Barbara Fiacco

Barbara Fiacco

Foley Hoag LLP

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A Fractured Federal Circuit Panel Interprets The Biosimilars Patent Resolution Procedures

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 FDA Approval Notice Requirements Opt-Outs Patent Applications Patent Infringement Patent Litigation Patents Pharmaceutical Industry Popular Preliminary Injunctions Prescription Drugs

Divided Federal Circuit Panel Upholds Patent Office’s “Broadest Reasonable Interpretation” Standard for Construing Claims in...

In a 2-1 decision in In re Cuozzo Speed Technologies LLC, No. 14-1301 (Fed. Cir. Feb. 4, 2015), the Federal Circuit recently held that the Patent Office may apply the “broadest reasonable interpretation” standard to construe...more

2/24/2015 - America Invents Act Inter Partes Review Proceedings Patents Post-Grant Review USPTO

Supreme Court Calls for Greater Deference to District Court Claim Construction

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

1/23/2015 - Claim Construction Clear Error Standard De Novo Standard of Review Federal Rules of Civil Procedure Patent Litigation Patents Pharmaceutical Industry Pharmaceutical Patents SCOTUS Teva v Sandoz

Federal Circuit’s Sandoz v. Amgen Decision Forecloses Early Declaratory Judgment Suits by Biosimilars Applicants

On December 5, in the closely watched Sandoz v. Amgen case, the Federal Circuit held that a biosimilars applicant cannot use the Declaratory Judgment Act to challenge a reference product sponsor's patent prior to filing a...more

12/17/2014 - Amgen Biologics Biologics Price Competition and Innovation Act of 2009 Biosimilars Declaratory Judgments FDA Patents Pharmaceutical Industry Pharmaceutical Patents Sandoz

What Did the Court Really Say About Patent Eligibility?

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

6/24/2014 - Alice Corporation CLS Bank CLS Bank v Alice Corp Patent Infringement Patent Litigation Patent-Eligible Subject Matter Patents Software Technology

Supreme Court Decision Invites More Challenges to Patent Claims as Indefinite

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

6/6/2014 - America Invents Act Claim Construction Indefiniteness Nautilus Inc. v. Biosig Instruments Patent Infringement Patent Litigation Patents Popular SCOTUS

Federal Circuit Holds that A Good-Faith Belief in Patent Invalidity Is a Defense to Claims of Inducing Patent Infringement

This week, the Federal Circuit issued an important decision for device manufacturers, developers, service providers, and any other company that might be targeted as an “indirect” patent infringer based on customers' use of...more

7/1/2013 - Contributory Infringement Good Faith Infringement Patents Validity

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