PODCAST: PODCAST: Williams Mullen's Trending Now: An IP Podcast - Cease and Desist Letters: Protecting Your Intellectual Property the Right Way
(Podcast) The Briefing: Who Owns Jack Nicklaus? Lessons for The Creator Economy From a Brand Battle
The Briefing: Who Owns Jack Nicklaus? Lessons for The Creator Economy From a Brand Battle
The Briefing: When a TikTok Costs You $150,000 - Copyright Pitfalls in Influencer Marketing
A Guide to SEP: Standard Essential Patents for Tech Startups
What Were the Cooler Wars? (Part 1) — No Infringement Intended Podcast
Season 6 Ep #1 IP State of the Union- Billion Dollar Character Acquisitions- Part 1
(Podcast) The Briefing: 2025 IP Resolutions Start With a Review of IP Assets
The Briefing: 2025 IP Resolutions Start With a Review of IP Assets
A Conversation with Phil Hamzik
PODCAST: Williams Mullen's Trending Now: An IP Podcast - IP and M&A Transactions
Implementing IP Best Practices to Maximize Exit Value
4 Tips for Protecting Your AI Products
The Briefing: How to Avoid Bearing The Risks of A Naked License (Featured Podcast)
The Briefing: How to Avoid Bearing The Risks of A Naked License (Featured)
3 Key Takeaways | Corporate Perspectives on Intellectual Property
PODCAST: Williams Mullen's Trending Now: An IP Podcast - Artificial Intelligence: Issues Affecting Creators, Writers and Artists
3 Key Takeaways | New York State Bar Association IP Section Annual Meeting
From Academia to the Marketplace: The Ins and Outs of University Spinout Licenses with Dan O’Korn
#WorkforceWednesday: Invention Ownership - Why the Tense Matters in Employee IP Provisions - Employment Law This Week® - Spilling Secrets Podcast
On February 10, 2025, Bio-Thera Solutions, Ltd. announced that they entered into an exclusive licensing agreement with Intas Pharmaceuticals Ltd. to commercialize BAT2506 (golimumab), Bio-Thera’s proposed biosimilar of...more
On February 29, Biocon Biologics Ltd announced that it signed a settlement and license agreement with Janssen Biotech Inc. and Johnson & Johnson (“J&J”) regarding Bmab 1200, Biocon’s proposed biosimilar to STELARA....more
Insulin Biosimilars: Meitheal Pharmaceuticals, Inc. has announced an exclusive licensing agreement with Tonghua Dongbao Pharmaceuticals Co., Ltd. to commercialize Tonghua Dongbao’s three insulin biosimilars (insulin...more
Gain a comprehensive understanding of Hatch-Waxman and BPCIA essentials, a critical competency for legal and business professionals in the biopharmaceutical arena. Attend ACI’s Hatch-Waxman and BPCIA Proficiency Series...more
Alvotech Holdings S.A. (“Alvotech”) announced on February 28th that the U.S. Food and Drug Administration (FDA) has accepted for review the company’s Biologics Licensing Application (BLA) for ATV02 (100 mg/mL) that includes...more
Samsung Bioepis, Co. Ltd. and Biogen Inc. announced yesterday that their biosimilar product BYOOVIZ™ (ranibizumab-nuna) was approved by FDA. BYOOVIZ™ is a biosimilar to LUCENTIS®, which is indicated for the treatment of...more
New federal legislation will take effect this year that will require a reference product sponsor to submit to the FDA a list of any patents identified to a biosimilar applicant during the patent dance. The FDA is required to...more
This year, the BPCIA turns 10! As we prepare to enter the next decade of this revolutionary law, we cordially invite you to join us for ACI’s 11th Annual Biosimilars & Innovator Biologics Summit, in a fully virtual,...more
Hear from the FDA and the leaders of the biosimilars and innovator biologics industries about the impact of the pandemic on the global IP market and gain practical guidance for what is coming down the pipeline. The novel...more
On February 6, 2020, the U.S. Food and Drug Administration (“FDA”) issued a draft guidance (“Guidance”) that addresses the licensure of a biosimilar or biosimilar interchangeable product for fewer than all of the conditions...more
In passing H.R. 1865, the Further Consolidated Appropriations Act, 2020 (“FCAA”), on December 20, 2019, Congress adopted a number of changes to the BPCIA that impact biosimilars. Under the BPCIA, approved NDAs for biological...more
On November 7, Teva Pharmaceuticals USA, Inc., and Celltrion, Inc., announced that TRUXIMA® (rituximab-abbs) will be available in the United States beginning November 11. As we previously reported, TRUXIMA® is the first...more
Interview with Dr. Daniel Burnett of Theranova LLC - Wilson Sonsini Goodrich & Rosati partner James Huie recently interviewed Dr. Daniel Burnett, president and CEO of TheraNova. TheraNova is an experienced medical device...more
The U.S. Supreme Court rendered its first interpretations of the biosimilar patent dispute resolution procedures of the Biologics Price Competition and Innovation Act (BPCIA), ruling largely in favor of Sandoz on both issues...more
The FDA approved label for the first U.S. biosimilar, Sandoz’s Zarxio, has raised concerns. Zarxio was launched on September 3, 2015 with a label that does not state that the product was approved as a biosimilar to Amgen’s...more
On June 3, 2015, the Federal Circuit heard oral argument on Amgen Inc.’s (“Amgen”) appeal of the Northern District of California’s decision holding that the Biologics Price Competition and Innovation Act’s (“BPCIA’s”) “patent...more
The U.S. Food and Drug Administration rejected Amgen Inc.’s request that biosimilars makers be forced to share their applications and manufacturing processes with competitors, exacerbating the company’s recent defeat in...more