Bayer A.G. v. Elan Pharmaceutical Research Corp., Civ. 2:97-CV-143-WCO.
| Decision Date | 16 March 1999 |
| Docket Number | No. Civ. 2:97-CV-143-WCO.,Civ. 2:97-CV-143-WCO. |
| Citation | 64 F.Supp.2d 1295 |
| Parties | BAYER AG and Bayer Corporation, Plaintiffs, v. ELAN PHARMACEUTICAL RESEARCH CORPORATION and Elan Corporation, PLC, Defendants. |
| Court | U.S. District Court — Northern District of Georgia |
O'KELLEY, Senior District Judge.
The captioned case is before the court for consideration of two motions by defendants Elan Pharmaceutical Research Corporation and Elan Corporation, plc, ("Elan"): a motion for summary judgment [49-1] and a motion to file excess pages [102-1].1
Elan filed a motion to allow the filing of a reply memorandum in support of its motion for summary judgment which is five pages in excess of the page limit set forth in the local rules. This request will result in Elan's being granted the same number of additional pages as Bayer. Elan's motion is hereby GRANTED, and the court will consider the entirety of the reply brief in its consideration of the submitted summary judgment motion.
Plaintiffs Bayer AG and Bayer Corporation ("Bayer") hold U.S.Patent No. 5,264,446 ("'446 patent") for a high blood pressure drug, Adalat CC®. The invention described and claimed in the '446 patent centers on a solid pharmaceutical formulation containing a therapeutically effective amount of crystals of an active ingredient called nifedipine. The '446 patent provides that when relatively small crystals of nifedipine, defined by their specific surface area ("SSA"),2 are combined with a solid diluent, the resulting compositions produce a sustained release of active nifedipine into the bloodstream.
Once the FDA approves a new drug, generic versions may be developed. Congress enacted legislation to expedite U.S. Food and Drug Administration ("FDA") approval of generic drugs in order to increase the supply affordable drugs. A generic drug manufacturer is required to submit an Abbreviated New Drug Application ("ANDA"), giving detailed information about its generic product including its precise formulation, details about how it will be manufactured, and data showing that it is "bioequivalent" to the approved drug. 21 U.S.C. § 355(j).
If a generic drug manufacturer files an ANDA seeking approval to make a generic version of a drug claimed to be covered by a patent, the generic drug manufacturer must certify either that the generic drug will not enter the market before the patent's expiration date or that the patent is "invalid or will not be infringed by the manufacture, use, or sale of the drug for which the [ANDA] is submitted." 21 U.S.C. § 355(j)(2)(A)(vii)(III)-(IV). In such a case, the applicant must also notify the patent holder and state why the patent is not valid or will not be infringed. 21 U.S.C. § 355(j)(2)(B)(ii). If the patent holder disagrees with the certification, it has 45 days to sue the ANDA applicant for infringement under 35 U.S.C. § 271(e)(2). The filing of a suit suspends FDA approval of the proposed generic drug until the earlier of the court's resolution of the correctness of the ANDA applicant's certification of noninfringement or thirty months from the receipt of the notice.
In its complaint, Bayer alleges that Elan infringed the '446 patent under 35 U.S.C. § 271(e)(2) by filing an ANDA seeking FDA approval of a generic version of Bayer's Adalat CCA®. Section 35 U.S.C. § 271(e)(2) provides that it is "an act of infringement to submit [an ANDA] ... for a drug claimed in a patent or the use of which is claimed in a patent before the expiration of such patent." In its summary judgment motion, Elan argues that it has not infringed Bayer's patent because: (1) the SSA of Elan's nifedipine crystals, allegedly greater than 5m2/g, is above the literal upper limit of Bayer's claimed range of 1 to 4m2/g, and (2) the history of Bayer's prosecution of its claims in the U.S. Patent and Trademark Office ("PTO") estops Bayer from now asserting the doctrine of equivalents to cover Elan's drug.
Summary judgment shall be granted "if the pleadings, depositions, answers to interrogatories, and admissions on file, together with the affidavits, if any, show that there is no genuine issue as to any material fact and that the moving party is entitled to judgment as a matter of law." Fed.R.Civ.P. 56(c). Only those claims for which there is no need for a factual determination and for which there is a clear legal basis are properly disposed of through summary judgment. Celotex Corp. v. Catrett, 477 U.S. 317, 106 S.Ct. 2548, 91 L.Ed.2d 265 (1986). It is well settled that a court considering a motion for summary judgment must view the evidence in a light most favorable to the nonmoving party. See, e.g., Samples v. City of Atlanta, 846 F.2d 1328, 1330 (11th Cir. 1988). It is important to recognize, however, that this principle does not require the parties to concur on every factual point. Rule 56 "[b]y its very terms ... provides that the mere existence of some alleged factual dispute between the parties will not defeat an otherwise properly supported motion for summary judgment; the requirement is that there be no genuine issue of material fact." Anderson v. Liberty Lobby, Inc., 477 U.S. 242, 247-8, 106 S.Ct. 2505, 91 L.Ed.2d 202 (1986).
Summary judgment is equally available in a patent case, Brenner v. United States, 773 F.2d 306, 307 (Fed.Cir.1985), although "[a] district court should approach a motion for summary judgment on the fact issue of infringement with great care." Amhil Enterprises Ltd. v. Wawa, Inc., 81 F.3d 1554, 1557 (Fed.Cir.1996). Summary judgment is appropriate in patent infringement suits "where the claims do not `read on' the accused structure" for literal infringement purposes "and a prosecution history estoppel makes clear that no actual infringement under the doctrine of equivalents can be found." Townsend Engineering Co. v. Hitec Co., Ltd., 829 F.2d 1086, 1089 (Fed.Cir.1987) (quoting Brenner, 773 F.2d at 307).
Notwithstanding that 35 U.S.C. § 271(e)(2) provides patentees with a defined act of infringement enabling a court to promptly resolve disputes concerning infringement, a district court's inquiry in a suit brought under Section 271(e)(2) is the same as it is in any other infringement suit. Glaxo, Inc. v. Novopharm, Ltd., 110 F.3d 1562, 1569 (Fed.Cir.1997). The difference is that the allegedly infringing drug has not yet been marketed; therefore, the infringement determination focuses on what the ANDA applicant will likely market if its application is approved. Id. "Under § 271(e)(2)(A), a court must determine whether, if the drug were approved based upon the ANDA, the manufacture, use, or sale of that drug would infringe the patent in the conventional sense." Id.
Patent infringement occurs when an invention that is literally covered by the claims of a patent, or is equivalent to the claimed subject matter is made, used, or sold during the term of the patent without authorization. 35 U.S.C. § 271. A determination that a patent is infringed involves a two-stage process. Novopharm, 110 F.3d at 1565; Markman v. Westview Instruments, Inc., 52 F.3d 967, 976 (Fed.Cir. 1995), aff'd, 517 U.S. 370, 116 S.Ct. 1384, 134 L.Ed.2d 577 (1996). First, the claim is properly construed to determine its scope and meaning. Id. Claim construction is a matter of law, based upon the claim language, the specification, the prosecution history, and necessary extrinsic evidence. Novopharm, 110 F.3d at 1565; Markman, 52 F.3d at 979. Claims are construed through the eyes of the person of ordinary skill in the field of the invention. Multiform Desiccants, Inc. v. Medzam, Ltd., 133 F.3d 1473, 1477 (Fed.Cir.1998). Second, the claim as properly construed is compared to the accused device or process. Novopharm, 110 F.3d at 1565; Markman, 52 F.3d at 976. Whether an accused product infringes upon patent claims is a question of fact. Novopharm, 110 F.3d at 1565.
To prove literal infringement, a patentee must show that every limitation of the claims which he alleges to have been infringed is found in the accused device, i.e., "when the properly construed claim reads on the accused device exactly." Amhil Enter., 81 F.3d at 1562. "If an express limitation is absent from the accused product, there can be no literal infringement as a matter of law." Wolverine World Wide, Inc. v. Nike, Inc., 38 F.3d 1192, 1199 (Fed. Cir.1994).
Bayer's '446 patent includes twelve claims, each of which requires "an effective amount of nifedipine crystals with a specific surface area" within a certain range. Claims 1 through 4 define the range as 1.0 to 4m2/g; claims 5 through 8 define the range as "about 1.2 to 3.6 m2/g; claims 9 through 12 define the range as 1.3 to 3.1m2/g." The only measurement methods taught in the '446 patent are BET measurements made on the batch of starting raw material. Elan's ANDA sets a specification for its proposed product of a specific surface area greater than 5m2/g. Elan's supplier of nifedipine is Arzneimittelwerk Dresden GmbH ("AWD"). Elan has provided evidence that AWD's requirements do not allow the sale of nifedipine under 4.7m2/g to customers for use in products sold in the U.S. Furthermore, Elan offers a certified test of the nifedipine used in its batch of...
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