HEALTH MINISTRY CONFIRMS US PHARMACEUTICAL PATENT

UNCLAS MUSCAT 000105 SIPDIS SIPDIS STATE FOR NEA/ARP, EB/TPP/MTA/IPC STATE PASS USTR FOR JBUNTIN COMMERCE FOR COBERG E.O. 12958: N/A TAGS: BEXP ECON KIPR MU SUBJECT: HEALTH MINISTRY CONFIRMS US PHARMACEUTICAL PATENT PROTECTION REF: 06 MUSCAT 1579 ¶1. In response to U.S. pharmaceutical company concerns (reftel),Econoff arranged for a January 30 teleconference between Dr. Batool Jaffer Suleiman, Director of Rational Drug Use, Ministry of Health, and Samir Mansour, Regional Pharmaceutical Research and Manufacturers of America (PhRMA) Director, and Nidal Fakhoury, Chairman of PhMRA Middle East and General Manager of Merck. Suleiman reaffirmed her position that the Ministry of Health would recognize all U.S. pharmaceutical product patent expiration dates once the U.S.-Oman FTA comes into effect. She requested that those U.S. pharmaceutical companies with products in Oman submit a master list of the products they produce, to include trade name, chemical name, first filing date, strength, patent expiration date, and a copy of the original U.S. patent. Suleiman noted that to date, 28 U.S. companies had 177 products registered in Oman. ¶2. Suleiman continued that the Ministry of Commerce and Industry was developing a mechanism to handle patent registration concerns, given the inadequacies of the GCC Patent Office. (Note: Fakhoury pointed out that out of 5,000 applications submitted to the GCC office, only 15 had been approved. End note.) In the interim, she remarked that U.S. pharmaceutical concerns would be able to go directly to the Ministry of Health to ensure their products were protected in Oman. This avenue would only be available to American companies per the requirements of the FTA. ¶3. Fakhoury and Mansour raised the issue of patent violations for pharmaceutical products already in the Omani market. Suleiman responded that per discussions during FTA negotiations, patent protection would not be retroactive. She agreed, however, to look into the cases of an estimated four products where copycat pharmaceuticals may have been purchased through a GCC tender during the negotiation process. These include copies of Combivir (GSK),Fosamax (MSD),Cozaar (MSD),and Lipitor (Pfizer). Suleiman added that in some of these specific cases, the Minister of Health had stopped production, while in other cases the Ministry never granted marketing approval for the products. GRAPPO