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Graceway Pharmaceuticals, LLC v. Perrigo Co.

March 8, 2010

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

I. INTRODUCTION

This law suit is brought by Plaintiffs Graceway, LLC, (Graceway), founded in 2006, and Plaintiff 3M Innovative Products Co., ("3M IPC"). Three distinct patents are involved in this lawsuit.

First, the '338 Patent, (Patent No. 4,698,338), covers imiquimod, the active pharmacological ingredient in Aldara, a product originally approved by the Food and Drug Administration, ("FDA"), in 1997. Aldara is Graceway's core product, a mature product which it acquired in 2006 from 3M IPC. The '338 Patent expired on August 25, 2009, with a period of exclusivity which ran to February 25, 2010.

Second, Graceway also holds the '944 Patent, (Patent No. 5,238,944), or a license thereunder, a formulation of imiquimod with isostearic acid. This patent was approved on August 24, 1993, and will expire on August 24, 2010, with a period of exclusivity running to February 24, 2011. The '944 Patent covers Aldara.

Third, Plaintiff 3M IPC is the owner of the '672 Patent, (Patent No. 7,655,672), with Graceway holding an exclusive license. This patent was issued on February 2, 2010. It protects a formulation of imiquimod and oleic acid. Graceway markets no product in the United States covered by the '672 Patent.

On January 10, 2007, Nycomed informed Graceway by letter that it had filed an Abbreviated New Drug Application, ("ANDA"), to produce a bioequivalent generic version of Aldara. Graceway understood this to mean that Nycomed would manufacture, use, offer for sale, etc., its product after Nycomed received FDA approval for its ANDA and after the '338 Patent on imiquimod had expired on February 25, 2010. On February 25, 2010, the FDA approved Defendant Nycomed's ANDA application seeking to produce a generic of Aldara, albeit one with a different formulation from Aldara. Nycomed's bioequivalent of Aldara, i.e., "Nycomed's Product," has been determined by the FDA to be a bioequivalent of Aldara, with both products functioning as creams for application to dermal or mucosal surfaces for delivery of imiquimod. Once approved, Nycomed immediately began advertising, selling, and distributing its product domestically. It is not disputed that Nycomed's Product does not infringe either the '338 Patent (which is now expired) or the '944 Patent (covering a formulation using isostearic acid). Nycomed's Product, like the formulation described in the '672 Patent, makes use of a formulation of imiquimod and oleic acid (or super-refined oleic acid).

In a Complaint filed on Tuesday, February 23, 2010, Graceway alleges that Nycomed's Product infringes the '672 Patent and seeks damages and (preliminary and permanent) injunctive relief for the injury it has and will sustain in consequence of lost sales and profits of Aldara (a bioequivalent of Nycomed's Product), including lost reputation and market share, and lost business opportunities associated with an inability to fund current research ventures, including meeting payroll, and, perhaps, debt service. However, Graceway did not file a motion for a temporary restraining order at this time. The Court notes that during this week the east coast of the United States was inundated with a severe snowfall, in consequence of which the Court of the District of New Jersey closed early on Thursday, February 25, 2010 and was entirely closed on Friday, February 26, 2010: although attorneys of record were nevertheless able to make filings on the Court's docket -- which would be automatically available to their opponents -- through the CM/ECF system. On Sunday, February 28, 2010, Graceway filed a motion seeking a temporary restraining order against Nycomed (although not against the two Perrigo defendants appearing on the caption to the Complaint).

On March 2, 2010, this case was reassigned by Chief Judge Garrett E. Brown, Jr. to me (William J. Martini) after having been initially assigned to Judge Susan D. Wigenton. A hearing was held the next day, on March 3, 2010.

For the reasons elaborated below, the Court will DENY Plaintiffs' Motion for a Temporary Restraining Order, (Doc. No. 17).

II. FACTS AND PROCEDURAL POSTURE

3M IPC applied for the '672 Patent on or about December 12, 2004. Ultimately, the '672 Patent was approved on February 2, 2010. Graceway holds an exclusive license under the '672 Patent. The '672 patent makes use of a formulation including imiquimod and oleic acid. Aldara by contrast, protected under the '944 Patent makes use of a formulation including imiquimod and isostearic acid. Sales from Aldara is Graceway's primary revenue stream.

On or about January 10, 2007, Nycomed filed ANDA No. 78-548 seeking to produce a product bioequivalent to Aldara, but making use of an imiquimod and oleic acid formulation. Nycomed sent Graceway a notice letter ("Nycomed's Notice Letter"), to this effect. Notwithstanding the '338 Patent (now expired) and the '944 Patent (covering an isostearic acid formulation, as opposed to the oleic acid formulation in Aldara), the FDA approved Nycomed's ANDA on February 25, 2010. Apparently, Nycomed immediately began advertising and distributing its product and has sought to exploit the 180 day period of market exclusivity for the first generic on the market. Prior to February 25, 2010, Graceway had made some efforts to stop FDA approval of Nycomed's ANDA through the citizens' petition process. The FDA denied Graceway the relief it sought through the citizens' petition process on or about January 26, 2010, and, again, on February 24, 2010.

Plaintiffs allege that Nycomed's Product infringes the '672 Patent, which was approved on February 2, 2010. Plaintiffs seek relief, including damages and injunctive relief, in regard to lost sales of Aldara, which is not protected by the patent in suit. Plaintiffs filed this action, on February 23, 2010, three full weeks after the '672 Patent was approved. Furthermore, Plaintiffs filed this action one day prior to the FDA's denying Graceway's second citizens' petition, and two days prior to the FDA's approving Nycomed's ANDA application, and two days prior to the expiration of the '338 Patent (covering imiquimod). However, Plaintiffs' motion for a temporary restraining ...


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