Intellectual property rights grant the right holder a monopoly and market exclusivity for a stipulated few years.
However, there are few exceptions where the right holder’s monopoly is eroded and a third party can utilize the innovation for one or more legal purposes that do not come within the definition of infringement. A Bolar Provision is one such provisions, as discussed in this blog.
The most well-known of the several limited exceptions to the patentee’s exclusive rights under TRIPS Article 30 is the Bolar Provision, which is notably important to drugs and medicinal products.
The Bolar Provision is one of the most important concepts under the Patents Act. This provision allows the generic players to develop the innovative product for commercialization once the patent period of the innovator product comes to an end. Developing the generic product during the patent period under this provision is not considered as an <<infringement>> and does not attract any penalties. Thus, once the patent period is over, the generic companies can file ANDAs at the US FDA and obtain approval for the generic version of the innovator medicinal product. The generic copies cost less compared to the innovator product and thus brings in price advantage and affordability in the market. The Roche v. Bolar case led to the U.S. introducing the bolar exemption for the first time in the Hatch-Waxman Act.
The Bolar Provision protects research activities conducted in advance of an FDA filing against infringement claims.
It declared that it was not considered an “act of infringement” to “create, use, cater to be sold, trade within the USA, or import into the USA a patented invention only for reasonably important purposes to the development and submission of information under a Federal law which controls the production, utilization, or sale of pharmaceuticals or veterinary biological goods.”
Competitive products, which include generic drugs and biosimilars, would not be permitted to access the market for extended periods of time after the patent on originator products expired without the regulatory review or “Bolar” exception.
The Bolar exception’s protection against patent infringement encourages the swift regulatory clearance of generics and biosimilars once the patent of the original manufacturer is no longer valid.
The Bolar Exemption is also a provision of the Indian Patent Act found in Section 107A. Section 107 A’s main goal is to define specific demonstrations that are not to be regarded as incursion. Bolar Provision is a defence used to prevent patent infringement and legal complications. This provision gives conventional drug manufacturers the necessary time and opportunity to conduct research on the product while the patent is still in effect. These drug manufacturers attempt to support their businesses in the market not long after the expiration of the licences held by the innovator organisation. Bolar provision thus help to boost the research and development activities for the generic players as well as provide necessary permissible exclusivity to the patented product.
