Promoting Innovation in the Life Science Sector and Supporting Pro-Competitive Collaborations: The Role of Intellectual Property

On this page:

Workshop Information

This joint USPTO-Department of Justice (DOJ) program focused on how patents and copyrights drive innovation in the life science sector and the effects of collaborations and partnerships, with specific attention paid to the antitrust implications of different cooperation and licensing strategies.

This free conference included 10 sessions spread over two mornings. Panelists and speakers included leading figures from industry, government agencies, prominent research labs, the non-profit sector, academia, and the broader legal and economic community. In addition, the second day featured a fireside chat with USPTO Director Andrei Iancu and Assistant Attorney General for the Antitrust Division Makan Delrahim and a keynote address by former Director of the National Institutes of Health Dr. Elias A. Zerhouni.

Date and Virtual Attendance

September 23, 2020
1:00 p.m. – 5:00 p.m. EST

September 24, 2020
12:30 p.m. – 5:20 p.m. EST

The workshop was free and open to the public and made available as a webcast.

Workshop Agenda

Day One: How Patents and Copyrights Impact Collaboration and Innovation for Business Development in Life Science Technologies

Wednesday, September 23, 2020

Masters of Ceremony

Nyeemah A. Grazier, Patent Attorney, Office of Policy and International Affairs (OPIA), United States Patent and Trademark Office (USPTO)

Brian T. Yeh, Attorney-Advisor, OPIA, USPTO

1:00–1:05 p.m.

Introductions

Nyeemah A. Grazier, Patent Attorney, OPIA, USPTO

1:05–1:15 p.m.

Opening Remarks

Andrei Iancu, Under Secretary of Commerce for Intellectual Property and Director of the USPTO

1:15–1:35 p.m.

Session I: The role of patents in research and development of therapeutics, diagnostics, and vaccines, particularly during pandemics

In this session, we explored the link between patents and innovation, and the value of innovation in the diagnostic and therapeutic arena in improving public health.

Presenter

Ms. Genia Long, Senior Advisor, Analysis Group

1:35­–2:00 p.m.

Session II: Update on USPTO guidance on patentability of life science inventions

In this session, we discussed the agency’s most recent guidance to examiners on the analysis of claims in this area for compliance with subject matter eligibility and disclosure requirements under the patent law.

Presenter

Mr. Ali R. Salimi, Senior Legal Advisor, Office of Patent Legal Administration (OPLA), USPTO

2:00–­2:30 p.m.

Session III: Life science patents in practice

In this session, the speakers shared their experience with ways that the patent system protects inventions in the life sciences, promotes innovation, and facilitates collaboration in life sciences. Topics included, for example, the importance of new use claims and other examples of incremental innovation, and the role that subject matter eligibility plays in life sciences-related inventions.

Presenters

David E. Korn, Vice President, Intellectual Property and Law, Pharmaceutical Research and Manufacturers of America (PhRMA)

Dr. Gaby Longsworth, Director, Sterne Kessler Goldstein & Fox

2:30–2:40 p.m. Coffee/Tea Break
2:40–3:40 p.m.

Panel Discussion I: Are changes to U.S. patent law needed to better support innovation in life sciences and the development of COVID-19 solutions?

Using the COVID pandemic to exemplify and emphasize the importance of innovation, the panelists exchanged ideas about whether changes are needed to support innovation in the life sciences sector and to support collaboration. In this session, the panelists, representing academia, pharmaceutical corporations, and private practice, provided their experience and unique perspective on this topic.

Panelists

The Honorable Paul R. Michel, Chief Judge, US Court of Appeals for the Federal Circuit (CAFC) (Ret.)

Steven Caltrider, V.P. and General Patent Counsel, Eli Lilly & Co.

Karin Hessler, Assistant General Counsel, Association for Accessible Medicines (AAM)

Arti Rai, Elvin R. Latty Professor of Law and Director, Center for Innovation Policy, Duke University School of Law

Corey Salsberg, Vice President, Global Head IP Affairs, Novartis

Hans Sauer, Deputy General Counsel and VP, Biotechnology Innovation Organization

Hiba Zarour, Head of IP Department, Hikma Pharmaceuticals

USPTO Moderator: Andrei Iancu, Under Secretary of Commerce for Intellectual Property and Director of the USPTO

3:40–3:50 p.m. Coffee/Tea Break
3:50–4:15 p.m.

Session IV: Copyright and innovation in the life sciences

This series of presentations provided an overview of copyright in the life sciences and how it encourages innovation. Topics included digital technologies such as artificial intelligence, open access, and publishing in the life sciences sector.

Presenters

Michael W. Carroll, Professor of Law and Faculty Director, Program on Information Justice and Intellectual Property (PIJIP), American University Washington College of Law (WCL)

Mark Seeley, Consultant, SciPubLaw LLC and Adjunct Faculty, Suffolk University Law School

Bhamati Viswanathan, Affiliate Professor, Emerson College

4:15­–4:50 p.m.

Panel Discussion II: Copyright discussion: Enhancing access to life science: How copyright can create incentives or barriers to building data or information pools, and related licensing

In this session, the panelists discussd copyright’s integral role in supporting the dissemination of information and facilitating different licensing models.

Panelists

Michael W. Carroll, Professor of Law and Faculty Director, PIJIP, WCL

Mark Seeley, Consultant, SciPubLaw LLC and Adjunct Faculty, Suffolk University Law School

Bhamati Viswanathan, Affiliate Professor, Emerson College

USPTO Moderator: Susan Allen, Attorney-Advisor, OPIA, USPTO

4:50–5:00 p.m. Closing Remarks
5:00 p.m. End of Day 1

Day Two: Competition, Collaboration and Licensing to Promote Access to Therapeutics, Diagnostics and Vaccines

Thursday, September 24, 2020

Master of Ceremony

Jennifer Dixton, Special Counsel for Policy & Intellectual Property, Antitrust Division, U.S. Department of Justice

12:30–12:40 p.m.

Welcome Remarks

Makan Delrahim, Assistant Attorney General, Antitrust Division, U.S. Department of Justice

 
12:40–1:10 p.m.

Fireside Chat

Speakers

Andrei Iancu, Under Secretary of Commerce for Intellectual Property and Director of the USPTO

Makan Delrahim, Assistant Attorney General for the Antitrust Division, United States Department of Justice (USDOJ)

Moderator: The Honorable Kathleen O'Malley, Circuit Judge, U.S. Court of Appeals for the Federal Circuit

1:10–1:15 p.m.

Program Overview

David Lawrence, Chief, Competition Policy & Advocacy Section, U.S. Department of Justice

1:15­–2:10 p.m.

Session V: Collaboration and Licensing Strategies

In this session, panelists discussed partnerships that facilitate the development of therapeutics and vaccines in the devolvement and market-ready stages. Panelists considered public-private partnerships; private partnerships; exclusive versus non-exclusive licensing; ownership rights; and information pooling. Panelists also discussed how these partnerships and licensing strategies apply in addressing the current pandemic.

Presenters

Laura A. Coruzzi, Senior Vice President, Intellectual Property, Regenxbio

Lauren Foster, Associate Director, Technology Licensing Office, Massachusetts Institute of Technology

Sheridan Miyamoto, Assistant Professor, Principal Investigator, SAFE-T Center, Penn State University

Mita Mukherjee, Associate General Counsel, Intellectual Property, Emergent BioSolutions

Mark Rohrbaugh, Senior Advisor for Technology Transfer, National Institutes of Health

Dick Wilder, General Counsel, Coalition for Epidemic Preparedness Innovations

DOJ Moderator: Brian Pandya, Deputy Associate Attorney General, U.S. Department of Justice

2:10–2:15 p.m. Coffee/Tea Break
2:15–3:05 p.m.

Session VI: How do Regulation and Antitrust Enforcement Impact Competition and Incentives for Innovation?

In this session, panelists discussed the extent to which regulation and antitrust enforcement are necessary to maintain competition among safe and effective products, which can impact the incentives for innovation. What are the tradeoffs of antitrust enforcement and regulation in terms of the incentives for innovation during a pandemic?

Presenters

Alden Abbott, General Counsel, Federal Trade Commission

Ernst Berndt, Louis E. Seley Professor in Applied Economics, Emeritus, Alfred P. Sloan School of Management, MIT

David J. Kappos, Partner, Cravath, Swaine & Moore, LLP

William Kovacic, Global Competition Professor of Law and Policy, George Washington University Law School

Dick Wilder, General Counsel, Coalition for Epidemic Preparedness Innovations

DOJ Moderator: Alexander Okuliar, Deputy Assistant Attorney General, Antitrust Division, U.S. Department of Justice

3:05–3:10 p.m. Coffee/Tea Break
3:10–3:55 p.m.

Session VII: Competition and Collaboration: Examining Competitive Effects and Antitrust Risks Associated with Collaborations

In this session, panelists discussed what makes a collaboration or partnership successful and procompetitive; antitrust concerns that can arise; and potential safeguards that reduce antitrust risk, including guidance from the DOJ-FTC Collaboration Guidelines and DOJ’s recent expedited business review letters.

Presenters

William Diaz, Senior Counsel, Amgen

Andrew Finch, Partner, Paul Weiss

Luba Greenwood, Lecturer in Engineering Sciences, Harvard University

Chuck Loughlin, Partner, Hogan Lovells

DOJ Moderator: Jennifer Dixton, Special Counsel for Policy & Intellectual Property, Antitrust Division, U.S. Department of Justice

3:55–4:00 p.m. Coffee/Tea Break
4:00–4:30 p.m.

Keynote Speech

Dr. Elias A. Zerhouni, Emeritus Professor of Radiology and Biomedical Engineering and Senior Advisor, John Hopkins Medicine

4:30–5:15 p.m.

Session VIII: Academics’ and Economists’ Views on Collaboration and Competition

In this session, panelists discussed collaboration versus competition and how they can affect innovation incentives. In addition, panelists considered how reducing risk and uncertainty from regulation or enforcement impacts innovation. Finally, panelists discussed both the short-term and long-term risks to markets from collaboration that enable anticompetitive behavior.

Presenters

Rena Conti, Associate Research Director, Biopharma and Public Policy, Associate Professor, Questrom School of Business, Boston University

Scott Hemphill, Moses H. Grossman Professor of Law, New York University

Richard Manning, Partner, Bates White Economic Consulting

Joanna M. Shepherd, Vice Dean and Thomas Simmons Professor of Law, Emory Law School

DOJ Moderator: Patrick Greenlee, Economist, Antitrust Division, U.S. Department of Justice

5:15–5:20 p.m.

Closing Remarks

Rene Augustine, Deputy Assistant Attorney General, Antitrust Division

5:20 p.m. End of Day 2
Updated October 19, 2020

Was this page helpful?

Was this page helpful?
Yes No