Courtenay C. Brinckerhoff

Courtenay C. Brinckerhoff

Foley & Lardner LLP

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Biosimilars Can Sit Out Patent Dance, But May Have To Wait Out Second Exclusivity Period

In Amgen v. Sandoz, Fed. Cir., No. 15-1499 (July 21, 2015), a divided panel of the Federal Circuit issued its first decision interpreting the Biologics Price Competition and Innovation Act (BPCIA), and did so in a manner that...more

7/23/2015 - Amgen Biosimilars BPCIA Drug Manufacturers Generic Drugs Patent Dispute Process Patent Infringement Patent Litigation Patents Pharmaceutical Manufacturers Prescription Drugs Sandoz Sandoz v Amgen

Stricter Standing for Inter Partes Review?

Neither the statutes nor the regulations governing Inter Partes Review (IPR) require the party challenging the patent to have been charged with infringement, or even to establish any interest in practicing the claimed subject...more

4/15/2015 - Fund Managers Inter Partes Review Proceedings Orange Book Patent Infringement Patents Pharmaceutical Manufacturers Pharmaceutical Patents Prescription Drugs Standing

Federal Circuit Finds Apotex ANDAs Do Not Infringe Lysteda Patents

In two decisions issued under the same name (Ferring B.V. v. Watson Laboratories, Inc.), the Federal Circuit upheld the validity of the Orange Book-listed patents for Lysteda®, but found that they were not infringed by either...more

9/3/2014 - ANDA Patent Infringement Patent Litigation Patents Pharmaceutical Pharmaceutical Patents Prescription Drugs

Federal Circuit Upholds Validity of Lysteda Patents

In two decisions issued under the same name (Ferring B.V. v. Watson Laboratories, Inc.), the Federal Circuit upheld the validity of the Orange Book-listed patents for Lysteda®, but found that they were not infringed by either...more

8/29/2014 - ANDA Patent Infringement Patent Litigation Patents Pharmaceutical Patents Prescription Drugs

Federal Circuit Finds That FDA Citizen Petition Could Give Rise to Antitrust Liability

In Tyco Healthcare Group LP v. Mutual Pharmaceutical Co., Inc., the Federal Circuit remanded-in-part for the district court to determine whether Tyco’s citizen petition to the FDA gave rise to antitrust liability. Judge...more

8/8/2014 - ANDA Antitrust Litigation FDA Pharmaceutical Prescription Drugs

Federal Circuit Looks for a Different Kind of Unexpected Results in BMS v. Teva

In Bristol-Myers Squibb Co. v. Teva Pharmaceuticals USA, Inc., the Federal Circuit affirmed the district court’s finding that BMS’s Baraclude® patent is invalid as obvious. In so doing, the court gave little weight to...more

7/3/2014 - ANDA Bristol-Myers Squibb Obviousness Patent Litigation Patents Pharmaceutical Pharmaceutical Patents Prescription Drugs Teva Pharmaceuticals

Federal Circuit Finds LUNESTA Patent Infringement Based on ANDA Product Description Not Avoided by Other Certifications

In Sunovion Pharmaceuticals, Inc. v. Teva Pharmaceuticals USA, Inc., the Federal Circuit reversed the district’s holding of no Lunesta® patent infringement that was based on a certification submitted to the court, and found...more

10/1/2013 - ANDA Claim Construction FDA Infringement Patents Pharmaceutical Prescription Drugs

Federal Circuit Finds Wyeth Restenosis Claims Invalid as Not Enabled

In Wyeth v. Abbott Laboratories, the Federal Circuit affirmed the district court’s decision that the claims at issue are invalid for failing to satisfy the enablement requirement of 35 USC § 112....more

7/2/2013 - Abbott Laboratories Enablement Inquiries Patents Pharmaceutical Prescription Drugs Validity Wyeth

Federal Circuit Invalidates Prandin Patent Claim as Obvious

In its third look at the Novo Nordisk A/S patent related to Prandin®, in Novo Nordisk A/S v. Caraco Pharmaceutical Laboratories Ltd., the Federal Circuit affirmed the district court’s finding that claim 4 of U.S. Patent No....more

6/27/2013 - ANDA Obviousness Patents Pharmaceutical Prescription Drugs USPTO

Supreme Court Applies Antitrust Scrutiny to ANDA Reverse Payment Settlement Agreements

In Federal Trade Commission v. Actavis, Inc., the Supreme Court held that reverse payment (“pay-for-delay”) settlement agreements made in the context of settling Hatch-Waxman ANDA litigation should be evaluated for antitrust...more

6/20/2013 - Actavis Inc. ANDA FTC FTC v Actavis Generic Drugs Hatch-Waxman Patents Pay-For-Delay Pharmaceutical Prescription Drugs Reverse Payment Settlement Agreements SCOTUS

Federal Circuit Holds That Third Party Clinical Trial May Not Constitute Public Use

In Dey, L.P. v. Sunovion Pharmaceuticals, Inc., the Federal Circuit vacated the district court’s grant of summary judgment in favor of Sunovion, and remanded for further consideration of whether Sunovion’s clinical trial...more

5/30/2013 - Clinical Trials Infringement Patents Pharmaceutical Prescription Drugs Public Use

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