Timothy “Tim” J. Shea, Jr. is a director in Sterne Kessler’s Biotechnology & Chemical Practice Group where he has practiced for over 25 years and leads the firm’s Biosimilar Initiative. He specializes in advising biopharmaceutical companies and research institutions on complex legal issues relating to the protection, enforcement and transfer of their intellectual property. He practices primarily in the fields of immunology, molecular biology, genetic and medical diagnostics, biotherapeutics, and drug delivery. He has extensive experience advising clients on the creation and management of strategic patent portfolios, freedom-to-operate and patentability issues, complex prosecution strategies, validity and infringement issues, and due diligence investigations in connection with acquisitions and investments. Tim has published and spoken extensively on IP issues related to therapeutic antibodies and biosimilars.

Tim’s biosimilar experience includes advising biosimilar developers on pre-aBLA strategies and tactics, including freedom-to-operate, clearance analyses, label and carve out strategies, exclusivity analyses, and launch timing. He also has represented biosimilar developers in inter partes review proceedings before the Patent Trial and Appeal Board involving patents covering the reference product. Tim was part of the lead counsel team representing Sandoz in its litigation with Genentech related to rituximab (RITUXAN). He has also represented both brand companies and biosimilar companies in connection with due diligences related to the acquisition, or divesting, of biosimilar products.

A significant portion of Tim’s practice involves counseling emerging companies on strategies for creating, protecting and leveraging their IP assets to grow their businesses. He frequently advises clients on all aspects of technology transfer, including the drafting and negotiation of patent and technology license agreements, material transfer agreements, sponsored research agreements, confidentiality and nondisclosure agreements, joint developments agreements, etc. Tim is a past Vice-Chair of the Life Sciences Committee for Licensing Executives Society International, an international network of IP licensing professionals. He also serves as the Executive Editor of the Chicago-Kent Law Review.

Tim is also is a contributing author of Patent Office Litigation, Second Edition, published in 2017, the book provides a fresh and comprehensive exploration of patent office litigation proceedings, including how the proceedings interact with other aspects of patent procurement and enforcement, while delivering practical analysis and advice. This second edition of Patent Office Litigation is the follow up to the first version of the book that was published in 2012 by Thomson Reuters Westlaw that focused on the contested proceedings that were introduced under the America Invents Act that year.

Tim received his B.S. in Biology from Washington and Lee University in 1988 and his J.D. from Chicago-Kent College of Law (with High Honors, Order of the Coif) in 1995. During law school, Tim served as an Executive Editor of the Law Review. He then served as a judicial extern to the Honorable Rebecca Pallmeyer of the U.S. District Court for the Northern District of Illinois. Prior to attending law school, Tim worked for several years in the biotech industry in the areas of genetic diagnostics.

  • J.D., Chicago-Kent College of Law, with high honors, order of the coif
  • B.S., Biology, Washington & Lee University

  • District of Columbia
  • U.S. District Court for the Eastern District of Virginia
  • United States Patent & Trademark Office
  • Virginia

Speaking Engagement

2023 Focus on Pharma

Washington, DC, April 14, 2023 8:30 AM - 6:00 PM EST

Speaking Engagement

Patent Reform and Market Access Dynamics

Basel, Switzerland, Congress Center Basel, November 4, 2022 11:40 AM - 12:10 PM EST

Speaking Engagement

The Licensure of a Biosimilar or Biosimilar Interchangeable Product

Basel, Switzerland, Congress Center Basel, November 11, 2021 11:10 AM - 11:30 AM EST

Speaking Engagement

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

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

Speaking Engagement

US Biosimilar Litigation in 2020 – Key Decisions and Trends

Virtual, September 29, 2020 10:30 AM - 11:00 AM EST

Speaking Engagement

2019 Global IP Strategy Conference

Washington, DC, March 15, 2019 12:00 AM - 11:59 PM EST

World Biosimilar Congress Europe 2015

November 9, 2015 12:00 AM - 6:59 PM EST

5th Annual MIBio Conference

October 21, 2015 1:00 AM - 7:59 PM EST

4th Annual Pharma IPR India

February 11, 2015 12:00 AM - 6:59 PM EST

BIO IP & Diagnostics Symposium

July 22, 2013 1:00 AM - 7:59 PM EST

ACI’s 3rd Advanced Forum on Biosimilars

May 21, 2012 1:00 AM - 7:59 PM EST

FDA’s New Biosimilar Draft Guidances

May 15, 2012 1:00 AM - 7:59 PM EST

8th Annual BioProcess International Conference

April 19, 2012 1:00 AM - 7:59 PM EST

Related Resources

From Timothy "Tim" J. Shea, Jr.

In the News

January 27, 2023

Second Wave of Biosimilar Cases Sharpens Patent Counsel Focus

Managing IP

In the News

July 13, 2021

We Can Dance If We Want To, We Can Put Our Patents Online

Law360

In the News

April 20, 2021

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

The Center for Biosimilars

Client Alert

July 7, 2020

IP Hot Topic: Patent Prosecution Tool Kit

Carla Ji-Eun Kim

Reports

July 7, 2020

Patent Prosecution Tool Kit

Sterne, Kessler, Goldstein & Fox Multiple Authors

Bylined Articles

July 7, 2020

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

Sterne, Kessler, Goldstein & Fox Paul A. Calvo, Ph.D., Timothy “Tim” J. Shea, Jr.

Client Alert

February 12, 2020

FDA Issues Biosimilar Guidance for Label Carve-Outs and Supplements

Timothy “Tim” J. Shea, Jr.

Bylined Articles

August 25, 2017

Strategy Considerations for Biosimilar Applicants after Sandoz v. Amgen

Bloomberg BNA Multiple Authors

Bylined Articles

July 17, 2017

You Can Dance If You Want To

Sterne, Kessler, Goldstein & Fox Multiple Authors

Client Alert

June 12, 2017

The Patent Dance is Optional

Multiple Authors

Books and Chapters

February 17, 2017

Patent Office Litigation - Second Edition 2017

Thomson Reuters Westlaw Multiple Authors

Client Alert

July 8, 2016

Federal Circuit Backs Amgen on Key Provision of Biosimilars Statute

Timothy “Tim” J. Shea, Jr., Paul A. Calvo, Ph.D.

In the News

February 17, 2016

Sandoz Seeks High Court Take On Biosimilar Law

Law360 Timothy “Tim” J. Shea, Jr., Paul A. Calvo, Ph.D.

In the News

February 12, 2016

Sterne Kessler Shares the Love for Valentine's Day

Bisnow Timothy “Tim” J. Shea, Jr., Paul A. Calvo, Ph.D.

Client Alert

December 31, 2015

FDA Finalizes Guidance For Formal Meetings Between the FDA and Biosimilars Applicants

Paul A. Calvo, Ph.D., Timothy “Tim” J. Shea, Jr.

Client Alert

August 17, 2015

Amgen v. Apotex – what is the outcome when biosimilar applicants actually dance?

Paul A. Calvo, Ph.D., Timothy “Tim” J. Shea, Jr.

Bylined Articles

July 21, 2015

Amgen, Sandoz Both Winners and Losers At Federal Circuit

Law360 Paul A. Calvo, Ph.D., Timothy “Tim” J. Shea, Jr.

In the News

July 21, 2015

5 Takeaways After Fed. Circ. Amgen – Sandoz Ruling

Law360 Paul A. Calvo, Ph.D., Timothy “Tim” J. Shea, Jr.

Client Alert

June 4, 2015

Act II: Oral Argument in Amgen v. Sandoz is heard at the Court of Appeals for the Federal Circuit

Paul A. Calvo, Ph.D., Timothy “Tim” J. Shea, Jr.

Client Alert

May 22, 2015

FDA releases additional draft guidance regarding implementation of BPCIA

Paul A. Calvo, Ph.D., Timothy “Tim” J. Shea, Jr.

Client Alert

May 7, 2015

Federal Circuit Grants Injunction Keeping Sandoz’s Biosimilar Version of Neupogen Off Market Until Appeal Decided

Paul A. Calvo, Ph.D., Timothy “Tim” J. Shea, Jr.

Client Alert

May 1, 2015

FDA Finalizes Guidance Documents on Biosimilarity

Paul A. Calvo, Ph.D., Timothy “Tim” J. Shea, Jr.

Client Alert

March 23, 2015

One More Hurdle Cleared - Amgen's Preliminary Injunction Motion for Filgrastim is Denied

Paul A. Calvo, Ph.D., Timothy “Tim” J. Shea, Jr.

Client Alert

March 9, 2015

FDA Approves First US Biosimilar But Court Action Could Delay Market Entry

Timothy “Tim” J. Shea, Jr.

Bylined Articles

January 29, 2015

Sandoz Decision Increases Importance of Post-Grant Proceedings to Biosimilar Developers

IP Litigator Paul A. Calvo, Ph.D., Timothy “Tim” J. Shea, Jr.

Client Alert

December 10, 2014

Federal Circuit’s Sandoz Decision Increases Importance of Post-Grant Proceedings to Biosimilar Developers

Paul A. Calvo, Ph.D., Timothy “Tim” J. Shea, Jr.

Bylined Articles

October 30, 2014

US Biosimilar Biologics – The Ship has Sailed

European Biotechnology News Paul A. Calvo, Ph.D., Timothy “Tim” J. Shea, Jr.

Client Alert

May 14, 2014

FDA Releases New Guidance for Biosimilar Applications

Timothy “Tim” J. Shea, Jr., Paul A. Calvo, Ph.D.

In the News

May 13, 2014

FDA Sheds New Light on Biosimilars Approval Pathway

Law360 Timothy “Tim” J. Shea, Jr., Paul A. Calvo, Ph.D.

In the News

February 3, 2014

7 Intellectual Property Mistakes Startup Entrepreneurs Often Make

JD Supra Timothy “Tim” J. Shea, Jr., Paul A. Calvo, Ph.D.