Bolar exception is one of the exceptional acts where the use of patented invention without consent of the patentee doesn’t constitute infringement.
U/S 107A [Certain acts not to be considered as infringement] of Indian Patents Act 1970, any act of making, constructing, using, selling or importing a patented invention solely for uses reasonably related to the development and submission of information required under any law for the time being in force, in India, or in a country other than India, that regulates the manufacture, construction, use, sale or import of any product.
Some countries allow manufacturers of generic drugs to use the patented inventions for development and submission of information required under law. For example, from public health authorities, without the patent owner’s permission and before the patent protection expires. The generic producers can then market their version as soon as the patent expires. This provision is called “Bolar Exceptions” or “regulatory exception”.
Case-Study: Roche Products v. Bolar Pharmaceutical
This is a landmark case in the United States related to the manufacturing of generic pharmaceuticals. Bolar was a generic drug manufacturer and Roche was a brand-name pharmaceutical company which made and sold Valium, the active ingredient of which was protected by patent. Before patent expiration, Bolar used the patented chemical in experiments to determine, if its generic product was bioequivalent to Valium in order to obtain FDA approval for its generic version of Valium. Bolar argued that its use of the patented product was not infringement under the experimental use exception to the patent law.
The Court of Appeals for the Federal Circuit rejected Bolar’s contention holding that the experimental use exception did not apply because Bolar intended to sell its generic product in competition with Roche’s Valium after patent expiration and, therefore, Bolar’s experiments had a business purpose. Bolar also argued that public policy in favor of availability of generic drugs immediately following patent expiration justified the experimental use of the patented chemical because denying such use would extend Roche’s monopoly beyond the date of patent expiration.
The court rejected this argument, stating that such policy decisions should be made by congress. Likewise, the court decided that apparent policy conflicts between statutes such as the Food and Drug Act and the Patent Act should be decided by congress and not the courts. Shortly after Roche v Bolar was decided, congress did pass a law permitting use of patented products in experiments for the purpose of obtaining FDA approval, which established the modern system for FDA approval of generic drugs.
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