Replies to post #146698 on Biotech Values

[mouton29]

MNTA - Guttag commentary on MNTA v. Amphastar

The Proveris case is reasonably short and can br read here, http://caselaw.findlaw.com/us-federal-circuit/1137433.html, and here is some law school commentary http://www.law.washington.edu/Casrip/Newsletter/default.aspx?year=2009&article=newsv16i1Proveris

Basically, Proveris developed a device that was not itself used to submit informatin to the FDA; Spheris incorporated it into its own analystic device, which it then sold to pharmaceutica companies who do submit information with it to the FDA. The court found the Bolar amendment inapplicable, citing the Supreme Court decision in Eli Lilly. Accoring to the Proveris court, the Supreme COurt interpreted the Bolar amendment to address two distortions,

In Eli Lilly, the Supreme Court explained that the first distortion was the reduction of effective patent life caused by the FDA premarket approval process, while the second distortion was the de facto extension of effective patent life at the end of the patent term-also caused by the FDA premarket approval process. 496 U.S. at 669-70, 110 S.Ct. 2683. The first distortion adversely affected patentees; ?the second distortion adversely affected those seeking FDA approval in order to enter the market to compete with patentees. It is the second distortion that is relevant to this case.

Since, in Proveris, neither Proveris nor Spheris needed FDA premarketing approval for their device, neither of these distortions was present.

Guttag is saying that MNTA is like Proveris, its patented analytic method was not itself subject to FDA preapproval -- but you may retort, the drug MNTA used it to analyze was subject to such preapproval.