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Recent Events in Pharmaceutical Litigation – March 4, 2019 – March 15, 2019

Posted on Mar 27, 2019 in News

New ANDA Cases Filed

Neupro® (rotigotine transdermal system) – NDA No. 021829

UCB, Inc., UCB Pharma GmgH and LTS Lohmann Therapie-Systeme AG v. Actavis Laboratories UT, Inc., U.S.D.C. D. Del., Case No. 1:19-cv-00474.  UCB, in a second action initiated on March 6, 2019, seeks to block approval of Actavis’ ANDA product (rotigotine transdermal system) prior to the expiration of U.S. Patent No. 10,130,589 – an Orange Book listed patent for Neupro®, which is indicated for the treatment of Parkinson’s disease and moderate-to-severe restless leg syndrome.  UCB, in a suit filed on August 21, 2014, also asserted U.S. Patent Nos. 6,699,498; 6,884,434; 7,413,747; 8,246,979; 8,246,980 and 8,617,591 against Actavis’ predecessors in interest.  See UCB, Inc. UCB Manufacturing Ireland Limited, UCB Pharma GmbH and LTS Lohmann Therapie-System AG v. Watson Laboratories, Inc. (Nevada) and Watson Laboratories, Inc. (Delaware), U.S.D.C. D. Del., Case No. 1:14-cv-0183.  UCB, in a second complaint filed in this action on May 5, 2015, asserted U.S. Patent Nos. 6,699,498; 6,884,434; 7,413,747; 8,617,591; 8,232,414 and 8,932,665 against Actavis’ predecessors in interest.  Id. at Docket No. 61.  This action resulted in a finding of infringement as to the asserted claims of U.S. Patent No. 6,884,434 and the invalidation of U.S. Patent No. 8,232,414.  See id at Docket No. 284.

Velcade® (bortezomib) – NDA No. 021602

Millennium Pharmaceuticals, Inc. v. Aurobindo Pharma USA Inc. and Aurobindo Pharma Limited, U.S.D.C. D. Del., Case No. 1:19-cv-00471.  Millennium, in a complaint filed on March 6, 2019, seeks to block approval of Aurobindo’s ANDA product (bortezomib) prior to expiration of U.S. Patent Nos. 6,713,446 and 6,958,319 – Orange Book listed patents for Velcade®, which is indicated for the treatment of patients with multiple myeloma and mantle cell lymphoma.

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. Slayback Pharma, LLC and Slayback Pharma India LLP, U.S.D.C. D.N.J., Case No. 3:19-cv-08218.  Valeant/Dow/Kaken, in a second complaint filed on March 8, 2019, seek to block approval of Slayback’s ANDA products (efinaconazole topical solution – 10%) prior to the 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. Slayback Pharma, LLC and Slayback Pharma India LLP, U.S.D.C. D.N.J., Case No. 3:18-cv-14208, previously asserted eight other Orange Book listed patents against Slayback, 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.

Valeant Pharmaceuticals North America LLC, Valeant Pharmaceuticals Ireland Ltd., Dow Pharmaceutical Sciences, Inc. and Kaken Pharmaceutical Co., Ltd. v. Mylan Pharmaceuticals Inc., Mylan Laboratories Ltd. and Mylan Inc. U.S.D.C. D.N.J., Case No. 3:19-cv-08233 and U.S.D.C. D.W.V., Case No. 1:19-cv-00037.  Valeant/Dow/Kaken, in two additional complaints filed on March 8, 2019 and March 11, 2019, respectively, seek to block approval of Mylan’s ANDA products (efinaconazole topical solution – 10%) prior to the 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. Mylan Pharmaceuticals et al., U.S.D.C. D.N.J., Case No. 3:18-cv-14305, previously asserted eight other Orange Book listed patents against Slayback, 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.

Xeljanz® (tofacitinib) – NDA No. 203214

Pfizer Inc., PF Prism C.V., C.P. Pharmaceuticals International C.V., Pfizer Pharmaceuticals LLC and Pfizer PFE Ireland Pharmaceuticals Holding 1 B.V. v. Ajanta Pharma Ltd. and Ajanta Pharma USA Inc., U.S.D.C. D. Del., Case No. 1:19-cv-00517.  Pfizer, in a complaint filed on March 15, 2019, seeks to block approval of Ajanta’s ANDA product (tofacitinib 5 mg tablets) prior to expiration of U.S. Patent No. 6,965,027 and RE41,783 – two of seven Orange Bool listed patents for Xeljanz®, which is indicted for the treatment of adult patients with moderately to severely active rheumatoid arthritis who have had an inadequate response or intolerance to methotrexate; adult patients with active psoriatic arthritis who have had an an inadequate response or intolerance to methotrexate and adult patient with moderately to serverly active ulcerative colitis.

Belbuca® (buprenorphine buccal film) – NDA No. 207932

Biodelivery Sciences International, Inc. and Arius Two, Inc. v. Chemo Research, S.L., Insud Pharma S.L., IntelGenx Corp., and IntelGenx Technologies Corp., U.S.D.C. D.N.J., Case No. 2:19-cv-08660.  Biodelivery/Arius, in a second complaint filed on March 15, 2019, seek to block approval of Chemo Research’s ANDA products (buprenorphine buccal film) prior to the expiration of U.S. Patent Nos. 8,147,866; 9,655,843 and 9,901,539 – Orange Book listed patents for Belbuca®, which is indicated for the management of pain severe enough to require daily, around-the-clock, long-term opioid treatment and from which alternative treatment options are inadequate.  Biodelivery Sciences/Arius previously asserted these patents against Chemo Research in the District of Delaware in a complaint filed on March 1, 2019.  See Biodelivery Sciences International Inc. et al. v. Chemo Research S.L. et al., U.S.D.C. D. Del., Case No. 1:19-cv-00444.

Auryxia® (ferric citrate tablets) – NDA No. 205874

Keryx Biopharmaceuticals, Inc., Panion & BF Biotech, Inc. and Chen Hsing Hsu v. Mylan Pharmaceuticals Inc.., U.S.D.C. D. Del., Case No. 1:19-cv-00040.  Keryx/Panion/Chen Hsing Hsu, in a complaint filed on March 15, 2019, seek to block approval of Mylan’s ANDA products (ferric citrate tablets) prior to the expiration of U.S. Patent 5,753,706; 7,767,851; 8,093,423; 8,299,298; 8,338,642; 8,609,896; 8,754,257; 8,754,258; 8,846,976; 8,901,349; 9,050,316; 9,328,133; 9,387,191 and 9,757,416 – Orange Book listed patents for Auryxia® tablets which are indicated for the control of serum phosphorus levels in patients with chronic kidney disease who are on dialysis and for the treatment of iron deficiency anemia in adult patient with chronic kidney disease not on dialysis.

Declaratory Judgment Cases

Isosulfan Blue – ANDA No. 090874

Apicore US LLC and Mylan Institutional LLC v. Beloteca, Inc., U.S.D.C. E.D. Tex., Case No. 2:19-cv-0077.  Apicore/Mylan, in a complaint filed on March 4, 2019, seek a declaratory judgment on infringement as to U.S. Patent Nos. 8,969,616 and 9,353,050, which allegedly encompass processes for preparing and isolating isosulfan blue, which is indicated for use in delineating lymphatic vessels.  Beloteca’s ANDA for isosulfan blue was approved by the FDA on January 16, 2019 and Beloteca filed a complaint on January 17, 2019, seeking a declaratory judgment on non-infringement of U.S. Patent Nos. 7,622,992; 8,969,616 and 9,353,050, see Beloteca, Inc. v. Apicore US LLC and Mylan Institutional LLC., U.S.D.C. N. Ill., Case No. 1:19-cv-00360.

Anti-Trust Cases

Sensipar (cinacalcet hydrochloride) – NDA No. 021688

Teamsters Local 237 Welfare Fund and Teamsters Local 237 Retirees’ Benefit Fund v. Amgen Inc., Watson Laboratories, Inc., Watson Pharmaceuticals, Inc., Actavis PLC, Actavis Pharma, Inc., Teva Pharmaceuticals Industries Ltd. and Teva Pharmaceuticals USA, Inc., U.S.D.C. D.N.J., Case No. 2:19-cv-08561.  Teamsters Local 237, in a class action complaint filed on March 14, 2019, seeks damages for violations of the Sherman Act and state law anti-trust and unfair trade practice violations arising from the agreement between Amgen and Teva to settle the Hatch-Waxman litigation regarding the infringement of U.S. Patent No. 9,375,405 by Teva’s ANDA products (cinacalcet hydrochloride tablets), which is indicated for the treatment of secondary hyperparathyroidism in patients with chronic kidney disease on dialysis and for the treatment of hypercalcemia in patients with parathyroid carcinoma.  Teamsters Local 237 alleges in its complaint that Teva received a judgment of non-infringement in the Hatch-Waxman litigation.  Teva engaged in an at risk launch during the pendency of Amgen’s appeal, but subsequently entered into a settlement agreement in which it allegedly agreed to cease all sales of its ANDA products; to delay all future sales for two and one-half years and to pay Amgen an undisclosed sum of money, which apparently represented a portion of its at risk sales.

Legislation

Biologic Patent Transparency Act (S. 659)

Senator Susan M. Collins of Maine introduced Senate Bill No. 659, the Biologic Patent Transparency Act on March 5, 2019.  The bipartisan bill is co-sponsored by Senator Tim Kaine of Virginia, Senator Rob Portman of Ohio, Senatory Jeanne Shaheen of New Hampshire, Senator Mike Braun of Indiana and Senator Debbie Stanbenow of Michigan.  The text of the bill, as available on Senator Collins’ web site, will amend section 351 of  Public Health Services Act (42 USC § 262) to require the publication of the Purple Book as a single searchable list.  The bill, if enacted, would require BLA holders to list, in the Purple Books, patents claiming or relating to the BLA products, including composition, method of use and methods of manufacture patents; information related to biosimilarity, interchangeability and exclusivity and the approved indications for the BLA product.  The holders of applications for products previously approved under section 351 of the Public Health Services Act would be required to submit patents for publication in the Purple Book no later than 30 days after enactment of the Act while the holders of applications for biological products under section 505 of the Federal Food, Drug, and Cosmetic Act would be required to submit patents for publication in the Purple Book no later than 30 days after March 23, 2020.  The bill, if enacted, would give holders of applications for biologic products thirty (30) days to list newly issued patents in the Purple Book and would also require them to submit a list of any patent or claim which are subsequently determined to be invalid or unenforceable within 30 days of such a determination.  Finally, the bill, if enacted, would bar enforcement of patents that should have, but were not listed timely in the Purple Book under the Public Health Services Act.

 

By Lynn M. Terrebonne

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