Biosimilars are defined under the Communiqué on Pricing of Medicinal Products for Human Use1 as medicines that (i) are similar to and hold the same strength with licensed original biological medicines, (ii) are used to treat the same diseases as the original product, and (iii) are not generic.
In line with this definition, the Guidelines on Biosimilar Medicinal Products2 describes biosimilars as "(...) medicines that are similar to a licensed and original biological medicine. The active ingredients of biosimilar products are similar to those of original biological medicines. Biosimilars and biological reference medicines usually have the same strength, and are used to treat the same diseases. Biosimilar medicines are only different from original biological medicines in terms of commercial name, appearance and packaging."
Generally, when a patented invention is exploited without the patent holder's permission, and this exploitation occurs within the patent protection period in a country where the patent is recognized; patent rights are infringed. This generality, however, is not without its exceptions – among which is the Bolar Exception3.
The basis of this principle is that tests and research conducted for the purpose of obtaining regulatory licenses/approvals do not infringe patent rights. Bolar-inspired provisions have since been adopted in various legislations around the world - including Turkey.
Article 75 of the Turkish Patent Law was amended in 2004 to include a provision stating that actions carried out for trial purposes, including the licensing stage of pharmaceuticals, and tests and experiments necessary for such licensing, are not within the scope of patent rights. The provision does not refer to generics or biosimilars (nor make any other distinction) and uses instead the general term "pharmaceuticals", indicating that the exception also applies to biosimilars.
Thus, tests and experiments conducted with regard to licensing of biosimilars, license applications and even obtaining a license within the patent period do not constitute an infringement of patent rights. This provision, however, does not allow for the production, storing or sales of biosimilars before the expiry of the original biological product's patent. Such acts would still constitute an infringement of the original manufacturer's patent rights, against which the patent holder may exercise remedies provided under the Patent Law (and the Turkish Commercial Code)4.
While the Bolar exception serves the purpose of enabling biosimilars to enter the market as soon as the patent of the original product expires; Article 9 of the Regulation on Licensing of Medicinal Products for Human Use (the "Licensing Regulation") provides the original pharmaceutical manufacturer with "data exclusivity" for a certain period of time – which is essentially a limitation to the license application filed by the biosimilar manufacturer.
Article 9/a/3 of the Licensing Regulation provides that if a medicinal product is fundamentally similar to a licensed medicine, the data exclusivity period of which has expired; then the manufacturer may file a brief application to obtain a license for that similar product. Accordingly, this provision protects the data that manufacturers of original pharmaceuticals submit to the licensing authority, and prevents the manufacturers of similar products from using / referring to the data in their license applications.
Under the Licensing Regulation, data exclusivity is granted to (i) original products that have been licensed for the first time in a Customs Union country following 1 January 2001 for which there have been no generic license applications in Turkey until 1 January 2005, and (ii) original products that are licensed for the first time in a Customs Union country following 1 January 2005.
The data exclusivity period is six (6) years starting from the date of first licensing within the Customs Union country. However, the Licensing Regulation also limits the data exclusivity period to the patent protection period in Turkey. Accordingly, the data exclusivity expires at the expiry date of the patent in Turkey, regardless of when the data exclusivity period commenced for the original product.
The Guidelines on Biosimilar Medicinal Products further provides that if additional documents that are not necessary for a brief license application (e.g. results of toxicological or pharmacological tests, clinical studies, etc.) are submitted by the biosimilar product manufacturer to the licensing authority, biosimilar products are exempt from data exclusivity periods.
1. Published in the Official Gazette dated 22 September 2007 no. 26651.
2. Prepared by the Directorate of Pharmaceuticals and Pharmacy pursuant to the Regulation on Licensing of Medicinal Products for Human Use dated 19 January 2005.
3. The Bolar Exception takes its name from the Roche v. Bolar case filed in the United States.
4. Depending on the case and whether the plaintiff is a trademark holder, the Trademark Law may also be applicable.
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