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Recent Events in Pharmaceutical Litigation – January 14 – February 8, 2019

Posted on Feb 13, 2019 in News

New ANDA Cases Filed

Esbriet® (pirfenidone capsules) – NDA No. 022535

Genentech, Inc. and Intermune, Inc. v. Accord Healthcare, Inc. and Intas Pharmaceuticals Limited, U.S.D.C. D. Del., Case No. 1:19-cv-00141.  Genentech and Intermune, in a complaint filed on January 25, 2019, seek to block approval of Accord’s ANDA products (267 mg pirfenidone capsules) prior to the expiration of U.S. Patent Nos. 7,566,729; 7,635,707; 7,767,700; 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® capsules which are indicated for the treatment for idiopathic pulmonary fibrosis (IPF).

Genentech, Inc. and Intermune, Inc. v. MacLeods Pharmaceuticals Ltd. and MacLeods Pharma USA, Inc., U.S.D.C. D. Del., Case No. 1:19-cv-00154.  Genentech and Intermune, in a complaint filed on January 28, 2019, seek to block approval of MacLeods’ ANDA products (267 mg pirfenidone capsules) prior to the expiration of U.S. Patent Nos. 7,566,729; 7,635,707; 7,767,700; 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® capsules which are indicated for the treatment for idiopathic pulmonary fibrosis (IPF).

Genentech, Inc. and Intermune, Inc. v. Amneal Pharmaceuticals LLC, Amneal Pharmaceuticals of New York LLC and Amneal Pharmaceuticals Company GmbH, U.S.D.C. D. Del., Case No. 1:19-cv-00195.  Genentech and Intermune, in a complaint filed on January 30, 2019, seek to block approval of Amneal’s ANDA products (267 mg pirfenidone capsules) prior to the expiration of U.S. Patent Nos. 7,566,729; 7,635,707; 7,767,700; 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® capsules which are indicated for the treatment for idiopathic pulmonary fibrosis (IPF).

Genentech, Inc. and Intermune, Inc. v. Sandoz, Inc., Sandoz International GmbH and Sandoz AG, U.S.D.C. D. Del., Case No. 1:19-cv-00203.  Genentech and Intermune, in a complaint filed on January 31, 2019, seek to block approval of Sandoz’s ANDA products (267 mg pirfenidone capsules) prior to the expiration of U.S. Patent Nos. 7,566,729; 7,635,707; 7,767,700; 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® capsules which are indicated for the treatment for idiopathic pulmonary fibrosis (IPF).

Esbriet® (pirfenidone tablets) – NDA No. 208780

Genentech, Inc. and Intermune, Inc. v. Accord Healthcare, Inc. and Intas Pharmaceuticals Limited, U.S.D.C. D. Del., Case No. 1:19-cv-00142.  Genentech and Intermune, in a complaint filed on January 25, 2019, seek to block approval of Accord’s ANDA products (267 and 801 mg pirfenidone tablets) prior to the expiration of U.S. Patent Nos. 7,566,729; 7,635,707; 7,767,700; 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 and 8,778,947 – Orange Book listed patents for Esbriet® tablets which are indicated for the treatment for idiopathic pulmonary fibrosis (IPF).

Genentech, Inc. and Intermune, Inc. v. Granules Pharmaceuticals, Inc., Granules India Ltd. and Granules USA, Inc., U.S.D.C. D. Del., Case No. 1:19-cv-00164.  Genentech and Intermune, in a complaint filed on January 28, 2019, seek to block approval of Granules’ ANDA products (267 and 801 mg pirfenidone tablets) prior to the expiration of U.S. Patent Nos. 8,383,150; 8,420,674 and 8,778,947 – Orange Book listed patents for Esbriet® tablets which are indicated for the treatment for idiopathic pulmonary fibrosis (IPF).

Genentech, Inc. and Intermune, Inc. v. Alembic Pharmaceuticals, Ltd., Alembic Global Holdings SA and Alembic Pharmaceuticals, Inc., U.S.D.C. D. Del., Case No. 1:19-cv-00177.  Genentech and Intermune, in a complaint filed on January 29, 2019, seek to block approval of Alembic’s ANDA products (267 and 801 mg pirfenidone tablets) prior to the expiration of U.S. Patent Nos. 7,566,729; 7,635,707; 7,767,700; 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 and 8,778,947 – Orange Book listed patents for Esbriet® tablets which are indicated for the treatment for idiopathic pulmonary fibrosis (IPF).

Genentech, Inc. and Intermune, Inc. v. Hetero Labs Limited, Hetero Labs Limited Unit V and Hetero USA Inc., U.S.D.C. D. Del., Case No. 1:19-cv-00178.  Genentech and Intermune, in a complaint filed on January 29, 2019, seek to block approval of Hetero’s ANDA products (267 and 801 mg pirfenidone tablets) prior to the expiration of U.S. Patent Nos. 7,566,729; 7,635,707; 7,767,700; 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 and 8,778,947 – Orange Book listed patents for Esbriet® tablets which are indicated for the treatment for idiopathic pulmonary fibrosis (IPF).

Genentech, Inc. and Intermune, Inc. v. Amneal Pharmaceuticals LLC, Amneal Pharmaceuticals of New York LLC and Amneal Pharmaceuticals Company GmbH, U.S.D.C. D. Del., Case No. 1:19-cv-00190.  Genentech and Intermune, in a complaint filed on January 30, 2019, seek to block approval of Amneal’s ANDA products (267 and 801 mg pirfenidone tablets) prior to the expiration of U.S. Patent Nos. 7,566,729; 7,635,707; 7,767,700; 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 and 8,778,947 – Orange Book listed patents for Esbriet® tablets which are indicated for the treatment for idiopathic pulmonary fibrosis (IPF).

Genentech, Inc. and Intermune, Inc. v. Sandoz, Inc., Sandoz International GmbH and Sandoz AG, U.S.D.C. D. Del., Case No. 1:19-cv-00202.  Genentech and Intermune, in a complaint filed on January 31, 2019, seek to block approval of Sandoz’s ANDA products (267, 534 and 801 mg pirfenidone tablets) prior to the expiration of U.S. Patent Nos. 7,566,729; 7,635,707; 7,767,700; 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 and 9,561,217 – Orange Book listed patents for Esbriet® tablets which are indicated for the treatment for idiopathic pulmonary fibrosis (IPF).

Genentech, Inc. and Intermune, Inc. v. MSN Laboratories Private Limited and MSN Pharmaceuticals Inc., U.S.D.C. D. Del., Case No. 1:19-cv-00205.  Genentech and Intermune, in a complaint filed on January 31, 2019, seek to block approval of MSN’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).

Genentech, Inc. and Intermune, Inc. v. CIPLA Limited, Invagen Pharmaceuticals, Inc. and CIPLA USA, Inc., U.S.D.C. D. Del., Case No. 1:19-cv-00219.  Genentech and Intermune, in a complaint filed on February 1, 2019, seek to block approval of CIPLA’s ANDA products (267 and 801 mg pirfenidone tablets) prior to the expiration of U.S. Patent Nos. 7,566,729; 7,635,707; 7,767,700; 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 and 8,778,947 – Orange Book listed patents for Esbriet® tablets which are indicated for the treatment for idiopathic pulmonary fibrosis (IPF).

Genentech, Inc. and Intermune, Inc. v. Aizant Drug Research Solutions Pvt. Ltd., U.S.D.C. D. Del., Case No. 1:19-cv-00223.  Genentech and Intermune, in a complaint filed on February 1, 2019, seek to block approval of Aizant’s ANDA products (267, 534 and 801 mg pirfenidone tablets) prior to the expiration of U.S. Patent Nos. 7,566,729; 7,635,707; 7,767,700; 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 and 8,778,947 – Orange Book listed patents for Esbriet® tablets which are indicated for the treatment for idiopathic pulmonary fibrosis (IPF).

Imbruvica® (ibrutinib capsules) – NDA No. 205552

Pharmacyclics LLC and Janssen Biotech, Inc. v. Zydus Worldwide DMCC and Cadila Healthcare Limited, D. D. Del., Case No. 1:19-cv-00143.  Pharmacyclics, in a complaint filed on January 25, 2019, seeks to block approval of Zydus’ ANDA products (70 mg ibrutinib capsules) prior to the expiration of U.S. Patent Nos. 7,514,444; 8,008,309; 8,697,711; 8,735,403; 8,957,079; 9,181,257; 8,754,091; 8,497,277; 8,952,015; 8,476,284; 8,754,090; 9,296,753; 9,725,455; 10,125,140 and 10,106,548 – Orange Book listed patents for Imbruvica® capsules which are indicated for the treatment of mantle cell lymphoma (MCL) and chronic lymphocytic leukemia (CLL) in patients that have received at least one prior therapy.

Absorica® (isotretinoin capsules) – NDA No. 021951

Galephar Pharmaceutical Research, Inc., Cipher Pharmaceuticals Inc. and Sun Pharmaceutical Industries, Inc. v. Upsher-Smith Laboratories, LLC, U.S.D.C. D.N.J., Case No. 2:19-cv-02546.  Galephar, Cipher and Sun, in a complaint filed on January 30, 2019 seek to block approval of Upshire-Smith’s ANDA products (10, 20 and 30 mg isotretinoin capsules) prior to the expiration of U.S. Patent Nos. 7,435,427; 8,367,102; 8,952,064; 9,078,925 and 9,089,534 – Orange Book listed patents for Absorica® capsules which are indicated for the treatment of severe recalcitrant nodular acne in patients 12 years of age and older.

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

Biogen International GmbH v. Hetero USA Inc., Hetero Labs Limited Unit-III, and Hetero Labs Limited, U.S.D.C. D. Del., Case No. 1:19-cv-00211.  Biogen, in a second complaint filed on January 31, 2019, seeks to block approval of Hetero’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. Hetero USA, Inc., U.S.D.C. Del., Case No. 1:17-cv-00825-LPS, 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 Hetero.

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

Keryx Biopharmeuticals, Inc., Panion & BF Biotech, Inc. and Chen Hsing Hsu v. Chemo Research S.L. and Insud Pharma S.A., U.S.D.C. D. Del., Case No. 1:19-cv-00220.  Keryx/Panion/Chen Hsing Hsu, in a complaint filed on February 1, 2019, seek to block approval of Chemo Research/Insud Pharma’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.

Finacea® (azelaic acid foam – 15%) – NDA No. 207071

Leo Pharma A/S., Leo Pharma Inc. and Foamix Pharmaceuticals Ltd v. Taro Pharmaceuticals U.S.A. and Taro Pharmaceuticals Industries, Ltd., U.S.D.C. D. Del., Case No. 1:19-cv-00221 and U.S.D.C. S.D. N.Y., Case No. 1:19-cv-01051.  Leo and Foamix, in complaints filed on February 1, 2019 and February 4, 2019, respectively, seek to block approval of Taro’s ANDA products (azelaic acid foam – 15%) prior to the expiration of U.S. Patent Nos. 7,700,076; 8,435,498; 8,722,021; 8,900,554; 9,211,259; 9,265,725 and 10,117,812 – Orange Book listed patents for Finacea® foam which is indicated for the topical treatment of inflammatory papules and pustules of mild to moderate rosacea.

Cerdelga® (eliglustat capsules) – NDA No. 205494

Genzyme Corp. and the Reagents of the University of Michigan v. Zenara Pharma Private Limited, U.S.D.C. D. Del., Case No. 1:19-cv-00264 and U.S.D.C. D.N.J., Case No. 3:19-cv-05160.  Genzyme/Reagents, in complaints filed on February 7, 2019 and February 8, 2019, respectively, seek to block approval of Zenara’s ANDA Products (84 mg eliglustat capsules) prior to the expiration of U.S. Patent Nos. 6,916,802; 7,196,205; 7,253,185 and 7,615,573 – Orange Bool listed patents for Cerdelga® capsules which are indicated for the long term treatment of adult patients with Gaucher disease type I who are CYP2D6 extensive metabolizers (EMs), intermediate metabolizers (IMs), or poor metabolizers (PMs) as detected by an FDA-cleared test.

Korlym® (mifepristone tablets) – NDA No. 202107

Corcept Therapeutics, Inc. v. Teva Pharmaceuticals USA, Inc. and Teva Pharmaceuticals Industries Ltd., U.S.D.C. D.N.J., Case No. 2:19-cv-05066.  Corcept, in a complaint filed on February 8, 2019, seeks to block approval of Teva’s ANDA products (300 mg mifepristone tablets) prior to the expiration of U.S. Patent Nos. 10,166,242; 10,166,243 and 10,195,214 – Orange Book listed patents for Korlym® which is indicated for control of hyperglycemia secondary to hypercortisolism in adult patients with endogenous Cushing’s syndrome who have type 2 diabetes mellitus or glucose intolerance and have failed surgery or are not candidates for surgery.

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. Zydus Pharmaceuticals (USA) Inc., Zudus Worldwide DMCC and Cadila Healthcare Limited d/b/a Zydus Cadila, U.S.D.C. D.N.J. Case No. 3:19-cv-05162.  Valeant/Dow/Kaken, in a second complaint filed on February 8, 2019, seek to block approval of Zydus’ 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. Zydus Pharmaceuticals (USA) Inc., et al., U.S.D.C. D.N.J., Case No. 3:18-cv-13635, previously asserted eight other Orange Book listed patents against Zydus, 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.

New Declaratory Judgment Cases Filed

Janumet XR (sitagliptin phosphate and metformin hydrochloride) – NDA No. 202270

Par Pharmaceutical, Inc. v. Merck Sharp & Dohme Corp., U.S.D.C. D.N.J., Case No. 2:19-cv-04432.  Par, in a complaint filed on February 1, 2019, seeks a declaratory judgment of non-infringement as to U.S. Patent No. 7,326,708 – an Orange Book listed patent for Janumet XR (sitagliptin phosphate and metformin hydrochloride 50 mg/500 mg, 50 mg/1000mg, 100 mg/100 mg extended release tablets) which are 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.

New Non-ANDA Cases Filed

Amgevita™ (adalimumab)

Coherus Biosciences, Inc. v. Amgen, Inc., U.S.D.C. D. Del., Case No. 1:19-cv-00139.  Coherus, in a suit filed on January 24, 2019, asserts that Amgen’s manufacture of Amgevita™, a biosimilar to adalimumab, in the United States for sale in Europe infringes U.S. Patent Nos. 10,155,039; 10,159,732; and 10,159,733.  The European Commission has approved Amgevita™, for the treatment of inflammatory disease, including rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, axial spondyloarthritis, plaque psoriasis, Crohn’s disease and ulcerative colitis.

Recent Case Law

Judge Stark Grants Janssen Biotech’s Motions for Summary Judgment on Non-Infringement and Lack of Enablement

MorphoSys AG v. Janssen Biotech, Inc., C.A. No. 16-221-LPS, 2019 U.S. Dist. LEXIS 12772 (D. Del. Jan. 28, 2019).  The case involved the alleged infringement of U.S. Patent Nos. 8,263,746; 9,200,061 and 9,758,590 which encompass anti CD38 antibodies by Janssen’s Darzalex® (daratumumab) which is indicated for the treatment of multiple myeloma in patients that have undergone at least three prior lines of therapy.

Janssen contended that the issue of literal infringement of the “human” antibody claims could be determined as a matter of law because 1) daratumumab is a “humanized” antibody under the Court’s claim construction; 2) under the Court’s claim construction “human” and “humanized” antibodies are mutually exclusive; and 3) the undisputed facts establish that daratumumab is humanized.  Id. at *3.  MorphoSys argued that an antibody could be both “human” and “humanized; that a reasonable fact finder could conclude that daratumumab was a “human” antibody because daratumumab is derived from human genes and because Janssen had characterized their product as “human” in representations to regulators and others.  Id. 

The Court agreed with Janssen that no reasonable juror could conclude that daratumumab is a “human” antibody in light of the Court’s claim construction, i.e., “for an antibody to be ‘human’ it must not be any of the following: (i) chimeric, (ii) humanized, and (iii) derived even in part from a nonhuman species.”  Id. at *3-4 (emphasis in original).  The Court found that it was not disputed that daratumumab was made using a human germiline sequence in transgenic mice.  Id. at *4.  As such, any reasonable fact finder would conclude that it was “‘from (either in whole or in part) a nonhuman species,’” and, therefore, did not fall under the Court’s construction of “human.”  Id. at *4.  The Court also discounted MorphoSys’ argument that an antibody could be both “human” and “humanized,” in part, because MorphoSys admitted at the hearing on the motion that the terms “human” and “humanized” were mutual exclusive. Id. at 3.  The Court also discounted MorphoSys’s argument regarding Janssen’s characterization of daratumumab as human to regulators because Janssen was not using the term “human” as construed by the Court and these characterizations were extrinsic evidence as to a POSA’s understanding of the term “human” and may not be used to modify a meaning clearly directed by the intrinsic evidence.  Id. at *4 citing Philipps v. AWH Corp., 415 F.3d 1303, 1316 (Fed. Cir. 2005).

The Court also found that the disclosure-dedication rule and the specific exclusion principle applied to foreclose MorphoSys’s claims of infringement under the doctrine of equivalence.  Id.  The Court held that MorphoSys could not argue that those claims covered humanized antibodies under the doctrine of equivalents because the patent disclosed that humanized antibodies could be made from transgenic mice but did not claim them in the relevant claims.  Id. at *4.  Additionally, MorphoSys could not us the doctrine of equivalents to capture humanized antibodies which are specifically excluded from claims directed solely to human antibodies because the specific exclusion principle prohibited the use of equivalents to broaden a claim to encompass a feature that is the opposite of or inconsistent with a recited limitation,.  Id. at *5.

Finally, the Court granted Janssen’s motion for summary judgment on the issue of enablement based on its determination that the patents-in-suit did not “teach those skilled in the art how to make and use the full scope of the claimed invention without undue experimentation.”  Id. at 8 (emphasis in original) citing MagSil Corp. v. Hitachi Glob. Storage Techs., Inc., 687 F.2d 1377, 1380 (Fed. Cir. 2012).  The Court held that a reasonable fact finder would have found that “very many unique anti-CD38 antibodies existed;” id.at *9, “each claim covers a vary large number of antibodies;” id. at *10, that new antibodies within the claims can be discovered by varying known antibodies and if this was done using non-conservative point substitutions the non-conserative variants would need to be screened to determine effectiveness; id., daratumumab is not a conservative varioant of MOR03079; id. at *11, and that the time and effort involved in a POSA obtaining a non-conservative but claimed variant would be substantial; id.  The Court went on to analyze the Wands factors and found that

Although the patents provide four working examples, they do not teach a POSA how to predict from an antibody’s sequence whether it will bind to CD38.  Nor do the patents improve a POSA’s ability to discover any of the conuntless antibodies within the scope of the claims that are not a conservative variant of a disclosed antibody.  Rather a POSA attempting to obtain a claimed antibody that is not a variant of a known antibody would have to do essentially the same amount of work as the inventors of the patents-in-suit.

Id.

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