Therapeutic Antibodies

Sterne Kessler provides integrated, strategic IP advice to therapeutic antibody innovators, including patent prosecution, opinions of counsel, and litigation.

Therapeutic antibodies have become big business. More than 100 antibodies have been approved by the FDA, including multiple blockbuster biopharmaceuticals. Sterne Kessler helps clients operating in this space to carefully manage intellectual property (IP) issues, ensuring they navigate development hurdles and achieve ambitious financial objectives.

Immunotherapy is among the most promising approaches to curing a wide range of diseases, from autoimmune disorders to cancer. However, the IP landscape in therapeutic antibodies is complex and highly competitive. Sterne Kessler’s team brings the technical depth and legal acumen necessary to obtain patent protection, defend exclusivities, launch new products with freedom to operate, and litigate disputes in any venue.

Strategic issues to consider include:

Freedom to Operate

A patent does not grant the patent holder the affirmative right to practice the patented technology—a patent conveys only the right to exclude others from practicing that technology. It is a real possibility that in making, using or selling patented technology, companies may unwittingly infringe a separate patent of a third party. Growth in the therapeutic antibody market has created a minefield of third-party patents which must be carefully navigated as innovators seek to commercialize proprietary antibody technologies.

Product Lifecycle Management

Many of the therapeutic antibodies launched in recent years are the result of groundbreaking technologies first developed a decade or more ago. As the use of these technologies becomes more common, and their broad applicability becomes increasingly apparent, they are no longer considered groundbreaking—their use becomes more of an industry norm. Consequently, the argument for patentability of the products of these technologies has become more difficult. Companies can address this by adopting a well-planned filing strategy that seeks to time the filings of new patent applications so as to minimize the threat posed by their own prior patents, while at the same time maximizing patent term for potentially blockbuster products. By crafting a careful patent lifecycle management strategy, innovators can continue to obtain patents to new inventions surrounding a valuable antibody product.

Changing Legal Landscape

The legal landscape in which antibody patents are procured and enforced is constantly being reshaped by Congress and the courts. Several recent decisions by the U.S. Supreme Court may affect the patentability of recombinant antibodies, as well as the very right of patent holders to effectively license their technologies or to exclude others from practicing them. Sterne Kessler has the technical depth, legal acumen, and industry experience to help innovators in the therapeutic antibody industry navigate these IP challenges.

Related Resources

Speaking Engagement

10th LSX World Congress

April 29, 2024

Press Release

Sterne Kessler Promotes Eight Attorneys to Counsel

Sterne, Kessler, Goldstein & Fox March 25, 2024

Speaking Engagement

2024 Reservation Economic Summit

March 13, 2024 11:15 AM - 12:00 PM PST

Bylined Articles

Amgen Inc. v. Sanofi, 598 U.S. 594 (2023)

Sterne, Kessler, Goldstein & Fox January 24, 2024

Press Release

Sterne Kessler Publishes Federal Circuit IP Appeals: Summaries of Key 2023 Decisions Report

Sterne, Kessler, Goldstein & Fox January 24, 2024

Webinar Recordings & Materials

Federal Circuit IP Appeals: Summaries of Key 2023 Decisions

January 23, 2024

Reports

Federal Circuit IP Appeals: Summaries of Key 2023 Decisions (8th Edition)

Sterne, Kessler, Goldstein & Fox January 22, 2024

In the News

Raise Your Wands: Counsel Welcome USPTO’s Enablement Guidance

Managing IP January 11, 2024

Firm Announcements

Sterne Kessler Secures Denial of PGR for Largest Cancer Center in the US

Sterne, Kessler, Goldstein & Fox November 27, 2023

In the News

Bristol-Myers To Buy Orum’s Cancer Treatment Program

Law360 November 6, 2023

Speaking Engagement

LSPN Chairman’s Opening Address and Closing Remarks

October 10, 2023 9:30 AM - 6:50 PM PST

Books and Chapters

U.S. Biotechnology Patent Law, 2023 ed.

Thomson Reuters September 8, 2023

Bylined Articles

The Supreme Court Takes Enablement Law Back to Basics

The Patent Lawyer June 13, 2023

Speaking Engagement

How to Pitch to Biotech VCs

June 1, 2023 9:00 AM - 10:00 AM PST

Speaking Engagement

Chairman’s Opening Address and Closing Remarks

May 3, 2023 9:00 AM - 5:00 PM PST

Speaking Engagement

2023 Focus on Pharma

April 14, 2023 8:30 AM - 6:00 PM PST

Bylined Articles

4 Potential Paths for High Court in Amgen Patent Case

Law360 March 31, 2023

In the News

Counsel Predict Sanofi Victory in SCOTUS Enablement Case

Managing IP March 29, 2023

In the News

Supreme Court Brief: Fact-Dependent IP Hearing | ADA ‘Tester’ Case

Supreme Court Brief March 28, 2023

Speaking Engagement

Written Description Enablement After Juno v. Kite

November 29, 2022 1:40 PM - 3:05 PM PST

Speaking Engagement

Opening Address and Closing Remarks

November 1, 2022 8:30 AM - 6:25 PM PST

Press Release

Sterne Kessler Director Eldora L. Ellison Appointed to Advisory Council for the CAFC

Sterne, Kessler, Goldstein & Fox September 30, 2022

Books and Chapters

U.S. Biotechnology Patent Law, 2022 ed.

Thomson Reuters August 31, 2022

In the News

WTO Waiver Spurs In-House Fears of Broader Deals

Managing IP June 29, 2022

In the News

New Trustees to Join Cornell Board

Cornell Chronicle June 2, 2022

Speaking Engagement

Chairman’s Opening Address and Closing Remarks

May 11, 2022 9:00 AM - 4:45 PM PST

Speaking Engagement

Phoenix Issue VI

March 18, 2022 3:30 PM - 5:00 PM PST

Bylined Articles

Case Studies and Trends at the PTAB Involving 35 U.S.C. § 112

Sterne, Kessler, Goldstein & Fox March 7, 2022

In the News

Moderna Delays Bid for Covid Shot Patent Disputed by NIH

Bloomberg December 17, 2021

In the News

Inside the Life of a Patent Prosecution Boss

Managing IP October 22, 2021

Speaking Engagement

Patenting Antibodies in the Current Climate: Global Considerations and Strategies

October 7, 2021 11:15 AM - 12:00 PM PST

Books and Chapters

U.S. Biotechnology Patent Law, 2021 ed.

Thomson Reuters September 8, 2021

Speaking Engagement

Comprehensive and Effective IP Due Diligence

June 17, 2021 12:20 PM - 1:10 PM PST

Podcast Recording

Innovation Conversations: Dr. Claire Fraser

January 26, 2021

Speaking Engagement

Protecting and Defending Inventions in the Microbiome Space: Challenges and Strategies

December 1, 2020 9:15 AM - 9:45 AM PST

Speaking Engagement

Protecting and Defending Inventions in the Microbiome Space: Challenges and Strategies

November 6, 2020 4:30 PM - 5:00 PM PST

Press Release

Sterne Kessler Named Among 2021 “Best Law Firms” by Best Lawyers

Sterne, Kessler, Goldstein & Fox November 6, 2020

Webinar

Drug Development Pathway Series: Intellectual Property Workshop

October 28, 2020 4:00 PM - 5:00 PM PST

Press Release

Firm and Seven Directors Recognized in 2020 LMG Life Sciences Rankings

Sterne, Kessler, Goldstein & Fox P.L.L.C. October 6, 2020

Books and Chapters

U.S. Biotechnology Patent Law, 2020-2021 Edition

Thomson Reuters August 12, 2020

Bylined Articles

Joint Research Considerations As Biotech Responds To Virus

Law360 April 27, 2020

Speaking Engagement

Pharma IPR Conference 2020

March 4, 2020 12:00 AM - 11:59 PM PST

Books and Chapters

U.S. Biotechnology Patent Law, 2019-2020 Edition

Thomson Reuters November 1, 2019

Speaking Engagement

Life Sciences Patent Network North America – Fall 2019

October 16, 2019

Press Release

Director Eldora L. Ellison, Ph.D. Receives Top Honor at 2019 LMG Life Sciences Awards

Sterne, Kessler, Goldstein & Fox P.L.L.C September 23, 2019

Speaking Engagement

Microbiome R&D and Business Collaboration Forum: USA

October 29, 2018 12:00 AM - 11:59 PM PST

Books and Chapters

U.S. Biotechnology Patent Law, 2018-2019 Edition

Thomson Reuters October 10, 2018

Press Release

Sterne Kessler Recognized By LMG Life Sciences Among The Top IP Firms and Attorneys

Sterne, Kessler, Goldstein & Fox September 25, 2018

In the News

Seeking outsized results

The Boston Globe June 8, 2018

In the News

Important PTAB Decisions of 2017 and Cases to Watch in 2018

The Patent Lawyer December 29, 2017

Bylined Articles

March-in Rights and Compulsory License in the United States

Sterne, Kessler, Goldstein & Fox October 16, 2017

Bylined Articles

Compulsory Licensing of Biopharmaceutical Inventions

Sterne, Kessler, Goldstein & Fox October 16, 2017

Bylined Articles

Recent Trends on the U.S. Doctrine of Equivalents

Sterne, Kessler, Goldstein & Fox September 15, 2017

Bylined Articles

A Seismic Shift in UK Patent Infringement Law – Actavis v. Eli Lilly

Sterne, Kessler, Goldstein & Fox September 15, 2017

Bylined Articles

Doctrine of Equivalents and Prosecution History Estoppel Around the World

Sterne, Kessler, Goldstein & Fox September 15, 2017

Bylined Articles

How Courts Treat USPTO Subject Matter Eligibility Guidelines

Law360 August 29, 2017

Bylined Articles

Patent Term Extension Consideration for BioPharma Patents

Sterne, Kessler, Goldstein & Fox August 15, 2017

Bylined Articles

Considerations for Developing a Global Patent Term Extension Strategy

Sterne, Kessler, Goldstein & Fox August 15, 2017

Bylined Articles

Global Patent Term Extension/Supplementary Protection Certificate Provisions

Sterne, Kessler, Goldstein & Fox August 15, 2017

Publication

Approved Biosimilar Products Around the World

Sterne, Kessler, Goldstein & Fox July 17, 2017

Bylined Articles

Top 5 PTAB Tips for Big Pharma

New Jersey Law Journal April 3, 2017