The Future of IVD IP

Ariosa v Sequenom:  How will the Supreme Court shape the future of the IVD industry?

Three recent US Supreme Court decisions (Mayo, Myriad, and Alice) have produced a landslide change in IP protection for diagnostics. As a result, patent applicants and patent holders have been battled at the US Patent Office and the US courts. Many players are forced out of patent protection altogether. The currently pending case Ariosa v Sequenom is seminal in attempting to re-dress the issues.

• Current state of IP protection in the US and abroad for diagnostics
• Substance of Ariosa v Sequenom case and how it relates to prior Supreme Court decisions
• Industry position
• Potential future developments and practical approaches

Presenters:

– Konstantin Linnik, Ph.D., Partner, Nutter LLP

– Kristin Neuman, Executive Director, Biotechnology Licensing and Librassay,® MPEG LA

Presenter: Lana Gladstein, Partner, Nutter McClennen & Fish, LLP

Precision Medicine Round-up

• Explore the origins of Precision Medicine and what this means for in vitro diagnostics companies today and tomorrow:
• Drivers behind Precision Medicine:
• Concept of personalized medicine born with Novartis’ Gleevac, 2001, first of a new class of drugs that act by inhibiting a specific enzyme, i.e., receptor called tyrosine kinase, identified by specific diagnostic tests (Philadelphia chromosome abnormality test).
• President Obama’s Precision Medicine Initiative: intensify efforts to apply precision medicine to the development of cancer treatments.
• Elements of Precision Medicine from an In Vitro Diagnostics and Biopharma Perspective: biomarkers, companion diagnostics and complementary diagnostics
• Future State with Next Generation Sequencing ….

Presenter: Pam Weagraff, Director, Medical Device & Diagnostics Regulatory, Quintiles Advisory