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 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
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
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
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In its non-precedential decision in INO Therapeutics LLC v. Praxair Distribution Inc., the Federal Circuit agreed with the district court that method of treatment claims reciting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
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
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
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 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
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 Endo Pharmaceuticals Solutions, Inc. v. Custopharm Inc., the Federal Circuit affirmed the district court’s finding that two patents listed in the Orange Book for Aveed® had not been shown to be obvious. Although prior art...more
7/26/2018
/ CAFC ,
Inherency ,
Intellectual Property Protection ,
Patent Infringement ,
Patent Litigation ,
Patents ,
Pharmaceutical Industry ,
Pharmaceutical Patents ,
Prior Art ,
Public Use ,
Section 103
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
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
In Sumitomo Dainippon Pharma Co. V. Emcure Pharm. Ltd., the Federal Circuit affirmed the district court’s decision that construed a chemical structure as reading on the lurasidone enantiomer that is the active ingredient of...more
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
The USPTO issued a two page memorandum to the Patent Examining Corps noting that some of the USPTO’s written description guidance pertaining to antibody claims is “outdated.” The memo specifically notes withdrawal of the...more
The Federal Circuit has issued its final decision in the biosimilar patent litigation between Amgen and Sandoz over the first product to be approved under the Biologics Price Competition and Innovation Act (BPCIA). Not...more
12/27/2017
/ Amgen ,
Biosimilars ,
BPCIA ,
Patent Dance ,
Patent Infringement ,
Patent Litigation ,
Patents ,
Pharmaceutical Industry ,
Pharmaceutical Patents ,
Preemption ,
Sandoz ,
Sandoz v Amgen ,
Unfair Competition
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
The Federal Circuit decision in Cleveland Clinic Foundation v. True Health Diagnostics LLC, strikes another blow against the patent eligibility of diagnostic methods and highlights the difficulty of enforcing personalized...more