Replies to post #128321 on Biotech Values

[exwannabe]

I personally think that reading of the statute goes beyond the intent of the law, but it is still an argument that MNTA will have to deal with.

Yes and no.

If Amphastar is infringing in the ongoing process then the clause would not apply.

It is interesting to note that A used the phrase (paraphrasing) "if we are infringing ...". They might be trying to claim with that something far beyond the written statute.

If A only infringed in the ANDA then I agree the case is far more difficult. Though I agree the intent was that the orriginal drug can be used to prep the ANDA, this is a much harder path.

[mouton29]

Since the article was written back in 2000, the Supreme decided a case in 2005,
MERCK KGAA, PETITIONER v. INTEGRA LIFESCIENCES I, LTD., ET AL, http://www.law.cornell.edu/supct/pdf/03-1237P.ZO

The case involved use of patented compounds as research to decide which drugs to test and ultimately seek FDA approval on. The lower court held that the statute did not protect use of patented compounds in unsuccessful experiments that did not lead to an NDA. The court rejected that and held:

The statutory text does not require such a result. Congress did not limit ß271(e)(1)ís safe harbor to the development of information for inclusion in a submission to the FDA; nor did it create an exemption applicable only to the research relevant to filing an ANDA for approval of a
generic drug. Rather, it exempted from infringement all uses of patented compounds ìreasonably relatedî to the process of developing information for submission under
any federal law regulating the manufacture, use, or distribution of drugs. See Eli Lilly, 496 U. S., at 674. We decline to read the ìreasonable relationî requirement so narrowly as to render ß271(e)(1)ís stated protection of activities leading to FDA approval for all drugs illusory.
Properly construed, ß271(e)(1) leaves adequate space for experimentation and failure on the road to regulatory approval: At least where a drugmaker has a reasonable
basis for believing that a patented compound may work, through a particular biological process, to produce a particular physiological effect, and uses the compound in research that, if successful, would be appropriate to include in a submission to the FDA, that use is ìreasonably relatedî to the ìdevelopment and submission of information under . . . Federal law.î ß271(e)(1)

This is not particularly relevant to the MNTA situation, but I think the case is useful as background.

The court also declined to address whether narrower construction of the statute is appropriate for patented "research tools":

footnote 7
The Court of Appeals also suggested that a limited construction of
ß271(e)(1) is necessary to avoid depriving so-called ìresearch toolsî of
the complete value of their patents. Respondents have never argued
the RGD peptides were used at Scripps as research tools, and it is
apparent from the record that they were not. See 331 F. 3d, at 878
(Newman, J., dissenting) (ìUse of an existing tool in oneís research is
quite different from study of the tool itselfî). We therefore need notó
and do notóexpress a view about whether, or to what extent, ß271(e)(1)
exempts from infringement the use of ìresearch toolsî in the development of information for the regulatory process