Tag Archives: Myriad

Federal Circuit Hears Arguments In Other Myriad Gene Patents Case

On October 6, 2014, the Federal Circuit heard oral arguments in a case involving the claims of the Myriad gene patents that were not invalidated by the Supreme Court’s 2013 decision. The Federal Circuit is reviewing the district court’s denial of Myriad’s motion for a preliminary injunction against Ambry Genetics Corp., based on the finding that Ambry … Continue reading this entry

Comments On Patent Subject Matter Eligibility Guidance Due By July 31

This week brings the July 31, 2014 deadline for submitting written comments on two USPTO patent subject matter eligibility guidance documents: The “Myriad-Mayo” Guidance issued March 4, 2014 (for claims involving laws of nature, natural phenomena, and natural products) and the “Alice Corp. v. CLS Bank” Guidance issued June 24, 2014 (for claims involving abstract … Continue reading this entry

Putting Structure And Function Into Context For USPTO Patent Subject Matter Eligibility Guidance

The USPTO’s ”Guidance For Determining Subject Matter Eligibility Of Claims Reciting Or Involving Laws of Nature, Natural Phenomena, and Natural Products” has been criticized for requiring a product to be markedly different in structure from a product of nature in order to be eligible for patenting, even though the Supreme Court has considered both structure and function when evaluating the … Continue reading this entry

USPTO Asks For Patent Subject Matter Eligibility Comments By July 31, 2014

In a June 30, 2014 Federal Register notice, the USPTO requested public comments by July 31, 2014  on patent subject matter eligibility under the recent Supreme Court decision in Alice Corporation Pty. Ltd. v. CLS Bank International and on the USPTO’s March 4, 2014 “Guidance For Determining Subject Matter Eligibility Of Claims Reciting Or Involving Laws of Nature, Natural Phenomena, and Natural … Continue reading this entry

Update From The May 9, 2014 USPTO Patent Eligibility Guidelines Forum

On May 9, 2014, the USPTO hosted a forum to receive public feedback on the patent subject matter eligibility guidance for examiners circulated on March 4, 2014. The USPTO heard formal presentations from ten speakers (including myself) and comments from audience members. Most speakers suggested alternative approaches to applying the Supreme Court’s “product of nature” and “law … Continue reading this entry

Update On Myriad Appeal And Announcing A Public Forum On The USPTO 101 Guidelines

Myriad has appealed the district court decision that denied its motion for a preliminary injunction against Ambry Genetics Corp. According to a report in Bloomberg BNA Life Sciences Law & Industry Report™, on April 14 , 2014, the Federal Circuit denied Myriad’s motion to expedite proceedings, but it is still possible that this Myriad appeal will … Continue reading this entry

A First Look At The USPTO 101 Training Slides

The USPTO has set up a new web page with resources for examining claims for patent subject matter eligibility, including a link to the slides used in training programs for Examiners in Technology Centers 1600 and 1700. While the slides hew closely to the Guidelines, they include additional commentary and examples that illustrate how the … Continue reading this entry

Myriad's Trade Secret Trump Card: The Myriad Database Of Genetic Variants

One of the most interesting arguments that Myriad made in its Motion for Preliminary Injunctive Relief in its infringement action against Ambry Genetics Corporation relates to the database of genetic information that Myriad has developed over its years of conducting BRCA1 and BRCA2  genetic testing. Myriad asserts that the proprietary database makes its testing more accurate … Continue reading this entry

Myriad Sues Ambry For Offering BRCA1/BRCA2 Breast Cancer Genetic Testing

On July 9, 2013, Myriad Genetics, Inc. brought suit against Ambry Genetics Corporation, alleging that Ambry is infringing ten (10) patents by offering breast cancer genetic testing for the BRCA1 and/or BRCA2 mutations associated with aggressive forms of breast and ovarian cancer. While Association for Molecular Pathology v. Myriad Genetics, Inc. was making its way to the … Continue reading this entry

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

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