Courtenay C. Brinckerhoff

Courtenay C. Brinckerhoff

Foley & Lardner LLP

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Patent Safe Harbor Applies to Supplemental New Drug Applications

On May 13, 2015, the Federal Circuit confirmed in Classen Immunotherapies, Inc. v. Elan Pharmaceuticals, Inc. that the safe harbor provisions of 35 U.S.C. § 271(e)(1) can shield post-FDA approval activities from liability for...more

5/22/2015 - Classen Immunotherapies Elan Pharmaceuticals FDA Patent Litigation Patents Pharmaceutical Manufacturers Pharmaceutical Patents Safe Harbors

Amicus Briefs on Biosimilar Patent Litigation

Amgen has appealed the district court decision denying its motion for a preliminary injunction to keep Sandoz’ biosimilar version of Neupogen® off the market. The appeal is on an expedited briefing schedule at the Federal...more

4/25/2015 - AbbVie Amicus Briefs Biosimilars Biotechnology BPCIA FDA Patent Litigation Pharmaceutical Patents Sandoz v Amgen

Judge Finds Biosimilar Patent Procedures Optional

Judge Seeborg of the U.S. District Court for the Northern District of California issued an order in Amgen, Inc. v. Sandoz, Inc., ruling that the patent dispute resolution procedures of the Biologics Price Competition and...more

3/24/2015 - Biosimilars BPCIA FDA Patent Infringement Patent Litigation Patents Pharmaceutical Pharmaceutical Patents Sandoz v Amgen

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 Find Fractures in Roche Boniva Patents

In Hoffman-LaRoche, Inc. v. Apotex, Inc., the Federal Circuit affirmed the district court’s summary judgment that two Roche Boniva patents are invalid as obvious. The conclusion of obviousness is not particularly remarkable...more

4/15/2014 - FDA Generic Drugs Hoffman LaRoche Patent Litigation Patents Pharmaceutical Prior Art Summary Judgment

Federal Circuit Finds Easy Solution to Avodart Solvate Written Description Question

Are claims that recite a “solvate” of a chemical compound invalid for lack of written description if the patent does not describe any specific solvates? In GlaxoSmithKline LLC v. Banner Pharmacaps, Inc., the Federal Circuit...more

3/13/2014 - Chemicals Claim Construction FDA GlaxoSmithKline Patent Litigation Patents Pharmaceutical Written Descriptions

FDA to Give 5 Year NCE Exclusivity to Combinations

In a Federal Register Notice dated February 24, 2014, the U.S. FDA announced a draft guidance for industry that will provide a 5 year NCE exclusivity period to fixed-combination drug products that include at least one new...more

2/26/2014 - Combination Products Exclusive Use FDA

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

Supreme Court to Hear AndroGel Reverse Payment Case

The Supreme Court granted certiorari in Federal Trade Commission v. Watson Pharmaceuticals, Inc., to address whether and when “reverse payment” agreements made to settle ANDA litigation violate antitrust laws....more

1/10/2013 - ANDA FDA FTC Generic Drugs Patents Pharmaceutical Reverse Payment Settlement Agreements SCOTUS Watson Pharmaceuticals

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