President-elect Trump’s plans for his first 100 days in office include “cutting the red tape at the FDA” and “speed[ing] the approval of life-saving medications.” Here, we consider specific steps Trump could take–without or...more
On August 4, 2016, Abbvie Inc. filed a complaint against Amgen, Inc. under the Biologics Price Competition and Innovation Act (BPCIA), asserting that Amgen’s application for approval of a biosimilar version of HUMIRA®...more
8/10/2016
/ Abbreviated New Drug Application (ANDA) ,
AbbVie ,
Amgen ,
Biosimilars ,
BPCIA ,
Commercial Marketing ,
Patent Dance ,
Patent Infringement ,
Patent Litigation ,
Pharmaceutical Industry ,
Pharmaceutical Patents
In Merck & CIE v. Watson Laboratories, Inc., the Federal Circuit found communications between Merck and a potential joint venture partner amounted to a commercial offer to sell that invalidated the Orange Book-listed folate...more
5/31/2016
/ Abbreviated New Drug Application (ANDA) ,
America Invents Act ,
Confidentiality Agreements ,
Generic Drugs ,
Joint Venture ,
Merck ,
Non-Compete Agreements ,
On-Sale Bar ,
Patent Invalidity ,
Patent Litigation ,
Pharmaceutical Patents ,
Reversal ,
Watson Pharmaceuticals
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
In Acorda Therapeutics Inc. v. Mylan Pharmaceuticals Inc., the Federal Circuit held that the filing of an Abbreviated New Drug Application (ANDA) and intentions to market the product across the United States–including in the...more
3/25/2016
/ Abbreviated New Drug Application (ANDA) ,
AstraZeneca ,
Forum Shopping ,
General Jurisdiction ,
Generic Drugs ,
Minimum Contacts ,
Mylan Pharmaceuticals ,
Patent Infringement ,
Patent Litigation ,
Personal Jurisdiction ,
Pharmaceutical Patents ,
Proposed Legislation ,
Specific Jurisdiction
In Purdue Pharma L.P. v. Epic Pharma LLC, the Federal Circuit affirmed the district court decision holding four OxyContin patents invalid as obvious. In so doing, the court rejected Purdue’s arguments that its discovery of...more
In Prometheus Laboratories, Inc. v. Roxane Laboratories, Inc., the Federal Circuit affirmed the district court’s finding that Prometheus’ claims were invalid as obvious, but in so doing it cited its own precedent regarding...more
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
Recent jurisprudence on the issue of divided infringement has arisen in the context of computer-related technologies, where a user or customer performs one or more steps of a patented method. Now the issue has arisen in the...more
10/1/2015
/ Abbreviated New Drug Application (ANDA) ,
Direct Infringement ,
Divided Infringement ,
Eli Lilly ,
En Banc Review ,
Generic Drugs ,
Induced Infringement ,
Limelight v Akamai ,
Method Claims ,
Orange Book ,
Patent Infringement ,
Patent Litigation ,
Patents ,
Patients ,
Pharmaceutical Industry ,
Physicians ,
Product Labels
In The Medicines Company v. Hospira, Inc., the Federal Circuit held that a transaction with a contract manufacturer gave rise to an on sale bar that invalidated The Medicines Company’s Angiomax® patents. Are the facts of this...more
7/14/2015
/ Abbreviated New Drug Application (ANDA) ,
America Invents Act ,
Disclosure ,
Generic Drugs ,
Manufacturers ,
On-Sale Bar ,
Patent Invalidity ,
Patent Litigation ,
Patents ,
Pharmaceutical Patents ,
Prior Art ,
Transfer of Title
In In Re Cipro Cases I & II, the California Supreme Court laid out a four-part rule of reason analysis for evaluating ANDA settlements that involve a reverse payment to the generic challenger (also referred to as “pay for...more
In two decisions issued under the same name (Ferring B.V. v. Watson Laboratories, Inc.), the Federal Circuit upheld the validity of the Orange Book-listed patents for Lysteda®, but found that they were not infringed by either...more
In two decisions issued under the same name (Ferring B.V. v. Watson Laboratories, Inc.), the Federal Circuit upheld the validity of the Orange Book-listed patents for Lysteda®, but found that they were not infringed by either...more
In Tyco Healthcare Group LP v. Mutual Pharmaceutical Co., Inc., the Federal Circuit remanded-in-part for the district court to determine whether Tyco’s citizen petition to the FDA gave rise to antitrust liability. Judge...more
In Bristol-Myers Squibb Co. v. Teva Pharmaceuticals USA, Inc., the Federal Circuit affirmed the district court’s finding that BMS’s Baraclude® patent is invalid as obvious. In so doing, the court gave little weight to...more
In a divided opinion issued in Braintree Labs., Inc. v. Novel Labs., Inc., the Federal Circuit reversed the district court on one of two challenged claim construction issues and vacated the district court’s finding of...more
In Galderma Laboratories v. Tolmar, Inc., the Federal Circuit reversed the district court’s findings that the Orange Book-listed patents for Galderma’s Differin® 0.3% gel product were not invalid as obvious. In so doing, the...more
In Sunovion Pharmaceuticals, Inc. v. Teva Pharmaceuticals USA, Inc., the Federal Circuit reversed the district’s holding of no Lunesta® patent infringement that was based on a certification submitted to the court, and found...more
In its third look at the Novo Nordisk A/S patent related to Prandin®, in Novo Nordisk A/S v. Caraco Pharmaceutical Laboratories Ltd., the Federal Circuit affirmed the district court’s finding that claim 4 of U.S. Patent No....more
In Federal Trade Commission v. Actavis, Inc., the Supreme Court held that reverse payment (“pay-for-delay”) settlement agreements made in the context of settling Hatch-Waxman ANDA litigation should be evaluated for antitrust...more
6/20/2013
/ Abbreviated New Drug Application (ANDA) ,
Actavis Inc. ,
Federal Trade Commission (FTC) ,
FTC v Actavis ,
Generic Drugs ,
Hatch-Waxman ,
Patents ,
Pay-For-Delay ,
Pharmaceutical Industry ,
Prescription Drugs ,
Reverse Payment Settlement Agreements ,
SCOTUS
In Cephalon, Inc. v. Watson Pharmaceuticals, Inc., the Federal Circuit reversed the district court’s finding that two Orange Book-listed patents for Cephalon’s FENTORA® product were invalid, but affirmed the district court’s...more
The Supreme Court granted certiorari in Federal Trade Commission v. Watson Pharmaceuticals, Inc., to address whether and when “reverse payment” agreements made to settle ANDA litigation violate antitrust laws....more