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Recent Events in Pharmaceutical Litigation

Posted on Jan 21, 2019 in News

New ANDA Cases Filed

January 14, 2019

Genentech, Inc. and Intermune, Inc. v. Laurus Labs Ltd. and Laurus Generics Inc., U.S.D.C. Del., Case No. 1:19-cv-00078.  Genentech and Intermune seek to block approval of Laurus’ ANDA products prior to the expiration of U.S. Patent Nos. 7,816,383; 7,910,610; 8,013,002; 8,084,475; 8,318,780; 8,383,150; 8,420,674; 8,592,462; 8,609,701; 8,648,098; 8,754,109; 8,778,947; 7,696,236; 7,767,225; 7,988,994; and 8,753,679 Orange Book listed patents for Esbriet® (pirfenidone capsules) which is indicated for the treatment for idiopathic pulmonary fibrosis (IPF).

Gilead Sciences, Inc. and Emory University v. Zydus Pharmaceuticals (USA) Inc. and Cadila Healthcare Ltd. (d/b/a Zydus Cadila, U.S.D.C. N.J., Case No. 3:19-cv-00529.  Gilead and Emory University seek to block approval of Zydus’ ANDA products prior to the expiration of U.S. Patent Nos. 6,642,245; 6,703,396; 6,703,396; 8,592,397; 8,716,264; 9,457,036; and 9,744,181 Orange Book listed patents for Truvada® (emtricitabine/tenofovir disoproxil fumarate) which is indicated for the treatment for HIV-1 infections.

January 11, 2019

Onyx Therapeutics, Inc. v. Breckenridge Pharmaceutical, Inc., U.S.D.C. Del., Case No. 1:19-cv-0071.  Onyx Therapeutics filed this third suit seeking to block approval of Breckenridge Pharmaceutical’s  10 mg ANDA Product prior to the expiration of U.S. Patent Nos. 7,417,042; 7,737,112 and 8,207,125 Orange Book listed patents for Kyprolis® (carfilzomib) which is indicated for the treatment of multiple myeloma.

January 9, 2019

Sun Pharmaceutical Industries Limited v. Novartis Pharmaceuticals Corp and Novartis AG, U.S.D.C N.J. Case No. 2-19-cv-00276.  Sun Pharmaceutical Industries seeks a declaratory judgment of invalidity, unenforceability and/or non-infringement of U.S. Patent No. 9,283,209 an Orange Book listed patent for Novartis’ Jadenu® (deferasirox tablets) which are indicated for the treatment of chronic iron overloads due to blood transfusions.

Bristol-Myers Squibb Company v. Unichem Laboratories, Ltd., U.S.D.C. for the District of Delaware Case No. 1:19-cv-00055.  Bristol-Myers Squibb seeks to block approval of Unichem’s ANDA products until expiration of U.S. Patent No. 6,967,208 an Orange Book listed patent for the anticoagulant Eliquis® (apixaban).

Arbor Pharmaceuticals, LLC v. Teva Pharmaceuticals USA, Inc. and Teva Pharmaceutical Industries, Ltd., U.S.D.C. Del., Case No. 1:19-cv-00053.  Arbor seeks to block approval of Teva’s ANDA products prior to expiration of U.S. Patent Nos. 8,791,153 and 8,927,595 Orange Book listed patents for Sklice® (invermetin lotion) which is indicated for the topical treatment of head lice infestations.

January 4, 2019

Celgene Corporation v. Aurobindo Pharma Limited et al., U.S.D.C. Del. Case No. 2:19-cv-00143.  Celgene seeks to block approval of Aurobindo’s ANDA products until the expiration of U.S. Patent No. 9,993,467 an Orange Book listed patent for Pomalyst® (pomalidomid) which is indicated for the treatment for myltiple myeloma.

Valeant Pharmaceuticals North America LLC, Valeant Pharmaceuticals Ireland Ltd., Dow Pharmaceutical Sciences, Inc. and Kaken Pharmaceutical Co., Ltd. v. Strides Pharma Inc. and Strides Pharma Global PTE Ltd., U.S.D.C. Del. Case No. 3:19-cv-00133.  Valeant seeks to block approval of Strides’ ANDA products until expiration of U.S. Patent No. 10,105,444 an Orange Book listed patent for Jublia® (efinaconazole topical solution) which is indicated for the treatment of onychomycosis of the toe nail.

Pharmacyclics LLC and Janssen Biotech, Inc. v. Hetero USA Inc., et al., U.S.D.C. Del. Case No. 1:19-cv-00014.  Pharmacyclics and Janssen Biotech filed this second suit seeking to block Hetero’s ANDA products until expiration of U.S. Patent 10,106,548 an Orange Book listed patent for Imbruvica® (ibrutinib) a Bruton’s tyrosine kinase inhibitor indicated for the treatment of mantle cell lymphoma (MCL) and chronic lymphocytic leukemia (CLL).

Recent Case Law

Standing to Appeal from a PTAB Decision – Has the Federal Circuit Sanctioned a New Strategy for Invalidating Orange Book Listed Patents Outside of the Hatch-Waxman Act.

Amerigen Pharms. Ltd. v. UCB Pharma GmbH, No. 2017-2596, 2019 U.S. App. LEXIS 997 (Fed/ Cir. Jan. 11, 2019).  The case arose from an appeal of a Patent Trial and Appeals Board (PTAB) decision in Inter Partes Review (IPR) No. 2016-00510 confirming the validity of U.S. Patent No. 6,858,650 (the ’650 patent) an Orange Book listed patent for Toviaz® (fesoterodine fumarate), an antimuscarinic drug which is indicated for use in the treatment of urinary incontinence.  Id. at *2.

The Federal Circuit, in an opinion authored by Circuit Judge Lourie, rejected U.C.B’s argument that Amerigen, which had filed a Paragraph III Certification, see 21 U.S.C. §§ 355(j)(2)(vii)(III) (2012), as to the ’650 patent, lacked standing to appeal the PTAB decision because there could be no injury in fact absent a Paragraph IV Certification under the Hatch-Waxman Act, 21 U.S.C. §§ 355,360 (2012), the fundamental jurisdictional basis for litigating Orange Book listed patents. Id. at. *6.  Rather, the Court held that causes of action under the Hatch-Waxman Act do not necessarily control the issue of standing in an appeal from an IPR decision, and more particularly did not control in this case in which the “mere listing of the ‘650 patent in the Orange Book inflicts a concrete commercial injury redressable by this court.” Id. at *6.  The Federal Circuit reasoned that Amerigen had “demonstrated an injury consistent with the generally applicable requirements of Article III, i.e., a controversy ‘of sufficient immediacy and reality’ to warrant the requested judicial relief.”  id. at *7, citing MedImmune, Inc. v. Genentech, Inc., 549 U.S. 118,127 (2007), because the listing of the ’650 patent in the Orange Book effectively blocked the entry of Amerigen’s tentatively approved ANDA products during the approximately three (3) year period between the May 2019 expiration of the Orange Book listed patents that were not at issue during the IPR, and the July 2022 expiration of  the ’650 patent.  Id. at *6.  Amerigen, therefore, has “a concrete economic interest in the sales of its tentatively approved drug that were obstructed by the listing of the ’650 patent” and had thus “demonstrated a controversy of sufficient immediacy and reality” to establish Article III standing.”  Id.  As such, the Federal Circuit held that [b]ecause Amerigen has demonstrated such a controversy traceable to UBC’s ’650 patent and redressable by this court, it has standing to appeal from the [PTAB’s] decision even though it may be incapable (as a Paragraph III filer) of maintaining a parallel Hatch Waxman suit.  Id. at 7.

by Lynn M. Terrebonne

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