Replies to post #113333 on Biotech Values

[poorgradstudent]

>this subsection seems to be limited to genetic manipulation. Is that what is used in manufacturing Lovenox? <

No.

[biomaven0]

You are misreading the provision - probably because of the confusing double set of parentheses:

(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.

The provision thus explicitly excludes (see italics) biologics from its reach, not as you thought applying only to biologics.