Here is an update on recent activity at the Supreme Court in cases decided by the Federal Circuit. In the only pending case, a patent case addressing inducement of infringement and so-called skinny-labeling, since our last update five amicus briefs were filed that support neither party. As for pending petitions, since our last update three new petitions were filed in a patent case, a takings case, and a case addressing use of Federal Circuit Rule 36. In addition, a waiver of the right to respond a petition was filed in a pro se case, a reply brief was filed in support of a petition in a patent case, and the Supreme Court denied a petition in another patent case. Here are the details.
Pending Cases
Since our last update, five amicus briefs were filed in Hikma Pharmaceuticals USA Inc. v. Amarin Pharma, Inc., the only currently pending case previously decided by the Federal Circuit. As a reminder, the petition presented the Court with the following questions:
- “Does a complaint state a claim for induced infringement of a patented method if it does not allege any instruction or other statement by the defendant that encourages, or even mentions, the patented use?”
- “When a generic drug label fully carves out a patented use, are allegations that the generic drugmaker calls its product a ‘generic version’ and cites public information about the branded drug (e.g., sales) enough to plead induced infringement of the patented use?”
Each of the five amicus briefs supports neither party:
- An amicus brief filed by the New York Intellectual Property Law Association contends “both parties in this case have accused the other of seeking some modified pleading standard.” NYIPLA argues the Court “should reinforce that there is no special or specific standard for inducement, no heightened or permissive pleading standard, and no prescriptive rules about what can or cannot be considered under either standard.”
- An amicus brief filed by the Intellectual Property Owners Association maintains “the requirements for adequately pleading a claim for active inducement of infringement under 35 U.S.C. § 271(b) should be no different than the standards established” by the Supreme Court in previous cases, which “apply to all types of federal claims.”
- An amicus brief filed by the Licensing Executives Society (USA and Canada), Inc. asserts “[i]nducement law and the pleading standards apply equally to all patent fields.”
- An amicus brief filed by Patent Law Professors Paul R. Gugliuzza and Jacob S. Sherkow contends the “Federal Circuit has improperly relied on Food and Drug Administration (FDA) regulated drug labeling to expand inducement liability beyond its proper boundaries.” According to the professors, the Court “should reaffirm that inducement requires evidence of voluntary, targeted efforts that influence prescribing behavior—not a textual exegesis of isolated phrases from mandatory labels and innocuous statements about ‘generic equivalence.'”
- An amicus brief filed by the Public Interest Patent Law Institute suggests the Court should “preserve” the balance “between encouraging pharmaceutical innovation and ensuring timely public access to lower-cost medicines” while following “Congress’s prescribed intent in § 271(b) of the Patent Act.” The Institute argues the Court should “reject any rule that would further burden the public by limiting access to affordable medicines, suppressing competition, and creating uncertainty in the marketplace.”
Pending Petitions
New Petitions
Since our last update, three new petitions have been filed in cases decided by the Federal Circuit.
In Hyatt v. Squires, a patent case, Gilbert P. Hyatt filed a petition asking the Court to review the following question:
- “Whether the PTO may invoke the equitable doctrine of ‘prosecution laches’ to deny a patent to an applicant who has complied with all the Patent Act’s timeliness provisions.”
In Operating Engineers Trust Fund of Washington, D.C. v. United States, a takings case, the Operating Engineers Trust Fund filed a petition asking the Court to review the following question:
- “Whether the [Affordable Care Act’s] requirement that group health plans contribute billions of dollars to subsidize reinsurance for third parties was a taking of the plans’ private property. “
In CAO Lighting, Inc. v. Wolfspeed, Inc., CAO Lighting, Inc. filed a petition asking the court to consider the following question:
- “Whether the Federal Circuit’s use of its Local Rule 36, which allows summary affirmance without opinion, (a) improperly defers to the Patent Trial and Appeal Board’s interpretations of law in inter partes review proceedings and so denies judicial review of agency decisions on questions of law as required by Loper Bright Enterprises v. Raimondo, (b) improperly insulates the PTAB from the de novo review required by the Administrative Procedure Act, and (c) violates Congress’s explicit direction in 35 U.S.C. § 144 requiring an ‘opinion’ of all appeals from the Patent Office.”
Waiver of the Right to Respond
Since our last update, a waiver of the right to respond to a petition was filed in Engen v. United States, a pro se case.
Reply Brief
Since our last update, Agilent Technologies, Inc. filed a reply brief in support of its petition in Agilent Technologies, Inc. v. Synthego Corp., a patent case. As a reminder, the petition asked the Court to review the following questions:
- “Should the holding in Rasmusson v. SmithKline Beecham Corp., 413 F.3d 1318, 1326 (Fed. Cir. 2005), that ‘proof of efficacy is not required in order for a reference to be enabled for purposes of anticipation,’ be vacated or significantly narrowed?”
- “Should printed publications be presumed to be enabling when a party challenging the validity of issued patent claims asserts that a printed publication is anticipatory prior art, such that the burden of proving that the printed publication is nonenabling lies with the patentee?”
In its brief in opposition, Synthego maintained the “presumption of prior art enablement describes a burden of production, not a burden of persuasion.” According to Synthego, the “petition conflates the two.” Synthego contended the burden of persuasion “never shifts to the patent owner.” Furthermore, Synthego argued, this case is an improper vehicle for the questions presented “because [p]etitioner failed to raise either of the asserted issues below.” As for why, Synthego said “neither issue mattered in light of the findings below.” Lastly, Synthego argues, “the questions present do not warrant review” because there is “no split of authority.”
Now, in its reply brief, Agilent Technologies asserts this “case is an excellent vehicle” for considering the questions presented. According to Agilent Technologies, “[w]hether described as a shifting the burden of production or the entire burden of proof—which is what the Federal Circuit cases actually hold, as evidenced by their application here—the current framework conflicts with controlling statutes and precedent.” Agilent Technologies argues the “appropriate remedy is the ordinary one—vacatur and remand for reconsideration under the proper standard.” In particular, Agilent maintains, it is asking “the Court to correct the rules that governed the outcome below and remand.”
Denial
Since our last update, the Supreme Court denied the petition in Lynk Labs, Inc. v. Samsung Electronics Co., a patent case raising the following question:
- “Whether patent applications that became publicly accessible only after the challenged patent’s critical date are ‘prior art . . . printed publications’ within the meaning of 35 U.S.C. §311(b).”
