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Green, Griffith & Borg-Breen LLP

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Significant Matters

Pending Litigation

Lipocine Inc. v. Clarus Therapeutics, Inc. (D. Del.)

We serve as lead counsel in a declaratory judgment suit defending Clarus against alleged infringement of Lipocine’s patents related to Lipocine’s New Drug Application seeking to market an oral delivery testosterone undecanoate product.

Clarus Therapeutics, Inc. v. Lipocine Inc., Patent Interference No. 106,045 (PTAB, CAFC)

We represent Clarus in a pending appeal to the Federal Circuit of a PTAB judgment entered in a patent interference in favour of Lipocine involving Clarus’ U.S. Patent 8,828,428, which claims an oral formulation of testosterone undecanoate.

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 by Par against QuVa and those individual defendants with respect to alleged trade secrets, including alleged trade secrets relating to vasopressin for injection.

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

We serve as lead counsel in Hatch-Waxman litigation against generic applicant Alkem involving Horizon’s patents relating to its DUEXIS® oral famotidine and ibuprofen formulation.

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 related to their Abbreviated New Drug Applications that seek approval to market a generic equivalent to Adapt’s Narcan® (naloxone HCl) nasal rescue product, which was developed by Opiant for emergency rescue of patients suffering from opioid overdose.

Boehringer Ingelheim Pharmaceuticals, Inc. v. HEC Pharm Co., et al. (D.N.J., CAFC)

We serve as lead counsel for Aurobindo in Boehringer Ingelheim’s appeal of the district court decision in favour of Aurobindo in Hatch-Waxman litigation involving Boehringer Ingelheim’s Orange Book patents relating to linagliptin tablets (Tradjenta®). Boehringer Ingelheim asserted two of those patents against Aurobindo. We prevailed in dismissing one of the asserted patents via a motion for judgment on the pleadings in which we asserted the claims were invalid under Section 101. The second patent was held invalid for both obviousness-type double patenting and obviousness following a trial held in June 2018.  

Concluded Litigation

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). Teva appealed the ruling to the Federal Circuit, where Caryn Borg-Breen presented oral arguments. The Federal Circuit affirmed the district court’s decision, which found Horizon’s ’913 patent to be nonobvious. As a result, Teva is barred from launching a generic version of PENNSAID® 2% in the United States until the expiration of the ’913 patent in October 2027.

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.  Following the district court win against first-filer Actavis, the litigations with Lupin were settled favorably and dismissed with Lupin being prevented from market entry until October 2027.

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.);

Dexcel Pharma Technologies, Ltd. v. Apotex (D.N.J.)

We served as co-lead counsel in Hatch Waxman litigation against generic applicants Sun, DRL and Apotex 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.

 

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