Chelsea Nimmo

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Governmental Use of Patented Inventions during a Pandemic: A Global Survey

Key Contacts: Jeffrey Lewis (New York), Jenny Shum (New York), Clemens Rubel (Munich), Seiko Hidaka (London), Justin Davidson (Hong Kong SAR), Jackie O’Brien (Sydney) Around the globe, pharmaceutical and medical device companies are helping in the fight of the COVID-19 pandemic. Many of these companies may have patents pertaining to technology that could be used … Continue reading

New Federal initiatives to combat pandemic: Patent Act amended to allow limited government use of patented inventions for public health emergencies

On March 25, 2020, the Canadian Government passed into law Bill C-13, An Act respecting certain measures in response to COVID-19, following emergency sittings of Parliament and the Senate. Bill C-13 amends both the Patent Act and the Food and Drugs Act and may have implications for the pharmaceutical industry. Patent Act – Limited government … Continue reading

Two generics, one hearing: Federal Court orders common trial on patent validity issues in section 6 actions

The Federal Court has ordered that the trial of two actions brought under the post-CETA Patented Medicines (Notice of Compliance) Regulations (the Regulations), against two separate generics, be heard concurrently, on issues of invalidity. This decision highlights the Federal Court’s push to streamline section 6 actions. The court rejected the defendant Taro’s arguments that the … Continue reading

First motion for early patent dismissal fails to meet high burden under newly-amended PM(NOC) Regulations

On July 6, 2018, the Federal Court dismissed the first motion brought under section 6.08 of the newly-amended Patented Medicines (Notice of Compliance) Regulations (the Regulations). The Court’s public reasons were released July 30, 2018. The moving party, Amgen Canada Inc. (Amgen), was seeking an order dismissing the Plaintiffs’ action in respect of two of … Continue reading

CADTH releases updated guidelines for biosimilars

The CADTH Common Drug Review Procedure and Submission Guidelines for Biosimilars (Non-Cancer) and the CADTH pan-Canadian Oncology Drug Review Submission Guidelines for Biosimilars (Cancer) provide an overview of the Common Drug Review procedures and guidance to applicants for biosimilar submissions. The new guidelines are effective as of February 13, 2018. CADTH reports the following key … Continue reading

Federal Court of Appeal affirms that the Patent Act’s price control provisions over patented medicines were validly enacted

The Federal Court of Appeal has reaffirmed the constitutionality of the excessive price provisions of the Patent Act that ground the jurisdiction of the Patented Medicine Prices Review Board (PMPRB) over patented medicines. Background In 2015, the PMPRB commenced a proceeding against Alexion alleging that the price of Alexion’s drug SOLIRIS® (eculizumab) was excessive.  In … Continue reading

PMPRB applies unknown test against patentee to make excessive-pricing order outside of the Guidelines

The Patented Medicine Prices Review Board (PMPRB) has issued an excessive-pricing order against Alexion Pharmaceuticals Inc. (Alexion) in respect of SOLIRIS (eculizumab) based on the application of a Lowest International Price Comparison (LIPC) test. In public reasons issued September 27, 2017, the PMPRB ordered Alexion to (i) repay excess revenues to the Crown from the … Continue reading

CETA Tracker: Pharmaceutical patent reform to be provisionally implemented in September 2017

As we reported, the Canadian government has approved changes to Canada’s pharmaceutical patent regime, including the introduction of patent term restoration and the replacement of the current summary proceedings under the Patented Medicines (Notice of Compliance) Regulations with full actions.  The reforms were originally scheduled to come into force on July 1, 2017; however, the … Continue reading

CETA Tracker: Delays for the implementation of pharmaceutical patent reform

As we reported, the Canadian government has approved changes to Canada’s pharmaceutical patent regime, including the introduction of patent term restoration and the replacement of the current summary proceedings under the Patented Medicines (Notice of Compliance) Regulations with full actions.  The reforms were expected to come into force on July 1, 2017; however, media sources … Continue reading

Government of Canada opens NAFTA consultations: IP on agenda

The Canadian government is requesting feedback relating to the renegotiation of the North American Free Trade Agreement.  In particular, the government is asking for the public’s “views on the key areas in NAFTA that could be clarified or updated, and on any new areas that should form part of a modernized agreement.” Treaty/Act:        North American … Continue reading

Health Canada seeks feedback on proposed regulatory amendments to PMPRB pricing regime of patented medicines

On May 16, 2017, Health Canada published a consulting paper titled “Protecting Canadians from Excessive Drug Prices.”  The paper describes five proposed amendments to the Patented Medicines Regulations that are meant to help better assess whether the price of a patented drug is excessive. Stakeholders can provide feedback on the proposed amendments by June 28, … Continue reading

CETA tracker: CETA Bill C-30 receives royal assent to implement pharmaceutical patent reform

It’s official – the Canadian government has approved the changes to Canada’s pharmaceutical patent regime. On May 16, 2017, Bill C-30 (the act intended to implement CETA into Canadian law) received royal assent, the final stage of the legislative process. Treaty/Act:        CETA/Bill C-30 (An Act to implement the Comprehensive Economic and Trade Agreement between Canada … Continue reading

CETA tracker: patent term restoration is coming soon to Canada – what you need to know now

Treaty/Act: CETA/Bill C-30 (An Act to implement the Comprehensive Economic and Trade Agreement between Canada and the European Union and its Member States and to provide for certain other measures) With Canada moving closer towards implementing the Comprehensive Economic and Trade Agreement (CETA), major reforms to Canada’s Patent Act are coming soon, including the availability … Continue reading
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