IP Views

DOH Says IPR Issues Beyond BFAD's Jurisdiction
September 20, 2007

What is the legal recourse of manufacturers, importers, and distributors of pharmaceutical products when another person or entity seeks to apply for a certificate of product registration (CPR) with the Bureau of Food & Drugs (BFAD) for a drug that may infringe upon the intellectual property rights of such manufacturer, importer or distributor?

In the past, it was the practice of companies to oppose or block the applications for CPR with the BFAD. But those days are now over.

According to the Department of Health, the BFAD is mandated only to ensure the safety, efficacy and quality of drugs that are the subject of applications for CPR. Issues pertaining to intellectual property rights, particularly patent rights, trademarks, and unfair competition fall beyond the agency's jurisdiction.

In an opinion written by Undersecretary Alexander A. Padilla, the Department of Health (DOH) clarified that parties who have an interest in IPR issues that may conflict with applications for CPR may notify the BFAD in writing, but the BFAD should, as a matter of course, refer the matter to the Intellectual Property Office (IPO) for proper action.

Unless the IPO or a court with proper jurisdiction enjoins the BFAD, the latter is duty bound to continue processing the application for CPR. The DOH also discontinued the practice of the BFAD from inserting the phrase "The effectivity of this Certificate of Product Registration (CPR) will be the date after the patent of this product expires."

Some legal observers view this development as a step in properly delineating the functions of government, by recognizing that certain agencies are more technically competent to rule upon legal issues (i.e., the IPO and matters related to IPR) while preserving the focus of other agencies as mandated by law (i.e., the BFAD and processing of applications for CPR).

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