Intellectual Property Protection
The United States, the European Union and Turkey have been in negotiations over the improvement of Turkey's intellectual property regime for several years. With the conclusion of the Customs Union agreement between Turkey and the EU, Turkey has now committed to having in place a TRIPs-consistent patent law by not later than 1999. The patent law issued by Executive decree in June 1995, however, falls well short of TRIPs standards in numerous areas, including:
Title 1, Chapter 2, "Conditions of Patentability"
1. Article 6, "Unpatentable Inventions and Subject Matters." Many kinds of crucial biotechnology inventions could be excluded by the terms of Article 6, in particular Article 6(2) which exempts from patentability "plant and animal varieties or biological processes for the production thereof."
2. Article 7, "Novelty." This provision appears to change the standard definition of novelty in order to exclude any possibility of pharmaceutical pipeline protection as well as potentially invalidating any "mailbox" patent filings made under the terms of TRIPs Article 70(8). This Article should be changed specifically to recognize the validity, at least, of "mailbox" filings.
Title V, "Effects of Patent Rights
3. Article 72, "The Term of the Patent." Pharmaceuticals and many other products such as agricultural chemicals require a lengthy registration/approval process before they are brought to market but after they are patented. This article should be changed to allow for the extension of patent terms for products that require a lengthy pre-marketing approval process.
4. Article 82, "The Effects of the Publication of the Patent Application." Paragraph 3 of this article appears to be unjustified because there are microbiological processes where deposition of the microorganism is not necessary and therefore not done because the process can be started by using one organism which is based on another already available to the public.
5. Article 83, "The Limits of Protection of the Patent Application or the Patent, The Interpretation of the Claims" This article appears to provide some protection for proprietary data by prohibiting government disclosure. However, the law should also prohibit the use and/or disclosure by non-government parties who may have received such information. In other words, use as well as disclosure should be prohibited.
Chapter IV, Obligation to Work
6. Article 96 "Obligation to Work." This article is highly problematic. By requiring working within three years of patent grant, it would appear to exclude pharmaceuticals and agricultural chemicals from patentability since the marketing registration period typically takes far longer than three years after patent grant.
7. Article 97, "Evidence of Use." This article implies that importation does not satisfy working requirements since inspection of "manufacturing" facilities is a condition of patentability.
Title VII, "Compulsory Licenses"
8. Articles 99-120. The length and detail of this section betrays its purpose -- to facilitate the granting of compulsory licenses in violation of the patent owner's rights. In general, the provisions are far too broad, allowing for compulsory licenses for technical progress if the invention is not of "significant merit" (opening the door to arbitrary government decisions), and for vague and undefined "public interest". There appear to be no provisions for the termination of a compulsory license when the conditions leading to its grant cease to exist. Lest there is any doubt of the government's intentions to facilitate the issuance of compulsory licenses, Article 120 requires the government to provide publicity and financial incentives for applicants to seek compulsory licenses. This entire section should be deleted and re-written to conform with Article 31 of TRIPs.
Other Barriers: Registration Standards and Lack of Protection of Proprietary Data
A principal means by which pharmaceutical intellectual property is pirated in Turkey is the unauthorized use of the originator's proprietary data submitted as part of the registration/marketing authorization process. The material, which includes safety and efficacy information gathered from lengthy and expensive clinical and human testing is often simply photocopied and submitted to the authorities who then approve the copied product without requiring any bioequivalence or bioavailability testing. This unsafe practice is also in direct conflict with TRIPs Article 39.3 of TRIPs, "Protection of Undisclosed Information." PhRMA urges that the protection of proprietary information also be improved in Turkey. Turkey should be required to implement a system of data exclusivity consistent with TRIPs Article 39, as of the effective date of the new patent law, i.e., January 1999.
Potential Exports/Foreign Sales
PhRMA estimates that, were the aforementioned problems to be corrected, the increase in sales that would accrue to American research-based pharmaceutical company affiliates in Turkey would be in the range of $60 million annually.