Posts in US Supreme Court

Reactions to Amgen: Hard Work Ahead for Biotech Innovators and Attorneys Trying to Enable Genus Claims

As most in the IP world know by now, the U.S. Supreme Court issued its ruling in Amgen v. Sanofi on Thursday, holding that the U.S. Court of Appeals for the Federal Circuit (CAFC) was correct in finding that Amgen’s patents for its popular cholesterol drug failed to meet the enablement requirement…. IP practitioners diverge on the degree to which the decision will change patent practice in the biotech industry going forward, with some claiming the Court merely reiterated the existing law on enablement, and others saying it represents a major shift.

Recapping Abitron at the High Court: The Long Arm of the…Lanham Act?

Can the Lanham Act apply to the conduct of foreign entities occurring entirely outside the United States and, if so, what is the test? The Supreme Court will soon decide this issue in Abitron v. Hetronic, potentially resolving a long-standing circuit split where six different tests presently co-exist. It will mark the first time since the Court’s 1952 ruling in Steele v. Bulova Watch Co. that it has spoken on extraterritoriality as it relates to the Lanham Act. Steele found that the Lanham Act does apply to a U.S. citizen using a registered U.S. trademark on spurious Bulova watches, many of which were bought by U.S. citizens in Mexico and brought back to the United States. Steele did not address whether the defendant’s U.S. citizenship, or his sourcing of parts from U.S. suppliers, were necessary conditions to subject matter jurisdiction. Enter Hetronic.

SCOTUS Ushers in New Era of Enablement Law in Amgen Ruling

Earlier today, the United States Supreme Court issued its decision in Amgen, Inc. v. Sanofi et al. The Court held, as many feared they would, that the 26 antibody examples and detailed instructions for generating additional antibodies within the genus—which covered some 400 pages and included a CD Rom of the x-ray crystallography coordinates of Amgen’s “anchor” (or lead) antibodies 21B12 (Repatha) and 31H4—was insufficient to satisfy the enablement requirement. Unfortunately, the Supreme Court did not explain what level of detail would have been sufficient, nor did the Court provide direction to the industry on what more is expected to satisfy the enablement requirement. So, we simply learned today that the extraordinary disclosure and detail provided by Amgen was not enough.

Dissent Says SCOTUS Ruling Against Warhol Foundation on Fair Use Will ‘Stifle Creativity’

The Supreme Court ruled today in Andy Warhol Foundation v. Goldsmith, Lynn, et. al. that the U.S. Court of Appeals for the Second Circuit was correct in holding that the Andy Warhol Foundation’s (AWF’s) licensing of an orange silkscreen portrait of the musician Prince, created by Andy Warhol using photographer Lynn Goldsmith’s photo, was not fair. Justices Gorsuch and Jackson authored a concurrence, while Justice Kagan, joined by Chief Justice Roberts, filed a 35-page dissent from Justice Sotomayor’s opinion, calling out the majority’s contradictory interpretation of similar facts in the recent Google v. Oracle case.

Why the Supreme Court Should Weigh in on CMI Violations Under the DMCA

Real estate data firm CoStar and real estate digital marketplace CREXi are currently engaged in a high-profile intellectual property fight. Costar, which runs, alleges that CREXi is violating the Digital Millennium Copyright Act (DMCA) by using its images on without regard to its terms of service. The company has gone so far as to say that “CREXi is attempting to build its own online commercial real estate marketplace and auction platform by free-riding on CoStar’s billions of dollars of investments and the thirty-plus years of hard work by CoStar’s employees.” CrEXi, on the other hand, argues that all the images on the site are uploaded at brokers’ (not CrEXi’s) direction and thus the company can’t be held liable for IP violations. 

SCOTUS Kills Hope for Eligibility Certainty and Nixes Teva’s ‘Skinny Label’ Appeal

On May 15, the U.S. Supreme Court issued an order list denying petitions for writ of certiorari filed to appeal several patent rulings, including a pair of 35 U.S.C. § 101 subject matter eligibility cases that the U.S. Solicitor General previously urged the nation’s highest court to hear. The Supreme Court also denied Teva Pharmaceuticals’ petition to review its appeal of the Federal Circuit’s “skinny label” induced infringement ruling over its generic version of carvedilol. While the full Court denied certiorari to these cases, the order list notes that Associate Justice Brett Kavanaugh would have granted cert to these three petitions.

Recapping Eight Years of the Patent Eligibility Mess: Clearly, It’s Past Time for the Supreme Court or Congress to Provide Clarity

Last month, the U.S. Department of Justice filed an amicus brief with the Supreme Court urging the Court to accept a certiorari case relating to patent eligibility. See Interactive Wearables, LLC v. Polar Electro Oy, et al, and David A. Tropp v. Travel Sentry, Inc., Nos. 21-1281 and 22-22. In each of these cases, which were separate from one another, the U.S. Court of Appeals for the Federal Circuit ruled the patents to be ineligible as being abstract ideas, and thus an exception to Section 101 patentable subject matter. This amicus brief follows an earlier amicus brief from the Justice Department, in May 2022, also supporting the petition for certiorari on a patent found by the Federal Circuit to be an abstract idea, and therefore not patentable under Section 101.

The U.S. Patent System, the Coase Theorem, and the Era of Efficient Infringement

There is little doubt that the way patent rights are viewed and protected has transformed over the last 15 to 17 years. The patent system our government has enabled over that timeframe incentivizes stealing patent rights rather than engaging in an arm’s length negotiation. This is antithetical to basic, fundamental principles embedded throughout American law, and has caused dispute resolution, licensing and enforcement to emphatically derail.

Avery Dennison Urges SCOTUS Review to Prevent Lowered Section 101 Bar from Inflaming ‘Raging Debate’ on Patent Eligibility

On May 8, digital ID solutions company Avery Dennison filed a reply brief with the U.S. Supreme Court in support of its petition for writ of certiorari to appeal the U.S. Court of Appeals for the Federal Circuit’s decision last December affirming the validity of patent claims owned by ADASA. Of the cert petitions currently before the Supreme Court involving issues of patent subject matter eligibility under 35 U.S.C. § 101, Avery Dennison contends that its appeal provides the most useful vehicle for clarifying Section 101 invalidity in information management and technology, a field where the Federal Circuit’s division on patent eligibility “is especially stark and recurrent.”

CareDx/Stanford Tell Justices the Court ‘Needs to Take Another Section 101 Case’

CareDx, Inc. and the Board of Trustees of the Leland Stanford Junior University earlier this week filed a petition for certiorari with the U.S. Supreme Court asking the justices to review a 2022 decision holding certain claims of its patents directed to detection levels of donor cell-free DNA (cfDNA) in the blood of an organ transplant patient patent ineligible.

Patent Owner Tells SCOTUS Avery Dennison Petition is Not the Eligibility Case the U.S. Patent System Needs

In late February, Avery Dennison corporation petitioned the U.S. Supreme Court to grant certiorari in its appeal of a decision upholding ADASA, Inc.’s patent for Radio Frequency Identification Device (RFID) technology as patent eligible. ADASA has now responded, telling the High Court that the U.S. Court of Appeals for the Federal Circuit’s (CAFC’s) decision in the case “is a beacon of clarity and oasis of correct legal analysis, not a plea for this Court’s intervention.” Avery Dennison said the CAFC’s decision “illustrates the depths of the Federal Circuit’s division” and represents “the other side of the coin” in the eligibility debate. While SCOTUS petitions on eligibility have traditionally focused on uncertainty due to the CAFC’s too-narrow view of the law and tendency to invalidate patents under Section 101, Avery Dennison’s petition takes the position that the Federal Circuit’s reading of 101 is too broad.

Killian Petitions Supreme Court to End Alice/Mayo

Jeffrey Killian yesterday submitted a petition for writ of certiorari to the United States Supreme Court asking the Court to provide clear guidance on or else throw out the Alice/Mayo test for patent eligibility. Killian is involved in an ongoing patent dispute in which the Patent Trial and Appeal Board (PTAB) rejected claims of his  U.S. Patent Application No. 14/450,042 under Section 101. The U.S. Court of Appeals for the Federal Circuit (CAFC) affirmed the ruling in August 2022. In the petition, Killian claims that the U.S. Patent and Trademark Office (USPTO) violated Supreme Court precedent by ruling the patent application ineligible under the Alice/Mayo test.

Supreme Court Dodges AI Inventor Question with Denial of DABUS Case

One day before the U.S. Patent and Trademark Office (USPTO) is set to hold its first public listening session on AI inventorship, the U.S. Supreme Court today denied certiorari in the case of Thaler v. Vidal, which asked the Court to consider the question: “Does the Patent Act categorically restrict the statutory term ‘inventor’ to human beings alone?” Dr. Stephen Thaler lost his case at the U.S. Court of Appeals for the Federal Circuit (CAFC) last August, when the CAFC said the USPTO’s reading of the statute as clearly referring to inventors as natural person was “unambiguously” correct.

Newman Strikes Back in Letter Calling for Moore’s Investigation to be Transferred

The New Civil Liberties Alliance (NCLA), the firm representing U.S. Court of Appeals for the Federal Circuit (CAFC) Judge Pauline Newman in CAFC Chief Judge Kimberly Moore’s bid to oust her from the court, sent a letter today to the CAFC Chief Judge calling for the case to be transferred to a new circuit. The letter charges that Moore has ordered that no new cases be assigned to Newman, that the complaint Moore identified against her “contains basic errors of fact”, and that Newman was not afforded enough time to respond to Moore’s numerous demands, among other accusations. U.S. Supreme Court Chief Justice John Roberts also received a copy of the letter.

SCOTUS Denial of Novartis Petition for Cert Returns Focus Toward ‘Procedural Insanity’ at the Federal Circuit

On April 17, the U.S. Supreme Court denied a petition for writ of certiorari filed by pharmaceutical developer Novartis seeking to overturn a decision on rehearing by the U.S. Court of Appeals for the Federal Circuit that invalidated patent claims covering the blockbuster multiple sclerosis (MS) treatment, Gilenya. The cert denial leaves in place a CAFC decision derided by commentators as “procedural insanity” and increases the focus upon certain machinations at the appellate court bearing the fingerprints of Chief Judge Kimberly Moore.