Tag Archives: Product Of Nature

Supreme Court Oral Arguments in ACLU Myriad Gene Patent Case

Posted by Courtenay Brinckerhoff on 15 April 2013 Posted in 101; Myriad; Supreme Court Decisions

On April 15, 2013, the Supreme Court heard oral arguments in one of the most controversial and publicized biotech patent cases–the “ACLU/Myriad” gene patent case (e.g., The Association For Molecular Pathology v. USPTO). While it is always risky to predict the outcome of a Supreme Court case from the oral arguments, the Justices seemed to have accepted the U.S. Solicitor General’s arguments that cDNA molecules satisfy § 101, but seem unlikely to find that human genes can be patented.Continue reading this entry

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

Posted by Courtenay Brinckerhoff on 16 August 2012 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.

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

Posted by Courtenay Brinckerhoff on 26 June 2012 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

Non-Legal Perspectives On Isolated DNA: The Watson And Holman Amicus Briefs In The Myriad Remand

Posted by Courtenay Brinckerhoff on 25 June 2012 Posted in 101; Myriad

The most interesting briefs in the Federal Circuit remand of Association for Molecular Pathology v. Myriad Genetics, Inc. (the ACLU “gene patenting”/BRCA1 case) may be those submitted by James D. Watson and Christopher M. Holman, which each present non-legal perspectives on the issues before the court.Continue reading this entry

The Myriad And ACLU Supplemental Briefs On Remand To The Federal Circuit

Posted by Courtenay Brinckerhoff on 22 June 2012 Posted in 101; Myriad; Personalized Medicine; Prometheus

Myriad and the ACLU filed their supplemental briefs in the remand of Association for Molecular Pathology v. Myriad Genetics, Inc. (the ACLU “gene patenting”/BRCA1 case), addressing the Federal Circuit’s question as to the applicability of the Supreme Court’s decision in Mayo Collaborative Servs. v. Prometheus Labs., Inc. to the patent eligibility of Myriad’s isolated DNA claims and method claim 20 of Myriad’s U.S. Patent 5,747,282. While the parties’ positions are predictable, it is interesting to see how they frame the issues.Continue reading this entry

The United States Files Its Amicus Brief In Myriad

Posted by Courtenay Brinckerhoff on 18 June 2012 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

Vlog: Why Prometheus Doesn’t Govern Myriad But Might Impact It Anyway

Posted by Courtenay Brinckerhoff on 30 April 2012 Posted in 101; Myriad; Personalized Medicine; Prometheus

I was honored to be invited by the Washington Legal Foundation to prepare a video commentary on the recent Supreme Court decision in Prometheus and its possible impact on the Myriad isolated DNA case for their Legally Brief series.

Here’s what I had to say:

WLF Legally Brief: Supreme Court Prometheus Patent Decision

My Myriad Nightmare

Posted by Courtenay Brinckerhoff on 22 March 2012 Posted in 101; Myriad; Personalized Medicine; Prometheus; Supreme Court Decisions

Now that the Supreme Court has issued its unanimous decision reversing the Federal Circuit decision in Prometheus, it is expected to decide the petition for certiorari in Association for Molecular Pathology v. Myriad Genetics, Inc. (the ACLU ”gene patenting”/BRCAI case), as early as Monday (March 26). Many are predicting that the Court will issue a “GVR” to grant certiorari only to vacate the Federal Circuit decision that upheld the patent-eligibility of Myriad’s “isolated DNA” claims, and remand the case to the Federal Circuit for rehearing in view of Prometheus. As I try to understand how the Supreme Court’s decision that Prometheus’ method claims do not satisfy 35 § USC 101 because they “effectively claim underlying laws of nature” would impact the Federal Circuit’s decision that Myriad’s isolated DNA claims satisfy 35 § USC 101 because they “cover molecules that are markedly different—have a distinctive chemical identity and nature—from molecules that exist in nature,” I am frightened by a line of reasoning that could undermine the patent-eligibility of a host of pharmaceutical and biological products. Continue reading this entry

Myriad Calls ACLU Bluff On Standing

Posted by Courtenay Brinckerhoff on 31 August 2011 Posted in 101; Myriad; Personalized Medicine

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 arguments, and now Myriad has filed its own Petition for Panel Rehearing challenging the standing of the ACLU plaintiffs. Because standing is a threshold issue, and because the factual basis of standing has changed, it is possible that the Federal Circuit will grant Myriad’s motion and rehear the case, at least on the standing issue.

Continue reading this entry

ACLU Files Petition For Panel Rehearing In Myriad

Posted by Courtenay Brinckerhoff on 30 August 2011 Posted in 101; Myriad; Personalized Medicine

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 issue, but is not likely to be granted. While the petition may foreshadow the arguments being formulated for Supreme Court review, its most likely effect will be to delay that review, further extending the period of uncertainty that is hanging over isolated DNA claims.