Friday, January 12, 2007

Merck v. Integra and patents on research tools

Here are some further thoughts on Merck v. Integra -->

--> The 271blog stated on Jan. 8, 07 of the case in which Classen Immunotherapies asserted two of its patents related to Skelaxin against Elan:

This appears to be the first district court decision that addresses whether research tool patents are covered by the safe harbor provision. The case is Classen Immunotherapies v. King Pharmaceuticals (Westlaw cite is 2006 WL 3716920), and the case number is WDQ-04-3521

The blog had noted: the Court [in Merck v. Integra] declined to rule on whether the use of "research tools" was protected. AND the [district] court found [in Classen] extension of the safe harbor to cover the use of these tools under the language of Merck and a plain reading of the statute. [thus summary judgment to Elan.]

IPBiz notes that LBE, prior to the Supreme Court decision in Merck, had argued in JPTOS that 271(e)(1) should NOT be extended to research tools.

IPBiz also notes the law review article by Brendan M. O'Malley, MERCK V. INTEGRA AND ITS AFTERMATH: A SAFE HARBOR FOR THE COMMERCIAL USE OF BIOTECHNOLOGY RESEARCH TOOLS?, 23 Cardozo Arts & Ent LJ 739, discusses a DIFFERENT Classen case:

In Classen Immunotherapies v. Biogen IDEC, decided just a month after Merck in the
District of Maryland, the district court interpreted Merck's holding in the
broadest possible manner, dismissing Classen's claims against Biogen IDEC
("Biogen") and GlaxoSmithKline ("GSK") when the defendants successfully argued that
their allegedly infringing acts of research tool use fell within the safe
harbor provision of 271(e)(1) as construed in Lilly and Merck. n89

footnote 89 states: Classen Immunotherapies, Inc. v. Biogen IDEC, 381 F. Supp.
2d 452 (D. Md. 2005).

Thus, the 2006 Elan case may not be the first on Merck v. Integra and research tools. In passing, O'Malley did not cite the 2005 JPTOS article of LBE.

LBE had discussed Classen v. Biogen in Intellectual Property Today in 2005 (You Only Look Twice, IPT, p. 18 (Nov. 2005)). The case itself notes:

Classen owns the following United States Patent Numbers: (1) 6,420,139 ("the 139 patent"); (2) 6,638,739 ("the 739 patent"); (3) 5,728,385 ("the 385 patent "); and (4) 5,723,283 ("the 283 patent") (collectively, "the patents in suit"). Am. Compl. at P 3. Each patent involves a mechanism for evaluating the safety of vaccine administration schedules by comparing or identifying the adverse events associated with various vaccine schedules. [IPBiz: thus, not the drug nor a method of using the drug; ergo a tool.]


Because their alleged participation in a study evaluating risks associated with
various vaccination schedules was reasonably related to the development and
submission of information required under the Federal Food, Drug, and Cosmetic Act,
GSK and Biogen's motion to dismiss Counts I, II, and IV will be granted.

Julie Baher also discusses the Biogen case, as does Ian G. DiBernardo.

--> IPBiz author LBE managed to get a quote about Merck v. Integra in a law review, but the quote was from someone else's blog (not IPBiz, or from JPTOS):

footnote 29 of Samuel Rubin, Merck KGaA v. Integra Lifesciences I, Ltd.: Greater Research Protection for Drug Manufacturers, DJCLPP:

See Lawrence Ebert, One Response to Merck v. Integra, September 25, 2005, available at (last visited Nov. 8, 2005) ("Although a strict constructionist, Justice Scalia did not analyze the word "solely" in 271(e)(1). However, by allowing that the jury instruction in Merck v. Integra was not inconsistent with the Supreme Court decision, Justice Scalia generated a mechanism to re-introduce 'solely'"). Emphasis added.

LBE also discussed the strict constructionist issue in Merck v. Integra in his article in the 2005 issue of JPTOS. Going back to Justice Scalia in Medtronic, the Scalia/Kennedy schism therein looks pretty tame compared to the footnote battle of Scalia/Thomas in MedImmune.


See also Benjamin G. Jackson, Merck v. Integra: Bailing Water Without Plugging the
Hole, 20 BYU J. Pub. L. 579 (2006).

The law review mentions the use of the word "solely:"

According to the court [CAFC], by limiting the safe-harbor to "solely ...
uses reasonably related to the development and submission of information,"
Congress intended that the exemption be narrowly construed. (...) Although some experiments that do not directly produce information to the FDA might be allowed, the term "solely" requires that these activities be closely scrutinized by the court.

The law review does not mention that the Supreme Court did not address the meaning of the word "solely."


Post a Comment

<< Home