Schering Corp. v. Amgen, Inc.
| Decision Date | 09 October 1998 |
| Docket Number | No. CIV.A.96-587 MMS.,CIV.A.96-587 MMS. |
| Citation | 25 F.Supp.2d 293 |
| Parties | SCHERING CORPORATION and Biogen, Inc., Plaintiffs, v. AMGEN INC., Defendant. |
| Court | U.S. District Court — District of Delaware |
Steven J. Balick, and Steven T. Margolin, of Ashby & Geddes, Wilmington, Delaware; Of Counsel: Gerald Sobel, Aaron Stiefel, and Daniel DiNapoli, of Kaye, Scholer, Fierman, Hays & Handler, LLP, New York, New York; James F. Jr., Haley, of Fish & Neave, New York, New York, for plaintiffs.
Richard K. Herrmann, of Blank, Rome, Comisky & McCauley LLP, Wilmington, Delaware; Of Counsel: John J. McDonnell, Daniel A. Boehnen, and Grantland G. Drutchas, of McDonnell Boehnen Hulbert & Berghoff, Chicago, Illinois; D. Dennis Allegretti, of Burns & Levinson LLP, Boston, Massachusetts, for defendant.
Schering Corporation and Biogen, Inc. (collectively "Schering") filed a patent infringement suit against Amgen, Inc. ("Amgen") alleging Amgen infringed Biogen's U.S. Patent No. 4,530,901 entitled "Recombinant DNA Molecules and Their Use in Producing Human Interferon-Like Polypeptides" (the "'901 Patent"). Schering is Biogen's exclusive licensee. A hearing pursuant to Markman v. Westview Instruments, Inc., 517 U.S. 370, 116 S.Ct. 1384, 134 L.Ed.2d 577 (1996), was held June 23, 1998 ("Markman hearing"). An Opinion and Order which issued on July 30, 1998, 18 F.Supp.2d 372 ("Markman Opinion"), construed seven separate aspects of language found in the claims of the '901 Patent. Schering has moved for reargument on only one of the seven claim constructions, namely, "a polypeptide of the IFN-α type" language found in Claims 1, 5, 8, 9 and 12. If the Court does not grant reargument, Schering has advised it cannot succeed on its infringement action against Amgen and will appeal the claim construction ruling.
The District of Delaware, through published case law, has developed rules that govern motions for reargument under Local Rule 7.1.5. These governing principles are simply stated: 1) reargument should be granted only when the merits clearly warrant and should never be afforded a litigant if reargument would not result in an amendment of an order, see StairMaster Sports/Medical Products v. Groupe Procycle, Inc., Civ. A. No. 97-396 MMS, ___ F.Supp. ___ (D.Del. Sept. 3, 1998); 2) the purpose of reargument is to permit the Court to correct error without unduly sacrificing finality; 3) grant of the reargument motion can only occur in one of three circumstances: a) "where the Court has patently misunderstood a party," b) "[where the Court] has made a decision outside the adversarial issues presented to the Court by the parties," or c) "[where the Court] has made an error not of reasoning but of apprehension," see Brambles USA, Inc. v. Blocker, 735 F.Supp. 1239, 1241 (D.Del.1990); and 4) a motion for reargument may not be used by the losing litigant as a vehicle to supplement or enlarge the record provided to the Court and upon which the merits decision was made unless "new factual matters not previously obtainable have been discovered since the issue was submitted to the Court," id. (emphasis added).
A guiding principle in applying the limitations on reargument under Local Rule 7.1.5 is that a motion for reargument can never be allowed to encourage "a never ending polemic between litigants and the Court." Pirelli Cable Corporation v. Ciena, 988 F.Supp. 424 (D.Del.1997); Oglesby v. Penn Mutual Life Insurance Company, 877 F.Supp. 872, 892 (D.Del.1994), aff'd, 127 F.3d 1096 (3d Cir.1997). It follows that grant of reargument should be denied where the proponent simply rehashes materials and theories already briefed, argued and decided.
Because Schering has run afoul of several of these principles, reargument will be denied. Further, since, with one exception the grounds asserted for reargument merely constitute Schering's disagreement with the Court's conclusions, and the remaining ground is not a basis for reargument but rather for appeal to the Federal Circuit Court of Appeals, the Court's treatment of the various aspects of the motion will be somewhat summary. If it were otherwise, the Court itself would simply be repeating and rehashing that which is already in the July 30, 1998, Markman Opinion.
Schering urges six points in support of its motion for reargument:
Point I This Court Erred by Disregarding the Use of the Term "IFN-α" in the '901
Patent Specification
Point II The Court Erred by Not Considering the Use of the Terms "IFN-α" and
"IFN-α type" in the Prosecution History
Point III This Court Erred in Narrowing the Meaning of the Term "IFN-α type" Based
on the Federal Circuit's Recent Decision in the Digital Biometrics Case
Point IV Startling New Evidence that Dr. Weissmann's Deposited "4c" Insert Was a
Portion of the DNA Encoding IFN-α-14 Conflicts With this Court's Reasoning
as to the Meaning of "IFN-α"
Point V This Court Erred in Interpreting the Phrase "IFN-α type" to Exclude "IFN-α"
Point VI The Court Erred in Concluding that the Term "IFN-α type" Can Include
"Incomplete" Forms of Human Leukocyte Interferon Protein
Each point, and any subargument under that point, will be discussed seriatim.
Point I: This Court erred by disregarding the use of the term "IFN-α" in the '901 Patent specification
A. Is the Determination of New Matter in the context of a Markman Hearing for a Judge of a Jury
Schering contends the Court improperly decided that reference in the specification to the IFN-α nomenclature was new matter as a matter of law, because such determinations are a province reserved for a jury. Amgen, on the other hand, argued that this section of the patent was new matter in violation of the patent statute and should not be considered. See Docket Item ("D.I.") 175, at 16-17. The Court held that the new matter prohibition under 35 U.S.C. § 132 must be interpreted in the same manner as the identical new matter prohibition found in 35 U.S.C. § 251, citing Application of Oda, 58 C.C.P.A. 1353, 443 F.2d 1200, 1203 n. 2 (C.C.P.A.1971). Because the question of whether the new matter prohibition in 35 U.S.C. § 251 has been violated has been found to be a question of law, see Hester Industries, Inc. v. Stein, Inc., 142 F.3d 1472, 1479 (Fed.Cir.1998), the Court concluded that the question of whether the new matter prohibition in 35 U.S.C. § 132 has been violated is also a matter of law.
While plaintiff argues otherwise, no outstanding issue of fact existed. Rather, the prosecution history, the claim, the specification and the July 1980 Nature, referenced in the prosecution history, contain all the pertinent facts. In short, all the facts are uncontested and found within the intrinsic and extrinsic evidence. Further, were Schering correct that the determination of new matter in the context of a Markman hearing is for the jury, a logistical nightmare would evolve. For example, should the Court, during the infringement trial, be compelled to conduct a mini-trial on new matter, or alternatively, would the Court convene a separate jury prior to the infringement trial solely to have a jury determine the new matter issue? This logistical problem need not occur and, indeed, appears contrary to the teaching of Cybor Corp. v. FAS Technologies, Inc., 138 F.3d 1448, 1465 (Fed.Cir.1998) (en banc) . The Court's conclusion on this issue is neither an error of misapprehension nor an instance of deciding an adversarial issue outside those presented to the Court by the parties. To the extent Schering disagrees with the Court's reasoning in this regard, its remedy lies with the Federal Circuit Court of Appeals.
B. Shift from "Leukocyte Interferon" to "IFN-α" — Simple Nomenclature Change or Substantive Change
Schering argues the Court erred in finding the definition of interferon proteins was cell-specific during the time when the patent application for the '901 Patent was filed. However, the extrinsic evidence referenced in the specification and relied upon by the Court in its claim construction belies Schering's contention. The extrinsic evidence stated:
Interferons will be classified into types on the basis of antigenic specificities, type designations to be alpha, beta, and gamma, corresponding to previous designations of leukocyte (Le), fibroblast (F) and type II (immune) interferons, respectively. The old terminology of `leukocyte', `fibroblast', and `immune' interferons were, by committee consensus, abolished, as they clearly were misnomers: both leukocytes and fibroblasts can produce each of these two types of interferon ....
Interferon Nomenclature, Nature, July 10, 1980, at 110. (emphasis added). Schering claims a priority date of January 1980 with a February 1980 filing date. However, Schering has conceded the meeting upon which the Nature article was based did not occur until March 1980, and the Nature article did not come out until July 10, 1980. Schering has supplied no case authority for its somewhat astounding proposition that one of ordinary skill in the art is assumed to know of unpublished decisions made by leaders in their respective fields. The Court reaffirms that July 10, 1980, was the date the new classification based upon antigenic specificities, as opposed to cell-specific criteria, was first published to the world scientific community, including those skilled in the art. Thus, when the patent application was filed in February 1980, interferon definitions were based on cell-specific criteria. Although it is true that Schering recognized in the '901 specification that leukocyte interferon produced small amounts of fibroblast...
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