Senator Ben Sasse (R-NE) has introduced legislation that would delay and then extend the term of patents related to the treatment of COVID-19. The “Facilitating Innovation to Fight Coronavirus Act” also would shield health...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
The Federal Circuit decision in HZNP Medicines LLC v. Horizon Pharma USA, Inc. is a good reminder that even standard “patent lingo” can cause trouble down the line. Now that the court has denied rehearing en banc (with Judges...more
As set forth in this March 2, 2020 Federal Register Notice and effective immediately, the USPTO is going to start inquiring into petitions to revive an abandoned application, accept a delayed maintenance fee payment, or...more
The January 29, 2020, Federal Circuit decision in Galderma Laboratories, L.P. v. Teva Pharmaceuticals USA, Inc., is a non-precedential decision that was issued on the briefs (without oral argument), but is worth reviewing for...more
In Liqwd, Inc. v. L’Oreal USA, Inc., the Federal Circuit vacated a decision of the USPTO Patent Trial and Appeal Board (PTAB) that failed to take into account evidence of copying in its obviousness analysis. The Federal...more
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
In OSI Pharmaceuticals LLC v. Apotex, Inc., the Federal Circuit reversed the PTAB’s determination that a Tarceva® patent was invalid as obvious because the decision was not supported by a reasonable expectation of success....more
10/17/2019
/ Apotex ,
Clinical Trials ,
Obviousness ,
Patent Invalidity ,
Patent Litigation ,
Patent Trial and Appeal Board ,
Patents ,
Pharmaceutical Industry ,
Pharmaceutical Patents ,
Prescription Drugs ,
Prior Art ,
Reasonable Expectations Test ,
Reversal
In Supernus Pharmaceuticals, Inc. v. Iancu, the Federal Circuit held that the USPTO cannot charge a Patent Term Adjustment (PTA) deduction for “applicant delay” during a period when the applicant “could have done nothing to...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 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
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