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?
On July 24, 2025, Acting Director of the USPTO, Coke Morgan Stewart, denied institution of inter partes review in IPR2025-00601 and IPR2025-00602, but referred the petition in IPR2025-00603 to the Board in Amgen Inc. v....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
The Trump administration is considering changing the U.S. patent maintenance fee structure from the existing three fixed flat fees to an annual, value‑based “tax” model where patent holders would pay 1%–5% of the estimated...more
On June 30, 2025, the Federal Circuit issued a precedential opinion in Eye Therapies v. Slayback Pharma in which the court interpreted the transition phrase “consisting essentially of” to be a closed term excluding other...more
The WSJ reports the Trump administration wants to charge patent holders 1% to 5% of their patent’s value to maintain the patent after grant. If implemented, this would mark a dramatic departure from the traditional flat-fee...more
On July 24, 2025, the PTO Acting Director Coke Morgan Stewart discretionarily denied Amgen’s IPR2025-00601 and IPR2025-00602 challenging Bristol-Myers Squibb’s (“BMS”) U.S. Patent Nos. 9,856,320 (“the ’320 patent”) and...more
Cell and gene therapies represent a transformative frontier in modern medicine, offering potential cures for previously untreatable conditions. However, securing intellectual property (IP) protection for these innovations...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
As has been noted recently (Agilent Technologies, Inc. v. Synthego Corp.), fact-based decisions from the U.S. Patent and Trademark Office (typically from the Patent Trial and Appeal Board) are reviewed under the substantial...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
On May 1, 2025, Senators Chris Coons (D-DE), Thom Tillis (R-NC), Dick Durbin (D-IL), and Mazie Hirono (D-HI) reintroduced the Promoting and Respecting Economically Vital American Innovation Leadership (PREVAIL) Act. The...more
Patent claims reciting compounds where at least one group of a compound genus is defined by its function are common. For example, familiar claim terms such as “chelating moiety,” “linker,” and “binding moiety” describe a...more
The CRISPR-Cas9 patent landscape remains complex and unsettled. The Federal Circuit’s latest decision in University of California v. Broad Institute1 revived the high-stakes dispute between UC2 and Broad3 over foundational...more
The Federal Circuit recently affirmed a district court’s holding that patent term extension (PTE) for a reissued patent was properly based on the issue date of the original patent and not that of the reissued patent. The...more
This week, we take a closer look at two precedential cases concerning pharmaceutical patent protections as applied to drugs in development. In Incyte Corp. v. Sun Pharm., Judge Hughes entered a dissent pushing back on the...more
Insulin Glargine Challenged Claim Types in IPR and Litigation: Claims include those challenged in litigations and IPRs. Claims are counted in each litigation and IPR, so claims from the same patent challenged in multiple...more
At ACI’s 23rd Advanced Summit on Life Sciences Patents, you can expect informational overviews and thorough discussion of every facet of the industry. In a time of major legislative, regulatory, and judicial change, you can't...more
Artificial intelligence is revolutionizing life science R&D (particularly in the realm of drug discovery) and challenging the traditional "human inventorship" requirement for U.S. patents. Recent guidance from the USPTO...more
The U.S. Court of Appeals for the Federal Circuit (CAFC) recently considered a novel question regarding calculation of the regulatory review period for patent term extension (PTE) under 35 USC § 156 for reissued patents....more
As we previously discussed, beginning in 2022, a series of patent infringement lawsuits were filed against Moderna and collaborators Pfizer+BioNTech seeking damages based on their respective sales of the Spikevax® and...more
In 1910, German scientist Paul Ehrlich introduced a groundbreaking concept to the world: chemical compounds could be engineered to interact with unique receptors on disease-causing cells while avoiding interaction with...more
In 2024, not one but two Nobel Prizes (in Chemistry and Physics) were awarded to researchers for their work in artificial intelligence ("AI"). Particularly noteworthy for the life science community is the Nobel Prize in...more
Addressing the calculation of patent term extensions (PTEs) under the Hatch-Waxman Act, the US Court of Appeals for the Federal Circuit affirmed a district court decision that under the act the issue date of the original...more
Welcome to the first issue of the BakerHostetler Life Sciences Newsletter! Within it you will find an overview of noteworthy developments in the life sciences space and at BakerHostetler. ...more
On March 13, 2025, the Federal Circuit issued a decision in Merck Sharp & Dohme B.V. v. Aurobindo Pharma USA, Inc., No. 23-2254 (Fed. Cir. 2025) that clarifies how patent term extension (PTE) is calculated for reissue...more