Sunday, July 29, 2007

Integra loses on remand from Supreme Court

Of the possible extension of 35 USC 271(e)(1) to research tool patents, the majority in the July 2007 CAFC decision in Merck v. Integra clearly state:

Contrary to the position of our colleague in dissent, the Court's ruling and our application thereof casts no "large shadow" on the subject of "research tools." On remand to this court, the parties emphatically confirmed that research tools were not at issue. See, e.g., Letter from Mauricio A. Flores, Counsel for Integra, to the panel (June 13, 2006) ("Integra agrees with Merck that this is not an appropriate case in which to make new law on the issue of whether patent claims to research tools (however that term may be defined) are excluded from the ambit of Section 271(e)(1). The Supreme Court has ruled that this case does not raise that issue. Hence, its resolution is outside the Supreme Court's mandate. Integra has never argued, and does not now contend, that any of its claims at issue belong to a class of patent claims outside the reach of that statutory exemption."). There is no "devastating impact on research tool inventions," dissent at 5; indeed, the issue is not present, and the criticism inapt.

Merck won on the contested issue: The challenged experiments, all of which were conducted after discovery of the anti-angiogenesis property of the experimental RGD peptide provided by Merck, meet the criteria of being reasonably related to research that, if successful, would be appropriate to include in a submission to the FDA. This statutory construction both recognizes the nature of the scientific process and implements the legislative purpose of encouraging the development of new drugs. On application of the law of 35 U.S.C. ยง 271(e)(1), no reasonable jury could find other than that the challenged experiments are within the FDA Exemption. The district court's judgment of infringement is reversed.

Separately, of another matter that californiastemcellreport will not discuss, one notes the full caption of this case:

Integra, Burnham, and Telios (plaintiffs)


Merck, Scripps, and Cheresh (defendants)

Effectively, one had one California research institute (Burnham) suing another California research institute (Scripps).

[refer to 2007 WL 2142878 (Fed. Cir.)]

See also prior IPBiz posts:


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