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Recent Events in Pharmaceutical Litigation – February 19, 2019 – March 1, 2019

Posted on Mar 19, 2019 in Articles

New ANDA Cases Filed

Soolantra® (ivermectin – 1% cream) – NDA No. 206255

Galderma Laboratories L.P., Galderma S.A., and Nestlé Skin Health S.A. v. Teva Pharmaceuticals USA, Inc., U.S.D.C. D. Del., Case No. 1:19-cv-00351.  Galderma, in a second complaint filed on February 19, 2019, seeks to block approval of Teva’s ANDA products (ivermectin – 1% cream) prior to expiration of U.S. patent No. 10,206,939 – an Orange Book listed patent for Soolantra®, which is indicated for the treatment of inflammatory lesions of rosacea.  Galderma has previously asserted other Orange Book listed patents against Teva, i.e., U.S. Patent Nos. 8,362,069; 8,815,816; 9,089,587; 9,233,117 and 9,233, 118 against Teva in Galderma Laboratories L.P., Galderma S.A., and Nestlé Skin Health S.A. v. Teva Pharmaceuticals USA, Inc., U.S.D.C. N.D. Texas., Case No. 1:17-cv-01783, which was subsequently transferred to the U.S.D.C. for the District of Delaware.

Janumet® (sitagliptin phosphate, metformin hydrochloride) – NDA No. 022044

Merck Sharp & Dohme Corp. v. Lupin Limited and Lupin Pharmaceuticals, Inc., U.S.D.C. D. Del., Case No. 1:19-cv-00347.  Merck, in a complaint filed on February 19, 2019, seeks to block approval of Lupin’s ANDA Products (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 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.

Revlimid® (lenalidomide capsules) – NDA No. 21880

Celegene Corporation v. Apotex Inc., U.S.D.C. D.N.J., Case No. 2-19-cv-06999.  Celegene, in a second complaint filed on February 26, 2019, seeks to block approval of Apotex’s ANDA products 2.5, 5, 10, 15, 20, and 25 mg lenalidomide capsules) prior to the expiration of U.S. Patent Nos. 7,189,740; 8,404,717 and 9,056,120 – Orange Book listed patents for Revlimid®, which is indicated for the treatment of patients with transfusion dependent anemia due to low or intermediate-1-risk myelodysplastic sydromes associated with a deletion 5q cytogenetic abnormality with or without additional cytogenetic abnormalities.  Celegen, in Celgen Corporation v. Apotex Inc., U.S.D.C. D.N.J., Case No. 2:18-cv-00461, asserted additional Orange Book listed patents against Apotex, i.e., U.S. Patent Nos. 6,315,720; 6,561,977; 6,755,784; 8,315,886; 8,626,531; 7,465,800; 7,855,217; 7,468,363 and 8,741,929.

Invokamet XR® (canagliflozin and metformin hydrochloride extended release tablets) – NDA No. 205879

Mitsubishi Tanabe Pharma Corporation, Janssen Pharmaceuticals, Inc., Janssen Pharmaeutica NV, Janssen Research and Development, LLC and Cilag GmbH International v. Lupin Limited and Lupin Pharmaceuticals, Inc., U.S.D.C. D.N.J., Case No. 3:19-cv-07165.  Janssen, in a complaint filed on February 27, 2019, seeks to block approval of Lupin’s ANDA products (50 mg/500 mg, 50 mg/1000 mg, 150 mg/500 mg and 150 mg/1000 mg canagliflozin and metformin hydrochloride extended release tablets) prior to expiration of U.S. Patent Nos. 7,943,582 and 8,513,202 – Orange Book listed patents for Invokamet XR®, a sodium-glucose co-transporter 2 (SGLT2) inhibitor/biguanide combination that is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus when treatment with both canagliflozin and metformin is appropriate.  Janssen, in Mitsubishi Tanabe Pharma Corporation, Janssen Pharmaceuticals, Inc., Janssen Pharmaeutica NV, Janssen Research and Development, LLC and Cilag GmbH International v. Lupin Limited and Lupin Pharmaceuticals, Inc., U.S.D.C. D.N.J., Case No. 3:18-cv-00292, also asserted U.S. Patent Nos. 7,943,582 and 8,513,202 against Lupin in association with other ANDA submissions related to its generic versions of both Invokana®, an STLG2 inhibitor that is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus, and Invokamet®, a combination of an SGLT2 inhibitor and metformin that 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 a regimen containing metformin or canagliflozin or in patients already being treated with both canagliflozin 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. Macleods Pharmaceuticals Ltd. and Macleods Pharma USA, Inc., U.S.D.C. D.N.J., Case No. 3:19-cv-07269.  Valeant/Dow/Kaken, in a second complaint filed on February 28, 2019, seek to block approval of Maleods’ 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. Macleods Pharmaceuticals Ltd. and Macleods Pharma USA, Inc., U.S.D.C. D.N.J., Case No. 3:18-cv-14204, previously asserted eight other Orange Book listed patents against Macleods, 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.

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. Del., Case No. 1:19-cv-00444.  Biodelivery/Arius, in a complaint filed on March 1, 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.

Nascobal® nasal spray (cyanocobalamin, USP nasal spray 500 mcg/spray) – NDA No. 021642

Endo Pharmaceuticals Inc. v. Perrigo UK FINCO Limited Partnership, U.S.D.C. D. Del., Case No. 1:19-cv-00437.  Endo, in a complaint filed on March 1, 2019, seeks to block approval of Perrigo’s ANDA products (cyanocobalamin nasal spray) prior to expiration of U.S. Patent Nos. 7,229,636; 7,404,489; 7,879,349; 8,003,353; 8,940,714 and 9,415,007 – Orange Book listed patents for Nascobal® nasal spray, which is indicated for the maintenance of normal hematologic status in pernicious anemia patients who are in remission following intramuscular vitamin B12 therapy and who have no nervous system involvement.  Nascobal® nasal spray also is indicated as a supplement for other vitamin B12 deficiencies, including dietary deficiencies in strict vegetarians; malabsorption of vitamin B12 resulting from structural or functional damage to the stomach or ileum; inadequate secretion of intrinsic factor; competition for vitamin B12 by intestinal parasites or bacteria and inadequate utilization of vitamin B12.

Oracea® capsules (doxycycline) – NDA No. 050805

Galderma Laboratories, L.P. and Nestlé Skin Health S.A. v. Amneal Pharmaceuticals, LLC and Amneal Pharmaceuticals Pvt. Ltd., U.S.D.C. D. Del., Case No. 1:19-cv-00440.  Galderma, in a second complaint filed on March 1, 2019, seeks to block approval of Amneal’s ANDA products (40 mg doxycycline capsules) prior to expiration of U.S. Patent No. 10,058,564 – one of eleven Orange Book listed patents for Oracea®, which is indicated for the treatment of only inflammatory lesions (papules and pustules) of rosacea in adult patients.  Galderma, in Galderma Laboratories, L.P., Nestlé Skin Health S.A. and TCD Royalty Sub, LLC v. Amneal Pharmaceuticals, LLC and Amneal Pharmaceuticals Co. (I) Pvt. Ltd., U.S.D.C. D. Del., Case No. 1:16-cv-00207-LPS, the final judgment of which is currently under appeal (Galderma Laboratories, L.P. et al. v. Amneal Pharmaceuticals LLC et al., Fed. Cir. No. 2019-1021), asserted U.S. Patent Nos. 7,211,267; 7,232,572; 8,603,506; 9,241,946; 7,749,532; 8,206,740; 8,394,405; 8,394,406; 8,470,364 and 8,709,478 against Amneal.

Imbruvica® (ibrutinib) – NDA No. 210563

Pharmacyclics LLC and Janssen Biotech, Inc. v. Alvogen Pine Brook LLC and Natco Pharma Ltd., U.S.D.C. D. Del. Case No. 1:19-cv-00434.  Pharmacyclics and Janssen Biotech, in a complaint filed on March 1, 2019, seek to block approval of Alvogen’s ANDA products (140 mg, 280 mg, 420 mg and 560 mg ibrutinib tablets) until expiration of U.S. Patent Nos. 7,514,444; 8,008,309; 8,476,284; 8,497,277; 8,697,711; 8,735,403; 8,754,090; 8,754,091; 8,952,015; 8,957,079; 9,181,257; 9,296,753; 9,655,857; 9,725,455; 10,010,507; 10,106,548 and 10,125,140 – Orange Book listed patents for Imbruvica®, a kinase inhibitor indicated for the treatment of adult patients with mantle cell lymphoma (MCL) who have received at least one prior therapy; chronic lymphocytic leukemia (CLL)/small lymphocytic lymphoma (SSL); CCL/SSL with 17p deletion; Waldenström’s macroglobulinemia (WM); marginal zone lymphoma (MZL) who require systemic therapy and have received at least one prior anti-CD20-based therapy and chronic graft versus host disease (cGVHD) after failure of one or more lines of systemic therapy.

Riomet® (metformin hydrochloride oral solution) – NDA No. 021591

Sun Pharmaceutical Industries Ltd. and Ranbaxy Signature, LLC v. Vistapharm, Inc., U.S.D.C. D.N.J., Case No. 2:19-cv-07536.  Sun/Ranbaxy, in a complaint filed on March 1, 2019, seek to block approval of Vistapharm’s ANDA products (metformine hydrochloride oral solution) prior to the expiration of U.S. Patent No. 6,890,957 – an Orange Book listed patent for Riomet®, which is indicated as an adjunct to diet and exercise as a monotherapy to improve glycemic control in patients (10 years of age and older) with type 2 diabetes and in combination with a sulfonylurea or insulin to improve glycemic control in adults (17 years of age and older).

Declaratory Judgment Cases

Neupogen® (filgrastim) – BLA No. 103353/Neulasta® (pegfilgrastim) – BLA No. 125031

Sandoz Inc. v. Amgen Inc. and Amgen Manufacturing, Limited, U.S.D.C. N.D. Cal., Case No. 5:19-cv-00977-VKD.  Sandoz, in a complaint filed on February 21, 2019, seeks a declaratory judgment of non-infringement and invalidity as to U.S. Patent No. 9,643,997 as to its approved biosimilar filgrastim product, Zarxio™ (filgrastim-sndz), which is indicated for use in decreasing the incidence of infection, as manifested by febrile neutropenia, in patients with nonmyeloid malignancies receiving myelosuppressive anti-cancer drugs associated with a significant incidence of severe neutropenia with fever; to reduce the time to neutrophil recovery and the duration of fever, following induction of consolidation chemotherapy treatment of patients with acute myeloid leukemia (AML); to reduce the duration of neutropenia and neutropenia-related clinical sequelae, e.g., febrile neutropenia, in patients with nonmyeloid malignancies undergoing myeloablative chemotherapy followed by bone marrow transplantation; to mobilize autologous hematopoietic progenitor cells into the peripheral blood for collection by leukapheresis and to reduce the incidence and duration of sequelae of severe neutropenia (e.g., fever, infections, oropharyngeal ulcers) in symptomatic patients with congenital neutropenia, cyclic neutropenia or idiopathic neutropenia; and as to the products covered by its pending biosimilar application for pegfilgrastim, which is indicated for use in decreasing the incidence of infection, as manifested by febrile neutropenia, in patients with non-myeloid malignancies receiving myelosuppressive anti-cancer drugs associated with a clinically significant incidence of febrile neutropenia.  Amgen, in Amgen Inc. and Amgen Manufacturing, Limited v. Sandoz Inc., Sandoz International GmbH, and Sandoz GmbH, U.S.D.C. N.D. Cal., Case No. 3:14-cv-04741-RS, asserted that Sandoz’s filgrastim products would infringe U.S. Patent No. 6,162,427 and 8,940,878, but the Court granted Sandoz’s motion for summary judgment of non-infringement.  Additionally, in Amgen Inc. and Amgen Manufacturing, Limited v. Sandoz Inc., Sandoz International GmbH, Sandoz GmbH and Lek Pharmaceuticals D.D., U.S.D.C. N.D. Cal., Case No. 3:16-cv-02581-RS, Amgen asserted that Sandoz’s pegfilgrastim products would infringe U.S. Patent No. 5,824,784 and 8,940,878, but the Court granted Sandoz’s motion for summary judgment of non-infringement as to U.S. patent No. 8,940,878 and dismissed without prejudice Amgen’s claims as to U.S. Patent No. 5,824,784.

Nexium® for Delayed-Release Oral Suspension (esomeprazole magnesium delayed release oral suspension) –            NDA No. 021957

Cipla Limited and Cipla USA, Inc. v. AstraZeneca AB, Aktiebolaget Hässle, AstraZeneca Pharmaceuticals LP, and Zeneca Inc., U.S.D.C. D. Del., Case No. 1:19-cv-00438.  Cipla, moved on March 1, 2019 for leave to file a complaint under seal seeking a declaratory judgment of non-infringement and invalidity as to U.S. Patent No. 6,428,810 – an Orange Book listed patents for Nexium® for Delayed-Release Oral Suspension, which is indicated for the short-term treatment in the healing and symptomatic resolution of diagnostically confirmed erosive esophagitis; to maintain symptom resolution and healing of erosive esophagitis; for the treatment of heartburn and other symptoms associated with GERD; for the reduction in the occurrence of gastric ulcers associated with continuous NSAID therapy in patients at risk of developing gastric ulcers; in combination with amoxicillin and clarithromycin, for the treatment of patients with H. pylori infection and duodenal ulcer disease and for the long-term treatment of pathological hypersecretory conditions, including Zollinger-Ellison Syndrome.

Anti-Trust Cases

Sensipar (cinacalcet hydrochloride) – NDA No. 021688

UFCW Local 1500 Welfare Fund v. Amgen Inc., Teva Pharmaceuticals USA, Inc., Watson Laboratories, Inc., Actavis Inc., and Actavis Pharma Inc., U.S.D.C. D. Del., Case No. 1:19-cv-00369.  UFCW Local 1500, in a class action complaint filed on February 21, 2019, seeks damages for violations of the Sherman Act and state law anti-trust 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), 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.  UFCW Local 1500 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.

César Castillo, Inc. v. Amgen Inc., Teva Pharmaceuticals USA, Inc., Teva Pharmaceuticals Industries Ltd., Watson Pharmaceuticals, Inc., Watson Laboratories, Inc., Actavis Pharma, Inc. and Actavis PLC, U.S.D.C. D. Del., Case No. 1:19-cv-00396.  César Castillo, Inc., in a class action complaint filed on February 26, 2019, seeks damages for violations of the Sherman Act 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), 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.  César Castillo, Inc. 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.

Recent Case Law

Abbvie Inc. v. Boehringer Ingelheim Int’l GmbH, Civil No. 17-cv-01065-MSG-RL, 2019 U.S. Dist. LEXIS 28950 (D. Del. Feb. 25, 2019).

Magistrate Judge Richard A. Lloret orders a limited production of evidence related to Boehringer’s launch plans in this biosimilar litigation involving Humira® (adalimumab)Abbvie Inc. v. Boehringer Ingelheim Int’l GmbH, Civil No. 17-cv-01065-MSG-RL, 2019 U.S. Dist. LEXIS 28950 at *5-6 (D. Del. Feb. 25, 2019).  Magistrate Lloret, in his ruling made a distinction between the discovery of information regarding a defendant’s plans to launch its products in litigation under the Biologics Price Competition and Innovation Act (“BPCIA”) and the Hatch-Waxman Act.  He pointed out that, while the Hatch-Waxman Act does not require a defendant to provide early notice of an intent to launch an ANDA product, id. at *2 citing Allergan, Inc. v. Teva Pharm. USA, Inc., Case No. 2:15-cv-1455-WCB, 2017 U.S. Dist. LEXIS, at *4 (E.D. Tex. Aug. 25, 2017) and Otsuka Pharm. Co. v. Torrent Pharms. Ltd., Inc., 99 F. Supp. 3d 461, 471-72 (D.N.J. 2015), the BPCIA specifically requires defendants to provide 180 days’ notice of its intent to launch to allow for the timely resolution of a preliminary injunction, Abbvie Inc. v. Boehringer Ingelheim Int’l GmbH, 2019 U.S. Dist. LEXIS 28950 at * 2.  Magistrate Lloret also made a distinction between requiring Boehringer to provide discovery regarding its launch plans and compelling it to provide advance notice of its intent to launch.  Finding that “Boehringer would not be bound by the disclosure of contingent plans, and Abbvie would not be authorized under the BPCIA to initate a preliminary injunction proceeding if the discovery revealed that Boehringer has reached an internal decision about when it will launch.”  Id. at *3.

Magistrate Lloret then addressed the issue of the relevance of Abbvie’s requests for information regarding Boehringer’s launch plans in light of its unclean hands defense which he analyzed under the Federal Court’s ruling in Gilead Sciences, Inc. v. Merck & Co., Inc., 888 F.3d 1231 (Fed. Cir. 2018), that actual injury was not an element of an unclean hands defense but rather the “wrongful conduct had to have only an ‘immediate and necessary relation’ to the litigation between the parties.”  Abbvie Inc. v. Boehringer Ingelheim Int’l GmbH, 2019 U.S. Dist. LEXIS 28950 at * 3, citing Gilead Sciences, Inc. v. Merck & Co., 888 F.3d at 1240.  The Court determined that Boehringer’s launch plans were relevant to its unclean hands defense because of how Boehringer had characterized its defense, i.e.,

…  AbbVie generated “a vast portfolio of dubious, overlapping patents years after the launch of Humira®” which were “designed to prevent an adalimumab biosilimar …”  All this was “part of a larger scheme to thwart adalimumab competition.” … “AbbVie’s business strategy has been to leverage its thicket of dubious and overlapping patents to delay biosimilar competition” [with] “AbbVie [having] an ulterior motive for using the BPCIA process and patent litigation to delay Defendants’ entry onto the market, and thus obtain[ing] an unfair advantage over competitors to maintain its ‘dominant position’ in the marketplace.”

Abbvie v. Boehringer, 2019 U.S. Dist. LEXIS 28950 at * 4 (citations omitted).  Magistrate Lloret, therefore, held that the request for information regarding the launch of Boehringer’s biosimilar was relevant, given how Boehringer had caged its defense and the unfairness of allowing it to argue “that the purpose and effect of the ‘patent thicket’ was to delay competition and damage competitors, and seeks to prove the purpose and effect” while it refused to quantify the delay and the damage.  Id.

Magistrate Lloret, however, put limits on the discovery of Boehringer’s launch plans holding that “[d]eveloping business intelligence is not a legitimate purpose of discovery” and that it was “appropriate to consider outsized commercial effects of the proposed discovery against the discovery’s more limited ultility in resolving core legal issues in a case.”  Id. at *5, citing Card-Monroe Corp. v. Tuftco Corp, Case No. 1:14-cv-292, 2015 WL 11110143, at *2 (E.D. Tenn., 2015).  Magistrate Lloret also recognized the likelihood of there being a significant and time consuming effort involved in separating privilege and work-product related documents because while attorneys may not have been the final decisions makers as to launch plans, they likely were integral to the assessment of the patent thicket and associated litigation on the commercial launch of Boehringer’s biosimilar.  Id.  Magistrate Lloret then put the ball in Boehringers’ court by ordering it to state whether it contends that the patent thicket delayed its launch plans and whether it contents that evidence of the delayed launch is admissible to prove its unclean hands defense.  Id.  Furthermore, if Boehringer contends that evidence of the delayed launch was admissible to prove its unclean hands defense, it must explain when it would have launched absent the patent thicket; how much time the launch was delayed by the patent thicket; how the patent thicket operated to delay its launch and a calculation of damages resulting from the delay.  Id.

Teva Pharm. USA, Inc. v. Azar, Civ. Action No. 19-2394 (RDM), 2019 U.S. Dist. LEXIS 30346 (D.D.C. Feb. 26, 2019).

Judge Randolph D. Moss of the U.S. District Court for the District of Columbia dismissed Teva’s suit seeking a preliminary injunction to enjoin the FDA from depriving it of its alleged right to 180-day exclusivity as to its generic version of Restasis® (cyclosporine) due to lack of standing in Teva Pharms. United States v. Azar, Civ. Action No. 19-2394 (RDM), 2019 U.S. Dist. LEXIS 30346 (D.D.C. Feb. 26, 2019).  Teva argued that a preliminary injunction was appropriate because it qualifies as a “first applicant” to file a Paragraph IV certification for Restasis®, as defined by the Hatch-Waxman Act; but that its alleged statutory right to 180-days of generic exclusivity would be extinguished when the FDA applied its letter decision regarding the issue of “first applicant” in a letter decision involving Suboxone® or, alternatively, that the Suboxone® letter decision was invalid under the Administrative Procedure Act.  Id. at *3.  The FDA along with three intervenors, Mylan Pharmaceuticals, Inc., Deva Holdings AS and Famy Care Private Limited, moved to dismiss the suit for lack of standing.  Id. at *1.

The dispute arises from delays by the FDA in accepting Teva’s ANDA and from the addition of late listed Orange Book patents regarding Restasis®.  Teva filed its ANDA on January 23, 2012 with a Paragraph III certificate as to U.S. Patent No. 5,474,979 which was due to expire on May 17, 2014.  Id. at *4.  The FDA initially refused to accept Teva’s ANDA – a decision that it did not rescind until June 9, 2015.  Id.  The NDA holder, Allergan, Inc., added U.S. Patent No. 8,629,111 to the Orange Book on January 14, 2014 and Teva amended its ANDA to include a Paragraph IV certification to this patent on the same day.  Id.  Teva, however, did to immediately notify Allergan or the patent holders as required by 21 U.S.C. § 355(j)(2)(B)(ii)(II); but, rather waited until the FDA reversed its decision to receive Teva’s ANDA based on Allergan Inc. v. Actavis, Inc., Nos. 14-cv-638 & 14-cv-188, 2014 U.S. Dist. LEXIS 176551, 2014 WL 7336692 at *11-12 (E.D. Tex. Dec. 23, 2014).  Teva Pharm. USA, Inc. v. Azar, 2019 U.S. Dist. LEXIS 30346 at *4.  Teva also timely effected notice of its Paragraph IV certifications as to the other five Orange Book listed patents.  Id.  The District Court, in the patent litigation that ensued, invalidated four of the remaining Orange Book listed patents, including U.S. Patent No. 8,629,111, and Allergan Inc. entered into covenants not to sue as to the remaining two.  Id. at *5 citing Allergan Inc. v. Teva Pharm. USA, Inc., 2017 U.S. Dist. LEXIS 170825, WL 4803941 at *15 and 65.  The Federal Circuit subsequently upheld the District Court’s invalidity ruling and Allegan sought an in banc review of this decision.  Teva Pharm. USA, Inc. v. Azar, 2019 U.S. Dist. LEXIS 30346 at *5 citing Allergan, Inc. v. Teva Pharms. USA, Inc., 742 Fed. Appx. 511 (Fed. Cir. 2018) and Allergan Inc. v. Teva Pharm. USA, Inc., No. 18-1130 (Fed. Cir. Dec. 21, 2018).

Judge Moss held that Teva first was required to show a “substantial likelihood” of standing before it would be entitled to pursue a preliminary injunction.   Teva Pharm. USA, Inc. v. Azar, 2019 U.S. Dist. LEXIS 30346 at *8, citing Food & Water, Inc. v. Vilsack, 808 F.3d 905, 913 (D.C. Cir. 2015).  Teva, to survive the defendants’ motion to dismiss for lack of standing under Fed. R. Civ. Pro. 12(b)(1), “‘must state a plausible claim that [it] has suffered an injury in fact fairly traceable to the actions of the defendant that is likely to be redressed by a favorable decision on the merits.  Teva Pharm. USA, Inc. v. Azar, 2019 U.S. Dist. LEXIS 30346 at *8 citing, Humane Soc’y of the U.S. v. Vilsack, 797 F.3d 4, 8 (D.C. Cir. 2015).

Judge Moss found that Teva had not cleared this standing threshold because it had not established that it had suffered an injury in fact under the circumstances of this case.  The District Court declined to adopt Teva’s argument that its “‘first applicant status’ constitutes a property right ‘no different from a patent’ and that the right exists ‘[r]egardless of whether the exclusivity holder uses the right itself,’” id. at *10, and, therefore, it would face an immediate loss of right to exclude other non-first to file ANDA applicants if the Suboxone® letter decision was allowed to stand.  Rather Judge Moss held that “[f]irst applicant status [   ] dictates only the order and timing with which the FDA may approve ANDAs, and, neither history nor statutory text suggests that Congress intended to confer first applicants an immediate property interest.” Id.  Judge Moss also found that Teva had failed to establish that allowing the Suboxone® letter decision to stand would result in a concrete future loss of right that was redressible by the Court because there was no guarantee that the FDA would approve any of the existing ANDAs; even if the FDA were to approve an ANDA the Court could only speculate as to whether Teva’s ANDA would still be under review at that time; and the possibility existed that Teva could face a forfeiture of its 180-day exclusivity if it did not obtain tentative approval within 30 months of the FDA’s receipt of the ANDA and/or was unable to market its ANDA products within 75 days of the entry of a final judgment in the underlying litigation from which no appeal is taken.  Id. at *14, citing 21 U.S.C. §§ 355(j)(5)(D)(i)(IV) and 355(j)(5)(D)(i)(I)(bb).  Judge Moss also found Teva had not established standing as to its claim to a procedural injury under the Administrative Procedure Act based on the same reasoning.  Id. at *15.

By Lynn M. Terrebonne

 

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