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Our pharmaceutical regulatory & compliance group has extensive experience understanding and managing issues that arise at the pharmaceutical/biologic patent-regulatory interface. We recognize the importance of coordinating patent prosecution and enforcement with regulatory and market status of pharmaceutical and biologic drug products. Drawing on the experience of our professionals with patent prosecution experience, litigation experience, and our professionals that have specific expertise in regulatory areas, we provide an integrated team approach and a level of technical depth and support that is unmatched in Canada.
Our expertise includes the following:
Patented Medicine Prices Review Board (PMPRB)
We provide assistance in preparing materials and appearing before the PMPRB, including on questions of jurisdiction and reporting requirements, such as sales and pricing data.
Patent Listing: The Office of Patented Medicines and Liaison (OPML)
It is our practice to work with our clients in prosecuting the most appropriate claim set for the purposes of enforcement in Canada, including taking into consideration patent listing requirements. We can assist in preparation and/or review of patent listing forms and in instances where the OPML does object to listing a patent on the Patent Register, we have successfully addressed objections through written and/or personal appearances before the Office.
Data Protection
Data protection is a key factor that we consider in advising our clients. We can also assist in ensuring that an "innovative drug" is properly identified as such by the OPML and thus subject to the data protection provisions of the Food and Drug Regulations. As with patent listing, we can assist through written or personal appearance before the OPML.
Access to Information (ATI) Requests
We have significant experience in providing assistance in responding to ATI requests received by provincial and federal agencies, and we have a team of professionals and paraprofessionals that have handled numerous such requests in a timely and cost efficient manner.
Applications for Judicial Review
Should it be necessary, we can also pursue a judicial review of any administrative decision noted above before the Federal Court and appellate courts.
 Primary Contacts
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