Chair’s Opening Remarks

Dianne Elderkin Partner, Patent Litigation Woodcock Washburn

Renee Kosslak General Patent Counsel PDL BioPharma

PDL BioPharma, Inc., is a mid-size biopharmaceutical company that is utilizing its antibody humanization technology to build a strong pipeline of antibody therapeutics for the treatment of cancer and autoimmune diseases. Renee counsels the company on all IP related issues, including life cycle management, IP related transactions and litigation.

IP protection is critical to the pharma/biotech industry. However, when you are able to align your product development initiative through to portfolio management to life cycle management you are truly putting in place a strategy that ensures protection of your vital patents. Renee provides insights into:

• Exploring the link between product development, portfolio management and lifecycle management
• Ensuring effective communication between product development, commercial functions and intellectual property to make better informed life cycle extension decisions
• Leveraging on synergies across all three areas to maximise the commercial value of intellectual assets

	Gerald Murphy Partner, Intellectual Property & Life Sciences Birch Stewart Kolasch & Birch
	James Gould Legal Director – Global Patent Litigation Schering-Plough

Cindy Clay Senior Counsel - Intellectual Property, Global Personal Health Care and Pharmaceuticals The Procter & Gamble Company

Cindy is the Category Leader for Respiratory, Gastrointestinal Health, Pain and Analgesia for the Personal Health Care Business and Gastrointestinal Health for the Pharmaceutical Business. She is primarily responsible for the prosecution, preparation, evaluation, opinion work, and licensing of patent technology. Additionally, Cindy actively advises in the strategic life cycle management of the patent portfolio of both the Personal Health Care and Pharmaceutical businesses.

KSR has had a revolutionary impact on how pharma/biotech companies protect and enforce their patents. It not only puts issued patents at risk to be found invalid for obviousness, it also makes it much harder to get a patent when it’s not a new active ingredient. Whether or not KSR will have an impact statistically on number of patents granted or number of litigations remains to be seen, but there is no doubt it has a tremendous impact.

In the second of our keynote panels, our panellists discuss and debate the impact of KSR, but more importantly how to adapt your prosecution and litigation strategies to ensure optimal protection and prosecution of your patents.

• Impacts of drafting style and the link between drafting and potential litigation down the line
• Identifying what needs to be emphasised what to include and what to argue
• Litigation strategies from both the plaintiff and defendant patent owner perspectives

Winston Henderson Vice President, General Counsel Surface Logix

Winston’s experience covers many areas of intellectual property, including patent, trademark and copyright litigation, licensing and prosecution, corporate intellectual property strategy, valuation and due diligence. Winston’s patent litigation and prosecution experience is focused primarily in life sciences including biotechnology and medical-related devices.

Smaller innovator companies face a very competitive environment not only from more established pharma/biotech companies but also from academic laboratories. In addition, smaller startups may not necessarily have the resources to put into litigation. Winston’s experience covers many areas of intellectual property, including patent, trademark and copyright litigation, licensing and prosecution, corporate intellectual property strategy, valuation and due diligence. Drawing on his experience, Winston sheds light on formulating an effective IP protection strategy that not only ensures enforcement, but also maximizes commercial opportunities. Key areas to be discussed include:

• Effective portfolio enforcement in light of experimental use exemption
• Within this framework what does and does not constitute infringement and how do you track it?
• Discussing recent declaratory judgement rules and the impact on licensing and out-licensing

David Earp Senior Vice President Business Development and Chief Patent Counsel Geron Corporation

David manages Geron’s intellectual property assets and oversees the company’s in-licensing, out-licensing and partnering activities. Geron is developing products in regenerative medicine (based on human embryonic stem cells) and oncology (based on the enzyme telomerase), and holds rights to nuclear transfer (cloning) technology used to produce Dolly the sheep.

Companies talk about intellectual property in terms of the patents that they own, but rarely publicly address freedom to operate issues that inevitably arise in IP-focused business sectors. This presentation discusses when and how companies should evaluate and monitor freedom to operate issues in making investment and development decisions. It considers strategies available to address risks identified in freedom to operate searches and points out key differences in the US and EP patent systems that impact choices made in each jurisdiction.

Chair’s Opening Remarks

James Kelley Associate General Counsel Eli Lilly & Co

James manages a group of eight attorneys and associates supporting Lilly’s large molecule products and he has general responsibility for IP matters in Lilly’s product development functions, including both small and large molecules. Jim has led Lilly’s amicus efforts, including: Pfizer v. Dr. Reddy’s, Rochester v. Searle, Noelle v. Lederman, Merck v. Integra, In re Fisher, Microsoft v. AT&T, and Pfizer v. Apotex.

One year after KSR and Pfizer, it appears that these decisions have had little, if any, impact on the outcomes of pharmaceutical and biotech validity questions in the courts. Courts have almost uniformly struggled to find KSR's holding pertinent to pharmaceutical and biotech patents, and Pfizer has been strictly confined to its very particular facts. Nevertheless, important lessons pertinent to drafting and prosecuting can be drawn. In August 2007, the Office issued guidelines to its examiner for applying KSR. Besides KSR and Pfizer, the presentation will include: Takeda v. Alphapharm, Forest v. Ivax, Aventis v. Lupin, Sanofi v. Apotex, Novartis v. Teva, Altana v. Teva, Bayer v. Dr. Reddy’s, and In re Kubin.

This session discusses how to apply lessons from the Patent Office’s responses and from cases after KSR and Pfizer to drafting and prosecuting. After the session, the group will discuss interpretations and implications for drafting, prosecution, and litigation.

Lee Caffin Divisional Vice President Global IP Strategy Abbott Laboratories

A 25 year IP veteran, Lee has held senior positions in major pharmaceutical companies in Europe, Japan and the USA. In the fall of 2007 Lee was promoted to DVP of Global IP Strategy for the Abbott Pharmaceutical business and is uniquely placed to share experiences and best practices as pharmaceutical companies look to integrate IP into the day to day operation of their business and capitalize on their IP assets.

Software and high tech companies have developed sophisticated business models for maximizing returns on their IP investments. In the high risk world of pharmaceuticals, Lee shares insights that draw on his experience in a relatively new strategic role to demonstrate how, with support from the business, related strategic models can be utilized to make IP a competitive advantage for pharmaceutical companies. Lee will also discuss strategies to fully align intellectual assets with current and future business plans and enhance IP portfolios in a cost-efficient manner.

Margaret Snowden Vice President Intellectual Property Impax Laboratories

Meg is responsible for all intellectual property matters, including patent prosecution, advice and patent litigation, as well as Hatch- Waxman Act advice and counseling. Impax Laboratories, Inc., is a technology-based specialty pharmaceutical company applying its formulation expertise and drug delivery technology to the development of controlled-release and specialty branded and generic products.

A controversial issue is how damages are apportioned in the context of patent damages calculation. Some observers argue that the threat of outsized damage awards casts an ever present shadow on patent litigation. This session explores pending legislation addressing this issue and compare the proposals to existing case law, providing insights into how damages could be apportioned and the evolution of patent damages calculations.

Chair’s Opening Remarks

Joshua R. Slavitt Partner, Intellectual Property Law Pepper Hamilton

Tom Plant Assistant General Patent Counsel Eli Lilly & Co

Jennifer Tegfeldt Director Business Initiatives and Strategy Genzyme Corporation

Ira Weiss VP of Finance and Operations BioDtech

Ira has primary responsibility for the financial operation including the contract negotiations and intellectual property transfer. He has worked extensively with universities, non-profit foundations and research facilities, pharmaceutical companies and executives at both management and board levels.

One of the key issues from a licensing and transactions point of view is quick and effective IP due diligence. However, the slew of rule changes makes this increasingly challenging. There needs to be open communication to ensure that motivations are transparent and aligned with business objectives. In addition, there needs to be a balance between entrepreneurship and caution to ensure the deal delivers the value it promises.

This session debates:

• How do recent rule changes and potential reforms impact swift conducting IP due diligence?
• How do you conduct a due diligence review that best serves the needs of the business?
• How do you factor IP valuation into the due diligence process?

Reinhold Nowak General Director Dennemeyer

Nils Omland Director Dennemeyer AG

Nils is an expert in the valuation of patented technologies. He evaluates and benchmarks large patent portfolios for corporations, investors and other organizations. He also works as a trainer in the evaluation of patents. Nils wrote his doctoral thesis on the value of patented technologies theorizing and validating the factors that determine the value of patented technology.

Recent changes by IFRS 3 and SFAS 141/142, M&A activity and buyouts have all put the spotlight on the valuation of intellectual property. But how do you go about putting a value on the seemingly intangible? This session shares how you can practically value assets and how to communicate this internally to get buy-in for your patent decisions. Moving beyond legal valuation, this session focuses on how you can put a financial value on your assets:

• Auditing your portfolio qualitatively so you can identify winners, losers and future stars
• Shedding light on various methodologies for valuing patents
• Strategies to effectively communicate your valuations internally to get buy-in and instant comprehension

Joseph Vittiglio Corporate Attorney AVEO Pharmaceuticals

Hugh M. Cole Vice President of Business Development Shire Human Genetic Therapies

Hugh has completed numerous transactions in his business development career, including in-licensing, out-licensing, copromotion, and merger/acquisition transactions. Before joining the biopharmaceutical industry, Hugh spent several years in the investment management and management consulting fields.

The assessment of an IP portfolio is a key when you decide to either go public, enter into collaborations or in M&A. This presentation details what considerations are taken and lets you into the mindset of the investor/partner. Key takeaways enables you to ensure that you position you portfolio most effectively to garner the most value for your company.

• How do you position your IP with regard to strategic collaborations and Wall Street valuations?
• How do you position your IP as an exclusive gem in an industry inundated with drugs?
• How do you categorise IP and begin to place a value on it?

With more changes ahead in terms of regulations and the future business model of the pharmaceutical/biotech industry, it is impossible to deny the impact of future intellectual property strategies. As a wrap up to the PharmaBiotech IP Summit, this closing panel session is an excellent opportunity to raise outstanding questions and debate key issues that have arisen during the last three days. Join our speakers in a lively debate on how to adapt your prosecution and litigation strategies in line with potential changes. In addition, discuss the evolving role of IP in the pharmaceutical/biotech organization.

Key issues to be addressed include:

• Adapting your patent strategies based on differing needs and aligning this to all IP stakeholders
• Rules, regulations and future rulings – what is the road ahead and what is the potential impact of future prosecution & litigations strategies?
• Paragraph IV disputes – what are the most common avenues of generic attack and what do you need to watch out for?
• IP valuation – how do you put a dollar value on intangible assets?

This is just a sample of possible questions to be discussed at this exciting panel. If you have more exciting questions or any suggestions for topics of discussion, please visit pharmabiotechip@ wbresearch.com

Don’t forget – champagne will be served during this panel session!