposed amendments to the NOC Regulations. These amendments will implement sweeping changes to pharmaceutical patent litigation in Canada pursuant to obligations imposed under CETA. There will be a 15-day comment period, after which, the amendments will be published in final form. The finalized amendments are expected to be in force around late September 2017. These revamped NOC Regulations will apply to Notices of Allegation (“NOAs”) served on or after the date the revamped NOC Regulations come into force.
Overall, the revamped NOC Regulations… Continue Reading
On June 30, 2017, the Supreme Court of Canada, released a landmark patent decision (2017 SCC 36) abolishing Canada’s so-called ‘Promise Doctrine’ by finding it “unsound”, “not good law” and “incongruent with the both the words and scheme of the Patent Act.”… Continue Reading
On January 4, 2017, the Honourable Justice Locke of the Federal Court of Canada released his decision in Mediatube Corp. et al. v. Bell Canada, 2017 FC 6. This was a patent infringement action in respect of Canadian Patent No. 2,339,477 (the “‘477 Patent”) by the plaintiffs, NorthVu Inc. (patent owner) and MediaTube Corp. (licensee) against Bell Canada (including former Bell Aliant Regional Communications, Limited Partnership, together “Bell”). The plaintiffs alleged that Bell infringed the ‘477 Patent through the delivery of its digital Internet Protocol Television (“IPTV”) services called Fibe TV and FibreOp … Continue Reading
Changes are coming swiftly, as the federal government moves to implement the Comprehensive Economic and Trade Agreement (“CETA”) just days after it was signed by Prime Minister Trudeau in Brussels at the end of October 2016.
These changes will significantly impact biologic/pharma patents in two major ways. First, they will implement, for the first time, a Canadianized version of patent-term restoration. Second, they will revamp the current framework for linkage between patents and the approval of biosimilar/generic drugs in Canada by giving innovators the right of appeal, by changing the nature of the PM(NOC) proceedings to a more U.S.-style approach, … Continue Reading
On April 14, 2016, the Supreme Court of Canada denied Apotex’s final attempt at obtaining leave to appeal in the storied patent battle between Merck and Apotex over Merck’s lovastatin patent.
The case began in 1997 when Apotex launched its generic lovastatin product. At the liability trial in 2010, Justice Judith Snider of the Federal Court found Merck’s lovastatin patent to be valid and infringed (2010 FC 1265). The judgment included reference to DNA evidence establishing that Apotex had infringed through its operations in Winnipeg. The Judge also found that Apotex’s joint venture partner fabricated batch records and … Continue Reading
Behind every successful innovation strategy is a sophisticated intellectual property strategy. Intellectual property is the currency of innovation: it is a tradable that can be used to lend credibility to innovation programs, allow freedom to operate, provide access to third-party technology and ward off infringement actions.
Innovation is accelerating in almost every sector of the economy – banking, telecommunications, retail, and services. Customers, especially Millennials, are hungry for the next new technology that will make their lives easier and the customer experience more enjoyable. At the same time, customers are less loyal than ever, since digitization gives them a tremendous … Continue Reading
In a Judgment released July 23, 2015, the Federal Court of Appeal upheld the Federal Court’s award of more than C$180 million in damages and interest for Apotex’s infringement of Merck’s Canadian lovastatin patent. In this decision, the Federal Court of Appeal reversed the Trial Judge and held that the availability of a non-infringing alternative (“NIA”) is relevant under Canadian law but held that Apotex could not have and would not have deployed it.… Continue Reading
In a decision released on June 3, 2015 (2015 FCA 137), a unanimous Federal Court of Appeal (“FCA”) dismissed Apotex’s appeal of Justice O’Reilly’s order prohibiting the Minister of Health from issuing a NOC to Apotex to market its generic version of LUMIGAN RC® until the expiry of Canadian Patent No. 2,585,691 (the “‘691 Patent”).
Significantly, on the issue of sound prediction the FCA held that the elements of sound prediction need not be disclosed in a patent if they would be self-evident to the skilled person. The Federal Court of Appeal has previously stated this … Continue Reading
On September 26, 2014, Prime Minister Harper announced that Canada and the European Union have successfully concluded negotiations on a new trade agreement, the Comprehensive Economic and Trade Agreement (CETA) that was five years in the making, and publicly released the consolidated text of the agreement.
CETA is deeper in substance and broader in scope than any other such agreement in Canadian history, significantly affecting all economic areas, including the pharmaceutical sector.
The CETA chapter on intellectual property is of particular interest to the pharmaceutical industry, because it will introduce into Canada for the first time:
- additional (sui generis
On September 12, 2013, a panel of three judges of the Ontario Court of Appeal unanimously upheld the decision of the Ontario Superior Court earlier this year to grant partial 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, relating to its drug Prevacid®. The PM(NOC) proceedings were ultimately discontinued by Abbott following a settlement agreement between the parties, and Apotex thereafter brought an action in the Ontario Superior Court for … Continue Reading
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