Bolar exception: An overview

Intellectual property systems are created to incentivize and safeguard the rights of creators and inventors. More specifically, patent regimes that are in place across the world can help safeguard an invention for a limited period of time. Patents carry great relevance in the pharmaceutical industry by contributing up to 80% of the overall revenue of pharmaceutical companies. Drug patents ensure a continuous influx of monetary incentives which is crucial for promoting further research and development. Most often than not, pharmaceutical inventions require pre-authorization from certain regulatory bodies. Pharmaceutical regulations are vital since it plays an important role in verifying the safety and efficacy of a pharmaceutical product. Moreover, such regulatory bodies also control the pricing and quality of pharmaceutical drugs, thus contributing to improving the overall health status of a particular region. However, in order to regulate such pharmaceutical products, certain patented drugs may have to be manufactured in advance without impacting their patent-related rights. Thus, in order to facilitate the regulation of pharmaceutical products, several countries across the globe have devised an exception which is termed as the Bolar exception (or otherwise referred to as research exception or safe harbor exception). A Bolar exception can be referred to as a provision or a defense for patent infringement wherein a patented pharmaceutical product can be manufactured and exploited for research and development purposes as well as to procure approvals from pharmaceutical regulatory bodies. The Bolar provision also ensures that the patent that subsists on the pharmaceutical product is still valid while the product is being exploited.

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Origin of the Bolar exception and the Waxman Act

The origin of research exceptions can be traced back to as early as 1813. In the case of Whittemore v. Cutter, Judge Joseph Story held that the legislature cannot punish a person who infringes upon a patent for scientific experiments or “for the purpose of ascertaining the sufficiency of the machine to produce its described effects”. However, the origin of the Bolar exception roots from the case of Roche Product Inc v. Bolar Pharmaceutical Co Inc. In this case, the Federal Court adjudicated that the use of a patented product for the purpose of experimentation and the exception for the same was narrowly provided under US law. Moreover, it was held that the research exceptions provided under US law would not allow Bolar pharmaceuticals to infringe a patent purely for testing purposes in order to obtain market approval of a generic product. However, in order to overturn the US Federal Circuit decision, the US Drug Price Competition and the Patent Term Restoration Act of 1984 introduced the Bolar exception.  The Bolar exception was first mentioned and brought into force through the Hatch Waxman Act. 35 U.S.C 271 (e) (1) of the Act elucidates upon the Bolar exception. It states as follows:

“It shall not be an act of infringement to make, use, offer to sell, or sell within the United States or import into the United States a patented invention (other than a new animal drug or veterinary biological product (as those terms are used in the Federal Food, Drug, and Cosmetic Act and the Act of March 4, 1913) which is primarily manufactured using recombinant DNA, recombinant RNA, hybridoma technology, or other processes involving site-specific genetic manipulation techniques) solely for uses reasonably related to the development and submission of information under a Federal law which regulates the manufacture, use, or sale of drugs or veterinary biological products.”

Thus, the Bolar exception that was introduced through the Waxman Act provides protection to drug manufacturers for preparing their products in order to obtain regulatory approvals. Moreover in Eli Lilly and Co. v. Medtronic, the Supreme Court of the United States held that the Bolar exception applies to medical devices as well. In several other judgments, the Supreme Court of the United States has adjudicated that the Bolar exception is created to explicitly protect patented compounds for clinical testing as well as for submitting it to regulatory agencies. Additionally, the Bolar exception is applicable in countries such as Canada and Mexico. Section 55.2 (1) of the Canadian Patent Act notes that if a person constructs, uses, or sells a patented invention solely for its development or for the submission of information that is required as per Canadian laws, would not amount to infringement.

Bolar exception in India

Section 107A of the Patents Act specifies an exception to patent infringement. According to this section, the constructing, importing, and selling of a patented invention is permissible if it is for research and development purposes. Additionally, a third party may also exploit the patented invention in order to obtain regulatory approvals. The exception as per section 107A was introduced to the Act through the Patents Amendment Act, 2005.  As per section 48 of the Indian Patents Act, legal protection over pharmaceutical drugs or similar products subsists for 20 years. After this period, the invention will fall into the public domain and can be exploited by anyone. It is pertinent to note that the Bolar exception is valid only as long as the patent is valid and is not in the public domain. Additionally, importing a patented product by an authorized person or a company is not considered an infringement of patent rights. Issues pertaining to the export of patented products were discussed in detail by the Delhi High Court in the case of Bayer Corporation v. Union of India and Ors. as well as Bayer Intellectual Property GMBH and Anr v. Alembic Pharmaceutical Ltd. The Delhi High Court adjudicated that the Indian Constitution upholds export as a valid part of the Bolar exception. Hence, the exporting of patented products for the purpose of research and clinical trials will not amount to patent infringement.  Most often than not, pharmaceutical products can be of the dire need to society. In such cases, as per the exception, the patented drug can be used for further research and development without having to obtain consent from the patent holder.

In conclusion, the Bolar exception permits drug manufacturers to experiment and develop patented products. Moreover, the exception also permits manufacturers to produce limited quantities of patented products for research purposes. The Bolar exception is an important provision in the patent regime especially since it manages to strike a balance between the interests of manufacturers as well as patent holders. The exception also facilitates the development of patented pharmaceutical products without violating patent rights, thus, contributing to the overall betterment of health products in a particular region.

Author: Sanjana, a BBA LLB student of  Symbiosis Law School (Hyderabad),  in case of any queries please contact/write back GLOBAL PATENT FILING at support@globalpatentfiling.com.