Replies to post #113332 on Biotech Values

[mouton29]

<<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.

[tinkershaw]

There were several cases where the court ruled that the Bolar exception provision applied as long as the act of using a patented invention was reasonably related to gaining data for the FDA's regulatory approval.

This is some legal conjecture here (for those tired of conjecture - not me, as good investing involves conjecture) but the Bolar exception I would think applies to the innovator's patents. MNTA is not the innovator of the underlying drug. I don't necessarily think the Bolar exception is applicable to MNTA's patents.

The purpose of the Bolar exception is to enable the innovator drug to be copied and made into a generic, and use of innovator patents may be necessary for the process, but using a third-parties patents, not related to the innovator patent or drug, is a much different matter, and probably not a matter that was contemplated by statute of Bolar.

Patent law is not my field, but it is not difficult to see an easy distinction here. Is there any precedent for utilizing a third-party patent to characterize an innovator's drug? Because this would for all practical purposes neuter MNTA's patent rights. Which is a totally different matter from what the Bolar exception allows (if I understand it correctly).

Tinker