ANDA Litigation Settlements - First Quarter 2026
During Q1 2026, U.S. district courts issued a wave of ANDA litigation settlements covering dozens of branded drugs, from ophthalmic gels to diabetes tablets. Most disputes were dismissed, many with prejudice, while several parties entered license agreements that preserve patent exclusivity. Generic manufacturers often retained the right to file Paragraph IV certifications but were enjoined from selling infringing products until patents expire. All parties were ordered to bear their own attorneys’ fees, shifting litigation costs.
Spotlight On: Enbrel® (Etanercept) / Erelzi® (Etanercept-Szzs) / Eticovo® (Etanercept-Ykro) - April 2026
The April 2026 Spotlight On update details how etanercept patents—covering Enbrel®, Erelzi® and Eticovo®—are being contested in both inter partes reviews (IPRs) and court litigations. It explains that each claim is counted once per proceeding, but the same claim can appear...
Spotlight On: Actemra® (Tocilizumab) / Tofidence™ (Tocilizumab-Bavi) / Tyenne® (Tocilizumab-Aazg) / Avtozma® (Tocilizumab-Anoh) - April 2026
The Venable LLP briefing explains how claims in Inter Partes Review (IPR) proceedings are tallied for the tocilizumab family of drugs, including Actemra®, Tofidence™, Tyenne®, and Avtozma®. It notes that each IPR counts claims separately, so the same patent challenged...
Vietnam Accelerates IP Process: Pros and Cons of the New Timelines for IP Owners
Effective 1 April 2026 Vietnam’s amended Intellectual Property Law slashes examination periods for trademarks, industrial designs and patents, and trims opposition windows. Substantive patent examination drops from eighteen to twelve months, with a fast‑track option that can finish in three months. The...
9th Circ. Copyright Ruling Highlights Doubts On Intrinsic Test
The Ninth Circuit upheld a jury’s noninfringement finding in Sedlik v. Von Drachenberg, but two judges used their concurrences to criticize the circuit’s intrinsic test for substantial similarity. The intrinsic test, which asks whether an ordinary observer perceives overall similarity, is...
Spotlight On: Biosimilar Litigations - April 2026
The April 2026 Spotlight On: Biosimilar Litigations memo outlines which patent disputes are tracked in the sector. It clarifies that lawsuits between biosimilar applicants or manufacturers and reference‑product sponsors are included, while conflicts solely among reference sponsors or non‑practicing entities are...
Spotlight On: Rituxan® (Rituximab) / Truxima® (Rituximab-Abbs) / Ruxience® (Rituximab-Pvvr) / Riabni™ (Rituximab-Arrx) - April 2026
The April 2026 Venable LLP update details how patent claims covering Rituxan® and its biosimilars—Truxima®, Ruxience®, and Riabni™—are being contested in both Inter‑Partes Review (IPR) proceedings and federal litigation. The report explains that each claim is counted once per proceeding, meaning...
USPTO, DOJ Statement of Interest Supports Injunctive Relief
The U.S. Patent and Trademark Office and the Department of Justice jointly filed a statement of interest urging courts to apply permanent injunctions more broadly in patent infringement cases, including those brought by non‑practicing entities. The agencies argue that NPEs...
Spotlight On: Humira® (Adalimumab) / Amjevita™ (Adalimumab-Atto) / Cyltezo® (Adalimumab-Adbm) / Hyrimoz™ (Adalimumab-Adaz) / Hadlima™ (Adalimumab-Bwwd) / Abrilada™ (Adalimumab-Afzb) /...
The April 2026 update spotlights the extensive patent‑litigation landscape surrounding adalimumab and its biosimilar portfolio, including Humira® and ten newer biosimilars such as Amjevita™ and Cyltezo®. It explains how claims are tallied across Inter‑Partes Review (IPR) proceedings and federal lawsuits, noting...
A Comparative Overview of Patenting AI Inventions
The 2026 update compares AI‑related patent eligibility, inventive‑step standards, and disclosure rules across the United States, Europe, and China. In the U.S., recent USPTO guidance and SMEDs let applicants bolster eligibility by emphasizing concrete technical improvements. Europe maintains a two‑hurdle...
The Precedent: Federal Circuit Confirms Limits on Claim Scope in Magnolia Med. Techs., Inc. V. Kurin, Inc.
The Federal Circuit affirmed district‑court rulings that Kurin does not infringe Magnolia Medical Technologies’ patents. It held that the ’483 patent’s claim requires physically separate vent and seal members, which Magnolia’s single porous plug cannot satisfy, and that the ’001...
Two Years on From Its Launch, How Has the UPC Impacted European Patent Litigation in the Life Sciences Sector?
Two years after its June 2023 launch, the Unified Patent Court (UPC) has handled over 480 life‑science patents, with litigation volume steadily rising. The court has established a holistic approach to claim interpretation, inventive step, added matter and sufficiency, often favoring...
“Baby Shark” And the Hague Service Convention: The Second Circuit Limits Email Service Abroad
The Second Circuit in Smart Study Co., Ltd. v. Shenzhenshixindajixieyouxiangongsi held that the Hague Service Convention creates a “closed universe” that bars email service on Chinese defendants. The court rejected arguments that the treaty’s silence on email or Rule 4(f)(3) permits...
Latest Federal Court Cases: IronSource Ltd. V. Digital Turbine, Inc. - April 2026
The Federal Circuit dismissed ironSource Ltd.’s appeal of a post‑grant review decision involving Digital Turbine’s U.S. Patent No. 11,157,256. The court ruled ironSource lacked Article III standing because it could not show concrete plans to re‑introduce product features that would infringe the...
In Re Entresto (Sacubitril/Valsartan) Patent Litigation (Novartis Pharms. Corp. V. MSN Labs. Private Ltd.
The Delaware District Court granted Novartis summary judgment in the Entresto patent case, invoking both issue and claim preclusion to bar MSN Labs from relitigating claim construction, validity, and infringement of U.S. Patent No. 8,101,659. The court held that the prior...
PTAB Update | March 2026
The PTAB announced a sua sponte rehearing of Ex parte Baurin, revisiting the interplay between obviousness‑type double‑patenting and patent term adjustment in light of the Cellect and Allergan decisions. Simultaneously, the USPTO Director issued a new policy requiring parties in...
AI Legal Watch: April 2026
The White House released a nonbinding National Policy Framework for Artificial Intelligence, outlining seven priority areas such as child protection, IP rights, and pre‑empting state regulation, while urging Congress to let courts decide whether AI training on copyrighted material is...
Launching the Latest Edition of Our Life Sciences and Healthcare Insights
A&O Shearman released the second edition of its Life Sciences and Healthcare Insights report on April 14, 2026. The edition examines six critical topics—from rising shareholder activism and AI‑driven drug discovery to China’s expanding pharma innovation ecosystem. It also analyzes EU reforms to...
Federal Circuit’s Holding on Patent Eligibility for Engineered Host Cells Dovetails With PERA
The Federal Circuit ruled in REGENXBIO v. Sarepta that a host cell engineered to contain an AAV capsid gene plus a heterologous non‑AAV sequence is patent‑eligible under 35 U.S.C. §101. The opinion leans on the Chakrabarty precedent and distinguishes Myriad by emphasizing the material...
One Battle After Another: Broad Institute Wins at PTAB in CRISPR Dispute
On March 26, 2026 the Patent Trial and Appeal Board ruled that the Broad Institute, not the University of California‑Vienna team led by Emmanuelle Charpentier, was the first to invent a CRISPR‑Cas9 system that works in eukaryotic cells. The board found CVC’s lab...
Once More Into the Valley of Death: Navigating SBIR/STTR Funding for Tech Startups After 2025
The Small Business Innovation Research (SBIR) and Small Business Technology Transfer (STTR) programs were reauthorized through September 2031, adding a new Strategic Breakthrough Awards tier of up to $30 million for transformative technologies. Annual federal non‑dilutive capital now exceeds $4 billion, with cumulative...
![[Podcast] The Great Patent Pivot: How Recent USPTO Policy Shifts Made Challenging Patents Harder – and Enforcing Them Easier](/cdn-cgi/image/width=1200,quality=75,format=auto,fit=cover/https://jdsupra-static.s3.amazonaws.com/profile-images/og.14750_4752.jpg)
[Podcast] The Great Patent Pivot: How Recent USPTO Policy Shifts Made Challenging Patents Harder – and Enforcing Them Easier
The USPTO rolled out sweeping policy reforms in 2025 that make post‑grant challenges harder while giving patent owners stronger enforcement tools. Higher filing fees, stricter standing requirements, and tighter claim‑construction standards raise the cost and risk of contesting patents. At...
A Small Character Becomes a Big Win for Creative Freedom in California
The California Court of Appeal reversed a lower‑court ruling in Hara v. Netflix, granting Netflix’s anti‑SLAPP motion and dismissing a right‑of‑publicity claim by drag‑queen performer Vicky Vox. The court held that a fleeting character resembling Vox in the series “Q‑Force”...
Patents, Defense, and Startups: What Dual-Use Startups Need to Know About Patents in 2026
The Department of Defense’s two‑year patent holiday lets startups access hundreds of government‑owned patents through no‑fee Commercial Evaluation Licenses, with applications due July 22, 2026. Section 1498 shifts patent enforcement to the federal government, limiting contractors’ liability and offering a narrow defense for...
Astellas Pharma Inc. V. Ascent Pharms., Inc.
In a March 2026 bench trial, the Delaware District Court ruled that Ascent Pharmaceuticals' ANDA for mirabegron infringed all of Astellas Pharma's patents covering the extended‑release Myrbetriq formulation. The court dismissed Ascent's defenses on patent‑eligibility, anticipation, obviousness, and written description,...
Spring Cleaning Your Trademark Portfolio: A Plain-English Guide for In-House Teams
Companies often let trademark portfolios grow haphazardly, resulting in registrations that no longer match current branding or business lines. An annual "spring cleaning" review helps in‑house counsel verify that core marks reflect actual use, retire legacy filings, and spot coverage...
The Supreme Court Changes the Landscape for Contributory Liability
The U.S. Supreme Court in Cox Communications v. Sony Music narrowed contributory copyright liability to cases where a provider intentionally facilitates infringement. The Court rejected the Fourth Circuit’s knowledge‑plus‑continued‑service test, establishing two intent‑based pathways: affirmative inducement and a service tailored...
[Audio] 'Urgent National Action to Save College Sports': Trump’s NIL Playbook — Highway to NIL Podcast
In a recent Highway to NIL podcast, Troutman Pepper Locke attorneys dissect President Donald Trump’s new executive order titled “Urgent National Action to Save College Sports.” The order calls for a unified national framework governing name, image, and likeness (NIL) deals,...
Failed Arguments, Lasting Consequences: Prosecution Disclaimer in Puradigm V. DBG
The Federal Circuit affirmed summary judgment of noninfringement in *Puradigm, LLC v. DBG Group Investments*, holding that a prosecution‑history disclaimer narrowed the claim term “specular UV reflector.” The disclaimer stemmed from the applicant’s earlier argument distinguishing specular reflectance from mere...
2025 Post-Grant Annual Report
John A. Squires was confirmed as the 60th Director of the USPTO in September 2025, bringing a free‑market, AI‑focused agenda. Since taking office, he has centralized PTAB institution decisions, tightened real‑party‑interest disclosures, and issued a rule limiting inter‑ partes review...
New Procedure for Ex Parte Reexaminations: Patent Owners May File 'Pre-Order' Papers Prior to the Substantial New Question Determination
The USPTO announced a new ex parte reexamination framework that lets patent owners submit a limited “pre‑order” paper before the Office decides if a substantial new question exists. The option applies to requests filed on or after April 5 2026 and must be...
![[Video] March Madness or Trademark Madness? The NCAA V. DraftKings Lawsuit](/cdn-cgi/image/width=1200,quality=75,format=auto,fit=cover/https://jdsupra-static.s3.amazonaws.com/profile-images/og.15496_4323.png)
[Video] March Madness or Trademark Madness? The NCAA V. DraftKings Lawsuit
The NCAA has filed a lawsuit against DraftKings alleging trademark infringement for the fantasy‑sports platform’s use of the phrase “March Madness.” The league argues the usage creates a false association and dilutes its brand, while DraftKings contends the term is...
Space Force Awards Kratos $447 Million Contract for Missile Warning Tracking
The U.S. Space Force awarded Kratos Technology & Training Solutions a $447 million Other Transaction Agreement to build a ground‑management integration system for its missile‑warning satellites. The contract will initially support the 12‑satellite Epoch 1 constellation slated for launch in 2027‑28, followed...
Mexico Publishes Amendments to Intellectual Property Law
On 3 April 2026 Mexico published amendments to its Federal Law for the Protection of Industrial Property, introducing a suite of procedural tools aimed at greater flexibility and speed in patent prosecution. The changes allow restoration of priority rights within two months,...
Augusta National Blazes a Trail to Registration of Its Iconic Green Jacket
Augusta National Golf Club has officially registered the iconic green‑and‑gold jacket color scheme as a federal trademark, covering both sponsorship promotion (International Class 035) and tournament organization (International Class 041). The registration, filed under application number 88310303, follows more than 70 years of...
What's Patentable About Software?
Software patents protect functional aspects of programs, not just code, allowing owners to block competitors even if they develop similar solutions independently. While the USPTO still grants patents for new, useful, non‑obvious inventions, recent guidance tightens the "useful" requirement and...
Readily Ascertainable - WilmerHale's Trade Secret Bulletin: January and February 2026
The Federal Circuit, Fifth Circuit, Seventh Circuit, and district courts issued several 2026 decisions clarifying trade‑secret law. Courts emphasized that plaintiffs must precisely define alleged secrets, apportion damages to each proven secret, and provide technical details rather than functional descriptions....
Federal Circuit: Info Exchange Patent Fails Section 101, and Michigan Won the National Championship
The U.S. Federal Circuit upheld the PTAB’s rejection of Brian McFadden’s patent for an information‑exchange apparatus, finding the claims abstract under the Alice framework. The court emphasized that generic software performing mathematical calculations does not supply an inventive concept, and it...
Where Are We on Copyright and AI in the UK
The UK government has issued a Report and Economic Impact Assessment on copyright use in AI, abandoning its earlier preference for a broad text‑and‑data‑mining (TDM) exception with an opt‑out. Instead, it will adopt a "wait‑and‑see" stance, allowing industry‑led licensing schemes...
Analyzing SEPs: Strategies To Avoid Or Prepare For Litigation
Standard‑essential patent (SEP) licensing and litigation remain a dominant legal focus, affecting companies that embed standardized technologies in their products. The article outlines proactive strategies—such as early licensing negotiations, rigorous SEP portfolio tracking, and leveraging FRAND commitments—to mitigate the risk...
[Podcast] When Creativity Meets Code: Copyright and Trademark Troubles with AI-Generated Material
Businesses are rapidly adopting generative AI tools to craft brand names, logos, and product designs, dramatically speeding up creative workflows. This surge raises complex legal questions about who holds copyright and trademark rights when AI contributes to the work. The...
Argentina Repeals Pharmaceutical Patent Examination Guidelines
Argentina repealed its 2012 pharmaceutical patent examination guidelines on March 18, 2026, fulfilling commitments under the US‑Argentina Reciprocal Trade and Investment Agreement to harmonize IP standards. The outdated rules had excluded patents on crystalline forms, enantiomers, formulations and other biotech inventions, limiting...
USPTO Issues Updated Guidance on Patent Reexamination Practice
On April 1, 2026 the USPTO released new guidance that creates a “pre‑order” briefing option for patent owners in ex parte reexamination proceedings. Owners can submit a 30‑day, 30‑page brief before the agency decides on a third‑party request, influencing the Substantial New...
Aerospace Update | March 2026
The University of Alabama in Huntsville and aerospace firm ASKA are negotiating a joint drive‑and‑fly aircraft project, emphasizing the need for clear IP ownership, especially when public funds are involved. Concurrently, the ongoing war in Iran is accelerating demand for...
The Lion King Chant Roars Into Federal Court
South African composer Lebo M has filed a federal lawsuit against comedian Learnmore Jonasi, alleging the comedian’s viral joke mis‑translating the iconic Lion King chant damaged his reputation and commercial prospects. The complaint, filed in the Central District of California, seeks more...
Apple Verdict May Inform Jury Instruction in Patent Suits
A Texas jury cleared Apple of infringing Optis Wireless’s standard‑essential 4G patents, but the case reshaped how courts must instruct juries on § 101 eligibility. The Federal Circuit’s 2025 opinion required Step 2 instructions to explicitly identify the abstract idea and exclude...
EU Design Act: Designing the Future - Why the EU Design Act Matters for Medical Devices
The EU Design Act, taking effect on 1 May 2025 with technical rules due 1 July 2026, modernises EU design protection to cover digital and dynamic elements. It extends coverage to medical software interfaces, dashboards, and animations, and strengthens enforcement against unauthorised CAD files...
Latest Federal Court Cases: Fortress Iron, LP V. Digger Specialties, Inc.
The Federal Circuit affirmed a district court ruling that Fortress Iron's patent was invalid because it omitted a co‑inventor, Huang, and the error could not be corrected under 35 U.S.C. § 256(b). The court held that an inventor is a “party concerned” for...
USPTO Issues Final Rule Requiring U.S.-Registered Patent Practitioner Representation for Foreign Applicants and Patent Owners
The USPTO issued a Final Rule on March 20, 2026 requiring any foreign‑domiciled patent applicant, inventor, or owner to be represented by a U.S.-registered patent attorney or agent for all submissions. The rule takes effect on July 20, 2026 and applies to every filing...
From Content Creation to the Courtroom: Influencer Liability for Promoting Counterfeit Goods
Nike won an $11 million jury verdict against influencer Nicholas Tuinenburg for willful counterfeiting and trademark infringement, marking a pivotal court decision in March 2026. The Central District of California held the creator of “Divide The Youth” liable for promoting counterfeit Nike...