Abbott Laboratories v. Torpharm, Inc.
| Citation | 300 F.3d 1367 |
| Decision Date | 13 August 2002 |
| Docket Number | No. 02-1014.,02-1014. |
| Parties | ABBOTT LABORATORIES, Plaintiff-Appellee, v. TORPHARM, INC., Apotex, Inc., and Apotex Corp., Defendants-Appellants. |
| Court | United States Courts of Appeals. United States Court of Appeals for the Federal Circuit |
Daniel E. Reidy, Jones, Day, Reavis & Pogue, of Chicago, IL, argued for plaintiff-appellee. With him on the brief were James R. Daly, Robert C. Micheletto, and Jason G. Winchester, of Chicago, Illinois, and Gregory A. Castanias, of Washington, DC.
Scott B. Feder, Lord, Bissell & Brook, of Chicago, IL, argued for defendants-appellants. With him on the brief were Hugh L. Moore, Keith D. Parr, Hugh S. Balsam, and William A. Rakoczy.
Before CLEVENGER, Circuit Judge, PLAGER, Senior Circuit Judge, and BRYSON, Circuit Judge.
TorPharm, Inc., Apotex, Inc., and Apotex Corporation ("TorPharm") appeal the judgment of the United States District Court for the Northern District of Illinois, granting summary judgment of infringement of U.S. Patents No. 4,988,731 and No. 5,212,326 to Abbott Laboratories ("Abbott"). See Abbott Labs. v. Torpharm, Inc., 156 F.Supp.2d 738 (N.D.Ill.2001). Because we find genuine disputes of material fact remain concerning the nature of TorPharm's accused product, we vacate the grant of summary judgment of infringement to Abbott. We affirm, however, the district court's judgment that the patents in suit are not invalid for lack of novelty or enablement, and that the patents in suit are not unenforceable for inequitable conduct during their prosecution.
This appeal arises from TorPharm's attempt to introduce a generic version of Abbott's Depakote, an anticonvulsant medication approved for treatment of epilepsy as well as migraine headaches and bipolar disorder. Abbott has listed the two patents in suit under Depakote's entry in the "Orange Book," the Food and Drug Administration's roster of approved drugs in which a manufacturer must list those patents that the manufacturer believes cover the drug. Depakote consists of an equimolar mixture of the acid and sodium salt derivatives of its active species, the valproate ion. According to the patent specifications, while both the acid (valproic acid) and the salt (sodium valproate) were known to have anticonvulsant properties, both the acid and the salt have significant drawbacks as pharmaceutical preparations. Valproic acid is a liquid, which is inconvenient for the preparation of an oral formulation; sodium valproate is a solid, but its hygroscopicity (tendency to absorb moisture) poses problems for stability and storage.
In the late 1970s, Abbott chemists discovered that by mixing sodium valproate and valproic acid in a 1:1 molar ratio (that is, one molecule of sodium valproate for every molecule of valproic acid), they could obtain a substance that was solid but not hygroscopic, making it much more suitable for pharmaceutical formulations than either sodium valproate or valproic acid. This new substance was designated divalproex sodium, or, alternatively, sodium hydrogen divalproate. Although Abbott chemists knew that their divalproex sodium consisted of equal parts sodium valproate and valproic acid, they were not certain exactly how those molecules were arranged in the solid form. At first, Abbott's chemists believed that the sodium valproate salt and the valproic acid were simply paired with each other. Eventually, however, Abbott came to believe that divalproex sodium existed in the form of several acid/salt pairs (or subunits) associated into a longer chain.
Abbott obtained two patents, U.S. Patents No. 4,988,731 and No. 5,212,326, on this "oligomeric" form of divalproex sodium. The '731 patent claims an oligomer having "about 4" acid/salt subunits, while '326 recites oligomers with "about 6" or "about 4 to 6" acid/salt subunits. The '326 patent also includes one claim, claim 5, which does not recite a particular number of subunits. Although like the other claims, '326 claim 5 requires an "oligomer having a 1:1 molar ratio of sodium valproate and valproic acid," claim 5 recites three physical properties of the oligomer (its appearance, melting point, and characteristic bands in its infrared absorption spectrum) instead of a particular number of subunits.
Abbott's original application did not include the "about 4," "about 6", or "about 4 to 6" limitations. To avoid a new matter rejection when it added claims reciting oligomers of these particular lengths, Abbott submitted test data to the Patent Office measuring the molecular weight of its divalproex sodium by several different methods. Each technique showed that the molecular weight of divalproex sodium was higher than would be expected from a single sodium valproate / valproic acid pair. Based on these test results, Abbott argued that the original disclosure of divalproex sodium inherently disclosed the numerical limitations. Abbott's inherency argument eventually succeeded in securing the claims in suit, although not until after the Board of Patent Appeals and Interferences had affirmed the rejections of the "about 6" and "about 4 to 6" claims.
Abbott brought suit against TorPharm after TorPharm filed with the FDA an Abbreviated New Drug Application (ANDA) seeking approval for a generic version of Depakote, an act giving rise to an infringement suit under 35 U.S.C. § 271(e)(2). See Bayer AG v. Elan Pharm. Research Corp., 212 F.3d 1241, 1244-45, 54 USPQ2d 1711, 1712-13 (Fed. Cir.2000). The district court granted summary judgment of infringement to Abbott, based on the description of TorPharm's product in its package insert (part of the ANDA submission) and on Abbott's test data showing that TorPharm's biobatch material had a high molecular weight similar to material prepared according to the '326 and '731 patents. Rejecting TorPharm's arguments that evidence of a high molecular weight cannot prove a particular oligomeric structure, the district court also rejected TorPharm's defenses that (i) the patents are nonenabled because the claimed oligomeric structure does not actually exist, (ii) the '326 patent was anticipated by Abbott's prior sales of Depakote, and (iii) the patents are unenforceable by Abbott's failure to disclose to the Patent and Trademark Office a contradictory result about divalproex sodium's structure during prosecution. TorPharm appeals the grant of summary judgment to Abbott, and we exercise jurisdiction over TorPharm's appeal in accordance with 28 U.S.C. § 1295(a)(1).
TorPharm first takes issue with the district court's claim construction, a question of law that we review de novo. Cybor Corp. v. FAS Techs., Inc., 138 F.3d 1448, 1456, 46 USPQ2d 1169, 1174 (Fed. Cir.1998) (en banc). Neither Abbott nor TorPharm questions the district court's definition of "oligomer" as "a composition made up of a relatively small number of repeating units joined end to end." TorPharm, however, contends that the district court erred by refusing to exclude from the definition of "oligomer" any material described as a "complex," "ionic complex," "dimer," "derivative," "mixed salt," or "salt," asserting that Abbott abandoned all these terms as representative of the claimed oligomers during prosecution of the patents in suit. We note that although TorPharm disclaims any intent to limit the claims to covalently1 associated oligomers only, little but covalent oligomers would seem to remain if the claims were so constricted. We further note that TorPharm has neither defined these terms nor demonstrated their applicability to any species appearing in this suit, rendering the alleged error of questionable significance.
We need not muse on these questions, however, because we find no error in the district court's claim construction. Of course, prosecution history may limit claim scope if the patentee disclaimed or disavowed a particular interpretation of the claims during prosecution. Standard Oil Co. v. Am. Cyanamid Co., 774 F.2d 448, 452, 227 USPQ 293, 296 (Fed.Cir.1985). This principle does not, however, mean that any words appearing in the prosecution history but not in the issued claims are forever banished. The prosecution history inquiry asks not what words the patentee discarded, but what subject matter the patentee relinquished or disclaimed. Our review of the relevant prosecution history shows that while Abbott and the examiner may have disagreed about which words best described the compounds disclosed by the specification, their colloquy reveals no intent or requirement to surrender any or all compounds that might be described as a "complex," "ionic complex," "dimer," "derivative," "mixed salt," or "salt."
Furthermore, as TorPharm admits, TorPharm's construction would exclude the preferred embodiment (as well as all other embodiments) disclosed by the patent specifications. Such claim constructions are "rarely, if ever, correct," Vitronics Corp. v. Conceptronic, Inc., 90 F.3d 1576, 1583, 39 USPQ2d 1573, 1578 (Fed. Cir.1996). TorPharm contends that the ordinary reluctance to reach such an interpretation should be overcome here because the preferred embodiment described by the specification does not actually exist. However, as we explain below, TorPharm has not substantiated its challenges against the existence of the oligomeric structure described by the specification and encompassed within the district court's claim construction. We thus conclude that TorPharm has shown no error in the district court's claim construction.
When a district court grants summary judgment, we review without deference to the trial court whether there are disputed material facts, and review independently whether the prevailing party is entitled to judgment as a matter of law. SunTiger, Inc. v. Scientific Research Funding Group, 189 F.3d 1327, 1333, 51 USPQ2d 1811, 1814 (Fed.Cir.1999). Summary judgment is proper "if the pleadings, depositions, answers...
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