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
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
In a recent decision, the Patent Trial and Appeals Board (“PTAB”) exercised its discretion under 35 U.S.C. § 314(a) to deny institution of an inter partes review (“IPR”) after applying the Fintiv factors, despite Petitioner’s...more
On May 1, 2025, the Patent Trial and Appeal Board (PTAB) denied institution of inter partes review (IPR) of U.S. Patent No. 11,140,841 in the case of Aardevo North America, LLC v. Agventure B.V. The patent in question, owned...more
In a decision that underscores the primacy of prosecution history to determine claim scope, the US Court of Appeals for the Federal Circuit reversed the Patent Trial & Appeal Board’s interpretation of the transitional phrase...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
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
AGILENT TECHNOLOGIES, INC. v. SYNTHEGO CORP. - Before Prost, Linn, and Reyna. Appeal from the Patent Trial and Appeal Board. Obviousness does not require all claimed limitations to be expressly disclosed in a primary prior...more
On June 11, 2025, the U.S. Court of Appeals for the Federal Circuit decided Agilent Technologies, Inc. v. Synthego Corp. (No. 23-2186), addressing enablement of prior art references for disputed CRISPR-Cas9 gene-editing...more
In a decision underscoring the distinct standards governing enablement under §§ 102 and 112, the US Court of Appeals for the Federal Circuit affirmed the Patent Trial & Appeal Board’s finding that a prior art reference was...more
Restem filed a petition for inter partes review of U.S. Patent No. 9,803,176, directed to stem cells obtained from umbilical cord tissue and isolated through a two-step process to create a specific cell marker expression...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
Regents of the Univ. of California v. Broad Inst., Inc., No. 2022-1594, 2025 WL 1363125 (Fed. Cir. May 12, 2025) - On May 12, 2025, the U.S. Court of Appeals for the Federal Circuit vacated the Patent Trial and Appeals...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
It is relatively uncommon for parties to submit expert declarations in the preliminary-response phase of an IPR proceeding, but recently the Patent Owner in Imperative Care, Inc. v. Inari Medical, Inc. effectively used that...more
On March 13, 2025, the US Court of Appeals for the Federal Circuit (Federal Circuit) issued a decision titled In Re: Xencor, Inc. (the Xencor decision). The Xencor decision affirms the decision of the Appeals Review Panel...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
In re: Xencor, Inc., Appeal No. 2024-1870 (Fed. Cir. Mar. 13, 2025) Our case of the week is an appeal from a decision of the Appeals Review Panel of the Patent Trial and Appeal Board, concerning Xencor’s patent application...more
In a precedential opinion issued on March 6, the Federal Circuit affirmed the US District Court for the Eastern District of Virginia that the claims in ImmunoGen’s US patent application 14/509,809 (“the ’809 application,”...more
In the biotechnology and chemical spaces, genus claims are often sought by patent applicants to protect not only a specific product of interest, but also as a means to protect against others making related products that...more
1. Background: ImmunoGen’s Patent Application & Dispute - In 2014, ImmunoGen, Inc. (Immunogen) filed U.S. Patent Application No. 14/509,809 (the ’809 application)....more
On February 28, 2025, Amgen filed three IPRs against Bristol-Myers Squibb’s patents covering methods of treatment using a combination of Opdivo® (nivolumab), an anti-PD-1 antibody, and Yervoy® (ipilimumab), an anti-CTLA-4...more