By P. Kandiah & Kimberly Liam
What happens when a patent for a particular drug expires or is about to expire? Patented drugs lose their patent exclusivity as they go off patent and pharmaceutical companies that own these patents start to worry as the generic pharmaceutical companies begin to sell their drugs in the market. Generic drug makers will most likely begin to manufacture these drugs on a smaller scale in order to apply for regulatory approval prior to manufacturing them on a larger scale for commercial purposes.
Most of us will know that the manufacture, use, sale or import of a patented product without permission is an act of patent infringement, in places where a patent for the product subsists. So how can generic drug makers go about taking steps to manufacture the generic drugs to obtain regulatory approval and so forth well before the expiration of the patents of the drug of interest?
In the U.S. and Europe, the Bolar provision (also known as the Roche-Bolar provision) allows other parties to conduct studies, research and tests for drug regulatory approval and other related acts such as manufacturing the drug. This provision or exemption originated in the U.S. by virtue of the Roche Products vs. Bolar Pharmaceuticals judgment.