Lupin Ltd. v. Abbott Laboratories
| Decision Date | 27 April 2007 |
| Docket Number | Civil Action No. 3:06cv400. |
| Citation | 484 F.Supp.2d 448 |
| Parties | LUPIN LIMITED, Plaintiff, v. ABBOTT LABORATORIES, and Astellas Pharma, Inc., Defendants. Abbott Laboratories, and Astellas Pharma, Inc., Counterclaim Plaintiffs, v. Lupin Limited, and Lupin Pharmaceuticals, Inc., Counterclaim Defendants. |
| Court | U.S. District Court — Eastern District of Virginia |
Conrad Moss Shumadine, Willcox & Savage PC, Norfolk, VA, Amy Denise Brody, Deanne M. Mazzochi, Paul J. Molino, William A. Rakoczy, Rakoczy Molino Mazzochi Siwik LLP, Chicago, IL, for Plaintiff and Counterclaim Defendants.
Dabney Jefferson Carr, IV, Robert Armistead Angle, Troutman Sanders LLP, Richmond, VA, Ivan Michael Poullaos, James Francis Hurst, Kathleen Bridget Barry, Raymond Cortez Perkins, Winston & Strawn LLP, Chicago, IL, Jeffrey I. D. Lewis, John Charles Knapp, Stuart E. Pollack, William F. Cavanaugh, Jr., Patterson Belknap Webb & Tyler LLP, New York, NY, Richard D. Kelly, Frank Jonah West, Stephen Gene Baxter, Oblon Spivak
McClelland Maier & Neustadt PC, Alexandria, VA, for Defendants and Counterclaim Plaintiffs.
This matter is before the Court on the construction of U.S. Patent No. 4,935,507 ("'507 patent"). The '507 patent relates to the antibiotic cefdinir in its crystalline form. The parties dispute the scope of the '507 patent and, specifically, whether it encompasses only one particular form of crystalline cefdinir.
Cefdinir is an effective antibiotic which, in its crystalline form, has worldwide sales exceeding $600 million per year. Cefdinir's inventor, Astellas Pharma, Inc. ("Astellas"), has secured, in the United States, two patents for cefdinir. According to Astellas, the first, U.S. Patent No. 4,559,334 ("'334 patent"), covers a crystalline-like amorphous form of cefdinir. The '334 patent was issued in 1985. Its term was extended and is set to expire on May 6, 2007. The '507 patent, the patent-in-suit, does not expire until December 4, 2011 and covers only some form, or forms, of the crystalline cefdinir which is on the market today.1
One of the cefdinir forms indisputably covered by the '507 patent is Onmicef®, the branded crystalline cefdinir product and marketed by Abbott Laboratories ("Abbott"). After the expiration of the '334 patent, Lupin Limited ("Lupin") hopes to produce and market a generic form of crystalline cefdinir to compete with Omnicef®, and seeks a declaration that its product "has not infringed, does not infringe, and will not infringe any valid and enforceable claim of" the '507 patent. (Compl. for Declaratory J. at 1.) Abbott and Astellas each have filed counterclaims against Lupin, alleging that Lupin's crystalline cefdinir product infringes the '507 patent. (Dockets No. 18 and 21.) The first step in resolving this infringement dispute requires the Court to construe the claims of the '507 patent.
The specification of the '507 patent explains that Astellas developed the invention claimed in the '507 patent because the cefdinir forms disclosed in the '334 patent have somewhat limited use as a marketable antibiotic. Indeed, shortly after obtaining the '334 patent, Astellas discovered at least two crystalline forms of cefdinir featuring certain qualities that make the drug more marketable and, therefore, more valuable.2 Unsurprisingly, Astellas sought to patent the new crystalline forms. In 1987, Astellas filed a patent application in Japan ("the Japanese priority application" or "'199 Application") seeking explicitly to claim the two newly-discovered crystalline forms of cefdinir, which Astellas labeled "Crystal A" and "Crystal B." See Japanese Patent Application No. 62-206199 at 1-2 (filed Aug. 19, 1987).3 One year later, Astellas filed a similar patent application in the United States and claimed priority to the patent application filed in Japan the year before.4 See United States Patent Application No. 07/229,489 (filed Aug. 8, 1988). The patent application filed in the United States eventually became, with a few changes, the '507 patent.
Whereas the Japanese priority application sought explicitly to claim the forms of cefdinir called Crystal A and Crystal B, the claims of the '507 patent are worded more generally, and read as follows:
What we claim is:
1. Crystalline 7-[2-(2-aminothiazol-4-yl) -2-hydroxyiminoacetamido]-3-vi-nyl-3-cephem4-carboxylic acid (syn isomer)5 which shows the peaks at the diffraction angles shown in the following table in its x-ray diffraction pattern:
diffraction angle (°)
about 14.7
about 17.8
about 21.5
about 22.0
about 23.4
about 24.5
about 28.1
2. Crystalline 7-[2-(2-aminothiazol-4-yl) -2-hydroxyiminoacetamido]-3-vi-nyl-3-cephem4-carboxylic acid (syn isomer) which is obtainable by acidifying a solution containing 7-(2-(2-aminothiazol-4-yl) — 2-hydroxyiminoacetamido)-3-vinyl-3-cephem4-carboxylic acid (syn isomer) at room temperature or under warming.
3. Crystalline substance of claim 2, wherein a solution containing 7-[2-(2-aminothiazol-4-yl)2 -hydroxyiminoacetamido]-3-vinyl-3-cephem4-carboxylic acid (syn isomer) is an aqueous solution of an alkali metal salt of said compound.
4. Crystalline substance of claim 3, wherein the acidifying of the solution is carried out at the temperature from room temperature to 40° C. at the pH from 1 to 4.
5. Crystalline 7-[2-(2-aminothiazol-4-yl)-2-hydroxyiminoacetamido]-3-vi-nyl-3-cephem-4-carboxylic acid (syn isomer) which is obtainable by dissolving 7-(2-(2-aminothiazol-4-yl)-2-hydroxyiminoacetamido)-3-vinyl-3-cephem-4-carboxylic acid (syn isomer) in an alcohol, continuing to stir the solution slowly under warming, then cooling the solution to room temperature and allowing the solution to stand.
U.S. Patent No. 4,935,507 col.16 ll.12-50 (filed Aug. 8, 1988).
Although the claims of the '507 patent do not use the terms Crystal A or Crystal B, Lupin argues that the '507 patent's claims must be limited to Crystal A because the specification declares the invention of the '507 patent to be Crystal A. Moreover, Lupin points out, the specification addresses itself exclusively to touting the benefits of, and reciting the processes for preparing, Crystal A. Finally, Lupin argues that the '507 patent's prosecution history confirms that Astellas patented only Crystal A to the exclusion both of Crystal B, which was disclosed in the Japanese priority application, and of any forms of cefdinir disclosed in the '334 patent. Astellas and Abbott disagree, and contend that Crystal A is only the preferred embodiment of the '507 patent's invention, and that the patent's claims are not limited to Crystal A.
To support their different constructions of the '507 patent, the parties have focused on the proper interpretation of three claim terms: "crystalline," "show the peaks," and "about." As a general matter, Lupin seeks a restrictive reading of those three terms that would explicitly or practically limit the scope of the '507 patent to Crystal A. On the other hand, Abbott and Astellas generally urge a broader reading of those three terms that would potentially expand the patent's reach beyond Crystal A.
The parties also dispute the proper reading of Claims 2-5. Lupin argues that they should be construed to be process claims or, alternatively, limited to Crystal A if construed to be product-by-process claims. Abbott and Astellas contend that Claims 2-5 are clearly product-by-process claims that, like Claim 1, are not necessarily limited to Crystal A alone.
The construction of patent claims is a matter of law for the court. Markman v. Westview Instruments, Inc., 517 U.S. 370, 116 S.Ct. 1384, 134 L.Ed.2d 577 (1996). It is axiomatic in patent law that "the claims of a patent define the invention to which the patentee is entitled the right to exclude." Innova/Pure Water, Inc. v. Safari Water Filtration Systems, Inc., 381 F.3d 1111, 1115 (Fed.Cir.2004). Therefore, "the words of a claim `are generally given their ordinary and customary meaning.'" Phillips v. AWH Corp., 415 F.3d 1303, 1312 (Fed.Cir.2005) (quoting Vitronics Corp. v. Conceptronic, Inc., 90 F.3d 1576, 1582 (Fed.Cir.1996)). The ordinary and customary meaning of a claim term is the meaning it would have to a person of ordinary skill in the art. Id. at 1313.
Importantly, however, the claims "do not stand alone." Id. at 1315. Indeed, the person of ordinary skill in the art is deemed to have read the claims, and, specifically, a disputed claim term, "not only in the context of the particular claim in which the disputed term appears, but in the context of the entire patent, including the specification." Id. Because the claims and the specification are part of a "fully integrated written instrument," Markman v. Westview Instruments, Inc., 52 F.3d 967, 978 (Fed.Cir.1995), the specification is "the single best guide to the meaning of a disputed term," Vitronics, 90 F.3d at 1582. In fact, "[u]sually, it is dispositive." Vitronics, 90 F.3d at 1582.
That said, courts, in construing claim terms, must be careful not to read limitations from the specification into the claims. Phillips, 415 F.3d at 1323. In that regard, the Federal Circuit has "expressly rejected the contention that if a patent describes only a single embodiment, the claims of the patent must be construed as being limited to that embodiment." Id. That is not to say, however, that the claims of a patent are never limited in scope to the embodiment or embodiments described in the specification. After reading the specification it will become clear, on most occasions, "whether the patentee is setting out specific examples of the invention ... or whether the patentee instead intends for the claims and the embodiments in the specification to be strictly coextensive." Id. While there may be some cases in which the specification does not...
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