U.S. Department
of Justice
Promoting Innovation in the Life Science Sector and Supporting Pro-Competitive Collaborations: The Role of Intellectual Property
Washington, DC
United States
Event Details
Workshop Information
This joint U.S. Patent and Trademark Office (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
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September 23, 2020 September 24, 2020 |
The workshop was free and open to the public and made available as a webcast. |
Workshop Agenda
Find the following on the USPTO’s event web page:
Agenda PDF
Day One: How Patents and Copyrights Impact Collaboration and Innovation for Business Development in Life Science TechnologiesWednesday, September 23, 2020 Find the following on the USPTO’s event web page:
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| 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 VaccinesThursday, September 24, 2020 Find the following on the USPTO’s event web page:
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| 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 |
Day One Video