<<That's my understanding of the § 271(e)(1) of the 35 U.S.C. namely the Bolar exception provision>>
In fact TEVA's answer cites 271e)(1) as an affirmative defense. I set forth 271(e)(1) below.
At the risk of displaying complete ignorance as well as laziness, this subsection seems to be limited to genetic manipulation. Is that what is used in manufacturing Lovenox?
(e)
(1) 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 (other than a new animal drug or veterinary biological product (as those terms are used in the Federal Food, Drug, and Cosmetic Act and the Act of March 4, 1913) which is primarily manufactured using recombinant DNA, recombinant RNA, hybridoma technology, or other processes involving site specific genetic manipulation techniques) 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.
