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?
Under a new U.S. Patent and Trademark Office (“USPTO”) policy issued in March 2025, pre-institution inter partes review (“IPR”) proceedings are now bifurcated, consisting of a first phase in which the director considers...more
Under a new U.S. Patent and Trademark Office ("USPTO") policy issued in March 2025, pre-institution inter partes review ("IPR") proceedings are now bifurcated, consisting of a first phase in which the director considers...more
Biosimilar Litigations include litigations relating to biosimilar/follow-on products of CDER-listed reference products. Litigations between biosimilar applicants/manufacturers and reference product sponsors as well as...more
Precedential and Key Federal Circuit Opinions - TEVA BRANDED PHARMACEUTICAL PRODUCTS R&D, INC. v. AMNEAL PHARMACEUTICALS OF NEW YORK, LLC [OPINION] (2024-1936, 12/20/2024) (Prost, Taranto, Hughes) - Prost, J. The...more
As 2021 comes to a close, Big Molecule Watch reviews the top five biosimilar regulatory developments of the year... President Biden Signs Orange Book Transparency Act - In January, we reported that President Biden...more
As we noted in this article on PTAB Trial Insights, Senator Hatch (R-UT) has introduced the Hatch-Waxman Integrity Act, which is intended to restore the brand-generic balance many say has been skewed by Inter Partes Review...more
The battle between Mylan and Allergan over the six Orange Book patents covering Restasis has taken a next formal step. On Sept. 22, the new patent-owner, the Saint Regis Mohawk Tribe, moved to dismiss Mylan’s requests for...more
In Amerigen Pharmaceuticals Limited v. Shire LLC, IPR2015-02009 (March 31, 2017), the PTAB granted Shire’s Motion to Amend the claims in U.S. Reissued Patent RE 42,096, listed in the FDA’s Orange Book as covering Shire’s...more
At the end of March, the Intellectual Property Counsels' Committee (IPCC) of the Biotechnology Innovation Organization (BIO) held its Spring meeting, convening in-house counsel and outside counsel involved in patenting the...more
The America Invents Act established inter partes review and post-grant reviews mechanisms to challenge the validity of issued United States patents. These procedures were created to improve patent quality, and were introduced...more
In three petitions filed on the same day in 2013, styled Amneal v. Supernus, Amneal filed what appears to be the first challenge of Orange Book listed pharmaceutical patents that led to institution followed by a final...more
Neither the statutes nor the regulations governing Inter Partes Review (IPR) require the party challenging the patent to have been charged with infringement, or even to establish any interest in practicing the claimed subject...more