Category Archives: Personalized Medicine

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Cleveland Clinic Decision Highlights Catch-22 Of Personalized Medicine Patents

The Federal Circuit decision in Cleveland Clinic Foundation v. True Health Diagnostics LLC, strikes another blow against the patent eligibility of diagnostic methods and highlights the difficulty of enforcing personalized medicine patents. The court affirmed the invalidity of claims related to a blood test for atherosclerotic cardiovascular disease, and agreed with the district court that diagnostic … Continue reading this entry

Sequenom Seeks Rehearing En Banc

Sequenom, Inc. has filed a petition for rehearing en banc of the Federal Circuit decision that held its diagnostic method claims invalid under 35 USC § 101. (You can read my synopsis of that decision here). Stakeholders in the diagnostic and personalized medicine space will be watching to see if the court grants the petition and … Continue reading this entry

Federal Circuit Holds Sequenom Diagnostic Method Patent Invalid Under 101

The Federal Circuit has issued its decision in Ariosa Diagnostics, Inc. v. Sequenom, Inc., affirming the district court’s finding that Sequenom’s claims are invalid under 35 USC § 101. The court’s decision shows the sweeping impact of the Supreme Court’s decision in Mayo v. Prometheus on the patent eligibility of diagnostic methods, and could have a ripple effect … 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

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

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

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

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

En Banc Federal Circuit Eases Requirements For Induced Infringement Of Method Claims

On August 31, 2012, the Federal Circuit issued an en banc, per curiam opinion deciding both Akamai Technologies, Inc. v. Limelight Networks, Inc. and McKesson Technologies, Inc. v. Epic Systems Corp., which each relate to the requirements for establishing infringement when all of the steps of a method claim are not performed by a single … 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

USPTO Issues Prometheus Examination Guidelines

On July 3, 2012, the USPTO issued its 2012 Interim Procedure for Subject Matter Eligibility Analysis 0f Process Claims Involving Laws of Nature.  According to the introduction, the guidelines are “for use by USPTO personnel in determining subject matter eligibility of process claims involving laws of nature under 35 USC § 101,”  in view of … 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

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

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

The USPTO Examines Prometheus

The day after the Supreme Court issued its unanimous decision in Mayo Collaborative Services v. Prometheus Laboratories, Inc., the USPTO issued a letter to the Patent Examining Corps that provides preliminary guidance to examiners and promises that more detailed guidance is forthcoming.… 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