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Recent Events in Pharmaceutical Litigation – February 12-15, 2019

Posted on Feb 22, 2019 in News

New ANDA Cases Filed

Esbriet® (pirfenidone tablets) – NDA No. 208780

Genentech, Inc. and Intermune, Inc. v. Torrent Pharmaceuticals Ltd. and Torrent Pharma Inc., U.S.D.C. D. Del., Case No. 1:19-cv-00324.  Genentech and Intermune, in a complaint filed on February 14, 2019, seek to block approval of Torrent’s ANDA products (267 and 801 mg pirfenidone tablets) prior to the expiration of U.S. Patent Nos. 8,383,150  and 8,778,947 – Orange Book listed patents for Esbriet® tablets, which are indicated for the treatment for idiopathic pulmonary fibrosis (IPF).

Tecfidera® (dimethyl fumarate delayed-release capsules) – NDA No. 204063

Biogen International GmbH v. Accord Healthcare Inc., U.S.D.C. D. Del., Case No. 1:19-cv-00303.  Biogen, in a third complaint filed on February 12, 2019, seeks to block approval of Accord’s ANDA products (120 and 240 mg dimethyl fumarate delayed-release capsules) prior to the expiration of U.S. Patent No. 7,619,001 – one of five Orange Book listed patents for Tecfidera® capsules, which are indicated for the treatment of patients with relapsing forms of multiple sclerosis.  Biogen, in Biogen International GmbH et al. v. Accord Healthcare Inc., U.S.D.C. Del., Case No. 1:17-cv-00872-LPS and Biogen International GmbH et al. v. Accord Healthcare Inc., U.S.D.C. M.D.N.C., Case No. 1:17-cv-00612-WO-LPA, previously asserted three of the other Orange Book listed patents against Hetero, i.e., U.S. Patent Nos. 6,509,376; 7,320,999 and 8,399,514 against Accord.

Biogen International GmbH v. Zydus Pharmaceuticals (USA) Inc., U.S.D.C. D.N.J., Case No. 3:19-cv-05987.  Biogen, in a fourth complaint filed on February 15, 2019, seeks to block approval of Zydus’ ANDA products (120 and 240 mg dimethyl fumarate delayed-release capsules) prior to the expiration of U.S. Patent No. 7,619,001 – one of five Orange Book listed patents for Tecfidera® capsules, which are indicated for the treatment of patients with relapsing forms of multiple sclerosis.  Biogen, in Biogen International GmbH et al. v. Zydus Pharmaceuticals (USA) Inc., U.S.D.C. D.N.J.., Case No. 3:17-cv-4857-BRM-LHG and Biogen International GmbH et al. v.Zydus Pharmaceuticals (USA) Inc., U.S.D.C. D. Del, Case No. 1:17-cv-00954-LPS, previously asserted two of the other Orange Book listed patents against Hetero, i.e., U.S. Patent Nos. 7,320,999 and 8,399,514 against Accord.  Biogen, in Biogen International GmbH et al. v. Zydus Pharmaceuticals (USA) Inc., U.S.D.C. D.N.J., Case No. 3:18-cv-08323-BRM-LHG, and Biogen International GmbH et al. v. Zydus Pharmaceuticals (USA) Inc., U.S.D.C. D. Del., Case No. 1:18-cv-00623-LPS, also asserted another Orange Book listed patent, U.S. Patent No. 6,509,376 against Zydus.

Astepro® (azelastine hydrochloride nasal spray) – NDA No. 022203

Meda Pharmaceuticals Inc. v. Aurobindo Pharma Limited and Aurobindo Pharma USA., Inc., U.S.D.C. D.N.J., Case No. 3:19-cv-05501.  Meda, in a complaint, filed on February 12, 2019, seeks to block approval of Aurobindo’s ANDA products (azelastine hydrochloride nasal spray – 15% EQ 0.1876 mg base/spray) prior to the expiration of U.S. Patent Nos. 8,071,073; 8,518,919 and 9,919,050 – Orange Book listed patents for Astepro®, which is indicated for relief of the symptoms of seasonal allergic rhinitis in patients 2 years of age and older and perennial allergic rhinitis in patients 6 month of age and older.

Pomalyst® (pomalidomide capsules) – NDA No. 204026

Celgene Corporation v. Hetero Labs Limited, Hetero Labs Limited Unit-V, Hetero Drugs Limited, and Hetero USA, Inc., U.S.D.C. D.N.J., Case No. 2:19-cv-05797.  Celegen, in a third complaint filed on February 14, 2019, seeks to block approval of Hetero’s ANDA products (1, 2, 3 and 4mg pomalidomide capsules) prior to the expiration of U.S. Patent No. 10,093,647 – 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 bortezomib and who have demonstrated disease progression on or within 60 days of completion of the last therapy.  Celgene, in Celgene Corporation v. Hetero Labs Limited et al., U.S.D.C. D.N.J., Case No. 2:17-cv-03387-ES-JAD, previously asserted U.S. Patent Nos. 8,198,262; 8,673,939; 8,735,428 and 8,828,427 against Hetero.  Celgene, also asserted another Orange Book listed patent, U.S. Patent No. 9,993,467, against Hetero in Celgene Corporation v. Hetero Labs Limited et al., U.S.D.C. D.N.J., Case No. 2:18-cv-14111.

Celgene Corporation v. Aurobindo Pharma Limited, Aurobindo Pharma USA, Inc., Aurolife Pharma LLC and Eugia Pharma Specialties Limited, U.S.D.C. D.N.J., Case No. 2:19-cv-05799.  Celegen, in a third complaint filed on February 14, 2019, seeks to block approval of Aurobindo’s ANDA products (1, 2, 3 and 4mg pomalidomide capsules) prior to the expiration of U.S. Patent No. 10,093,647 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 bortezomib and who have demonstrated disease progression on or within 60 days of completion of the last therapy.  Celgene, in Celgene Corporation v. Hetero Labs Limited et al., U.S.D.C. D.N.J., Case No. 2:17-cv-03387-ES-JAD, previously asserted U.S. Patent Nos. 8,198,262; 8,673,939; 8,735,428 and 8,828,427 against Aurobindo.  Celgene, also asserted another Orange Book listed patent, U.S. Patent No. 9,993,467, against Aurobindo in Celgene Corporation v. Aurobindo Pharma Limited et al., U.S.D.C. D.N.J., Case No. 2:19-cv-00143.

Celgene Corporation v. Mylan Pharmaceuticals Inc., Mylan Inc., and Mylan N.V., U.S.D.C. D.N.J., Case No. 2:19-cv-05802.  Celegen, in a third complaint filed on February 14, 2019, seeks to block approval of Mylan’s ANDA products (1, 2, 3 and 4mg pomalidomide capsules) prior to the expiration of U.S. Patent No. 10,093,647 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 bortezomib and who have demonstrated disease progression on or within 60 days of completion of the last therapy.  Celgene, in Celgene Corporation v. Hetero Labs Limited et al., U.S.D.C. D.N.J., Case No. 2:17-cv-03387-ES-JAD, previously asserted U.S. Patent Nos. 8,198,262; 8,673,939; 8,735,428 and 8,828,427 against Mylan.  Celgene, also asserted another Orange Book listed patent, U.S. Patent No. 9,993,467, against Mylan in Celgene Corporation v. Mylan Pharmaceuticals Inc. et al., U.S.D.C. D.N.J., Case No. 2:18-cv-16035.

Celgene Corporation v. Breckenridge Pharmaceutical, Inc. and Natco Pharma Limited, U.S.D.C. D.N.J., Case No. 2:19-cv-05804.  Celegen, in a third complaint filed on February 14, 2019, seeks to block approval of Breckenridge’s ANDA products (1, 2, 3 and 4mg pomalidomide capsules) prior to the expiration of U.S. Patent No. 10,093,647 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 bortezomib and who have demonstrated disease progression on or within 60 days of completion of the last therapy.  Celgene, in Celgene Corporation v. Hetero Labs Limited et al., U.S.D.C. D.N.J., Case No. 2:17-cv-03387-ES-JAD, previously asserted U.S. Patent Nos. 8,198,262; 8,673,939; 8,735,428 and 8,828,427 against Breckenridge.  Celgene, also asserted another Orange Book listed patent, U.S. Patent No. 9,993,467, against Breckinridge in Celgene Corporation v. Breckenridge Pharmaceutical Inc. et al., U.S.D.C. D.N.J., Case No. 2:19-cv-05804.

Celgene Corporation v. Apotex Inc., U.S.D.C. D.N.J., Case No. 2:19-cv-05804.  Celegen, in a third complaint filed on February 14, 2019, seeks to block approval of Apotex’s ANDA products (1, 2, 3 and 4mg pomalidomide capsules) prior to the expiration of U.S. Patent No. 10,093,647 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 bortezomib and who have demonstrated disease progression on or within 60 days of completion of the last therapy.  Celgene, in Celgene Corporation v. Hetero Labs Limited et al., U.S.D.C. D.N.J., Case No. 2:17-cv-03387-ES-JAD, previously asserted U.S. Patent Nos. 8,198,262; 8,673,939; 8,735,428 and 8,828,427 against Apotex.  Celgene, also asserted another Orange Book listed patent, U.S. Patent No. 9,993,467, against Apotex in Celgene Corporation v. Apotex, Inc., U.S.D.C. D.N.J., Case No. 2:18-cv-16395.

Janumet® XR (sitagliptin phosphate, metformin hydrochloride extended release tablets) – NDA No. 202270

Januvia® (sitagliptin phosphate) – NDA No. 21995

Janumet® (sitagliptin phosphate, metformin hydrochloride) – NDA No. 22044

Juvisync® (sitagliptin phosphate, simvastatin) – NDA No. 202343

Merck Sharp & Dohme Corp. v. Alvogen Pine Brook LLC f/k/a Alvogen Pine Brook, Inc., Alvogen Malta Operations Ltd., Alvogen Lux Holdings S.à.r.l., U.S.D.C. D. Del., Case No. 1:19-cv-00310.  Merck, in a complaint filed on January 13, 2019, seeks to block approval of Alvogen’s ANDA Products (sitagliptin phosphate, metformin hydrochloride extended release tablets) prior to the expiration of U.S. Patent No. 7,326,708 – an Orange Book listed patent for Janumet® XR, which is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus when treatment with both sitagliptin and metformin extended release is appropriate.

Merck Sharp & Dohme Corp. v. Anchen Pharmaeuticals, Inc. and Par Pharmaceutical, Inc., U.S.D.C. D. Del., Case No. 1:19-cv-00311.  Merck, in a complaint filed on January 13, 2019, seeks to block approval of Anchen/Par’s ANDA Products (sitagliptin phosphate, metformin hydrochloride extended release tablets) prior to the expiration of U.S. Patent No. 7,326,708 – an Orange Book listed patent for Janumet® XR, which is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus when treatment with both sitagliptin and metformin extended release is appropriate.

Merck Sharp & Dohme Corp. v. Sandoz Inc., U.S.D.C. D. Del., Case No. 1:19-cv-00312.  Merck, in a complaint filed on January 13, 2019, seeks to block approval of Sandoz’s ANDA Products (sitagliptin phosphate and sitagliptin phosphate in combination with metformin hydrochloride) prior to the expiration of U.S. Patent No. 7,326,708 – an Orange Book listed patent for Januvia®, which is indicated as an adjunct to diet and exercise to improve glycemic control in patients with type 2 diabetes mellitus in mono- and combination therapy, and Janumet®, which is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus who are not adequately controlled on metformin or sitagliptin alone or in patients already being treated with combinations of sitagliptin and metformin.

Merck Sharp & Dohme Corp. v. Apotex Inc. and Apotex Corp., U.S.D.C. D. Del., Case No. 1:19-cv-00313.  Merck, in a complaint filed on January 13, 2019, seeks to block approval of Apotex’s ANDA Products (sitagliptin phosphate; sitagliptin phosphate in combination with metformin hydrochloride and sitagliptin phosphate, metformin hydrochloride extended release tablets) prior to the expiration of U.S. Patent No. 7,326,708 – an Orange Book listed patent for Januvia®, which is indicated as an adjunct to diet and exercise to improve glycemic control in patients with type 2 diabetes mellitus in mono- and combination therapy, Janumet®, which is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus who are not adequately controlled on metformin or sitagliptin alone or in patients already being treated with combinations of sitagliptin and metformin, and Janumet® XR, which is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus when treatment with both sitagliptin and metformin extended release is appropriate.

Merck Sharp & Dohme Corp. v. Zydus Pharmaceuticals (USA) Inc. and Cadila Healthcare Ltd., U.S.D.C. D. Del., Case No. 1:19-cv-00314.  Merck, in a complaint filed on January 13, 2019, seeks to block approval of Zydus’ ANDA Products (sitagliptin phosphate; sitagliptin phosphate in combination with metformin hydrochloride and sitagliptin phosphate, metformin hydrochloride extended release tablets) prior to the expiration of U.S. Patent No. 7,326,708 – an Orange Book listed patent for Januvia®, which is indicated as an adjunct to diet and exercise to improve glycemic control in patients with type 2 diabetes mellitus in mono- and combination therapy, Janumet®, which is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus who are not adequately controlled on metformin or sitagliptin alone or in patients already being treated with combinations of sitagliptin and metformin, and Janumet® XR, which is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus when treatment with both sitagliptin and metformin extended release is appropriate.

Merck Sharp & Dohme Corp. v. Mylan Pharmaceuticals Inc. and Mylan Inc., U.S.D.C. D. Del., Case No. 1:19-cv-00315.  Merck, in a complaint filed on January 13, 2019, seeks to block approval of Mylan’s ANDA Products (sitagliptin phosphate and sitagliptin phosphate in combination with metformin hydrochloride) prior to the expiration of U.S. Patent No. 7,326,708 – an Orange Book listed patent for Januvia®, which is indicated as an adjunct to diet and exercise to improve glycemic control in patients with type 2 diabetes mellitus in mono- and combination therapy, and Janumet®, which is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus who are not adequately controlled on metformin or sitagliptin alone or in patients already being treated with combinations of sitagliptin and metformin; and U.S. Patent No. 8,414,921 – an Orange Book listed patent for Janumet®.

Merck Sharp & Dohme Corp. v. Macleods Pharmaceuticals Limited and Macleods Pharma USA, Inc., U.S.D.C. D. Del., Case No. 1:19-cv-00316.  Merck, in a complaint filed on January 13, 2019, seeks to block approval of Macleod’s ANDA Products (sitagliptin phosphate and sitagliptin phosphate in combination with metformin hydrochloride) prior to the expiration of U.S. Patent No. 7,326,708 – an Orange Book listed patent for Januvia®, which is indicated as an adjunct to diet and exercise to improve glycemic control in patients with type 2 diabetes mellitus in mono- and combination therapy, and Janumet®, which is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus who are not adequately controlled on metformin or sitagliptin alone or in patients already being treated with combinations of sitagliptin and metformin.

Merck Sharp & Dohme Corp. v. Watson Laboratories, Inc., Teva Pharmaceuticals USA, Inc. and Teva Pharmaceutical Industries Ltd., U.S.D.C. D. Del., Case No. 1:19-cv-00317.  Merck, in a complaint filed on January 13, 2019, seeks to block approval of Watson’s ANDA Products (sitagliptin phosphate and sitagliptin phosphate in combination with metformin hydrochloride) prior to the expiration of U.S. Patent No. 7,326,708 – an Orange Book listed patent for Januvia®, which is indicated as an adjunct to diet and exercise to improve glycemic control in patients with type 2 diabetes mellitus in mono- and combination therapy, and Janumet®, which is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus who are not adequately controlled on metformin or sitagliptin alone or in patients already being treated with combinations of sitagliptin and metformin; and U.S. Patent No. 8,414,921 – an Orange Book listed patent for Janumet®.

Merck Sharp & Dohme Corp. v. Teva Pharmaceuticals USA, Inc. and Teva Pharmaceutical Industries Ltd, U.S.D.C. D. Del., Case No. 1:19-cv-00318.  Merck, in a complaint filed on January 13, 2019, seeks to block approval of Teva’s ANDA Products (sitagliptin phosphate; sitagliptin phosphate in combination with metformin hydrochloride; sitagliptin in combination with simvastatin; and sitagliptin phosphate, metformin hydrochloride extended release tablets) prior to the expiration of U.S. Patent No. 7,326,708 – an Orange Book listed patent for Januvia®, which is indicated as an adjunct to diet and exercise to improve glycemic control in patients with type 2 diabetes mellitus in mono- and combination therapy, Janumet®, which is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus who are not adequately controlled on metformin or sitagliptin alone or in patients already being treated with combinations of sitagliptin and metformin, Juvisync®, which is indicated for use in patients for whom treatment with both sitagliptin and simvastatin is appropriate, and Janumet® XR, which is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus when treatment with both sitagliptin and metformin extended release is appropriate.

Merck Sharp & Dohme Corp. v. Sun Pharma Global FZE and Sun Pharmaceutical Industries Ltd., U.S.D.C. D. Del., Case No. 1:19-cv-00319.  Merck, in a complaint filed on January 13, 2019, seeks to block approval of Sun’s ANDA Products (sitagliptin phosphate; sitagliptin phosphate in combination with metformin hydrochloride and sitagliptin phosphate, metformin hydrochloride extended release tablets) prior to the expiration of U.S. Patent No. 7,326,708 – an Orange Book listed patent for Januvia®, which is indicated as an adjunct to diet and exercise to improve glycemic control in patients with type 2 diabetes mellitus in mono- and combination therapy, Janumet®, which is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus who are not adequately controlled on metformin or sitagliptin alone or in patients already being treated with combinations of sitagliptin and metformin, and Janumet® XR, which is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus when treatment with both sitagliptin and metformin extended release is appropriate; and U.S. Patent No. 8,414,921 – an Orange Book listed patent for Janument®.

Merck Sharp & Dohme Corp. v. Torrent Pharmaceuticals Limited and Torrent Pharma Inc., U.S.D.C. D. Del., Case No. 1:19-cv-00320.  Merck, in a complaint filed on January 13, 2019, seeks to block approval of Torrent’s ANDA Products (sitagliptin phosphate) prior to the expiration of U.S. Patent No. 7,326,708 – an Orange Book listed patent for Januvia®, which is indicated as an adjunct to diet and exercise to improve glycemic control in patients with type 2 diabetes mellitus in mono- and combination therapy.

Merck Sharp & Dohme Corp. v. Wockhardt Bio AG and Wockhardt USA LLC, U.S.D.C. D. Del. Case No. 1:19-cv-00321.  Merck, in a complaint filed on January 13, 2019, seeks to block approval of Wockhardt’s ANDA Products (sitagliptin phosphate and sitagliptin phosphate in combination with metformin hydrochloride) prior to the expiration of U.S. Patent No. 7,326,708 – an Orange Book listed patent for Januvia®, which is indicated as an adjunct to diet and exercise to improve glycemic control in patients with type 2 diabetes mellitus in mono- and combination therapy, and Janumet®, which is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus who are not adequately controlled on metformin or sitagliptin alone or in patients already being treated with combinations of sitagliptin and metformin.

Jublia® (efinaconazole topical solution – 10%) – NDA No. 203567

Valeant Pharmaceuticals North America LLC, Valeant Pharmaceuticals Ireland Ltd., Dow Pharmaceutical Sciences, Inc. and Kaken Pharmaceutical Co., Ltd. v. Apotex Inc. and Apotex Corp., U.S.D.C. D.N.J., Case No. 3:19-cv-05939.  Valeant/Dow/Kaken, in a second complaint filed on February 15, 2019, seek to block approval of Apotex’s ANDA products (efinaconazole topical solution – 10%) until expiration of U.S. Patent No. 10,105,444 – an Orange Book listed patent for Jublia®, which is indicated for the treatment of onychomycosis of the toe nail.  Valeant/Dow/Kaken, in Valeant Pharmaceuticals North America LLC, et al. v. Apotex Inc. et al., U.S.D.C. D.N.J., Case No. 3:18-cv-14202, previously asserted eight other Orange Book listed patents against Apotex, i.e., 7,214,506; 8,039,494; 8,486,978; 9,302,009; 9,566,272; 9,662,394; 9,861,698 and 9,877,955.

Recent Case Law

Judge Stark Outlines The Standard For Determining Who Is An ANDA Submittor

Adverio Pharma GmbH v. Alembic Pharms., C.A. No. 18-73-LPS, 2019 U.S. Dist. LEXIS 23021 (D. Del. Feb. 13, 2019), addresses the issue of how to determine whether a defendant is a submitter of an abbreviated new drug application (“ANDA”) and, therefore, a proper party in a Hatch-Waxman litigation.  Judge Stark, in granting INC Research, LLC’s motion to dismiss, held that for one to submit and abbreviated new drug application under 35 U.S.C. § 271(e)(2)(A) and, therefore, be subject to liability in a Hatch-Waxman litigation,

[T]he filing entity must intend to financially benefit, in a significant manner, from the FDA’s approval of the application.  An entity that signs an ANDA is a “submitter” if it intends to be financially compensated for active involvement in the commercial manufavture, use or sale f the generic drug.

By contrast, an entity that merely assists in collecting materials for submission to the FDA, signs the ANDA, presents the ANDA to the FDA for approval, and acts in an ongoing manner as the liaison between the FDA and the applicant during the regulatory process, but will have no involvement with the ANDA produt following FDA approval is not a submitter.

Id. at *6 (emphasis in original).  Judge Stark also delineated what factors were not relevant to the analysis of whether an entity was an ANDA submitter.  For example,

Other factors – such as the formal corporate relationship (e.g., parent-subsidiary), if any, between the “real filer in interest” and the entity filing the ANDA on the former’s behalf; the entity’s participation, or not, in preparation of the ANDA; and the financial compensation the assisting entity is receiving – are not dispositive, and, in most (maybe all) instances, will not even be pertinent to assessing whether the entity is a “sumit[ter].”  If the assisting entity is paid to assist with the preparation and filign of the ANDA, and is paid to interact with the FDA on behalf of the submitter throughout the review process, these payments do not transform the assisting entity into a sumitter itself, whether the entity is a submitter depends on whether it is also going to engage in the commercial manufacture, use or sale of the proposed generic drug product.  This is so even if some or all of the assisting entity’s compensation is contingent on the FDA approving the proposed generic drug product.

Id. at *6-*7 (emphasis in original) see also In re Rosuvastatin Calcium Patent Litig., 703 F.3d 511 (Fed. Cir. 2012).

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