Goodwin’s Annual Rare Disease Symposium
Life Sciences Perspectives
by Life Sciences Regulatory & Compliance Group
6d ago
Goodwin’s Life Sciences team will be hosting an upcoming event in our Boston office on March 13, 2024 to spotlight the critical work being done to address the 7,000+ rare diseases that impact more than 300 million people globally. Join us in person in our Boston office or attend virtually for our Annual Rare Disease Symposium on March 13, 2024. Look forward to an afternoon of engaging fireside chats, inspirational presentations, and networking with your peers in the rare disease community. This year’s program will include speakers covering the patient, advocacy, policy, research, and CEO’s pe ..read more
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Antitrust & Competition Life Sciences Year in Review 2023
Life Sciences Perspectives
by Antitrust Group
1w ago
Despite increasingly aggressive rhetoric from the agencies, 2022 was largely characterized as “business as usual” in the antitrust world. In contrast, 2023 featured a significant step up in enforcement activity, including multiple challenged transactions and lengthy investigations in the life sciences space. As notable, many of these enforcement activities involved more “novel” theories of harm — such as bundling, potential competition, and harm to research, development, and innovation — displaying a willingness by the Federal Trade Commission (FTC) to put its rhetoric into action. At the same ..read more
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Life Sciences Companies Make Up a Small Portion of the Companies Opting-In to the Unitary Patent; Ireland Announces Referendum Date
Life Sciences Perspectives
by Sabrina Poulos
1M ago
Life sciences companies continue to make up a small portion of the companies registering for Unitary Patents. Per the European Patent Office’s statistics portal, as of January 30, 2024 there have been 18,721 registered Unitary Patents. The Uptake Rate is 17.5%. Of this, Medical Technology companies account for 2,266 (or, 11.8%) of the registrations. This is the largest of the 35 technology fields that the portal is tracking. Pharmaceuticals account for 717 (or, 3.7%) of the registrations. Biotechnology accounts for 444 (or, 2.3%) of the registrations. Notably, Johnson & Johnson has the lar ..read more
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USPTO Publishes Enablement Guidelines in view of Amgen v. Sanofi
Life Sciences Perspectives
by Stephanie Dusaban Gonzales|Sabrina Poulos
1M ago
On January 10, 2024, the USPTO published guidelines for assessing enablement in view of Amgen v. Sanofi and other recent court cases (“the Guidelines”). The Guidelines state that they are not intended to “announce any major changes to USPTO practice or procedure” but instead “incorporat[e] guidance from the Amgen decision and several post-Amgen enablement court decisions that are consistent with current USPTO policy.” “The enablement requirement refers to the requirement of 35 U.S.C. § 112(a) that the specification must describe the invention in such terms t ..read more
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Federal Circuit Remands to USPTO to Clarify Analysis of Jepson-Format and Means-Plus-Function Claims in the Field of Biotechnology
Life Sciences Perspectives
by Stephanie Dusaban Gonzales|Sabrina Poulos
1M ago
On January 23, 2024, the U.S. Court of Appeals for the Federal Circuit (“Federal Circuit”) issued its decision granting the USPTO’s request to remand Xencor’s appeal of the rejection of U.S. Patent App. No 16/803,690 (“’690 patent application”) back to the USPTO. The USPTO requested remand so that the USPTO’s Appeals Review Panel can “clarify the USPTO’s position on the proper analysis of Jepson-format and means-plus function claims in the field of biotechnology, and particularly in the antibody art,” and issue “a revised decision.” The claims at issue in the ’690 patent application cover ..read more
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PTAB Issues Final Written Decision Finding Seagen Antibody-Drug Conjugate Patent Claims to be Unpatentable
Life Sciences Perspectives
by Greg Gutierrez
1M ago
On January 16, 2024, the Patent Trial and Appeal Board (PTAB) of the United States Patent and Trademark Office issued a Final Written Decision in a post-grant review (PGR) (PGR2021-00030) of claims in US Patent No. 10,808,039 (“the ’039 patent”) owned by Seagen. The PGR, filed by Daiichi Sankyo, Inc. and AstraZeneca Pharmaceuticals, LP, requested review of claims 1-5, 9, and 10 of the ’039 patent, which are directed to antibody-drug conjugates (ADC) capable of intracellular cleavage. The ’039 patent is at issue in a patent infringement lawsuit brought by Seagen against Daiichi Sankyo ..read more
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Master(ing) Protocols for Randomized Umbrella and Platform Trials
Life Sciences Perspectives
by Susan Lee|Emily Tribulski
1M ago
The U.S. Food and Drug Administration (FDA) recently issued a draft guidance, “Master Protocols for Drug and Biological Product Development”, that echoes and builds on principles that the Agency previously set forth in guidance for COVID-19 master protocols (2019), master protocols in oncology (2022) and clinical trials for multiple versions of cellular or gene therapy products (2022). The draft guidance offers numerous (and at times very detailed) recommendations to facilitate the design, efficient analysis of data, and regulatory review of clinical trials conducted under such master protocol ..read more
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A Look Ahead in Life Sciences: What We Are Tracking in Q1 2024 and Beyond
Life Sciences Perspectives
by Life Sciences Regulatory & Compliance Group
2M ago
As the life sciences, medtech, and diagnostic industries continue to expand and grow increasingly complex, so does the legal, regulatory, and compliance landscape. To help companies and investors navigate the many evolving and emerging laws and regulations across pharmaceuticals, biologics, medical devices, diagnostics, and laboratory testing, our Life Sciences Regulatory & Compliance team has provided an overview of key developments. We update and publish a quarterly tracker detailing these developments. You can read about the Q1 2024 updates here. The post A Look Ahead in Life Sciences ..read more
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FDA Targets April 2024 for Laboratory Developed Test (LDT) Final Rule
Life Sciences Perspectives
by Steven Tjoe|Matt Wetzel|Liz Caruso
3M ago
On December 6, 2023, the Office of Information and Regulatory Affairs (“OIRA”) released the Fall 2023 Unified Agenda of Regulatory and Deregulatory Actions (the “Agenda”), a semiannual compilation of information regarding regulations under development by federal agencies. In its preamble, the Department of Health and Human Services (“HHS”) notes that the regulatory actions forecasted for the Agenda reflect the priorities of HHS Secretary Xavier Becerra and the Biden-Harris Administration, HHS, and the U.S. Food and Drug Administration (“FDA”). As we analyzed in detail in recent articles (see h ..read more
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A Practical Look at OIG’s New Compliance Guidance
Life Sciences Perspectives
by Gregory Demske|Matt Wetzel|Miranda Hooker|Ilene Albala|Heath Ingram
3M ago
On November 6, 2023, for the first time in 15 years, HHS OIG issued a new reference guide for the health care compliance community – the General Compliance Program Guidance, or GCPG. While the GCPG does not set new legal standards and largely reinforces existing guidance, it is a tremendous tool to help health care and life sciences companies advance their compliance efforts. Indeed, within its 91 pages, the GCPG provides the most comprehensive and user-friendly trove of health care compliance insights, tips, and guidance ever provided by the federal government. Read the full alert here. The p ..read more
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