Roche Products V. Bolar Case Study

Certain acts not to be considered as infringement

There are certain exceptional acts where the use of patented invention without consent of the patentee doesn’t constitute infringement . Such acts are as follows:

(a) Any act of making, constructing, using, selling or importing apatented invention solely for uses reasonably related to thedevelopment and submission of information required under any lawfor 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,

Bolar Pharmaceutical is a court 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

BBS Kraftfahrzeug Technik A.G. ("BBS") of Germany held both German and Japanese patents for certain aluminum automobile hubcaps. The hubcaps were legitimately purchased in Germany by a Japanese company which was engaged in the export of the relevant goods to Japan where an affiliated Japanese company was engaged in the sale of the goods. These two companies were virtually under the same management when the goods were imported into Japan for sale at a price lower than that charged by BBS dealerships in Japan. Subsequently, BBS filed suit for patent infringement in Tokyo District Court in June of 1994. The district court found that the two companies had infringed the BBS Japanese patent. However, on appeal the judgment in favor of BBS was reversed. In reversing the district court, the High Court held that the patentee 's right to enforce its Japanese patent against the imported goods had been exhausted since the patentee had legally transferred title to a rightful purchaser of the patented product. Because parallel imports of patented goods had previously constituted infringement of patents in Japan, this appellate court decision has invoked substantial