Program as of September 18, 2017. Subject to change
7:30 am – 2:00 pm
7:45 am – 8:15 am
Session 1: The Walls Are Closing In – The Bleak Future of Claims Reciting Natural ‘Correlations’ and Products of Nature
Sponsored by: Schwegman, Lundberg & Woessner, P.A.
8:15 am – 9:30 am
Post-Ariosa, the district courts and the Federal Circuit have increasingly used this decision to justify application of the Mayo/Alice rule to deny the patentability of claims directed to diagnostic methods and products of nature. Apart from the CellzDirect decision, which was characterized as a new method of making freeze/thaw resistant cells, the Court has been resistant to allowing diagnostic claims that arise from the discovery of naturally occurring correlations. In Meriel, and in Cleveland Clinic, the diagnostic conclusions were dismissed as being no more than natural phenomenon, detected and evaluated using “routine steps”. The court has reiterated that the “inventive concept” required by the Mayo/Alice Rule cannot be provided by recognition of the importance of a natural correlation, even while recognizing that the rule renders many important advances in diagnostic medicine patent-ineligible. At least one district court has held that claims to unit dosage forms of naturally occurring compounds, such as vitamins, are patent-ineligible attempts to claim natural products. While the Patent Office continues to allow method of treatment claims, it may not be long before the Federal Circuit takes another look at Myriad and bans these claims as well.
The audience will learn nature from a panel discussion, focusing on recent case law and proposals to legislatively amend section 101 of the patent statute to moot the Mayo/Alice rule and restore the ability to obtain patents on advances in this increasingly important technology.
- Dr. Leslie Fischer, Novartis
- Hans Sauer, Biotechnology Innovation Organization
- Warren Woessner, Schwegman, Lundberg & Woessner, P.A.
Session 2: Adapting Patent Prosecution Practice for the Next Generation of Life Science Inventions
Sponsored by: McDonnell Boehnen Hulbert & Berghoff LLP
9:30 am – 10:45 am
Despite calls for judicial and legislative reform of the current broken Mayo/Alice framework for assessing patent eligibility for diagnostic method claims, it is unlikely that the framework will substantially change in the near term. This panel will discuss how best to maximize patent protection for diagnostic claims under the current regime and in view of recent guidance from the U.S. Patent and Trademark Office, particularly with regard to developing technologies that have advanced and have advantages over conventional “if A then B” style diagnostic claims.
- Donald Zuhn, Partner, McDonnell Boehnen Hulbert & Berghoff LLP
- June Cohan, Legal Advisor Office of Patent Legal Administration, U.S. Patent and Trademark Office
- Benjamin Jackson, Vice President Legal Affairs, Myriad Genetics
- Kwame Mensah, Senior Patent Attorney; Immunooncology IP Lead, AstraZeneca/MedImmune
10:45 am - 11:00 am
Session 3: The Regulatory Environment for Diagnostic Tests and Companion Diagnostics
Sponsored by: Covington
11:00 am – 12:15 pm
Panelists will provide an overview and update on the regulatory landscape and reimbursement environment for diagnostic tests. Topics will include: FDA regulatory policies relating to genetic testing, companion diagnostics, and LDTs; pathways and challenges in obtaining reimbursement for laboratory testing; and Congressional and state activities that could impact the regulation of diagnostic testing.
- Scott Danzis, Partner, Covington
- Lakshman Ramamurthy, Ph.D., Global Regulatory Lead, Foundation Medicine Inc.
- Esther Scherb, Of Counsel, Covington
Working Lunch & Keynote Speaker: Life Sciences Valuations - Where IP fits in
Sponsored by: European Patent Office
12:15 pm – 2:00 pm
Dr Frei will discuss how the valuation of IP rights depends both on the commercial value of the patent protected technology and the legal certainty of the patent protection itself. Within the PCT, the EPO maximises legal certainty through short processing times in search, examination and opposition. Valuation is key for a company to raise money for financing R&D, and – for biotechnology companies – patents are a major part of that valuation. And so how are valuations of companies and products done, and what are the key drivers for their value? The valuation of individual products is also essential for understanding the licensing terms. This keynote session will go on to discuss the valuation of biotechnology companies and products, and its link to IP. Patrik will give a short introduction to risk-adjusted net present value calculations, the main value drivers and a look at how these can drive deal terms and negotiations. The session will conclude with a Q&A fireside chat session.
- Dr. Patrick Frei, CEO, Venture Valuation
- Ulrich Thiele, Director, European Patent Office
2:00 pm - 2:15 pm