Abbott Laboratories v. Sandoz, Inc.: Federal Circuit Resolves Split Regarding Product-by-Process Claims

Abbott Laboratories v. Sandoz, Inc., May 18, 2009, No. 07-1400, -1406

Opinion (hosted by Patently-O)

On May 18th the Court of Appeals for the Federal Circuit, sitting en banc, reconciled a long-standing conflict between two lines of cases determining the scope of product-by-process claims. The Federal Circuit affirmed the Atlantic Thermoplastics Co. v. Faytex Corp. rule that infringement of a product-by-process claim requires actually using those claimed process steps to make the product, and overruled the more inclusive Scripps Clinic & Research Foundation v. Genentech, Inc. rule, which defined product-by-process claims as limited solely by the end product.

Peter Zura of the 271 Patent Blog summarizes the opinion and provides excerpts that outline past relevant Supreme Court decisions. Kevin E. Noonan of Patent Docs provides an overview of the case and particularly emphasizes Judge Newman's dissenting opinion. The Patent Prospector provides an in-depth summary and long excerpts from the decision.

On appeal were two cases from the Eastern District of Virginia and the Northern District of Illinois between Abbott Labs and two generic drug makers over United States Patent 4,935,507, which claims a chemical composition by process for the creation of an antibacterial drug. Abbott argued that the District Court erred in construing infringement of the process claim to require performing the process steps from the claims, and instead wanted the court to follow the more inclusive Scripps test.  Writing for the majority, Judge Rader disagreed, affirming the District Court's finding of no infringement and overruling the Scripps test in favor of the Atlantic Thermoplastics test, which limits product-by-process claims to the actual process and not the product itself.  The majority argued that even when a product's structure process is not known or is too complex to categorize, the inventor can use the process steps to define the product. However, in doing so, the inventor is limiting the bounds of his or her patent. 

Only the issue of how to interpret the scope of a product-by-process claim was considered en banc. Generally, the Federal Circuit will only take cases en banc when it wants to focus on important or extremely complex questions of patent law. Remarkably, the judges took this issue of the case en banc even though the court received no briefing and held no oral argument on the issue. Because there was no public notice and no opportunity for amicus briefs, there was little input from patent holders and practitioners, thereby allowing for what Brian Galvin terms "guerilla judging" in his patent blog.

Judge Newman (who wrote the Scripps opinion) dissented, joined by Judges Mayer and Lourie. Judge Newman accused the court of "overturn[ing] a century of precedent and practice" in its decision. Dissenting both on procedural and substantive grounds, she warned that this decision will place new restraints on patent holders of new products, "particularly today's complex chemical and biological products whose structure may be difficult to analyze with precision." In a separate dissent, Judge Lourie argued that the Supreme Court precedents on which the majority relied were based on mechanical processes of more than a century ago, and this bright line rule can be detrimental for chemical-biological products today.

Following this decision many patents can be presented for reissue to bring claims into better conformance with the law. Though the repercussions of the bright line rule set down in Abbott Laboratories are certainly debatable, this decision resolves a long-standing split within the Federal Circuit and clarifies the rules for future and current patent holders.