Biosimilars

Sterne Kessler’s industry team helps companies navigate the substantial opportunities and challenges associated with the launch of biosimilar drugs.

The global market for biosimilars is poised for rapid expansion as patents for landmark biological drugs expire. As a pioneer in the protection, leveraging, and enforcement of biotechnology innovations, Sterne Kessler is uniquely positioned to address the IP needs of companies seeking to capitalize—both biotech innovators and biosimilar developers.

We have one of the most experienced biotechnology practices in the United States. Sterne Kessler has been at the forefront of the rapidly evolving biotechnology industry for more than 30 years. In addition, we have a proven track record in high-stakes Hatch-Waxman/ANDA counseling and litigation. The Biologics Price Competition and Innovation Act (BPCIA) has created a unique pathway for biosimilar drugs and our experience makes us uniquely qualified to help.

Unique Pathway Requires Unique Attorneys

The abbreviated approval pathway for biosimilars in the United States is fundamentally distinct from the Hatch-Waxman pathway for generic small-molecule drugs. Companies anticipating biosimilar competition for their key products or contemplating bringing a biosimilar challenge require an IP legal team that understands the nuances and the issues that can arise with each. Our knowledge of biotech patent law and years of experience dealing with the patent issues involved in Hatch-Waxman/ANDA matters combine to create a team of professionals that can tackle the most sophisticated IP issues faced by those in this emerging industry, whether they are innovators or biosimilar challengers.

What Sets Sterne Kessler Apart?

  • Our team of professionals is both legally adept and technically astute. Most have earned an advanced technical degree (more than 60 have a Ph.D.) and significant industry or academic experience.
  • We are experienced biotech advisors, having represented companies through the years that have been positioned at the cutting edge of technologies like genomics, bioinformatics, vaccines, nanomedicine, and pharmacogenomics.
  • We are recognized leaders in IP issues relating to therapeutic antibodies, which now make up the fastest-growing segment of the pharmaceutical industry.
  • We have assembled a deep bench of experienced litigators, technical experts, patent attorneys, and patent agents with extensive experience representing both branded and generic pharmaceutical companies in blockbuster ANDA matters.
    • Our body of ANDA work comprises more than 50 Paragraph IV filings and over 500 opinions.
    • We have translated that extensive ANDA experience to navigating the BPCIA, and particularly the litigation options available under that regime.
  • We are the clear leaders in life sciences and biotechnology litigation before the Patent Trial and Appeal Board (PTAB).
  • Our professionals are trained to evaluate complex intellectual property issues in the context of the business environment to ensure alignment with your strategic goals.

Related Resources

Webinar

2023 PTAB Year in Review: Analysis & Trends

February 7, 2024 1:00 PM - 2:00 PM PST

Webinar Recordings & Materials

2023 PTAB Year in Review: Analysis & Trends

February 7, 2024

Webinar Recordings & Materials

Federal Circuit IP Appeals: Summaries of Key 2023 Decisions

January 23, 2024

Books and Chapters

U.S. Biotechnology Patent Law, 2023 ed.

Thomson Reuters September 8, 2023

Speaking Engagement

Preparing for Biosimilar Carve Outs: Will Skinny Labelling Work for Biosimilars?

June 27, 2023 4:15 PM - 5:15 PM PST

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How to Pitch to Biotech VCs

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

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2023 Focus on Pharma

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

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Second Wave of Biosimilar Cases Sharpens Patent Counsel Focus

Managing IP January 27, 2023

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Patent Reform and Market Access Dynamics

November 4, 2022 11:40 AM - 12:10 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.

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Speaking Engagement

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June 29, 2022 4:30 PM - 5:30 PM PST

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Cornell Chronicle June 2, 2022

Speaking Engagement

Chairman’s Opening Address and Closing Remarks

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

Reports

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Sterne, Kessler, Goldstein & Fox March 7, 2022

Bylined Articles

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Speaking Engagement

The Licensure of a Biosimilar or Biosimilar Interchangeable Product

November 11, 2021 11:10 AM - 11:30 AM PST

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Books and Chapters

U.S. Biotechnology Patent Law, 2021 ed.

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Bloomberg Law August 17, 2021

Speaking Engagement

Comprehensive and Effective IP Due Diligence

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

In the News

Panel: Should Biologics Manufacturers Have to Disclose More About Their Patents?

The Center for Biosimilars April 20, 2021

Speaking Engagement

Round Table Discussion: Litigation in an Age of Biologics Versus Biosimilars

April 15, 2021 11:55 AM - 1:00 PM PST

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Biologics Price Competition and Innovation Act: Current and Future Legal Challenges

March 30, 2021 2:20 PM - 3:20 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

Speaking Engagement

US Biosimilar Litigation in 2020 – Key Decisions and Trends

September 29, 2020 10:30 AM - 11:00 AM PST

In the News

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Law360 September 11, 2020

Bylined Articles

Patent License Considerations After Fed. Circ. Enbrel Ruling

Law360 September 4, 2020

Books and Chapters

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

Thomson Reuters August 12, 2020

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July 7, 2020

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Patent Prosecution Tool Kit

Sterne, Kessler, Goldstein & Fox July 7, 2020

Bylined Articles

Implications of the BPCIA on the IP Strategies of Brand Companies and Biosimilar Developers

Sterne, Kessler, Goldstein & Fox July 7, 2020

Speaking Engagement

Pharma IPR Conference 2020

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

Speaking Engagement

International IP Skills Summit (IIPSS)

February 26, 2020 12:00 AM - 11:59 PM PST

Bylined Articles

Fed. Circ. Amgen Biosimilar Ruling Raises IP Damages Risk

Law360 February 26, 2020

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

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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

MIP Life Sciences Forum 2019

September 18, 2019

Speaking Engagement

Summit on Biosimilars

June 24, 2019 1:30 PM - 2:30 PM PST

Bylined Articles

Proposed BPCIA reforms: More music, same dance

Managing Intellectual Property May 16, 2019

Speaking Engagement

Biosimilars Commercialisation Summit

May 14, 2019

Speaking Engagement

13th Annual Paragraph IV Disputes

April 29, 2019

Speaking Engagement

Access! 2019 – AAM Annual Meeting

February 4, 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

In the News

Seeking outsized results

The Boston Globe June 8, 2018

Bylined Articles

CAFC Rule 36 Judgement: 24 Hour Affirmance with No Explanation

Sterne, Kessler, Goldstein & Fox February 21, 2018

Bylined Articles

Exclusion of Evidence at the PTAB – Does it ever happen?

Sterne, Kessler, Goldstein & Fox February 21, 2018

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Sterne, Kessler, Goldstein & Fox February 21, 2018

PTAB Strategies and Insights

PTAB Strategies and Insights – February 2018

February 14, 2018

Webinar

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February 8, 2018 2:00 PM - 3:00 PM PST

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December 18, 2017

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Bolar Exemptions in North America

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Bolar Exemption in Europe and Asia

Sterne, Kessler, Goldstein & Fox December 18, 2017

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Worldwide Bolar-type Provisions*

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Global Patent Prosecution

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September 15, 2017

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Sterne, Kessler, Goldstein & Fox September 15, 2017

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Patent Term Extension Consideration for BioPharma Patents

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Global Patent Term Extension/Supplementary Protection Certificate Provisions

Sterne, Kessler, Goldstein & Fox August 15, 2017

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Global Patent Prosecution Newsletter – July 2017

July 17, 2017

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You Can Dance If You Want To

Sterne, Kessler, Goldstein & Fox July 17, 2017

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Biosimilars in Europe

Sterne, Kessler, Goldstein & Fox July 17, 2017

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Biosimilar Uptake and Patent Litigation in Japan

Sterne, Kessler, Goldstein & Fox July 17, 2017

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Approved Biosimilar Products Around the World

Sterne, Kessler, Goldstein & Fox July 17, 2017

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Divided Infringement After Eli Lilly V. Teva

Law360 April 18, 2017

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New Jersey Law Journal April 3, 2017

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The DAIMLER Series: Lessons In Personal Jurisdiction for Biologic and Biosimilar Litigants

Bloomberg BNA: Pharmaceutical Law & Industry Report May 6, 2016

Bylined Articles

The ITC and Biosimilars: Strategies for Brand-Biologics Companies Against Biosimilar Applicants

Bloomberg BNA Pharmaceutical Law & Industry Report March 4, 2016

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Sandoz Seeks High Court Take On Biosimilar Law

Law360 February 17, 2016

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Biosimilars in the United States – where do things stand

European Biotechnology Magazine September 29, 2015

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The 1st IPR Institution Decisions For Biosimilars

Law360 August 21, 2015

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Amgen, Sandoz Both Winners and Losers At Federal Circuit

Law360 July 21, 2015

In the News

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Law360 July 21, 2015

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Post-Grant Proceedings Are Important For Biosimilars

Law360 March 19, 2015

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Post-Grant Review May Impact Biosimilars Litigation

Law360 November 17, 2014

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US Biosimilar Biologics – The Ship has Sailed

European Biotechnology News October 30, 2014

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Defense to Myriad Patent Infringement Claim Now Moved to Patent Trial and Appeal Board

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European Biopharmaceutical Review July 2, 2014