Generic pharmaceutical companies are not availing themselves of a potentially powerful took in the Abbreviated New Drug Application (ANDA) litigation process: §101 challenges.
“Any patent practitioner knows that §101 challenges are filed as a matter of course in patent infringement cases involving software and business methods. On the other hand, challenges under §101 are rarely used in ANDA cases,” Goldberg Segalla partners Debra L. Doby, Chandran B. Iyer, and Michael A. Siem write in New York Law Journal. Since the Supreme Court’s decision in Alice Corp. Pty. v. CLS Bank Int’l 134 S.Ct. 2347 (2014), which established the two-prong test for analyzing §101 challenges, only six of 490 ANDA cases filed — less than two percent — address §101 challenges.
Deb, Chandran, and Mike — members of the firm’s Intellectual Property practice — look to decisions in Alice and the earlier Mayo v. Prometheus Lab., 566 U.S. 66 (2012) and Ass’n for Molecular Pathology v. Myriad Genetics, 569 U.S. 576 (2013) as important precedents pertaining to §101 challenges in ANDA cases. In Mayo, the court held that “If a law of nature is not patentable, then neither is a process reciting a law of nature, unless that process has additional features [that are] more than a drafting effort designed to monopolize the law of nature itself.” The court ruled similarly in Myriad, invalidating a patent for an isolated segment of two genes and primers used in diagnostics. Building on these cases, Alice established the test: “The first prong inquires whether the claims at issue are directed at ‘a patent-ineligible concept.’ If yes, the court moves to the second prong and searches for an ‘inventive concept’ to determine whether the additional claim elements ‘transform the nature of the claim.'”
In their article, Deb, Chandran, and Mike discuss in detail possible applications of §101 challenges in ANDA litigation, including for cases involving method of treatment, PK profiles, and polymorph patents. “The recent judicial interpretations of §101 provide ample opportunity for ANDA litigants to challenge whether certain types of patents are truly patent-eligible or merely recitations of natural laws,” they write. “Generic companies should consider adding §101 to their arsenal of challenges, especially for claims directed to a method of treatment, PK profiles, and polymorphs. Section 101 challenges may very well prove fruitful for other types of claims, though — and creative ANDA litigators are sure to test this in the coming years.”