IP Law Daily, PATENT NEWS: High Court asked to clarify patent law on subject matter, enablement, and ‘skinny’ drug labels, (Oct 18, 2022)

By Thomas Long, J.D.

The Court has invited the Solicitor General to submit briefs expressing the views of the government as to pending petitions in four patent cases; in the only brief so far submitted, the government recommends the Court not take the case.

The law of patent-eligibility under 35 U.S.C. § 101—last explicated by the Supreme Court in the pivotal case of Alice Corporation Pty. Ltd. v. CLS Bank International, 573 U.S. 208 (2014)—remains, in the view of many practitioners and patentees, murky and confusing. So it’s no wonder that patent owners continue to petition the Court to clarify its test for determining when patent claims are unpatentably “abstract” and lack an “inventive concept” making them eligible for patent protection under Section 101. Thus far, the Court has turned away all comers, but its invitation for the Solicitor General to submit briefs explaining the views of the U.S. government on two Section 101 cases—one involving wearable media players and one involving luggage locks—could signal an increased willingness by the Court to revisit Alice.

The Court also asked the government to submit a brief in a dispute over a “skinny label” for a generic drug product. In a fourth case—the only case in which the government’s views have yet been submitted—the Solicitor General recommends that the Court deny a petition seeking review of a Federal Circuit decision upholding an invalidity ruling as to a biopharmaceutical patent on the ground of lack of enablement.

These four notable pending patent cases before the Court are described below.

Amgen Inc. v. Sanofi. Biopharmaceutical company Amgen Inc. asks the Court to decide whether the Federal Circuit improperly held that an Amgen patent’s broad genus claims for antibody compounds for lowering cholesterol were invalid for lack of enablement. A jury determined that Sanofi Aventisub, accused of infringing Amgen’s patent, failed to prove that the asserted claims were invalid for lack of written description and enablement. The district court, however, granted Sanofi’s motion for judgment as a matter of law (JMOL) for lack of enablement, after concluding that the patents are invalid. The Federal Circuit affirmed, agreeing that the patent claims are not enabled because they require undue experimentation.

The questions presented by the petition for certiorari are:

(1) Whether enablement is “a question of fact to be determined by the jury,” Wood v. Underhill, 46 U.S. (5 How.) 1, 4 (1846), as this Court has held, or “a question of law that [the court] review[s] without deference,” Pet. App. 6a, as the Federal Circuit holds; (2) Whether enablement is governed by the statutory requirement that the specification teach those skilled in the art to “make and use” the claimed invention, 35 U.S.C. § 112, or whether it must instead enable those skilled in the art “to reach the full scope of claimed embodiments” without undue experimentation—i.e., to cumulatively identify and make all or nearly all embodiments of the invention without substantial ‘time and effort,’” Pet. App. 14a (emphasis added).

Government’s views. The U.S. government filed an amicus curiae brief on September 21. The government recommends that the Court deny Amgen’s petition. The government said Amgen’s contention that the Federal Circuit erred by treating enablement as a question of law and by examining the full scope of the claims in assessing whether they are fully enabled lacks merit. First, the government argues that the enablement inquiry includes both legal and factual components. The brief notes that the district court submitted enablement to the jury. Although Amgen argued that the district court usurped the jury’s role by overturning the verdict, it conceded that a court may resolve a question initially decided by the jury on a motion for JMOL. The government also rejects the proposition that the degree of experimentation required to implement the full scope of a patent’s claims is irrelevant to the enablement inquiry. “The Patent Act requires a patent to enable the ‘invention,’” the brief points out, citing 35 U.S.C. 112(a). “Thus, where a patentee purports to invent an entire genus, it must enable the entire genus.”

The case is No. 21-757.

Interactive Wearables, LLC v. Polar Electro Oy. An owner of patents relating to wearable media players seeks review of a Federal Circuit Rule 36 judgment affirming a district court’s holding that the patented invention—which covered media players that provide information related to media content as well as to media content itself—were directed to an unpatentable abstract idea. The district court also determined that the patents displayed no inventive concept because they relied entirely on well-known, conventional components used in the conventional manner.

The questions presented by the patent owner’s petition are:

(1) What is the appropriate standard for determining whether a patent claim is “directed to” a patent-ineligible concept under step one of the Court’s two-step framework for determining whether an invention is eligible for patenting under 35 U.S.C. § 101?; (2) Is patent eligibility (at each step of the Court’s two-step framework) a question of law for the court based on the scope of the claims or a question of fact for the jury based on the state of art at the time of the patent?; and (3) Is it proper to apply 35 U.S.C. § 112 considerations to determine whether a patent claims eligible subject matter under 35 U.S.C. § 101?

The Solicitor General was invited to file a brief in this case expressing the views of the United States on October 3. The government’s amicus brief has not yet been filed.

The case is No. 21-1281.

Tropp v. Travel Sentry, Inc. In its petition for review, a patent holder asks the Court to decide whether claims in his patents that recited physical rather than computer-processing steps are patent-eligible under 35 U.S.C. § 101, as interpreted in Alice Corporation Pty v. CLS Bank International, 573 U.S. 208 (2014).

The U.S. Court of Appeals for the Federal Circuit held that the petitioner’s patents for luggage locks—which disclosed a system of master keys that allowed inspection by airport security staff without breaking the locks—were invalid as an unpatentable abstract idea. According to the appellate court, the patents merely applied the existing and conventional technology of dual-access locks.

The Solicitor General was invited on October 17 to file a brief in this case expressing the views of the United States.

The case is No. 22-22.

Teva Pharmaceuticals USA, Inc., v. GlaxoSmithKline LLC. Pharmaceuticals manufacturer Teva has asked the Court to weigh in on a dispute over a “skinny label” for a generic drug product. Teva’s petition asks, “If a generic drug’s FDA-approved label carves out all of the language that the brand manufacturer has identified as covering its patented uses, can the generic manufacturer be held liable on a theory that its label still intentionally encourages infringement of those carved-out uses?”

A federal jury found that Teva had infringed and awarded brand-name manufacturer GlaxoSmithKline over $235 million in damages. The district court then tossed that verdict and ruled in Teva’s favor, finding that no reasonable juror could have found induced infringement. A divided panel of the Federal Circuit vacated the district court’s decision in October 2020, thus restoring the jury verdict. Teva and a wide range of amici prevailed upon the panel to rehear the case, but the panel reaffirmed its opinion, again over sharp dissent, in August of 2021. In February 2022, the Federal Circuit declined to conduct a panel rehearing or en banc rehearing.

On October 3, the Court invited the Solicitor General to file a brief in this case expressing the views of the United States. That brief has not yet been submitted.

The case is No. 22-37.

Attorneys: Sarah J. Newman (MoloLamken LLP) for Amgen Inc. George William Hicks Jr. (Kirkland & Ellis LLP) for Sanofi, et al. Elizabeth B. Prelogar, U.S. Department of Justice, for Untied States. Ndrea Pacelli (King & Wood Mallesons LLP) for Interactive Wearables, LLC. Anthony James Fuga (Holland & Knight LLP) for Polar Electro Oy, et al. Eric Alan White (Mayer Brown LLP) for David A. Tropp. William Prickett (Seyfarth Shaw LLP) for Travel Sentry, Inc., et al. William M. Jay (Goodwin Procter LLP) for Teva Pharmaceuticals USA, Inc. Juanita R. Brooks (Fish & Richardson) for GlaxoSmithKline LLC, et al.

Companies: Amgen Inc.; Sanofi; Interactive Wearables, LLC; Polar Electro Oy; Travel Sentry, Inc.; Teva Pharmaceuticals USA, Inc.; GlaxoSmithKline LLC

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