Speech at US Patent Experts Conference in Naples Florida

The University of Akron School of Law will host the 2nd Annual Midwinter Patent Experts Conference in Naples, Florida February 10-11, 2014. The conference will be held at the Naples Hilton Hotel.

The faculty for the program includes, from the judiciary, the Hon. Kathleen O’Malley and the Hon. Richard Linn, of the Federal Circuit, as well the Hon. Roger T. Hughes, of the Federal Court of Canada. From the executive branch, the current acting director of the PTO, the Hon. Teresa Stanek Rea, will participate, as will the current Chairman of the Patent Trial and Appeal Board, James S. Smith, and former Administrative Patent Judge William F. Smith. Former PTO Deputy Director Sharon Barner and former Commissioner for Patents Robert Stoll will also participate. Robert A. Armitage, the father of the Leahy-Smith America Invents Act, will also be a featured participant.

A number of law professors who specialize in patent law are also included in the program. They include Dean Timothy Holbrook and Assoc. Professor Timo Minssen, Christal Sheppard, Dennis Crouch, Jason Rantanen, W. Keith Robinson, William Hubbard and Dr. Heinz Goddar. Senior corporate lawyers include Sharon R. Barner, Vice-President of Cummins Inc., and Richard Rainey, in charge of worldwide IP litigation for GE.

I have been invited to participate in a panel debate on “non-obviousness” and to give a speech on “A comparative US/European view on the law of non-obviousness” . My presentation will provide an introductory overview over relevant legal frameworks and various doctrinal concepts of the European and U.S. non-obviousness assessment. I will also discuss recent case-law developments that are of particular practical relevance. Special emphasis will be laid on chemical and biotech case law. I intend to argue that the KSR-induced, more flexible US-approach to obviousness has moved closer to the European approach and that I welcome this development. Yet, I also underline that specific statements in KSR and subsequent case law rightfully attracted criticism in both Europe and the US. Moreover, I plan to point out that by carefully aligning national case law with EPO precedent, recent U.K. decisions have applied a more “patent-friendly” approach with respect to, inter alia, the “obvious to try” issue and selection inventions. These decisions provide valuable insights and arguments to those who fear that KSR inevitably tipped the pendulum towards an overly strict non-obviousness standard, which disregards hindsight problems, the dynamics of the research environment, and the importance of patents in pharmaceutical R&D.

View the slides from this presentation here.

Book Review: Pharmaceutical Innovation, Competition and Patent Law – A Trilateral Perspective

Following a request by the European Competition Law Review (Sweet Maxwell), I have today submitted a review of the recent publication  “Pharmaceutical Innovation, Competition and Patent Law – A Trilateral Perspective”, edited by Max Planck Director Josef Drexl and Finnish scholar Nari Lee (Edward Elgar 2013, 322 p., ISBN 978 0 85793 245 7). The full contribution (6 pp.) is curently undergoing peer-review.

In summary, I conclude that the editors, who also contributed with excellent papers, have succeeded very well in the difficult task of structuring, systemizing and arranging a compilation of very interesting papers written by high profile authors. This has resulted in a very readable book providing a superb overview and up-to-date analysis of recent developments that have such a substantial impact on a significant area of law and practice. But are there any flaws?

Considering the numerous useful case law citations, as well as the wide scope of the book, it is a little unfortunate that the book does not contain a table of cases or a bibliography of material cited by the respective authors. Also it might perhaps have been beneficial to include some contributions from the pharmaceutical industry, private practice or NGOs. There is of course no doubt that all papers have been written by very competent authors and address real-world issues with much devotion to facts, details and commercial realities. But additional contributions by the industry or “field workers” would probably have enriched the numerous debates that are placed in such an extraordinarily complex environment at the interface of business realities, competition, technological innovation, and access to health care.

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Medicare Stops Hearing Provider Appeals in Hopes of Clearing Backlog

When Medicare refuses to cover a treatment (such as inpatient hospitalization) or device (like diabetes testing supplies), the statute gives the disappointed beneficiary the right to appeal.  Furthermore, there are mechanisms by which the provider–which may be a hospital, doctor, durable medical equipment manufacturer, etc.–that recommended the treatment (and often stands to profit if it is covered) can appeal on the beneficiary’s behalf (or on their own if the claim is assigned).

The statute sets deadlines for decisions on appeal, but in recent years a flood of new cases has led to a growing backlog and long delays.  (The backlog is caused in large part by the Recovery Audit Contractor program, through which Medicare has been revisiting and revising coverage determinations from the past several years.   That is a subject for another day.)

On Christmas Eve, the office in the Department of Health and Human Services responsible for hearing appeals (that is, the Office of Medicare Hearings and Appeals), adopted a controversial mitigation measure: They’ve stopped hearing new appeals, while they work to clear the backlog.  Which will take at least two years.  (See recent coverage here.)

Yes, the law says that Medicare must hear appeals, so yes, this temporary measure is technically inconsistent with the law (which is not to say it is illegal, more below on that).  But in my view it is actually a good idea, and consistent with what I think is the best ultimate solution to the “backlog” problem.  Here’s why:

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