Bayer Ag v. Schein Pharmaceutical, Inc.
| Decision Date | 09 February 2001 |
| Docket Number | Civ. No. 99-2181(GEB). |
| Citation | 129 F.Supp.2d 705 |
| Parties | BAYER AG and Bayer Corp., Plaintiffs, v. SCHEIN PHARMACEUTICAL, INC., Danbury Pharmacal, Inc., and Reddy-Cheminor, Inc., Defendants/Counter-claimants. Bayer AG and Bayer Corp., Plaintiffs, v. Mylan Pharmaceuticals Inc., and Mylan Laboratories Inc., Defendants/Counter-claimants. |
| Court | U.S. District Court — District of New Jersey |
Andrew Miller, Budd, Larner, Gross, Rosenbaum, Greenberg & Sade PC, Short Hills, NJ, Steven J. Lee, James Galbraith Robert V. Cerwinski, Kenyon & Kenyon, NY, for Schein Pharmaceutical, Inc., Danbury Pharmacal, Inc., Reddy-Cheminor, Inc.
Frank Holahan, Harwood Lloyd, LLC, Hackensack, NJ, E. Anthony Figg, Glenn E. Karta, Elizabeth A. Leff, Rothwell, Figg, Ernst & Kurz, P.C., Washington, DC, for Mylan Laboratories Inc., Mylan Pharmaceuticals Inc.
This matter comes before the Court upon the motion for summary judgment of defendants/counter-claimants Schein Pharmaceutical, Inc., Danbury Pharmacal, Inc. and Reddy-Cheminor, Inc. (collectively "Schein"), the cross-motion for summary judgment of plaintiffs Bayer AG and Bayer Corporation (collectively "Bayer"), and upon Bayer's motion to strike certain arguments raised in Schein's reply brief in the two related actions Bayer AG v. Schein Pharmaceutical, Inc., 99-2181 and Bayer AG v. Schein Pharmaceutical, Inc., 99-5093; and upon the motion for summary judgment of Mylan Pharmaceuticals Inc. and Mylan Laboratories Inc. ("Mylan") and the cross-motion for summary judgment of Bayer in Bayer AG v. Mylan Pharmaceuticals Inc., 99-4659. The Court has jurisdiction over this action pursuant to 28 U.S.C. § 1338(a). For the reasons discussed below, Schein and Mylan's motions for summary judgment are denied, Bayer's motion to strike certain arguments raised in Schein's reply brief is granted in part and denied in part, and Bayer's cross-motions for summary judgment are granted.
Schein and Mylan filed Abbreviated New Drug Applications ("ANDAs") with the United States Food and Drug Administration ("FDA") pursuant to 21 U.S.C. § 355(j) seeking approval to market generic drug products containing the antibiotic ciprofloxacin. Bayer alleges in its three complaints that the ANDAs infringe Bayer's United States Patent 4,670,444 (the "'444 patent") under 35 U.S.C. § 271(e)(2), which provides that it is an act of infringement to file certain applications with the FDA seeking approval to market drugs claimed in a patent. The defendants counter that the '444 patent is invalid, but otherwise concede that if the patent is not invalid, the marketing of generic products containing ciprofloxacin would infringe the '444 patent. Pursuant to 21 U.S.C. § 355(j)(5)(B)(iii), Bayer's initiation of these actions has stayed the ANDAs pending before the FDA.
Schein argues in its motion for summary judgment that the '444 patent is invalid under 35 U.S.C. § 102(d) because Bayer filed a foreign patent application claiming ciprofloxacin more than twelve months before it filed its United States patent application claiming the same drug and the foreign patent issued before Bayer filed its United States application. Schein further argues that Bayer cannot rely on the filing date of the earlier United States Application No. 292,560 (the "'560 application") pursuant to 35 U.S.C. § 120 because the '560 application does not satisfy the "best mode" requirement of 35 U.S.C. § 112, ¶ 1. Bayer argues in opposition and in support if its cross-motion that the '444 patent is not invalid because it can rely on the earlier filing date of the '560 application pursuant to 35 U.S.C. § 120 and that application satisfies the best mode requirement of 35 U.S.C. § 112, ¶ 1. Bayer also raises three alternative arguments. First, it claims that if the '560 application violates § 112's best mode requirements, then so does the foreign application relied upon by Schein in its § 102(d) argument, thus disqualifying that foreign application as a § 102(d) bar as a matter of law. Second, Bayer argues in the alternative that Schein's § 102(d) defense fails as a matter of law because Bayer is entitled to rely on an earlier filed German patent application pursuant to 35 U.S.C. §§ 119 and 120. Finally, Bayer argues that Schein cannot rely upon a foreign South African patent as a § 102(d) bar because Bayer did not have the right to enforce that patent under South African law until after it filed the relevant United States counterpart application. Mylan raises substantially the same arguments in support of its motion for summary judgment as Schein raised, but Mylan relies on three additional foreign patent applications filed in Chile, Spain and Argentina in support of its § 102(d) arguments.
Two days after the parties submitted their motion package in accordance with Appendix N of the local rules of civil procedure, the United States Court of Appeals for the Federal Circuit decided Eli Lilly and Co. v. Barr Laboratories, Inc., 222 F.3d 973 (Fed.Cir.2000). For obvious reasons, the Court instructed the parties to submit supplemental briefing on Lilly's impact on the best mode issues presently pending before the Court. The parties submitted additional briefing on the Lilly decision and the Court thereafter heard the arguments of counsel.1
Before hearing the arguments of counsel, the Court asked the parties why these three actions should not be consolidated for all purposes pursuant to Fed.R.Civ.P. 42(a). All counsel agreed to consolidation, and the Court entered an order consolidating Bayer AG v. Schein Pharmaceutical, Inc., 99-2181, Bayer AG v. Schein Pharmaceutical, Inc., 99-5093, and Bayer AG v. Mylan Pharmaceuticals Inc., 99-4659 under lead docket number 99-2181.
After the Court heard the arguments of counsel and while the matter was under consideration, the Court received from counsel for Mylan and counsel for Bayer a series of correspondence addressing Mylan's voluntarily withdrawal of certain of its counterclaims. By letter dated January 23, 2001, the Court received from Bayer's counsel a Joint Stipulation and Order of Dismissal dismissing with prejudice Counts I, II, III, that portion of Count IV relating to unenforceability, and Count V of Mylan's counterclaims. The Court signed and entered the Joint Stipulation and Order on January 24, 2001.
The compound at issue here that is the subject of the defendants' ANDAs and covered by Bayer's '444 patent is known as ciprofloxacin.2 Ciprofloxacin is a powerful antibiotic that can be administered orally and is effective against a broad range of bacteria. Thus, the drug is widely prescribed and used.
The ciprofloxacin molecule as disclosed in the '444 patent is illustrated as follows:
NOTE: OPINION CONTAINING TABLE OR OTHER DATA THAT IS NOT VIEWABLE
Between the *** mid-1970's and 1980, a group of Bayer scientists, including Dr. Klaus Grohe, were involved in a project whose purpose was to synthesize derivatives of known antibacterial agents and develop broad spectrum antibiotics. During the course of this research, Dr. Grohe and his colleagues discovered that certain molecules that had a cyclopropyl group at the 1-position had particularly potent antibacterial properties.
On September 13, 1980, Bayer filed a German patent application P 30 33 157.8 naming Drs. Grohe, Zeiler and Metzger as inventors. The defendants claim that the first German application's claims were broad enough to cover generically certain compounds within the naphthyridine and quinolone classes of compounds, but that the application contained only examples of naphthyridines. Bayer, on the other hand, states that the disclosures of the application were broad enough to include both naphthyridine and quinolene compounds generally but each claim indicated that the claimed compound is a naphthyridine.
In December 1980, Dr. Grohe experimented with methods to create intermediate materials needed to synthesize ciprofloxacin. Dr. Grohe used his previously published cycloaracylation method in an attempt to make 6-fluoroquinolonic acid ("6 FQA"), the intermediate compound that when combined with piperazine yields ciprofloxacin. Schein claims that Dr. Grohe first experimented with 5-nitrobenzoyl halide as a starting compound, but failed to achieve the desired result, and then attempted to synthesize 6-FQA using 6-nitrobenzoyl halide as a starting material, which also proved unsuccessful. Schein claims that in early 1981 Dr. Grohe again attempted to make 6-FQA and ciprofloxacin using the cycloaracylation method, but this time used 5-fluorobenzoyl halide as the cycloaracylation starting compound. Bayer, on the other hand, claims that Dr. Grohe planned from the outset to use the cycloaracylation method with a 5-fluoro starting compound. According to Bayer, Dr. Grohe learned from a process known as retrosynthesis that he should begin the process of making 6-FQA with a starting compound that had a fluorine atom in the 5 position. Dr. Grohe did not have such a compound available to him. He, therefore, attempted to make 6-FQA using a nitro starting compound that was available in his lab, but this starting material did not have a fluorine atom in the 5 position. Dr. Grohe's efforts yielded a starting material, but not the 6-FQA he needed, that is 6-FQA with a fluorine atom in the 5-position. The nitro starting material that Dr. Grohe first used is illustrated as follows:
NOTE: OPINION CONTAINING TABLE OR OTHER DATA THAT IS NOT VIEWABLE
To make 6-FQA, Dr. Grohe tried to substitute a fluorine group for the nitro group in his intermediate compound using a procedure known as the Balz Schiemann reaction, but was not successful. Dr. Grohe then asked another Bayer chemist, Dr. Klauke, to provide him...
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