August 16, 2012
Usually, during the life of a patent, acts of manufacturing or importation are considered an infringement of the patent owner’s rights. The “Bolar provision” exempts from infringement all uses of a patented product that are required for the Food and Drug Administration (FDA) approval process for drugs not previously registered. The point in time, during the life of a patent, when a generic drug company can apply for FDA approval is, and has been for some time, rather vague in Thai law.