|Exiting Bolar Provisions
Article 8 -- In the case of a product or process protected by patent, any third party may use the invention prior to its patent expiration for experimental purposes and to obtain the information required for the approval of a product or process by the competent authority so that it may be marketed following the patent expiration.
It is not an infringement of a patent for any person who makes, constructs, uses or sells a patented invention in accordance with subsection (1) to make, construct or use the invention, during the applicable period provided for by the regulations, for the manufacture and storage of articles intended for sale after the date on which the term of the patent expires.
It shall not be an act of infringement to make, use, offer to sell, or sell within the United States or import into the United States a patented invention . . . solely for uses reasonably related to the development and submission of information under a Federal law which regulates the manufacture, use, or sale of drugs or veterinary biological products.
|Model Bolar Provisions
In addition to the provisions of Sections 1 and 2, use without the authorization of the patent owner shall also be permitted in the following cases... ` (d) When the use of the invention is solely for purposes reasonably related to the development and submission of information required under any country that regulates the manufacture, construction, use or sale of any product.
The patent shall have no effect with respect to any acts, including testing, using, making or selling the invention, solely for purposes reasonably related to the development and submission of information required under any law of ... (country) or of another country that regulates the manufacture, construction, use or sale of any product.