Pending Supreme Court Petition—A New Battle Over 35 U.S.C. § 101: Hikma Pharms. USA Inc. v. Vanda Pharms. Inc.

The parties in Hikma Pharms. USA Inc. v. Vanda Pharms Inc., No. 18-817, have asked the Supreme Court to review whether the Federal Circuit correctly applied Section 101 jurisprudence when it held the involved method of treatment claims were patent eligible.

In 2013, Hikma Pharmaceuticals USA Inc. (“Hikma”) sought to market a generic version of Vanda Pharmaceuticals Inc.’s (“Vanda”) iloperidone drug product and filed an ANDA. Vanda asserted two patents against Hikma, one directed to the iloperidone compound and another directed to a method of using iloperidone to treat schizophrenia.

The Federal Circuit found the method of treatment claims patent eligible under Section 101. The Court held, although the patent acknowledged a natural relationship between iloperidone, a genotype, and a side effect, it instead claimed specific “treatment steps,” which the court reasoned went beyond the claims rejected in Mayo by reciting specific steps carrying out a dosage regimen. Chief Judge Prost dissented, writing the majority’s decision undermined Mayo and, in effect, encouraged creative drafting to get around Mayo’s requirements.

Hikma has petitioned the Supreme Court for review. In its petition, Hikma emphasizes Chief Judge Prost’s dissent, arguing the Federal Circuit’s decision enables patentees to evade Section 101 by merely redrafting claims to include “treatment steps.” According to Hikma, the Federal Circuit created a slippery slope whereby all method of treatment claims are patent eligible, which it believes is evidenced in the USPTO’s recent Section 101 memorandum for patent examiners.

Vanda asserts that Hikma’s petition misrepresents the impact of the Federal Circuit’s decision. According to Vanda, the decision did not render all method of treatment claims patent eligible. Rather, it simply applied Section 101 precedent to the specific involved claims and found them to be a patent eligible application of a natural law. Vanda points out that in fifteen of sixteen subsequent patent eligibility decisions, the Federal Circuit found claims to be ineligible, and argues that “[t]here is [accordingly] no crisis of patent eligibility at the Federal Circuit requiring this Court’s review.”

The Supreme Court invited the Solicitor General to file a brief on behalf of the United States. It its brief, the government recommended that the Court deny Hikma’s petition. Although the government acknowledged “confusion stemming from this Court’s recent Section 101 decisions,” it stated this case is not the proper vehicle to address Section 101. Instead, the government suggested the Court should grant the petition in another case also raising Section 101 issues: Athena Diagnostics, Inc. v. Mayo Collaborative Servs., 927 F.3d 1333 (Fed. Cir. 2019).