In Illumina, Inc. v. Ariosa Diagnostics, Inc., a divided panel of the Federal Circuit found claims directed to methods of preparing DNA samples for analysis satisfy the patent eligibility requirement of 35 USC § 101. Although...more
Responding to the invitation from the Supreme Court, the Solicitor General for the United States has filed an amicus brief for the United States in Hikma Pharmaceuticals USC Inc. v. Vanda Pharmaceuticals Inc. Stakeholders...more
1/10/2020
/ Alice Corporation ,
Amicus Briefs ,
Bilski ,
Mayo v. Prometheus ,
Patent Litigation ,
Patent-Eligible Subject Matter ,
Personalized Medicine ,
Petition for Writ of Certiorari ,
Pharmaceutical Industry ,
Pharmaceutical Patents ,
Section 101 ,
Solicitor General ,
Split of Authority
On Friday I will be speaking at the AUTM Eastern Regional Meeting, on a panel discussing patent eligibility issues for life sciences inventions. My topic relates to what the USPTO refers to as “nature-based products,” but...more
In its non-precedential decision in INO Therapeutics LLC v. Praxair Distribution Inc., the Federal Circuit agreed with the district court that method of treatment claims reciting “excluding” specific patients from treatment...more
In Genetic Veterinary Sciences, Inc. v. Laboklin GMBH & Co., the Federal Circuit upheld the district court decision that held claims directed to methods for genotyping a Labrador Retriever invalid under 35 USC § 101 at the...more
8/13/2019
/ Alice Corporation ,
Diagnostic Method ,
DNA ,
Dogs ,
Due Process ,
Federal Rules of Civil Procedure ,
FISA ,
Genetic Materials ,
Genetic Testing ,
Patent Litigation ,
Patent-Eligible Subject Matter ,
Patents ,
Personal Jurisdiction ,
Section 101
In United Cannabis Corp. v. Pure Hemp Collective, Inc., Judge Martinez of the U.S. District Court for the District of Colorado determined that UCANN's CBD patent was not invalid under 35 USC § 101. The court reached its...more
In Endo Pharmaceuticals Inc. v. Teva Pharmaceuticals USA, Inc., the Federal Circuit distinguished method of treatment claims that involve personalized dosing from the claims invalidated in Mayo v. Prometheus, and found them...more
4/4/2019
/ Abbreviated New Drug Application (ANDA) ,
Alice Corporation ,
Appeals ,
Endo Pharmaceuticals ,
Mayo v. Prometheus ,
Patent Litigation ,
Patent-Eligible Subject Matter ,
Pharmaceutical Industry ,
Pharmaceutical Patents ,
Section 101 ,
Teva Pharmaceuticals ,
USPTO
In Natural Alternatives Internat'l v. Creative Compounds, LLC, the Federal Circuit vacated the district court decision that held the asserted claims invalid under 35 USC § 101 at the pleadings stage. I previously wrote about...more
In Natural Alternatives Internat’l v. Creative Compounds, LLC, the Federal Circuit vacated the district court decision that held the asserted claims invalid under 35 USC § 101 at the pleadings stage. The claims at issue...more
In Roche Molecular Systems, Inc. v. Cepheid, the Federal Circuit affirmed the summary judgment decision of the U.S. District Court for the Northern District of California that held nucleotide primer claims and detection...more
10/12/2018
/ CLS Bank v Alice Corp ,
Life Sciences ,
Patent Infringement ,
Patent Litigation ,
Patent-Eligible Subject Matter ,
Patents ,
Pharmaceutical Patents ,
Prior Art ,
Section 101 ,
Summary Judgment ,
USPTO
In his keynote address at the Intellectual Property Owners Association Annual Meeting, USPTO Director Iancu revealed that the USPTO is working on revised patent eligibility guidelines he hopes will help keep patent...more
On June 7, 2018, the USPTO issued a memorandum to the Examining Corps providing patent eligibility examination guidance based on the recent Federal Circuit decision in Vanda Pharmaceuticals Inc. v. West-Ward Pharmaceuticals....more
In Praxair Distrib., Inc. v. Mallinckrodt Hospital Prods. IP Ltd., the Federal Circuit found that the printed matter doctrine applies equally to physically embodied information and mental steps, and can be invoked in the...more
5/29/2018
/ Claim Limitations ,
Evidence ,
Patent Invalidity ,
Patent Trial and Appeal Board ,
Patent-Eligible Subject Matter ,
Patents ,
Personalized Medicine ,
Pharmaceutical Patents ,
Printed Matter Doctrine ,
Prior Art ,
Section 101 ,
Section 102 ,
Section 103
Our first article on Vanda Pharmaceuticals, Inc. v. Aventisub, LLC focused on the subject matter eligibility of the personalized method of treatment claims under 35 USC § 101. Next, we considered how the Fanapt® label was...more
5/8/2018
/ Abbreviated New Drug Application (ANDA) ,
Generic Drugs ,
Hatch-Waxman ,
Orange Book ,
Patent Infringement ,
Patent Litigation ,
Patent-Eligible Subject Matter ,
Patents ,
Pharmaceutical Industry ,
Pharmaceutical Patents ,
Prescription Drugs ,
Section 101 ,
Subject Matter Jurisdiction
Our first article on Vanda Pharmaceuticals, Inc. v. Aventisub, LLC focused on the Federal Circuit’s decision upholding the subject matter eligibility of the personalized method of treatment claims under 35 USC § 101. Here, we...more
5/1/2018
/ Abbreviated New Drug Application (ANDA) ,
Induced Infringement ,
Method Claims ,
Orange Book ,
Patent Infringement ,
Patent Litigation ,
Patents ,
Patients ,
Pharmaceutical Industry ,
Physicians ,
Product Labels ,
Section 101
As announced in a Federal Register Notice dated April 20, 2018, the USPTO has issued a new memorandum to the Examining Corps providing supplemental patent eligibility examination guidance under Berkheimer, a Federal Circuit...more
In Vanda Pharmaceuticals Inc. v. West-Ward Pharmaceuticals Int’l Ltd., a divided panel of the Federal Circuit upheld Vanda’s personalized method of treatment claims relating to its Fanapt® (iloperidone) product against a...more
In a non-precedential decision issued in In re Bhagat, the Federal Circuit affirmed the decision of the USPTO Patent Trial and Appeal Board (PTAB) that claims directed to certain lipid compositions were ineligible for...more
In the non-precedential decision issued in Exergen Corp. v. Kaz USA, Inc., Judge Moore considered the time and money it took to develop the invention at issue when deciding that the claims satisfy the patent eligibility...more
We’ve written previously about ex parte decisions of the Patent Trial and Appeal Board (PTAB) affirming patent eligibility rejections that seem to be inconsistent with the USPTO’s Subject Matter Eligibility Guidance....more
In Ex Parte Timothy, the USPTO Patent Trial and Appeal Board (PTAB) affirmed the Examiner’s rejection of personalized medicine treatment claims. This decision highlights the PTAB’s willingness to invalidate claims that it...more
10/7/2017
/ Appeals ,
Innovation ,
Intellectual Property Protection ,
Mayo v. Prometheus ,
Patent Trial and Appeal Board ,
Patent-Eligible Subject Matter ,
Patents ,
Personalized Medicine ,
Pharmaceutical Patents ,
Product of Nature Doctrine ,
Section 101 ,
USPTO
On July 24, 2017, the USPTO issued a 48-page report on Patent Eligible Subject Matter. The report summarizes key court decisions interpreting and applying 35 USC § 101, international views on eligible subject matter, and...more
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...more
7/12/2017
/ Biotechnology ,
CLS Bank v Alice Corp ,
Dietary Supplements ,
Motion to Dismiss ,
Myriad-Mayo ,
Patent Invalidity ,
Patent-Eligible Subject Matter ,
Patents ,
Pharmaceutical Patents ,
Product of Nature Doctrine ,
Section 101
While the Supreme Court decisions in Myriad and Mayo have been applied to diagnostic-type claims, method of treatment patents were thought to be safe from the recent judicial expansion of the patent-(in)eligibility doctrine....more
3/4/2017
/ Administrative Appeals ,
Diagnostic Method ,
Ex Partes Reexamination ,
Mayo v. Prometheus ,
Method Claims ,
Patent Invalidity ,
Patent Trial and Appeal Board ,
Patent-Eligible Subject Matter ,
Patents ,
Personalized Medicine ,
SCOTUS ,
Section 101 ,
USPTO
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...more