News & Analysis as of

United States Patent and Trademark Office Biotechnology Pharmaceutical Industry

The U.S. Patent and Trademark Office is an agency of the United States Department of Commerce that serves a fundamental role in the U.S. intellectual property system by issuing patents and registering trademarks.... more +
The U.S. Patent and Trademark Office is an agency of the United States Department of Commerce that serves a fundamental role in the U.S. intellectual property system by issuing patents and registering trademarks.    less -
Foley & Lardner LLP

Patent Fees Reimagined: Evaluating the Trump Administration's Value-Driven Fee Structure and Its Impact on Innovators

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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

MoFo Life Sciences

What Makes a Good Cell and Gene Therapy Application?

MoFo Life Sciences on

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

American Conference Institute (ACI)

[Event] 23rd Advanced Summit on Life Sciences Patents - May 19th - 20th, New York, NY

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

Wolf, Greenfield & Sacks, P.C.

A Look Ahead: Key Intellectual Property Legal Developments in 2024 - and What to Expect in 2025

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

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

Key Inventorship Considerations in AI-assisted Drug Development

The utilization of artificial intelligence (“AI”) is becoming ubiquitous across a wide range of industry sectors. The biotech industry is no exception. AI-driven platforms have become increasingly useful to biotech...more

Wilson Sonsini Goodrich & Rosati

The Life Sciences Report – June 2024

This latest edition features articles on biotech client Siolta Therapeutics, the use of safety and efficacy findings to extend drug exclusivity periods, life sciences venture financings for clients in 2023, and updated USPTO...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

Goodwin

Federal Circuit Remands to USPTO to Clarify Analysis of Jepson-Format and Means-Plus-Function Claims in the Field of Biotechnology

Goodwin on

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...more

Akin Gump Strauss Hauer & Feld LLP

US Seeks Comments on Text for WIPO Genetic Resources Treaty

Summary - Last year the World Intellectual Property Organization (WIPO), under a threat of a vote, accelerated negotiations on an international legal instrument related to intellectual property (IP) and genetic resources...more

Proskauer - The Patent Playbook

Calls for USPTO to Adopt Policies to Modulate Drug Pricing

In the wake of the nomination of Kathi Vidal as Director of the USPTO, there will be significant attention paid to the agency’s responses to calls from both the executive and legislative branches to remake the agency’s...more

Jones Day

Executive Order on Promoting Competition in the American Economy: A Focus on Patent and Drug Law to Reduce Health Care Spending

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Each year, Americans spend more than $1,500 per person on prescription drugs. Critics calling for measures to lower prescription drug costs often cast blame on alleged abuses of patent and competition laws. To address these...more

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

The mRNA IP and Competitive Landscape: Translate BIO; Arcturus; eTheRNA and Other Startups; and LNP Technology (Part II)

In Part I of this three-part series, we focused on three mRNA technology market players: BioNTech, Moderna and CureVac. In this second post, we will focus on Translate BIO, Arcturus Therapeutics, and eTheRNA and discuss...more

Troutman Pepper Locke

Enforcing IP in a Pandemic: Considerations, Risks, Strategies

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Moderna, a biotechnology company that is currently advancing a leading COVID-19 vaccine candidate, recently stated that it would not enforce its vaccine patents during the current health crisis. In light of this...more

Sterne, Kessler, Goldstein & Fox P.L.L.C.

Patent Prosecution Tool Kit: Summary of Subject Matter Eligibility: Biotech/Pharma Inventions

It has nearly been ten years since the Supreme Court’s landmark Mayo v. Prometheus (132 S.Ct. 1289 (2012)) decision, in which the Court established a two-prong test for determining patentable subject matter under 35 U.S.C. §...more

Akin Gump Strauss Hauer & Feld LLP

MedTech Update 2020: Legal and Regulatory Issues to Watch For in the Medical Technology Industry in the New Year

Medical device and diagnostics companies and laboratories should anticipate significant legal, regulatory and market changes in 2020 that will have a lasting impact on the industry. From revisions to how the government...more

Jones Day

Artificial Intelligence and the Biopharmaceutical Industry: What's Next?

Jones Day on

The Situation: Artificial intelligence ("AI") is emerging as a key driver of innovation in the biopharmaceutical industry, which uses AI in research and development ("R&D") to analyze big data. The Result: AI is already...more

American Conference Institute (ACI)

[Event] Life Sciences Patents Summit – Perfect Your Patent Prosecution Strategies in the U.S. and Around the World - May 16-17,...

Come to network and benchmark with top life sciences industry patent and intellectual property counsel. ACI’s 17th Global Summit on Life Sciences Patents returns to New York in May to provide practical insights on how to...more

Troutman Pepper Locke

Why Biotech and Pharma Patents Survive IPR

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When the America Invents Act of 2011 ushered in a number of new administrative procedures for challenging issued patents, the biotechnology and pharmaceutical industries at first seemed largely unconcerned. Originally...more

American Conference Institute (ACI)

[Event] 11th Pharma & Biotech Patent Litigation - February 26 - 27, 2019 - Radisson Blu Hotel, Amsterdam

The annual gathering exploring the inherently complex and continually contentious pharma and biotech patent litigation - Life Science patent litigation filings are predicted to rise at new levels. Be part of the only event...more

McDonnell Boehnen Hulbert & Berghoff LLP

Bioquark Seeks to Reverse Brain Death

Last year, two biotech companies announced that they had received institutional review board (IRB) approval for a study focused on the clinical intervention of brain death in humans. The study, entitled "Non-randomized,...more

McDonnell Boehnen Hulbert & Berghoff LLP

Court Report - August 2016

About Court Report: Each week we will report briefly on recently filed biotech and pharma cases. Takeda Pharmaceutical Co. Ltd. v. Lee - 1:16-cv-00852; filed July 1, 2016 in the Eastern District of Virginia ...more

Ward and Smith, P.A.

New Patent Office Initiative Provides a Boost to Cancer Immunotherapy Patent Applications

Ward and Smith, P.A. on

On June 29, 2016, the United States Patent and Trademark Office (USPTO) announced that it is implementing a pilot program to more quickly review patent applications related to treating cancer using immunotherapy. This...more

McDonnell Boehnen Hulbert & Berghoff LLP

BIO IPCC Panel Discusses Impact of Myriad-Mayo Guidance

Yesterday, we reported on a session of the Biotechnology Industry Organization (BIO) Intellectual Property Counsel's Committee fall conference, which took place earlier this week in Nashville, TN, in which the U.S. Patent and...more

McDonnell Boehnen Hulbert & Berghoff LLP

Examination of Myriad-Mayo Guidance Comments -- BIO Joint Comment

On March 4, the U.S. Patent and Trademark Office issued a guidance memorandum, entitled "Guidance For Determining Subject Matter Eligibility Of Claims Reciting Or Involving Laws of Nature, Natural Phenomena, & Natural...more

Foley & Lardner LLP

Update on Mayo Myriad Patent Eligibility From USPTO BCP Partnership Meeting

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On September 17, 2015, the USPTO held the first “bicoastal” Biotechnology/Chemical/Pharmaceutical Customer Partnership meeting, with live participation from the USPTO’s main campus in Alexandria, VA and from San Jose...more

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