Topic: Intellectual property

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FCA Limits Scope of Dutch Industries and Declines to Invalidate Patent on the Basis of Administrative Non-Compliance with Patent Act in latanoprost s. 8 case

Pfizer Canada Inc. successfully resisted Apotex’s appeal of the Federal Court’s dismissal of Apotex’s motion for summary judgment for invalidity based on a failure to pay the correct “final fee” owing prior to patent grant. The Federal Court of Appeal upheld the lower court’s decision and held that alleged infringers of a patent cannot rely … Continue reading

Federal Court confirms innovator must be named as respondent when PM(NOC) Regulations engaged

The applicant brought a judicial review of Health Canada’s decision that its new drug submission triggered the PM(NOC) Regulations, and moved for a confidentiality order. The Federal Court has now upheld a decision requiring notice of the motion to another innovator company, confirming that the second innovator has a legal interest in the determination of … 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

Federal Court releases new guidelines for prohibition actions under the amended Patented Medicines (Notice of Compliance) Regulations

As we reported, amendments to the Patented Medicines (Notice of Compliance) Regulations (the Regulations) took effect on September 21, 2017, as part of the broader roll-out of measures implementing the Comprehensive Economic and Trade Agreement (CETA) with the European Union. The amendments introduce significant changes to proceedings under the Regulations, which will now proceed by … Continue reading

Update on utility and the impact of the SCC decision in NEXIUM case

The impact of the Supreme Court’s landmark ruling in AstraZeneca Canada Inc. v Apotex Inc., 2017 SCC 36 (NEXIUM decision) rejecting the “Promise Doctrine” is taking shape in the Federal Court. As we reported, the SCC held that the level of utility required of a Canadian patent is driven by the claims of the patent … Continue reading

CETA tracker: CETA implemented September 21

Final CETA regulations impacting pharmaceuticals come into force Canadian and European Union leaders signed the Comprehensive Economic and Trade Agreement (CETA) on October 30, 2016. As we reported, the Canada–European Union Comprehensive Economic and Trade Agreement Implementation Act (CETA Act) and accompanying regulations provide key reforms to the Patent Act affecting the pharmaceutical industry, including … Continue reading

Apotex disentitled to section 8 recovery on the basis of patent infringement in omeprazole case

For the first time, the Federal Court has disentitled compensation pursuant to section 8 of the Regulations on the basis of infringement of a patent. This holding was also based on the court’s finding that Apotex would not have had an available non-infringing alternative (NIA) at any point during the period of infringement (September 5, … Continue reading

CETA tracker: Final Regulations released

Final CETA regulations impacting pharmaceuticals published but not yet in force As we reported, in July the Canadian government released draft versions of the proposed patent term restoration / Certificate of Supplementary Protection (CSP) and Patented Medicines (Notice of Compliance) Regulations (PM(NOC) Regulations) under Bill C-30. On September 7, the government released the final versions … Continue reading

FCA upholds Gilead victory invalidating Idenix patent relating to anti-HCV compounds

In a brief decision, the Federal Court of Appeal dismissed Idenix’s appeal of a Federal Court decision which found that a patent owned by Idenix and purporting to claim anti-HCV compounds was invalid for: (i) failing to sufficiently disclose a synthetic method by which the claimed compounds could be made; and (ii) for lack of … Continue reading

Mid-year roundup – 2017

Hard to believe, but we are halfway through 2017 already! It has been a busy six months, with major developments, including Canada preparing to implement CETA and the Supreme Court of Canada abolishing the “Promise Doctrine.” Below, Pharma in Brief has compiled the top headlines so far this year. The Big Three: Utility and the … Continue reading

Updated statistics on protection of patented and innovative drugs released in the Therapeutic Products Directorate Statistical Report for PM(NOC) Regulations and Data Protection

  Innovators’ growing use of the Patent Register is highlighted in the annual statistical report on the Patented Medicines (Notice of Compliance) Regulations and Data Protection issued by the Therapeutic Products Directorate (TPD) on July 14, 2017. This report includes data up to the end of fiscal year (FY) 2016/2017, which ended March 31, 2017. … Continue reading

CETA tracker: CETA Upends the Once-Delicate Balance

New CETA regulations impacting pharmaceuticals published but not yet in force The Canadian government has published the proposed patent term restoration / Certificate of Supplementary Protection (CSP) and Patented Medicines (Notice of Compliance) Regulations (PM(NOC) Regulations) under Bill C-30.  A 15-day consultation is open for interested parties to make submissions. Since their first enactment, the … Continue reading

Innovator must be named as respondent when PM(NOC) Regulations engaged

The applicant brought a judicial review application regarding the Minister of Health’s determination that it compared its product to a product with listed patents and was therefore required to address the listed patents. The Federal Court determined that the third-party innovator of the product with listed patents is a person “directly affected” by the application … 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

“Promise Doctrine” rejected as a basis for invalidating patents for lack of utility in landmark Supreme Court of Canada ruling

The “Promise Doctrine” has been conclusively rejected by Canada’s highest court as a basis for invalidating a Canadian patent. In a judgment that reverses years of jurisprudence in the lower courts, the Supreme Court of Canada today held that the level of utility required of a Canadian patent must not be measured by statements in … 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

Apotex files leave to appeal to SCC on damages against Health Canada for Apo-Trazodone

Apotex filed an application for leave to appeal the decision allowing its claim for damages for misfeasance of public office, negligence and breach of contract against Health Canada based on its review of Apotex’s drug submission for Apo-Trazodone. Apotex has appealed the finding that Health Canada does not owe a duty of care to drug … 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

Supreme Court dismisses leave to appeal regarding patent validity and infringement in omeprazole case

On June 2, 2017, the Supreme Court dismissed Apotex’s application for leave to appeal the decision finding that AstraZeneca’s Canadian Patent No. 1,292,693 was valid and infringed by Apotex’s manufacture, sale, and promotion of Apo-Omeprazole capsules. Case:  Apotex Inc v AstraZeneca Canada Inc, et al (SCC Docket: 37478) Drug:  LOSEC® (omeprazole) Nature of case:  Appeal … 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

Federal Court releases new trial management guidelines for actions and discusses impact of proposed regulations

On April 28 the Federal Court issued a Notice to the Parties and the Profession containing new guidelines for the trial management of actions. Among other things, they set new deadlines for various pre-trial steps and for the filing of motions, provide guidance regarding the scheduling and agenda of trial management conferences and streamline the … 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

Proposed regulations published on additional elements of Vanessa’s Law

On April 22, 2017, the Government of Canada published draft regulations Amending the Food and Drug Regulations (Vanessa’s Law) that provide details regarding the minister of health’s powers to require tests, assessments and studies of a drug post-market authorization. The draft regulations also set out additional reporting requirements for manufacturers based on the actions of … 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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