Topic: Pharmaceuticals and life sciences

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Coulda, Shoulda, but Not Likely Woulda: Federal Court of Appeal affirms finding that generic would not have used a non-infringing alternative

The Federal Court of Appeal has affirmed the Federal Court’s decision awarding an accounting of profits to ADIR and Servier Canada Inc. (Servier), concluding that Apotex Inc. and Apotex Pharmachem Inc. (Apotex) would not have used a non-infringing alternative (NIA). Background In 2008, the Federal Court found that Servier’s patent for the drug perindopril was … 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

Ontario and Quebec Introduce Changes to Pharmacy Practice and Highlight the Drug Supply Chain as an Essential Service

Changes Affecting Ontario The Government of Ontario has made changes to the Ontario Drug Benefit (ODB) Program in an effort to reduce the risk of drug shortages in the province during the COVID-19 outbreak. Effective immediately, ODB eligible drugs are subject to the following changes to rules on dispensing and fees: The dispensing of medication … Continue reading

PM(NOC) Statutory Deadlines Still Applicable

As we reported, the Federal Court (FC) has suspended its hearings scheduled between March 16, 2020 and April 17, 2020 (the Suspension Period) sine die. Proceedings brought in accordance with the Patented Medicines (Notice of Compliance) Regulations (Regulations) fall under the FC’s jurisdiction. However, certain deadlines related to these proceedings are set by the Regulations … Continue reading

COVID-19: Health Canada simplifies regulatory requirements for COVID-19-related products

Health Canada is taking measures to help expedite the importation and sale of certain licensed products required to combat COVID-19. Expedited review of Health Product Submissions and Applications Health Canada has announced that it will expedite the review of any COVID-19 related vaccines, therapeutic products and other health product submissions and applications. Until a vaccine … Continue reading

COVID-19: Sharing information for licensed health products during a pandemic

The public health call for social distancing to help curb the COVID-19 pandemic has no doubt already affected how companies will be sharing information about pharmaceuticals and other licensed health products with healthcare professionals (HCPs), patients, and the public. As industry plays its part in keeping sales representatives and medical science liaisons (MSLs) home to … Continue reading

Bill C-4: New CUSMA Implementation Act Received Royal Assent

On March 13, 2020, the Government passed Bill C-4 to implement the Canada-United States-Mexico Agreement (CUSMA). Canada will be the third and final party to ratify the treaty. The Bill, sponsored by Deputy Prime Minister Freeland, was introduced on January 29, 2020. The Bill was recently expedited in order to ensure that it passed before … Continue reading

COVID-19: Health Canada Issues Bulletin Confirming Obligations of DEL Holders

In light of recent developments relating to the to the 2019 novel coronavirus (COVID-19), Health Canada recently sent a reminder to all Drug Establishment License (DEL) holders of their obligations under the Food and Drug Regulations (FDR) regarding reporting of events that could affect operations and lead to shortages or issues affecting quality, safety, and … Continue reading

Federal Court invalidates Health Canada’s decision to disclose records in response to ATI request

The Federal Court has invalidated Health Canada’s decision to disclose records pertaining to a veterinary pharmaceutical product, Fortekor Flavour Tabs (Fortekor), pursuant to the Access to Information Act (the Act). Health Canada defended its decision on the basis that the information contained in the records was “part of public domain information”. On judicial review, the … Continue reading

Patent owner files its own pleading in a PM(NOC) action

The Federal Court granted leave to the United States of America (USA), in its capacity as co-owner of a patent, to file its own pleading in an action under s 6(1) of the Patented Medicines (Notice of Compliance) Regulations (PM(NOC) Regulations). The USA was permitted to respond to the defendant’s (Apotex Inc.) allegations of invalidity, … Continue reading

Health Canada Provides Guidance on Regulation of Software as a Medical Device (SaMD)

On December 18, 2019, Health Canada published a new Guidance Document Software as a Medical Device (SaMD): Definition and Classification (Guidance Document). The Guidance Document explains what products would be regulated as SaMD under the Food and Drugs Act (Act) and the Medical Devices Regulations (Regulations) as well as information on classification of SaMD. What … Continue reading

Pharma in Brief: The 2019 Year in Review

In this article, the Pharma in Brief team curated the most significant topics we covered during 2019. The Canadian pharma and life sciences space saw many developments in 2019. These included major policy initiatives and regulatory changes affecting the industry, driven in part by three high-profile federal objectives: lowering drug prices to move towards national … Continue reading

Ontario reduces restrictions on ordinary commercial term benefits and private label products

The Ontario Ministry of Health and Long-Term Care (the Ministry) introduced changes to regulations (collectively, the Regulations) made under the Ontario Drug Benefit Act (ODBA) and the Drug Interchangeability and Dispensing Fee Act (DIDFA). These changes will remove the financial caps on ordinary commercial term (OCT) payments made by drug manufacturers to pharmacies and allow … Continue reading

Amended CUSMA no longer extends data protection for biologics

On December 10, 2019, Canada, the United States, and Mexico agreed to amend the Canada-United States-Mexico Agreement (CUSMA, also referred to as USMCA) as the trade agreement proceeds toward ratification in each country. Among other changes, the amended CUSMA no longer requires Canada to extend data protection for biologics to 10 years from the 8 years … Continue reading

PMPRB extends consultation on new Draft Guidelines implementing amendments to the Patented Medicines Regulations

The Patented Medicine Prices Review aboard (PMPRB) has extended the deadline for written submissions on new Draft Guidelines until January 31, 2020. Originally, the consultation was scheduled to run until January 20, 2020. Background As we reported, the Board proposed Draft Guidelines to replace its existing price-review practices, including the Compendium of Policies, Guidelines and … Continue reading

Federal Court dismisses motion for determination of an issue of law under the new PM(NOC) Regulations

The Federal Court dismissed Pharmascience Inc.’s (Pharmascience) motion to determine a question of law on the issue of whether a first person can commence an action under subsection 6(1) of the Patented Medicines (Notice of Compliance) Regulations (PM(NOC) Regulations) for a drug for which there are no patents listed on the patent register. The Court … Continue reading

Federal Court refuses to allow fifth generic to join common trial on validity

The Federal Court has denied a motion by Dr. Reddy’s Laboratories’ (Dr. Reddy’s) seeking to participate in a common validity issues trial in actions concerning four other generic versions of the same drug under the Patented Medicines (Notice of Compliance) Regulations (PM(NOC) Regulations). Background As we reported, the Federal Court has made a number of … Continue reading

PMPRB launches 60-day consultation on new Draft Guidelines following amendments to the Patented Medicines Regulations

Today, the PMPRB launched a consultation on Draft Guidelines intended to implement recent amendments to the Patented Medicines Regulations. The PMPRB also released a Q&A-style Consultation Backgrounder. Interested parties have 60 days, until January 20, 2020, to make submissions on the Draft Guidelines. Background As we reported, the Government released final amendments to the Patented Medicines … Continue reading

Apotex held to induce infringement in one of the last applications under the old PM(NOC) Regulations

The Federal Court has granted an order prohibiting the Minister of Health from issuing a Notice of Compliance to Apotex Inc. for a generic version of ZYTIGA (abiraterone acetate). It held that the use of the combination of abiraterone acetate and prednisone claimed by Janssen Inc.’s patent was patentable subject matter, and that the patent’s … Continue reading

Federal Court of Appeal applies holistic approach to the “palpable and overriding error” standard of review

The Federal Court of Appeal has provided a detailed review of the proper approach to identifying palpable and overriding errors of fact or mixed fact and law in an appeal concerning the obviousness of two patents. The Court of Appeal concluded that when viewed as a whole, there was no reviewable error in the judgment … Continue reading

Ontario consults on changes to streamline drug formulary listing and reduce government payments to pharmacies

The Ontario Ministry of Health and Long-Term Care (the Ministry) has proposed draft amendments to Regulations made under the Ontario Drug Benefit Act (ODBA) and the Ontario Drug Interchangeability and Dispensing Fee Act. The proposed changes are intended to reduce technical requirements for listing a product on the Ontario formulary and align policies with industry … Continue reading

Federal Court rejects the concept of “first mover advantage” for generics in PM(NOC) infringement actions

The Federal Court has ordered that two additional generic defendants (Taro Pharmaceuticals Inc., Sandoz Canada Inc.) be added to a trial of common issues currently set for Bayer Inc.’s claims against Teva Canada Limited and Apotex Inc. concerning generic versions of XARELTO® (rivaroxaban) under the Patented Medicines (Notice of Compliance) Regulations (the Regulations). All four … Continue reading

Stockpiling generic manufacturers may be liable for direct infringement of “composition for a use” claims

The Federal Court has found that it is reasonably arguable that a claim for “a composition for use in the treatment of a disorder” may be directly infringed through the importation, manufacture and stockpiling of the composition. The Court distinguished these claims from pure “use of a composition for a treatment” claims, which can only … Continue reading

Federal Court refuses to permit reply evidence on validity issues in action under the PM(NOC) Regulations

On a motion for leave to file reply expert reports, the Federal Court has reinforced the rule against case splitting and outlined the circumstances under which reply expert reports are permissible under the Federal Courts Rules. The Court concluded that none of the proposed reply reports put forward by Teva Canada Limited (Teva) in respect … Continue reading
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