Biotech Values

[iwfal]

MNTA - 466 Patent Comments:

Amphastar appears to be making two arguments:

1) Patent is invalid because it is an obvious combination of Linhardt et al., United States Patent No. 4,847,338 (’338 patent) and Sasisekharan ’642.

I have no comments on this at this time. Hopefully somebody smarter about chemistry (like winchem) will make some interesting comments

2) Use is covered under Safe Harbor. Amphastar's primary claim here is that ANY use of ANY patent that is used solely to make the FDA happy is protected. More specifically they appear to be implicitly acknowledging routine use subsequent to regulatory filing - but claiming Safe Harbor because the language of the law is not specific to filings to get approvals. (this is consistent with what I noted in a post at the very start of these hearings - Amphastar is attempting to extend Safe Harbor not just to use of patents of branded drugs about to expire, but to ANY use of ANY patent for ANY testing required by the FDA at ANY time.)

Comment: I think Amphastar will have a hard time on this one. For instance, Momenta appears to be asserting portions of Classen v Biogen for which the CAFC ruled very crisply

"§271(e)(1) provides an exception to the law of infringement in order to expedite development of information for regulatory approval of generic counterparts of patented products. The statute does not apply to information that may be routinely reported to the FDA, long after marketing approval has been obtained."

And, interestingly, as others have noted on this board, even if Amphastar were only using the patent for submission for approval of the generic I think the Classen case is still reasonably clear since they cite some of the congressional notes which are completely unambiguous:

The House Report explains that the Act “provides that it is not an act of patent infringement for a generic drug maker to import or to test a patented drug in preparation for seeking FDA approval if marketing of the drug would occur after expiration of the patent[emphasis added]."

This purpose was emphasized throughout the legislative process: “The purpose of sections 271(e)(1) and (2) is to establish that experimentation with a patented drug product, when the purpose is to prepare for commercial activity which will begin after a valid patent expires, is not a patent infringement.” Id. Again in Part 2 of H.R. Rep. No. 98-857, at 8 (1984), the Report is explicit that “the only activity which will be permitted by the bill is a limited amount of testing so that generic manufacturers can establish the bioequivalency of a generic substitute.” The Report states that “the generic manufacturer is not permitted to market the patented drug during the life of the patent; all that the generic can do is test the drug for purposes of submitting data to the FDA for approval.” Id. at 30.

See Patent Barista Classen v Biogen

Amphastar's primary defense for their very broad interpretation of Safe Harbor is a SC ruling on Merck KGaA vs Integra. This ruling was about the use of patented items used in pre-clinical studies of new drugs even though, in the end, the data was not submitted as part of the IND for the drug found. The SC ruled that because the experimenter could not know in advance what, precisely, would end up being needed for FDA submission it was therefore protected by Safe Harbor.

Interesting notes:

1) Merck pointed out in their brief to the USCA that they would not market their drug until after the patent had expired in any case. And that they had not done so in the past.

2) The USCA clearly violated one of the expressed intents of congress when they broadened Safe Harbor - i.e. the house notes I quoted above said "the only activity which will be permitted by the bill is a limited amount of testing so that generic manufacturers can establish the bioequivalency of a generic substitute" and yet the USCA broadened the statute to cover non-generics. The point here being that although the congress is crystal clear that Safe Harbor should not apply in Amphastar's case the USCA does not always live within the congressional intent.

Comparing the two cases referenced by the two parties I think it is very clear that Classen is very very much more on-point than the Merck. Of course Merck is a USCA ruling and Classen is only a CAFC case, but it toto I think Amphastar is likely to lose on this.