Worldwide Business Research

Scott Brown Vice President, General Counsel, Head of NIBR Patents, Novartis Institute of Biomedical Research Novartis

Scott oversees a global organization dedicated to the legal and intellectual property needs of NIBR, the research and early development arm of Novartis. His team is responsible for development and implementation of the Company’s intellectual property and transactional strategy, including procurement of patents, analyzing intellectual property issues relating to Company activities, risk and litigation management and Company licensing and M&A transactions.

Guy Donatiello Vice President Intellectual Property Endo Pharmaceuticals

Karen F. Clark Associate General Counsel, Global Health, Well Being and Beauty Care The Procter & Gamble Company

Karen has over 20 years of experience in intellectual property. She is in charge of the intellectual property group for Global Health, Well Being and Beauty Care and is responsible for the strategic direction of IP initiatives. Her group is also responsible for patent preparation and prosecution, portfolio development, IP support for mergers, acquisitions and divestitures, and IP enforcement.

Dorothy Auth, Partner Litigation and Intellectual Property Cadwalader Wickersham & Taft

Intellectual property has long been recognised as the most valuable asset that a pharma/biotech company has. However, while aligning IP and the business is a widely recognised necessity, actually implementing and executing this is challenging. This high level panel discussion will provide a forum for lively debate centering on these key questions:

• How do you determine whether today’s discovery will be tomorrow’s blockbuster?
• How do you bring together diverse function groups and get them on the same IP page?
• How do you become a resource and not a roadblock to innovation?
• How do you ensure IP strategies evolve with the business?
• Who should own the initiative to align business and IP?

Li Westerlund Vice President of Global Intellectual Property Bavarian Nordic

Li is a Swedish lawyer and a U.S. Attorney-at-Law (CA bar). She has a doctoral in biotech patents based on her dissertation Biotech Patents: Equivalency and Exclusions under European and US Patent Law, which was published by Jure AB in 2001 and by Kluwer Law International in 2002. Academically, she was further appointed Professor-of-Law in Swedish and international patent law by Linköping University in 2004.

In practice, traditional portfolio management or theory has not changed. But what has changed are shifting goal posts with regards to rule changes and increasing complexity of the pharma/biotech business. Li is tasked with not only legal aspects of IP, but also working within a multi-disciplinary team that brings together product development, with marketing and business development to create a comprehensive IP strategy. This is to ensure all areas are aligned as ultimately IP must serve the business. Drawing on her experience, she will detail how to take a fresh perspective on portfolio management including:

• From a business perspective how best can you identify the commercial chokepoints that will enable strong patent portfolio?
• Based on this, what criteria can be used to decide what applications to file to ensure utmost relevance to your business
• Effectively keeping track of internal changing business models and critically evaluating commercial decisions to drive growth and enhance protection
• Enforcement of the strategic portfolio including Safe Harbour issues and implication of Merck v Integra

Robert Hrubiec Vice President Intellectual Property and Chief Patent Counsel Cephalon

Gary Creason Vice President Intellectual Property AVEO Pharmaceuticals

John T. Li Patents, Head, Biology & Biologics, Novartis Institutes for Biomedical Research Novartis

John’s role involves coordination and quality control of biologics patenting and freedom-to-operate analysis across all disease areas, platforms, and functions within NIBR. Previously he was Director of Intellectual Property at Therion Biologics Corp., a Senior Patent Agent and Assistant General Counsel in the IP group of Biogen Idec and was formerly a Technology Specialist at the law firm of Fish & Richardson.

Robert J. Paradiso Partner, Head of Life Sciences Patent Practice Lowenstein Sandler

Robert J. Paradiso is an Intellectual Property Attorney in the Tech Group and leads the firm’s life sciences patent practice. He assists domestic and international corporations, as well as higher learning institutions, on virtually all aspects of intellectual property, including the drafting and prosecution of patent applications. Mr. Paradiso also counsels on matters related to non-infringement, patentability, litigation, due diligence, freedom to operate, licensing and technology transfer.

It’s the perfect storm in the US at the moment with changes happening at the Patent Office, Congress and the Supreme Court all at the same time. Whether sea change or not, they will alter the practice of how you capture inventions, how you define them and how you claim them in the IP world.

This high level panel kicks off the summit and set the backdrop for presentations going forward. The panel focuses on understanding the reform efforts and what the patent office is attempting to do. Specifically they focus on how this will eventually play out in terms of strategic thinking and development of IP strategies covering the Patent Reform Act of 2007.

Martin Voet Senior Vice President, Chief Intellectual Property Counsel Allergan

Martin Voet has over 20 years of experience in pharmaceutical intellectual property field. He graduated from the University of California at Berkeley with a degree in Chemistry; received his Juris Doctorate degree with Honors from the George Washington University National Law Center and an MBA from Pepperdine University School of Business and Management. He recently published a book on pharmaceutical life cycle management entitled “The Generic Challenge: Understanding patents, FDA and Pharmaceutical Life-Cycle Management.”

There is increasing recognition that aligning both patent and regulatory counsel can maximise exclusivity. However, how can you effectively bring both practices together to leverage on this synergy? This session details how to develop and foster a comprehensive strategy that aligns regulatory and intellectual property practices to extend patent lifecycles.

• Ensuring communication between patent and regulatory counsel to avoid inconsistencies at the PTO and FDA
• Effectively integrating feedback from other stakeholder functions such as marketing to formulate more effective life cycle extension strategies

Chairperson’s Opening Remarks

Sam Baxter Chief Technology Officer IP.com

Balaram Gupta Associate Vice President, U.S. Patent Operations Sanofi Aventis

Balaram currently heads the CNS patent group in the US, and is responsible for all of the patent matters for the CNS therapeutic group, which includes patent drafting and prosecution, client counseling, rendering freedom to operate opinions, FDA listings, administrative responsibilities as well as patent portfolio management in the US.

During this session, Balu draws on his over 27 years of experience to detail how recent rule changes impact patentability and ultimately how you effectively manage your portfolio to ensure protection and extend life cycles:

• Effective project management and its role in maintaining control of the portfolio
• Ensuring patent strategy alignment with science and product development groups to validate the patent strategy
• What do the rule changes spell for portfolio management in terms of strategy and driving innovation or retrenchment of the existing portfolio?

Jim Diehl Executive Director of Intellectual Property and Associate General Counsel Rigel Pharmaceuticals

Jim has been at Rigel in the IP department since the beginning of 2002, where he has focused on building the company’s IP portfolio, particularly the patent estate. His current duties include managing the IP and Contracts portions of the Legal Department and supporting Rigel’s General Counsel in Corporate and all other legal affairs.

Drawing on practical tips and strategies, Jim provides you with key insights enabling you to assess and alter your portfolio management strategies to gain maximum value and protection, despite massive rule changes.

This case study focuses on first hand experience of:

• Assessing the severity of the rule changes and which ones to focus on with regard to portfolio management
• Reviewing the pending portfolio to identify key potential problem areas
• Establishing a game plan for all cases that could be severely impacted both going forward and retroactively

Mark E. Boulding Senior Vice President and General Counsel PTC Therapeutics

Mark’s responsibilities include development and management of PTC’s intellectual property portfolio, negotiation of licensing arrangements and business development transactions, interactions with the government and universities on technology transfer matters.

From a biotech perspective, Mark discusses key portfolio development and design strategies to enhance the perception potential license partners have of the long term viability of your patent portfolio. This is even more critical in light of recent proposed rule changes in the US, which may impact pursuit of multiple claims and optimal time to file. Drawing on these key issues, Mark gives his insights on:

• Designing portfolios that deliver perceived value in the licensing context even prior to issuance
• Aligning development of cases and claims with both short and long term business objectives to maximize value
• Understanding the perspective potential partners have on endof- life strategies and litigation risk management

Geraldine Baldwin Director Patents Schering-Plough

Geraldine heads the Life Cycle Management Group in the Law Dept at Schering-Plough. She has extensive experience developing global (domestic and foreign) intellectual property strategies in biotechnology and pharmaceutical chemistry fields and currently focuses on developing global life cycle strategies.

Rule changes and increasingly aggressive paragraph IV litigators make the road to pharmaceutical extension extremely tenuous. This session debates how best to extend your patents in light of these current challenges.

• What are viable extension strategies?
• What types of strategies can no longer withstand challenge?
• How can you effectively develop secondary areas of patent protection?
• What will be the impact of continuation rules on lifecycle and extensions

Luisa Bigornia Vice President Intellectual Property BioMarin Pharmaceutical

Luisa is responsible for the management of all company IP matters, the development and implementation of patent strategy for all company programs, and the provision of IPrelated support to Business Development, Commercial Planning, Regulatory, Clinical, Research, Legal Corporate and other groups within the company.

How do you ensure your patents are protected by your label? Are you implementing all the possible regulatory exclusivities you can get for that product? One of the biggest challenges is developing an effective regulatory strategy to ensure life cycle extension. Drawing on experience with their small molecule portfolio, Luisa explores in detail how you can extend life cycle through exclusivity and discuss the following:

• Integrating patent practice and regulatory practice to ensure they are complementing each other
• Preventing inconsistencies to prevent litigation later on
• Coordinating filing of applications before an ANDA comes
• Exploring different options with regards to forms of exclusivities

Stephen Donovan Vice President and Assistant General Counsel Allergan

As a registered patent attorney Stephen is responsible for the botulinum toxin (i.e. Botox) and retinal therapeutics patent portfolios at Allergan, including prosecution, oppositions, and licensing and manages related staff and outside counsel. He is the inventor or co-inventor of 50 granted U.S. patents and has degrees in science, business and law.

During his session he details:

• The nature of and suggested timing for seeking various pharmaceutical patent exclusivities (eg compound, use, formulation, manufacturing and biologics patents) and the reasons to choose between them, including the effect of recent Supreme Court decisions
• The scope and and value of available regulatory exclusivities (FDA granted orphan, new chemical entity, clinical study, formulation, and pediatric exclusivities, as well as the 180 day and 30 month generic periods)
• Followed by a detailed case study of how patent and regulatory exclusivities can work together to provide effective drug life cycle management for improved patient benefits

James Kelley Associate General Counsel Eli Lilly & Co

Bruce S. Manheim Jr. Partner Ropes & Gray LLP

Biotech drugs are especially appealing because they face no competition from generics and are driving much collaboration and research in the industry. Currently, no regulatory pathway yet exists in the U.S. for bringing to market generic biotech drugs, however, what happens when Congress creates such a pathway? This session discusses what the potential impacts will be and how to chart the way forward.

• Biosimilars & follow-on biologics – what can we expect in terms of regulations and what are the implications for strategy?
• Updates from Europe – how far have they come along and how much of a lead with the USPTO take from the EPO?
• If regime similar to Hatch-Waxman, what are the anti-trust implications?
• How do we address the safety and efficacy issues?

After a day filled with constructive discussion, case studies and critical information for your intellectual property strategy, RELAX, UNWIND and make new friends and contacts at the Networking Cocktail Party! Take advantage of this opportunity to network with the industry’s brightest and most forward thinking leaders in a relaxed and informal atmosphere. Bring plenty of business cards and expand your intellectual property network!