The U.S. Court of Appeals for the Federal Circuit, in SmithKline Beecham Corp. and GlaxoSmithKline v. Apotex Corp (04-1522), held that 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.

Earlier, SmithKline sued Apotex for infringing SmithKline’s patent, U.S. Patent No. 6,113,944 (a product-by-process patent claiming paroxetine made by an allegedly novel process). Apotex moved for summary judgment, arguing that the ‘944 patent was invalid. The district court granted summary judgment to Apotex that the patent was invalid for being anticipated by SmithKline’s earlier patent for paroxetine, U.S. Patent No. 4,721,723 (a patent on the product paroxetine).

The ‘723 patent claimed a pharmaceutical product aimed at treating depression and disclosed a pharmaceutical composition in tablet form containing paroxetine. The ‘723 patent also disclosed that the product is “usually presented as a unit dose composition containing from 1 to 200 mg, more usually from 5 to 100 mg, for example 10 to 50 mg such as 12.5, 15, 20, 25 or 30 mg.”

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 what became the ‘944 patent containing 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.

Apotex then 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 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. In this case, 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.

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.

Following the earlier decision in Scripps Clinic & Research Foundation v. Genentech, Inc., 927 F.2d 1565 (Fed. Cir. 1991) holding that the process steps were not 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.” 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.

SmithKline’s argued 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.”

On appeal, the Federal Circuit made it clear that 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. 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 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.” 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.

In its decision, the Federal Circuit held that:

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.

…anticipation by an earlier product patent cannot be avoided by claiming the same product more narrowly in a product-process claim. It makes no difference here whether the ‘944 patent’s product-by-process claims are construed broadly to cover the product made by any process or narrowly to cover only the product made by a dry admixing process. Either way, anticipation by an earlier product disclosure (which disclosed the product itself) cannot be avoided. While the process set forth in the product-by-process claim may be new, that novelty can only be captured by obtaining a process claim. We agree with the district court’s conclusion that the ‘723 patent disclosure anticipated the identical product claimed by the ‘944 patent even though that product was produced by an allegedly novel process.

In looking at whether the product produced by the process claimed in the ’944 patent was, in fact, a different product than that disclosed in the ‘723 patent, the court stated that those product-by-process claims produced a different product than that disclosed by the ‘723 patent, there would be an argument that the ‘723 patent disclosure did not anticipate. However, the court conclude that this issue has been waived for failure to brief it on appeal.

Judge Newman, in a dissent, stated that the law of “anticipation” does not change in the special situation where claims contain both product and process limitations. In his view:

It is not the law that process limitations in product claims are not claim limitations. It is not the law that process limitations are ignored in construing claims, whatever the nature of the invention. Claims state the invention for which a patent is sought. … This rule is not suspended when product and process limitations appear in the same claim. No precedent so requires, and no policy is served by this creative new rule.

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.

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