Category Archives: Personalized Medicine

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Justice Breyer Gets The Last Word And Invalidates Prometheus Personalized Medicine Claims

On March 20, 2012, Justice Breyer issued the unanimous decision for the Supreme Court in Mayo Collaborative Services v. Prometheus Laboratories, Inc., holding that Prometheus’ claims directed to methods of optimizing the dose of specific drugs used in the treatment of specific conditions are invalid under 35 USC § 101 because they impermissibly claim laws … 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

Federal Circuit Hears Oral Arguments in Myriad

On April 4, 2011, Judges Lourie, Bryson and Moore at the U.S. Court of Appeals for the Federal Circuit heard oral arguments in Association for Molecular Pathology v. USPTO, also known as the ACLU/Myriad “gene patenting” case. This case has garnered extraordinary attention from the biotech, pharmaceutical, and health care industries, from academic and government … 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

Solicitor General Asks To Argue Myriad on April 4

In an unusual (if not unprecedented) move, the Solicitor General of the United States wrote a letter to the Federal Circuit asking that oral argument in Association for Molecular Pathology v. Myriad Genetics be scheduled for April 4, 2011. The Solicitor General (Neal Katyal) noted that “the United States will file an unopposed motion to participate in … 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

Testing The Separation Of Powers: Will The Federal Circuit Rule Against The Department Of Justice On The Patent-Eligibility of DNA Claims?

In a move that surprised many in the U.S. patent community, the Department of Justice filed a brief in the Federal Circuit appeal of Association for Molecular Pathology v. USPTO, arguing against the patentability of isolated genomic DNA sequences. This brief may raise the stakes in the appeal, and certainly shines a brighter spotlight on … 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