December 2018

FCA overturns cefaclor damages decision on prejudgment interest issue, provides guidance on NIA defence

On November 23, 2018, the Federal Court of Appeal (FCA) allowed in part Apotex’s appeal of a decision awarding Eli Lilly over $100 million for Apotex’s infringement of eight process patents related to the antibiotic cefaclor: Apotex v Eli Lilly, 2018 FCA 217. The Federal Court (FC, decision reported here) had awarded Eli Lilly roughly $31 million in damages for infringement and $75 million in prejudgment interest as damages for the time value of the money lost in the 17 years that elapsed before the reference trial on damages took place. The FCA remitted the decision to the FC for reconsideration solely on the issue of interest. The Court also provided guidance regarding the application and objective of the non-infringing alternative (NIA) defence.

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Webinar: Wed Jan 9th, 2019 | 12PM ET | 9AM PT

Join us for a one-hour webinar where our experts will provide a special Canadian Life Sciences Regulatory Update covering:

• biologics/biosimilars
• intersection between regulatory / PMNOC / data protection / CSP / PMPRB regimes
• patient support programs
• privacy
• transparency
• medical cannabis
  
  

This webinar is limited to invited guests and clients of the firm.

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Canada signs new trade agreement with United States and Mexico

On November 30, 2018, Global Affairs Canada issued a news release announcing the signing of the Canada-United States-Mexico Agreement (CUSMA or USMCA), a new agreement to modernize the North American Free Trade Agreement between Canada, the United States, and Mexico. The changes relating to intellectual property are particularly notable as they modify the landscape for pharmaceuticals, and for patent, copyright and trademark owners. The potential impact on Canada's intellectual property laws was previously reported here, including the requirement to provide a data protection term (market exclusivity) for biologics of at least ten years from the date of first marketing approval.  Canada must implement this change within five years of the date the CUSMA enters into force.

Health Canada News

List of Generic Submissions Under Review Now Available

As previously reported, Health Canada had advised that beginning on October 1, 2018, it would implement certain proposals for its prescription drug product transparency initiatives. Health Canada will start providing Regulatory Decisions Summaries (RDSs) for approvals of certain drugs approved on the basis of abbreviated new drug submissions (ANDSs). For submissions accepted into review on or after October 1, 2018, Health Canada now provides the following information:

• The Submissions Under Review List now includes sponsor names and submission class for new drug submissions and supplemental new drug submissions; and
  
  

• The new, separate Generic Submissions Under Review (GSUR) List includes a list of the generic submissions under review by medicinal ingredient.

Health Canada publishes revisions to “Notifying Health Canada of Foreign Actions – Guidance Document for Industry”

As previously reported, on July 12, 2018, Health Canada had published “Guidance on Notifying Health Canada of Foreign Actions – Guidance Document for Industry”. On November 20, 2018, Health Canada updated its Guidance, including with a link to an on-line reporting form: Notifying Health Canada of Foreign Actions - Guidance Document for Industry, updated November 20, 2018. This update comes after the foreign risk reporting requirement provisions of the Food and Drug Regulations (as previously reported) came into force in October 2018. We have updated our previously published chart to include this Guidance.

New Court Proceedings

For complete details about these proceedings, click here.

PMNOC Proceedings

rivaroxaban (XARELTO): Bayer v Apotex

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