Category Archives: Myriad

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Magistrate Judge Nixes TB Test Kit Claims

In a “Report and Recommendation on Defendants’ Joint Motion To Dismiss,” U.S. Magistrate Judge Cabell of the U.S. District Court for the District of Massachusetts determined that TB test kit claims do not satisfy the patent eligibility requirement of 35 USC § 101, but declined to reach the same conclusion with regard to related method claims. The decision … Continue reading this entry

Australian Patent Office Provides Patent Eligibility Guidance

The Australian Patent Office (IP Australia) has issued final patent eligibility guidance under the Australian High Court’s decision in D’Arcy v. Myriad Genetics, Inc. Where the USPTO extrapolated from the U.S. Supreme Court decision when it promulgated its patent eligibility guidance, IP Australia seems to have taken a more conservative approach. This means that despite similar rulings against … Continue reading this entry

Australia High Court Rules Against Gene Patents

Colleagues in Australia have been spreading the bad news: The High Court of Australia followed the lead (?) of the U.S. Supreme Court and determined that Myriad cannot patent the isolated BRCA1 gene in Australia. Thanks to Adam Denley, Ph.D., Senior Associate at Freehills Patent Attorneys, for providing the article below on the October 6, 2015 decision … Continue reading this entry

Can Any DNA Claims Still Be Patented?

In a decision issued December 17, 2014, in In Re BRCA1- And BRCA2-Based Hereditary Cancer Test Patent Litigation (Myriad II), the Federal Circuit invalidated Myriad’s primer claims and detection method claims under 35 USC § 101. I first reported the decision here, and now revisit that decision and the Supreme Court decision in Association for … Continue reading this entry

Federal Circuit Invalidates Myriad Primer And Method Claims As Lacking Subject Matter Eligibility

In a case styled as In re BRCA1- and BRCA2-Based Hereditary Cancer Test Patent Litigation (also known as Myriad v. Ambry), the Federal Circuit held four of Myriad’s “primer” claims and two of Myriad’s detection method claims invalid for lack of subject matter eligibility under 35 USC § 101. The timing of this decision–coming two days after … Continue reading this entry

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

Update On Mayo Myriad Patent Eligibility From USPTO BCP Partnership Meeting

On September 17, 2014, the USPTO held the first “bicoastal” Biotechnology/Chemical/Pharmaceutical Customer Partnership meeting, with live participation from the USPTO’s main campus in Alexandria, VA and from San Jose University in San Jose, CA. The last item on the agenda was a panel on the Mayo-Myriad Guidance, so I joined the meeting by WebEx to hear … Continue reading this entry

Australia Upholds Patent Eligibility Of Isolated DNA

Thanks to Adam Denley, Ph.D., Senior Associate at Freehills Patent Attorneys in Australia, for alerting me to the September 5, 2014 decision of the Full Federal Court of Australia upholding the patent eligibility of isolated nucleic acids, and for letting me share his initial summary here.… 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

Do The USPTO 101 Guidelines Violate International Trade Agreements?

One advantage of being a blogger in the relatively small world of patents is that I have gotten to know practitioners in other countries who also have a keen interest in patent law. One such person is Australian Registered Patent Attorney Mark Summerfield, who blogs at Patentology. I enjoyed his article on the new USPTO … Continue reading this entry

The State Of Vaccines Under The USPTO 101 Guidelines

In his State of the Union Address given on January 28, 2014, President Obama recognized the need for continued and increased investment in new technologies, including technologies specific to the biological and pharmaceutical fields. (Original Official White House Photo by Pete Souza, licensed under Creative Commons Attribution License 3.0) How would “vaccines that stay ahead of drug-resistant … 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

District Court Doubts Patent Eligibility Of Myriad BRCA Claims

In a decision issued March 10, 2014, Judge Shelby of the U.S. District Court for the District of Utah denied Myriad’s motion for a preliminary injunction against Ambry Genetics Corp. While Ambry had challenged the validity of the Myriad BRCA claims on several grounds, the district court ruled on the most interesting one–patent eligibility. In particular, … Continue reading this entry

Five Things You Should Know About The USPTO Patent Subject Matter Eligibility Guidelines

The new USPTO patent subject matter eligibility guidelines set forth a detailed analytical framework for evaluating whether claims satisfy the patent subject matter eligibility requirement of 35 USC § 101. If you are an examiner, patent agent, patent attorney, or applicant overseeing patent portfolios in chemical, biotechnology, or life sciences technologies, you should read and study … Continue reading this entry

Do Pharmaceutical Compositions Have Patent Subject Matter Eligibility Under The New USPTO Guidelines?

The USPTO’s new patent subject matter eligibility guidelines  (the “Guidelines”) include examples that apply the multi-factored analysis mandated by the Guidelines to compositions that include one or more “natural products” as a component. Do these examples indicate that pharmaceutical compositions with an active ingredient that can be obtained from a natural source no longer can be … Continue reading this entry

USPTO Issues New Patent Subject Matter Eligibility Guidelines

The USPTO has issued new patent subject matter eligibility guidelines to aid examiners in applying the principles of Myriad and Prometheus to any claim “reciting or involving laws of nature/natural principles, natural phenomena, and/or natural products.” The guidelines include a general framework for analyzing such claims for patent subject matter eligibility and examples applying the … Continue reading this entry

Do These Sequence Analysis Method Patents Satisfy Section 101?

According to an article on Law360, Bristol-Myers Squibb Co. is challenging the validity of two Genetic Technologies Ltd. patents on the basis that the claimed intron sequence analysis methods recite natural phenomena that do not satisfy the patent-eligibility requirements of 35 USC § 101. This case highlights some of the questions left unanswered by the Supreme Court … Continue reading this entry

Myriad Preliminary Injunction Hearing To Be Held September 11, 2013

The hearing on Myriad’s motion for a preliminary injunction against Ambry Genetics is scheduled for September 11, 2013, before Judge Robert A. Shelby at the U.S. District Court for the Central District of Utah. The primary question before the court is whether it should issue a preliminary injunction to stop Ambry from selling its allegedly … Continue reading this entry

Federal Circuit Remands Sequenom Down Syndrome Test Platform Patent For Consideration Under Myriad

In Aria Diagnostics, Inc. v. Sequenom, Inc., the Federal Circuit vacated and remanded the district court’s decision denying Sequenom’s motion for a preliminary injunction relating to a patent covering the non-invasive Sequenom Down Syndrome test. The Federal Circuit found that the district court had “incorrectly interpreted the asserted claims and improperly balanced factors regarding issuance … 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

A Look At The Myriad Gene Patent Claims And The USPTO Memo To Examiners On Myriad

Now that the Supreme Court has issued its decision in the “ACLU/Myriad” gene patents case (Association For Molecular Pathology v. Myriad Genetics, Inc.), people are wondering what the decision means for the Myriad patents and BRCA1/BRCA2 genetic testing. If you missed it, this article provides an overview of the Supreme Court Myriad decision. Here, I review … Continue reading this entry

Supreme Court Decides Myriad Gene Patents Case, Holds Isolated Human Genes May Not Be Patented

On June 13, 2013, the Supreme Court issued its long-awaited decision in the “ACLU/Myriad” gene patents case (Association For Molecular Pathology v. Myriad Genetics, Inc.). In a unanimous opinion authored by Justice Thomas, the Court held that “a naturally occurring DNA segment is a product of nature and not patent eligible merely because it has … 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