Our Troutman Sanders IP group colleagues have a more detailed analysis of yesterday's decision by the United States Supreme Court in Bilski v. Kappos, available at this link:
Also, Richmonders interested in more about Bilski should plan to attend the GRIPLA meeting on July 7, 2010, from 5-7 pm, at the University of Richmond Downtown location at 626 E. Broad Street. The meeting will feature Professor Chris Cotropia of the University of Richmond Law School addressing Bilski.
In its long-awaited opinion in Bilksi v. Kappos, found here, the Supreme Court unanimously affirmed the Federal Circuit's judgment that the claims at issue were unpatentable but also held unanimously that the "machine or transformation" test of determining whether a claimed process is patentable is not the sole test for determining patentability. Beyond holding that the petitioners' claims were unpatentable abstract ideas, however, the majority did not go any further, merely stating that it "need not define further what constitutes a patentable 'process,' beyond pointing to the definition of that term provided in §100(b)" and its earlier precedents.
Kennedy wrote the majority opinion, which was joined in full by Roberts, Thomas and Alito. Scalia joined in all but two parts of Kennedy's opinion. Stevens wrote a concurrence joined by Ginsburg, Breyer and Sotomayor; and Breyer wrote an opinion concurring in the judgment, in which Scalia joined in part.
In May 2009, the American Civil Liberties Union and the Public Patent Foundation filed a lawsuit arguing to invalidate a group of patents having claims directed to human genes and the generic testing of human genes to determine their risk of breast and ovarian cancer. The gene patents are owned or licensed by Myriad Genetics. The inventors of the patents recognized that mutations along the BRCA1 and BRCA2 gene sequences are indicators of an increased risk of breast and ovarian cancer in women. (Details of the lawsuit are available here on the ACLU website.) At least in part, the patents claim methods of determining the risk of these cancers by comparing the BRCA1 and BRCA2 gene sequences of a patient with the normal sequence of the genes. The ACLU and AMA argue that such claims should be found to be invalid and unpatentable as unconstitutional and for reasons of public policy.
The ACLU filed the lawsuit in U.S. District Court for the Southern District of New York against the U.S. Patent and Trademark Office (PTO) and Myriad Genetics and the University of Utah Research Foundation on behalf of breast cancer and women’s health groups, individual women and scientific associations.
This week, the American Medical Association along with other medical and genetic organizations have filed a “Brief for Amici Curiae” backing the ACLU position. The brief (found here)argues that the Myriad claims are unpatentable "laws of nature," do not claim patentable subject matter based upon the machine or transformation test as interpreted by the Court of Appeals of the Federal Circuit in Bilski, and provide compelling public policy arguments against the patentability of these claims and similar medical and biotechnology method claims.
This is an important case to the biotech industry and may change how patent applications are prepared for gene and diagnostic method inventions.
As you may know, the United States Supreme Court will help clarify what is patent eligible subject matter in the case Bilski v. Kappos. The holding in Bilski will tell us how determine whether business method/software/medical process inventions are patentable and whether many issued patents with such claims are still valid. But before the Supreme Court issues its opinion (Oral argument is not scheduled until November 9, 2009), the examiners of the United States Patent and Trademark Office (USPTO) must continue to make decisions on patentability every day. The examiners just can't wait for the Supreme Court to ponder, mull and then opine on the issue. So the USPTO has provided their examiners Interim Examination Instructions for Evaluating Patent Subject Matter Eligibility to help them determine which claims are directed to patent eligible subject matter under 35 U.S.C. § 101. The examiners should follow these instructions until further notice. These instruction are important so that we may know exactly what the examiner is looking for in your patent claims to determine patentability and to prepare arguments against the increasing number of rejections of business method/software and other method claims in patent applications.
In 2008, the Court of Appeals for the Federal Circuit (“CAFC”) issued an opinion in In re Bilski establishing the rule for determining whether a new process or improvement to a process is eligible for patent protection. Generally, processes are patentable subject matter in the United States. U.S. Patent Law provides that “[w]hoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.”
The CAFC held Mr. Bilski’s process, a method of managing the risk for commodity seller, was ineligible for patent protection because it did not meet their “machine or transformation” test. In stating the test, the CAFC held that a “process is surely patentable subject matter if (1) it is tied to a particular machine or apparatus, or (2) it transforms a particular article into a different state or thing.” This test does not establish the clearly resolve the question of whether business method or software inventions are patentable subject matter. It is surely not a bright line test. The CAFC opinion leaves open that other processes or methods may be eligible for patent protection, but if meets the “machine or transformation” test is surely patentable subject matter. The CAFC also stated that the old test stating that the method must produce a “useful, concrete and tangible result” test from State Street is not to be relied upon by patent owners.
This week, the justices of the U.S. Supreme Court granted Bilski’s petition for writ of certiorari and will review the decision of the CAFC. Hopefully, the Supreme Court will be able to review the precedent and provide clarity to the issue. Many issued patents include claims directed to business methods, biotechnology, and software may not meet this “machine or transformation” test. The validity of these patents and patentability of many pending patent applications is at stake in this case. We anticipate many amicus briefs zealously arguing both sides of this contentious issue.
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