Here is an update on recent activity at the Supreme Court in cases decided by the Federal Circuit. With respect to granted cases, there is no new activity to report. With respect to petitions, two new petitions were filed raising questions related to injunctive relief related to generic drugs and appellate procedure, new waivers of the right to respond were filed in a patent case and a pro se case, and one new reply in support of a petition was filed in a patent case raising questions regarding inter partes review. Here are the details.
Granted Cases
There is no new activity to report.
Petition Cases
New Petitions
In Norwich Pharmaceuticals Inc. v. Salix Pharmaceuticals, Ltd., Norwich Pharmaceuticals asked the Court to review the following question:
- “Whether 35 U.S.C. § 271(e)(4)(A) requires courts to issue injunctive orders that are broader in scope than the underlying infringement, thereby delaying FDA approval of generic drug applications for indications that have not been found to infringe any valid patent.”
In Salix Pharmaceuticals, Ltd. v. Norwich Pharmaceuticals Inc., Salix Pharmaceuticals asked the Court to review the following two questions:
- “When a district court’s findings of fact are unsupported by the evidence the district court relied on, may a court of appeals affirm based on other evidence in the record, particularly when the relevance of that evidence depends on unresolved factual disputes.”
- “When a district court’s findings of fact rely on impermissible evidence, what standard applies to determine whether the error is harmless.”
Waivers of Right to Respond
Waivers of the right to respond to petitions were filed in the following cases:
- Roku, Inc. v. International Trade Commission (patent)
- Campbell v. Tube-Mac Industries, Inc. (pro se)
New Reply
In United Therapeutics Corp. v. Liquidia Technologies, Inc., a patent case, United Therapeutics filed its reply brief in support of its petition. The petition presented the following questions:
- “Whether the IPR statute and SAS require the Federal Circuit to review de novo, or only for an abuse of discretion, the PTO’s reliance on new grounds and new printed publications—not raised in the initial petition— when deciding to cancel patent claims.”
- “Whether, if § 312 is deemed ambiguous, the Court should overrule Chevron.”
In its response brief, Liquidia Technologies argued the petition “is based on a fundamentally false premise: that the Federal Circuit, contrary to 35 U.S.C. § 312(a)(3) (Section 312), deferred to a determination by the Patent Trial and Appeal Board . . . allowing ‘new grounds and new printed publications’ supporting unpatentability to be introduced into the inter partes review . . . proceedings.” According to Liquidia Technologies, “[t]he Federal Circuit did no such thing here.”
Now, in its reply, United Therapeutics argues that “Liquidia cannot meaningfully deny the existence of a split in the Federal Circuit concerning the standard of review in appeals challenging decisions in excess of an agency’s statutory authority.” Furthermore, United Therapeutics asserts, “[t]he statute required that ‘copies’ of the printed publications relied on by the Board be ‘includ[ed]’ with the initial IPR petition.” Thus, according to United Therapeutics, “there is a substantial question whether the Board relied on a ground that is ‘new’,” and the question of “whether [the] agency has acted within its statutory authority” should be reviewed de novo.