The Cross-Border Biotech Blog

Biotechnology, Health and Business in Canada, the United States and Worldwide

Mixed Reaction to U.S. Patent Reform

Guest post by Andrew Franklin, a colleague in the Pharmaceuticals and Life Sciences practice at Norton Rose.

With the passage of the America Invents Act of 2011, the United States’ patent system will change from a “first-to-invent” system to a “first-to-file” system for granting patents. Under the new system, patents will be granted to the first person to submit an application to the U.S. Patent and Trademark Office (“USPTO”) as opposed to the first person who first  invented the subject matter of the invention. This is the most significant change to US patent law since 1952.

While this legal reform aligns the US patent law with the rest of the world, it has been met with mixed reaction. Read more of this post

Canadian Drug Pricing and Reimbursement Conference Report

Earlier this week, the Canadian Institute held its 5th annual Drug Pricing and Reimbursement Conference in Toronto. The conference highlighted a number of key issues including market access for pharmaceutical companies, Federal and Provincial regulatory and reimbursement policies, and global trends that may affect Canada’s pharmaceutical landscape. Attendees included both innovative and generic drug manufacturers, public and private payers, policy makers and lawyers.  One recurring theme at the meeting was a focus on patients as the target/end-users of the regulatory and pricing initiatives being discussed.

Of particular interest was the Patented Medicine Prices Review Board’s (“PMPRB”) session, one year after the new guidelines were released. Michelle Boudreau, Executive Director of the PMPRB, gave an update in light of the impact of the guidelines and touched on the future directions of the board. She focused on the issue of transparency in drug pricing including access to public information and open hearings for the PMPRB. In terms of moving forward, she commented on the Board’s new direction in trying to become more aligned with our international counterparts. In the coming months, the PMPRB’s transparency initiative will be exemplified through ongoing monitoring and evaluation, and increased public information made available on their web site. A consolidated version of the guidelines was promised to be available on the website by the end of June. A pdf of the presentation is available here.

Special thanks to the Canadian Institute for the conference pass and to Norton Rose summer student Karen Sie for this report.

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