Donald Ware

Donald Ware

Foley Hoag LLP

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En Banc Federal Circuit Clarifies Application of On-Sale Bar to Contract Manufacturing

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

7/13/2016 - Hospira On-Sale Bar Patent Litigation Patents

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

Federal Circuit Expands Scope of Liability for Divided Infringement

The Federal Circuit, sitting en banc in Akamai Technologies, Inc. v. Limelight Networks, Inc., this week adopted a new standard governing divided infringement under 35 U.S.C. § 271(a). The new standard is likely to enhance...more

8/18/2015 - Covered Business Method Patents Direct Infringement Divided Infringement En Banc Review Induced Infringement Joint Tortfeasors Limelight v Akamai Patent Infringement Patents Reversal Section 271

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

How Not to Get Snared in Brulotte’s Web

The Supreme Court’s Kimble Decision Reminds Licensors and Licensees to Evaluate Post-Expiration Royalties with Care - On June 22, 2015, the Supreme Court, in Kimble v. Marvel Entertainment, LLC, declined to overrule–on...more

7/1/2015 - Brulotte Contract Term IP License Kimble v Marvel Enterprises Patent Royalties Patents Royalties SCOTUS Stare Decisis

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

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

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