IP Forum For Pharmaceuticals, Biotechnology & Medical Devices

Transcription

1 IP Forum For Pharmaceuticals, Biotechnology & Medical Devices December 8-10, 2013 Fairmont Newport Beach Hotel Newport Beach, CA Fairmont Newport Beach Hotel 4500 MacArthur Blvd Newport Beach, CA (949) newport-beach In today s fiercely competitive markets, the use and protection of intellectual property could very well be the difference between success and failure, particularly in the pharmaceutical and biotechnology industries. Now, more than ever, Chief Intellectual Property Counsel are expected to turn corporate innovation into profit by implementing the right market protection strategies. The protection of IP, and keeping a close watch for shifts in patent law, are an integral part of life cycle management in an expanding market and ever-changing regulatory environment. Consero s 2013 IP Forum For Pharmaceuticals, Biotechnology & Medical Devices will address the most crucial, top-of-mind issues facing heads of intellectual property, offering a unique, intimate opportunity to exchange best practices, benchmark efforts, and explore strategies and tactics to ensure continued success. Topics For Discussion: Creating And Implementing A Successful Patent Master Plan Lessons Learned Under The America Invents Act The Eternal Balancing Act: Protecting Your Global IP And Sticking To Budget Reading The Tea Leaves: What Is The Future Of Biopharmaceuticals? h h Investing In Innovation Through Your Research And Development Strategy Consero Group LLC 4915 St. Elmo Ave., Suite 100 Bethesda, MD (202)

2 2www.consero.comDecember 8-10, 2013 Fairmont Newport Beach Hotel IP Forum For Pharmaceuticals, Biotechnology & Medical Devices AGENDA KEY General Session General Sessions address top-of-mind issues in issues a conversational faced by the exchange participants among in a two or more conversational corporate executives exchange and among other two industry or thought more corporate leaders, enabling executives participants and other to share industry experience, thought expertise, leaders, enabling leadership skills, and participants practical tools. share experience, expertise, leadership skills, and practical tools. SUNDAY, DECEMBER 8 1:30 PM 2:00 PM Opening Remarks 2:00 PM 3:00 PM Creating And Implementing A Successful Patent Master Plan How have you gone beyond your existing IP Strategy to begin developing a departmental IP Master Plan? How do you best define the primary moving parts and parameters that will characterize such a plan? How can you weather-proof your Master Plan to ensure that it will not require drastic revisions from year to year, given the dynamic nature of a growing Pharmaceutical, Biotechnology, or Medical Device company? How do you best align your IP Master Plan with the overall corporate strategy? Gillian Fenton Vice President of Legal Affairs and Chief Counsel Emergent BioSolutions, Michael Schiffer Vice President, General Patent Counsel Beckman Coulter 3:00 PM 4:00 PM Lessons Learned Under The America Invents Act Stephen Perkins Associate General Counsel, Covidien How have you been able to restructure your global IP strategy to include the newer provisions of the AIA? How has the AIA changed your approach to the in-house patent process? How have you been able to use the new procedures in the AIA to provide tactical advantages for your IP department? What complexities have the new Post-Grant Review and Inter Partes Review procedures presented for your patent litigation strategy? How have you managed to overcome these complications successfully? Richard Hake Chief Patent Counsel Kythera Biopharmaceuticals 4:00 PM 5:00 PM KnowledgeBridge Nicholas Triano Director of Intellectual Property Synta Pharmaceuticals KnowledgeBridge TM Consero s KnowledgeBridge sessions facilitate advanced, high-level dialogue in in an an informal boardroom-style setting on on specific more topics specific that topics are particularly that are particularly suited to well intimate suited group to intimate discussions. group discussions. Todd Garcia Principal Fish & Richardson

3 3www.consero.comDecember 8-10, 2013 Fairmont Newport Beach Hotel IP Forum For Pharmaceuticals, Biotechnology & Medical Devices SUNDAY, DECEMBER 8 6:00 PM 7:00 PM The Perfect Storm: Forecasting The Long-Term Effects Of The Myriad Decision On Your IP Portfolio Strategy What are the far-reaching implications of the Supreme Court decision regarding Association of Molecular Biology v. Myriad Genetics on the Pharmaceutical, Biotechnology, and Medical Device industries? What impact has the outcome of the decision had on your overall IP strategy? What are some creative ways you have found to reform your patent portfolio in the wake of the Supreme Court s decision that human genes cannot be patented? What impact, if any, has Myriad had on research and development at your business? Raymond Parker Assistant General Counsel, Patents Aptalis Pharma US, Bryan Zielinski Vice President and Assistant General Counsel Pfizer, 7:00 PM 7:45 PM Welcome Cocktail Reception 7:45 PM Networking Dinner Sonya Penfold Senior Director, Luminex Corporation The most effective way to meet and share with my peers. Chief Intellectual Property Counsel Weatherford International Ltd Claire Vasios Vice President, Alkermes, The most useful Forum for interaction between corporate IP counsel, coupled with an excellent opportunity to meet and evaluate select vendors in the IP space. Director, Intellectual Property Portfolio ManTech

4 4www.consero.comDecember 8-10, 2013 Fairmont Newport Beach Hotel IP Forum For Pharmaceuticals, Biotechnology & Medical Devices MONDAY, DECEMBER 9 7:00 AM 8:00 AM Networking Breakfast 8:00 AM 9:00 AM The Eternal Balancing Act: Protecting Your Global IP And Sticking To Budget What strategies do you use to evaluate your need for full protection of your global IP portfolio against what you can afford? What are some creative ways to reassess your overall IP portfolio to identify which of your patents will most successfully contribute to the company s bottom line? What specific criteria do you typically consider prior to determining in which global markets to file your intellectual property? How do you successfully decrease internal spending while continuing to pursue an effective offensive and defensive IP strategy? Christine Bellon Vice President, Legal Affairs Blueprint Medicines Gwilym Attwell Principal Fish & Richardson P.C. Karen Brown Chief Counsel Ironwood Pharmaceuticals, 9:00 AM 10:00 AM Post Grant Proceedings At The USPTO Lessons From The First Year Of Inter Partes Review Evjatar Cohen Vice President, Global Innovations Catalent Pharma Solutions, At one year old, inter partes review (IPR) is in full force and its impact on US patent practice is profound. With an average of at least one IPR filed at the U.S.P.T.O. each day, it is evident that third parties are taking advantage of this new proceeding as an alternative or supplement to district court litigation. What should general counsel be aware of and be doing to best prepare their company to adapt to this very real threat or to launch an attack on third party patents? Hear from those on the battlefront as to their experience with these new procedures what has worked, what has not, and what strategies are proving successful when facing concurrent litigation. This session will include a discussion of the following: How can post-issuance proceedings be used as a strategy to stay district court litigation, develop claim construction positions, or focus arguments on particular claims? How can in-house counsel best prepare for and manage the IPR process as a petitioner and as a patent owner? Whether, and to what extent, a successful IPR challenge by a subsequent ANDA filer might cause a forfeiture of 180-day exclusivity under the failure-to-market forfeiture provisions? John Covert Director Sterne Kessler Goldstein Fox

5 5www.consero.comDecember 8-10, 2013 Fairmont Newport Beach Hotel IP Forum For Pharmaceuticals, Biotechnology & Medical Devices MONDAY, DECEMBER 9 11:00 AM 12:00 PM Protecting Your IP While Maintaining Close Ties With China What specific steps have you taken to alleviate the risk of IPR infringement on your IP in China? How prepared are you to lessen the damage when IP issues do arise? How can you most strategically file your IP in China to protect your supply chain against violations? Looking back on your experiences in China, what were you most surprised to encounter with respect to your IP? Randy Berholtz Acting General Counsel and Secretary Innovus Pharmaceuticals John Merkling Chief Patent Counsel Terumo BCT, 12:00 PM 1:00 PM Networking Luncheon Reading The Tea Leaves: What Is The Future Of Biopharmaceuticals? What is the future of biopharmaceuticals? How have you incorporated biopharmaceuticals into your IP pipeline? How have you been able to develop a departmental strategy regarding biosimilars and follow-on biologics despite the uncertainty of how they will be implemented by the FDA? Considering the inevitability of a more effective biopharmaceutical approval pathway, how can biotechnology companies use the history between brand and generic drugs to influence their IP strategy? Andy Cohen Vice President and General Counsel KBI Biopharma Kevin Helmbacher Associate General Counsel and Chief Patent Counsel Dendreon Corporation 1:00 PM 2:00 PM Strategy Session: Creating Successful Collaboration With Institutions Of Higher Learning What factors can you attribute to your most and least successful relationships with institutions of higher learning? What specific surprises did you experience in negotiating licensing terms with these institutions? How can you reevaluate your strategy to mitigate these surprises in your next negotiation? What resources do you use to evaluate the ROI of your relationships with institutions of higher learning? David Abraham General Counsel and Corporate Secretary Selecta Biosciences, Zoran Zdraveski Senior Director, Epizyme OR Janice M. Klunder Vice President, Head of Patents Ipsen Amy Mendel Vice President and Associate General Counsel, Intellectual Property ZIOPHARM Oncology,

6 6www.consero.comDecember 8-10, 2013 Fairmont Newport Beach Hotel IP Forum For Pharmaceuticals, Biotechnology & Medical Devices MONDAY, DECEMBER 9 2:00 PM 3:00 PM Strategic IP Positioning Relative To Organizational Growth And Pipeline How does your IP strategy change as your company progresses from a start up to an emerging company to a market leader? Who is the audience of your overall IP message? How does this audience and IP message change as the company or product pipeline matures? How do you derive value from your IP well before it is time to litigate? Peter Socarras Director, Intellectual Property Nevro Corporation 4:30 PM 5:30 PM Key Case Law Developments: A Defining Year For The Industry Can the Supreme Court s ruling in Myriad be attributed in some part to its earlier ruling in Mayo v. Prometheus? What implications does the FTC v. Actavis ruling have on the Pharmaceutical, Biotechnology, & Medical Device industries? How have the developments in these cases influenced your overall approach to IP within your company? What other cases have been keeping you up at in night in 2013? Huong Nguyen Senior Director, Impax Laboratories, 6:30 PM 9:30 PM Networking Dinner And Entertainment Jim Harrington Chief Counsel Shire Pharmaceuticals Gerald M. Murphy, Jr. Partner Birch, Stewart, Kolasch & Birch, LLP

7 7www.consero.comDecember 8-10, 2013 Fairmont Newport Beach Hotel IP Forum For Pharmaceuticals, Biotechnology & Medical Devices TUESDAY, DECEMBER 10 7:30 AM 8:30 AM Networking Breakfast 8:30 AM 9:30 AM Hindsight Is 20/20: Best Practices For Patent Prosecutors From A Litigator s Perspective How can you draw upon your litigation experiences to influence the way you approach current and future patent prosecution? What are some ways to improve the way you initially prosecute a patent in order to alleviate the risk of potential litigation down the road? What best practices can you share with your patent prosecution team to ensure the most defensible patents, given the inevitability of patent litigation? Krisha Banerjee Senior Patent Counsel Allergan, Thomas Briscoe Senior Principal IP Strategist Dako 10:30 AM 11:30 AM Mergers, Acquisitions, And Joint Ventures, Oh My! Seth Fidel Lead IP Counsel Merrimack Pharmaceuticals What criteria should Chief IP Counsel look for when deciding with which companies to strategically partner? What role are emerging markets currently playing in M&A, and how can companies capitalize on these highgrowth markets? Is acquiring a company with a strong R&D pipeline a safe decision? How do you value the R&D? Timothy Howe General Counsel and Head of Acquisitions & Licensing Transactions Sanofi Pasteur Karun Naga Vice President, Strategy and Corporate Affairs Altura Medical, George Ng 11:30 AM 12:30 PM Investing In Innovation Through Your Research And Development Strategy Senior Vice President and General Counsel BioDelivery Sciences International, How can you successfully leverage the recent Supreme Court decision in Myriad, which could otherwise be perceived as a blow to the industry, to bolster new and innovative R&D efforts? How do you evaluate the ROI of sourced R&D? Is it worth the potential financial risk? What are some creative ways to incentivize in-house R&D, and how can you recruit and retain top R&D talent? Is it possible to contain costs associated with R&D without sacrificing quality or quantity in your pipeline? Earl Bright Executive Vice President and General Counsel ExploraMed Developmend, LLC 12:30 PM 1:30 PM Networking Luncheon Melissa Leuenberger- Fisher Executive Director & Senior Patent Counsel ISIS Pharmaceuticals Laleh Shayesteh Assistant General Counsel, Intellectual Property SRI International

8 8www.consero.comDecember 8-10, 2013 Fairmont Newport Beach Hotel IP Forum For Pharmaceuticals, Biotechnology & Medical Devices Traditional Conference vs. The Consero Difference Most conferences have attendees with little in common. Most conferences rely on lectures with Death by PowerPoint. The value of most conferences lies in free branded pens and keychains from a sea of vendor booths. vs. vs. vs. With Consero, rest assured that you will be among a select group of best-in-class partners. With Consero, the sessions are discussionbased with content driven by you and your industry colleagues. With Consero, you have the opportunity to meet one-on-one with qualified prospects who have chosen to meet with you, based on their needs. The result is a conference model that works. With Consero, you will never look at a traditional conference the same way. /Company/Consero-Group SEE THE FULL See the full consero.com

9 December 8-10, 2013 Fairmont Newport Beach Hotel IP Forum For Pharmaceuticals, Biotechnology & Medical Devices Your Involvement As A Solution Provider Includes: 10 guaranteed, one-on-one meetings with Private company meeting area, including all Customized binder containing full profiles and Editorial company profile featured in the on-site Access prior to the Forum to ConseroLinkTM, Detailed, customized itinerary from time of decision makers relevant to your business contact details for all attending delegates our proprietary software platform, in order to customize your itinerary A Consero Forum Planning Manager dedicated to assisting you before, during, and after the Forum All meals and receptions, including formal dinners corporate signage brochure directory arrival to time of departure Post-forum support, including specific survey feedback and optional follow-up assistance Two nights accommodations for one person at the Fairmont Newport Beach Hotel and other networking functions Consero Group LLC St. Elmo Ave. Suite 100 Bethesda, MD (202) tel