PODCAST: Williams Mullen's Trending Now: An IP Podcast - Cease and Desist Letters: Protecting Your Intellectual Property the Right Way
What Were the Cooler Wars? (Part 2) — No Infringement Intended Podcast
What Were the Cooler Wars? (Part 1) — No Infringement Intended Podcast
PODCAST: Williams Mullen's Trending Now: An IP Podcast - IP and M&A Transactions
AGG Talks: Cross-Border Business Podcast - Episode 20: Mastering ITC Section 337 Investigations
3 Key Takeaways | What Corporate Counsel Need to Know About Patent Damages
Patent Litigation: How Low Can You Go?
(Podcast) The Briefing: Netflix to Pay $2.5M to GoTV for Patent Infringement
The Briefing: Netflix to Pay $2.5M to GoTV for Patent Infringement
The Art of Teaching Complex Technology in Patent Litigation - IMS Insights Podcast Episode 67
The Briefing: Failure to Disclose Relationship with Real Party in Interest Results in Serious Sanctions
Podcast: The Briefing - Failure to Disclose Relationship with Real Party in Interest Results in Serious Sanctions
5 Key Takeaways | How to Effectively Leverage the Chinese Patent System
Estoppel Doctrine in China's Patent System
Donation (Disclosure-Dedication) Doctrine in China’s Patent Litigation
6 Key Takeaways | Patent Opinions – New Developments and Pitfalls
Patent Right Evaluation Report in China’s Patent System
Kidon IP War Stories: David Cohen & Daryl Lim
Protecting the PB&J – Preserving IP Rights from Concept to Market
Patent Marking in China
On August 14, 2025, Genentech filed BPCIA litigation No. 2:25-cv-14648 (D.N.J.) against Shanghai Henlius Biotech (“Henlius”) and Organon alleging infringement of 24 patents by Henlius / Organon’s proposed Perjeta®...more
ACI’s virtual Annual Passport to Proficiency on the Essentials of Hatch-Waxman and BPCIA equips early-career professionals with the legal and regulatory fluency needed to contribute meaningfully to product strategy and...more
On December 8, 2023, the PTAB instituted three of Samsung Bioepis’s pending IPRs against Alexion’s Soliris® (eculizumab), IPR2023-00933, IPR2023-00998, and IPR2023-00999. The challenged patents include composition of matter,...more
In what appears to be a case of first impression, on August 23, 2021 U.S. District Judge John Z. Lee of the United States District Court for the Northern District of Illinois denied a biosimilar applicant’s motion to dismiss...more
In a procedurally unusual decision (but one unsurprising in all other respects), the Federal Circuit on Monday affirmed a district court's denial of a temporary restraining order to keep off the market Amgen's biosimilar...more
On July 23, 2019, Amgen, maker of the cancer treatment drug Neupogen (filgrastim), filed patent infringement claims in the Southern District of California against Tanvex Biopharma over Tanvex’s proposed filgrastim biosimilar...more
The Federal Circuit affirmed a district court decision barring Amgen from asserting an infringement claim under the doctrine of equivalents against Coherus Biosciences because Amgen disclaimed all combinations not identified...more
INTRODUCTION & BACKGROUND - On May 8, 2019 in Amgen, Inc. v. Sandoz International GmbH, the Federal Circuit Court affirmed the district court’s judgment, concluding that the district court correctly construed the claims and...more
Decisions in the Amgen v. Sandoz case involving Sandoz’s biosimilar versions of Amgen’s Neupogen® and Neulasta® drugs have provided significant guidance to biosimilar litigants over the years. ...more
Coherus announced today that it has executed settlement agreements with AbbVie that grant Coherus global, non-exclusive, royalty-bearing license rights under AbbVie’s intellectual property to commercialize CHS-1420, Coherus’...more
As biosimilar litigation between Amgen, the maker of Enbrel® (etanercept), and Sandoz, the maker of biosimilar ErelziTM (etanercept-szzs) heads toward trial before Judge Claire Cecchi in the District of New Jersey, Sandoz is...more
Courts have begun to shape the contours of the Biologics Price Competition and Innovation Act (“BPCIA”) and the progress of biosimilar litigation, but the use of declaratory judgment actions by biosimilar manufacturers...more
Since the passage of the Biologics Price Competition and Innovation Act (BPCIA), 2017 has been the most active year yet for drug manufacturers. Fish attorneys Tasha Francis, Jenny Shmuel, and Brianna Chamberlin addressed the...more
On December 14, 2017, the U.S. Court of Appeals for the Federal Circuit again interpreted the Biologics Price Competition and Innovation Act ("BPCIA"). In Amgen Inc. et al. v. Sandoz Inc., 15-cv-1499 (Fed. Cir. 2017), the...more
On December 14, the Federal Circuit issued a decision that further clarifies the ground rules for disclosures of product information by manufacturers of biosimilar pharmaceutical products. In particular, the Federal Circuit...more
The Situation: The Biologics Price Competition and Innovation Act was considered in a November 2017 decision by the United States Court of Appeals for the Federal Circuit. The Result: The court found that the commercial...more
On November 13th, in an opinion drafted by Judge Taranto, the Federal Circuit affirmed the Southern District Court of Florida’s judgment that Apotex’s biosimilar versions of Neulasta® and Neupogen® do not infringe Amgen’s...more
The Federal Circuit issued its opinion in the Amgen v. Hospira appeal (16-2179) on August 10, 2017, dismissing the appeal for lack of jurisdiction and denying Amgen’s petition for a writ of mandamus. The decision affirmed...more
In the third installment of the "Amgen v." trilogy of BPCIA Federal Circuit cases, the Court in Amgen Inc. v. Hospira, Inc. answered a question that had been lingering since the very first case -- can a reference product...more
While the Supreme Court held in Amgen v. Sandoz that biosimilar applicants cannot be forced with a federal injunction to provide a copy of their biosimilar application (aBLA) and manufacturing information to the reference...more
A theme emerging in biosimilar litigation is when –and how much—discovery is available to reference product sponsors. The Supreme Court in Amgen v. Sandoz grappled with this issue in the spring, as it decided whether...more
On June 12, 2017, the Supreme Court handed down its opinion in Sandoz Inc. v. Amgen Inc., marking the first time the Court has interpreted the Biologics Price Competition and Innovation Act ("BPCIA") for the approval of...more
On May 10, 2017, Amgen filed a complaint in the District of Delaware asserting that, under section 35 U.S.C. § 271(e)(2)(C)(i) of the Biologics Price Competition and Innovation Act (“BPCIA”), Coherus infringed Amgen’s U.S....more
On April 26, 2017, the Supreme Court heard oral arguments in Sandoz Inc. v. Amgen Inc. from Sandoz counsel (Deanne E. Maynard), Amgen counsel (Seth P. Waxman), and presenting the opinion of the United States, an Assistant to...more
On April 26, 2017, the Supreme Court heard oral arguments in Sandoz Inc. v. Amgen Inc. Sandoz was represented by Deanne E. Maynard, and Amgen was represented by Seth P. Waxman. In addition, Anthony A. Yang presented the...more