Workshop Session A
Wednesday, May 16
2:00 PM - 3:15 PM
Finding the Right Time to Partner: Can You Maximize Value While Balancing Risk and Reward?
Each company, whether a licensor or licensee, faces the strategic question of when best to partner a product and when. If you partner too soon, the risk may outweigh the reward. Yet if you wait too long, you will miss out on a partner's support and expertise that could optimize the end result. The panel will provide candid recommendations and case studies on partnering dos and don’ts, citing real world examples. Each panelist will share his or her perspective on the partnering "dance" and how to generate and sustain deal momentum.
Christine Bellon, Vice President, Legal Affairs, Blueprint Medicines
Hemmie Chang, Chair Licensing & Strategic Alliances Group, Partner, Life Sciences Group, Foley Hoag LLP
Douglas Fambrough, CEO, Dicerna Pharmaceuticals
Jason Rhodes, Executive Vice President and Chief Business Officer, Epizyme, Inc.
Innovative Dealmaking that Pivots on Collaboration between Competitors
Creative insights from three game-changing deals will highlight a way of bringing competition and cooperation together to achieve major gains for all. Lessons learned from this highly interactive workshop will be valuable when negotiating increasingly complex biopharma deal structures. The innovative deals featured include:
- Pfizer’s landmark 5-member pharmaceutical consortium to fund Ablexis' development of the next generation AlivaMab, Mouse technology, for antibody drug discovery.
- Enlight Biosciences’ partnerships with major pharmaceutical companies and leading academics to achieve breakthrough innovations.
- The Merck/Roche clinical development collaboration deal to evaluate investigational combination regimens that include drugs from both companies for cHCV.
Elaine Jones, Executive Director, Venture Capital, Worldwide Business Development, Pfizer
Ellen Locker, Executive Director, Alliance Management, Merck
Ruth Plager, President, ZenithBIO
Annette Weissbach, Global Alliance Director, Pharma Partnering, Hoffmann-La Roche Inc.
Daphne Zohar, Founder, Managing Partner, Puretech Ventures
Licensing Strategies in the Cloud Computing Era
The rise of cloud computing presents unique licensing issues - for example, who is the appropriate licensee or even infringer under a divided infringement analysis? The workshop will provide a background of the current legal landscape and identify real life concerns, and propose strategies, including identifying the appropriate party to license, to maximize the value of the IP taking potential liability and value into account. The workshop will also discuss how divided infringement may be used to minimize liability, if not defeat, claims of infringement, and unique wrinkles in typical licensing provisions, including indemnification and enforcement provisions.
Krish Gupta, Senior Vice President & Deputy General Counsel, EMC Corp.
Branko Pejic, Partner, Greenblum & Bernstein
Kevin Spivak, Of Counsel, Greenblum & Bernstein
Royalty Rates, Transfer Pricing, and Clean Tech
Many high technology companies transfer patents and know-how to intangible holding or to manufacturing subsidiaries in lower tax countries. These transfers are often challenged by the IRS and CRA and usually engender tax controversy. This workshop will help the CEEM/high tech licensing professional put these issues in perspective. The panel will present CEEM royalty rates with an emphasis on clean tech and provide insights into the key areas of intangibles transfer pricing tax challenges, and clean tech deal issues and best practices.
Hal Craig, Principal, Trout Creek Consulting, LLC
Myron Kassaraba, Partner, Pluritas, LLC
Ednaldo Silva, Managing Partner, RoyaltyStat
Workshop Session B
Wednesday, May 16
3:45 PM - 5:00 PM
Disease Foundation-Funded Drug Development Partnerships: Structuring for Success
Funding from disease foundations for U.S. biomedical research has tripled over the past decade. By contributing funds, disease foundations seek to speed up the drug discovery and approval process. Although foundations contribute a portion of the costs, pharma and biotech companies, government agencies and research institutions are also contributors and have interests in how research and development will be conducted and the ultimate drug commercialized. As the number of seats at the table increase, so do the number of legal agreements and potential for conflicts. This panel will highlight the various parties particular interests (including governance structure, data sharing, IP ownership, royalties or equity, interruption licenses, indemnification) and issues that may arise with the goal of suggesting best practices for structuring these arrangements to facilitate drug development and avoid conflict.
Beth Arnold, a veteran IP attorney with expertise in drug development agreements, will lead a panel representing two disease foundations involved in funding development of certain drugs, a biotech company developing a drug having benefited from foundation funding, and a university technology transfer officer experienced in negotiating sponsored research agreements with disease foundations. Panelists will discuss agreement merits and risks, best practices and deal structures.
Beth Arnold, Partner, Foley Hoag LLP
Katrine Bosley, CEO, Avila Therapeutics
Skip Irving, Partner and Managing Director, Health Advances
Linda Johnson, National Director Strategic Alliances, Juvenile Diabetes Research Foundation
Frances Toneguzzo, Executive Director of Research Ventures & Licensing, Partners Research Ventures and Licensing
IP Issues in Joint Ventures
The use of joint ventures as strategic transactions has been on the rise in the current economic climate, where companies are very protective of their capital and external financing is difficult. While JVs typically require a smaller upfront investment and may allow final valuation to be deferred, they present unique IP issues. This workshop will highlight how to determine what IP should be contributed to the JV and what should be licensed; the nature of those licenses and their interplay with any non-competition provisions in the JV’s governing agreements; the nature of any licenses back from the joint venture to the parent companies; appropriate liability allocations among the parties; appropriate governance structures to address ongoing IP questions; and IP issues related to exit rights.
Steven Barrett, Partner, Co-Chair, Technology Transactions and Licensing Practice Group, WilmerHale
Jeffrey Rothstein, Partner, Sidley Austin
Can Rx to OTC Switch Licensing Save the Day After Patent Expiration?
Every day we read about another pharmaceutical company that must replace an income stream that will be lost after key patents expire. The pharma dilemma is clear: it takes huge R&D investments and long timelines to get products to market and after patent expiration, the income stream is gone. The panel will discuss how Rx-to-OTC switch licensing can provide lifecycle management for the pharma company and will answer: Why should Pharma consider OTC licensing? What products are good Rx-to-OTC switch candidates? What are the capabilities of a good OTC partner? What is the role of Pharma in the process?
Kim Houston, Executive Director, everythingHEALTH, LLC
Susan Levy, Principal, Susan B. Levy Consulting
Robert Nissen, President, Nissen Consulting Group, LLC
Robin Sitver, Executive Director, Business Development, Johnson & Johnson Healthcare Products
Maximizing the Value of Corporate Intellectual Property Assets Following Enactment of the America Invents Act
The Leahy-Smith America Invents Act (AIA) signed into law on September 16, 2011, makes numerous changes to U.S. patent law and USPTO practice. These changes necessitate a reevaluation of business strategies for patent prosecution, litigation, and technology transfer. This discussion will highlight practical considerations for in-house counsel and technology transfer professionals in view of the AIA. Topics to be considered include provisions of the AIA that potentially affect practices for internal invention review, patent prosecution, litigation, and collaboration and license agreements.
Janet MacLeod, Partner, Fox Rothschild LLP
Gerard Norton, Partner, Fox Rothschild LLP
Charles Ryan, Sr. V.P. and Chief I.P. Counsel, Forest Laboratories
Teri Willey, Vice President for Technology and Business Development, Mount Sinai School of Medicine
Workshop Session C
Thursday, May 17
10:15 AM - 11:30 AM
De-risking the Target: Securing Long-Term Value across Multiple Early Stage Target Deals
Innovators with platform technologies for screening molecular targets and discovering drug candidates may wish to license their technologies to multiple partners. These iterative, concurrent licenses can maximize the IP portfolio's value by enabling the innovator to secure robust R&D funding and pursue multiple uses through parallel projects. Permitting several partners access requires terms that permit fair, non-overlapping use. Licensors must coordinate FTO issues, gatekeeping, field limitations, exclusivity mechanisms, grantbacks and reversion rights to preserve long-term access to IP generated under each program. A reasoned approach can yield a clear path to successful licensing.
Sandhya Kilaru, Wiggin and Dana LLP
Patricia Melick, Partner, Wiggin and Dana LLP
Lesley Stolz, VP Business Development, Sutro Biopharma
Robin Walker, Associate GC, Biogen Idec
Early Stage Deal Structures
Recent experience in pharmaceutical development reveals a shift in collaborative arrangements. Traditional inventors patent and license products to biotech and big pharma. Population Council scientists invented Nestragel™ with Antares, and the two companies are in the process of licensing the product for contraception. But the landscape is changing as funding agencies mobilize broader multi-party product development collaborations. The Council has executed 65 agreements in the past four years to support development of a product limited only by its medical indication, to diminish the likelihood of communicating HIV. How do a dozen shareholders with disparate intellectual assets, create a commercially viable opportunity?
Pavan Handa, Senior Vice President, Business Development, Antares Pharma, Inc.
James Sailer, Vice President, Corporate Affairs, Population Council
George Young, Business & Financial Manager, Population Council
Academic - Industry Licensing and Partnering: New/Emerging Models
What types of collaborations can bridge gaps between the interests of commercial sponsors of academic research, the research interests of the academic institutions, and/or the entrepreneurial interests of the researchers? How can we structure sponsored research agreements in a way that avoids potential roadblocks, such as arguing over the disposition of resulting IP? How can we partner effectively to bridge the innovation gap, ensure a longer patent-protected life of a new therapy, and generate higher value for all the parties? This workshop will discuss academic sponsored research and licensing programs, models of creative early deal structures, and examples to explore when and how to facilitate spin-outs from industrially-sponsored research.
Christopher Noble, Technology Licensing Officer, Massachusetts Institute of Technology
Rekha Paleyanda, Sr. Business Strategy & Licensing Manager, Massachusetts General Hospital
Anish Patel, PharmD, Associate Director, CTI Strategy & Operations, Centers for Therapeutic Innovation (CTI)
Stefani Shek, Industrial Contracts Associate, Stanford University
Structuring Deals to Maximize the Ability to Enforce Your Patent Portfolio
In this workshop, through a series of hypothetical scenarios, the presenters will explore how licensing and other business decisions can impact the ability of a company to enforce its intellectual property rights in federal district court and the United States International Trade Commission. The discussion will focus on strategies to maximize the ability of holders of IP rights to establish standing in federal court and the ITC, how they can take steps to establish domestic industry, a prerequisite for ITC standing, through their licensing program, and how they can lose those rights if certain business or licensing practices are not maintained.
Nicholas M. Boivin, Director, Intellectual Property Counsel, Cubist Pharmaceuticals, Inc.
Carl Charneski, Counsel, Brinks Hofer Gilson & Lione
Robert Mallin, Shareholder, Brinks Hofer Gilson & Lione
Jill Pierard, Director, Intellectual Property, Sigma-Aldrich
Lyle Vander Schaaf, Managing Partner, Brinks Hofer Gilson & Lione
Extra! Extra! This Just in! The Now Uncertain Future of Personalized Medicine and Life Sciences Innovation
In this unanimous decision, the Supreme Court of the United States departed from its long-standing precedent that section 101 of the patent statute should be interpreted broadly in favor of patent eligibility. Instead, the Supreme Court appears to have conflated 35 U.S.C. § 102, which requires patent claims to be novel, and 35 U.S.C. § 103, requiring claims to be nonobvious, into the patent eligibility analysis under § 101 and held that Prometheus' dosing process is not eligible for patent protection because the process is effectively an unpatentable law of nature. In this workshop, we will evaluate the effects this decision may have on licensing personalized medicine and life sciences innovations.
Tom Filarski, Partner, Steptoe & Johnson
Kevin Noonan, Partner, McDonnel Boehnen Hulbert & Berghoff