Smithkline Beecham Corp. v. Apotex Corp.
| Citation | 286 F.Supp.2d 925 |
| Decision Date | 03 December 2001 |
| Docket Number | No. 98 C 3952.,98 C 3952. |
| Parties | SMITHKLINE BEECHAM, CORPORATION and Beecham Group, p.l.c., Plaintiffs, v. APOTEX CORP., Apotex, Inc., and Torpharm, Inc., Defendants. |
| Court | U.S. District Court — Northern District of Illinois |
William F. Conlon, John W. Treece, Richard J. O'Brien, Sidley Austin Brown & Wood LLP, Chicago, IL, Ford F. Farabow, Richard B. Racine, Howard W. Levine, Finnegan, Henderson, Farabow, Garrett & Dunner, Washington, DC, for Plaintiffs.
Hugh L. Moore, Richard Philip Beem, Scott B. Feder, Keith D. Parr, Paul J. Molino, William Andrew Rakoczy, Deanne M. Mazzochi, Lord, Bissell & Brook LLP, Chicago, IL, for Defendants.
Robert F. Green, Leydig, Voit & Mayer, Ltd., Chicago, IL, for Intervenor.
This matter is before the Court on motions for summary judgment regarding the validity of Plaintiffs' patent and noninfringement of that patent by Defendants' proposed drug. For the reasons set forth below, we deny the Defendants' motions. We grant the Plaintiffs' motions on the issue of invalidity under 35 U.S.C. § 102(b), (f), and (g).
In the 1970s, scientists at the Danish company of A/S Ferrosan ("Ferrosan") discovered a new class of chemical compounds, at least some of which were reported to selectively inhibit the reuptake of serotonin, a naturally occurring chemical in the brain. Several commercial anti-depressants common at the time acted by inhibiting the neuronal reuptake of serotonin, and Ferrosan determined in laboratory tests that the serotonin-uptake inhibitory activity of its new compounds was comparable to that exhibited by these existing antidepressant drugs. Ferrosan then applied for, and on February 8, 1977, was assigned, U.S. Patent No. 4,007,196 ("the '196 patent"). (TP Ex. 4.1) The patent was entitled "4-PHENYLPIPERIDINE COMPOUNDS;" according to the abstract, it "relate[d] to new 3-substituted 1-alkyl-4-phenylpiperidines, being useful as antidepressant and anti-Parkinson agents, and to their production." (Id.)
One of the 3-substituted 1-alkyl-4-phenylpiperidine compounds created by Ferrosan was paroxetine. (SB Resp. ¶ 10.) Ferrosan lacked the financial resources to fully commercialize a paroxetine-based drug product (SB Resp. ¶ 31), and on or about July 31, 1980, it licensed its paroxetine technology to the U.K. company Beecham Group Limited ("Beecham"). (Id. ¶ 32; TP Exh. 20.) The license granted Beecham the exclusive right to make, have made, use and sell "Paroxetine ... (free base or any salt)" throughout the world save in specified Scandinavian countries. (TP Exh. 20.) Pursuant to the license agreement, Ferrosan provided Beecham with information on the chemical structure of paroxetine free base and paroxetine hydrochloride, as well as its method for synthesis of paroxetine hydrochloride and analytical test results. (SB Resp. ¶¶ 40-42.)
In the early 1980s, using information obtained from Ferrosan under the license agreement, chemists employed by Plaintiffs ("SmithKline") and located at a pilot plant in Harlow, U.K. worked to improve the process for the manufacture of paroxetine and paroxetine hydrochloride. (SB Resp. ¶ 39-42.) Between 1982 and 1985, the Harlow plant chemists made over 30 batches of paroxetine hydrochloride. (SP Resp. ¶ 41.)
On May 29, 1985, SmithKline scientist Alan Curzons issued a memorandum entitled "Paroxetine Polymorphism." In the memorandum Curzon stated that paroxetine "ha[d] been shown to exist in two discreet [sic] crystalline polymorphic FORMS," a stable, nonhygroscopic hemihydrate and a hygroscopic anhydrate. Curzon further opined that the discovery of the hemihydrate "may offer patent opportunities." The parties dispute whether it was SmithKline scientists who discovered or "invented" the hemihydrate form of paroxetine or whether the hemihydrate was previously conceived by Ferrosan and communicated to SmithKline under the license agreement. They also disagree as to whether and to what extent SmithKline knew during this period that paroxetine in any form would work as an antidepressant.
On October 25, 1985, Plaintiff Beecham Group p.l.c. ("Beecham"), a British corporation, filed a patent application with GB Application Serial Number 8526407 in the British Patent Office ("GB 8526407"). GB 8526407 "relate[d] to crystalline paroxetine hydrochloride, its preparation and its use as a therapeutic agent." (TP Exh. 48, p. 1.) In it, Beecham specified that the subject invention provided both the hemihydrate and anhydrate forms of crystalline paroxetine hydrochloride, as well as mixtures that contained a major proportion of either form. (Id., p. 3.)
A year later, on October 23, 1986, Beecham filed a patent application in the U.S. Patent and Trademark Office. (TP ¶ 3.) The application included six claims:
1. Crystalline paroxetine hydrochloride hemihydrate.
2. Crystalline paroxetine hydrochloride hemihydrate in substantially pure form.
3. Crystalline paroxetine hydrochloride hemihydrate, having substantially the same X-ray diffractogram as set out in FIG. 1, substantially the same IR spectrum, in a Nujol mull, as set out in FIG. 2, and substantially the same DSC profile as set out in FIG. 3.
4. A process for the preparation of crystalline paroxetine hydrochloride hemihydrate, which process comprises forming a solution of paroxetine hydrochloride and crystallizing said hemihydrate from solution by precipitation or recrystallization.
5. An anti-depressant pharmaceutical composition comprising an effective anti-depressant amount of crystalline paroxetine hydrochloride hemihydrate and a pharmaceutically acceptable carrier.
6. A method of treatment of depression in mammals, which method comprises administering an effective amount of crystalline paroxetine hydrochloride hemihydrate.
The application eventually issued on January 26, 1988, as United States Patent 4,721,723 ("the '723 patent"), the patent in suit. (Id.) The '723 patent, entitled "Antidepressant Crystalline Paroxetine Hydrochloride Hemihydrate,"2 relates to an invention that, according to the Abstract, "provides crystalline paroxetine hydrochloride hemihydrate, processes for its preparation, compositions containing the same and its therapeutic use as an anti-depressant." (Id.)
On November 1, 1995, Beecham assigned the '723 patent, which is due to expire on December 29, 2006, to Plaintiff SmithKline Beecham Corporation ("SmithKline Beecham"). (SB Resp. ¶ 143.) SmithKline Beecham is a Pennsylvania corporation engaged in the business of research, development, manufacture, and sale of pharmaceutical products throughout the world. Pursuant to the '723 patent, SmithKline markets a paroxetine hemihydrate-based product in the United States under the trademark Paxil®. (SB Public Use Exh. 1 ¶ 3.) Paxil is indicated for use in the treatment of depression, obsessive compulsive disorder, and panic disorder. (Id.) According to SmithKline, Paxil is one of the most widely prescribed prescription drugs in the United States. (Id.)
In or about May 1998, Defendant TorPharm, Inc. ("TorPharm"), a Canadian corporation, through its United States agent Defendant Apotex Corp. ("Apotex"), filed an Abbreviated New Drug Application ("ANDA") with the Food and Drug Administration for "Paroxetine HCl Tablets." The application contained a "Paragraph IV" certification stating that, to the best of TorPharm's knowledge, the '723 patent would not be infringed by the manufacture, use or sale of the proposed paroxetine HCl Tablets. See 21 U.S.C. § 355(j)(2)(A)(vii)(IV). On or about May 12, 1998, TorPharm sent SmithKline a 21 U.S.C. § 355(j)(2)(B) Notice of Certification informing it of the filing of the ANDA. The letter offered the following factual and legal basis for TorPharm's assertion that its proposed product would not infringe the '723 patent:
TorPharm's Paroxetine HCl does not fall within the scope of any of the claims of United States Patent No. 4,721,723 (the '723 patent). All of the claims of the '723 patent are directed to a crystalline paroxetine hydrochloride hemihydrate. TorPharm's Paroxetine HCl is anhydrous.
On June 26, 1998, SmithKline timely filed this patent infringement action pursuant to 35 U.S.C. § 271(e), which makes it an act of infringement to file an ANDA for a drug claimed in a patent. TorPharm answered the complaint and asserted four affirmative defenses, including the invalidity of the patent under 35 U.S.C. §§ 101, 102, 103, and/or 112 and estoppel by reason of statements and representations made to the United States Patent Office to induce the grant of the '723 patent.
In the matter at hand, four of the motions address the validity of the '723 patent. SmithKline asserts that the patent is not invalidated by 35 U.S.C. § 102(f) and (g) and that the hemihydrate was not in public use for more than a year before the patent issued, which would place the substance in the public domain and render it unpatentable. TorPharm has filed a cross-motion on the public use issue and seeks to have the patent invalidated on the grounds that its language is fatally indefinite. Finally if we deem the patent valid, TorPharm seeks summary judgment that their proposed drug will not infringe the '723 patent.
Summary judgment is appropriate when the record, viewed in the light most favorable to the nonmoving party, reveals 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). The moving party bears the initial burden of showing that no genuine issue of material fact exists. Celotex Corp. v. Catrett, 477 U.S. 317, 325, 106 S.Ct. 2548, 91 L.Ed.2d 265 (1986). The burden then shifts to the nonmoving party to show through specific evidence that a triable issue of fact remains on issues on which the nonmovant bears the burden of proof at trial. Id. The nonmovant may not rest upon mere allegations in the...
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Smithkline Beecham Corp. v. Apotex Corp.
...§ 102(b). The district court reasoned that the clinical trials qualified as experimental uses. See SmithKline Beecham Corp. v. Apotex Corp., 286 F.Supp.2d 925, 932-38 (N.D.Ill.2001). The district court then held a bench trial to determine the proper interpretation of claim 1 and to resolve ......
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Smithkline Beecham Corp. v. Apotex Corp.
...§ 102(b). The district court reasoned that the clinical trials qualified as experimental uses. See SmithKline Beecham Corp. v. Apotex Corp., 286 F.Supp.2d 925, 932-38 (N.D.Ill.2001). The district court then held a bench trial to determine the proper interpretation of claim 1 and resolve the......