C. Pharmaceutical Patent Law in Tha

C. Pharmaceutical Patent Law in Thailand
1. Background of Pharmaceutical Patent Protection in Thailand
Requests from domestic industries and the national policy in promoting industrial development and international trade were the early forces that drove Thailand to turn towards patent protection. As a civil law country, Thailand must enact an Act in order to legitimately recognize patent rights. The Thai government had first proposed a draft patent act for consideration by the legislature in 1965, but it was refused because of the fear that patent law would result in trade monopoly and an increased burden on consumers. The lack of readiness in terms of manpower and facilities to accommodate the patent system was another concern of the legislature.
Patent protection in Thailand was eventually recognized through the enactment of the Patent Act B.E. 2522 (A.D. 1979) (1979 Act), which came into effect on September 12, 1979. It was clearly specified under this 1979 Act that pharmaceutical products were not patentable. Only pharmaceutical processes were eligible for patent protection, which corresponded to the level of pharmaceutical development of the country at that time.
During the 1980s-1990s, the U.S. government pressured Thailand to amend the patent protection granted under the 1979 Act by tying trade retaliation measures to the protection of intellectual property rights. For instance, it cut Thailand’s Generalized System of Preferences for certain goods in January 1989 for the reason that Thailand did not provide sufficient intellectual property protection to U.S. nationals, especially on the protection of computer programs and pharmaceutical products. It also threatened to use Section 301 of the Omnibus Trade and Competitiveness Act of 1988 as a trade retaliation measure.
As a result, Thailand amended the 1979 Act in 1992 on various important issues, including making pharmaceutical products patentable. The amendment also set up mechanisms to monitor the price and availability of drugs in the market, in order to prevent pharmaceutical patent holders from abusing their rights. However, such mechanisms were later revoked by the second amendment to the 1979 Act in 1999.
2. Current Pharmaceutical Patent Protection
On the international level, Thailand is not a party to any international treaty or convention regarding patent protection, except for the TRIPS Agreement. The 1979 Act, which was amended twice respectively in 1992 and 1999, is the domestic law governing pharmaceutical patent protection in Thailand. Currently, the Patent Act recognizes protection of inventions, which include pharmaceutical products and processes. An invention is patentable if: (1) it is a new invention; (2) it involved in higher inventive step; and (3) it is capable of industrial application. The inventor might also choose to apply for a petty patent if criteria (1) and (3) are met. However, the law does not allow the application for both a patent and a petty patent for the same invention.
In order to obtain patent protection under the law, applicants have to file applications with the relevant authority in accordance with the formalities specified in the Patent Act. Generally, the patent lasts for a term of twenty years from the filing date of the patent application within the country.
As in the TRIPS Agreement, the Patent Act has also specified some flexibility for patent protection. The Patent Act recognizes compulsory licensing as a remedy to the abuse of a monopoly right. There are also two exceptions to the exclusive rights that directly concern the pharmaceutical industry. First, professional pharmacists or medical practitioners may compound drugs to fill a doctor’s prescription as well as use pharmaceutical products without the consent of, or remuneration paid to, the patent holder. This exception is aimed at protecting the public against a monopoly by the patent holders and preventing the medical practitioners from infringing pharmaceutical patent in treating patients.
The second exception is similar to the Bolar exception under the TRIPS Agreement. The Patent Act allows applicants to file for drug registration if they intend to produce, distribute or import patented pharmaceutical products after the expiration of the existing patent term. Such exception allows pharmaceutical companies to file a drug application during the patented term and enable them to release the products immediately after the expiration of the patent term. The provision is meant to promote competition among pharmaceutical companies and lessen time for generic drugs to be available to the market, which will enhance public benefit