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Tag Archives: Mayo

Deja Vu All Over Again In Federal Circuit’s August 16 Myriad Decision

Posted in 101; Federal Circuit Decisions; Myriad; Personalized Medicine

On August 16, 2012, just four weeks after it heard oral arguments, the Federal Circuit issued its second decision in Association for Molecular Pathology v. Myriad Genetics, Inc. (the ACLU ”gene patenting”/BRCAI case), which was on remand in view of the Supreme Court’s March 20, 2012 decision in Mayo v. Prometheus. The same three-judge panel heard the case on remand, and the judges reached essentially the same results on the interpretation of 35 USC § 101 as set forth in their July 29, 2011 decision. Thus, once again, Judge Lourie wrote the opinion for the court, Judge Moore concurred in the result, and Judge Bryson concurred in part and dissented in part.

All judges agree that at least one plaintiff has standing, that the diagnostic method claims based on “comparing” or “analyzing” DNA sequences are not patent-eligible, and that the drug screening method claim is patent-eligible. The court again held that all of the “isolated DNA” claims are patent-eligible, including those encompassing genomic DNA. Judge Bryson once again dissented with regard to the genomic DNA claims, but agreed with the majority that the cDNA claims satisfy 35 USC § 101.

While it is not surprising that the Federal Circuit reached the same conclusion in this decision, many will be relieved that they maintained the status quo as we move one step closer to final resolution of the issues by the Supreme Court.

For a more detailed review of the decision, please see this August 16, 2012 Foley & Lardner LLP Legal News Alert.

Federal Circuit To Hear Oral Arguments In Myriad Remand Today

Posted in Federal Circuit Decisions; Myriad

Later today the Federal Circuit will hear oral arguments in Association for Molecular Pathology v. Myriad Genetics, Inc. (the ACLU ”gene patenting”/BRCAI case), which is on remand in view of the Supreme Court decision in Mayo v. Prometheus.

In advance of today’s hearing, the Federal Circuit asked for briefing on the following issue:

What is the applicability of the Supreme Court’s decision in Mayo to Myriad’s isolated DNA claims and to method claim 20 of the ’282 patent?

You can find my articles reviewing the parties’ briefs, the government brief, Eli Lilly’s briefs, the briefs of several intellectual property associations, and two non-legal briefs here.

I plan to attend the oral arguments today, but you can listen to them yourself once the recording is made available on the Federal Circuit website (which should be by the end of the day).

Eli Lilly Suggests Bright-Line Rule In Myriad Amicus Brief

Posted in 101; Myriad; Personalized Medicine; Prometheus

Eli Lilly filed an interesting amicus brief in the remand of Association for Molecular Pathology v. Myriad Genetics, Inc. (the ACLU ”gene patenting”/BRCAI case). The Lilly brief focuses on claim 20 of Myriad’s U.S. Patent 5,747,282, and urges the Federal Circuit to adopt a bright-line rule that would hold any method claim that includes a step that “may be performed mentally” not eligible for patenting under 35 USC § 101. Continue reading this entry

The United States Files Its Amicus Brief In Myriad

Posted in 101; Myriad; Personalized Medicine; Prometheus

The briefs in the remand of Association for Molecular Pathology v. Myriad Genetics, Inc. (the ACLU ”gene patenting”/BRCAI case) were due last Friday, June 15, 2012. While the views of the parties and other amici may be of interest to the Federal Circuit, I am particularly interested in the position taken in the U.S. Department of Justice’s amicus brief. It is disappointing but not surprising that the United States asserts that the Supreme Court’s decision in Mayo Collaborative Services v. Prometheus Laboratories, Inc. supports its position that isolated genomic DNA is not patent-eligible under 35 USC § 101. Continue reading this entry

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

Posted in 101; Prometheus; Supreme Court Decisions

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 not. Continue reading this entry

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

Posted in Supreme Court Decisions

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

Supreme Court Grants Cert In Mayo v. Prometheus

Posted in 101; Prometheus; Supreme Court Decisions

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 if Justice Breyer will be able to use this case to resurrect the anti-patent views he expressed in his opinion dissenting from the GVR in Laboratory Corp. of America Holdings v. Metabolite Laboratories, Inc.

You can read my summary of the Federal Circuit’s Prometheus decision here and my separate discussion of the court’s treatment of Justice Breyer’s Metabolite opinion here.

Mayo Petitions for Certiorari Against Prometheus

Posted in 101; Myriad; Personalized Medicine; 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 the issue on which it has twice granted certiorari, and yet failed to address.

Continue reading this entry