Innovator declaration

Requirements for drugs declared as innovator:

1. Paten granted by one of the competent Intellectual Property Agencies (in the List specified in section V) granting for:

(i) active ingredient of medicine containing an active ingredient; or
(ii) mixture of active ingredients if medicine contains many active ingredients; or
(iii) Pharmaceutical products or preparations or dosage forms of injection medicine, infusion medicine, ophthalmic medicine, aerosol spray, transplant medicine, patch, medicine in gel.
The patent encloses referencing point requiring protection, determining scope of protection (the original needs to be legalized as prescribed; or a valid notarized copy as prescribed; or a copy certified by the seal of facility if the patent may search, define at websites supplying database of Intellectual property Agencies in this case, it should indicate clearly address for search, name of intellectual property agency and search code).

2. Documents certifying on being transfer of patent use rights  (license transfer) or transferring ownership of patent from the owner of patent specified in clause 2, section I above in case the facility is not owner of patent of active ingredient, enclosed with the facility’s commitment for exactness of this documents.
3. Certificate of pharmacy product (CPP) or certificate of free sale (FSC) or Marketing Authorization (MA) of medicine granted by competent agencies to owner (original needs to be legalized as prescribed; or valid notarized copy as prescribed).
4. Other documents to prove (if any).

Section V. List of Intellectual Property Agencies granting patent approved for the declaration of original proprietary medicines:

Vietnam National Organization of Intellectual Property or other Intellectual Property Agencies recognized by the World Intellectual Property Organization (WIPO) for being national agencies competent in international searching and preliminary appraisal, including content appraisal when granting patent include:

1. Austrian Patent Office (national code: AT);
   2. Intellectual property Australia (national code: AU);
   3. National Industrial Property Institute of Brazil (national code: BR);
   4. Canadian intellectual property Office (national code: CA);
   5. State Intellectual Property Office of China (national code: CN);
   6. European Patent Office (agency code: EP);
   7. Spanish Patent and Trademark Office (national code: ES);
   8. National Board of Patents and Registration of Finland (national code: FI);
   9. Israel Patent Office (national code: IL);
   10. Japan Patent Office (national code: JP);
   11. Korean Intellectual Property Office (national code: KR);
   12. Intellectual Property Service of Russian Federal (national code: RU);
   13. Swedish Patent and Registration Office (national code: SE);
   14. United States Patent and Trademark Office (national code: US).
   15. German Patent and Trade Mark Office) (national code: DE).
   16. United Kingdom Intellectual Property Office) (national code: GB).