District Court Correctly Construed Patent Claims as Measuring pH at the Standard Temperature

** DISTRICT COURT CORRECTLY CONSTRUED PATENT CLAIMS AS MEASURING PH AT THE STANDARD TEMPERATURE

Actelion Pharms. Ltd. v. Mylan Pharms. Inc., 24-1641 — Yesterday in an opinion by Judge TARANTO, the Federal Circuit affirmed a district court finding that Mylan did not infringe Actelion’s patent for pharmaceutical compositions involving epoprostenol. Actelion argued the district court erred in construing the claim term “a bulk solution having a pH of 13 or higher” as including only pH measurements conducted on a solution at the standard temperature of 25±2°C.

The Federal Circuit disagreed. Although the claim language did not specify temperature conditions, the specification “identified ‘an alkaline environment’ as ‘pH>7,’ which undisputedly was accurate only at standard temperature.” Experiments reported in the specification suggested a “uniform approach to measuring pH” and most of the specification’s tables reflected pH measured at standard temperature. The examiner’s statement and invention’s stated both recognized that pH imparted a critical function to the composition, consistent with measurement at the standard temperature. The court credited the U.S. Pharmacopeia and chemistry textbooks establishing that skilled artisans understood pH references to mean standard-temperature measurements unless otherwise indicated.
(1 to 4 stars rate impact of opinion on patent & trademark law)

UPC UPDATES — TECHNICITY AT THE UPC: NOTHING NEW UNDER THE SUN

by Aloys Hüttermann, Michalski Hüttermann & Partner

Beginning today, this new biweekly column will cover important recent decisions from the Unified Patent Court. Comments and suggestions are invited.

Unlike in the US, before the EPO the question of technicity is not handled via patent eligibility but instead via inventiveness. In its landmark 2002 decision T 641/00 (COMVIK), the EPO established the following framework:

a) If only one feature in a claim is technical, the whole claim is technical.

b) However, non-technical features cannot contribute to inventive step.

c) There is one exception to b) though: A feature that is non-technical as such may still be considered if together with other features a technical effect is reached.

How does the UPC deal with this? Apparently in the same fashion as the EPO.

Why “apparently”? In UPC_CoA_901/2025 (Abbott v. Sinocare), a decisive claim feature involved the display of information, a non-technical feature the defendant argued should be disregarded for inventiveness purposes. The UPC disagreed, invoking the third prong of the COMVIK framework: the feature produced a technical effect in combination with other claim elements, so it could not simply be set aside. The court granted an injunction.

Implicit in this decision is that the UPC will presumably follow the entire COMVIK framework. So again the UPC confirms my thesis that “there is nothing new under the sun” concerning patent validity. The court follows the EPO.

IPO FILES COMMENTS ON USPTO SUPPLEMENTAL GUIDANCE RELATED TO DESIGN PATENT APPLICATIONS FOR COMPUTER-GENERATED INTERFACES AND ICONS

As previously reported, earlier this year the USPTO issued supplemental guidance for examiners clarifying how design patent applications covering computer-generated electronic images, including graphical user interfaces (GUIs) and computer icons, satisfy the statutory requirement that a design be embodied in an “article of manufacture” under 35 U.S.C. § 171. IPO had previously raised this topic in the ID5 harmonization forum and filed comments related to this issue with USPTO in November 2024 and in February 2021.

On Tuesday IPO President JOHN CHEEK (Tenneco LLC) filed comments with USPTO on the supplemental guidance stating that “IPO applauds and fully supports the greater flexibility afforded to applicants in their pursuit of design patent protection for graphical user interfaces and icons as a result of the 2026 Guidance, and the clarifications included in the 2026 Guidance.” IPO also offered suggestions for further improvements. Thank you to IPO’s Industrial Designs Committee for assisting with the preparation of the comments. A special thanks to Committee Vice Chair DANIEL A. GAJEWSKI (Sterne, Kessler, Goldstein & Fox, PLLC), Committee Secretary JEREMY KRIEGEL (Marshall, Gerstein & Borun LLP), and working group members TRACY-GENE DURKIN (Sterne, Kessler, Goldstein & Fox, PLLC) and DUNSTAN BARNES (McDonnell Boehnen Hulbert & Berghoff LLP).

REGISTER OF COPYRIGHTS TESTIFIES ON AI, FOREIGN PIRACY, AND USCO MODERNIZATION AT SENATE IP SUBCOMMITTEE HEARING

On Tuesday Register of Copyrights SHIRA PERLMUTTER testified before the Senate Judiciary Subcommittee on Intellectual Property at a U.S. Copyright Office oversight hearing. Members on both sides of the aisle expressed broad support for the BLOCK BEARD Act, Subcommittee Chairman TOM TILLIS’S (R-NC) draft bill authorizing no-fault injunctions against foreign websites primarily dedicated to copyright piracy. Perlmutter said the DMCA framework provides no meaningful remedy and more than 40 countries have adopted no-fault injunctions with evidence of effectiveness. Hirono raised the Supreme Court’s recent decision in Cox Communications v. Sony, which Perlmutter said significantly narrowed secondary liability and altered internet service providers’ incentives to curb infringement, calling a legislative response more urgent than artificial intelligence fair use questions currently before the courts.

On AI, Perlmutter discussed the Copyright Office’s three-part report series. Part 1 recommended federal legislation protecting individuals from unauthorized digital replicas, in connection with the pending NO FAKES Act (S. 1367, H.R. 2794). Part 2 affirmed that purely AI-generated material is not copyrightable and that prompts alone are unlikely to constitute sufficient human authorship, a position upheld by the D.C. Circuit in Thaler v. Perlmutter and left intact when the Supreme Court denied certiorari in March 2026. Part 3 concluded that use of copyrighted works in AI training might qualify as fair use in some but not all circumstances, with key factors including the legality of the source, output guardrails, purpose of use, and market impact. Perlmutter recommended that licensing markets be given time to develop before government intervention and described litigation as incentivizing licensing discussions among interested parties. Sens. MARSHA BLACKBURN (R-TN) and PETER WELCH (D-VT) raised the TRAIN Act, a bill that would create a subpoena mechanism for rights holders to determine whether their works were used in AI training; Perlmutter said she strongly supports the need for transparency and described the approach as creative and viable.

Perlmutter also reported on operations and budget. Among other updates, she said the Copyright Claims Board has received over 2,000 claims, is generating high-quality decisions and facilitating settlements, and USCO has recommended statutory amendments to streamline its procedures. Perlmutter’s written testimony is available here.

NEXT WEEK ON THE IP CHAT CHANNEL™: INTERNATIONAL CONSIDERATIONS IN IP PORTFOLIO MANAGEMENT: BUSINESS, LEGAL, AND PROCEDURAL PERSPECTIVES

Join the IP Chat Channel™ on Tuesday, May 19 at 1:00pm ET for International Considerations In IP Portfolio Management: Business, Legal, and Procedural Perspectives. Intellectual property owners face a range of strategic choices when building and maintaining international IP portfolios. Decisions about whether, when, and where to seek patent, trademark, or other IP protection vary across industries, technologies, markets, and business objectives and are shaped by differing legal frameworks, enforcement environments, and procedural options around the world.

This webinar will explore how organizations evaluate those choices in practice. Through illustrative examples, the discussion will consider why portfolio strategies may look different across sectors and regions and how international filing options such as regional or centralized systems fit into broader business goals. Panelists CHARLIE EVERITT, DIANE GABL KRATZ (Dolby Laboratories), and ANDREW LEVITT (Leydig, Voit & Mayer, Ltd.) will share insights on aligning IP strategy with commercial objectives and delivering value when advising clients or stakeholders navigating the global IP landscape.

IP Chat Channel™ webinars are free for IPO members. Advance registration is required. CLE offered in most states.

IPO THANKS THE SPONSORS OF THE MAY 28 EUROPEAN PRACTICE COMMITTEE CONFERENCE

Thank you to the following members for sponsoring IPO’s European Practice Committee organized conference entitled “Watch Your Words – Claim Interpretations, Estoppel, Information Sharing, Chat Bots and Much More.” The 2026 event will take place on May 28 at Gesellschaftshaus Palmengarten in Frankfurt, Germany. Visit the conference website for more information or to register.