Trends, analysis and insights in IP Law
On June 17, the 2022 Ministerial Conference of the World Trade Organization (“WTO”) issued a decision [PDF] pursuant to the Agreement on Trade-related Aspects of Intellectual Property Rights (“TRIPS Agreement”) and allowed certain members to use patented inventions for the production and supply of COVID-19 vaccines in specific circumstances (“Ministerial Decision”).
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The Canadian Intellectual Property Office (“CIPO”) has announced its final extension of the deadlines under the Patent Act, Trademarks Act and/or Industrial Design Act as a result of the COVID-19 outbreak. As we reported previously, March 16th to August 10th were considered “designated days” under the applicable Canadian intellectual property legislation; the time to respond to certain CIPO actions therefore had been extended to August 10th.
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The Canadian Intellectual Property Office (“CIPO”) continues to provide updates on the continuing disruption to IP office deadlines under the Patent Act, Trademarks Act and/or Industrial Design Act caused by the COVID-19 outbreak. As we reported previously, March 16th to July 17th were considered “designated days” under the applicable Canadian intellectual property legislation; the time to respond to certain CIPO actions therefore had been extended to July 20th.
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On July 7th, 2020, the Canadian Intellectual Property Office (“CIPO”) announced a pilot project allowing applicants who qualify as “small entities” (e.g. universities, or businesses employing 50 or fewer employees) to expedite the examination of their patent applications for COVID-19-related inventions. Details of the program can be found on the CIPO website here. The program is limited, however, to only fifty (50) patent applications.
As businesses work to address the COVID-19 pandemic, this pilot project is designed to help smaller sized entities get products to market as soon as possible. To request accelerated examination under the program, applicants must include a statement that the technology is medical and related to COVID-19 and that an approval for its use has been obtained from or has been submitted to Health Canada. Applicants must also have requested examination and paid the applicable Canadian government fee for requesting examination. Finally, the application must be open to public inspection or the applicant must have submitted a request for early publication. There is no additional fees to use this process.
For further information on whether you qualify and how to take advantage of this program or any other program at CIPO, please reach out to one of the patent professionals at Fasken.
Fasken’s IP group continues to take steps to ensure continuity of our services to our clients during the pandemic. As CIPO’s online solutions are available 24/7 and from anywhere, we are available to continue to assist our clients during this period. Please don’t hesitate to reach out, should you need assistance with your intellectual property.
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UPDATE: On April 14, 2022, the Minister of Health announced that the federal government will not proceed with amendments to the Patented Medicines Regulations introducing new pharmacoeconomic factors and requiring that price and revenue information be reported net of all adjustments. The federal government will proceed with amendments establishing a new basket of comparator countries, with a coming-into-force date of July 1, 2022. For more information, see our Life Sciences Bulletin on the Minister’s announcement.
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The Patented Medicine Prices Review Board (PMPRB) has delayed the coming into force of the amended Patent Medicines Regulations to January 1, 2021.
The Regulations Amending the Patented Medicines Regulations (Additional Factors and Information Reporting Requirements) were set to come into force on July 1, 2020 and provide the PMPRB with additional price regulatory factors to assess whether the price of a patented medicine sold in Canada was “excessive”. But on June 1st, 2020, the Canadian government delayed their coming into force, citing an increased demand on the pharmaceutical industry in light of COVID-19.
Then, on June 19th, 2020, the PMPRB released its Draft Guidelines 2020. These changes were the result of extensive stakeholder feedback received during public consultations. While the new Guidelines have the same conceptual structure as those released back in November 2019, there are now some substantial quantitative changes.
In particular, in the new Draft Guidelines 2020, the thresholds for identifying high-priority drugs has changed: The PMPRB will classify new patented drugs as either high or low priority based on their anticipated financial impact. If they have a high treatment cost (now above $90,000 annually per patient) or large anticipated marketed size (now above $50M in sales) then they will be subject to a more comprehensive price review. This comprehensive review will take into consideration new additional price regulatory factors, including a drug’s pharmacoeconomic value, market size and the gross domestic product (GDP) and GDP per capita in Canada.
The Draft Guidelines are available for public comment until July 20, 2020. We have extensive experience in this area and are available for a consultation if you are interested in responding.
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