Taking a common route to patent infringement for generic drug companies, Apotex submitted an an Abbreviated New Drug Application (“ANDA”) to the FDA, seeking approval to market a generic version of Paxil®. As part of the application, Apotex filed a required "paragraph IV certification," regarding relevant patents, that '944 was invalid.

Pursuant to 35 U.S.C. § 271(e)(2), which makes submitting an ANDA itself an act of infringement, SmithKline filed against Apotex. Apotex counterclaimed with invalidity, and in due course moved for summary judgment.

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) (which the district court viewed as holding that the process steps were not claim limitations) and Atlantic Thermoplastics Co., Inc. v. Faytex Corp., 970 F.2d 834 (Fed. Cir. 1992) (which the district court viewed as holding that the process steps were claim limitations). 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.

As the CAFC majority explained -

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. (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, 459 F.2d 531, 535 (C.C.P.A. 1972); In re Steppan, 394 F.2d 1013, 1018 (C.C.P.A. 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

² See 3 Chisum on Patents § 8.05[2][c] (2003 ed.) (explaining that the Patent and Trademark Office (“PTO”) has rejected the “necessity rule” which permitted product-by-process claims only in cases where the product was otherwise undefinable; instead, the PTO has opted to allow product-by-process claims so long as the definiteness requirement is met).

In Scripps, we held that the product-by-process claims at issue were not limited by the process steps within those claims... A year later this court decided Atlantic Thermoplastics. There, we held that the process steps in a product-by-process claim do serve as claim limitations. 970 F.2d at 846-47... The patentee argued that the defendant had infringed its product-by-process claim. Id. at 836. Finding that the accused products were made by a different process than that claimed in the patent’s product-by-process claim, the court determined that the patent did not extend to cover the product as made by any process. Id. at 846-47. This court stated that “[i]n light of Supreme Court caselaw and the history of product-by-process claims, this court acknowledges that infringement analysis proceeds with reference to the patent claims. Thus, process terms in product-by-process claims serve as limitations in determining infringement.” Id.

The CAFC recognized the conflict between Scripps and Atlantic Thermoplastics, but did not feel a need to address the issue in this case.

The issue here does not turn on how broadly or narrowly we construe the ‘944 patent’s claims, for it is undisputed that the product that is the subject of the patent’s claims is paroxetine. Rather the issue is whether the ‘723 patent anticipated the ‘944 product-by-process patent, when the ‘723 patent broadly claimed paroxetine without regard to the process by which it was made. Thus, the ultimate issue is simply whether the prior art disclosure of a product precludes a future claim to that same product when it is made by an allegedly novel process.

The CAFC regaled the history of case law regarding product-by-process claims, which, with regard to anticipation, ultimately go to the product itself, not just the process.

Regardless of how broadly or narrowly one construes a product-by-process claim, it is clear that such claims are always to a product, not a process. It has long been established that one cannot avoid anticipation by an earlier product disclosure by claiming the same product more narrowly, that is, by claiming the product as produced by a particular process.

The current MPEP states:

[Even] though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process.

MPEP § 2113 (8th ed., Rev. 2, May 2004) (quoting In re Thorpe, 777 F.2d at 698).

SmithKline belatedly tried to raise an argument that the '944 product was in fact different than the '723 product, but, having failed to sufficiently make the argument in its opening brief, the CAFC would have none of that.

As is his wont, Judge Newman dissented.

In this case the district court found "anticipation" based on a claim construction that erased critical limitations of the claim.

The fundamentals of claim analysis require that all of the claim limitations limit the claim. We have so held in myriad decisions. The panel majority's holding that a claim to a product is never limited by the process limitations in the claim is an extraordinarily mischievous holding, for there are thousands of patents with such claims. It is for the inventor, not the judge, to state what has been invented and to choose how to claim it.

The term "anticipation" in patent usage means that the invention was previously known to the public; that is, that it previously existed in the precise form in which it is claimed, including all of the limitations in the claim. It is not correct that, as a rule of claim construction, a claim that contains product and process limitations is free of the process limitations, whatever the nature of the invention. The district court felt constrained to apply the holding in Scripps to the quite different facts of this case, a constraint for which this court must take responsibility by refusing to clarify the growing uncertainty. When the process limitations in a claim distinguish the invention as a whole from the prior art, when they are material to the invention as set forth by the inventor, the claim cannot be "anticipated" by prior art that does not have all of the limitations in the claim. Helifix Ltd. v. Blok-Lok, Ltd., 208 F.3d 1339, 1346 (Fed. Cir. 2000) (anticipating reference must disclose "each and every limitation of the claimed invention"); General Electric Co. v. Nintendo Co., 179 F.3d 1350, 1356-57 (Fed. Cir. 1999) ("To anticipate a claim, a reference must disclose every element of the challenged claim and enable one skilled in the art to make the anticipating subject matter."). Applying the law correctly, the claims here at issue cannot be found on summary judgment to be anticipated.