Life Sciences — Regulatory & Compliance
Our life science 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, throughout a product’s life cycle, from early clinical development to regulatory approval to litigation and beyond. 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 extends to pharmaceuticals (small molecules), biologics, medical devices, natural health products, and veterinary products, and 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. We also assist with preparing the necessary reporting forms.
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 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 Act (ATI), Freedom of Information and Protection of Privacy Act (FIPPA) Requests
We have significant experience in providing assistance in responding to ATI and FIPPA requests received by federal and provincial agencies, and we have a team of professionals and paraprofessionals that have handled numerous such requests in a timely and cost efficient manner.
Regulatory Compliance Issues
We provide compliance advice regarding the Food and Drugs Act and associated regulations, including under the recent Vanessa’s Law (Bill C-17) amendments.
Regulatory Due Diligence
In connection with transactions, we can provide due diligence review, not only from an IP perspective, but also regarding regulatory compliance matters.
Submissions on Draft Statutory/Regulatory Amendments
We have extensive experience in preparing draft submissions on proposed regulatory amendments, including amendments to the Patented Medicines (Notice of Compliance) Regulations and to the Food and Drug Regulations.
Health Canada Brand Name Assessments including Look-alike Sound-alike (LA/SA) Assessments of Drug Product Names
We assist in preparation and review of brand name assessments to Health Canada. Our trademark practitioners also assist in securing the necessary registration of the drug product name.
Marketing and Advertising Advice
Working with colleagues in our marketing and advertising group, we provide advice regarding advertising and labelling of drug products.
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.