Michael Werner

A crisp set of key takeaways for IP professionals from the July 2, 2025 Delaware court decision in HQ Specialty Pharma Corp. et al. v. Fresenius Kabi USA, LLC: Strategic Lessons from the Calcium Gluconate Patent Case - Inventorship Accuracy Is Critical Claims 2 and 3 were invalidated due to improper inventorship, reinforcing that precise inventor attribution is essential for patent enforceability. - Formulation Patents Can Be Resilient The court upheld the patent against an obviousness challenge, showing that clinical advantages like shelf-stability can support strong formulation claims. - Inequitable Conduct Requires High Proof Allegations of misconduct during prosecution were dismissed, reminding litigants that clear and convincing evidence is the standard. - Corrective Measures Are Viable The plaintiffs plan to correct inventorship post-verdict, demonstrating that errors can be remedied, though they may delay enforcement. - FDA Approval Doesn’t Shield Against IP Risk Fresenius’s experience highlights that regulatory clearance doesn’t immunize generic products from patent litigation. This case is a powerful reminder that IP diligence isn’t just about drafting—it’s about foresight, documentation, and strategic defense.

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The Federal Circuit has upheld a precedential ruling in favor of Sterne Kessler client Hopewell Pharma Ventures. https://gag.gl/B9QLdh In a case involving Merck's EMD Serono unit, the Federal Circuit declined to reconsider an earlier decision invalidating Merck's key patents for its multiple sclerosis drug MAVENCLAD. The decision upholds rulings by the PTAB in favor of Hopewell, finding Merck's patent claims obvious. "We are delighted that the Federal Circuit has once again ruled in our favor, correctly applying settled law," said Dr. Jonathan Embleton, Hopewell's co-founder and CEO. "Sterne Kessler has again demonstrated its ability to litigate skillfully and successfully at the PTAB and on appeal, and we are grateful for the result." The Sterne Kessler team was led by Director J.C. Rozendaal and included Directors Eldora Ellison, Olga Partington, Chandrika Vira, and Richard A. Crudo, along with Counsel Christina Dashe and Tyler Liu.

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#Healthcare attorney John T. Vaughan was featured in a BioSpace article discussing how the #SupremeCourt’s overturning of Chevron deference is shifting regulatory power from agencies like the #FDA to the courts. He explains this change will make it easier to challenge agency actions and increase judicial scrutiny of federal regulations. https://bit.ly/43mYYVQ #healthcareregulation

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The Federal Circuit's decision In Re Riggs provides clarification regarding what is required for a published patent application to qualify as prior art from its provisional filing date. 📓 The decision reinforces the importance of drafting detailed provisional applications to establish prior art under both pre-AIA and AIA law. 🏛️A provisional application must provide written description support for both at least one claim AND the specific portions of the specification relied upon in a prior art rejection. 🖋️ Practitioners should draft comprehensive provisional applications to ensure entitlement to the earliest priority date. Read more on our life science blog. https://lnkd.in/g6d3Y8h4

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How exciting for FDA Commissioner Makary to stop by the Food and Drug Law Institute (FDLI) Annual Conference of #FDA lawyers in DC for a fireside chat on his priorities, including: reducing animal testing where foreign clinical data are available or computational modeling eliminates the need for extensive animal testing, leveraging #AI in drug application reviews, combatting chronic diseases like diabetes, addressing entry of illegal vaping products, & more! Mark Abdoo, FDA Assoc. Commissioner for Global Policy & Strategy shared FDA's plans to increase unannounced inspections abroad ending FDA's practice of announcing inspections, starting first in countries where entry of FDA personnel is easiest, & noting that "global supply chain threats are also global supply chain opportunities." Grace Graham, FDA Assoc. Commissioner for Policy, Legislation & International Affairs previewed potential scrutiny of older-approved products, noting many drugs are used today in a way not envisioned on approval & with old clinical data, questioning whether label changes or updates are needed. She also noted the need to continue speeding the multi-year arc of a product reaching patients, particularly in #rarediseases. #Deregulation, streamlining FDA processes, & driving foreign scrutiny were clear themes from FDA across the Conference. #Goodwinlaw

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The 26th Annual Pharmaceutical and Medical Device Ethics Compliance Congress will take place October 22–24 in Washington, DC and virtually. Ropes & Gray partners and counsel will participate across a range of sessions. Health care partners Margaux J. Hall and @Eve Brunts, along with counsel Alison Fethke, will speak on “Patient-Oriented Commercial Models: Legal and Market Access Considerations.” Health care partner @Christine Moundas, co-head of the firm’s digital health initiative, will join the discussion and Q&A on “State Consumer Privacy Laws – Compliance Tips for Pharma and Med Device Companies.” Litigation & enforcement partner Samantha Barrett Badlam will be part of “External Funding Risks and Mitigation – Latest Trends in Exhibit & Display and Sponsorship Requests,” while litigation & enforcement partner Joshua S. Levy will take part in the plenary session of former government officials. Health care partner Jamie Darch will speak on “Examining Business Relationships and Compliance Risks with Pharmacy Benefit Manager (PBM) Arrangements.” Learn more and register here: https://lnkd.in/e6JHAAh

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On August 13, 2025, the Unified Patent Court (UPC) Court of Appeal issued a landmark ruling in the dispute between Boehringer Ingelheim and Zentiva. The Court overturned the lower court's decision and granted a provisional injunction against Zentiva, recognizing that completion of national pricing and reimbursement procedures can constitute imminent patent infringement. This ruling strengthens protections for patent holders against premature entry of generics into the market. The dispute concerned Boehringer Ingelheim’s European Patent EP 1 830 843, protecting indolidone derivatives for treating fibrotic diseases, valid until December 21, 2025. Boehringer markets Ofev for conditions including idiopathic pulmonary fibrosis (IPF). Zentiva obtained marketing authorisations in Portugal on August 30, 2024, for generic nintedanib products covering the same indications and subsequently secured pricing and reimbursement approval from INFARMED by December 6, 2024, with a notice allowing public healthcare entities to purchase the generics. Boehringer Ingelheim sought provisional measures from the UPC Lisbon Local Division, alleging imminent patent infringement through Zentiva’s potential market entry. However, on May 8, 2025, the Local Division denied the request, holding that obtaining marketing authorisation and completing administrative pricing procedures alone did not constitute imminent infringement, as Boehringer had not demonstrated any concrete conduct by Zentiva indicating an immediate market launch. The Court of Appeal held that the mere application for or grant of a marketing authorisation does not, in itself, constitute imminent infringement. However, the completion of national procedures for pricing and reimbursement may amount to such infringement. Noting that Zentiva completed these procedures prematurely, over a year prior to the patent’s expiry, the Court found it more likely than not that Zentiva had prepared to offer generics in Portugal. The Court clarified that the current Bolar exemption, allowing certain activities before patent expiry without constituting infringement, does not extend to activities related to health technology assessment or pricing and reimbursement. Acknowledging the potential for irreparable harm to Boehringer Ingelheim due to price erosion, the Court reversed the lower court’s decision and issued a pan-European injunction prohibiting Zentiva from marketing its nintedanib products in all UPC contracting member states where the patent is in force. #PatentInfringement #IP #IntellectualProperty #PatentProtection #PharmaLaw #GenericDrugs

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