Patent Protection on Pharmaceutical Products and Processes

     Turkey is one of the countries which signed and ratified the Agreement Establishing World Trade Organisation. This Agreement has entered into force in all member states in January 1, 1995. As it is clearly known that the developed countries had 1 year transition period for adoption of national legislation making them being compatible to TRIPS Agreement. The developing countries of which Turkey is one of them had 4 more years for reflecting the provisions of TRIPS to their national legislation. This period has ended in January 1, 2000.

     Although having totally 5 years transition period up to the year 2000, Turkey has adopted its national industrial property legislation for patents, trademarks, industrial designs and geographical signs in June 1995. All elements of this legislation are not only compatible to TRIPS standards but also contain many better and more effective provisions. This progress shows that Turkey is the first developing country which amended its national legislation according to TRIPS Agreement. When the situation in all other developed countries has been analysed, it will easily be understood that Turkey has adopted new legislation being compatible to TRIPS Agreement before than most of the developed and all of developing countries.

     Patent protection of the pharmaceuticals has been excluded from the patent protection by the Transitional Provision 4 of the above mentioned Decree Law No . 551 up to January 1, 2000 for processes and January 1, 2005 for products. Although this provision is compatible to Article 65/1, 65/2 and 65/4 of the TRIPS Agreement. This Article of the Decree Law has been amended by the new Decree Law 566 on September 22, 1995. Amended Article has excluded the patent protection of both pharmaceutical processes and products up to January 1, 1999.

Turkey as being a party to the Agreement of Establishing World Trade Organisation, the provisions of the Article 70/8 and 70/9 of TRIPS Agreement have been applied. This means that all the patent applications related to the the pharmaceuticals have been filed to the Turkish Patent Institute since January 1, 1995. Article 70/9 which states exclusive marketing right for a period of five years to the applicant of the patents according to Article 70/8 who obtained patent and marketing approval related to that product in any member country has not bben applied in Turkey, because Turkey has started to accept patent protection in pharmaceutical products and processes on January 1, 1999.

     Although a transition period of 5 years for the developing countries, and that of 10 years for the underdeveloped countries have been given in order to enact legislation in the matters they did not provide protection on the effective date of the Agreement, according to Article 65 of Intellectual property Rights Related to Trade Annexed to World Trade Organization Agreement, the obligation to transact the pharmaceuticals patent applications has been brought for the countries applying transition period according to the provisions of clause 8 of Article 70 of the same Agreement. As required by this provision, Turkish Patent Institution has started to transact all pharmaceuticals patent applications as of January 1, 1995. All the pharmaceuticals patent applications are being reviewed by the Turkish Patent Institute according to the provisions of patent law, no matter whether they are process or product patent. This review is being carried out as the stages of search report preparation and examination report preparation, as applied to the other patent applications.

     Turkish patent legislation doesn't include pipeline protection and supplementary protection provisions for pharmaceutical inventions.

As conclusion, it can be said;

• The pharmaceuticals which are protected by patent legislation shall be produced and marketed by only the patent holder.
• The pharmaceuticals which may be protected by patent legislation are the only ones which have been applied to Turkish Patent Institute (TPI) since January 1, 1995.
• The generics of the pharmaceuticals which have been applied to TPI for product patents may not be produced.
• New processes for known products may be protected by process patent, but the generics having produced by the process of not patented (different process), will be produced and marketed (example : VIAGRA & SILDEGRA).