US Court Clarifies Scope of Product-by-Process Patent Claims

Abbott Laboratories, Inc (Abbott) is the exclusive licensee of US Patent No 4,935,507 ("˜507 Patent) covering the antibiotic drug cefdinir, marketed under the trade-mark OMNICEF. The "˜507 patent claims a crystalline cefdinir compound by claiming the process by which the cefdinir compound is made, giving rise to the term "product-by-process" claims. Lupin Ltd and Lupin Pharmaceuticals Inc (collectively, Lupin) brought an action in the US District Court for the Eastern District of Virginia (Virginia District Court) for declaratory judgment that its proposed product would not infringe the "˜507 Patent. Lupin's generic version of Omnicef contains almost exclusively the Crystal B form of crystalline cefdinir (cefdinir monohydrate), whereas the Abbott Omnicef product contains the Crystal A form of crystalline cefdinir (cefdinir anhydrate). The Virginia District Court granted Lupin's motion for summary judgment of non-infringement. On appeal to the US Court of Appeals for the Federal Circuit (Court of Appeals) the issue was whether or not the product-by-process claims were limited by the claimed processes. The Court of Appeals adopted the reasoning in Atlantic Thermoplastics Co v Faytex Corp, 970 F2d 834 and clarified that process terms in product-by-process claims serve as limitations in determining infringement. As a result, a product cannot infringe a product-by-process patent if the product is made using a different process. Accordingly, the Court of Appeals affirmed the Virginia District Court decision and held that Lupin's generic version of OMNICEF did not infringe the "˜507 Patent because Lupin did not use the process steps of the "˜507 Patent. At the same time, the Court of Appeals heard Abbott Laboratories v Sandoz Inc (Sandoz Case) and issued joint reasons for the two cases. The Sandoz Case was an appeal of a decision of the US District Court for the Northern District of Illinois to deny a preliminary injunction to Abbott against several generic companies. For the full reasons for judgment in Lupin v Abbott Laboratories and Abbott Laboratories v Sandoz, see: http://www.cafc.uscourts.gov/opinions/07-1400.pdf Summary by: Lauren Lodenquai