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 Intra-Cellular Therapies, Inc. v. Iancu, the Federal Circuit agreed with the USPTO’s Patent Term Adjustment (PTA) calculation that charged a deduction for “applicant delay” for time after the applicant filed a first...more
In Mayo Foundation for Medical Education and Research v. Iancu, the Federal Circuit agreed with the USPTO’s Patent Term Adjustment (PTA) calculation that excluded prosecution that occurred after an interference was decided...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In its non-precedential decision in INO Therapeutics LLC v. Praxair Distribution Inc., the Federal Circuit agreed with the district court that method of treatment claims reciting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 contrast to its decision in Nuvo Pharmaceuticals, Inc. v. Dr. Reddy’s Laboratories Inc., which seemed to impose a higher standard for satisfying the written description requirement, the Federal Circuit decision in...more
Recent Federal Circuit decisions demonstrate that the doctrine of equivalents is alive and well, and not always barred by claim amendments. In both Ajinomoto Co. v. ITC and Eli Lilly and Co. v. Hospira, Inc., the Federal...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
The USPTO has taken another major step in the fee-setting process for fee adjustments it expects to implement in January 2021, and published the proposed fees in the Federal Register. The major changes are the same as those...more
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 Senators Chris Coons (D-Del.) and Tom Cotton (R-Ark.) and Representative Steve Stivers (R-Ohio) and Bill Foster (D-Ill.) reintroduced the STRONGER Patents Act, originally introduced in 2017. While many recently...more
The claim construction determinations in Mayne Pharma International Pty. Ltd. V. Merck Sharp & Dohme Corp. may leave stakeholders in the pharmaceutical space scratching their heads, and highlights that it’s rarely possible to...more
The “Terminating the Extension of Rights Misappropriated (TERM) Act of 2019” would create a presumption that every other patent listed in the Orange Book has been terminally disclaimed over the earliest-expiring Orange...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
On June 10, 2019, the U.S. Supreme Court held that the U.S. government cannot challenge the validity of a U.S. patent in any AIA review proceeding (inter partes review, post-grant review, or covered business method review)....more
In Nuvo Pharmaceuticals, In. v. Dr. Reddy’s Laboratories Inc., the Federal Circuit reversed the district court and found the asserted patents invalid for failing to satisfy the written description requirement. This decision...more
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
The USPTO has announced new procedures patent holders can follow to obtain additional Patent Term Adjustment (PTA) under the Federal Circuit’s January 2019 decision in Supernus Pharm., Inc. v. Iancu. According to the May 9,...more
Provisional applications tempt stakeholders with the possibility of securing a filing date on an expedited basis and limited budget, but the value of that filing date will depend on its ability to serve as a valid priority...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 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 Momenta Pharmaceuticals, Inc. v. Bristol-Meyers Squibb Co., the Federal Circuit issued another decision analyzing the contours of a petitioner’s Article III standing to appeal PTAB decisions upholding a patent. In contrast...more
2/26/2019
/ Abbreviated New Drug Application (ANDA) ,
Appeals ,
Article III ,
Bristol-Myers Squibb ,
Inter Partes Review (IPR) Proceeding ,
Momenta ,
Patent Litigation ,
Patent Trial and Appeal Board ,
Patents ,
Pharmaceutical Patents ,
Standing
In Helsinn Healthcare S.A. v. Teva Pharmaceuticals USA, Inc., the Supreme Court interpreted the “on sale bar” of the America Invents Act (AIA) version of 35 U.S.C. § 102 as unchanged from the pre-AIA version. In so doing, the...more
1/30/2019
/ America Invents Act ,
Appeals ,
Assignment of Inventions ,
Confidentiality Agreements ,
Helsinn Healthcare SA v Teva Pharmaceuticals USA Inc ,
Inventions ,
On-Sale Bar ,
Patent Applications ,
Patent Infringement ,
Patents ,
Pharmaceutical Industry ,
Pharmaceutical Patents ,
Public Use ,
Reaffirmation ,
Reversal ,
SCOTUS ,
Section 102 ,
Third-Party Relationships
I previously wrote about the standing issue addressed in Amerigen Pharmaceuticals v. UCB Pharma GMBH. In this article, I look at the lead compound analysis that led the USPTO Patent Trial and Appeal Board (PTAB) to uphold the...more