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