Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 243: HIPAA Compliance and Potential Changes with Shannon Lipham of Maynard Nexsen
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 242: Business Planning in Healthcare & Life Sciences with Jennifer McEwen of Maynard Nexsen
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 241: Fighting Nurse Burnout with Data-Driven Innovation with Dr. Ecoee Rooney of Indicator Sciences
Unexpected Paths to IP Law with Dan Young and Colin White
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 237: Tackling Cancer with Cellular Immunotherapy with Dr. Leonardo Ferreira of Torpedo Bio
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 236: Advocating for Accessible Diagnoses with Sydney Severance of Operation Upright
Taking the Pulse: A Health Care and Life Sciences Video Podcast | Episode 235: Revolutionizing Cancer Care with Eric Perrault of Kiyatec
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
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 233: Prioritizing Women’s Health Through Innovation with Lindsey Calcutt of Incora Health
Taking the Pulse: A Health Care and Life Sciences Video Podcast | Episode 232: Commercial Real Estate for Life Sciences Companies with Vinnie Durand of Savills
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
Episode 230: Innovations in Cancer Treatment with Dr. Ray DuBois of MUSC Hollings Center
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 229: Public Health in South Carolina with Dr. Edward Simmer of SC Dept of Public Health
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 228: Designing & Manufacturing Auto-Injectors with Kimberlee Steele of SHL Medical
AGG Talks: Cross-Border Business Podcast - Episode 27: U.S. Healthcare Reimbursement Guidance for Foreign Life Sciences Companies
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 227: What’s Next for America’s Life Sciences Industry with Arda Ural of EY
Taking the Pulse, A Health Care and Life Sciences Video Podcast | SCbio 2025 Preview with President & CEO James Chappell
The biotechnology and life science sectors underpin breakthroughs in health care, agriculture, and environmental sustainability by leveraging living systems to create next-generation medicines, diagnostics, and bio-based...more
On May 12, 2025, the Federal Circuit issued a decision in Regents of the Univ. of California v. Broad Inst., Inc.1 concerning the ongoing priority dispute relating to competing inventor groups for the CRISPR-Cas9 eukaryotic...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
On May 12, 2025, the U.S. Court of Appeals for the Federal Circuit (CAFC) revived the Regents of the University of California’s (Regents) challenge to the Broad Institute’s CRISPR-Cas9 patents, overturning a 2022 decision by...more
For many, the journey to IP law is circuitous. And that’s undoubtedly true for Wolf Greenfield Shareholder Dan Young and Technology Specialist Colin White. Both had interesting careers outside of the legal industry before...more
For the past decade, controversy regarding the laws of patent eligibility has created uncertainty in the minds of inventors and investors, especially in the biotechnology, medical diagnostics, and software industries adjacent...more
On May 12, 2025, the U.S. Court of Appeals for the Federal Circuit issued a long-awaited decision in Regents of the University of California v. Broad Institute (Nos. 22-1594, 22-1653) addressing priority for disputed...more
Addressing the distinction between conception and reduction to practice and the requirement for written description in the unpredictable arts, the US Court of Appeals for the Federal Circuit explained that proof of conception...more
Key Takeaways: Federal Circuit Reopens CRISPR-Cas9 Priority Fight. The CAFC vacated the PTAB’s earlier ruling that UC lacked prior conception of CRISPR-Cas9 in eukaryotic cells, remanding the interference for reconsideration...more
The Regents of the University of California v. The Broad Institute, Inc., Appeal Nos. 2022-1594, -1653 (Fed. Cir. May 12, 2025) Must an inventor know their invention will work to demonstrate that they “conceived” of it? ...more
Those hoping the Court of Appeals for the Federal Circuit would finally resolve priority in the long-pending dispute between the University of California and the Broad Institute will have to wait a little longer. Oral...more
The use of microorganisms in human industry is ancient, but has increased markedly in recent years. The modern recognition of the role of microbial communities in the human body has intensified innovation in fields like...more
The Budapest Treaty on the International Recognition of the Deposit of Microorganisms for the Purposes of Patent Procedure is an international agreement to establish a uniform system for depositing microorganisms and other...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
IN RE: XENCOR, INC. Before Hughes, Stark, and Schroeder (sitting by designation). Appeal from the U.S. Patent and Trademark Office, Patent Trial and Appeal Board. To provide adequate written description for a Jepson claim,...more
Synopsis: In a case with implications for the litigious molecular diagnostics space and written description law, Chief Judge Connolly of the District of Delaware reversed a $96 million jury verdict in favor of Natera,...more
Inventions made in a particular country are generally first-filed in that country before entering the United States via a direct Paris Convention filing or, more commonly, a PCT national stage entry. Convenience, national...more
Earlier this month, the Federal Circuit decided a subject matter eligibility case closely watched in the pharmaceutical industry. The case involved composition-of-matter claims reciting measured results. Reversing the...more
The Federal Circuit affirmed six PTAB decisions that held unpatentable as obvious 79 claims of three Cytiva Bioprocess (“Cytiva”) challenged patents and reversed the PTAB decision upholding four claims....more
The U.S. Patent and Trademark Office has a history of attempting to challenge judicial decisions that the Office, usually for its own policy reasons, takes issue with.[1] Recently, the Office decided to challenge the...more
The landmark legal battle over who owns the intellectual property rights in genetically modified plants is heating up. Originally published in Law360 - October 23, 2024....more
The District of Delaware recently denied a motion to dismiss a patent infringement complaint involving gene editing technology that sought relief under the Safe Harbor Provision of the Hatch-Waxman Act. Specifically, the...more
In BlueAllele Corp. v. Intellia Therapeutics, Inc., 2024 U.S. Dist. Lexis 222094 (D. Del. Dec. 9, 2024)1, the District of Delaware addressed several issues relevant to the safe harbor defense in Hatch-Waxman litigation. ...more
From potential legal challenges to Chinese biopharma supply chains, Europe’s new Unified Patent Court (UPC), landmark decisions in life sciences, pharma’s Orange Book listings, design patent rejections, and likely shifts at...more
On October 14, 2024, Accord BioPharma, Inc. announced that the FDA has approved IMULDOSA (ustekinumab-srlf), a biosimilar to Johnson & Johnson’s STELARA (ustekinumab), indicated for the treatment of chronic...more