Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 247: Reimagining Cell Therapy for Solid Tumors with Ming-Wei Chen and Fangheng Zhou of RephImmune
HHS Policy Changes, Supreme Court Rulings, and the DOJ-HHS False Claims Act Working Group
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 246: The Next Generation of Treatment for Alzheimer's and Parkinson’s with Neal Goodwin and Pawel Krysiak of Jaya Bio
AI Today in 5: August 11, 2025, The ACHILLES Project Episode
False Claims Act Insights - Bitter Pills: DOJ Targets Pharmacies for FCA Enforcement
Key Discovery Points: BYOD Case Law Covering Subpoenas and Employee Handbooks
Daily Compliance News: June 23, 2025, The Is Walmart Cool Edition
Taking the Pulse: A Health Care & Life Sciences Video Podcast | Episode 239: Understanding the 340B Pricing Program with Chuck Melendi of Disruptive Dialogue
Unexpected Paths to IP Law with Dan Young and Colin White
Navigating Legal Strategies for Covering GLP-1s in Self-Insured Medical Plans — Employee Benefits and Executive Compensation Podcast
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 234: Life-Saving Collaboration in the Life Sciences Industry with John Crowley, President & CEO of BIO
AGG Talks: Cross-Border Business Podcast - Episode 28: How Life Sciences Companies Can Create a Culture of Compliance When Expanding to the U.S. Market
How Life Sciences Companies Can Create a Culture of Compliance When Expanding to the U.S. Market
Podcast - Hot Topics in FDA Regulation: GLP-1s, LDTs, AI and More
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 231: Advancing the Life Sciences Industry with Kendalle O’Connell of MassBio
Compliance Program Effectiveness: Keep it Streamlined and Strategic
AGG Talks: Cross-Border Business Podcast - Episode 26: U.S. Enforcement Trends Targeting Foreign Pharmaceutical and Medical Device Manufacturers
Podcast — Drug Pricing: 2025 J.P. Morgan Healthcare Conference Takeaways and Outlook
Prescribing GLP-1 Medications: Be Aware of Legal Limitations
Podcast — The Growth Rocketship: How BridgeBio’s Hub and Spoke Portfolio Strategy Set the Market for the Future of Biotech — Then, Now, and What’s Next?
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 November 30, 2023, Celltrion announced that it filed for an abbreviated Biologics License Application (aBLA) for FDA approval of CT-P41 (denosumab), a proposed biosimilar of Amgen’s Prolia® / Xgeva® (denosumab)...more
Innovent Biologics, Inc. announced the results of the Phase III ORIENT-31 study evaluating sintilimab in combination with BYVASDA (bevacizumab biosimilar) for the treatment of non-squamous non-small cell lung cancer. ...more
In December, in Amgen v. Hospira, 944 F.3d 1327 (Fed. Cir. 2019), a panel of the Federal Circuit issued the first decision applying the statutory Safe Harbor of 35 U.S.C. § 271(e)(1) to BPCIA patent litigation. ...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
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
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
In an opinion issued on December 14, 2017, the United States Court of Appeals for the Federal Circuit held that the 2010 Biologics Price Competition and Innovation Act (“BPCIA”) preempts the use of state law to penalize...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
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
In a landmark ruling for the biotech and pharmaceutical industries, a unanimous Supreme Court decided Sandoz Inc. v. Amgen Inc., 582 U.S. ____, Nos. 15-1039, 15-1195 (June 12, 2017), its first biosimilar case governed by the...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 Wednesday, April 26, the Supreme Court will hear oral arguments in the Sandoz Inc. v. Amgen Inc. case. This case involves the interpretation of the Biologics Price Competition and Innovation Act ("BPCIA"), which will be...more
2016 was a record year for the development of biologics in the United States. Below, we summarize a few key biosimilar developments to keep an eye on in 2017. SCOTUS Review of Amgen v. Sandoz - In 2016, Amgen,...more
Responding to the Supreme Court’s request for its views, the Solicitor General recently recommended granting certiorari and reversing some of the Federal Circuit’s key holdings in Amgen v. Sandoz (Nos. 15-1039 & 15-1195)....more
The Federal Circuit has now issued two decisions interpreting the Biologics Price Competition and Innovation Act of 2009 (BPCIA). In Amgen v. Sandoz, the first decision to interpret the BPCIA, the majority held that...more
The first biosimilar makers to file regulatory applications with FDA attempted to bypass all or a subset of the patent litigation provisions of the Biologics Price Competition and Innovation Act of 2009 (BPCIA). Apotex, the...more
Under 35 U.S.C. § 271(e), filing an Abbreviated Biologics License Application (aBLA)—like filing an Abbreviated New Drug Application (ANDA)— can be an act of patent infringement resulting in ‘artificial’ injury to a patentee....more
In Amgen Inc. v. Sandoz Inc. (No. 2015-1499), a fractured panel of the Federal Circuit Court of Appeals recently decided two issues of first impression relating to the Biologics Price Competition and Innovation Act of 2009...more
On July 21, 2015, brand-name biologics companies and companies developing biosimilars received a split in a significant decision with industry-wide ramifications in the high-stakes battle about how and when biosimilar...more
As we have been reporting this week, the Federal Circuit handed down its decision in Amgen Inc. v. Sandoz Inc. -- a case of first impression relating to the Biologics Price Competition and Innovation Act ("BPCIA") for...more
The courts must “say what the law is,” even when that law, as Judge Lourie described the BPCIA, is “a riddle wrapped in a mystery inside an enigma.” Today, in Amgen Inc. v. Sandoz Inc., No. 2015-1499 (Fed. Cir. July 23,...more