On Tuesday, September 3, 2019, in response to a petition for rehearing en banc, the Federal Circuit issued an order withdrawing language in the panel decision in Amgen Inc. v. Sandoz Inc., 2018-1551, stating that the doctrine...more
The Supreme Court last week issued its long-awaited decision regarding patent exhaustion in Impression Products, Inc. v. Lexmark International. The decision, which overturns longstanding Federal Circuit precedent, curtails...more
6/9/2017
/ Breach of Contract ,
Exports ,
Foreign Sales ,
Imports ,
Impression Products v Lexmark International ,
IP License ,
Patent Exhaustion ,
Patent Infringement ,
Patent Litigation ,
Patents ,
Resales Agreements ,
SCOTUS ,
Single-Use/No Resale Restriction ,
Stream of Commerce
The Supreme Court, in a 7-1 decision written by Justice Alito, has held that laches cannot be invoked as a defense against any claim for damages in a patent case brought within the 6-year limitation on damages prescribed by...more
Last week, the Supreme Court provided much-needed clarity to U.S. companies concerned about their potential liability for supplying a single component of a multicomponent invention abroad. The Court’s decision in Life...more
In its July 5, 2016 decision in Amgen v. Apotex, the Federal Circuit interpreted the Biologics Price Competition and Innovation Act (BPCIA) for the second time. The Court reiterated that the BPCIA requires a biosimilar...more
7/7/2016
/ Amgen ,
Apotex ,
Biologics ,
Biosimilars ,
BPCIA ,
Commercial Marketing ,
Food and Drug Administration (FDA) ,
Generic Drugs ,
Notice Requirements ,
Patent Dance ,
Patent Infringement ,
Patents ,
Pharmaceutical Patents ,
Preliminary Injunctions
Last week, a Federal Circuit panel rejected TC Heartland’s Petition for Mandamus to direct the United States District Court for the District of Delaware to either dismiss or transfer the patent infringement suit filed against...more
On July 21, the Federal Circuit interpreted the patent litigation procedures and requirements of the Biologics Price Competition and Innovation Act (BPCIA), including whether a company submitting an abbreviated BLA (“k...more
7/24/2015
/ Biosimilars ,
BPCIA ,
FDA Approval ,
Food and Drug Administration (FDA) ,
Notice Requirements ,
Opt-Outs ,
Patent Applications ,
Patent Infringement ,
Patent Litigation ,
Patents ,
Pharmaceutical Industry ,
Popular ,
Preliminary Injunctions ,
Prescription Drugs
Implications of Alice v. CLS Bank -
Late last week, the United States Supreme Court decided Alice Corp. Pty. Ltd. v. CLS Bank Int’l, et al., a case the technology community had hoped would clarify what kinds of...more
On Monday, in Nautilus Inc. v. Biosig Instruments, the United States Supreme Court unanimously set aside the Federal Circuit’s indefiniteness standard, potentially easing the way for defendants to invalidate ambiguous patent...more