The question of whether generic companies can use a patent for clinical trials, tests and experiments during the patent protection period has been a much-discussed issue for many years. Originator companies preventing a patent's use in this way has often been criticized for retarding access to cheaper generics in the market. However, through the well-known "Bolar exemption", the use of patents for clinical trials and tests during the patent protection period has been accepted by many countries.
What is the Bolar Exemption? Whose Rights Does it Serve?
Patent protection provides a patent holder with an exclusive right to prevent third parties from using, offering for sale, selling or importing a product in a given country for a 20-year term as of the date the patent application is filed in the relevant country. After the patent's expiration, the protected drug becomes public domain and available for any third party use for commercial purposes without the patent-holder's consent. However, pharmaceutical products cannot be manufactured and released to the market immediately after the patent protection period has expired. Generic companies, similar to originator companies, are obliged to obtain a license from the competent governmental authority to manufacture and market generic pharmaceuticals. The procedures for obtaining market authorization, including clinical trials and tests, takes a long time, and commencing these procedures after the expiration of patent protection causes the originator company to have a monopoly of the relevant drug patent for a longer period of time. Since patent protection also restricts the use of the relevant patent for conducting clinical trials and tests and applying for a drug license, it retards generic products' release to the market and damages the public's right to access affordable treatments. This situation justifies the need for the 'Bolar exemption'.
The Bolar exemption derives its origins from the US Federal Circuit decision1, which stated "it shall not be infringement to make, use, offer to sell, or sell within the US or import into the US a patented invention solely for reasonable uses regarding the development of the drug and submission of information under a Federal law which regulates the manufacture, use, or sale of drugs." The Bolar exemption is accepted in many countries including EU member states, the UK, Canada, China, and India.
Within the scope of the Bolar exemption, the right is given to generic companies to apply for bioequivalence studies and for drug licenses before a patent protection period expires. In this way, generic drugs can be released to the market on the day that the patent protection expires. If generic companies were prevented from commencing clinical trials, tests, and licensing procedures during the patent protection period, it would de facto extend the 20-year patent period.
The Bolar Exemption in Turkey
Turkey incorporated the Bolar exemption in 2004. According to Article 85 (3) (c) of the Industrial Property Law, "the trial practices involve the performances of the invention subject to a patent in order to register drugs including necessary tests and experiments needed for this purpose" are outside of the scope of rights provided by patents. Thus, pharma companies can use the patent for clinical trials, tests, and license applications for generic drugs before the expiration of a protection period, allowing generic drugs to be released to the market upon the expiration of the original patent protection period.
The Bolar exemption is accepted and implemented in a wide scope in Turkey. The Turkish Medicine and Medical Devices Agency and the Ministry of Health, and the Turkish courts do not consider any kind of clinical tests and trials, abbreviated drug applications and even the granting of drug licenses as a breach of patent protection. The practice allows generic drugs to be licensed during a patent protection period, and for their release to the market to be postponed until the period of patent protection has expired.
On the other hand, this wide interpretation of the Bolar exemption by Turkish courts may harm the rights of patent holders. The relevant law aims to enable the procedures required for market authorization by generic companies before a patent protection period has expired, allowing generics to be released to the market on the patent expiration date. However, in practice, courts show a tendency to reject originator patent holders' patent infringement claims or discovery of evidence requests before the relevant generic drugs are released to the market. Nonetheless, these claims are crucial for originator companies to determine as soon as possible whether there has been patent infringement. This is largely due to the fact that the price of the original product decreases by 40%, according to the Communique on the Pricing of the Medicinal Products for Human Use, regardless of whether the released generic infringes patent protection or not. Therefore, demonstrating whether there is an infringement before generics are released to the market is of significant importance to both originator companies, and generic companies before they commence mass production.
While patent protection would normally prevent the market release of generic drugs, the procedures required to obtain a license for market authorization including clinical trials and experiments or other activities are excluded by the Bolar exemption. Originator companies cannot claim for patent protection against generic companies due to their use of patents for the purposes of market authorisation applications. The Bolar exemption must be interpreted and implemented in a fair manner that does not damage the monopoly rights of patent-holding originator companies during the patent protection period and must only serve to prevent any hindrance to the generic market release, which may harm the public's access to cheaper generic drugs.
1 The US Federal Circuit decision on Roche Products, Inc. v. Bolar Pharmaceutical Co., Inc., 733 F.2d 858 (1984).
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