Last week, a federal judge in Boston answered a question of first impression arising under the patent dispute resolution provisions of the Biological Price Competition and Innovation Act (“BPCIA”), a process commonly known as...more
On July 11, 2016, the Federal Circuit, sitting en banc in The Medicines Company v. Hospira, held that a contract manufacturer’s sale of manufacturing services to an inventor did not constitute a sale of the patented invention...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 ,
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Patent Litigation ,
Patents ,
Pharmaceutical Industry ,
Popular ,
Preliminary Injunctions ,
Prescription Drugs
This week, in Teva Pharmaceuticals USA, Inc. v. Sandoz, Inc., the Supreme Court held that the Federal Circuit must apply a deferential “clear error” standard of review to any finding of fact underlying a district court’s...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