Pharma/Biotech IP Due Diligence

Your Complete Guide for M&As, Licensing, and Other Collaborations

Wednesday, January 30, 2008

About

IP due diligence is now a central concern and struggle for companies in life science-related industries, due to the substantial growth of mergers and acquisitions, spin-outs, and divestitures, as well as the evolving role of licensing and collaborative arrangements. If the due diligence is not properly conducted, you run the risk of loss of reputation, loss of profits, or even ruin.

Since the intellectual property at issue can make or break a deal, it is imperative that you are aware of all of the current changes to patent practices. This past year has seen patent reform efforts at all levels - in the courts, legislature and USPTO. KSR International Co. v. Teleflex, Inc. and its progeny could have a significant impact on the validity of a patent and consequently the value of the IP in question. The recently enacted USPTO Claims and Continuation Final Rule complicates the patent landscape even further.

As the person responsible for ensuring the IP’s value, you need to know the structure of the deal, what assets are important and the business drivers behind the transaction. These influence the type and depth of diligence needed. Only then can you develop an appropriate diligence strategy, build the team, and devise the right checklist.

As part of any diligence review, you need to determine whether title is clear, and whether there is the right to commercialize the IP. The portfolio’s value must be evaluated, including the validity of the patents involved and the potential risks.

With all of this in mind, ACI has developed this publication from the 5th National Conference on Pharma/Biotech IP Due Diligence: Your Complete Guide for M&As, Licensing, and Other Collaborations. An unparalleled faculty of leading IP practitioners and experienced in-house counsel provide you with best practices for conducting a successful and cost-effective IP diligence review.

Contents & Contributors

About

IP due diligence is now a central concern and struggle for companies in life science-related industries, due to the substantial growth of mergers and acquisitions, spin-outs, and divestitures, as well as the evolving role of licensing and collaborative arrangements. If the due diligence is not properly conducted, you run the risk of loss of reputation, loss of profits, or even ruin.

Since the intellectual property at issue can make or break a deal, it is imperative that you are aware of all of the current changes to patent practices. This past year has seen patent reform efforts at all levels - in the courts, legislature and USPTO. KSR International Co. v. Teleflex, Inc. and its progeny could have a significant impact on the validity of a patent and consequently the value of the IP in question. The recently enacted USPTO Claims and Continuation Final Rule complicates the patent landscape even further.

As the person responsible for ensuring the IP’s value, you need to know the structure of the deal, what assets are important and the business drivers behind the transaction. These influence the type and depth of diligence needed. Only then can you develop an appropriate diligence strategy, build the team, and devise the right checklist.

As part of any diligence review, you need to determine whether title is clear, and whether there is the right to commercialize the IP. The portfolio’s value must be evaluated, including the validity of the patents involved and the potential risks.

With all of this in mind, ACI has developed this publication from the 5th National Conference on Pharma/Biotech IP Due Diligence: Your Complete Guide for M&As, Licensing, and Other Collaborations. An unparalleled faculty of leading IP practitioners and experienced in-house counsel provide you with best practices for conducting a successful and cost-effective IP diligence review.

Contents & Contributors

RECENT FEDERAL CIRCUIT INEQUITABLE CONDUCT DECISIONS
Mark Rachlin, GlaxoSmithKline (King of Prussia, PA)

US PATENT REFORM (AS OF JANUARY 24, 2007)
Reza Green, Novo Nordisk (Princeton, NJ)

FACTORING CASE LAW INTO YOUR DUE DILIGENCE
Elizabeth Howard, Orrick, Herrington & Sutcliffe LLP (Menlo Park, CA)

INTELLECTUAL PROPERTY DUE DILIGENCE IN THE CONTEXT OF A DEAL
Michael Davitz, Axinn, Veltrop & Harkrider LLP (New York, NY)

DETERMINING WHAT DILIGENCE IS DUE IN LIGHT OF NEW AND INCREASINGLY COMPLEX MULTIPARTY TRANSACTIONS
David P. Frazier, Ph.D., Finnegan, Henderson, Farabow, Garrett & Dunner, LLP (Washington, DC)

EXTRACTING FROM THE DILIGENCE REVIEW THE CRITERIA THAT WILL IMPACT VALUATION
Michael James Lasinski, Ocean Tomo (Chicago, IL)

EXTRACTING FROM THE DILIGENCE REVIEW THE CRITERIA THAT WILL IMPACT VALUATION
Lewis Bender, Interleukin Genetics, Inc. (Waltham, MA)

DRAFTING THE CHECKLIST AND MANAGING THE DUE DILIGENCE TEAM
Christine Bellon, Infinity Pharmaceuticals, Inc. (Cambridge, MA)

TECHNOLOGY TRANSFER AT COLUMBIA UNIVERSITY
Jeffrey M. Sears, Ph.D., Columbia University (New York, NY)

EVALUATING THE SCOPE OF THE TARGET’S PATENTS
Kelly L. McDow, The Procter & Gamble Company (Cincinnati, OH)

EVALUATING THE SCOPE, VALIDITY AND ENFORCEABILITY OF THE TARGET’S PATENTS
Brian J. Del Buono, Ph.D., Sterne, Kessler, Goldstein & Fox P.L.L.C. (Washington, DC)

PROTECTING CONFIDENTIALITY, TRADE SECRETS AND ATTORNEY CLIENT PRIVILEGE DURING A DILIGENCE REVIEW
Carla B. Oakley, Morgan, Lewis & Bockius LLP (San Francisco, CA)
Barbara A. Ruskin, Ph.D., Ropes & Gray LLP (New York, NY)

UNCOVERING ISSUES WITH OWNERSHIP RIGHTS AND INVENTORSHIP
Steven R. Ludwig, Ph.D., Venable LLP (Washington, DC)

EXCLUSIVE RIGHTS & FREEDOM TO OPERATE
Scott Alban, Ph.D., J.D., MedImmune, Inc. (Gaithersburg, MD)
Anita Varma, Ropes & Gray LLP (Boston, MA)

FDA REGULATION OF SMALL MOLECULES AND BIOLOGICS
Veronica Mullally, Lovells LLP (New York, NY)

HATCH-WAXMAN AND PRODUCT EXCLUSIVITY ISSUES IN THE IP DUE DILIGENCE CONTEXT
Natalie M. Derzko, Covington & Burling LLP (Washington, DC)

THE DELIVERABLE: ASCERTAINING AND COMMUNICATING THE RESULTS OF THE ANALYSIS
John C. Todaro, Merck & Co., Inc. (Rahway, NJ)
Benjamin C. Hsing, Kaye Scholer LLP (New York, NY)



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