Intellectual Property Protection
Kuwait provides no legal protection for pharmaceutical product patents. As in some other countries in the Gulf, pharmaceutical piracy is now threatening to become a significant problem as pirating companies from other countries begin to penetrate these markets. There has been some encouraging progress, however, as there appears to be a new willingness among health and commerce officials to prevent pirate product registrations and amend the deficient 1962 patent law.
In 1998, Kuwait was upgraded to the "Special 301" Priority Watch list in response to the lack of tangible progress on intellectual property rights, including software, videos and adequate and effective patent protection for pharmaceuticals. The lack of progress stands in contrast to neighboring Saudi Arabia, which enacted a patent law in 1989, and the United Arab Emirates, which has announced an intention to revise its patent law by the year 2000.
The U.S. Embassy informs industry that a promise has been elicited for a "mail box" filing provision as required by the TRIPs agreement, but the Kuwaitis have not yet established a clearly defined mechanism. In fact, since the addition of Kuwait to the Special 301 in 1996, the position of the research pharmaceutical industry has worsened.
The Kuwait Ministry of Health registered two unauthorized copies of a top selling patented product, ignoring the patent holder's objections. American companies have been concerned that this recent pirate copy registration may signal a new attitude at the Ministry of Health -- where product quality and intellectual property rights are ignored in favor of "cheaper" pirated copies.
The Government's progress on revising the patent law has so far fallen short of its own public statements. In 1997, Kuwait announced that a committee was being established to study and revise the patent laws in order to implement TRIPS obligations. There is no indication, however, that any meaningful work has progressed in this area over the past two years.
There is some optimism, however, that the Ministry of Health, with the support of the Ministry of Commerce, will issue a "ministerial decision" that would offer de facto protection to patented pharmaceuticals by banning pirate product registrations. U.S. companies are hopeful that the new policy will be approved by the end of 1998. There is also optimism that Kuwait will continue to play an influential role among GCC states in advocating efficient and streamlined new product approvals and introductions for research based companies.
Potential Exports/Foreign Sales
Kuwait represents the third largest pharmaceutical market ($190 million ex manufacturer) among the Gulf Cooperation Council states. At this time, it is not possible to estimate accurately potential export growth. Action now, however, can help prevent a serious piracy problem from developing.
PhRMA believes that with sustained industry and diplomatic dialogue, Kuwait has the potential to implement WTO/TRIPS consistent patent protection by 2000. In the meantime, U.S. companies look forward to implementation of a new MOH policy barring pirate registrations and purchases in the government sector.