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Impact of Recent Court Decisions and IP Trends on Licenses American Chemical Society The 234th ACS National Meeting Boston, MA August 22, 2007. Presentation for. Intellectual Property. presented by Patrick R. H. Waller, Esq. Shareholder.
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Impact of Recent Court Decisions and IP Trends on Licenses American Chemical Society The 234th ACS National Meeting Boston, MA August 22, 2007 Presentation for Intellectual Property presented by Patrick R. H. Waller, Esq. Shareholder Wolf, Greenfield & Sacks, P.C.600 Atlantic AvenueBoston, Massachusetts 022101.617.646.8000 fax 1.617.646.8646 www.wolfgreenfield.com
Impact of Court Decisions and IP Trends in 2007 on Licensing Strategies
Licensing Context • Licensing chemical technology and intellectual property • Academic perspective • Interplay of pharmaceutical companies, CROs, and Academia • Information management • Government and academic issues relating to IP rights and licensing in Europe
2007 Court Decisions and IP Trends • Over 20 pharmaceutical CAFC patent decisions in 2007 • Important non-pharmaceutical decisions in 2007 • Patent Office rule changes in 2007 • Proposed patent law changes (2007?)
Non-Pharmaceutical Decisions in 2007 • MedImmune, Inc. v. Genentech, Inc. • SanDisk Corp. v. STMicroelectronics • KSR v. Teleflex
MedImmune, Inc. v. Genentech, Inc. • Summary • Licensee has jurisdiction to challenge patent validity even if Licensee is not in breach of license agreement • Impact on IP licenses and agreements
SanDisk Corp. v. STMicroelectronics • Summary • Potential Licensee has jurisdiction to challenge patent validity during license discussions • Impact on IP licenses and agreements
KSR v. Teleflex • Summary • Restated obviousness standard • Impact on IP licenses and agreements
Pharmaceutical Decisions in 2007 • Pfizer, Inc. v. Apotex • Integra Lifesciences v. Merck KGaA
Pfizer, Inc. v. Apotex • Summary • Certain pharmaceutical salts are obvious even if more effective (fact specific analysis of unexpected properties) • Impact on IP licenses and agreements
Integra Lifesciences v. Merck KGaA • Summary • Confirmed broad 271(e)(1) exemption to infringement of method claims relating to regulatory submissions • Impact on IP licenses and agreements
US Patent Office Rule Changes • November 1, 2007 effective date • Summary • Restricted flexibility for continuation filing • Impact on IP licenses and agreements
US Patent Law Changes? • Summary? • Impact on IP Licenses and Agreements?
Conclusion: Patent Issues • Patents more vulnerable to challenge in the context of a license agreement • Patent vulnerability to obviousness challenges • Broad regulatory exemption (271(e)(1)) • Reduced flexibility for portfolio development
Conclusion: Licensing Issues • Patentee/Licensee leverage • Strength/Value of patent rights • Control of prosecution strategy • Rights to patentable improvements • Importance of non-patent IP value • Know-how • Technical collaboration, non-patentable improvements, etc.
Wrapping Up … • Licensing chemical technology and intellectual property • Academic perspective • Interplay of pharmaceutical companies, CROs, and Academia • Information management • Government and academic issues relating to IP rights and licensing in Europe
Impact of Recent Court Decisions and IP Trends on Licenses American Chemical Society The 234th ACS National Meeting Boston, MA August 22, 2007 Presentation for Intellectual Property presented by Patrick R. H. Waller, Esq. Shareholder Wolf, Greenfield & Sacks, P.C.600 Atlantic AvenueBoston, Massachusetts 022101.617.646.8000 fax 1.617.646.8646 www.wolfgreenfield.com
Contact Wolf Greenfield is a full-service intellectual propertylaw firm that builds and enforces strong IPportfolios, assists businesses to manage IP risks, defends them from suit, and provides IP licensing and deal-making services. For questions and additional copies, please contact Jay Wager, Senior Manager of Business Development, at 617.646.8368 or jwager@wolfgreenfield.com. www.wolfgreenfield.com