Processing All Things Federal Circuit
October 10, 2022 - Federal Circuit Insights

Another Term, Another Section 101 CVSG

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Last week marked the start of the Supreme Court’s October 2022 Term. That meant another “long conference” order list acting on most of the petitions that had accumulated over the summer. The Court did not grant any new cases from the Federal Circuit. But it called for the views of the Solicitor General in two such cases—one of which may give our readers a sense of déjà vu. We’ve discussed the CVSG process in more detail in a previous post.

One CVSG came in Interactive Wearables, LLC v. Polar Electro Oy. The petition there asks the Court to consider questions including:

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?

Sound familiar? If so, that’s because those questions are nearly word-for-word identical to the questions presented in American Axle. As our readers may recall, in American Axle, a split Federal Circuit panel held a manufacturing-method claim ineligible under Section 101. The Federal Circuit denied en banc rehearing by a 6-6 vote. The Supreme Court then CVSGed the case. The Solicitor General recommended granting review, noting that the Supreme Court’s existing Mayo/Alice patent-eligibility framework “has given rise to substantial uncertainty.” But in an anticlimactic end to the saga, the Court nonetheless denied the petition.

Compared to American Axle, Interactive Wearables seems to be an unlikely candidate for review. In American Axle, there were strong dissents at the panel and rehearing stages. In Interactive Wearables, the Federal Circuit panel summarily affirmed under Rule 36, and there were no noted dissents from the denial of rehearing. And American Axle involved a method for manufacturing automobile parts; as the government’s CVSG brief noted, “such industrial techniques have long been viewed as the paradigmatic examples” of patentable inventions. Interactive Wearables, by contrast, involves a “wearable content player” with what the district court described as “generic computer components.” Those sorts of claims can raise greater eligibility concerns.

So what could explain the CVSG in Interactive Wearables just a few months after the American Axle cert denial? Perhaps the Justices had second (or third) thoughts about declining to enter the Section 101 fray. Or perhaps it had something to do with Justice Jackson replacing Justice Breyer in the interim. It will be interesting to see whether the Solicitor General recommends a grant again in Interactive Wearables—and, either way, whether the petition meets the same fate as American Axle.

The other CVSGed Federal Circuit case was Teva Pharmaceuticals USA, Inc. v. GlaxoSmithKline LLC. Some quick background: the Hatch-Waxman Act lets generic drug manufacturers market their products with a so-called “skinny label” that “carves out” uses covered by the brand manufacturer’s patents. In Teva, a jury found the generic manufacturer liable for induced infringement despite its use of such a carve-out. The brand manufacturer had argued that other parts of the generic’s label and the generic company’s marketing materials still encouraged physicians to prescribe the drug for infringing uses. A divided Federal Circuit panel upheld the jury’s verdict, and the Federal Circuit denied en banc rehearing over the dissent of three judges.

The generic manufacturer is now asking the Supreme Court to step in. The question presented in its petition is:

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?

There is no formal deadline for the CVSG briefs in these cases. But based on past practice, the briefs could come by next spring, in time for the Supreme Court to consider the petitions before it recesses at the end of June 2023.