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Public health and IP policy: Amicus briefs in the Bilski case

Questions presented in the recently argued Supreme Court case, Bilski v. Kappos (1), inspired the filing of a large number of Amicus Briefs and in many of them, strong concerns were expressed as to the kinds of potential impacts this Supreme Court decision might have on biotechnology patenting activities, flowing ultimately into health care issues. The oral argument transcript (63 pp, 11/9/09) reveals an interesting and helpful dialogue among the SCT justices and advocates for the parties, often using hypotheticals in comparison to explore and refine aspects of these complex questions.
Notably, the DOJ’s Deputy Solicitor General, on behalf of Respondent, observed that (2) ‘there are difficult problems out there in terms of patentability of software innovations and medical diagnostics…we thought that this case would provide an unsuitable vehicle for resolving the hard questions because the case does not involve computer software or medical diagnostic techniques and therefore we thought that the Court would…decide this case , and most of the hard questions remain unresolved…”
Nevertheless, the many Amicus briefs (with their support dox) that discuss biotech and related health care issues, presented by many IP law associations, national/international, and pro se, IP trade associations, law professors/academic centers in addition to those amicus briefs filed by parties in industry, will provide a lot of food for thought. International treaty and document references highlighting potential global impact include TRIPS, Vienna Convention on the Law of Treaties, NAFTA, the International World Health Assembly (adopting a global strategy and plan of action on public health, innovation and intellectual property).
Biotech/healthcare issues were presented or discussed in, for example:
-Brief for the American Medical Association, the American College of Medical Genetics, the American Society of Human Genetics, the Association of Professors of Human and Medical Genetics, and the Mayo Clinic in Support of Respondent
-Brief amicus curiae of Medistem Inc (in support of petitioners at the certiorari stage)
-Brief for the Biotechnology Industry Organization, Advanced Medical Technology Association, the Wisconsin Alumni Research Foundation, and Regents of University of California in Support of Neither Party
-Brief for University of South Florida in Support of Petitioner
(1)Bilski v. Kappos, argued November 9, 2009. Lyle Denniston, SCOTUSblog reports for SCOTUSWIKI recaps and analyses this case and provides links to the Amicus Briefs at http://www.scotuswiki.com/index.php?title=Bilski_v._Kappos
See below for a listing of more briefs, the Questions asked and more case history.

-Brief for the Novartis Corporation in Support of Petitioner
-Brief for Caris Diagnostics, Inc., in Support of Petitioner
-Brief for Georgia Biomedical Partnership, Inc., in Support of Petitioner
-Brief for Eleven Law Professors and AARP in Support of Respondent
-Brief for Adams Pharmaceuticals, Inc., and Tethys Bioscience, Inc., in Support of Respondent
-Brief for Prometheus Laboratories Inc. in Support of Neither Party
-Brief for Monogram Biosciences, Inc. and Genomic Health, Inc. in Support of Neither Party
-Brief for Medtronic in Support of Neither Party
-Brief for the Pharmaceutical Research and Manufacturers Association in Support of Neither Party
-Brief for the Franklin Pierce Law Center in Support of Petitioner

In granting certiorari 6/1/09, the Questions presented were:

Whether the Fed Circuit erred by holding that a ‘process’ must be tied to a particular machine or apparatus, or transform a particular article into a different state or thing (machine-or-transformation’ test), to be eligible for patenting under 35 U.S.C. Section 101, despite this Court’s precedent declining to limit the broad statutory grant of patent eligibility for ‘any’ new and useful process beyond excluding patents ‘laws of nature, physical phenomena, and abstract ideas.’
Whether the Fed Circuit’s ‘machine-or-transformation’ test for patent eligibility, which effectively forecloses meaningful patent protection to many business methods, contradicts clear Congressional intent that patents protect ‘method[s] of doing or conducting business.’ 35 U.S.C. section 273.


More on the case:
The U.S. Court of Appeals for the Federal Circuit decided Oct 30, 2008 an appeal by Bilski and Warsaw from the final decision of the Board of Patent Appeals and Interferences (Board) sustaining rejection of all 11 claims of their US patent application arguing that the examiner erroneously rejected the claims as not directed to patent –eligible subject matter under 35 U.S.C. Section 101, the Fed. Circuit affirmed the decision of the Board because they concluded that the claims were not patent –eligible subject matter, clarifying the standards applicable in determining whether a business method constitutes a statutory “process” under section 101.

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