Method-of-Treatment Claims, Comprising Excluding Certain Patients from Treatment, Found to Be Patent-Ineligible Under 35 U.S.C. § 101

Attorney: Matthew E. Barnet, Ph.D.
September 13, 2019

On August 27, 2019, in INO Therapeutics LLC v. Praxair Distribution Inc., in a 2-1 decision, the Federal Circuit upheld a district court decision that method-of-treatment claims, comprising excluding certain patients from treatment, were invalid under 35 U.S.C. § 101.... Read more

ATHENA DIAGNOSTICS - THE FEDERAL CIRCUIT AGAIN ABDICATES ITS RESPONSIBILITY

Attorney: Richard D. Kelly
July 15, 2019

In denying the petition for rehearing en banc the majority of the Federal Circuit abdicated its responsibility to define the limits of the Supreme Court's Mayo decision. Judge Dyk on the 25th birthday of the Federal Circuit noted that: Frequently, the Supreme Court in patent cases articulates a general principle and leaves it to our court to both administer the rule and apply it to the individual case.... Read more

The Proper Application of the Supreme Court's Alice Standard is an Evolving and Sometimes Hazy Area of Law

Attorney: Daniel J. Pereira, Ph.D.
April 29, 2019

Marijuana, for medical purposes and recreational purposes, is an area of great political, social and legal interest. By some accounts (https://www.forbes.com/sites/thomaspellechia/2018/03/01/double-digit-billions-puts-north-america-in-the-worldwide-cannabis-market-lead/#6d925dd76510), the industry is rapidly growing leaps and bounds. Not surprisingly, patents and disputes centered on patents for this industry are increasing in numbers.... Read more

Cleveland Clinic - Another Black Eye for the Federal Circuit and Dissing the USPTO

Attorney: Richard D. Kelly
April 3, 2019

In the April 1 Cleveland Clinic Foundation v. True Health Diagnostics LLC decision, the Federal Circuit has once again given itself a black eye in finding a new diagnostic procedure to be patent ineligible and with the same punch dissed the USPTO.... Read more

Natural Alternatives - Claim Construction Defeats A 101 Challenge On The Pleadings

Attorney: Richard D. Kelly
March 26, 2019

The Federal Circuit on March 19 in Natural Alternatives Intl. v Creative Compounds LLC. reversed a district court's opinion finding Natural's patent claims to be patent ineligible. The district court's decision arose out of a motion for judgment on the pleadings filed by Creative.... Read more


Category: Federal Circuit

The Federal Circuit Still Doesn't Get Diagnostic Claims

Attorney: Richard D. Kelly
December 12, 2018

In Roche Diagnostics the Federal Circuit continued its failure to recognize that diagnostic claims were not patent ineligible because they used a natural law. Roche involved claims detecting the Mycobacterium tuberculosis strains (MTB) quickly and accurately. Prior to the invention delays often occurred in diagnosing tuberculosis because of the time necessary to detect its presence involved a three to eight week cell culture. Roche discovered that the MTB strains could be quickly identified by identifying the presence of specific nucleotide sequence which functioned as a signature for the MTB. The technique used to identify the presence or absence of the signature nucleotide was conventional PCR analysis. The Federal Circuit affirmed a finding the diagnostic claims to be patent ineligible because the PCR technique was conventional and nucleotides naturally occurring.... Read more

A Different Lesson from Vanda v. West-Ward

Attorney: Stephen G. Baxter, Ph.D.
August 20, 2018

Last week the Federal Circuit denied West-Ward's petition for rehearing en banc. At the time of the original Federal Circuit decision (Vanda Pharms. Inc. v. West-Ward Pharms. Int'l Ltd., 887 F.3d 1117 (Fed. Cir. 2018), the case generated substantial commentary in regard to its patent eligibility context. West-Ward's petition focused on the question of whether "adjusting a dose of an old drug based on a patient's genetic risk of poorly metabolizing it" is patent eligible subject matter, so the pro-patent crowd will no doubt be pleased. There is another aspect of the case, however, which is worthy of consideration.... Read more

Sequenom v. Ariosa: The Saga Continues…

Attorney: J. Derek Mason, Ph.D., CLP
May 21, 2018

      Three years after a previous legal battle between Sequenom and Ariosa ended in a difficult loss for Sequenom (in what some commentators have characterized as a misapplication of the holding in Mayo Collaborative Services v. Prometheus Laboratories, Inc., 132 S. Ct. 1289 (2012)), Sequenom and its exclusive licensee Illumina have just this week filed a new patent infringement case against Ariosa Diagnostics, its parent Roche Molecular Systems, Inc. and sister company Roche Sequencing Solutions, Inc.,  in the US District Court for the Northern District of California San Francisco Division, for patents covering DNA testing in pregnant women. <... Read more

Federal Circuit Rules in Favor of Patent Eligibility

Attorney: Richard D. Kelly
April 16, 2018

On April 13 the Federal Circuit affirmed the lower court decision in Vanda Pharm. Inc. v. West-Ward Pharm. Int'l. Ltd., appeal Nos. 2016-2707 and 2016-2708. The opinion addresses a number of concerns in ANDA litigation including whether jurisdiction exists under 35 U.S.C. § 271(e)(2) for a "late listed" Orange Book patent (it does), the availability of an injunction to prevent inducement of infringement by a label (it is available), and the patent eligibility of a claim to using a drug based upon the results of a diagnostic technique. It is this latter point which is of significant importance. Claim 1 of the patent (USP 8,586,610 (‘610)):... Read more

In Re Urvashi Bhagat: One More Decision Denying Patent Eligibility of Nature-Based Product Claims

Attorney: Marina I. Miller, Ph.D.
March 29, 2018

Urvashi Bhagat appealed the decision of the PTAB ("the Board") affirming the examiner's anticipation rejections and the rejection under Section 101 of multiple claims in application 12/426,034. The Federal Circuit affirmed the Board's decision in the recent In re Urvashi Bhagat nonprecedential opinion. The claims of this application were directed to lipid-containing formulations comprising omega-6 and omega-3 fatty acids. The '034 application stated that dietary deficiency or imbalance of these fatty acids might lead to a variety of illnesses, and that omega-6 and omega-3 fatty acids are naturally occurring in oils, butters, nuts, and seeds. The '034 application claimed ranges and ratios of the fatty acids and other limitations.... Read more

A Glimmer of Hope for Diagnostic Patents (or Perhaps Just a Shimmering Mirage)

Attorney: Jacob A. Doughty
March 19, 2018

In the recent, nonprecedential Exergen opinion, a panel of the Federal Circuit considered the subject matter eligibility of a diagnostic method patent claim. The majority found a diagnostic method to be directed to patent-eligible subject matter, notwithstanding the Supreme Court's decision in Mayo and the Federal Circuit's subsequent decision in Ariosa.... Read more