Unified Patents Inc. v. Actelion Pharmaceuticals Ltd

This Inter Partes Review (IPR), IPR2025-01139, was initiated by Unified Patents Inc. against Actelion Pharmaceuticals Ltd concerning U.S. Patent No. 8,268,847. Unified Patents is a member-based organization focused on deterring frivolous patent litigation and improving patent quality, primarily by challenging patents asserted by Non-Practicing Entities (NPEs) or by targeting weak patents that stifle innovation, particularly in the pharmaceutical sector. Actelion Pharmaceuticals Ltd, a subsidiary of Johnson & Johnson's Janssen Pharmaceutical Companies, is a biopharmaceutical company headquartered in Switzerland that develops and commercializes drugs, particularly for rare and orphan diseases such as pulmonary arterial hypertension (PAH). As an operating company, Actelion is the patent owner in this proceeding.

The patent at issue, U.S. Patent No. 8,268,847, is titled "Therapeutic compositions comprising a specific endothelin receptor antagonist and a PDE5 inhibitor." Generally, the patent claims a product containing a specific compound (an endothelin receptor antagonist) in combination with a PDE5-inhibitory compound, or pharmaceutically acceptable salts thereof, for therapeutic use in treating diseases involving vasoconstriction, such as hypertension, pulmonary hypertension, and erectile dysfunction. The patent specifically protects drugs like OPSUMIT and OPSYNVI, used for pulmonary arterial hypertension. In an IPR, there is no "accused product" in the traditional sense of infringement litigation; instead, the IPR directly challenges the validity of the patent claims themselves.

This case was filed at the Patent Trial and Appeal Board (PTAB) of the U.S. Patent and Trademark Office, which is the administrative body responsible for conducting IPRs. The PTAB is a critical venue for challenging patent validity based on prior art, specifically patents and printed publications, typically involving anticipation or obviousness grounds. The procedural posture is "Not Instituted - Procedural," which means the PTAB declined to initiate the review on a procedural basis, rather than on the merits of the patentability arguments. This outcome is notable given recent trends at the PTAB, where procedural denials for IPR petitions have seen a significant increase, particularly in 2025, prompting petitioners to explore alternative patent challenges like ex parte reexaminations. While the specific procedural reason for the denial in IPR2025-01139 is not detailed in publicly available summaries, such denials can arise from various factors, including issues with the petition's form, compliance with regulations, or discretionary denials by the Board. Unified Patents' involvement in challenging pharmaceutical patents held by operating companies like Actelion highlights their broader mission to combat what they perceive as "weak pharmaceutical patents" that could lead to "patent thickets" and hinder the entry of more affordable generic and biosimilar drugs.

The Inter Partes Review (IPR) proceeding, IPR2025-01139, was initiated by Unified Patents Inc. against Actelion Pharmaceuticals Ltd concerning US patent 8,268,847. The proceeding resulted in a "Not Instituted - Procedural" outcome.

Here are the key legal developments in chronological order:

• 2007-08-28: Actelion Pharmaceuticals Ltd filed the application that led to US Patent 8,268,847.
• 2012-09-18: US Patent 8,268,847, titled "Therapeutic compositions comprising a specific endothelin receptor antagonist and a PDE5 inhibitor," was granted to Actelion Pharmaceuticals Ltd. The patent protects drugs such as OPSUMIT and OPSYNVI.
• 2025-07-22: Unified Patents Inc. filed a Petition for Inter Partes Review (IPR) against US Patent 8,268,847, initiating IPR2025-01139.
• October/November 2025: The USPTO Director, John Squires, implemented changes to the IPR institution process, assuming responsibility for determining whether to institute IPR and PGR proceedings. The Director began issuing "Notices of Decisions on Institution" without detailed written opinions, sometimes specifying whether denial was based on discretionary or merits factors.
• Final Disposition: The IPR proceeding IPR2025-01139 was "Not Instituted - Procedural." While the specific date of the "Not Instituted" decision for IPR2025-01139 is not explicitly available in the search results, this outcome falls within the period when the Director's new institution guidelines were being applied. The procedural denial of institution means the PTAB did not proceed to a full review of the patent's validity. This often occurs due to discretionary factors, such as issues with the petition itself, parallel litigation, or other policy considerations, rather than a decision on the merits of the patentability arguments.

Parallel District Court Litigation Involving Actelion Pharmaceuticals:

It is important to note that Actelion Pharmaceuticals Ltd has been involved in other patent litigation, although not directly related to US Patent 8,268,847, which helps illustrate the broader litigation landscape for the company.

• 2020-02: Mylan Pharmaceuticals Inc. submitted an abbreviated new drug application (ANDA) to the FDA to market a generic epoprostenol drug.
• 2020-06: Actelion Pharmaceuticals Ltd sued Mylan Pharmaceuticals Inc. in the U.S. District Court for the Northern District of West Virginia for infringement of US Patent Nos. 8,318,802 and 8,598,227, asserting both literal infringement and infringement under the doctrine of equivalents. These patents relate to epoprostenol formulations, the active ingredient in Actelion's hypertension drug Veletri®.
• Prior Claim Construction: The district court initially construed the claim term "a pH of 13 or higher" to include values as low as 12.5 based on ordinary rounding, leading to a stipulated judgment of infringement and a permanent injunction.
• 2023-11-06: The Federal Circuit vacated the district court's initial claim construction and judgment of infringement for the '802 and '227 patents, remanding the case for consideration of extrinsic evidence regarding the significant digits for pH values.
• District Court Remand Outcome: On remand, the district court construed "pH of 13 or higher" to refer to a pH measurement made at 25±2°C, a standard temperature in the field. It found no literal infringement by Mylan's ANDA product because there was no evidence it met this pH requirement.
• Doctrine of Equivalents Ruling: The district court also ruled that Actelion was barred from asserting infringement under the doctrine of equivalents due to prosecution history estoppel and the disclosure-dedication rule. The court found Actelion had narrowed its claims during prosecution from "greater than 12" to "13 or higher" to overcome an obviousness rejection, surrendering the intermediate territory. Additionally, the patent specification disclosed, but did not claim, pH ranges below 13, dedicating those to the public.
• 2024-03-18: The district court entered final judgment, finding no literal infringement and barring infringement under the doctrine of equivalents.
• 2026-05-13: The Federal Circuit affirmed the district court's judgment in Actelion Pharmaceuticals Ltd v. Mylan Pharmaceuticals Inc. (Case: 24-1641), upholding the findings of no literal infringement and that Actelion was barred from asserting the doctrine of equivalents for the '802 and '227 patents.

In addition, Actelion Pharmaceuticals was involved in an antitrust class action concerning its pulmonary arterial hypertension drug Tracleer (bosentan). This lawsuit, Government Employees Health Association v. Actelion Pharmaceuticals LTD, alleged that Actelion engaged in a scheme to prevent generic versions of Tracleer from coming to market. The case, originally filed in 2018 in the U.S. District Court of Maryland, was initially dismissed but revived and remanded by the Fourth Circuit in 2021.

• 2024-09-06: The district court granted class certification and denied Actelion's motion for summary judgment.
• 2026-03-13: A $65 million preliminary settlement was granted by the court, less than two weeks before a jury trial was scheduled to begin.

Unified Patents Inc. typically utilizes its in-house legal team for IPR proceedings. Based on publicly available information and their typical operating model, the following individuals from Unified Patents are likely to serve as counsel, preparing and litigating post-grant proceedings before the PTAB:

• Alyssa Holtslander - Senior Patent Counsel, Unified Patents.
  • Firm: Unified Patents, LLC.
  • Experience: Prior to joining Unified Patents, she practiced at Finnegan, Henderson, Farabow, Garrett & Dunner, LLP for over ten years, focusing on post-grant proceedings, ITC proceedings, and district court litigation across various technologies.
• Jessica L.A. Marks - SEP & Foreign Managing Counsel, Unified Patents.
  • Firm: Unified Patents, LLC.
  • Experience: Before joining Unified, she also practiced at Finnegan, Henderson, Farabow, Garrett & Dunner, LLP for over ten years, litigating post-grant proceedings, district court cases, and International Trade Commission proceedings.
• Jung Hahm - Senior Patent Counsel, Unified Patents.
  • Firm: Unified Patents, LLC.
  • Experience: Previously, he practiced at Amster, Rothstein & Ebenstein LLP for over 16 years, concentrating on PTAB trial practice, patent litigation, and patent prosecution.
• Jordan Rossen - Senior Patent Counsel, Unified Patents.
  • Firm: Unified Patents, LLC.
  • Experience: Prior to Unified, he practiced in intellectual property litigation at Ropes & Gray and Paul Hastings in Washington, D.C. for eleven years, representing clients before the PTAB, ITC, district courts, and the Federal Circuit.
• David Seastrunk - Senior Patent Counsel, Unified Patents.
  • Firm: Unified Patents, LLC.
  • Experience: Before joining Unified, he practiced at Finnegan, Henderson, Farabow, Garrett & Dunner, LLP, involved in all phases of post-grant proceedings, district court cases, and ITC investigations.
• Michelle Callaghan - Senior Patent Counsel, Unified Patents.
  • Firm: Unified Patents, LLC.
  • Experience: Previously practiced at Erise IP, where she defended clients in district courts, challenged patents before the PTAB, and prepared opinions on patent validity and infringement.

Unified Patents' legal team is primarily composed of in-house senior patent counsel with extensive experience in post-grant proceedings before the PTAB. They are known for challenging patents, particularly those asserted by Non-Practicing Entities (NPEs), and have been involved in numerous IPRs, including those that have reached the Federal Circuit.

While specific docket entries for IPR2025-01139 detailing counsel appearances are not immediately available in the search results, the individuals listed above represent the core of Unified Patents' team responsible for such filings. It is common for Unified Patents to rely on its in-house counsel for IPR petitions, rather than engaging outside law firms as lead counsel.

I'll research counsel of record for Actelion (the patent owner/defendant in this IPR).

Important metadata discrepancy noted. Let me verify the Patent Owner's counsel of record in detail.

Let me verify the petition document ID and check for the Unified Patents proceeding and counsel firm changes.

Threshold correction before answering

The case metadata in this prompt does not match the public record for IPR2025-01139, and this materially affects who the "defendant" is and who represents it:

Sources: Docket Alarm/IP Verse PTAB docket for IPR2025-01139 (United Therapeutics Corporation v. Actelion Pharmaceuticals Ltd., filed June 10, 2025, patent 8,268,847, status "Discretionary Denial"); Petitioner's Request for Refund of Post-Institution Fees (Paper 12, Jan. 6, 2026), which recites "On June 10, 2025, UTC filed a Petition for Inter Partes Review… On October 31, 2025, the Petition was denied institution. Paper 10."

There is no Unified Patents filing against the '847 patent in the record I could find. The "2025-07-22" date appears to belong to a different petition (PTAB petition ID 1557975, served on the same Sidley team), not to this IPR. I could not verify any Unified Patents–Actelion '847 proceeding; treat the prompt's petitioner/date fields as an error to be corrected rather than as a fact about this docket. Also note this is an IPR, not an infringement action — there is no "infringement defendant"; the responding party is the Patent Owner, Actelion Pharmaceuticals Ltd.

Counsel of record for the Patent Owner (Actelion)

Per Actelion's Mandatory Notice (Paper 4, filed June 27, 2025) and the Board's Notice of Filing Date Accorded (Paper 5, July 1, 2025):

Service/correspondence address for Patent Owner: Sidley Austin LLP, 1501 K Street NW, Washington, DC 20005; designated service emails JJ847IPR@sidley.com (Mandatory Notice) and J1847IPR@sidley.com (appears in later Petitioner filings and certificates of service — the "JJ" vs. "J1" strings are the same address as rendered in different documents).

Source trail for the above

• Paper 4 — Patent Owner's Mandatory Notice (June 27, 2025): "Lead Counsel is: Thomas A. Broughan III (Reg. No. 66,001), tbroughan@sidley.com, (202) 736-8314. Back-Up Counsel are: Stephanie Koh (pro hac vice to be requested)… and Amana Abdulwakeel (pro hac vice to be requested)… Service… by e-mail (JJ847IPR@sidley.com)… to Sidley Austin LLP, 1501 K Street, N.W., Washington, D.C. 20005." (docketalarm.com PDF)
• Paper 5 — Notice of Filing Date Accorded (July 1, 2025): "FOR PATENT OWNER: Thomas Broughan, SIDLEY AUSTIN LLP, tbroughan@sidley.com."
• Paper 8 — Petitioner's Updated Mandatory Notices (Oct. 1, 2025), certificate of service listing Patent Owner's counsel of record as Broughan, Abdulwakeel (Sidley, DC) and Koh (Sidley, Chicago) — confirming these three remained PO counsel of record as of October 2025.
• Paper 12 — Petitioner's Request for Refund (Jan. 6, 2026), certificate of service to the same three attorneys at Sidley — confirming the same counsel of record through the end of the proceeding.

Roles / caveats

• No "local counsel" and no in-house counsel on the Patent Owner side is identified in the public filings. PTAB practice does not use local counsel; the three Sidley attorneys above are the complete designated prosecution team. If Actelion used in-house or J&J/Janssen IP personnel, they were not designated of record in the papers I could access.
• Real parties-in-interest: Actelion's Mandatory Notice identifies Actelion Pharmaceuticals Ltd and Actelion Pharmaceuticals US, Inc. as wholly owned subsidiaries of Johnson & Johnson — but J&J itself was not listed as an RPI.
• I found no record of the pro hac vice motions for Koh and Abdulwakeel being granted or denied; they are designated as back-up counsel with PHV "to be requested." Treat their PHV status as unverified.

Flagged development to verify (do not treat as confirmed)

A legal-press item (CDR News) reports that Sidley Austin IP trial partners Ching-Lee Fukuda and Tom Broughan moved to Morrison Foerster, with the announcement described as occurring on a Tuesday, 9 June. If that report is accurate and refers to 2026, then Actelion's lead counsel of record in this (now-terminated) IPR may have changed firms after the denial of institution. I could not confirm the year, the effective date, or whether a change of counsel / updated mandatory notice was ever filed — and since the proceeding was denied institution and terminated, no such filing would be necessary. This should be verified against the current proceeding docket and Sidley/MoFo firm pages before being relied on. Note also that the MoFo news search returned only the headline snippet; no primary source (firm press release, docketed notice of change of counsel) was retrieved.

Practical bottom line

For IPR2025-01139, Actelion Pharmaceuticals Ltd (Patent Owner) was represented by Sidley Austin LLP, with Thomas A. Broughan III as lead counsel (Washington, DC) and Stephanie Koh (Chicago) and Amana Abdulwakeel (Washington, DC) as back-up counsel, all served via JJ847IPR@sidley.com. That team is consistent across the June 27, 2025 Mandatory Notice and every certificate of service through January 2026.