I have been waiting for developments on the Patent Eligibility Restoration Act (PERA) since I testified before the Subcommittee on Intellectual Property of the Senate Judiciary Committee in January 2024, and in the meantime...more
When we first wrote about the Patent Eligibility Restoration Act (PERA), I had no idea I would have the honor of being invited to testify before the Subcommittee on Intellectual Property of the Senate Judiciary Committee, but...more
Senators Chris Coons and Thom Tillis recently introduced the bipartisan 2023 Patent Eligibility Restoration Act that would make significant changes to U.S. patent eligibility law. The “Findings” section of the Act states that...more
It has been a while since the Federal Circuit weighed in on the patent eligibility of so-called “natural product” claims. While the finding of non-eligibility in ChromaDex, Inc. v. Elysium Health, Inc. is not surprising, it...more
In a Federal Register Notice published January 6, 2022, the USPTO announced a new pilot program that will permit certain applicants to temporarily defer responding to subject matter eligibility (“SME”) rejections. The program...more
In an effort to both promote innovation against COVID-19 and promote dissemination of information about innovation against COVID-19, the USPTO is launching a new “deferred fee” pilot program for certain provisional patent...more
9/18/2020
/ Certifications ,
Coronavirus/COVID-19 ,
Emergency Use Authorization (EUA) ,
Federal Register ,
Food and Drug Administration (FDA) ,
Investigational Device Exemptions ,
Investigational New Drug Application (IND) ,
Patent Applications ,
Patent-Eligible Subject Matter ,
Pilot Programs ,
Premarket Approval Applications ,
USPTO
In CardioNet, LLC v. InfoBionic, Inc., the Federal Circuit found that the medical device claims at issue were “directed to” patent-eligible subject matter under 35 USC § 101. The district court had reached the opposite...more
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
We previously discussed the new personalized medicine example in the USPTO’s October 2019 Patent Eligibility Guidance Update. Here, we look at the new nature-based product example, and consider how it may impact...more
The USPTO has released additional patent eligibility guidance to supplement the guidance released in January. While much of the October 2019 Patent Eligibility Guidance Update relates to claims falling under the “abstract...more
On October 17, 2019, the USPTO issued new patent subject matter eligibility guidance, the first such memo since the January 2019 guidance on 35 U.S.C. §101. The January 2019 memo described a three step, two prong procedure...more
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 a decision underscoring that the U.S. stands (nearly) alone in holding most diagnostic methods to be not eligible for patenting, the Federal Court of Australia upheld Sequenom’s Australian patent directed to prenatal...more
Last week the Senate Judiciary Committee held two of three scheduled hearings on “The State of Patent Eligibility in America.” Many witnesses with prominent roles in the patent field testified in favor of legislative action...more
6/12/2019
/ American Civil Liberties Union (ACLU) ,
Biosimilars ,
Congressional Committees ,
Congressional Investigations & Hearings ,
Expert Testimony ,
Expert Witness ,
Food and Drug Administration (FDA) ,
Generic Drugs ,
Patent Reform ,
Patent-Eligible Subject Matter ,
Patents ,
Pharmaceutical Industry ,
Pharmaceutical Patents ,
Prescription Drugs
Congress has taken an important step along the road to reforming patent eligibility law. As announced in this press release, Senators Tillis (R-NC) and Coons (D-DE) and Representatives Collins (R-GA-9), Johnson (D-GA-4) and...more
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 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