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Tag Archives: Isolated DNA

Myriad Marches Towards The Supreme Court (Again)

Posted by Courtenay Brinckerhoff on Posted in 101; Myriad; Prometheus; Supreme Court Decisions

The Association for Molecular Pathology (represented by the ACLU) has filed a petition for certiorari to the Supreme Court, seeking review of the Federal Circuit’s August 16, 2012 decision that upheld the patent-eligibility of Myriad’s “isolated DNA” claims. The petition raises three questions for Supreme Court review:

  1. Are human genes patentable?
  2. Did the court of appeals err in upholding a method claim by Myriad that is irreconcilable with this Court’s ruling in Mayo Collaborative Servs. v. Prometheus Labs., Inc., 132 S. Ct. 1289 (2012)?
  3. Did the court of appeals err in adopting a new and inflexible rule, contrary to normal standing rules and this Court’s decision in MedImmune, Inc. v. Genentech, Inc., 549 U.S. 118 (2007), that petitioners who have been indisputably deterred by Myriad’s “active enforcement” of its patent rights nonetheless lack standing to challenge those patents absent evidence that they have been personally threatened with an infringement action?

This petition will come as no surprise to those who have been following this case since the district court rendered the first decision on the merits in 2010. We should know by June whether the Supreme Court will grant certiorari, but it could be a year or more before a final decision is rendered.

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

Posted by Courtenay Brinckerhoff on 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.

Myriad Oral Arguments: Deja Vu?

Posted by Courtenay Brinckerhoff on Posted in 101; Myriad; Prometheus

On Friday, July 20, 2012, the Federal Circuit heard 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. The courtroom was crowded again, but the mood seemed a bit lighter than the first oral arguments in April 2011. Reading the tea leaves from the judges’ questions and comments, I think the panel decision will depend on whether Judge Moore again concurs with Judge Lourie on the patent-eligibility of isolated DNA, or whether she feels compelled by Mayo to join Judge Bryson, who would invalidate the claims. You can listen to the recording of the oral arguments here. A decision is likely a few months away, and the case is expected to make its way to the Supreme Court again.Continue reading this entry

Federal Circuit To Hear Oral Arguments In Myriad Remand Today

Posted by Courtenay Brinckerhoff on 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).

What Do The IP Lawyers Have To Say In The Myriad Remand?

Posted by Courtenay Brinckerhoff on Posted in 101; Myriad; Personalized Medicine; Prometheus

Several associations and organizations of intellectual property lawyers submitted amicus briefs in the Federal Circuit remand of Association for Molecular Pathology v. Myriad Genetics, Inc. (the ACLU “gene patenting”/BRCA1 case). While many make the same arguments, there are some points that may stand out enough to get the court’s attention.

(See this article for my review of the most interesting amicus briefs, this article for my discussion of the United States amicus brief, and this article for a summary of the parties’ briefs.)Continue reading this entry