Amgen, Inc. v. Hoechst Marion Roussel, Inc.

• Citation: 3 F.Supp.2d 104
• Decision Date: 15 April 1998
• Docket Number: Civil Action No. 97-10814-WGY.
• Parties: AMGEN, INC. Plaintiff, v. HOECHST MARION ROUSSEL, INC. and Transkaryotic Therapies, Inc. Defendants.
• Court: U.S. District Court — District of Massachusetts

3 F.Supp.2d 104

AMGEN, INC. Plaintiff, v. HOECHST MARION ROUSSEL, INC. and Transkaryotic Therapies, Inc. Defendants.

Civil Action No. 97-10814-WGY.

United States District Court, D. Massachusetts.

April 15, 1998.

Michael R. Gottfried, Dennis D. Allegretti, Burns & Levinson, Boston, MA, Douglass C. Hochstetler, Edward M. O'Toole, Jane J. Choi, Michael F. Borun, Marshall, O'Toole, Gerstein, Murray & Borun, Chicago, IL, for Plaintiff.

Robert S. Frank, Jr., Mark A. Michelson, Choate, Hall & Stewart, Boston, MA, Peter

C. McCabe, III, Raymond C. Perkins, Winston & Strawn, New York City, Steven F. Molo, Winston & Strawn, Chicago, IL, Kenneth B. Herman, Herbert F. Schwartz, James F. Haley, Jr., Russell W. Faegenburg, Fish & Neave, New York City, for Defendants.

MEMORANDUM AND ORDER

YOUNG, District Judge.

The Plaintiff, Amgen, Inc. ("Amgen"), brings this action against the Defendants, Hoechst Marion Roussel, Inc. ("Hoechst") and Transkaryotic Therapies, Inc. ("Transkaryotic") (collectively "the Defendants"), alleging patent infringement. Amgen holds several patents covering a recombinant (genetically engineered) form of erythropoietin ("EPO"), a hormone that stimulates the body's production of red blood cells. EPO is used in the treatment of anemia, particularly in patients suffering chronic renal failure. Amgen has successfully marketed embodiments of its EPO patents, called EPOGEN and NEUPOGEN.

Transkaryotic has entered into a collaborative agreement with Hoechst, a subsidiary of the German pharmaceutical giant Hoechst AG, in order to develop a competing EPO product, GA-EPO. Amgen contends in Count I of the complaint that the Defendants, in pursuing this development, have infringed its patents by making and using significant quantities of patented EPO. In Count II of the Complaint, Amgen requests a declaration that the Defendants will infringe its patents in the future.

BACKGROUND

This case was previously before the Court on the Defendants' motion to dismiss, or in the alternative for summary judgment, on the grounds that the actions complained of fell within the limited clinical trials exemption created by 35 U.S.C. § 271(e)(1).¹ The Court denied both motions orally from the bench, to allow Amgen an opportunity for necessary discovery, without prejudice to a renewed motion for summary judgment at an appropriate time. The parties have now completed their discovery pursuant to the Court's Pretrial Order of July 24, 1997.

The Defendants renew their motion for summary judgment, arguing that their activities fall under the section 271(e)(1) exemption, and that this Court has no jurisdiction to issue declaratory relief. Amgen, in turn, moves for partial summary judgment of infringement under Count I and summary declaration under Count II. In response, the Defendants reassert their section 271(e)(1) defense, and dispute Amgen's patent construction as well as the infringement analysis. The Defendants also renew their request for additional time under Fed.R.Civ.P. 56(f) to conduct discovery directed at the question of infringement.

It is helpful to sort out this tangle of motions into three distinct issues. First, does the section 271(e)(1) exemption shield the Defendants' activities from liability for infringement? Second, if so, does the Court nonetheless have jurisdiction to grant declaratory relief? Third, if there is any jurisdictional basis for the Court to consider the merits of the case, is there patent infringement?

DISCUSSION

A. Summary Judgment

Judgment is appropriate under Fed. R.Civ.P. 56 if "there is no genuine issue as to any material fact and ... the moving party is entitled to a judgment as a matter of law." Fed.R.Civ.P. 56(c); see A.B. Chance Co. v. RTE Corp., 854 F.2d 1307, 1310-11 (Fed.Cir. 1988). In deciding the motions, the Court resolves all disputed facts and inferences in favor of the non-moving party. See Opryland USA Inc. v. Great Am. Music Show, Inc., 970 F.2d 847, 850 (Fed.Cir.1992) (citing Anderson v. Liberty Lobby, Inc., 477 U.S 242, 255, 106 S.Ct. 2505, 91 L.Ed.2d 202 [1986]). Nevertheless, if there are no genuine issues of material fact, summary judgment is as appropriate in a patent infringement case as in any other. See Moeller v. Ionetics, Inc., 794 F.2d 653, 656 (Fed.Cir. 1986); Chore-Time Equip., Inc. v. Cumberland Corp., 713 F.2d 774, 778-79 (Fed.Cir. 1983). Under the proper circumstances, the Court will strive to avoid a long, complex, and unnecessary trial.

B. Section 271(e)(1).

The first question before the Court is whether any of six allegedly infringing activities Amgen has identified during discovery fall under the section 271(e)(1) exemption. Section 271(e)(1) permits research and development activities that would otherwise constitute patent infringement if they are conducted solely for uses reasonably related to the development and submission of information to the FDA. See 35 U.S.C. § 271(e)(1). The measure is one half of a 1984 legislative compromise, the Drug Price Competition and Patent Term Restoration Act of 1984, Pub.L. No. 98-417, 98 Stat. 1585, designed to alleviate the unintended effects of the FDA approval process on the length of pharmaceutical patent terms. The other half, section 156, allows patent holders to extend the term of their patent up to five years to compensate for delays caused by FDA approval. 35 U.S.C. § 156(g)(6)(A); see Abtox, Inc. v. Exitron Corp., 122 F.3d 1019, 1029 amended by, 131 F.3d 1009 (Fed.Cir.1997); Telectronics Pacing Sys., Inc. v. Ventritex, Inc., 982 F.2d 1520, 1524-25 (Fed.Cir.1992).

The Federal Circuit has identified several important aspects of the section 271(e)(1) exemption. First, section 271 applies generally only to activities that might constitute infringement. Thus, a defendant need not show that all of its conduct falls under the section 271(e)(1) exemption, only the making, using, or selling of the claimed invention. All other conduct falls outside the section 271(a) definition of infringement in the first instance. See Telectronics, 982 F.2d at 1525.

Second, the potentially infringing activity must be "solely for uses" related to FDA approval. The Federal Circuit has approved of uses such as demonstration of the invention itself to recruit clinical investigators, Telectronics, 982 F.2d at 1523, and hiring an outside firm to conduct testing on the invention, even though the decision to do so was motivated by the hope that the testing firm would purchase the rights to the device. Abtox, 122 F.3d at 1027, 1029-30. The statute "does not look to the underlying purposes or attendant consequences of the activity ... as long as the use is reasonably related to FDA approval." Id. at 1030. "[I]ntent or alternative uses are irrelevant" to the inquiry. Id.²

A number of district courts, including the District of Massachusetts, have applied the statute in ways that suggest a narrower scope. In Scripps Clinic & Research Found. v. Genentech, Inc., 666 F.Supp. 1379 (N.D.Cal.1987), the court read the statute to require that the "use is solely for purposes reasonably related to" FDA approval, held that the defendant must use the invention for meeting FDA requirements, and for no other purposes. Id. at 1396. Thus, sales and uses having multiple purposes fell outside the statutory exemption. Id.; see also Biogen, Inc. v. Schering AG, 954 F.Supp. 391, 396 (D.Mass.1996) (concluding without discussion that large scale production and market preparation took defendant out of "safe harbor"). This analysis conflates the statutory concept of "uses" with the concept of "purpose."

The phrase "solely for uses reasonably related" is not equivalent to the phrase "use is solely for purposes reasonably related." The later reflects a more restrictive view of permissible activities under the statute. Uses, such as animal testing, human clinical trials, or chemical composition analysis, may be related to FDA approval, and yet be conducted for purposes other than, or in addition to, obtaining FDA approval. The Federal Circuit precedents indicate that such ulterior motives or alternate purposes do not preclude application of the section 271(e)(1) exemption.³

Finally, the use must be reasonably related to (albeit not for the exclusive purpose of) FDA approval. The Federal Circuit has not squarely addressed this aspect of the analysis. The district court in Intermedics, Inc. v. Ventritex, Inc., 775 F.Supp. 1269 (N.D.Cal.1991), aff'd, 991 F.2d 808, 1993 WL 87405 (Fed.Cir.1993) (non-precedential), framed the relevant inquiry thus:

[W]ould it have been reasonable, objectively, for a party in defendant's situation to believe that there was a decent prospect that the "use" in question would contribute (relatively directly) to the generation of kinds of information that was likely to be relevant in the processes by which the FDA would decide whether to approve the product? If the answer is yes, it should not matter that other reasonable persons might have concluded that FDA approval could be secured even without the information in question.

775 F.Supp. at 1280. The Federal Circuit cited this opinion with approval in Telectronics, 982 F.2d at 1525 n. 5, and subsequent district court opinions have adopted the same formulation. See Abtox, Inc. v. Exitron Corp., 888 F.Supp. 6, 8 (D.Mass.1995), aff'd, 122 F.3d 1019 (Fed.Cir.1997); NeoRx Corp. v. Immunomedics, Inc., 877 F.Supp. 202, 205 (D.N.J.1994). The test is prospective, in that it evaluates the potential infringer's activities at the time they were undertaken, and objective, in that it does not concern itself with the potential infringer's state of mind. It thus acknowledges the inherently unpredictable nature of the FDA approval process. This Court finds the Intermedics test to be consistent with the statutory scheme and existing Federal Circuit law, and adopts it in the resolution of this case.

In order to come within the protection of section 271(e)(1), the Defendants thus must make, use, or...