Category Archives: Myriad

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Dispelling The Myriad Gene Patent Harmonization Myth

In the wake of the Supreme Court oral arguments in the Myriad “gene patent” case, most commentators are predicting that the Court will uphold the patent-eligibility of non-naturally occurring DNA sequences (such as cDNA), but will decide that even “isolated” forms of naturally occurring DNA cannot be patented under 35 USC § 101. I have … Continue reading this entry

Supreme Court Oral Arguments in ACLU Myriad Gene Patent Case

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 … Continue reading this entry

Briefing The Supreme Court In Myriad

March 15, 2013 was a big deadline for patent applicants seeking to secure first-to-invent filing dates for U.S. patent applications, but April 15 will be a big day for the biotechnology industry, when the Supreme Court hears oral arguments in The Association of Molecular Pathology v. Myriad Genetics, Inc. (also known as the ACLU/Myriad “gene … Continue reading this entry

An Update On Patenting Personalized Medicine After Prometheus

While the Supreme Court just granted certiorari in Myriad, case law surrounding the patent-eligibility of diagnostic and therapeutic personalized medicine has continued to develop in the wake of Mayo v. Prometheus. The good news for innovators is that the USPTO is still granting patents in the field of personalized medicine. The bad news is that … Continue reading this entry

Supreme Court Grants Cert In Myriad To Decide If Human Genes Can Be Patented

On November 30, 2012, the Supreme Court granted certiorari in the “ACLU/Myriad” gene patenting case (Association for Molecular Pathology v. Genetics, Inc.), guaranteeing that the debate over the patent-eligibility of human genes will continue for another round. The Court will review the August 16, 2012 Federal Circuit decision that held for the second time that … Continue reading this entry

Myriad Marches Towards The Supreme Court (Again)

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: Are human genes patentable? Did the court of … Continue reading this entry

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

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 … Continue reading this entry

Myriad Oral Arguments: Deja Vu?

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 … Continue reading this entry

Federal Circuit To Hear Oral Arguments In Myriad Remand Today

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 … Continue reading this entry

An Easy Patent Eligibility Exercise

While we struggle to understand the ramifications of difficult patent eligibility cases like Prometheus and Myriad, it can be helpful to examine an application that plainly fails to satisfy 35 USC § 101. When the USPTO Board of Patent Appeals and Interferences affirmed the Examiner’s rejections in Ex parte Nerenberg, it may not have added … Continue reading this entry

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

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 … Continue reading this entry

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

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

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 … Continue reading this entry

Eli Lilly Suggests Bright-Line Rule In Myriad Amicus Brief

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 … Continue reading this entry

The United States Files Its Amicus Brief In Myriad

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 … Continue reading this entry

Smoke Signals or Smokescreen: The Ultramercial GVR

After the Supreme Court decided that the personalized medicine method claims at issue in Mayo Collaborative Services v. Prometheus Laboratories, Inc. did not satisfy the patent eligibility requirements of 35 USC § 101, it was not surprising that the Court asked the U.S. Court of Appeals for the Federal Circuit to take a second look … Continue reading this entry

Federal Circuit Upholds Declaratory Judgment Jurisdiction Over Subsequent ANDA Litigation

In Dey Pharma, LP v. Sunovion Pharmaceuticals, Inc., the Federal Circuit affirmed the district court’s determination that it could exercise jurisdiction over a declaratory judgment action brought by a subsequent ANDA filer. This case follows earlier decisions in Teva Pharmaceuticals USA, Inc. v. Eisai Co., Ltd., Caraco Pharmaceutical Laboratories, Ltd. v. Forest Laboratories, Inc. and Janssen … Continue reading this entry

Federal Circuit Sets Briefing Deadline, Oral Argument Date For Myriad Isolated DNA Case

Pursuant to the Supreme Court’s March 26, 2012 order remanding Association for Molecular Pathology v. Myriad Genetics, Inc. (the ACLU “gene patenting”/BRCAI case), the Federal Circuit has issued an order requesting supplemental briefing to be filed by June 15, 2012.  Biotechnology companies interested in the patent-eligibility of  newly discovered, biologically relevant DNA sequences (and other similar compounds) should … Continue reading this entry

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

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… Continue reading this entry

Federal Circuit Looks At Requirements For Declaratory Judgment Jurisdiction

In 3M Co. v. Avery Dennison Corp., the Federal Circuit vacated and remanded the district court’s decision to dismiss 3M’s declaratory judgment action for lack of jurisdiction. Although the Federal Circuit did not render a decision in this case, its analysis sheds light on a scenario that might support declaratory judgment jurisdiction.… Continue reading this entry

Understanding The Shifting Patent Landscape: My Latest Podcast For The Burrill Report

While the early arrival of spring weather has many of us turning our attention to our gardends, pharmaceutical companies are facing a number of new developments in the patent landscape. In this podcast interview for  The Burrill Report, I talk about Prometheus, Myriad, the compulsory license for Bayer’s Nexvar drug in India, and the status of … Continue reading this entry

Supreme Court Sends Myriad Back to the Federal Circuit

The Supreme Court has issued a “GVR” in Association for Molecular Pathology v. Myriad Genetics, Inc. (the ACLU “gene patenting”/BRCAI case), granting certiorari only to vacate the Federal Circuit decision that upheld the patent-eligibility of Myriad’s “isolated DNA” claims, and remanding the case to the Federal Circuit for rehearing in view of the Supreme Court’s unanimous decision in … Continue reading this entry

My Myriad Nightmare

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 … 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