In Teva Branded Pharmaceutical Products R&D, Inc. v. Amneal Pharmaceuticals of New York, LLC, the Federal Circuit jumped on the bandwagon of scrutinizing the types of patents that can be listed in the Food & Drug...more
1/21/2025
/ Abbreviated New Drug Application (ANDA) ,
Anti-Competitive ,
Federal Trade Commission (FTC) ,
Food and Drug Administration (FDA) ,
Generic Drugs ,
Hatch-Waxman ,
Intellectual Property Protection ,
Orange Book ,
Patent Infringement ,
Patent Litigation ,
Patents ,
Pharmaceutical Industry ,
Regulatory Requirements
Share on Twitter Print Share Back to top The Patent Term Extension (PTE) provisions of 35 U.S.C. 256 were enacted as part of the Drug Price Competition and Patent Term Restoration Act of 1984. PTE partially compensates...more
The USPTO has released an updated report on Inter Partes Review (IPR) and Post Grant Review (PGR) proceedings involving Orange Book or biologic patents, taking into account data through March 31, 2023. Highlights of the...more
In UCB Inc. v. Actavis Laboratories UT Inc., the Federal Circuit affirmed the district court’s judgement of invalidity on obviousness grounds but reversed the finding of anticipation. In reaching its decision on anticipation,...more
The Supreme Court decided not to grant certiorari in Teva Pharms. USA, Inc. v. GlaxoSmithKline, LLC, which has come to be known as the “skinny label” case. That means the Federal Circuit’s August 2021 decision (which was a...more
It is hard to predict whether a given bill will gain traction, but when the Senate Judiciary Committee reports out five bipartisan bills targeting pharmaceutical patents and pricing, it seems likely they are determined to get...more
The original Federal Circuit decision in Novartis Pharms. Corp. v. Accord Healthcare, Inc. was on the list of “written description” cases I covered in several conference programs this spring. It was interesting because...more
In Valeant Pharmaceuticals North America LLC v. Mylan Pharmaceuticals Inc. the Federal Circuit decided that, for the purpose of establishing venue in ANDA litigation, the place “where an act of infringement has occurred”...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In its non-precedential decision in INO Therapeutics LLC v. Praxair Distribution Inc., the Federal Circuit agreed with the district court that method of treatment claims reciting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
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
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 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
Although “any person” except the owner can challenge a patent in an Inter Partes Review (IPR) proceeding, only those who satisfy the constitutional requirements for standing can appeal a decision of the USPTO Patent Trial and...more
1/23/2019
/ Abbreviated New Drug Application (ANDA) ,
Article III ,
FDA Approval ,
Hatch-Waxman ,
Inter Partes Review (IPR) Proceeding ,
Orange Book ,
Patent Applications ,
Patent Trial and Appeal Board ,
Patents ,
Pharmaceutical Patents ,
Standing
In Novartis Pharmaceuticals Corp. v. Breckenridge Pharmaceutical Inc., Novartis scored another obviousness-type double patenting (OTDP) win when the Federal Circuit held that a post-URAA child patent could not be cited as an...more
12/18/2018
/ Abbreviated New Drug Application (ANDA) ,
Novartis ,
Obviousness ,
Orange Book ,
OTDP ,
Patent Litigation ,
Patent Term Adjustment ,
Patent Term Extensions ,
Patents ,
Pharmaceutical Industry ,
Pharmaceutical Patents ,
Pre-GATT ,
USPTO
In Novartis AG v. Ezra Ventures LLC, the Federal Circuit addressed “the interplay between a patent term extension (PTE) granted pursuant to 35 U.S.C. § 156 and the obviousness-type double patenting doctrine.” In upholding the...more
In Acorda Therapeutics, Inc. v. Roxane Laboratories, Inc., the Federal Circuit affirmed the district court decision finding four Acorda Orange Book-listed patents for Ampyra® invalid as obvious. Acorda raised a number of...more
As we noted in this article on PTAB Trial Insights, Senator Hatch (R-UT) has introduced the Hatch-Waxman Integrity Act, which is intended to restore the brand-generic balance many say has been skewed by Inter Partes Review...more
6/19/2018
/ Abbreviated New Drug Application (ANDA) ,
Biosimilars ,
BPCIA ,
FDA Approval ,
Generic Drugs ,
Hatch-Waxman ,
Inter Partes Review (IPR) Proceeding ,
Orange Book ,
Patent Applications ,
Patent Litigation ,
Patent Trial and Appeal Board ,
Patents ,
Pharmaceutical Industry ,
Pharmaceutical Patents ,
Post-Grant Review
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
In Genzyme Corp. v. Dr. Reddy’s Labs. Ltd., the Federal Circuit affirmed the district court decision upholding Genzyme’s Orange Book listed patent for the cancer drug Mozobil® against an obviousness challenge, because the...more
In Millennium Pharmaceuticals, Inc. v. Sandoz, the Federal Circuit reversed the district court decision that invalidated one of the Orange Book-listed patents covering the anti-cancer drug Velcade. In so doing, the court...more
In a non-precedential decision issued in Braintree Labs., Inc. v. Breckenridge Pharmaceutical, Inc., the Federal Circuit reversed the district court’s grant of summary judgment of noninfringement in favor of Breckenridge, and...more
5/30/2017
/ Abbreviated New Drug Application (ANDA) ,
Appeals ,
CAFC ,
Claim Construction ,
Induced Infringement ,
Noninfringement ,
Patent Infringement ,
Patents ,
Pharmaceutical Patents ,
Product Labels ,
Reversal ,
Summary Judgment
In The Medicines Co. v. Mylan, Inc., the Federal Circuit construed composition claims of two Angiomax patents as requiring the recited “batches” to be made by a specific “efficient mixing” process illustrated in one of the...more