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–the petitioner filed its reply brief. As for pending petitions, since our last update two new petitions were filed in an Indian Tucker Act case and a pro se case; a brief in opposition was filed in a patent case; and an amicus brief was filed in a case addressing Rule 36 summary affirmances. Here are the details.
Pending Cases
Since our last update, the petitioner’s reply brief was 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:
- “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?”
- “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?”
In the respondent’s merits brief, Amarin Pharma argued Congress adopted the Hatch-Waxman Act as a “compromise between expanding the availability of generic pharmaceuticals and preserving the intellectual-property rights necessary to encourage innovation.” According to Amarin Pharma, however, Congress did not intend “to expand generic manufacturers’ market access by all-but immunizing them against patent-infringement liability when using ‘skinny label’ products.” Moreover, Amarin Pharma contended, the “petitioners told the world that their drug can be prescribed for a therapeutic category that infringes respondents’ patents.” Amarin Pharma asserted that the “Court should not make new law to excuse petitioners’ improper advertising, contrary to Congress’s careful incentive structure for finding new treatments.”
Now, in its reply brief, Hikma Pharmaceuticals argues Amarin Pharm “needed plausible allegations that Hikma advertised or instructed an infringing use—expressly,” yet there “are no such allegations here.” According to Hikma Pharmaceuticals, there is only “an unsupported theory of passive inducement.” Hikma Pharmaceuticals contends this this theory “cannot be squared with the language of 35 U.S.C. § 271(b), which is short and simple: liability attaches only when one ‘actively induces infringement of a patent.’” Hikma Pharmaceuticals contends the “Court should take particular care in the Hatch-Waxman context to avoid ‘trenching on regular commerce,’ . . . because even the specter of a damages award based on a vague product description would effectively shut down the section-viii pathway.”
Pending Petitions
New Petitions
Since our last update, two new petitions have been filed in cases decided by the Federal Circuit.
In Winnemucca Indian Colony v. United States, the Winnemucca Indian Colony filed a petition asking the Court to review the following questions:
- “Is the United States’ promise to provide the Winnemucca Indian Colony, a federally recognized Tribe with lands held in trust established by an Executive Order and a separate legislative act, coupled with the government’s nearly exclusive statutory and regulatory control over the water on Indian lands, sufficient to entitle an Indian tribe to money damages when the United States breaches its fiduciary duty to protect the natural resources on those Indian lands?”
- “Did the Federal Court of Appeals, Federal Circuit, err when it affirmed dismissal of the Winnemucca Indian Colony’s third claim for relief – Breach of Trust – Water?”
- “Can the Winnemucca Indian Colony state a cognizable claim for breach of trust against the United States in relation to BIA failure to prevent trespass and theft of natural resources by third parties, under the Winters doctrine and 25 C.F.R. § 152.22?”
In Hamilton v. United States, a pro se case, Jernice Hamilton filed a petition asking the Court to consider the following questions:
- “Whether a military separation is void ab initio when the Department of the Army fails to provide the mandatory ‘Full and Fair Hearing ‘required by 10 U.S.C. 1214, based upon an official government record (VA BIRLS) erroneously reporting the service Member as ‘Deceased?”
- “Whether the government violates the Due Process Clause and 10 U.S.C. 1214 when it administratively declares a living service member ‘deceased,’ subsequently denying benefits based on ‘no- shows’ for evaluations the Petitioner was legally barred from attending, and whether such a ‘state-created barrier’ requires a mandatory finding of Constructive Active-Duty Service for the period of the error.”
- “Whether a reviewing court commits reversible error by failing to apply the 5 U.S.C. 706 ‘Hard Look’ standard—an omission conceded by the Government – thereby insulating a 38-year-old structural error (including five misdiagnoses and a false death report) from the full retroactive relief now mandated by Soto v. United States (2025).”
- “Whether the Adamo Wrecking Doctrine and 5 U.S.C. 706 require a reviewing Court to set aside a military discharge as Void Ab Initio when the Government’s own record admits the Petitioner met medical referral standards ‘prior to discharge ‘But was denied the mandatory ‘full and fair hearing ‘ required by 10 U.S.C. 1214.”
Brief in Opposition
Since our last update, PNC Bank filed its brief in opposition to the petition in United Services Automobile Association v. PNC Bank N.A. As a reminder, the petition presented the following questions:
- “Whether the Federal Circuit has wrongly held that, as a matter of law, a computer-implemented technological invention is patent-eligible only if it claims improvements to computer functionality itself.”
- “Whether the Federal Circuit has wrongly extended the prohibition on patenting an ‘abstract idea’—such as mathematical formulae, fundamental economic practices, or methods of organizing human activity—to also prohibit patenting concrete technological processes.”
Now, in its brief in opposition, PNC Bank argues the petitioner “challenges purported bright-line rules that do not exist, in an effort to obtain case-specific relief on questions it did not raise below.” PNC Bank, moreover, asserts the patents in suit “are plainly directed to an abstract idea, as they seek to monopolize the basic business practice of depositing a check.” According to PNC Bank, a “faithful application of this Court’s Section 101 precedents would hold” the patent’s “claims patent-ineligible because they recite ‘a fundamental economic practice long prevalent in our system of commerce.'” In response to the second question presented, in particular, PNC Bank argues “the Federal Circuit has never announced such a categorical rule.”
Amicus Briefs
Since our last update, the Association for American Innovation and Professors of Law filed an amicus brief supporting the petitioner inn CAO Lighting, Inc. v. Wolfspeed, Inc. As a reminder, the petition presented 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.”
In its amicus brief, the Association explains that it supports the petitioner’s argument regarding “the failure of the Federal Circuit to provide a required analysis.” The Association argues the Patent Trial and Appeal Board “contradicts the [Administrative Procedure Act] with further ramifications for Rule 36.” According to the Association, the “deviance by the PTAB and the failure by the Federal Circuit to perform its oversight negatively impact the innovation ecosystem.” The Association contends the Federal Circuit’s “one word” affirmance of the PTAB’s ruling, in particular, “effectively abdicat[ed] its Article III responsibility to provide reasoned judicial review.” It says the Court should grant certiorari to ensure “meaningful judicial oversight rather than permitting agencies to expand invalidity grounds while courts remain silent.”