Tuesday, June 28, 2005

Bad coverage by Science of Merck v. Integra

Although the journal Science, in discussing the Supreme Court decision in Merck v. Integra, mentioned a

lower court ruling that had narrowed a legal exemption from infringement for "preclinical" studies

[308 Science 1725 (17 June 2005)]

the Supreme Court went out of its way to say that it did not understand the CAFC holding to exclude preclinical studies from the 271(e)(1) safe harbor.

Evidently, Science did not read footnote 6 of Merck v. Integra, 2005 U.S. LEXIS 4840, which said:

Although the Court of Appeals' opinion suggests in places that §
271(e)(1) 's exemption from infringement is limited to research conducted in clinical trials, see 331 F.3d at 866, we do not understand it to have adopted that position. The Court of Appeals recognized that information included in an IND would come within § 271(e)(1)'s safe harbor. Ibid. Because an IND must be filed before clinical trials may begin, such information would necessarily be developed in preclinical studies.

The Supreme Court basically said that two things were not per se bars to invoking the exemption of 35 USC 271(e)(1). Factual analysis is needed. Merck KGaA may still lose this case.

The Science article also quotes Kevin Noonan as "This is a big win for discovery drug companies." The case allows one "discovery drug company" to use the patents of another "discovery drug company" to generate information of relevance in seeking FDA approval of a drug or device.

Separately, my article on Merck v. Integra in the April 2005 JPTOS
[87 J. Pat. & Trademark Off. Soc'y 321] has appeared on LEXIS.

At page 327, I had quoted from the US brief, concerning the amended CAFC decision:

Although the court of appeals issued an "errata" sheet indicating that "the scope of the safe harbor is not limited to generic drug approval," Pet. App. 36a, the revised opinion
continues to hold that the statutory exemption should be construed to focus primarily on generic drugs, and appears to adopt the view that the exemption does not encompass pre-clinical studies prepared for an IND.

Footnote 6 of the Supreme Court decision shows that the Supreme Court did not see things this way.


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