Smithkline Beecham Corp. v. Apotex Corp.
| Decision Date | 24 February 2006 |
| Docket Number | No. 04-1522.,04-1522. |
| Citation | 439 F.3d 1312 |
| Parties | SMITHKLINE BEECHAM CORPORATION, SmithKline Beecham, P.L.C., Plaintiffs/Counterclaim Defendants-Appellants, and GlaxoSmithKline, P.L.C., Plaintiff/Counterclaim Defendant, and Beecham Group, P.L.C., Plaintiff, v. APOTEX CORPORATION, Apotex Inc., and Torpharm, Inc. Defendants/Counterclaimants-Appellees. |
| Court | U.S. Court of Appeals — Federal Circuit |
Ford F. Farabow, Jr., Finnegan, Henderson, Farabow, Garrett & Dunner, L.L.P., of Washington, DC, argued for plaintiffs/counterclaim defendants-appellants. With him on the brief were Robert D. Bajefsky, Howard W. Levine, Sanya Sukduang, and Jennifer S. Swan.
Hugh L. Moore, Lord, Bissell & Brook LLP, of Chicago, Illinois, argued for defendants/counterclaimants-appellees. With him on the brief were Scott B. Feder, Hugh S. Balsam, and Kevin M. Nelson. Of counsel were Keith D. Parr and Sara A. Lufrano.
Before NEWMAN, SCHALL, and DYK, Circuit Judges.
Opinion for the court filed by Circuit Judge DYK.
SmithKline Beecham Corporation and SmithKline Beecham, P.L.C. (collectively "SmithKline") brought suit against Apotex Corporation, Apotex Inc., and Torpharm, Inc. (collectively "Apotex") for infringement of SmithKline's patent, U.S. Patent No. 6,113,944 ("'944 patent"). Apotex moved for summary judgment, arguing that the '944 patent was invalid. The district court granted summary judgment to Apotex. We agree that the claims of the '944 patent are invalid and thus affirm.
This case presents the question whether SmithKline's product patent for paroxetine, U.S. Patent No. 4,721,723 (filed Oct. 23, 1986) ("'723 patent"), anticipated its 1 723 patent, col. 5, ll. 53-56.
In 1992, SmithKline obtained approval from the Food and Drug Administration ("FDA") to market crystalline paroxetine hydrochloride, which it began to sell under the trade name Paxil®. SmithKline then filed various other related patent applications, including application No. PCT/EP94/04164, on December 14, 1994, which eventually matured into the '944 patent. The '944 patent contained the following two product-by-process claims:
Claim 1. A pharmaceutical composition in tablet form containing paroxetine, produced on a commercial scale by a process which comprises the steps of:
a) dry admixing paroxetine and excipients in a mixer to form a mixture; or
b) dry admixing paroxetine and excipients, compressing the resulting combination into a slug material or roller compacting the resulting combination into a strand material, and milling the prepared material into a free flowing mixture; and
c) compressing the mixture into tablets. Claim 2. A pharmaceutical composition in tablet form according to claim 1 containing an amount of paroxetine selected from 10 mg, 20 mg, 30 mg, 40 mg and 50 mg, wherein the amount of paroxetine is expressed as the free base, produced on a commercial scale by a process which comprises the steps of:
a) dry admixing paroxetine and excipients in a mixer to form a mixture; or
b) dry admixing paroxetine and excipients, compressing the resulting combination into a slug material or roller compacting the resulting combination into a strand material, and milling the prepared material into a free flowing mixture; and
c) compressing the mixture into tablets using a single punch or rotary tablet machine.
J.A. 483-84 (Certificate of Correction).
On March 31, 1998, Apotex, a generic drug manufacturer and defendant here, submitted an Abbreviated New Drug Application ("ANDA") to the FDA, seeking approval to market a generic version of Paxil®. In connection with its ANDA, Apotex filed a so-called "paragraph IV certification," which is a statement by the applicant that designated patents claiming either the drug or a use of the drug at issue are invalid or will not be infringed by the applicant. 21 U.S.C. § 355(j)(2)(A)(vii)(IV) (2000). Apotex's paragraph IV certification claimed that the '944 patent was invalid. Pursuant to 35 U.S.C. § 271(e)(2), which makes submitting an ANDA an act of infringement, SmithKline brought suit against Apotex, alleging infringement of the '944 patent. Apotex counterclaimed that the '944 patent was invalid and in due course moved for summary judgment of invalidity.
In its decision, the district court held the '944 patent anticipated and thus invalid. The district court appeared to view the question of anticipation as turning on the scope of the '944 patent, namely whether the patent should be viewed as claiming paroxetine without regard to the process by which it was made or whether the process steps were to be treated as claim limitations. The district court perceived a conflict in this respect between our decisions in Scripps Clinic & Research Foundation v. Genentech, Inc., 927 F.2d 1565 (Fed.Cir.1991) () and Atlantic Thermoplastics Co., Inc. v. Faytex Corp., 970 F.2d 834 (Fed.Cir.1992) (). The district court concluded that it was bound to follow the earlier Scripps decision, finding that Scripps required it to "evaluate the validity of the ['944 patent's] claims by reference to the products claimed therein, without the process limitations of those claims." J.A. 61. Because the '723 patent disclosed tablets containing paroxetine, including in the dosages specified in claim 2 of the '944 patent, the court determined that the '723 patent anticipated the '944 patent.
In holding the '944 patent anticipated, the district court found that the product claimed by the '944 patent was the same product disclosed by the '723 patent, despite SmithKline's arguments that the paroxetine tablets claimed by the '944 patent were different because they lacked a pink hue, did not contain spherical granules, and had a different content uniformity. The court stated that these characteristics were "not required by the patent claims or specification" and that the "product characteristics now cited by SmithKline are insufficient to distinguish the product of the '944 Patent from the products claimed in the '723 Patent." J.A. 64-65. The court therefore granted Apotex's summary judgment motion. Pursuant to Fed. R.Civ.P. 54(b), the court entered a separate judgment with respect to the invalidity of the '944 patent. SmithKline timely appealed. We have jurisdiction pursuant to 28 U.S.C. § 1295(a)(1).
On appeal, SmithKline argues that the district court improperly "ignored the process limitations of the two product-by-process claims in the '944 patent" when it determined validity. SmithKline's Br. at 17, 23-24, 27. In other words, if the district court had treated the process steps recited in the '944 patent as claim limitations, it would have found that the '723 patent did not anticipate the '944 patent, or that there was a genuine issue of fact over whether the '723 patent disclosed those process limitations.
SmithKline misunderstands the nature of anticipation. As set forth below, once a product is fully disclosed in the art, future claims to that same product are precluded, even if that product is claimed as made by a new process.
A product-by-process claim is "one in which the product is defined at least in part in terms of the method or process by which it is made." Bonito Boats, Inc. v. Thunder Craft Boats, Inc., 489 U.S. 141, 158 n., 109 S.Ct. 971, 103 L.Ed.2d 118 (1989) (quoting D. Chisum, Patents § 8.05, at 8-67 (1988)). While the patent statute does not provide for product-by-process claims, the courts have long recognized the appropriateness of such claims. See, e.g., In re Thorpe, 777 F.2d 695, 697 (Fed.Cir.1985); In re Brown, 59 C.C.P.A. 1036, 459 F.2d 531, 535 (1972); In re Steppan, 55 C.C.P.A. 791, 394 F.2d 1013, 1018 (1967). The purpose of product-by-process claims is to allow inventors to claim "an otherwise patentable product that resists definition by other than the process by which it is made." In re Thorpe, 777 F.2d at 697. Thus, an inventor will not be foreclosed from the benefits of the patent system simply because a product is difficult to describe in words, or its structure is insufficiently understood. Today, however, product-by-process claims are used by inventors even if the invention could have been described independent of the process.2
This court has previously considered the scope of product-by-process claims. In Scripps, we held that the product-by-process claims at issue were not limited by the process steps within those claims. 927 F.2d at 1583. There, the patent concerned a protein, Factor VIII:C, essential to blood clotting. Id. at 1568. The patent contained product-by-process claims directed at the product made in accordance with a particular process, also claimed in the patent. Id. at 1570. The court found that Factor VIII:C that was produced by a different process would nonetheless infringe the product-by-process claims because:
In determining patentability we construe the product as not limited by the process stated in the claims. Since claims must be construed the same way for validity and for infringement, the correct reading of the product-by-process claims is that they are not limited to product prepared by the process set forth in the claims.
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