Legal Framework for Drug Registration and Intellectual Property
- Section 26(a), related to other sections of Republic Act No. 3720 (Food, Drugs and Devices and Cosmetic Act), and Republic Act No. 6675 (Generics Act) govern drug registration.
- Administrative Order No. 67, series 1989 provides rules for pharmaceutical product registration.
- Intellectual property (IP) issues such as patent rights, trademarks, and trade secrets are outside the regulatory scope of the Bureau of Food and Drugs (BFAD).
- The appropriate jurisdiction for IP matters is the Intellectual Property Office (IPO) or courts of law.
Purpose and Objectives of the Revised Order
- To revise and clarify policies combining the mandates of BFAD, IPO, and courts concerning pharmaceutical products and IP rights.
- To reaffirm BFAD’s role in ensuring safety, efficacy, and quality of pharmaceutical products without adjudicating IP rights.
- Defines "intellectual property rights" specifically as patents and trade secret rights over pharmaceutical products.
General Guidelines for Registration of Pharmaceutical Products
- BFAD evaluates pharmaceutical product registration applications solely based on safety, quality, and efficacy.
- Acceptance of applications by BFAD does not grant or imply any legal IP rights over the pharmaceutical product.
- Applicants must submit a notarized affidavit of undertaking acknowledging possible cancellation of their Certificate of Product Registration (CPR) if they lack IP rights, and undertake to indemnify BFAD from third-party claims.
- New applications for CPR must be posted on BFAD's website for at least 30 days including application number, generic name, brand name, and applicant’s name.
- BFAD will notify any interested party asserting prior IP rights that such issues fall outside its jurisdiction and should be addressed to IPO or courts.
- Notifications or postings do not cause suspension or delay in CPR processing unless BFAD is legally restrained by IPO or courts.
- Annotations linking the CPR's effectivity to patent expiry are invalid and shall no longer be included or recognized.
Repealing Clause
- Administrative Order No. 170, series 2004, and any other inconsistent issuances or guidelines are repealed or revoked.
Effectivity
- The Order takes effect immediately after publication in two newspapers of general circulation.