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…)

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…)

Navigating the Best Mode Requirement

            The Patent Act provides that the patent specification “shall set forth the best mode contemplated by the inventor of carrying out his invention.”[1]  This requirement, also known as the best mode requirement, is in essence a quid pro quo with the inventor.  In return for granting the right to exclude others from making or using a patented invention, the inventor must disclose or conversely not conceal from the public the preferred embodiment.  But, what constitutes the preferred embodiment, how much information actually needs to be disclosed, what can be withheld and what happens when the inventor is not aware of the best mode?  The recent case law provides some answers to these questions, but also raises other concerns, especially as we enter the brave new era of biosimilars and the inevitable wave of litigation that will likely ensue.

            In order to satisfy the best mode requirement, the inventor must disclose the preferred embodiment of his invention as well as any preferences that could materially affect the invention.[2]  The first step in a best mode inquiry begins, as is always the case with patent law, with the claims.[3]  This past March the Federal Circuit handed down a decision in Ajinomoto Co. v. ITC where the scope of the claims created a problem for the inventors.[4] (more…)

Goeddel V. Sugano: What’s The Difference Between “Envisioning” An Invention And Being “In Possession” Of The Invention?

The following post was written by Gerald M. Murphy, partner at Birch, Stewart, Kolasch & Birch, LLP and Practice Center Contributor.

In Goeddel v. Sugano, the Court of Appeals for the Federal Circuit (CAFC) has provided more guidance as to what is necessary for a sufficient “written description” of an invention, this time for a true “biotech” invention, in the context of a motion for benefit of priority in an interference.  This case involved two interferences; one directed to DNA encoding human fibroblast interferon (hFIF) unaccompanied by a hFIF presequence (mature hFIF) and one directed to a composition comprising  non-glycosylated hFIF.  Sugano filed a motion for benefit of its Japanese priority application (Sugano priority application) and was granted priority by the Board of Patent Appeals and Interferences (the Board) in both interferences.  Goeddel appealed that decision on the grounds that the Sugano priority application did not constitute a constructive reduction to practice because it did not enable the Counts and did not provide a sufficient written description of the Counts.  The Federal Circuit reversed on the ground that the Sugano priority application did not provide a sufficient written description of the Count because the inventors were not “in possession” of the invention. (more…)