In an effort to help independent inventors and small businesses bring “important and possibly life-saving treatments” to market more quickly, the United States Patent and Trademark Office (USPTO) is implementing the COVID-19...more
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
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 Amgen Inc. v. Hospira, Inc., the Federal Circuit held that Amgen could not obtain discovery related to activities that might infringe a patent that it had not asserted in its biosimilar patent litigation against Hospira....more
8/31/2017
/ Amgen ,
Appeals ,
Biosimilars ,
BPCIA ,
Collateral Order Doctrine ,
FDA Approval ,
Federal Rules of Civil Procedure ,
FRCP 11 ,
Hospira ,
Judicial Review ,
Motion to Compel ,
Patent Dance ,
Patent Infringement ,
Patent Litigation ,
Patents ,
Pharmaceutical Patents ,
Writ of Mandamus
The U.S. Supreme Court rendered its first interpretations of the biosimilar patent dispute resolution procedures of the Biologics Price Competition and Innovation Act (BPCIA), ruling largely in favor of Sandoz on both issues...more
6/13/2017
/ Amgen ,
Biologics ,
Biosimilars ,
BPCIA ,
Content Marketing ,
Dispute Resolution ,
FDA Approval ,
Food and Drug Administration (FDA) ,
IP License ,
Notice Requirements ,
Patent Dance ,
Patent Infringement ,
Patents ,
Pharmaceutical Patents ,
Preemption ,
Preliminary Injunctions ,
Sandoz ,
Sandoz v Amgen ,
SCOTUS ,
State Law Claims ,
Unfair Competition
In Novartis AG v. Torrent Pharmaceuticals Ltd., the Federal Circuit affirmed the decision of the USPTO Patent Trial and Appeal Board (PTAB) invalidating all claims of U.S. Patent 8,324,283, which is one of four Orange...more
4/25/2017
/ FDA Approval ,
Final Written Decisions ,
Inter Partes Review (IPR) Proceeding ,
Nexus ,
Novartis ,
Obviousness ,
Orange Book ,
Patent Invalidity ,
Patent Trial and Appeal Board ,
Patents ,
Pharmaceutical Patents ,
Substantial Evidence Standard
In Amgen v. Apotex, the Federal Circuit rejected Apotex’s arguments that the 180-day pre-marketing notice requirement does not apply to biosimilar applicants who participated in the “patent dance” process of the Biologics...more
7/8/2016
/ Amgen ,
Apotex ,
Biosimilars ,
BPCIA ,
Commercial Marketing ,
FDA Approval ,
Notice Requirements ,
Patent Dance ,
Patent Infringement ,
Petition for Writ of Certiorari ,
Pharmaceutical Industry ,
Pharmaceutical Patents ,
Preliminary Injunctions ,
Sandoz v Amgen
In Intendis GmbH v. Glenmark Pharmaceuticals Inc., USA, the Federal Circuit affirmed the district court decision that found infringement under the doctrine of equivalents. This case shows that the doctrine of equivalents...more
5/24/2016
/ Abbreviated New Drug Application (ANDA) ,
CAFC ,
De Novo Standard of Review ,
Doctrine of Equivalents ,
Estoppel ,
FDA Approval ,
Generic Drugs ,
Orange Book ,
Patent Infringement ,
Patent Litigation ,
Pharmaceutical Patents ,
Prior Art
Celltrion’s biosimilar version of Janssen’s Remicade® (infliximab) product cleared a significant regulatory hurdle on February 9, 2016, when the Food and Drug Administration’s (FDA’s) Arthritis Advisory Committee voted 21-3...more
Judge Cohn of the U.S. District Court for the Southern District of Florida has issued another decision interpreting the complicated provisions of the Biologics Price Competition and Innovation Action (BPCIA), ruling that the...more
The Federal Circuit denied the petitions for rehearing en banc filed in Amgen Inc. v. Sandoz Inc., which was the court’s first decision interpreting the Biologics Price Competition and Innovation Act (BPCIA). Perhaps the...more
10/20/2015
/ Amgen ,
Amicus Briefs ,
Biosimilars ,
BPCIA ,
FDA Approval ,
Notice Requirements ,
Patent Dance ,
Patent Infringement ,
Patent Litigation ,
Patents ,
Petition For Rehearing ,
Sandoz ,
Sandoz v Amgen
After filing over thirty petitions for Inter Partes Review of Orange Book-listed patents for various drugs, Kyle Bass and his Coalition for Affordable Drugs finally have made it over the first hurdle. The USPTO Patent Trial...more
10/13/2015
/ Abbreviated New Drug Application (ANDA) ,
FDA Approval ,
Generic Drugs ,
Hedge Funds ,
Inter Partes Review (IPR) Proceeding ,
Likelihood of Success ,
Obviousness ,
Orange Book ,
Patent Infringement ,
Patent Litigation ,
Patent Trial and Appeal Board ,
Patents ,
Pharmaceutical Patents ,
Prescription Drugs ,
Real Party in Interest ,
USPTO
Amgen has filed a complaint under the Biologics Price Competition and Innovation Act (BPCIA), asserting that a biosimilar application filed by Apotex, Inc. infringes two of its patents. Although several complaints have...more
8/31/2015
/ Amgen ,
Apotex ,
Biosimilars ,
BPCIA ,
FDA Approval ,
Notice Requirements ,
Patent Dance ,
Patent Infringement ,
Patent Litigation ,
Patents ,
Pharmaceutical Industry ,
Pharmaceutical Patents ,
Sandoz v Amgen