News & Analysis as of

Intellectual Property Protection Food and Drug Administration (FDA) Biotechnology

Rothwell, Figg, Ernst & Manbeck, P.C.

Beyond Guinea Pigs: Patent Risks and Opportunities in AI-Enabled Drug Development

On April 10, 2025, the U.S. Food and Drug Administration (FDA) announced a landmark initiative to phase out animal testing in drug development, signaling a major shift toward human-relevant, science-driven alternatives. This...more

Foley & Lardner LLP

The Patent Eligibility Restoration Act and Life Sciences Innovation

Foley & Lardner LLP on

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

Troutman Pepper Locke

Exclusive Licensing May Offer Biotechs a Financial Lifeline

Troutman Pepper Locke on

With volatile market conditions and recent FDA shakeups, biotech companies are increasingly focused on bolstering cash runways and accelerating R&D efforts. But fierce competition for financing has some biotechs turning to...more

Fish & Richardson

The Not-So-Safe Harbor for Research Tools: Lessons From the District of Delaware

Fish & Richardson on

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

Wilson Sonsini Goodrich & Rosati

[Event] Biotech Summit 2024 - October 9th - 10th, Boston, MA

Wilson Sonsini’s inaugural Biotech Summit will address topics of critical importance to Biotech and Biopharmaceutical companies, including early and late-stage venture financing, partnering strategies, current and future AI...more

Goodwin

Amgen and Sandoz Settle Denosumab BPCIA Litigation

Goodwin on

As we previously reported, in May 2023, Amgen filed a BPCIA complaint in the District of New Jersey alleging infringement based on Sandoz’s denosumab biosimilars of Amgen’s PROLIA and XGEVA (“the Sandoz Denosumab...more

Knobbe Martens

USPTO Issues Training Materials to Examiners for Searching FDA and NIH Resources

Knobbe Martens on

On March 20, 2024, The USPTO issued an alert, notifying practitioners that the USPTO had developed training materials for patent examiners regarding searching for prior art in FDA and NIH databases. ...more

Venable LLP

Celltrion Submits an aBLA for Actemra® (tocilizumab) Proposed Biosimilar CT-P47

Venable LLP on

On January 28, 2024 Celltrion announced the submission to the FDA of an aBLA for CT-P47, a proposed biosimilar of Genentech’s Actemra® (tocilizumab). This is the third publicly announced aBLA filing for an...more

Morrison & Foerster LLP

Comment on Morphing U.S. Biotechnology Regulations

Morrison & Foerster LLP on

The U.S. Department of Agriculture (USDA) and U.S. Patent and Trademark Office (USPTO) have recently opened requests for stakeholder engagement regarding biotechnology regulatory frameworks. These requests provide the...more

American Conference Institute (ACI)

[Event] 6th Annual Summit on Life Sciences IP Due Diligence - November 28th - 29th, Boston, MA

ACI’s 6th Annual Life Sciences IP Due Diligence Summit is devoted to providing corporate and IP counsel with expert strategies for assessing, valuing, and commercializing IP assets when conducting strategic IP due diligence –...more

Morgan Lewis

Blockbuster Biologics Review | Issue 16

Morgan Lewis on

Welcome to our quarterly update relating to biologics and biosimilars, including post-grant and patent litigation challenges to blockbuster biologics. Since the enactment of the Biologics Price Competition and Innovation Act...more

Morgan Lewis

Blockbuster Biologics Review Issue 15

Morgan Lewis on

Welcome to our quarterly update relating to biologics and biosimilars, including post-grant and patent litigation challenges to blockbuster biologics. Since the enactment of the Biologics Price Competition and Innovation Act...more

Proskauer - The Patent Playbook

GSK v. Teva: Federal Circuit Issues New Opinion Analyzing Induced Infringement

On August 5, 2021, the Federal Circuit withdrew its October 2020 opinion in GSK v. Teva, summarized in this post on induced infringement of method-of-treatment claims, and issued an opinion that reiterated the prior holding...more

Hogan Lovells

Life Sciences and Health Care Horizons - 2020

Hogan Lovells on

We are pleased to provide you with the third annual installment of our Life Sciences and Health Care Horizons guide. For each of these guides, we have asked our industry thought leaders throughout the world to write about...more

Herbert Smith Freehills Kramer

BPCIA Scope Widens: 2020 Spending Bill Moves Chemically Synthesized Polypeptides to Biologic Status

Buried in a 2020 spending bill passed in December 2019 is a provision that amends the definition of “Biological Product” in the Biologics Price Competition and Innovation Act of 2009 (BPCIA) and thereby expands the products...more

American Conference Institute (ACI)

[Event] Biosimilars Summit – Legal, Regulatory, and Commercial Strategies – June 24th-25th, New York City, NY

2019 marks the 9th anniversary of the Biologics Price Competition and Innovation Act (BPCIA). ACI has been with you from the introduction of the first House and Senate bills through to the actual signing of the law. As we...more

Foley & Lardner LLP

Guidebook: Cybersecurity in the Pharma, Biotech, and Medical Devices Industries

Foley & Lardner LLP on

As a life sciences or medical device company, it is mission critical to protect lab books, drug and clinical test data, product formulas and production processes that underlie your patents, trade secrets and know-how from...more

Foley & Lardner LLP

Three Pressing Challenges for Personalized Medicine

Foley & Lardner LLP on

Personalized medicine can be described as the science of targeted therapies. Advances in diagnostic and molecular medicine have made it possible to more precisely identify alternative treatment options for patients based on...more

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