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Green, Griffith & Borg-Breen LLP

1 National Ranking & 2 Metro Rankings | Website

Significant Matters

Pending Litigation

Adapt v. Teva; Adapt v. Perrigo (D.N.J.)

We serve as lead counsel for Opiant Pharmaceuticals, Inc., patent owner and licensor to Adapt Pharma, in Hatch-Waxman litigations against generic applicants Teva and Perrigo involving their Abbreviated New Drug Applications that seek approval to market generic equivalents to Adapt’s Narcan® nasal rescue product, which was developed by Opiant for emergency rescue of patients suffering from opioid overdose.

Nalox-1 v. Opiant (PTAB)

We serve as lead counsel for Opiant Pharmaceuticals, Inc. in defending multiple inter partes review proceedings filed by Nalox-1 against Opiant patents relating to Adapt’s Narcan® nasal rescue product.

Horizon Medicines LLC v. Alkem Laboratories Ltd. (D.Del.)

We serve as lead counsel in Hatch-Waxman ligitation against Alkem related to Alkem’s Abbreviated New Drug Application that seeks approval to market a generic equivalent of Horizon’s DUEXIS® Ibuprofen and Famotidine tablets.

Par Pharmaceutical, Inc, et al. v. QuVa Pharma, Inc., et al. (D.N.J.)

We serve as lead counsel for QuVa and certain individual defendants in an action for trade secret misappropriation and breach of contract brought by Par pursuant to the Defend Trade Secrets Act and state law with respect to various alleged trade secrets, including alleged trade secrets relating to vasopressin for injection.

Lipocine v. Clarus (D.Del.)

We serve as lead counsel for Clarus in declaratory judgment suit against alleged infringement of Lipocine’s patents by Clarus’s novel oral delivery testosterone undecanoate product. Lipocine has been unsuccessful in obtaining FDA approval to date.

Clarus Therapeutics, Inc. v. Lipocine Inc. (PTAB, Fed. Cir.)

We represent Clarus in Patent Interference with Lipocine involving Clarus’s U.S. Patent 8,828,428, which claims an oral form of testosterone undecanoate. An appeal is currently pending before the U.S. Court of Appeals for the Federal Circuit.

Boehringer Ingelheim Pharmaceuticals, Inc. v. Aurobindo et al. (D.N.J.)

We serve as lead counsel for Aurobindo in Boehringer Ingelheim’s appeal of the decisions of the U.S. District Court for the District of New Jersey holding two Boehringer Ingelheim Orange Book-listed patents invalid for obviousness-type double patenting and obviousness and holding another Boehringer Ingelheim Orange Book-listed patent invalid under 35 U.S.C. § 101. We were lead counsel for Aurobindo in the district court.

Horizon Pharma Ireland Limited, et al. v. Actavis Laboratories UT, Inc. (D.N.J.; CAFC)

As lead counsel, we successfully upheld the validity of Horizon Pharma’s Orange Book-listed patent for its PENNSAID® 2% topical diclofenac sodium product in Hatch Waxman litigation against generic applicant Actavis Labs-UT (now Teva). As a result, Teva is barred from launching a generic version of PENNSAID® 2% in the United States until October 2027. Actavis appealed the ruling to the Federal Circuit and the appeal is currently pending.

Horizon Therapeutics v. Iancu (PTAB, CAFC)

We serve as lead counsel in inter partes review proceeding defending one of Horizon Therapeutics’ patents relating to Horizon’s RAVICTI® product used for the treatment of Urea Cycle Disorders (UCDs) in patients two months of age and older.  The Federal Circuit appeal remains pending in this matter.

Concluded Litigation

Par v. Horizon (PTAB, CAFC)

As lead counsel, we successfully defended one of Horizon Therapeutics’ Orange Book-listed patents for its RAVICTI® oral liquid product in a PTAB IPR proceeding against Par, IPR2015-01117.  Par appealed PTAB’s decision to the Federal Circuit, where Bob Green presented oral arguments.  The Federal Circuit affirmed per curiam PTAB’s decision upholding the patentability of Horizon’s ’012 patent.

Horizon v. Par (E.D. Tex.; D. Del.)

We were lead counsel for Horizon in Hatch-Waxman litigations against generic applicant Par involving Horizon’s Orange Book-listed patents for its RAVICTI® oral liquid product for the treatment of Urea Cycle Disorders (UCD).  Subsequent to the Federal Circuit per curiam affirmation of PTAB’s decision upholding the patentability of Horizon’s ’012 patent, the litigation in E.D. Tex. was voluntarily dismissed.  Pursuant to a settlement agreement reached between the parties, a subsequently filed litigation in D. Del. was dismissed without prejudice.

Par v. Horizon Therapeutics (PTAB); Horizon Therapeutics v. Par (D.N.J.)

We represented Horizon in defending numerous PTAB IPR proceedings filed by Par against numerous Horizon patents, as well as in defending a D.N.J. litigation against Par, relating to Horizon’s RAVICTI® product used for the treatment of Urea Cycle Disorders (UCD) in patients two months of age and older. Pursuant to a settlement agreement reached between the parties, the D.N.J. litigation was dismissed without prejudice, and the IPRs were terminated.

Lupin v. Horizon Therapeutics (PTAB); Horizon Therapeutics v. Lupin (D.N.J.)

We represented Horizon in defending numerous PTAB IPR proceedings filed by Lupin against Horizon patents, as well as in defending several D.N.J. litigations against Lupin, relating to Horizon’s RAVICTI® product used for the treatment of Urea Cycle Disorders (UCD) in patients two months of age and older.  The litigations were settled, and pursuant to a settlement agreement reached between the parties, the IPRs were terminated.

Horizon Pharma Ireland Limited, et al. v. Lupin (D.N.J.)

We were lead counsel for Horizon in Hatch-Waxman litigation against generic applicant Lupin involving Horizon’s patents relating to its PENNSAID® topical diclofenac sodium product.  That litigation was successfully settled after we prevailed at trial against Actavis Laboratories UT, Inc.

Dexcel v. Takeda Pharmaceutical (D.N.J.)

As lead counsel, we successfully defended Dexcel against alleged infringement of Takeda’s Orange Book-listed patents for lansoprazole delayed-released orally disintegrating tablets (“ODT”).  As a result of this ruling, Dexcel launched the first lansoprazole ODT product sold Over-The-Counter (“OTC”) in the US market.

Dexcel Pharma Technologies, Ltd. v. Sun Pharma Global (D.N.J.);

Dexcel Pharma Technologies, Ltd. v. Dr. Reddy’s Laboratories, Ltd. (D.N.J.)

We served as co-lead counsel in Hatch Waxman litigation against generic applicants Sun and DRL involving Dexcel’s patents relating to its omeprazole DR tablet OTC product.  Those matters settled.

Horizon v. Amneal; Horizon v. Teligent (D.N.J.)

We were lead counsel for Horizon in Hatch-Waxman litigation against generic applicants Amneal and Teligent involving Horizon’s patents relating to its PENNSAID® topical diclofenac sodium product. Horizon successfully settled the actions. As a result of these settlements, Amneal and Teligent will not be able to enter the market until January 10, 2029, only 1 year prior to expiration of the last-expiring Orange Book-listed patent.

Abbvie v. Cipla (D.Del.)

We served as lead counsel in litigation relating to Cipla’s Abbreviated New Drug Application that was seeking approval to market a generic equivalent to Abbvie’s KALETRA® ritonavir/lopinavir product. That matter settled.  The terms of the agreement are confidential.

Helsinn v. Cipla (D.N.J.)

We served as lead counsel in litigation relating to Cipla’s Abbreviated New Drug Application that was seeking approval to market a generic equivalent to Helsinn’s ALOXI® palonsetron product. That matter settled.  Under the terms of the agreement, Cipla was permitted to launch an Authorized Generic of ALOXI® in March 2018.

Horizon v. Watson (D.N.J.)

We served as lead counsel for Horizon in litigation against Watson related to Watson’s Abbreviated New Drug Application that was seeking approval to market a generic equivalent to Horizon’s RAYOS® tablet product.  That litigation was successfully settled.  Under the terms of the agreement, Watson (now Actavis) may not launch its generic product until December 2022.