INTRODUCTION
Due to the intrinsic link between public health and patent law in the context of access to pharmaceuticals, the necessity of striking a reasonable balance between the intellectual property rights of patent holders and the interests of public health has given rise to the need for specific regulatory provisions within pharmaceutical patents.
Accordingly, while patent rights grant the holder broad exclusive rights over the drug, certain acts are exempt from the scope of patent protection. In particular, considering the direct impact of drug prices on access to medicine and the correlation between the market availability of generic drugs and the reduction of drug prices, an exemption has been introduced. This exemption allows generic drug manufacturers to conduct tests and trials for regulatory approval purposes without constituting an infringement on the patent rights of the original drug manufacturer, emphasizing the public’s right to health. This exception was first recognized in the United States through a Federal Court ruling and has subsequently been codified into law within European Union member states and Turkey.
This article will explore the “Bolar Exemption,” which exempts the acts of generic drug manufacturers conducting tests and trials for the purpose of obtaining marketing authorization from the scope of patent protection. Furthermore, it will examine the international legal implications of this exemption, as well as its application within Turkey under Article 85, paragraph 3(c) of the Industrial Property Law No. 6769 (“IPL”), in light of judicial interpretations.
A. EXPERIMENTAL ACTS INVOLVING TESTS AND TRIALS NECESSARY FOR THE AUTHORIZATION OF DRUGS COVERED BY THE EXEMPTION
Patent rights fundamentally confer upon the holder the authority to use and exploit the patented drug. However, to market a drug, it is necessary to complete the regulatory approval process. This process, which typically spans 9 to 11 years, poses a challenge for generic drugs and, by extension, for public health. The principal issue is that the regulatory approval procedure for generic drugs cannot commence prior to the expiration of the patent protection period for the original drug. Should the testing and trials required for the generic drug’s approval be deemed to infringe upon the patent rights of the original drug, the authorization process for the generic drug can only begin after the patent on the original drug has expired. Given the extended duration of this process, the emergence of competitive market conditions is consequently delayed.
To balance the interests between public health and the intellectual property rights of patent holders, a regulatory adjustment has been made to address the issue of delays in the market entry of generic drugs caused by the regulatory approval process. This adjustment allows generic drug manufacturers to conduct the necessary tests and trials for regulatory approval while the original drug’s patent protection is still in effect, without constituting an infringement on the patent rights. This exception, known as the “Bolar Exemption,” was first recognized by a Federal Court ruling in the United States.
B. INTERNATIONAL REGULATIONS REGARDING THE BOLAR EXEMPTION
Article 30 of the Trade-Related Aspects of Intellectual Property Rights (“TRIPS”) Agreement, which was added to the foundational agreement of the World Trade Organization (“WTO”), stipulates that limited exceptions may be applied to the exclusive rights conferred by patents under certain conditions. Based on this provision, the WTO Dispute Settlement Body confirmed the compatibility of the Bolar Exemption with TRIPS in its ruling WT/DS114/R.
“Members may provide limited exceptions to the exclusive rights conferred by a patent, provided that such exceptions do not unreasonably conflict with a normal exploitation of the patent and do not unreasonably prejudice the legitimate interests of the patent owner, taking account of the legitimate interests of third parties.”
The Bolar Exemption, which is a result of the European Union’s obligations under TRIPS, was incorporated into EU law through amendments made by Directive 2004/27/EC to Directive 2001/83/EC (the “Directive“). However, the implementation and scope of this exemption vary among member states. Moreover, considering the ambiguous language in the Directive, the adopted exemption is generally construed as narrower compared to American judicial interpretations, and the exemption’s scope is subject to interpretation within a legal framework conducive to such determination.
C. APPLICATION OF THE BOLAR EXEMPTION UNDER ARTICLE 85/3 OF THE IPL
Although the acts exempt from the scope of the rights conferred by a patent are enumerated in Article 85, paragraph 3 of the IPL, the scope of the Bolar Exemption as reflected in Turkish law is articulated in this provision as including “acts for experimental purposes involving the patented invention, including the regulatory approval of medicines and the necessary tests and trials for this purpose.”
As is clearly understood from the text of the provision, the Bolar Exemption in Turkish law pertains solely to the tests and trials necessary for obtaining regulatory approval. In doctrinal interpretations, it is suggested that the regulatory approval of medicines falls within the scope of this exemption, and that there are no barriers to the issuance of marketing authorizations by the Ministry of Health. Jurisprudence supports this interpretation by indicating that even if a medicine has obtained regulatory approval, it cannot be marketed until a sales permit is granted, thereby not constituting a patent infringement. In other words, the Court of Cassation, considering that there can be no risk of infringement unless the administrative process for the regulatory approval is completed, treats the application for a license under the Bolar Exemption and accepts that such acts do not constitute a violation of patent rights.
In its decision dated November 13, 2019, under case number 2018/5745E. 2019/7191 K., the 11th Civil Chamber of the Court of Cassation ruled that under the repealed Decree Law No. 551 on the Protection of Patent Rights, the act of filing a regulatory application and conducting the necessary analyses and tests falls within the scope of the “Bolar Exemption” and does not constitute patent infringement. The court found that merely filing a shortened regulatory application does not lead to patent infringement or pose a risk of infringement, unless the drug is actually marketed or there has been a public announcement or distribution to warehouses. Given that the defendant had not obtained the regulatory approval at the time the lawsuit was filed, the court concluded that the defendant’s actions were outside the scope of patent protection, and that these actions were covered by the Bolar Exemption and did not constitute infringement. Furthermore, the court determined that the defendant’s product did not infringe on the plaintiff’s patents either directly or equivalently, and thus upheld the decision.
CONCLUSION
The Bolar Exemption, established in response to the potential drawbacks of the regulatory procedure for pharmaceutical patents, permits the initiation of test and experimental activities necessary for the regulatory approval of generic drugs without waiting for the patent term of the original drug to expire. By legalizing such activities without treating them as patent infringement, the exemption accelerates the regulatory process for generic drugs, thereby shortening the period for the development of a competitive market and positively impacting public health. Under Turkish Law, the Bolar Exemption encompasses the tests and experiments required for regulatory approval, and even filing for a regulatory application for a generic drug is not considered a patent infringement by the Court of Cassation.
