Free Consultation 215.567.2010

Recent Events in Pharmaceutical Litigation – March 19, 2019 – March 22, 2019

Posted on Apr 5, 2019 in News

New ANDA Cases Filed

Pomalyst® (pomalidomide capsules) – NDA No. 204026

Celgene Corporation v. Teva Pharmaceuticals USA, Inc. and Teva Pharmaceutical Industries Limited, U.S.D.C. D.N.J., Case No. 2:19-cv-08758.  Celegen, in a thrid complaint filed on March 19, 2019, seeks to block approval of Teva’s ANDA products (1, 2, 3 and 4mg pomalidomide capsules) prior to the expiration of U.S. Patent No. 10,093,647; 10,093,648 and 10,093,649 – Orange Book listed patents for Pomalyst®, which is indicated for treatment of multiple myeloma in patients who have received at least two prior therapies including lenalidomide and a proteasome inhibitor and who have demonstrated disease progression on or within 60 days of completion of the last therapy.  Celgene, in Celgene Corporation v. Par Pharmaceutical, Inc., Par Pharmaceutical Companies, Inc., Teva Pharmaceuticals USA, Inc. and Teva Pharmaceutical Industries Limited, U.S.D.C. D.N.J., Case No. 2:17-cv-03159-ES-JAD, previously asserted U.S. Patent Nos. 8,198,262; 8,673,939; 8,735,428 and 8,828,427 against Teva.  Celgene, also asserted another Orange Book listed patent, U.S. Patent No. 9,993,467, against Teva in Celgene Corporation v. Teva Pharmaceuticals USA, Inc. and Teva Pharmaceutical Industries Limited, U.S.D.C. D.N.J., Case No. 2:18-cv-14366.

Doryx® MPC (doxycycline hyclate delayed-release tablets) – NDA No. 050795

Mayne Pharma International Pty Ltd. v. Prinston Pharmaceutical Inc., Zhejiang Huahai Pharmaceutical Co., Ltd. and Solco Healthcare U.S., LLC, U.S.D.C. D. Del., Case No. 1:19-cv-00549.  Mayne, in a complaint filed on March 21, 2019, seeks to block approval of Prinston’s ANDA products (120 mg doxycycline hyclate delayed-release tablets) prior to the expiration of U.S. Patent Nos. 9,295,652 and 9,511,031 – Orange Book listed patents for Doryx® MPC, which is indicated for the treatment of various infections including rickettsial infections, sexually transmitted infections, respiratory tract infections, specific bacterial infections, ophthalmic infections, anthrax, and including inhalation anthrax, as well as, an alternative treatment for selected infections when penicillin is contraindicated, as an adjunct therapy in acute intestinal amebiasis and severe acne and as a prophylaxis of malaria.

Pradaxa® (dabigatran etexilate mesylate capsules) – NDA No. 022512

Boehringer Ingelheim Pharma GmbH & Co. KG, Boehringer Ingelheim International GmbH and Boehringer Ingelheim Pharmaceuticals, Inc. v. Aurobindo Pharma Limited and Aurobindo Pharma USA, Inc., U.S.D.C. D.N.J., Case No. 3:19-cv-08840.  Boehringer, in a complaint filed on March 22, 2019, seeks to block approval of Aurobino’s ANDA Product (75 and 150 mg dabigatran etexilate mesylaete capsules) prior to expiration of U.S. Patent No. 6,087,380 – an Orange Book listed patent for Pradaxa®, which is indicated to reduce the risk of stroke and systemic embolism in patients with non-valvular atrial fibrillation; for the treatment of deep venous thrombosis (DVT) and pulmonary embolism (PE) in patients who have been treated with a parenteral anticoagulant for 5-10 days; to reduce the risk of recurrence of DVT and PE in patient who have been previously treated and for the prophylaxis of DVT and PE inpatients who have undergone hip replacement surgery.

Suboxone® (buprenorphine hydrochloride and naloxone hydrochloride) sublingual film – NDA No. 022410

Individor Inc., Indivior UK Limited, and Aquestive Therapeutics, Inc. v. Aveva Drug Delivery Systems, Inc., Apotex Corp. and Apotex Inc., U.S.D.C. S.D. Fla., Case No. 0:19-cv-60757.  Individor, in a complaint filed on March 22, 2019, seeks to block approval of Avena’s/Apotex’s ANDA Product (buprenorphine hydrochloride and naloxone hydrochloride sublingual film) prior to the expiration of U.S. Patent Nos. 8,017,150; 8,603,514; 9,687,454 and 9,931,305 – Orange Book listed patents for Suboxone® sublingual film, which is indicated for the treatment of opioid dependence.

Hetlioz® (tasimelteon oral capsules) – NDA No. 205677

Vanda Pharmaceuticals Inc. v. Teva Pharmaceuticals USA, Inc., U.S.D.C. D. Del., Case No. 1:19-cv-00560.  Vanda, in a complaint filed on March 22, 2019, seeks to block approval of Teva’s ANDA Product (20 mg tasimelteon capsules) prior to expiration of U.S. Patent No. 10,149,829 – an Orange Book listed patent for Hetlioz®, which is indicated for the treatment of non-24-hour sleep-wake disorder.

Declaratory Judgment Cases

Ofirmev® (acetaminophen) injectable – NDA No. 022450

Mallinckrodt Hospital Products IP Limited, Mallinckrodt Hospital Products Inc., and New Pharmatop L.P., v. Altan Pharma Ltd., U.S.D.C. D. Del., Case No. 1:19-cv-00552.  Mallinckrodt, in a complaint filed on March 22, 2019, seeks to block approval of the products that are the subject of Altan’s NDA No. 209841 (10 mg/mL acetaminophen solution) prior to expiration of U.S. Patent Nos. 9,399,012; 9,610,265; 9,987,238 and 6,992,218 – Orange Book listed patents for Ofirmev®, which is indicated for management of mild to moderate pain in adults and pediatric patients 2 years and older; for management of moderate to severe pain with adjunctive opioid analgesics in adults and pediatric patients 2 years and older and for the reduction of fever in adult and pediatric patients.

Anti-Trust Cases

Humira (adalimumab) – BLA No. 125057

Fraternal Order of Police, Miami Lodge 20, Insurance Trust Fund v. AbbVie Inc., AbbVie Biotechnology Ltd, and Amgen Inc., U.S.D.C. N.D. Ill., Case No. 1:19-cv-01933.  Fraternal Order of Police, in a class action complaint filed on March 20, 2019, seeks damages for violations of the Sherman Act and state law anti-trust and unfair trade practice violations arising from the AbbVie’s alleged creation of a patent thicket to prohibit approval of biosimilars for Humira®, as well as, AbbVie’s alleged entry into pay-for-delay agreements with multiple biosimilar applicants.

Mayor and City Council of Baltimore v. AbbVie Inc., AbbVie Biotechnology Ltd, and Amgen Inc., U.S.D.C. N.D. Ill., Case No. 1:19-cv-02015.  Baltimore, in a class action complaint filed on March 22, 2019, seeks damages for violations of the Sherman Act and state law anti-trust and unfair trade practice violations arising from the AbbVie’s alleged creation of a patent thicket to prohibit approval of biosimilars for Humira®, as well as, AbbVie’s alleged entry into pay-for-delay agreements with multiple biosimilar applicants.

By Lynn M. Terrebonne

Philadelphia

1635 Market Street, 12th Floor
Philadelphia, Pennsylvania 19103-2212

215-567-2010 | 215-751-1142

View Map

Delaware

King Street Plaza - Suite 304. 800 N. King Street
Wilmington, Delaware 19801

302-544-9100 | 302-544-9103

View Map

Lehigh Valley

2030 Tilghman Street, Suite 201A
Allentown, Pennsylvania 18104-4399

610-255-7551 | 610-255-7542

View Map