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

Decision Date19 January 2001
Docket NumberNo. 97-10814-WGY.,97-10814-WGY.
Citation126 F.Supp.2d 69
PartiesAMGEN, INC., Plaintiff, v. HOECHST MARION ROUSSEL, INC. and Transkaryotic Therapies, Inc., Defendants.
CourtU.S. District Court — District of Massachusetts

Lloyd R. Day, Jr., Craig H. Casebeer, David M. Madrid, Jackie N. Nakamura, Robert M. Galvin, Christopher E. Stretch, Day Casebeer Madrid & Batchelder LLP, Cupertino, CA, Edward M. O'Toole, Michael F.Borun, Kevin M. Flowers, Marshall, O'Toole, Gerstein, Murray & Borun, Chicago, IL, D. Dennis Allegretti, Richard M. Wong, Duane, Morris & Heckscher LLP, Boston, MA, Steven M. Odre, Stuart L. Watt, Robert R. Cook, Monique Cordray, Wendy A. Whiteford, AMGEN INC., Thousand Oaks, CA, of counsel, for Plaintiffs.

Robert S. Frank, Jr., Mark A. Michelson, Mark S. Freeman, Choate, Hall & Stewart, Boston, MA, Steven F. Molo, Winston & Strawn, Chicago, IL, Kenneth B. Herman, Herbert F. Schwartz, Robert B. Wilson, James F. Haley, Jr., Russell W. Faegenburg, Bindu Donovan, Gerald J Flattmann, Jr., Peter J. Knudsen, Anna A. Kobilansky, Denise L. Loring, Barbara A. Ruskin, Keith A. Zullow, Douglas J. Gilbert, Fish & Neave, New York, NY, for Defendants.

Edward DiLello, Darby & Darby, New York, NY, for Movant.


YOUNG, Chief Judge.

In this jury waived declaratory judgment action, Amgen, Inc. ("Amgen") seeks a declaration that certain of the patents protecting its best selling drug EPOGEN® are infringed by the conduct of the defendants, Hoechst Marion Roussel, Inc. and Transkaryotic Therapies, Inc. (collectively "TKT"). TKT denies infringement and, in turn, counterclaims that Amgen's patents are invalid on a number of grounds.

Amgen, the first to discover and manufacture a recombinant DNA product similar to natural erythropoietin ("EPO") and useful in various medical treatments, has reaped significant commercial rewards from its discoveries, see Patricia Van Arnum, Active Pharmaceutical Ingredients: The Opportunities in the Branded Prescription Market, Chemical Market Rep., Oct. 30, 2000, WL 10/30/00 CHEMMKT REP FR 14 (noting that Amgen's Epogen had sales of $1.76 billion in 1999); Vicki Brower, Amgen Comes Out on Top in Blood Drug Patent Tussle, Biotechnology Newswatch, Jan. 4, 1999, WL 1/4/99 BIOTECHNW 1 (noting that EPO was then the "biggest-selling biotechnology drug ever developed" and that Amgen's EPO sales accounted for over fifty percent of its 1997 $2.4 billion revenue). As one would expect, Amgen has sought to preserve its commercial success through a cluster of related patents that it has defended with skill and perseverance.1

In conjunction with Hoechst Marion Roussel, Inc., now known as Aventis Pharmaceuticals, Inc., TKT, a smaller company, seeks to capitalize upon apparent advances in genetic engineering by targeting the most lucrative commercial recombinant DNA products and designing around them. See Trial Tr. at 1772:21 to 1773:2, 1786:5 to 1787:7. It, too, as one might expect, is no stranger to litigation.2 The present litigation, in fact, has been brewing for some time, see Amgen, Inc. v. Hoechst Marion Roussel, Inc., 3 F.Supp.2d 104 (D.Mass. 1998), and when it ultimately erupted in June of 1999, the parties were ready.

As an aside, it is only just to note that this case has been presented with high integrity, an unswerving fidelity to court rules and procedures, and a consummate excellence in trial practice that makes it a model not only for the intellectual property bar, but for lawyers everywhere. Any failings in understanding are mine, and mine alone.

The course of the litigation may be briefly sketched.

Early on, the parties agreed on a list of experts upon whom the Court might call for technical assistance. The Court chose Professor Chris Kaiser of the Massachusetts Institute of Technology from this list, and has met privately with him for background tutorial assistance.3

Towards the close of discovery, Amgen moved for summary judgment on the issue of infringement.4 This motion necessitated construction of the patent claims, and the Court held a Markman hearing on March 27, March 28, and April 10, 2000. Thereafter, the Court granted summary judgment to Amgen on a particular claim in one of the five patents in issue. The motion for summary judgment was otherwise denied.

Trial commenced on May 15, 2000 and continued for twenty-three days spread over four months.5 At the close of Amgen's case in chief, the Court held, pursuant to Fed.R.Civ.P. 52(c), that TKT had not infringed the process claims of Amgen's U.S. Patent No. 5,618,698 (issued Apr. 8, 1997). Trial concluded on September 8, 2000, and the matter was taken under advisement.


There are five patents at issue in this case: U.S. Patent No. 5,547,933 (issued Aug. 20, 1996) ("'933 patent"), Trial Ex. 2; U.S. Patent No. 5,618,698 (issued Apr. 8, 1997) ("'698 patent"), Trial Ex. 4; U.S. Patent No. 5,621,080 (issued Apr. 15, 1997) ("'080 patent"), Trial Ex. 3; U.S. Patent No. 5,756,349 (issued May 26, 1998) ("'349 patent"), Trial Ex. 5; and U.S. Patent No. 5,955,422 (issued Sept. 21, 1999) ("'422 patent"), Trial Ex. 6.

All of these patents share a common disclosure and identical specifications. Trial Exs. 2-6. Only the claims differ. Each of the patents claim priority from the following common applications: U.S. Patent Application Serial No. 675,298 (Nov. 30, 1984), which is a continuation-in-part of U.S. Patent Application Serial No. 655,841 (Sept. 28, 1984), which is a continuation-inpart of U.S. Patent Application Serial No. 582,185 (Feb. 21, 1984), which is a continuation-in-part of U.S. Patent Application Serial No. 561,024 (Dec. 13, 1983). Trial Exs. 2-6.


Interactive Charting for Amgen, Inc., at (last visited Apr. 26, 2000).


Amgen's NASDAQ Quote, at (last visited May 18, 2000).


It is appropriate to pause for a moment to emphasize the particular procedural approach that this Court used in conducting the Markman hearing. District courts have differed significantly in the timing and procedure for Markman hearings — some engaging in claim construction prior to trial and others after hearing all of the evidence at trial. See William F. Lee & Anita K. Krug, Still Adjusting to Markman: A Prescription for the Timing of Claim Construction Hearings, 13 Harv. J.L. & Tech. 55, 73 (1999). I have consistently taken the procedural approach of conducting the Markman hearing at the summary judgment stage of litigation or at the point when discovery has closed and trial is approaching. See, e.g., MacNeill Eng'g Co. v. Trisport, Ltd., No. 98-12019, 2001 WL 46970, slip op. at 7 (D.Mass. Jan. 10, 2001); MediaCom, 4 F.Supp.2d at 22-23. I have taken care to note that the benefits of so doing range from constitutional concerns arising from conducting such a hearing too soon to efficiency concerns arising from conducting the hearing too late. See MediaCom, 4 F.Supp.2d at 22; Lee & Krug, supra at 82-85.

Here, however, I want more specifically to emphasize that when the Markman hearing is conducted at the summary judgment stage, it is also important to conduct the two hearings independently of each other — the Markman hearing being held prior to and entirely independently of the summary judgment hearing. This is exactly the procedure that the Court followed in the case at hand, although other courts have chosen to address the issues raised with respect to claim construction in the context of the motion for summary judgment and hence conduct the Markman hearing in conjunction with the hearings on summary judgment, see, e.g., Biogen v. Berlex Labs., Inc., 113 F.Supp.2d 77, 81 (D.Mass.2000) (conducting the Markman hearing "in connection with" the summary judgment hearings).

This Court's Markman procedure turns on what this Court sees as the crucial distinction between construing patent claims in the context of considering motions for summary judgment as opposed to construing the patent claims without regard to the alleged infringement issue presented in the summary judgment motion. With this distinction in mind, this Court scrupulously kept the issues separate in order to avoid conflating the legal explication required by Markman with the fact finding that the Seventh Amendment ultimately reserves for the American jury. See Ciulla v. Rigny, 89 F.Supp.2d 97, 101, 102 & n. 7 (D.Mass.2000) (discussing the constitutional and communitarian values strengthened by jury fact finding)

Although, under current law, both approaches are permitted in the wake of Markman, just as the Federal Circuit has spoken to the question of what evidence a court should consider in a Markman hearing, Vitronics Corp. v. Conceptronic, Inc., 90 F.3d 1576, 1582-83 (Fed.Cir.1996), perhaps it ought similarly fashion flexible procedural boundaries within which to conduct such a hearing. Failure to do so not only deprives litigants of the benefit of consistent treatment among districts (or even among specific judges), but also risks descending a slippery slope toward the erosion of the role of the fact finder in patent litigation.

This latter fear is the central concern of this Court with the procedural approach to Markman hearings that mixes issues of claim construction with that of infringement by simultaneously considering factual evidence of each. I concede that, analytically, such mixing ought not affect the outcome of claim construction. Nonetheless, I fear that such mixing cuts against the spirit of both Markman itself and its recognition of the importance of the fundamental divide between fact and law (and consequently, fact finder...

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  • Amgen v. HMR: a case for deference in claim construction.
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