Barbara Fiacco

Barbara Fiacco

Foley Hoag LLP

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Federal Circuit Offers Path Through Section 101 Thicket for Biotech Method Patents

In its July 5, 2016 decision in Rapid Litigation Management Ltd and In Vitro, Inc. v. CellzDirect, Inc. and Invitrogen Corp., the Federal Circuit held that patent claims directed to an improved method of cryopreserving...more

7/9/2016 - Ariosa Biotechnology CLS Bank v Alice Corp Examiners Life Sciences Mayo v. Prometheus Method Claims Obviousness Patent-Eligible Subject Matter Patents Petition for Writ of Certiorari Reversal Section 101 Sequenom Summary Judgment USPTO

Federal Circuit Invites FDA's Early Licensure of Biosimilars to Encourage Pre-Launch Resolution of Patent Disputes

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 FDA Generic Drugs Notice Requirements Patent Dance Patent Infringement Patents Pharmaceutical Patents Preliminary Injunctions

Objective Reasonableness Can Be Central to Fee-Shifting Analysis in Copyright Cases

In Kirtsaeng v. John Wiley & Sons, Inc., the Supreme Court clarified the test for awarding attorney’s fees when applying the Copyright Act’s discretionary fee-shifting provision, 17 U.S.C. § 505. The Court held that the...more

6/22/2016 - Attorney's Fees Copyright Copyright Infringement Fee-Shifting First Sale Doctrine Judicial Discretion Kirtsaeng v. John Wiley & Sons Objective Unreasonableness Standard Prevailing Party SCOTUS The Copyright Act

Federal Circuit Denies TC Heartland’s Petition to Change the Venue Standard, Renewing Interest in Congressional Venue Reform

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

5/4/2016 - Forum Shopping Kraft Mandamus Petitions Patent Infringement Patents Venue

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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