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Graceway Pharmaceuticals, LLC, and 3m Innovative v. Perrigo Company

July 27, 2011

GRACEWAY PHARMACEUTICALS, LLC, AND 3M INNOVATIVE PROPERTIES CO.,
PLAINTIFFS,
v.
PERRIGO COMPANY, PERRIGO ISRAEL PHARMACEUTICALS LTD., AND NYCOMED U.S. INC.,
DEFENDANTS.



The opinion of the court was delivered by: Hon. William J. Martini

OPINION

MEMORANDUM OPINION

Plaintiffs Graceway Pharmaceuticals, LLC (Graceway) and 3M Innovative Properties Co. (3M IPC) allege that Defendant Nycomed U.S. Inc. (Nycomed) has infringed U.S. Patent No. 7,655,672 (the Patent or the "672 Patent). Defendant Nycomed asserts that the Patent is invalid for indefiniteness and now seeks summary judgment.

For the reasons elaborated below, Defendant Nycomed‟s motion for summary judgment will be DENIED.

I. BACKGROUND AND CONTENTION OF THE PARTIES

This patent action is brought by Plaintiffs Graceway and 3M IPC against Defendant Nycomed*fn1 for allegedly infringing Graceway‟s "672 Patent, which was approved on February 2, 2010. Suit was filed February 23, 2010. Doc. No. 214-4. The Patent claims a pharmaceutical cream for topical application composed of imiquimod and oleic acid.

In prior proceedings Graceway moved for a temporary restraining order and preliminary injunction. These motions were denied on March 8, 2010 and on June 10, 2010 respectively. Currently before the Court is Defendant Nycomed‟s Motion for Summary Judgment for Indefiniteness. Defendant asserts indefiniteness in connection with patent language describing the invention‟s oleic acid component and in connection with patent language describing imiquimod-related impurities.

The '672 Patent.As explained, the Patent claims a pharmaceutical cream for topical application composed of imiquimod (an immune response modifier) and oleic acid. Claims 1, 7, and 13 recite that the cream is comprised of an "oleic acid component, wherein the oleic acid component at or prior to formulation . . . contains at least about 80% oleic acid by weight as a fatty acid." Patent 15, lines 44-48 (emphasis added). At least about language relating to the oleic acid component appears in the Patent three times. Id.; Patent 16, lines 26-30 (same); Patent 17, lines 12-16 (same).

Also, the claimed formulation is defined in terms of its impurities. Impurity related language appears in the Patent three times. First, claim 1 states:

[The] pharmaceutical cream contains imiquimod-related impurities in an amount of no more than about 0.03% wt./wt. after storage of said pharmaceutical cream at ambient conditions for about 15 days, when absorbance of said pharmaceutical cream is analyzed at about 308 nm using a UV detector.

Patent 15, lines 54-59 (emphasis added).

Second, claim 7 states:

[The] pharmaceutical cream contains imiquimod-related impurities in an amount of no more than about 0.15% wt./wt. after storage of said pharmaceutical cream for at least about*fn2 2 months at about 40○C. and about 75% humidity, when absorbance of said pharmaceutical cream is analyzed at about 308 nm using a UV detector.

Patent 16, lines 36-43 (emphasis added).

Third, and last, claim 13 states:

[The] pharmaceutical cream contains imiquimod-related impurities in an amount of no more than about 0.29% wt./wt. after storage for at least about*fn3 4 months at about 40○C. and about 75% humidity, when absorbance of said pharmaceutical cream is analyzed at about 308 nm using a UV detector.

Patent 17, lines 22-27 (emphasis added). The remaining claims, i.e., claims 2-6, 8-12, and 14-20 are dependent on claims 1, 7, and 13.

The parties dispute Defendant Nycomed‟s contention that both the phrases "at least about 80%" in regard to the oleic acid component and the phrase ...


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