Topic: Pharmaceuticals and life sciences

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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

Apotex continues battle to prevent release of ANDS information: FCA upholds decision that Commissioner of Information is a proper respondent to Apotex’s judicial review

As we reported, Apotex Inc. applied for judicial review of the Minister’s decisions to disclose information from Apotex’s abbreviated new drug submission in response to an access to information request. The Federal Court of Appeal upheld an order adding the Commissioner of Information as a respondent, holding that the test was whether the Commissioner’s participation … 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

Sections of Vanessa’s Law regulating drugs for urgent public health need come into force

On July 12, 2017, section 5 and subsections 6(3) and 6(4) of the Protecting Canadians from Unsafe Drugs Act (Vanessa’s Law) came into force. These sections amend the Food and Drugs Act to require healthcare institutions to report serious adverse drug reactions and permit the Governor in Council to make regulations that specify what this … 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

Health Canada consults on changes to broaden access to generic drug equivalence

Health Canada is seeking input on potential changes to the Food and Drug Regulations affecting which drug products would be approvable by way of an abbreviated new drug submission (ANDS) and thus be designated therapeutically equivalent. Comments can be provided until October 13, 2017. This is the first in a series of consultations on 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

Supreme Court dismisses leave to appeal regarding notice requirements under section 5 of the PM(NOC) Regulations

As we reported, Janssen Inc. et al. filed an application for leave to appeal with the Supreme Court of Canada on December 9, 2016 with respect to the Federal Court of Appeal’s decision addressing a generic manufacturer’s notice obligations when obtaining a notice of compliance (NOC) by way of a cross-referenced drug submission. On June … Continue reading

Health Canada releases Good Label and Package Practices Guide for Non-prescription Drugs and Natural Health Products

Health Canada recently released the Good Label and Package Practices Guide for Non-prescription Drugs and Natural Health Products (GLPP Guide). The GLPP Guide was released as part of the Regulations Amending the Food and Drug Regulations (Labelling, Packaging and Brand Names of Drugs for Human Use) – more commonly known as the “Plain Language Labelling … 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 publishes updated guidance document on data protection

Health Canada has released an updated version of Guidance Document: Data Protection under C.08.004.1 of the Food and Drug Regulations. According to Health Canada, the guidance document has been updated to reflect judicial consideration of “innovative drug” and current administrative practices, including requirements for submissions relying on third-party data, protection for products containing an innovative … 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

Supreme Court dismisses leave to appeal regarding test for obviousness-type double patenting in tadalafil s.6 case

Case: Apotex Inc v Eli Lilly Canada Inc, et al (SCC Docket 37368) Drug: CIALIS® (tadalafil) Nature of case: Application for leave to appeal decision upholding prohibition order granted pursuant to section 6 of the Patented Medicines (Notice of Compliance) Regulations, SOR/93-133 (the Regulations) Successful party: Eli Lilly Canada Inc. and ICOS Corporation (collectively Eli Lilly) Date of decision: April … Continue reading

Health Canada proposes regulations allowing importation of drugs not yet available in Canada for an urgent public health need

Health Canada has proposed regulations that will amend the Food and Drug Regulations to allow for importation of drugs that have not yet received regulatory approval from Health Canada. The new regulations will provide access to drugs that address an urgent public health need provided they have been approved in the United States, the European … Continue reading
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