Patent Law Practice Center

Federal Circuit Reaffirms Patent Eligibility of Personalized Medicine and Diagnostic Method Claims

Today’s guest post was written by our friends at Foley Lardner, Courtenay C. Brinckerhoff and Antoinette F. Konski.

Last Friday, in Prometheus Laboratories, Inc. v. Mayo Collaborative Services, No. 2008-1403 (Fed. Cir. 2010), the Federal Circuit affirmed that personalized medicine and medical diagnostic claims are not per se unpatentable for claiming natural phenomena. The Court’s opinion provides guidance on the post-Bilski application of patent-eligibility requirements to claims that define the relationship between a treatment or drug regimen to the presence or absence of a patient-specific clinical marker (in this case, a metabolite of the administered drug).

The patent-eligibility of such claims has been in question since the Supreme Court’s dismissal of the grant of certiorari in Laboratory Corp. of American Holdings v. Metabolite Labs., Inc., 548 U.S. 124 (2006). Supreme Court Justice Breyer dissented from the dismissal and wrote a non-binding opinion that “detecting” and “correlating” claims were not patent-eligible. More recently, the Supreme Court decision to vacate and remand the Federal Circuit’s 2009 Prometheus decision in view of its decision in Bilski v. Kappos, 130 S.Ct. 3218 (2010), fueled speculation that the patent-eligibility of such methods might not survive scrutiny under Bilski. (more…)

Bilski’s Impact On Life Science Patents

Today’s guest post was written by our friends at DLA Piper, Richard Mulloy (Partner in the Patent Litigation practic)  and Lisa Haile (Patent Prosecution partner and the co-chair of DLA Piper’s Global Life Sciences sector).

Two significant developments arose out of Bilski regarding life science patent claims.  First, the Supreme Court’s endorsement of the machine-or-transformation test as one tool to analyze claims under 35 U.S.C. §101 provides some guidance to patent applicants and litigants. Second, the Court’s suggestion that the Federal Circuit develop “other limiting criteria” to analyze claims under §101 provides additional flexibility to develop tests more applicable to the life sciences, where the machine-or-transformation test is not particularly appropriate.

The Federal Circuit will have an opportunity to provide additional guidance in two pending cases: Prometheus Laboratories, Inc. v. Mayo Collaborative Services, No. 2008-1403, and Classen Immunotherapies, Inc. v. Biogen IDEC, Nos. 2006-1634 and 2006-1649.  The Prometheus and Classen cases were both remanded to the Federal Circuit for additional consideration in light of Bilski.   (more…)

Cursory analysis of “abstract” by Bilski Court followed in Ultramercial case

The following guest post comes from Stuart Meyer,  a Partner with Fenwick & West.

Not saying, “We told you so, but…”

A decision from the Central District of California in August in the Ultramercial v Hulu case showcases a concern that we expressed about how cursory reliance on a claim being unpatentable because it is “abstract” can lead to unfortunate results. An amicus brief we filed in the Bilski case warned of the problems that could result if the Court applied the term “abstract” without providing a clear indication of the sense in which that term was being used. See amicus brief of On Time Systems.

A claim that is just a vague expression of a concept may be considered “abstract” and therefore correctly be held unpatentable. On the other hand, there are many claims that clearly are eligible for patent protection even though they deal with abstractions. For instance, any use of a sensor deals with something that is abstract – the example we gave in the brief was that a signal produced by a wind sensor is an abstraction of the force of air molecules striking the sensor. Just because a claim is based on a signal from a wind sensor does not mean that it is abstract and therefore unpatentable. (more…)

Bilski’s Impact On Software Patents

This post comes courtesy of our friends at DLA Piper, J.D. Harriman (Partner in DLA Piper’s Los Angeles office) and Robert Buergi (Senior Associate in DLA Piper’s Silicon Valley office).

Bilski is a favorable decision for software patents—it broadened patentable processes beyond those that meet the machine or transformation test, and expressly recognized that even some business methods are patentable.  Overall, Bilski will allow properly drafted software method claims to enjoy patentability for years to come.

In the majority opinion, the Court discussed the country’s shift from the Industrial Age to the Information Age, the former being characterized by traditional machines and the latter being characterized by, for example, computer programs.  Bilski v. Kappos, 130 S. Ct. 3218, 3227 (2010).  Determining patentability of processes using solely the machine or transformation test “would create uncertainty as to the patentability of software.” Id. (more…)

The Clones War: Chapter Two – Myriad Files Their Brief on Appeal

The following guest post was written by Birch, Stewart, Kolasch & Birch Partner Mark J. Nuell, Ph.D.

Myriad Genetics has filed their brief in their appeal of the decision in Assoc. of Med. Pathology et al. v. Myriad Genetics et al. This case is one having effect on patent-eligibility of claims directed to purified natural products and to sequence-based diagnostic methods.  Myriad’s brief is a paper of advocacy, and it is persuasive of an asserted lack of jurisdiction.  Thus, the Federal Circuit might not even reach the questions of patentability of isolated DNA and of nucleic acid (sequence)-based diagnostic methods.  But, should the Federal Circuit choose to consider those questions, it appears that claims to “isolated DNA” meet the standard for patent-eligibility.  Despite their arguments to the contrary, some of Myriad’s diagnostic method claims are likely to fail to meet the standard, as falling within the scope of abstract ideas or laws of nature.  The other method claims that are challenged, although they can be interpreted to include a “transformative” step and so include a strong clue in favor of patent-eligibility under Bilski v. Kappos, might be deemed ineligible for patent protection because the “transformative” steps represent mere data-gathering steps. (more…)