Tag Archives: Personalized Medicine

Who's On First? The Supreme Court Struggles With The Patent-Eligibility Of Personalized Medicine Claims

On December 7, 2011, the Supreme Court heard oral arguments in Mayo Collaborative Services v. Prometheus Laboratories, Inc. While the issue before the Court is patent-eligibility under 35 USC § 101, the arguments veered into the topic of patentability under 35 USC §§ 102 and 103, whether the Court intended to raise that issue or … Continue reading this entry

Supreme Court To Hear Oral Arguments In Two Important Cases This Week

This week the Supreme Court will hear oral arguments in two cases that are important to the pharmaceutical industry: (i) Caraco Pharmaceutical Laboratories, Ltd. v. Novo Nordisk A/S and (ii) Mayo Collaborative Services v. Prometheus Laboratories, Inc.… Continue reading this entry

Federal Circuit Ignores Claim Language To Identify The Underlying Invention

At first glance, the Federal Circuit decision in Cybersource Corp. v. Retail Decisions, Inc. may not be of much interest to those in the pharmaceutical field. The patent at issue relates to a “method and system for detecting fraud in a credit card transaction” and the question before the court was whether various computer-related claim limitations … Continue reading this entry

Federal Circuit Upholds Many Classen Method Claims, Also Limits Reach Of Safe Harbor

On August 31, 2011, the Federal Circuit issued its second decision in Classen Immunotherapies, Inc. v. Biogen Idec, which was on remand from the Supreme Court after Bilski v. Kappos. Judge Newman wrote the opinion for the court, which was joined by Chief Judge Rader, and holds that two of the three asserted patents recite … Continue reading this entry

Myriad Calls ACLU Bluff On Standing

As I wrote yesterday, the ACLU filed a Petition for Panel Rehearing in Association for Molecular Pathology v. USPTO, also known as the ACLU/Myriad “gene patenting” case, alleging factual and legal errors in the court’s July 29, 2011 decision on both the standing issue and the patent-eligibility issue. I was not impressed by the ACLU’s standing … Continue reading this entry

ACLU Files Petition For Panel Rehearing In Myriad

As reported by Kevin Noonan on Patent Docs, plaintiffs-appellees (e.g., the ACLU) have filed a Petition for Panel Rehearing in Association for Molecular Pathology v. USPTO, also known as the ACLU/Myriad “gene patenting” case. The Petition alleges factual and legal errors in the court’s July 29, 2011 decision on both the standing issue and the patent-eligibility … Continue reading this entry

Federal Circuit Issues Mixed Decision On Myriad Claims

On July 29, 2011, the Federal Circuit issued its decision in Association for Molecular Pathology v. USPTO, also known as the ACLU/Myriad “gene patenting” case. In a mixed decision, the court held that “isolated DNA” claims are patent-eligible under 35 USC § 101, but that the “comparing” or “analyzing” method claims are not. With a … Continue reading this entry

Supreme Court Grants Cert In Mayo v. Prometheus

Today (June 20, 2011), the Supreme Court granted Mayo’s petition for certiorari in Prometheus Laboratories, Inc. v. Mayo Collaborative Services, which means that the Supreme Court will review the Federal Circuit decision that upheld the patent-eligibility of Prometheus’ personalized medicine claims against a Bilski-type challenge. As I wrote last week, it will be interesting to see … Continue reading this entry

Justice Breyer Resurrects Metabolite

Justice Breyer’s dissenting opinion in Board of Trustees of Leland Stanford Junior University v. Roche Molecular Systems, Inc. is interesting for more than his views on inventor rights and the Bayh-Dole Act. As I was reviewing it, I was struck by his negative comments about patents and his citation of his own 2006 opinion dissenting from … Continue reading this entry

Mayo Petitions for Certiorari Against Prometheus

On March 17, 2011, Mayo Collaborative Services filed a petition for certiorari to the U.S. Supreme Court, challenging the Federal Circuit’s December 2010 decision in Prometheus Laboratories, Inc. v. Mayo Collaborative Services. Mayo asserts that the case raises the question “whether a patentee can monopolize basic, natural biological relationships,” and urges the Court to decide … Continue reading this entry

Who Will Infringe That Method Claim?

In Akamai Technologies, Inc. v. Limelight Networks, Inc., the Federal Circuit clarified the requirements for establishing joint infringement--a theory of direct infringement that may be used when a single party does not perform all of the steps of a method claim. The decision provides a good reminder to consider "who" is likely to perform each step of a method claim. This analysis can be particularly important in the context of diagnostic and personalized medicine methods. … Continue reading this entry

Cruisin' for a Bruisin' on Metabolite?

To many following the application of 35 U.S.C. § 101 to diagnostic and personalized medicine method claims, the Federal Circuit's decisions in Prometheus Laboratories, Inc. v. Mayo Collaborative Services seem to be at odds with Justice Breyer's dissent from the dismissal of the grant of certiorari in Laboratory Corp. of America Holdings v. Metabolite Laboratories, Inc. In both of its decisions (before and after Bilski), the Federal Circuit addressed Metabolite only in a footnote, which makes me wonder whether the court is setting itself up for a confrontation with Justice Breyer. (Justices Stevens and Souter, who joined the dissent, have since retired from the Court.) … Continue reading this entry

Federal Circuit Upholds Personalized Medicine Claims

The Federal Circuit decided for the second time that the personalized medicine claims at issue in Prometheus Laboratories, Inc. v. Mayo Collaborative Services satisfy the requirements for patent-eligibility set forth in 35 U.S.C. ¬ß 101, even under the Supreme Court's decision in Bilski v. Kappos. In so doing, the court followed a two-part analysis that provides a framework for analyzing other method claims that may raise similar issues. … Continue reading this entry

Pick Your Poison: Patent-Ineligibility or Inherency?

The Supreme Court’s Bilksi decision recognized three exceptions to 35 USC § 101: “laws of nature, physical phenomena, and abstract ideas.” The Federal Circuit’s decision in King Pharmaceuticals, Inc. v. Eon Labs., Inc. warns us that although satisfying the machine-or-transformation test might prove to be an effective antidote against § 101 defects, a patent claim still may … Continue reading this entry

Catching A Breath After Bilksi

On Monday, June 28, 2010, the last day of its 2009 term, the Supreme Court finally issued its decision in Bilski v. Kappos. While the case directly addresses the patent-eligibility of “business method patents,” many in the biotech and pharmaceutical industries were concerned that the Court might take this opportunity to limit the circumstances under … Continue reading this entry