Category Archives: Prometheus

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District Court Invalidates Dietary Supplement Patents On Motion To Dismiss

The U.S. District Court for the Southern District of California invalidated several dietary supplement product and method patents as being directed to ineligible subject matter, even though they claimed products providing a certain dose or combination of ingredients, or methods using the products. The decisions were rendered in the context of a motion to dismiss … Continue reading this entry

USPTO Patent Eligibility Guidance In View Of CellzDirect And Sequenom

On July 14, 2016, the USPTO issued a Memorandum to the Patent Examining Corps on patent eligibility in view of recent court decisions. The July 2016 Memorandum extracts more guidance for assessing patent eligibility from the Federal Circuit decision in CellzDirect, and notes that the Supreme decision denying certiorari in Sequenom “does not elevate” the significance of the panel decision … Continue reading this entry

CAFC Finds Cryopreservation Method Patent Eligible

The Federal Circuit ruled that the cryopreservation methods at issue in Rapid Litigation Mgmt. Ltd. v. CellzDirect Inc., are patent eligible under 35 USC § 101. It therefore vacated and remanded the decision of the U.S. District Court for the Northern District of Illinois that held the claims invalid on summary judgment. The Federal Circuit distinguished … Continue reading this entry

Supreme Court Deals Blow To Diagnostic Method Patents, Denies Cert In Sequenom

“If you can’t say something nice, don’t say anything at all” can be good words to live by, but in the context of the Supreme Court’s denial of certiorari in Sequenom (scroll down to page 3), the silence is deafening–and could have a chilling impact on innovation in the fields of diagnostic and personalized medicine. Without knowing … Continue reading this entry

New USPTO Guidance On Patent Eligibility Of Diagnostic Methods

The patent eligibility examples published by the USPTO on May 5, 2016 include two new examples relating to diagnostic methods and two new examples relating to “nature-based” products. This article will consider the diagnostic methods examples and ask whether they are consistent with recent Federal Circuit decisions, or whether the USPTO is taking a stand against … Continue reading this entry

District Court Applies Mayo To Treatment Claims But Denies Motion To Dismiss BMS Keytruda Litigation

The U.S. District Court for the District of Delaware accepted Merck’s arguments that method of treatment patents asserted by BMS against its Keytruda product “touch[] upon a natural phenomenon” such that they should be analyzed under the Mayo/Alice patent eligibility framework. However, in view of disputed issues of fact, the presumption of validity, and other presumptions arising from … Continue reading this entry

Methods Exploiting Junk DNA May Be Useful But Lack Patent Eligibility

Striking another blow against patent eligibility in the field of biotechnology, the Federal Circuit agreed with the district court that methods that use “junk DNA” to detect genetic variations lack patent eligibility under 35 USC § 101. Although Judge Dyk found the claims at issue to be similar to claims held invalid in other Federal Circuit … Continue reading this entry

Sequenom Throws Diagnositc Method Patents At The Mercy Of The Supreme Court

It comes as no surprise that Sequenom has filed a petition for certiorari to the Supreme Court, asking the Court to review the Federal Circuit decision that upheld the district court decision that held its diagnostic method claims invalid for failing to satisfy the patent eligibility requirements of 35 USC § 101. With no relief from Congress … Continue reading this entry

District Court Invalidates Cleveland Clinic Diagnostic Patents On Motion To Dismiss

Judge Gaughan of the U.S. District Court for the Northern District of Ohio granted the defendant’s motion to dismiss after finding three Cleveland Clinic Foundation diagnostic patents invalid under 35 USC § 101. While the result is not surprising in view of recent patent eligibility decisions, it serves as reminder of the real-world impact of recent Supreme … Continue reading this entry

Judge Lourie Suggests Jepson Claims For Patent Eligibility

As reported previously, the Federal Circuit has denied rehearing in Ariosa Diagnostics, Inc. v. Sequenom, Inc. I wrote about Judge ‘Dyk’s opinion concurring in the denial but offering alternative views on patent eligibility in this article. Here, I look at the other concurring opinion, which was authored by Judge Lourie and joined by Judge Moore. … Continue reading this entry

Judge Dyk Would Add Reduction To Practice To Patent Eligibility Requirement

As noted in this article, the Federal Circuit has denied rehearing in Ariosa Diagnostics, Inc. v. Sequenom, Inc.. The per curiam order was accompanied by two separate concurring opinions, one authored by Judge Lourie (joined by Judge Moore) and one authored by Judge Dyk, and one dissenting opinion authored by Judge Newman. Here, I look at Judge Dyk’s concurrence. … Continue reading this entry

Federal Circuit Denies Rehearing In Sequenom

The Federal Circuit has denied the petition for rehearing en banc in Ariosa Diagnostics, Inc. v. Sequenom, Inc., despite the filing of twelve amicus briefs in support of the petition, including briefs filed by Biotechnology Industry Organization and Pharmaceutical Research and Manufacturers of America, numerous innovator companies in the diagnostic space, and law professors. The en banc order was accompanied … 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

Another Sequenom Patent Appeal Heads To The Federal Circuit

While Sequenom’s appeal of the district court’s summary judgment of invalidity of U.S. Patent 6,258,540 under 35 USC § 101 has been pending at the Federal Circuit, the USPTO has been considering the validity of the patent under 35 USC §§ 102 and 103 in an Inter Partes Review proceeding. Now that the decision of the Patent … Continue reading this entry

Federal Circuit Looks For Inventive Concept In Sequenom Patent

On November 7, 2014, the Federal Circuit heard oral arguments in Aria Diagnostics, Inc. v. Sequenom, Inc., where Sequenom is appealing the district court’s summary judgment of invalidity under 35 USC § 101. The active questioning by the judges suggests that they are wrestling with how to apply the Supreme Court’s decision in Mayo to different … 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

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

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