Issue 06/16 | March 14, 2006
Process Steps in Product-by-Process Claims are Held Not to be Claim Limitations

Declining to address the conflict over whether process steps in product-by-process claims are claim limitations, the federal circuit held that a product made thereby was anticipated by its disclosure in the prior art. The decision should cause owners of product-by-process claims to reevaluate their scope in light of prior art disclosing the products.

In SmithKline Beecham Corp. v. Apotex Corp., No. 04-1522 (Fed. Cir. February 24, 2006), No. 04-1522 the federal circuit affirmed the grant of summary judgment that Smithkline Beckman's ("SKB's") `944 patent was invalid based on its own prior art `723 patent.

SKB's `944 patent contained two product-by-process claims directed to the manufacture of a tableted form of paroxetine, a drug marketed as Paxil® used to treat depression. SKB's earlier `723 patent disclosed and claimed paroxetine in a pharmaceutically acceptable carrier. The district court relied on Scripps Clinic & Research Foundation v. Genentech, Inc., 927 F.2d 1565 (Fed. Cir. 1991) in giving the process limitations of the claims no patentable weight, and held the claims anticipated because the product claimed in the `944 patent was the same product disclosed in the `723 patent.

The federal circuit affirmed, stating 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." Because the product was disclosed in the prior art `723 patent, it was immaterial whether the `944 patent's product-by-process claims were 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) could not be avoided. For that reason, the court declined to address the conflict between Scripps and Atlantic Thermoplastics Co., Inc. v. Faytex Corp., 970 F.2d 834 (Fed. Cir. 1992) (holding that the process steps were claim limitations).

Dissenting, Judge Newman criticized the majority opinion as erasing critical process limitations from the language of the claims and embracing a one-rule-fits-all position that process steps in a product-by-process claim are never claim limitations. Under Phillips, according to Judge Newman, process steps should be construed as any other claim language would be. The majority's "extraordinarily mischievous holding" demonstrated a lack of understanding of the differences between Scripps and Atlantic Thermoplastics and a "misunderstand[ing of]] the nature of anticipation."

Please visit http://media.aplf.org/rm/20060314-public/SKB-Apotex.pdf for a copy of the case for your reference.

To discuss these topics further, please feel free to contact the author, Michael R. Dzwonczyk (mdzwonczyk@sughrue.com), at Sughrue Mion, PLLC in Washington DC, USA.

The information contained in this email is provided for informational purposes only and does not represent legal advice. Neither the APLF nor the author intends to create an attorney client relationship by providing this information to you through this message.

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