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Brigham and Women's Hospital, Inc. v. Perrigo Co.

United States District Court, D. Massachusetts

January 28, 2015



RYA W. ZOBEL, District Judge.

Plaintiffs Brigham and Women's Hospital, Inc., and Investors Bio-Tech, L.P. (collectively, "BWH") seek damages from defendants Perrigo Company and L. Perrigo Company (collectively, "Perrigo") for alleged patent infringement under 35 U.S.C. §§ 271(a)-(c). BWH contends that the asserted patent, U.S. Patent No. 5, 229, 137 (the 137 patent"), covers the drug sold by its licensees under the brand name Pepcid® Complete®. Perrigo has sold a generic form of that drug since 2008.

Perrigo moves for judgment on the pleadings and for summary judgment, contending that BWH's claims are barred by laches and, in any event, are moot because BWH failed to ensure that Pepcid® Complete® was marked with the patent number. See Docket ## 27, 46. BWH moves to amend its complaint to plead around the alleged failure to mark. See Docket # 54. For the reasons that follow, Perrigo's motions are denied, and BWH's motion to amend is allowed.

I. Background

The 137 patent covers both a composition to treat episodic heartburn and a method of using that composition. The inventions claimed in the patent were purportedly developed by scientists at plaintiff Brigham and Women's Hospital, which owns the patent. Plaintiff Investors Bio-Tech, L.P., was, at all relevant times, the exclusive licensee of the patent.

In the late 1990s, a group of BWH's licensees filed a New Drug Application ("NDA") with the U.S. Food and Drug Administration ("FDA") for what is now know as Pepcid® Complete®. With their NDA, BWH's licensees told FDA that three patents, including the 137 patent, covered the drug. FDA added these patents to its Orange Book, which lists approved drugs and the patents that cover them. The FDA approved the Pepcid® Complete® NDA in 2000, and BWH's licensees have sold the drug ever since.

In 2004, Perrigo submitted an Abbreviated New Drug Application ("ANDA") to the FDA seeking to market a generic version of Pepcid® Complete®. With its ANDA, Perrigo submitted a certification alleging that each of the patents listed in the Orange Book for Pepcid® Complete® was invalid, unenforceable, or not infringed by its proposed generic product-a so-called Paragraph IV certification, named after the section of the law authorizing it. See 21 U.S.C. § 355(j)(2)(A)(vii)(IV). As required by the Hatch-Waxman Act, 21 U.S.C. § 355(j)(2)(B), Perrigo sent plaintiff Brigham and Women's Hospital-the owner of the Orange Book-listed 137 patent-notice of its Paragraph IV certification. Perrigo sent similar notifications to the owners of the other two Orange Book-listed patents.

The Hatch-Waxman Act makes a Paragraph IV certification an artificial act of patent infringement, creating subject matter jurisdiction for a patent infringement suit in federal courts. 35 U.S.C. § 271(e)(2); Eli Lilly & Co. v. Medtronic, Inc., 496 U.S. 661, 678 (1990) ("That is what is achieved by § 271(e)(2)-the creation of a highly artificial act of infringement that consists of submitting an ANDA or a paper NDA containing the fourth type of certification...."). In response to Perrigo's Paragraph IV certification, the owners and licensees of one of the other two Orange Book-listed patents timely sued Perrigo for patent infringement in the United States District Court for the Southern District of New York. BWH, however, did not react to the Paragraph IV certification for the 137 patent.

The Southern District of New York invalidated the only Pepcid® Complete® patent before it, and the Federal Circuit affirmed in 2008. Perrigo then launched its generic version of Pepcid® Complete®, and it has been making and selling the product ever since. On July 9, 2013-over a year after the patent expired-BWH sued Perrigo for infringement of the 137 patent.[1]

II. Perrigo's Motion for Judgment on the Pleadings

First, Perrigo moves for judgment on the pleadings under Federal Rule of Civil Procedure 12(c). Although this is a patent case where the law of the Federal Circuit governs substantive matters, First Circuit law governs the standard of review. Imation Corp. v. Koninklijke Philips Electronics N.V., 586 F.3d 980, 984 (Fed. Cir. 2009). In resolving this motion, the court considers only the pleadings, materials incorporated by reference in the pleadings, and facts susceptible to judicial notice. See R.G. Fin. Corp. v. Vergara-Nunez, 446 F.3d 178, 182 (1st Cir. 2006). All factual allegations of the non-moving party are taken as true, and all inferences of fact are drawn in the non-moving party's favor. Id.

Perrigo's motion contends that the equitable defense of laches bars BWH's claims. There are two factual elements to a laches defense: that "the plaintiff delayed filing suit for an unreasonable and inexcusable length of time from the time the plaintiff knew or reasonably should have known of its claim against the defendant, " and that "the delay operated to the prejudice or injury of the defendant." A.C. Aukerman Co. v. R.L. Chaides Const. Co., 960 F.2d 1020, 1032 (Fed. Cir. 1992). "The underlying critical factors of laches are presumed upon proof that the patentee delayed filing suit for more than six years after actual or constructive knowledge of the defendant's alleged infringing activity." Id. at 1035-36. This presumption, however, "completely vanishes upon the introduction of evidence sufficient to support a finding of the nonexistence of the presumed fact." Id. at 1037. Because "[t]he facts evidencing unreasonableness of the delay, lack of excuse, and material prejudice to the defendant, are seldom set forth in the complaint, " it is generally inappropriate to grant a motion for judgment on the pleadings "based solely on presumptions" of laches. Advanced Cardiovascular Sys., Inc. v. Scimed Life Sys., Inc., 988 F.2d 1157, 1161 (Fed. Cir. 1993).

Perrigo's motion, however, asks the court to do just that. Because BWH filed this suit more than six years after it found out about Perrigo's allegedly infringing activity, Perrigo contends that laches is presumed. However, BWH points out that this case is based not on Perrigo's ANDA activities but on its infringement activities proscribed by 35 U.S.C. § 271(a), which may have arisen more recently. Similarly, BWH contends that Perrigo has suffered no economic prejudice from its delay in bringing suit, which Perrigo contests. Docket # 40 at 19. Both of these points, as well as others raised in the parties' ...

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