Just over three years ago, the United States Supreme Court issued its decision in Bilski v. Kappos. The critical question presented to the Court for consideration was whether the Federal Circuit erred by creating the so-called “machine or transformation” test, which requires a process to be tied to a particular machine or apparatus, or transform an article into a different state or thing, in order to be patentable subject matter. The Supreme Court held that the machine-or-transformation test is not the sole test for patent eligibility under §101, but is an important clue, thereby overruling the Federal Circuit who had earlier ruled that the machine or transformation test was the test to determine whether an invention is patentable subject matter.
But what practical effect has the Supreme Court ruling in Bilski v. Kappos had? Truthfully, not much. at least in terms of the day-to-day approach of patent attorneys and the U.S. Patent and Trademark Office. (Certainly, the decision was important in that it preserved the patentability of at least some business methods and preserved the patentability of software.)
While the machine-or-transformation test is now only an important clue, it really has become a safe harbor for practitioners. The assumption has been that you satisfy the machine-or-transformation test announced by the Federal Circuit and you have a patentable invention. Fail to satisfy the machine-or-transformation test and you may have a patentable invention, but neither the Patent Office nor any court has yet found an invention that failed the machine-or-transformation test to be patentable.
In a case that will have a profound effect on biotech and pharmaceutical companies, the U.S. Supreme Court on March 20, 2012 issued its decision in Mayo Collaborative Services v. Prometheus Laboratories, Inc., and addressed the question as to when medical diagnostic methods fulfill the patentable subject matter requirement of Section 101 in the Patent Code.
As held by the Supreme Court, claimed processes are not patentable unless they have additional features that provide practical assurance that the processes are genuine applications of natural phenomena or laws of nature rather than correlations involving those laws. In addition, the U.S. Supreme Court clarified that the so called “machine or transformation test” articulated in Bilski v. Kappos is not a definitive test of patent eligibility.
As the U.S. Supreme Court has recently remanded Association for Molecular Pathology v. Myriad to the Federal Circuit for consideration in light the decision in Mayo v. Prometheus, the question of when are genes and gene fragments, methods of drug screening and medical diagnosis using genetic material and information patentable subject matter will again be addressed.
For more on the matter, you should really attend PLI’s next One Hour Briefing. On Wednesday, April 4th, at 1pm, PLI is hosting a One Hour Briefing entitled, “Prometheus: Implications of the U.S. Supreme Court’s Decision.” This briefing will be conducted by Keith J. McWha, partner in the law firm Day Pitney LLP, and Paul T. Martin Associate Director Intellectual Property and Assistant General Counsel at PTC Therapeutics Inc. Specific topics include:
- What are the consequences of the Court’s ruling on the patentability of process patent claims generally?
- How might this decision affect biotech and pharmaceutical patent claims such as dosage or method of use and naturally occurring therapeutics?
- What can be done to ensure that method claims for drug screening, diagnostics and dosing satisfy the Prometheus test for patentable subject matter?
Ryan Chirnomas, Partner in the Biotechnology group at Westerman, Hattori, Daniels and Adrian, sent in this article discussing the Court of Appeals for the Federal Circuit’s recent Classen v. Biogen decision. He highlights the key points of the decision and why he believes this case is a missed opportunity to clarify the machine-or-transformation test of Bilski.
Not long after issuing opinions in AMP v. USPTO and Prometheus v. Mayo, the CAFC has again taken on the difficult questions of patent eligible subject matter in Classen v. Biogen. In 2008, the CAFC issued a three-sentence non-precedential opinion holding that Classen’s claims do not recite patent eligible subject matter. This decision was appealed to the Supreme Court and subsequently remanded to the CAFC after the Supreme Court’s Bilski decision. The instant decision includes a discussion of patent-eligible subject matter, as well as the safe harbor exception to infringement of pharmaceutical patents. This discussion is limited to questions of patent eligible subject matter. This decision relates to three patents: U.S. Patent Nos. 6,638,739 (“the ‘739 patent”), 6,420,139 (“the ‘139 patent”) and 5,723,283 (“the ‘283 patent”). (more…)
Our friends at Foley & Lardner sent in this article discussing the Federal Circuit’s decision in Classen Immunotherapies, Inc. v. Biogen Idec.
On August 31, 2011, the Federal Circuit issued its second decision in Classen Immunotherapies, Inc. v. Biogen Idec (App. 2006-1643, -1649), on remand from the Supreme Court after Bilski v. Kappos (U.S. 2010). The Federal Circuit first decided Classen’s appeal in 2008, when a panel comprised of Circuit Judges Newman and Moore and District Judge Farnan (sitting by designation) held in a one-paragraph, non-precedential decision authored by Judge Moore that Classen’s claims do not satisfy 35 USC § 101. The second time around, the Federal Circuit (by a panel that included Chief Judge Rader in place of Judge Farnan) took a closer look at Classen’s claims, and determined that two of the three Classen patents at issue indeed are directed to subject matter that is patent-eligible under 35 USC § 101. In this decision, the Federal Circuit has provided useful guidance for method claims that involve some type of information gathering. It appears that if the claims recite a step of “putting this knowledge to practical use,” such as an active treatment step based on the information, they are likely to be patent-eligible under 35 USC § 101. On the other hand, if the claimed methods culminate in obtaining information, and nothing more, they may be vulnerable to challenge under 35 USC § 101.
Judge Newman wrote the opinion for the court, which was joined by Chief Judge Rader. Chief Judge Rader wrote a separate opinion to express “additional views,” which was joined by Judge Newman. Judge Moore wrote a dissenting opinion. (more…)
Michael Davitz, Partner at Axinn, Veltrop & Harkrider and Practice Center Contributor, recently sent in this article he wrote with colleague’s Josephine Liu and Stacie Ropka discussing recent case law on the patentability of process claims.
Not all inventions are patentable. The Federal Circuit recently handed down its decision in Myriad[i] and the Supreme Court will be hearing Prometheus[ii] in the term beginning in October 2011. The issues in both Myriad and Prometheus highlight the difficulty in determining when a claim directed to a process is patentable subject matter under § 101, a determination that is particularly troubling in many inventions related to the life sciences.
A first step for granting a patent is determining whether or not a patent application claims patentable subject-matter. In a line of cases from the late 70s to early 80s and reaffirmed in 2010, the Supreme Court explained that 35 U.S.C. § 101 is to be interpreted broadly and has articulated only three exceptions to what is patentable: (1) laws of nature; (2) physical phenomena; and (3) abstract ideas.[iii] With respect to process claims, the line between patentable “processes” and unpatentable principles or abstract ideas is not always clear. The Supreme Court has yet to provide a concrete test by which such a distinction can be made.[iv] It did, however, provide a hint in Gottschalk v. Benson stating that “[t]ransformation and reduction of an article ‘to a different state or thing’ is the clue to the patentability of a process claim that does not include particular machines.”[v] From this pronouncement, the Federal Circuit formally presented and applied the machine-or-transformation test in In re Bilski.[vi] (more…)