Amgen, Inc. v. F. Hoffman-Laroche Ltd.

Page 267

456 F.Supp.2d 267

AMGEN, INC, Plaintiff, v. F. HOFFMAN-LaROCHE LTD, Roche Diagnostics GmbH, & Hoffman LaRoche Inc, Defendants.

Civil Action No. 05-12237-WGY.

United States District Court, D. Massachusetts.

October 20, 2006.

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Andrew Kumamoto, Firasat Ali, Mary Boyle, Michelle E. Moreland, William G. Gaede, III, McDermott Will & Emery, Palo Alto, CA, Cullen N. Pendleton, Jennifer E. Flory, Jeremy D. Protas, Kevin M. Flowers, Mark Izraelewicz, Matthew C. Nielsen, Michael F. Borun, Sandip H. Patel, Thomas I. Ross, Marshall Gerstein & Borun LLP, Chicago, IL, D. Dennis Allegretti, Michael R. Gottfried, Patricia R. Rich, Duane Morris LLP, Boston, MA, Darcy A. Paul, David M. Madrid, Deborah E. Fishman, Jonathan D. Loeb, Katie J.L. Scott, Krista M. Carter, Lloyd R. Day, Jr., Mario Moore, Rebecca J. Wais, Renee Du'bord Brown, Linda Sasaki-Baxley, Day Casebeer Madrid & Batchelder, LLP, Cupertino, CA, for Plaintiff.

Howard Suh, Leora Ben-Ami, Patricia A. Carson, Thomas F. Fleming, Kaye Scholer LLP, New York, NY, Julia Huston, Keith E. Toms, Lee C. Bromberg, Bromberg & Sunstein LLP, Boston, MA, for Defendants.

MEMORANDUM AND ORDER

YOUNG, District Judge.

I. INTRODUCTION

Amgen, Inc. ("Amgen") commenced this action against F. Hoffman-LaRoche Ltd., Roche Diagnostics GmbH, & Hoffman-La-Roche, Inc. (collectively "Roche/Hoffman") seeking a declaratory judgment that Roche/Hoffman currently infringes or will infringe Amgen's patents for erythropoietin ("EPO"). Am. Compl. ¶ 26 [Doc. No. 52]. The patents at issue are U.S. Patent Nos. 5,441,868 (the '868 patent"), 5,547,-933 (the '933 patent"), 5,618,698 (the '698 patent"), 5,621,080 (the "'080 patent"), 5,756,349 (the '349 patent"), and 5,955,422 (the '422 patent"). Id. ¶¶ 14, 26.

II. PROCEDURAL HISTORY

Amgen filed a complaint in this action on November 8, 2005 [Doc. No. 1]. On March 9, 2006, Ortho Biotech Products, L.P.'s ("Ortho") filed a motion to intervene in this action on the side of Amgen. See Mot. to Intervene [Doc. No. 16]. On April 11, 2005, Roche/Hoffman filed a motion to dismiss for failure to state a claim and for lack of subject matter jurisdiction. See Mot. to Dismiss [Doc. No. 44]. Roche Diagnostics GmbH and F. Hoffman La-Roche Ltd. also filed motions to dismiss for lack of personal jurisdictional, see Roche Diagnostics Mot. to Dismiss [Doc. No. 38]; F. Hoffman-La Roche's Mot. to Dismiss [Doc. Nos. 41], but later withdrew those motions, see F. Hoffman-LaRoche Notice of Withdrawal [Doc. No. 83]; Roche Diagnostics GmbH Notice of Withdrawal [Doc. No. 84].

III. MOTION TO DISMISS FOR FAILURE TO STATE A CLAIM

Roche/Hoffman's motion to dismiss for failure to state a claim attacks Amgen's allegation of current infringement arguing it has not been sufficiently pled in light of the "safe harbor" provision of 35 U.S.C. § 271(e)(1). Def. Mem. at 1. The United States Code states that except as otherwise provided in title 35, whoever without authority "makes, uses, offers to sell, or sells any patented invention, within the United States or imports into the United States any patented invention during the term of the patent ... infringes the patent." 35 U.S.C. § 271(a).

Section 271(e)(1)creates a limited exception to this provision.

It shall not be an act of infringement to make, use, offer to sell, or sell within the United States or import into the United States a patented invention ... solely for uses reasonably related to the development and submission of information under a Federal law which regulates the manufacture, use or sale of drugs or veterinary biological products.

35 U.S.C. § 271(e)(1).

A. Alleged Facts

For purposes of this motion, all facts alleged in the complaint are taken as true. Arturet Velez v. R.J. Reynolds Tobacco Co., 429 F.3d 10, 13 (1st Cir.2005).

"On information and belief, [Roche/Hoffman is] currently importing into the United States a pharmaceutical composition containing a recombinant human EPO product that Roche[/Hofmnian] calls `Ro50-3821'" [referred to by Amgen as "PEEPO" and by Roche/Hoffman as "CERA"]. Am. Compl. ¶ 18. PEG-EPO/CERA contains glycosylated human EPO, to which Roche has attached a polyethylene glycol ("PEG") polymer. Id. ¶ 20. PEG-EPO/CERA, on information and belief, contains EPO as claimed in the '933, '080, '422 patents and produces glycoslyated human EPO "by means of one or more of the processes claimed in the '868, '698 and '349 patents." Id. ¶¶ 19, 21. The addition of PEG to glycosylated human EPO does not materially change the glycosylated human EPO contained in PEG-EPO/CERA. Id. ¶ 23.

On April 19, 2006, Roche submitted its Biologic License Application ("BLA") with the United States Food and Drug Administration to sell pharmaceutical compositions containing PEG-EPO for the treatment of anemia associated with chronic kidney disease.¹ Id. at 27. "Upon information and belief, Roche has completed all Phase III clinical trials it believes necessary to support its application for approval in the United States." Id. Roche announced that it expects to obtain regulatory approval to market and sell PEG-EPO in the United States within the next 12-14 months. Id. ¶ 28.

In addition to filing the BLA, upon in; formation and belief, Roche/Hoffman has been making preparations to market and sell PEG-EPO in the United States, including:

a. Hiring key management, support, and sales personnel, including actively recruiting Amgen marketing and medical personnel involved in the sale and use of recombinant human EPO, to market and sell PEG-EPO upon receipt of regulatory approval to market and sell PEG-EPO in the United States;

b. Retaining outside consultants and vendors to assist in its marketing and sale of PEG-EPO in the United States;

c. Contacting potential customers, including large dialysis organizations ("LDOs"), to solicit interest in purchasing PEG-EPO from Roche upon regulatory approval in the United States; and

d. Completing construction and commencing operations of a new facility in Penzberg, Germany to manufacture the recombinant human EPO in PEG-EPO for export to the United States, at a reported cost of 182 million Euros.

Id. ¶ 29.

B. Standard of Review

As this Court has noted, a motion to dismiss under Rule 12(b)(6) tests the sufficiency of the plaintiffs pleadings, and, as a result, must be considered in light of the liberal notice pleading requirements of the Federal Rules. See Andrews-Clarke v. Lucent Technologies, 157 F.Supp.2d 93, 96 (D.Mass.2001)(Dein, M.J.). Accordingly, "a complaint should not be dismissed for failure to state a claim unless it appears beyond doubt that the plaintiff can prove no set of facts in support of his claims which would entitle him to relief." Roeder v. Alpha Indus., Inc., 814 F.2d 22, 25 (1st Cir.1987)(quoting Conley v. Gibson, 355 U.S. 41, 45-46, 78 S.Ct. 99, 2 L.Ed.2d 80 (1957))(emphasis added); see also Rogan v. Menino, 175 F.3d 75, 78 (1st Cir.1999)(noting that the plaintiff must "set forth factual allegations, either direct or inferential, respecting each material element necessary to sustain recovery."). Moreover, "[t]he Court must accept as true all of the allegations made in the complaint and draw all reasonable inferences in the Plaintiffs favor." Baker v. Coxe, 940 F.Supp. 409, 414 (D.Mass.1996)(Saris, J.), aff'd, 230 F.3d 470 (1st Cir.2000) (citing Coyne v. City of Somerville, 972 F.2d 440, 442-43 (1st Cir. 1992)); see also Conley, 355 U.S. at 45-46, 78 S.Ct. 99. The standard for dismissal, however, is not without any bite. In taking the plaintiffs allegations as true, the Court is not obliged to credit bald assertions or unsubstantiated conclusions. See Campagna v. Massachusetts Dep't of Envtl. Prot., 334 F.3d 150, 155 (1st Cir. 2003).

C. Amgen's Complaint Properly Alleges Current Infringement

Roche/Hoffman argues that because all of their allegedly infringing acts are protected from infringement by the safe harbor exemption, Amgen does not state a claim for current infringement.² Def Mem. at 11. Further, Roche/Hoffman contends that Amgen makes no specific allegation of an act that would constitute infringement that falls outside the Section 271(e)(1) safe harbor and instead relies on an unsupported assertion that Roche is currently importing an infringing drug. Id.

This Court has previously noted that it is unclear "whether the [Section 271(e)(1)] exemption is an affirmative defense, rather than a part of the statutory definition of infringement that [the plaintiff] must establish." Amgen, Inc. v. Hoechst Marion Roussel, Inc., 3 F.Supp.2d 104, 109 (D.Mass.1998).³ If regarded as an affirmative defense, the applicability of this exemption must be raised by Roche/Hoffman in their responsive pleading and not by Amgen. See Fed. R.Civ.P. 12(b) ("Every defense, in law or fact to a claim for relief in any pleading ... shall be asserted in the responsive pleading thereto if one is required ...."). Roche/Hoffman's Rule 12(b)(6) motion would, therefore, necessarily fail, since Amgen's allegations comply with Section 271(a) in alleging the importing of a patented drug. The Court rules that 271(e)(1) safe harbor provision is an affirmative defense that must be asserted by the defendant. The Court's interpretation is supported by several other courts, including the Federal Circuit, which have referred to the 271(e)(1) exemption as an affirmative defense or a defense.⁴ See Intermedics v. Ventritex Co., No. 92-1076, 1993 WL 87405, at *1, 1993 U.S.App. LEXIS 3620, *2-3 (Fed.Cir. February 22, 1993) (referring to Ventritex's right to assert the Section 271(e)(1) defense); Eli Lilly & Co. v. Medtronic, Inc., 872 F.2d 402, 404 (Fed.Cir.1989) (describing as a matter of first impression the issue of whether the noninfringement defense of Rule 271(e)(1) applies to medical devices), aff'd, 496 U.S. 661, 110 S.Ct. 2683, 110 L.Ed.2d 605 (1990); Nexell Therapeutics v. AmCell Corp., 199 F.Supp.2d 197, 203-06 (D.Del.2002) ...