Patent Docs

Life Sciences Court Report & COVID-19 Impact on District Court Filings

By Bryan Helwig --

The COVID-19 pandemic has brought the world economy to a standstill and the U.S. legal industry has not been immune.  Firms continue to implement cost-saving measures by reducing salaries, implementing furloughs, and in dire situations, reducing staff and attorney numbers.  The legal industry is now clearly a COVID-19 work-from-home profession.  District courts, in an effort to adapt to the changing landscape while maintaining a sense of normalcy, have been forced to shift dockets, institute remote hearings, and postpone cases.

A review of patent-related district court filings over the past eight weeks reveals that, starting in late March, the number of new district court cases in the pharmaceutical industry began to show a COVID-19-related slowing of new filings.  As shown in the graph below, while total new district court filings remained steady, and have even trended upwards in the last two weeks, pharmaceutical-related filings, including ANDA filings, have seen a significant decline.  The drop is accompanied by an increase in statewide stay-at-home orders, many of which are being partially lifted in the month of May, reflecting an industry-wide conservative litigation approach in the pharmaceutical industry during the ongoing COVID-19 crisis.

The eight-week review of new district court patent litigation filings spans from March 9 to May 1.  Week 1, beginning March 9, 2020, saw 62 new patent-related district court filings.  Twenty of those filings, or 32%, were in the pharmaceutical field.  However, the pharmaceutical filings trended above average for the week as on March 11 Celgene filed seven ANDA-related infringement complaints related to POMALYST®, used for the treatment of multiple myeloma.  Similarly, on Friday, March 13, Bausch Health (f/k/a Valent Pharmaceuticals) filed nine ANDA litigations related to its efinaconazole topical solution to treat nail fungus.  March 13 is further characterized by the National Emergency declared by President Trump under the National Emergencies Act.[1]

Despite the National Emergency, district court filings remained steady during the week of March 16, with 9 of the 71 (15%) district court filings related to infringement of pharmaceutical patents.  The normalized trend continued into the week of March 23, where 13 of the 68 district court filings were pharmaceutical-related.  The consistent trend occurred at a time when only 9 states (i.e., CA, IL, LA, MA, NJ, NY, OH, OR, and WA) enacted statewide orders to stay-at-home or shelter-in-place.

Highlighting the urgency of containment efforts, three days later on March 26, statewide stay-at-home orders were enacted in 26 states.  Included in the stay at-home-orders were New Jersey, on March 21 and Delaware on March 24, two states that represent a significant number of pharma-related district court filings.

The CARES ACT, announced Friday, March 27, marked a second major event in the COVID-19 timeline.  As previously summarized, the CARES ACT mainly impacts patent prosecution and prosecution-related deadlines.  The CARES ACT was accompanied, by numbers reported on March 30, of statewide stay-at-home orders issued in 30 states.  Although a decline in district court filings may have been expected as the spread of COVID-19 strengthened its grip on a dormant U.S. economy, March 30 saw 85 new district court filings.  However, the upward trend in total filings included only three new pharmaceutical-related district court filings (i.e., 3.5% of all new filings) for the week.  This trend continued into the first week of April where only 3 of the 72 district court patent-related filings (i.e., 4%) were from the pharmaceutical industry.  As of April 7, all but eight states had enacted stay-at-home-orders.

This trend continued into the week of April 13 when 67 total district court cases were filed, but included only two pharmaceutical-related district court cases (2% of all new filings).  The week of April 20 was characterized by an almost 30% increase in district court filings, but no pharma-related district court filings.  This trend continued into the week of April 27, where total district court filings increased by almost 40% compared to the week of April 20, but only included 4 pharma related filing.  Overall, there were 382 district court filings in the month of April, but only 12 of these filings, as summarized below, were in the pharma space (~3%).  When compared to pre-COVID filings, the total number of pharma-related district court filings for the month of April was approximately the same as the weekly pharma-related district court filings prior to the COVID-19 pandemic.

Meanwhile, the trend of pharmaceutical cases accounting for less than five percent of all district court filings is likely to continue.  Consistent with this, pharma-related district court filings for the week of May 4 revealed two pharma-related cases out of the first 22 district court filings for the week.

The end of April brought discussions of states instituting partial reopenings as shown on the graph by a drop in the total number of states instituting strict stay at home orders.  The re-openings, while ill-advised by health experts, are unique to each state, with health experts raising valid concerns of a second COVID-19 outbreak.  Until the pharma industry is successful in producing a vaccine or antibody test, it is possible that district court pharmaceutical-related filings will not return to pre-COVID-19 levels in the near future.

[1] https://www.whitehouse.gov/presidential-actions/proclamation-declaring-national-emergency-concerning-novel-coronavirus-disease-covid-19-outbreak/

District Court Cases -- April 2020

TherapeuticsMD, Inc. v. Teva Pharmaceuticals USA, Inc.
2-20-cv-03485; filed April 1, 2020 in the District Court of New Jersey

• Plaintiff:  TherapeuticsMD, Inc.
• Defendants:  Teva Pharmaceuticals USA, Inc. and Teva Pharmaceutical Industries Ltd.

Claim:  Infringement of U.S. Patent Nos.:

• 10,258,630: "Vaginal inserted estradiol pharmaceutical compositions and methods"
• 10,398,708: "Vaginal inserted estradiol pharmaceutical compositions and methods"
• 10,471,072: "Vaginal inserted estradiol pharmaceutical compositions and methods"
• 9,180,091: "Soluble estradiol capsule for vaginal insertion"
• 9,289,382: "Vaginal inserted estradiol pharmaceutical compositions and methods"

Synoposis:  TherapeuticsMD asserts infringement of the '630, '708, '072, '091, and '382 patents.  TherapeuticsMD is the holder of approved NDA No. 208564 for the manufacture and sale of Imvexxy® (estradiol vaginal inserts) for the treatment of moderate to severe dyspareunia.  Teva has submitted ANDA No. 214137, seeking approval to engage in the commercial manufacture, use, and/or sale of generic estradiol vaginal Inserts.  TherapeuticsMD asserts that the method of manufacture and/or the sale of of generic Imvexxy® are covered by one or more claims of the patents-in-suit.

View the complaint here.

Merck Sharp & Dohme B.V. v. Mylan Pharmaceuticals Inc.
1-20-cv-61; filed April 2, 2020 in the District Court of West Virginia

• Plaintiffs:  Merck Sharp & Dohme B.V. and Organon USA Inc.
• Defendants:  Mylan Pharmaceuticals Inc., Mylan Inc., and Mylan API US LLC

Claim:  Infringement of U.S. Patent No.:

• RE44733: "6-mercapto-cyclodextrin derivatives:reversal agents for drug-induced neuromuscular block"

Synoposis:  Merck asserts infringement of the '733 patent.  The '733 patent is a reissue of U.S. Patent No. 6,670,340.  Organon is the holder of approved NDA No. 022225 for the manufacture and sale of Bridion® (sugammadex) Injection for the reversal of neuromuscular blockade induced by rocuronium bromide and vecuronium bromide in adults undergoing surgery.  Mylan has submitted ANDA No. 213915, seeking to obtain approval to engage in the commercial manufacture, use, offer to sell, or sale of generic sugammadex.  Merck asserts that the method of manufacture and/or the sale of generic Bridion® are covered by one or more claims of the '733 patent.

View the complaint here.

Chiesi USA, Inc. v. Hikma Pharmaceuticals USA Inc.
1-20-cv-00484; filed April 8, 2020 in the District Court of Delaware

• Plaintiffs:  Chiesi USA, Inc. and Chiesi Farmaceuti S.P.A.
• Defendants:  Hikam Pharmaceuticals USA Inc., Europhealth (U.S.A.) Inc., and Hikmma Pharmaceuticals PLC

Claim:  Infringement of U.S. Patent No.:

• 7,049,328: "Use for deferipron"

Synoposis:  Chiesi asserts infringement of the '328 patent.  Chiesi is the holder of approved NDA No. 021825 for the manufacture and sale of the Ferriprox® (deferiprone) for iron chelation in patients with transfusional iron overload due to thalassemia syndromes.  Hikma has submitted ANDA No. 213239, seeking approval to engage in the commercial manufacture, use, and/or sale of generic deferiprone.  Chiesi asserts that the method of manufacture and/or the sale of generic Ferriprox® are covered by one or more claims of the '328 patent.

View the complaint here.

Actelion Pharmaceuticals Ltd. v. MSN Pharmaceuticals Inc.
2-20-cv-03859; filed April 9, 2020 in the District Court of New Jersey

• Plaintiffs:  Actelion Pharmaceuticals Ltd. and Nippon Shinyaku Co., Ltd.
• Defendants:  MSN Pharmaceuticals Inc., MSN Laboratories Private Ltd., Alembic Pharmaceuticals Ltd., Vgyaan Pharmaceuticals LLC, Aizant Drug Research Solutions Private Ltd., Zydus Worldwide DMCC, and Zydus Pharmaceuticals (USA) Inc.

Claim:  Infringement of U.S. Patent Nos.:

• 7,205,302: "Heterocyclic compound derivatives and medicines"
• 8,791,122: "Form-I crystal of 2-{4-[N-(5,6-diphenylpyrazin-2-yl)-N-isopropylamino]butyloxy}-N-(methylsu- lfonyl)acetamide and method for producing the same"
• 9,284,280: "Use of form-I crystal of 2-{4-[N-(5,6-diphenylpyrazin-2-yl)-N-isopropylamino]butyloxy}-N-(methylsu- lfonyl)acetamide"

Synoposis:  Actelion asserts infringement of the '302, '122, and '280 patents.  Actelion is the holder of approved NDA No. 207947, for the manufacture and sale of UPTRAVI® (selexipag) for the treatment of pulmonary arterial hypertension to delay disease progression and reduce the risk of hospitalization for pulmonary arterial hypertension.  Defendants have submitted ADNA No. 214414 (Alembic), ANDA No. 214367 (MSN), ANDA No. 214055 (Aizant), and ANDA No. 214302 (Zydous), seeking approval to manufacture, use, market, or sell generic selexipag tablets.  Actelion asserts that the method of manufacture, use, market, and sale of generic UPTRAVI® are covered by one or more claims of the patents-in-suit.

View the complaint here.

Eisai R&D Management Co. v. Sandoz Inc.
3-20-cv-03895, filed April 9, 2020 in the District Court of New Jersey

• Plaintiffs:  Eisai R&D Management Co., Eisai Co., and Eisai Inc.
• Defendants:  Sandoz Inc. and Sandoz International GmbH

Claim:  Infringement of U.S. Patent No.:

• RE46965: "Austad  Intermediates for the preparation of analogs of Halichondrin B"

Synoposis:  Eisai asserts infringement of the '965 patent.  Eisai is the holder of approved NDA No. 201532 for Halaven® (eribulin mesylate) to treat patients with metastatic breast cancer who have previously received at least two chemotherapeutic regimens.  Halaven® has also been approved by the FDA to treat patients with unresectable or metastatic liposarcoma.  Sandoz Inc. submitted ANDA No. 214310, seeking approval to engage in the commercial manufacture, use, offer for sale, or sale generic eribulin mesylate.  Eisai asserts that the commercial manufacture, use, offer for sale, or sale of generic eribulin mesylate are covered by one or more claims of the '965 patent.

View the complaint here.

Huvepharma EOOD v. BASF Corp.
Huvepharma EOOD v. Koninklijke DSM N.V.
1-20-cv-00513 and 1-20-cv-00514; filed April 15, 2020 in the District Court of Delaware

• Plaintiffs:  Huvepharm EOOD (f/k/a Huvepharma AD) and Huvepharma, Inc.
• Defendants:  BASF Corp. and BASF SE (1-20-cv-00513) and Koninklijke DSM N.V.; DSM Nutritional Products, LLC; and DSM Nutritional Products Ltd. (1-20-cv-00514)

Claim:  Infringement of U.S. Patent No.:

• 8,993,300: "Overexpression of phytase genese in yeast systems"

Synopsis:  Huvepharma EOOD asserts infringement of the '300 patent.  Huvepharma sells OptiPhos®, a feed additive for animals.  This includes an E. coli derived 6-phytase, which is recombinantly produced in a heterologous yeast host in a submerged fermentation process.  Huvepharma exclusively licenses OptiPhos® from Cornell University.  Huvepharma asserts that the Defendants, during prosecution of their patent application, cited the child application of the '300 patent.  Despite the application being rejected, Defendants allegedly continued to sell the accused product after the '300 patent issued.  As such, Huvepharma alleges Defendants knowingly infringed the '300 patent.

View the complaint here (1-20-cv-00513) and here (1-20-cv-00514).

Purdue Pharma L.P. v. Intellipharmaceutics International Inc.
1:20-cv-00515; filed April 15, 2020 in the District Court of Delaware

• Plaintiffs:  Purdue Pharma L.P., Purdue Pharmaceuticals L.P., P.F. Laboratories, Inc., Rhodes Technologies, and Grüenthal GmbH
• Defendants:  Intellipharmaceutics International Inc., Intellipharmaceutics Corp., and Intellipharmaceutics Ltd.

Claim:  Infringement of U.S. Patent Nos.:

• 10,369,109: "Abuse-proofed dosage form"
• 10,407,434: "Process for preparing oxycodone compositions"

Synopsis:  Purdue asserts infringement of the '109 and '434 patents.  Purdue is the holder of approved NDA No. 022272 for OxyContin® (oxycodone hydrochloride), an extended-release pain medication.  Intellipharmaceutics submitted NDA No. 209653, seeking approval to engage in the commercial manufacture, use, or sale of a generic extended-release oxycodone product.  Purdue asserts that the method of manufacture and/or the use of generic OxyContin® are covered by one or more claims of the patents-in-suit.

View the complaint here.

Astellas US LLC v. Glenmark Pharmaceuticals Ltd.
1-20-cv-00516; filed April 15, 2020 in the District Court of Delaware

• Plaintiffs:  Astellas US LLC, Astellas Pharma Inc., and Gilead Sciences Inc.
• Defendant:  Glenmark Pharmaceuticals Ltd.

Claim:  Infringement of U.S. Patent Nos.:

• 8,106,183: "Process for preparing an A.sub.2A-adenosine receptor agonist and its polymorphs"
• 8,524,883: "Monohydrate of (1-{9-[4S,2R,3R,5R)-3,4-dihydroxy-5-(hydroxymethyl)oxolan-2-yl]-6-aminopu- rin-2-yl}pyrazol-4-yl)-N-methylcarboxamide"
• RE47301: "Process for preparing an A2A-adenosine receptor agonist and its polymorphs"

Synopsis:  Astellas asserts infringement of the '183, '883, and '301 patents.  Astellas is the holder of approved NDA No. 022161 for the marketing and sale of Lexiscan® (regadenoson) for use in cardiac nuclear stress tests.  Glenmark submitted ANDA No. 214440, seeking approval to commercially market a generic version of Lexiscan®.  Asrtellas asserts that the method of manufacture and/or the use of generic Lexiscan® are covered by one or more claims of the patents-in-suit.

View the complaint here.

Pharmacyclics LLC v. Zydus Worldwide DMCC
1-20-cv-00560; filed April 16, 2020 in the District Court of Delaware

• Plaintiffs:  Pharmacyclics LLC and Janssen Biotech, Inc.
• Defendants:  Zydus Biotech, Inc. and Cadila Healthcare Ltd.

Claim:  Infringement of U.S. Patent Nos.:

• 10,010,507: "Pharmaceutical formulations of a bruton's tyrosine kinase inhibitor"
• 10,106,548: "Crystalline forms of a Bruton's tyrosine kinase inhibitor"
• 10,125,140: "Crystalline forms of a bruton's tyrosine kinase inhibitor"
• 10,213,386: "Pharmaceutical formulations of a Bruton's tyrosine kinase inhibitor"
• 10,478,439: "Use of inhibitors of bruton's tyrosine kinase (Btk)"
• 7,514,444: "Inhibitors of bruton's tyrosine kinase"
• 8,008,309: "Inhibitors of bruton's tyrosine kinase"
• 8,476,284: "Inhibitors of Bruton's tyrosine kinase"
• 8,497,277: "Inhibitors of Bruton's tyrosine kinase"
• 8,697,711: "Inhibitors of bruton'S tyrosine kinase"
• 8,735,403: "Inhibitors of Bruton's tyrosine kinase"
• 8,754,090: "Use of inhibitors of bruton's tyrosine kinase (Btk)"
• 8,754,091: "Inhibitors of bruton's tyrosine kinase"
• 8,952,015: "Inhibitors of Bruton's tyrosine kinase"
• 8,957,079: "Inhibitors of Bruton's tyrosine kinase"
• 9,181,257: "Inhibitors of Bruton's tyrosine kinase"
• 9,296,753: "Crystalline forms of a Bruton's tyrosine kinase inhibitor"
• 9,725,455: "Crystalline forms of a bruton's tyrosine kinase inhibitor"

Synopsis:  Pharmacyclics asserts infringement of the '507, '548, '140, '386, '439, '444, '309, '284, '277, '711, '403, '090, '091, '015, '079, '257, 753, and '455 patents.  Pharmacyclics is the holder of NDA No. 210563 for IMBRUVICA® (ibrutinib) to treat mantle cell lymphoma, Waldenström's macroglobulinemia, chronic lymphocytic leukemia, small lymphocytic lymphoma, and chronic graft-versus-host-disease.  Zydus submitted ANDA No. 214296, seeking approval to market generic versions of IMBRUVICA®.  Pharmacyclics asserts that the method of manufacture and/or the use of generic IMBRUVICA® are covered by one or more claims of the patents-in-suit.

View the complaint here.

Amgen Inc. v. Hospira, Inc.
1-20-cv-00561; filed April 26, 2020 in the District Court of Delaware

• Plaintiffs:  Amgen Inc. and Amgen Manufacturing Ltd.
• Defendants:  Hospria Inc. and Pfizer Inc.

Claim:  Infringement of U.S. Patent No.:

• 10,577,392: "Capture processes for proteins expressed in a non-mammalian system"

Synopsis:  Amgen asserts infringement of the '392 patent.  Amgen manufactures and sells NEUPOGEN® (filgrastim) for the treatment of neutropenia.  Amgen is a Reference Product Sponsor and Hospira a biosimilar applicant for a biosimilar version of NEUPOGEN®.  Hospira used the subsection (k) pathway and submitted abbreviated Biologic License Application (aBLA) No. 761080.  In July 2018, Hospira received FDA approval for NIVESTYM® (filgrastim), a biosimilar to Neupogen® (filgrastim), for all eligible indications of the reference.  Amgen alleges that Hospira submitted the aBLA before expiration of the '392 patent, thereby infringing the '392 patent.

View the complaint here.

Tris Pharma, Inc. v. Teva Pharmaceuticals USA, Inc.
1-20-cv-05212; filed April 28, 2020 in the District Court of New Jersey

• Plaintiff:  Tris Pharma, Inc.
• Defendant:  Teva Pharmaceuticals USA, Inc.

Claim:  Infringement of U.S. Patent Nos.:

• 9,545,399: "Methylphenidate extended release chewable tablet"
• 9,844,544: "Methylphenidate extended release chewable tablet"
• 9,844,545: "Methylphenidate extended release chewable tablet"

Synoposis:  Tris asserts infringement of the '399, '544, and '545 patents.  The patents are directed at QuilliChew ER® (methylphenidate), a long-lasting chewable for the treatment of ADHD in children.  Teva submitted ANDA NO. 214202, seeking approval to manufacture and commercially market a generic version of QuilliChew ER®.  Tris asserts that the method of manufacture and/or the use of generic QuilliChew ER® are covered by one or more claims of the patents-in-suit.

View the complaint here.

TherapeuticsMD, Inc. v. Amneal Pharmaceuticals, Inc.
3-20-cv-05256; filed April 29, 2020 in the District Court of New Jersey

• Plaintiff:  TherapeuticsMD, Inc.
• Defendants:  Amneal Pharmaceuticals, Inc., Amneal Pharmaceuticals LLC, and Amneal Pharmaceuticals of New York LLC

Claim:  Infringement of U.S. Patent Nos.:

• 10,052,386: "Progesterone formulations"
• 10,206,932: "Natural combination hormone replacement formulations and therapies"
• 8,633,178: "Natural combination hormone replacement formulations and therapies"
• 8,846,648: "Natural combination hormone replacement formulations and therapies"
• 8,846,649: "Natural combination hormone replacement formulations and therapies"
• 8,987,237: "Natural combination hormone replacement formulations and therapies"
• 8,993,548: "Natural combination hormone replacement formulations and therapies"
• 8,993,549: "Natural combination hormone replacement formulations and therapies"
• 9,006,222: "Natural combination hormone replacement formulations and therapies"
• 9,114,145: "Natural combination hormone replacement formulations and therapies"
• 9,114,146: "Natural combination hormone replacement formulations and therapies"
• 9,301,920: "Natural combination hormone replacement formulations and therapies"

Synopsis:  TherapeuticsMD asserts infringement of the '386, '932, '178, '648, '649, '237, '548, '549, '222, '145, '146, and '920 patents.  TherapeuticsMD holds approved NDA No. 210132 for the BIJUVA® (estradiol and progesterone capsule) for the treatment of moderate to severe vasomotor symptoms due to menopause.  Amneal submitted ANDA No. 214293, seeking approval to commercially manufacture, import, market, offer for sale, and/or sell generic BIJUVA®.  TherapeuticsMD asserts that the method of manufacture and/or the use of BUJUVA® are covered by one or more claims of the patents-in-suit.

View the complaint here.

Life Sciences Court Report

    By Bryan Helwig --

About Life Sciences Court Report:  We will periodically report on recently filed biotech and pharma litigation.

Pfizer Inc. v. Viwit Pharmaceutical Co.
1-20-cv-000160; filed January 31, 2020 in the District Court of Delaware

• Plaintiffs: CP Pharmaceuticals International CV, PF Prism CV, Pfizer Inc., amd Pfizer Products Inc.
• Defendant: Viwit Pharmaceutical Co., Ltd.

Claim: Infringement of U.S. Patent Nos.:

• 6,410,550: Aryl fused azapolycyclic compounds
• 6,890,927: Tartrate salts of 5,8, 14-triazateracyclo[10.3.1.02,11 04.9]-hexadeca-2(11),3,5,7,9-pentaene and pharmaceutical compositions thereof
• 7,265,119 Tartrate salts of 5,8,14-triazatetracyclo[10.3.1.0.sup.2,11.0.sup.4.9]-hexadeca-2(11),3,5,7-,9-pentaene and pharmaceutical compositions thereof

Synoposis:  Pfizer asserts infringement of the '550, '927, and '119 patents.  PF PRISM is the holder of approved NDA No. 021928 for varenicline tartrate tablets, (Chantix®) a nicotinic receptor partial agonist for use in smoking cessation.  Viwit submitted ANDA No. 212879 seeking approval to commercially manufacture, use, and sell generic versions of Chantix®.  Pfizer asserts that the method of manufacture, and/or the use of Chantix® are covered by one or more claims of the Patents-in Suit.

View the complaint here.

Silvergate Pharmaceuticals, Inc. v. CMP Development LLC
1-20-cv-000161; filed January 17, 2020 in the District Court of Delaware

• Plaintiff: Silvergate Pharmaceuticals, Inc.
• Defendant: CMP Development LLC

Claim: Infringement of U.S. Patent Nos.:

• 10,039,800: Lisinopril formulations
• 10,265,370: Lisinopril formulations
• 10,406,199: Lisinopril formulations
• 9,463,183: Lisinopril formulations
• 9,616,096: Lisinopril formulations
• 9,814,751: Lisinopril formulations

Synopsis:  Silvergate asserts infringement of the '800, '370, '199, '183, '096, and '751 patents.  Silvergate is the holder of approved NDA No. 208401 for lisinopril formulations of the angiotensin converting enzyme (ACE) inhibitor QBRELIS® for the treatment of hypertension in adults and pediatric patients.  CMP Development submitted ANDA No. 213935, seeking FDA approval to engage in commercial manufacturing, sale, and use of a generic version of Silvergate's QBRELIS® product.

View the complaint here.

Boehringer Ingelheim Pharmaceuticals, Inc. v. Mylan Pharmaceuticals Inc.
1-20-cv-00019; filed February 5, 2020 in the Northern District Court of West Virginia

• Plaintiffs: Boehringer Ingelheim Corp., Boehringer Ingelheim International GmbH, Boehringer Ingelheim Pharma GmbH & Co. KG, Boehringer Ingelheim Pharmaceuticals, Inc.
• Defendants: Mylan Inc., Mylan Laboratories Ltd., Mylan Pharmaceuticals Inc.

Claim: Infringement of U.S. Patent No.:

• 9,286,526: Treatment for diabetes in patients inappropriate for metformin therapy

Synopsis:  Boehringer asserts infringement of the '526 patent.  Boehringer is the holder of NDA No. 201280 for TRADJENTA® for oral use for the treatment of type 2 diabetes via increasing incretin levels.  Mylan submitted ANDA No. 208431 seeking approval to engage in the commercial manufacture and sale of generic copies of TRADJENTA®.

View the complaint here.

Boehringer Ingelheim Pharmaceuticals, Inc. v. Aurobindo Pharma Ltd.
5-20-cv-00023; filed February 5, 2020 in the District Court of Delaware

• Plaintiffs: Boehringer Ingelheim Corp., Boehringer Ingelheim International GmbH, Boehringer Ingelheim Pharma GmbH & Co. KG, Boehringer Ingelheim Pharmaceuticals, Inc.
• Defendant: Aurobindo Pharma Ltd.

Claim: Infringement of U.S. Patent No.:

• 9,286,526: Treatment diabetes in patients inappropriate for metformin therapy rs

Synoposis:  Boehringer asserts infringement of the '526 patent.  Boehringer is the holder of NDA No. 201280 for TRADJENTA® for oral use for the treatment of type 2 diabetes via increasing incretin levels.  Aurobindo submitted ANDA No. 208415 seeking approval to engage in the commercial manufacture and sale of generic copies of TRADJENTA®.

View the complaint here.

Gilead Sciences, Inc. v. Apotex, Inc.
1-20-cv-00189; filed February 7, 2020 in the District Court of New Jersey

• Plaintiff: Gilead Sciences, Inc.
• Defendants: Apotex Inc., Cipla Ltd., Hetero Labs Ltd. Unit-V, Hetero Labs Ltd., Hetero USA Inc., Laurus Labs Ltd., Lupin Ltd., Macleods Pharmaceuticals Ltd., Natco Pharma Ltd., Shilpa Medicare Ltd., and Sunshine Lake Pharma Co., Ltd.

Claim: Infringement of U.S. Patent Nos.:

• 7,390,791: Prodrugs of phosphonate nucleotide analogues
• 7,803,788: Prodrugs of phosphonate nucoleotide analogues
• 8,754,065: Tenofovir alafenamide hemifumarate
• 9,296,769: Tenofovir alafenamide hemifumarate

Synoposis:  Gilead asserts infringement of the '791, '788, '065, and '769 patents.  Gilead is the holder of NDA No. 208464 for VEMLIDY® (tenofovir alafenamide; 25 mg tablets) for the treatment of chronic hepatitis B virus infection in adults with compensated liver disease.  Gilead also holds NDA No. 208215 for DESCOVY® (emtricitabine 200 mg, tenofovir alafenamide 25 mg, and anti-viral agents) for treatment of HIV-1 infection in adults and pediatric patients, and for at-risk adults and adolescents for pre-exposure prophylaxis (PrEP) to reduce the risk of HIV-1 infection.  Gilead also holds NDA  No. 208351 for ODEFSEY® (200 mg emtricitabine, 25 mg rilpivirine, and 25 mg tenofovir alafenamide) for the treatment of HIV-1 infection in adults and pediatric patients either as an initial therapy in those with no antiretroviral treatment history or to replace a stable antiretroviral regimen in those who are virologically-suppressed.  Defendants, each independently, submitted one or more ANDA applications to engage in the commercial manufacture, use, importation, offer for sale, and/or sale of VEMLIDY®, DESCOVY®, and/or ODEFSEY®.

View the complaint here.

Allergan Sales, LLC  v. Breckenridge Pharmaceutical, Inc.
1-20-cv-00199; filed February 10, 2020 in the District Court of Delaware

• Plaintiffs: Allergan Sales, LLC, Allergan Pharmaceuticals International Ltd., Allergan USA, Inc.
• Defendant: Breckenridge Pharmaceutical, Inc.

Claim: Infringement of U.S. Patent No.:

• 5,763,476: Sublingual or buccal pharmaceutical composition

Synopsis:  Allergen asserts infringement of the '476 patent.  Allergen is the holder of NDA No. 22117 for the use of SAPHRIS® (asenapine maleate) for the treatment of schizophrenia and bipolar disorder.  The FDA granted pediatric exclusivity on March 3, 2015, thereby awarding an additional 6-months of market exclusivity after expiration of the patents listed in the Orange Book for SAPHRIS®.  Breckenridge submitted ANDA No. 205960 seeking to obtain approval for the commercial manufacture, use, and sale of asenapine maleate tablets.

View the complaint here.

American Regent, Inc. f/k/a Luitpold Pharmaceuticals, Inc. v. Pharmacosmos A/S
3-20-cv-01350; filed February 7, 2020 in the District Court of New Jersey

• Plaintiff: American Reagent, Inc.
• Defendants: Pharmacosmos Therapeutics Inc. and Pharmacosmos A/S

Claim: Infringement of U.S. Patent Nos.:

• 10,478,450: Methods and compositions for administration of iron
• 8,431,549: Methods and compositions for administration of iron

Synoposis:  American Reagent asserts infringement of the '549 and '450 patents.  Pharmacosmos A/S submitted NDA No. 208171 to market Monoferric® for the treatment of iron deficiency.  Plaintiff contends that Pharmacosmos A/S is working with Pharmacosmos Therapeutics, the latter founded in 2019 "to commercialize Monoferric® in the rapidly growing US high-dose IV iron market."  American Reagent contends that Pharmacosmos A/S, in active concert with Pharmacosmos Therapeutics Inc., will import, manufacture, market, offer for sell, and/or sell Monoferric® immediately and imminently.

Previously, in 2015, Pharmacosmos filed an IPR seeking to invalidate claims 7, 17, and 21 of the '549 patent.  Pharmacosmos was denied in its validity challenge as to the non-instituted claims (IPR2015-01493).  In 2019, Pharmacosmos filed a second IPR petition against claims 7 and 21 of the '549 patent.  The petition was denied in its entirety (IPR2019-01142).  In January 2020, Pharmacosmos filed a post-grant review, seeking to invalidate all claims of the '450 patent (PGR2020-00009).

View the complaint here.

Amgen Inc. v. Hospira, Inc.
1-20-cv-00201; filed February 11, 2020 in the District Court of Delaware

• Plaintiffs: Amgen Inc. and Amgen Manufacturing Ltd.
• Defendants: Hospira Inc. and Pfizer Inc.

Claim: Infringement of U.S. Patent No.:

• 8,273,707: Process for purifying proteins

Synopsis:  Amgen asserts infringement of the '707 patent.  Amgen is the reference product sponsor (RPS), of Neulasta® (human granulocyte-colony stimulating factor conjugated to a monomethoxypolyethylene glycol), which is approved for use to decrease the incidence of infection in patients receiving myelosuppressive anti-cancer drugs, by stimulating neutrophil production.  Amgen asserts that Hospira, acting in concert with Pfizer, submitted an abbreviated Biologics License Application for a proposed biosimilar to Amgen's Neulasta® product.  In August 2019, Amgen and Hospira began exchanging information as required by the BPCIA.  However, Amgen asserts that Hospira failed to provide Amgen with a true copy of the FDA application as required under 42 U.S.C. § 262(l)(2)(A).  Amgen also asserts that the submission of the Hospira Biologics License Application constitutes one or more acts of infringement of one or more claims of the '707 patent under 35 U.S.C. § 271(e)(2)(C).

View the complaint here.

Life Sciences Court Report

    By Bryan Helwig --

About Life Sciences Court Report:  We will periodically report on recently filed biotech and pharma litigation.

Allergan USA, Inc. v. Prollenium US Inc.
1-20-cv-00104; filed January 23, 2020 in the District Court of Delaware

• Plaintiffs: Allergan USA, Inc. and Allergan Industrie SAS
• Defendants: Prollenium Medical Technologies Inc. and Prollenium US Inc.

Claim: Infringement of U.S. Patent Nos.:

• 10,391,202: Hyaluronic acid-based gels including lidocaine
• 10,485,896: Hyaluronic acid-based gels including lidocaine

Synopsis:  Allergan asserts infringement of the '202 and '896 patents.  Allergen develops, manufacturers, and distributes dermal filler products including JUVEDÉRM® Ultra XC, JUVEDÉRM® Ultra Plus XC, and JUVEDÉRM® VOLUMA® XC.  Prollenium makes, uses, sells, offers to sell, and/or imports into the United States Revanesse® Versa+TM, a dermal filler.  Allergen asserts that Revanesse® Versa+TM infringes one of more claims of the '202 and '896 patents.

View the complaint here.

Relypsa, Inc. v. Alkem Laboratories Ltd.
1-20-cv-00106; filed January 23, 2020 in the District Court of Delaware

• Plaintiffs: Relypsa, Inc. and Vifor (International) Ltd.
• Defendant(s): Alkem Laboratories, Ltd. And Ascent Pharmaceuticals, Inc.

Claim: Infringement of U.S. Patent Nos.:

• 8,147,873 Methods and compositions for treatment of ion imbalances
• 8,337,824 Linear polyol stabilized polyfluoroacrylate compositions
• 9,492,476 Potassium-binding agents for treating hypertension and hyperkalemia
• 9,925,212 Potassium-binding agents for treating hypertension and hyperkalemia

Synopsis:  Relypsa asserts infringement of the '873, '824, '476, and '212 patents.  Relypsa is the holder of approved NDA No. 205739 for patiromer sorbitex calcium powder for oral suspension sold under the trade name VELTASSA®, a potassium binder indicated for the treatment of hyperkalemia.  Relypsa submitted ANDA No. 214075 seeking approval to engage in commercial manufacture, use, offer for sale, sale, and/or importation of patiromer sorbitex as generic versions of VELTASSA®.

View the complaint here.

Amgen Inc. v. Bionpharma Inc.
1-20-cv-00105; filed January 23, 2020 in the District Court of Delaware

• Plaintiffs: Amgen Inc. and Les Laboratoires Servier
• Defendant: Bionpharma, Inc.

Claim: Infringement of U.S. Patent Nos.:

• 7,361,649: -crystalline form of ivabradine hydrochloride, a process for its preparation and pharmaceutical compositions containing it
• 7,361,650 -crystalline form of ivabradine hydrochloride, a process for its preparation and pharmaceutical compositions containing it
• 7,867,996 -crystalline form of ivabradine hydrochloride, a process for its preparation and pharmaceutical compositions containing it
• 7,879,842 Beta-crystalline form of ivabradine hydrochloride, a process for its preparation and pharmaceutical compositions containing it

Synoposis:  Amgen asserts infringement of the '649, '650, '996, and '842 patents.  Amgen is the holder of approved NDA 20-6143 for Corlanor® (ivabradine) for the treatment of certain cases of chronic heart failure.  Amgen asserts that the method of manufacture, and/or their use of Corlanor® are covered by one or more claims of the Patents-in Suit.  Cadila submitted ANDA No. 213276 seeking approval to market generic Corlanor®.

View the complaint here.

Janssen Products, LP v. Zydus Pharmaceuticals (USA) Inc.
3-20-cv-00787; filed January 23, 2020 in the District Court of New Jersey

• Plaintiffs: Janssen Products, LP and Janssen Sciences Ireland UC
• Defendants: Cadila Healthcare Limited d/b/a Zydus Cadila and Zydus Pharmaceuticals (USA) Inc.

Claim: Infringement of U.S. Patent Nos.:

• 7,126,015 Method for the preparation of hexahydro-furo-[2,3-b]furan-3-ol
• 7,595,408 Methods for the preparation of (3R,3aS,6aR) hexahydro-furo[2,3-b]furan-3-ol
• 7,700,645 Pseudopolymorphic forms of a HIV protease inhibitor
• 8,518,987 Pseudopolymorphic forms of a HIV protease inhibitor

Synoposis:  Jassen Products asserts infringement of the '015, '408, '645, and '987 patents.  Jassen is the holder of approved NDA 21-976 for PREZISTA® for the treatment of HIV.  Zydus submitted ANDA No. 214085 seeking approval to make substantial and meaningful preparations to import into the United States and/or offer to sell, and/or use generic versions of PREZISTA®.

View the complaint here.

Amgen Inc. v. Multiple Defendants (separate cases)
Several cases filed on January 24, 2020 in the District Court of Delaware

• Plaintiffs: Amgen Inc. and Les Laboratoires Servier
• Defendants: Annora Pharma Private Ltd., Hetero Labs Ltd., Hetero USA, Inc., and Centaur Pharmaceuticals Private Ltd.

Claim: Infringement of U.S. Patent Nos.:

• 7,361,649: -crystalline form of ivabradine hydrochloride, a process for its preparation and pharmaceutical compositions containing it
• 7,361,650 -crystalline form of ivabradine hydrochloride, a process for its preparation and pharmaceutical compositions containing it
• 7,867,996 -crystalline form of ivabradine hydrochloride, a process for its preparation and pharmaceutical compositions containing it
• 7,879,842 Beta-crystalline form of ivabradine hydrochloride, a process for its preparation and pharmaceutical compositions containing it

Synoposis:  Amgen asserts infringement of the '649, '650, '996, and '842 patents.  Amgen is the holder of approved NDA 20-6143 for Corlanor® (ivabradine) for the treatment of certain cases of chronic heart failure.  Amgen asserts that the method of manufacture, and/or their use of Corlanor® are covered by one or more claims of the Patents-in Suit.  Defendants submitted ANDAs seeking approval to manufacture, import into the United States, market, and sell generic Corlanor®.

Novartis Pharmaceuticals Corp. v. Apotex Inc.
1-20-cv-000133; filed January 28, 2020 in the District Court of Delaware

• Plaintiff: Novartis Pharmaceuticals Corp.
• Defendants: Apotex Inc., Bionpharma Inc., Cadila Healthcare Ltd. d/b/a Zydus Cadila, Emcure Pharmaceuticals Ltd., Ezra Ventures, LLC, Glenmark Pharmaceuticals Inc. USA f/k/a Glenmark Generics Inc. USA, Glenmark Pharmaceuticals Ltd. f/k/a Glenmark Generics Ltd., HEC Pharm Co., Ltd., HEC Pharm USA Inc., Heritage Pharmaceuticals Inc., Hetero Labs Ltd. Unit-V, Hetero Labs Ltd., Hetero USA, Inc., Prinston Pharmaceutical Inc., Strides Global Pharma Private Ltd., Strides Pharma Inc., Zydus Pharmaceuticals (USA) Inc.

Claim: Infringement of U.S. Patent No.:

• 10,543,179 Dosage regimen of an S1P receptor modulator

Synopsis:  Novartis asserts infringement of the '179 patent.  Novartis is the holder of approved NDA No. 022257 for GILENYA® (fingolimod) Capsules, a sphingosine 1-phosphate receptor (S1PR) modulator for the treatment of relapsing forms of multiple sclerosis (MS).  Novartis has pending litigation against the parties for infringement of U.S. Patent No. 9,187,405.  Novartis alleges that the the defendants continues to make, substantial preparation to engage in the commercial manufacture, use, offer to sell, or sale generic versions of Novartis’s GILENYA® Capsules.

View the complaint here.

Sucampo GmbH f/k/a Sucampo AG v. Zydus Pharmaceuticals (USA) Inc.
1-20-cv-00936; filed January 28, 2020 in the District Court of New Jersey

• Plaintiffs: Sucampo GmbH f/k/a Sucampo AG, Sucampo Pharma Americas LLC, Sucampo Pharma, LLC, Sucampo Pharmaceuticals, Inc., Takeda Pharmaceutical Co. Ltd., Takeda Pharmaceuticals America, Inc., Takeda Pharmaceuticals USA, Inc.
• Defendant: Zydus Pharmaceuticals (USA) Inc.

Claim: Infringement of U.S. Patent Nos.:

• 7,795,312 Method for treating abdominal discomfort
• 8,026,393 Soft-gelatin capsule formulation
• 8,338,639 Soft-gelatin capsule formulation
• 8,748,481 Method for treating gastrointestinal disorder
• 8,779,187 Soft-gelatin capsule formulationMethods of treatment and pharmaceutical composition

Synopsis:  Sucampo asserts infringement of the '312, '393, '639, '481, and '187 patents.  Sucampo is the holder of NDA No. 021908, lubiprostone capsules, both marketed in the United States under the trade name AMITIZA® for the treatment of chronic idiopathic constipation in adults and the treatment of opioid-induced constipation in adult patients with chronic, non-cancer pain.  Zydus submitted ANDA No. 2141313 seeking approval to commercially manufacture, use, market, or sell generic lubiprostone capsules.

View the complaint here.

Amgen Inc. v. MSN Pharmaceuticals, Inc.
1-20-cv-00137; filed January 29, 2020 in the District Court of Delaware

• Plaintiffs: Amgen Inc. and Les Laboratoires Servier
• Defendants: MSN PPharmaceuticals, Inc. and MSN Laboratories Private Ltd.

Claim: Infringement of U.S. Patent Nos.:

• 7,361,649: -crystalline form of ivabradine hydrochloride, a process for its preparation and pharmaceutical compositions containing it
• 7,361,650 -crystalline form of ivabradine hydrochloride, a process for its preparation and pharmaceutical compositions containing it
• 7,867,996 -crystalline form of ivabradine hydrochloride, a process for its preparation and pharmaceutical compositions containing it
• 7,879,842 Beta-crystalline form of ivabradine hydrochloride, a process for its preparation and pharmaceutical compositions containing it

Synopsis:  Amgen asserts infringement of the '649, '650, '996, and '842 patents.  Amgen is the holder of approved NDA 20-6143 for Corlanor® (ivabradine) for the treatment of certain cases of chronic heart failure.  Amgen asserts that the method of manufacture, and/or their use of Corlanor® are covered by one or more claims of the Patents-in Suit.  Defendants submitted ANDA 213483 seeking approval to manufacture, import into the United States, market, and sell generic Corlanor®.

View the complaint here.

Life Sciences Court Report

    By Bryan Helwig --

About Life Sciences Court Report:  We will periodically report on recently filed biotech and pharma litigation.

Amgen Inc. v. Zydus Pharmaceuticals (USA) Inc.
1-20-cv-00075; filed January 17, 2020 in the District Court of Delaware

• Plaintiffs: Amgen Inc. and Les Laboratoires Servier
• Defendants: Cadila Healthcare Ltd. d/b/a Zydus Cadila and Zydus Pharmaceuticals (USA) Inc.

Claim:  Infringement of U.S. Patent Nos.:

• 7,361,649: "β-crystalline form of ivabradine hydrochloride, a process for its preparation and pharmaceutical compositions containing it"
• 7,361,650: "γ-crystalline form of ivabradine hydrochloride, a process for its preparation and pharmaceutical compositions containing it"
• 7,867,996: "γ-crystalline form of ivabradine hydrochloride, a process for its preparation and pharmaceutical compositions containing it"
• 7,879,842: "β-crystalline form of ivabradine hydrochloride, a process for its preparation and pharmaceutical compositions containing it"

Synoposis:  Amgen asserts infringement of the '649, '650, '996, and '842 patents.  Amgen is the holder of approved NDA 20-6143 for Corlanor® (ivabradine) for the treatment of certain cases of chronic heart failure.  Amgen asserts that the method of manufacture, and/or their use of Corlanor® are covered by one or more claims of the Patents-in Suit.  Cadila submitted ANDA No. 213442 seeking approval to market generic Corlanor®.

View the complaint here.

Novartis Pharmaceuticals Corp. v. Alembic Pharmaceuticals, Ltd.
1-20-cv-00074; filed January 17, 2020 in the District Court of Delaware

• Plaintiff: Novartis Pharmaceuticals Corp.
• Defendants: Alembic Global Holdings SA, Alembic Pharmaceuticals, Inc., and Alembic Pharmaceuticals, Ltd.

Claim: Infringement of U.S. Patent Nos.:

• 8,101,659: "Methods of treatment and pharmaceutical composition"
• 8,796,331: "Methods of treatment and pharmaceutical composition"
• 8,877,938: "Compounds containing S-N-valeryl-N-{[2'-(1H-tetrazole-5-yl)-biphenyl-4-yl]-methyl}-valine and (2R,4S)-5-biphenyl-4-yl-4-(3-carboxy-propionylamino)-2-methyl-pentanoic acid ethyl ester moieties and cations"
• 9,388,134: "Compounds containing S-N-valeryl-N-{[2'-(1H-tetrazole-5-yl)-biphenyl-4-yl]-methyl)-valine and (2R,4S)-5-biphenyl-4-yl-4-(3-carboxy-propionylamino)-2-methyl-pentanoic acid ethyl ester moieties and cations"

Synopsis:  Novartis asserts infringement of the '659, '331, '938, and '134 patents.  Novartis is the holder of New Drug Application No. 207620 for the commercial manufacturing, marketing, sale, and use of ENTRESTO® (sacubitril and valsartan) tablets, to reduce the risk of cardiovascular death and hospitalization for heart failure in patients with chronic heart failure (NYHA Class II-IV) and reduced ejection fraction, and for the treatment of symptomatic heart failure with systemic left ventricular systolic dysfunction in pediatric patients aged one year and older.  Actavis submitted ANDA No. 213682, seeking FDA approval to engage in the commercial manufacture, use, sale, offer for sale, and/or importation of sacubitril/valsartan tablets, generic versions of Novartis’s ENTRESTO® tablets.

View the complaint here.

Merck Sharp and Dohme Corp. v. Actavis Laboratories FL, Inc. f/k/a Watson Laboratories, Inc.
1-20-cv-20217; filed January 17, 2020 in the Southern District Court of Florida

• Plaintiffs: Cubist Pharmaceuticals LLC f/k/a Cubist Pharmaceuticals, Inc.; MSD International GmbH; MSD Investment Holdings (Ireland); Merck Sharp & Dohme Corp.; Optimer Pharmaceuticals LLC f/k/a Optimer Pharmaceuticals, Inc.
• Defendants: Actavis Laboratories FL, Inc. f/k/a Watson Laboratories, Inc. – Florida; Actavis Pharma, Inc. f/k/a Watson Pharma, Inc.; Teva Pharmaceuticals USA, Inc.

Claim: Infringement of U.S. Patent Nos.:

• 7,378,508: "Polymorphic crystalline forms of tiacumicin B"
• 7,863,249: "Macrolide polymorphs, compositions comprising such polymorphs, and methods of use and manufacture thereof"
• 7,906,489: "18-membered macrocycles and analogs thereof"
• 8,586,551: "18-membered macrocycles and analogs thereof"
• 8,859,510: "Macrocyclic polymorphs, compositions comprising such polymorphs, and methods of use and manufacture thereof"

Synopsis:  Cubist asserts infringement of the '508, '249, '489, '551, and '510 patents.  Cubist is the holder of NDA No. 201699 for DIFICID® (fidaxomicin) tablets for oral use for the treatment of Clostridium difficile associated diarrhea in adults.  Actavis submitted ANDA No. 208443 seeking approval to engage in the commercial manufacture, use, sale, offer for sale, and/or importation of generic copies of DIFICID® (fidaxomicin) tablets.

View the complaint here.

Vanda Pharmaceuticals Inc. v. Apotex Inc.
1-20-cv-00083; filed January 21, 2020 in the District Court of Delaware

• Plaintiff: Vanda Pharmaceuticals Inc.
• Defendants: Apotex Corp. and Apotex Inc.

Claim: Infringement of U.S. Patent Nos.:

• 10,449,176: "Treatment of circadian rhythm disorder"

Synoposis: Vanda asserts infringement of the '176 patent.  Vanda is the holder of NDA 205,677 for Hetlioz® (tasimelteon) for the treatment of Non-24, a circadian rhythm sleep disorder.  Apotex submitted ANDA No. 211607 seeking approval to to commercially manufacture and sell generic tasimelteon capsules for the treatment of Non-24.

View the complaint here.

Amgen Inc. v. Zydus Pharmaceuticals (USA) Inc.
3-20-cv-00678; filed January 21, 2020 in the District Court of New Jersey

• Plaintiffs: Amgen Inc. and Les Laboratoires Servier
• Defendants: Cadila Healthcare Ltd. d/b/a Zydus Cadila and Zydus Pharmaceuticals (USA) Inc.

Claim:  Infringement of U.S. Patent Nos.:

• 7,361,649: "β-crystalline form of ivabradine hydrochloride, a process for its preparation and pharmaceutical compositions containing it"
• 7,361,650: "γ-crystalline form of ivabradine hydrochloride, a process for its preparation and pharmaceutical compositions containing it"
• 7,867,996: "γ-crystalline form of ivabradine hydrochloride, a process for its preparation and pharmaceutical compositions containing it"
• 7,879,842: "β-crystalline form of ivabradine hydrochloride, a process for its preparation and pharmaceutical compositions containing it"

Synoposis:  Amgen asserts infringement of the '649, '650, '996, and '842 patents.  Amgen is the holder of approved NDA 20-6143 for Corlanor® (ivabradine) for the treatment of certain cases of chronic heart failure.  Amgen asserts that the method of manufacture, and/or their use of Corlanor® are covered by one or more claims of the Patents-in Suit.  Cadila submitted ANDA No. 213442 seeking approval to market generic Corlanor®.

View the complaint here.

Vanda Pharmaceuticals Inc. v. Teva Pharmaceuticals USA, Inc.
1-20-cv-00093; filed January 22, 2020 in the District Court of Delaware

• Plaintiff(s): Vanda Pharmaceuticals Inc
• Defendant(s): Teva Pharmaceuticals USA, Inc.

Claim: Infringement of U.S. Patent No.:

• 10,449,176: "Treatment of circadian rhythm disorders"

Synopsis:  Vanda asserts infringement of the '176 patent.  Vanda is the holder of NDA 205,677 for Hetlioz® (tasimelteon) for the treatment of Non-24, a circadian rhythm sleep disorder.  Teva submitted ANDA No. 211601 seeking approval to to commercially manufacture and sell generic tasimelteon capsules for the treatment of Non-24.

View the complaint here.

Washington State University v. Pro Orchard Management LLC
2-20-cv-00038; filed January 22, 2020 in the District Court of Washington

• Plaintiff: Washington State University
• Defendants: Apple King LLC and Pro Orchard Management LLC

Claim: Infringement of U.S. Patent No.:

• PP21710: "Apple tree named 'WA-2'"

Synopsis: Washington State University (WSU) claims infringement of the '710 patent for an apple cultivar developed by WSU known as WA-2.  WSU alleges that Pro Orchard Management infringed Patent No. 21,710 by asexually reproducing and growing WA 2 apple trees and by harvesting WA 2 apples and consigning them to Apple King, LLC for sale.  WSU further alleges that Apple King, LLC has infringed the '710 patent by selling WA 2 apples that unlicensed growers such as Pro Orchard Management, LLC have consigned to it for sale.  In addition, the WSU alleges that Pro Orchard Management, LLC and,Apple King, LLC have induced infringement of Plant Patent No. 21,710 by providing WA 2 budwood to unlicensed persons who have used the budwood to asexually reproduce WA 2 apple trees.

View the complaint here.

Life Sciences Court Report

    By Bryan Helwig --

About Life Sciences Court Report:  We will periodically report on recently filed biotech and pharma litigation.

Horizon Therapeutics, LLC v. Par Pharmaceutical, Inc.
1-18-cv-01224; filed August 10, 2018 in the District Court of Delaware

• Plaintiff: Horizon Therapeutics, LLC
• Defendants: Par Pharmaceuticals, Inc., Par Pharmaceutical Companies, Inc.

Claim: Infringement of U.S. Patent No.

• 8,642,012: "Methods of treatment using ammonia-scavenging drugs"

Synopsis:  Horizon Therapeutics, LLC claims infringement of the ′012 patent for RAVICTI® (glycerol phenylbutyrate oral liquid 1.1gm/ml).  Horizion Therapeutics holds NDA No. 20324 for RAVICTI®, which is used as a nitrogen-binding agent for chronic management of adult and pediatric patients with urea cycle disorders.  Defendants, under ANDA No. 205742, seek approval to engage in the commercial manufacture, use, or sale of a generic version of RAVICTI® prior to the expiration of the '012 patent.

View the complaint here.

Allergan, Inc. v. Saptalis Pharmaceuticals, LLC
1-18-cv-01231; filed August 10, 2018 in the District Court of Delaware (Wilmington)

• Plaintiffs: Allergan, Inc. and Saint Regis Mohawk Tribe
• Defendant: Saptalis Pharmaceuticals, LLC

Claim: Infringement of U.S. Patent Nos.

• 8,633,162: ″Methods of providing therapeutic effects using cyclosporin components"
• 8,642,556: "Methods of providing therapeutic effects using cyclosporin components"

Synopsis:  Allergan and Saint Regis Mohawk Tribe allege infringement of the ′162 and ′556 patents.  The Saint Regis Mohawk Tribe, as assignee, owns the entire right, title, and interest in the ′162 and ′556 patents.  Allergan is the holder of approved NDA No. 50-790 for Cyclosporine Ophthalmic Emulsion, 0.05%, sold under the RESTASIS® trademark.  Allergan holds an exclusive field-of-use license to the ʼ162 and ′556 patents with respect to commercializing RESTASIS®.  On information and belief, Saptalis submitted ANDA No. 211943 seeking FDA approval to engage in the commercial manufacture, use, importation, sale, or offer for sale of Cyclosporine Ophthalmic Emulsion, 0.05%, a generic version of Allergan's RESTASIS® product.  Plaintiffs seek declaratory judgment of Infringement of the ′012 and '556 patents.

View the complaint here.

AstraZeneca LP v. Hisun Pharmaceutical (Hangzhou) Co., Ltd.
1-18-cv-01232; filed August 10, 2018 in the District Court of Delaware (Wilmington)

• Plaintiffs: AstraZeneca LP, AstraZeneca AB, AstraZeneca UK Ltd., and AstraZeneca Pharmaceuticals LP
• Defendants: Hisun Pharmaceutical (Hangzhou) Co., Ltd. and Hisun Pharmaceuticals USA, Inc.

Claim: Infringement of U.S. Patent Nos.

• 7,250,419: ″Trisubstituted triazolopyrimidines for use in platelet aggregation inhibition″
• 7,265,124: ″Cristalline and amorphous form of a triazolo (4,5-D) pyridimine compound″
• RE46276: ″Triazolo(4,5-D)pyrimidine compounds″

Synopsis:  AstraZeneca claims infringement of the ′419, ′124, and ′276 patents.  AstraZeneca is the holder of NDA No. 022433 for the marketing and sale of BRILINTA® (ticagrelor) tablets in 90 mg and 60 mg dosage strengths.  BRILINTA® is intended to reduce the rate of cardiovascular death, myocardial infarction, and stroke in patients with acute coronary syndrome or a history of myocardial infarction.  Hisun filed ANDA No. 208575 for commercial manufacture, use, and sale of generic ticagrelor tablets.

View the complaint here.

Related Cases: 15-cv-1042-RGA: AstraZeneca previously filed suit against Hisun regarding its ticagrelor ANDA and its proposed 90 mg dosage strength generic ticagrelor tablet. The parties later jointly dismissed the case without prejudice.

Boehringer Ingelheim Pharmaceuticals, Inc. v. Lupin Atlantis Holdings SA
3-18-cv-12663; filed August 10, 2018 in the District Court of New Jersey (Trenton)

• Plaintiffs: Boehringer Ingelheim Pharmaceuticals, Inc., Boehringer Ingelheim International GmbH, and Boehringer Ingelheim Pharma GmbH & Co. KG
• Defendants: Lupin Atlantis Holdings SA and Lupin Ltd.

Claim: Infringement of U.S. Patent Nos.

• 7,070,800: ″Inhalable Powder Containing Tiotropium″
• 7,694,676: ″Dry Powder Inhaler″

Synopsis:  Boehringer claims infringement of the ′800 and ′676 patents.  Boehringer is the holder of NDA No. 021395 for SPIRIVA® HandiHaler®, an anticholinergic indicated for the long-term, once-daily, maintenance treatment of bronchospasm associated with chronic obstructive pulmonary disease (COPD), and for reducing COPD exacerbations.  Lupin submitted ANDA No. 211287 to engage in the commercial manufacture, use, or sale of tiotropium bromide inhalation powder, 18 mcg/capsule, as a purported generic version of SPIRIVA® HandiHaler®.

View the complaint here.

AbbVie Inc. v. Sandoz Inc.
3-18-cv-12668; filed August 10, 2018 in the District Court of New Jersey (Trenton)

• Plaintiffs: AbbVie Inc., and Abbvie Biotechnology Ltd.
• Defendants: Sandoz Inc., Sandoz GmbH, and Sandoz International GmbH

Claim:  Infringement of U.S. Patent Nos.

• 9,187,559: ″Multiple-variable dose regimen for treating idiopathic inflammatory bowel disease″
• 9,750,808: ″Formulation of human antibodies for treating TNF-Alpha associated disorders″

Synopsis:  Abbvie Biotechnology Ltd. is the owner by assignment of the ′559 and ′808 patents.  AbbVie Inc. is the holder of Biologic License Application No. 125057 for HUMIRA®, whose active pharmaceutical ingredient is the antibody adalimumab.  Sandoz had submitted an abbreviated Biologics License Application ("aBLA") requesting that its biosimilar adalimumab product GP2017 be licensed for commercial sale by relying on AbbVie's demonstration that HUMIRA® is safe and effective.  Abbvie alleges that the aBLA provides Sandoz an abbreviated regulatory pathway for its biosimilar version of HUMIRA®, however in doing so Sandoz has infringed AbbVie's patents.

View the complaint here.

Athenex Pharma Solutions, LLC  v. Par Pharmaceutical, Inc.
1-18-cv-00896; filed August 13, 2018 in the District Court Western District of New York (Buffalo)

• Plaintiffs: Athenex Pharma Solutions, LLC and Athenex Pharmaceutical Division, LLC
• Defendants: Par Pharmaceutical, Inc., Par Sterile Products, LLC, and Endo Par Innovation Co., LLC

Claim: Infringement of U.S. Patent Nos.

• 9,375,478: ″Vasopressin formulations for use in treatment of hypotension″
• 9,687,526: ″Vasopressin formulations for use in treatment of hypotension″
• 9,744,209: ″Vasopressin formulations for use in treatment of hypotension″
• 9,744,239: ″Vasopressin formulations for use in treatment of hypotension″
• 9,750,785: ″Vasopressin formulations for use in treatment of hypotension″
• 9,937,223: ″Vasopressin formulations for use in treatment of hypotension″

Synopsis:  Athenex seeks a declaration of non-infringement and invalidity of the ′478, ′526, ′209, ′239, ′785, and ′223 Patent.  Par Sterile is the manufacturer of Vasostrict® and is the holder of NDA No. 204485.  The active ingredient in Vasostrict® is vasopressin.  Athenex's compounded vasopressin products will be administered to patients in a ready-to-use form, eliminating the need for mixing by a health care professional.  As a result, Plaintiffs allege that their compounded vasopressin products do not, and would not, if marketed, infringe any claims of the patents in suit.

View the complaint here.

Valeant Pharmaceuticals v. Actavis Laboratories FL., Inc.
1-18-cv-01288; filed August 22, 2018 in the District Court of Delaware (Wilmington)

• Plaintiff: Valeant Pharmaceuticals International, Salix Pharmaceuticals Ltd., and Cosmo Technologies Ltd.
• Defendant: Actavis Laboratories FL, Inc., Actavis Pharma, Inc., Teva Pharmaceuticals USA, Inc., Teva Pharmaceutical Industries Ltd.

Claim: Infringement of U.S. Patent No.

• 10,052,286: ″Controlled release and taste masking oral pharmaceutical composition″

Synopsis:  Valent claims infringement of the ′286 patent.  VPI holds NDA No. 203634 for oral tablets containing 9 mg of the active ingredient budesonide, which are sold in the United States under the brand name Uceris®.  Uceris® is indicated for the induction of remission in patients with active, mild to moderate ulcerative colitis.  Actavis Labs submitted ANDA No. 205457 and seeks to engage in making, using, offering to sell and selling in the United States and/or importing into the United States its generic version of Uceris®.

View the complaint here.

Insys Therapeutics, Inc. v. Teva Pharmaceuticals USA, Inc.
1-18-cv-01308; filed August 23, 2018 in the District Court of Delaware (Wilmington)

• Plaintiffs: Insys Therapeutics, Inc. and Insys Development Co., Inc.
• Defendants: Teva Pharmaceuticals USA, Inc. and Teva Pharmaceutical Industries Ltd.

Claim: Infringement of U.S. Patent Nos.

• 8,486,972:  ″Sublingual fentanyl spray″
• 8,486,973: ″Sublingual fentanyl spray″
• 8,835,459: ″Sublingual fentanyl spray″
• 8,835,460: ″Sublingual fentanyl spray and methods of treating pain″
• 9,241,935: ″Sublingual fentanyl spray″
• 9,289,387: ″Method of treating pain by administering sublingual fentanyl spray″
• 9,642,797:  ″Sublingual fentanyl spray and methods of use to treat pain″
• 9,642,844: ″Sublingual fentanyl spray″

Synopsis:  Insys claims infringement of the ′972, ′973, ′459, ′460, ′935, ′387, ′797, and ′844 patents.  Insys holds NDA No. 202788 on SUBSYS®, a fentanyl sublingual spray, and is the exclusive distributor of SUBSYS® in the United States.  Defendants, under ANDA No. 211209 have indicated they intend to engage in the commercial manufacture, use, or sale of a Fentanyl Sublingual Spray, 0.8 mg before the expiration of the patents-in-suit.

View the complaint here.

Life Sciences Court Report

    By Bryan Helwig --

About Life Sciences Court Report:  We will periodically report on recently filed biotech and pharma litigation.

Celgene Corp. v. Synthon Pharmaceuticals, Inc.
2:18-cv-10775; filed June 19, 2018 in the District of New Jersey (Newark)

• Plaintiffs: Celgene Corp.
• Defendants: Alvogen Pine Brook, LLC; Synthon BV; Synthon Pharmaceuticals, Inc.; and Synthon S.R.O

Claim: Infringement of U.S. Patent Nos.:

• 8,198,262: ″Methods for treating multiple myeloma using 4-(amino)-2-(2,6-dioxo(3-piperidyl))-isoindoline-1,3-dione″
• 8,673,939: ″Methods for treating multiple myeloma with 4-(amino)-2-(2,6-dioxo(3-piperidyl))-isoindoline-1,3-dione″
• 8,735,428: ″Methods for treating multiple myeloma with 4-(amino)-2-(2,6-dioxo(3-piperidyl))-isoindoline-1,3-dione″
• 8,828,427: ″Formulations of 4-amino-2-(2,6-dioxopiperidine-3-yl)isoindoline-1,3-dione″

Synoposis:  Celgene claims Infringement of the '262, '939, '428, and '427 patents.  Celgene holds approved NDA No. 204026 for pomalidomide capsules, which it sells under the trade name POMALYST®.  POMALYST® is an FDA-approved medication used for the treatment of multiple myeloma.  The claims of the patents-in-suit cover, inter alia, methods of use and administration of pomalidomide, or pharmaceutical compositions containing pomalidomide.  Synthon Pharmaceuticals, Inc. submitted ANDA No. 210232 to engage in the commercial manufacture, use, offer for sale, sale, or importation into the United States of Synthon's Proposed Products, prior to the expiration of the '262 patent.

View the complaint here.

Huvepharma EOOD f/k/a Huvepharma ADl v. E.I. du Pont de Nemours and Company
1-18-cv-00914; filed June 20, 2018 in the District of Delaware (Wilmington)

• Plaintiffs: Huvepharma EOOD and Huvepharma, Inc.
• Defendants: E.I. du Pont de Nemours and Company; DuPont Industrial Biosciences USA, LLC; Danisco USA, Inc.; and Danisco US Inc.

Claim:  Infringement of U.S. Patent Nos.:

• 7,026,150: ″Overexpression of phytase genes in yeast systems″
• 7,312,063: ″Overexpression of phytase genes in yeast systems″
• 8,455,232: ″Overexpression of phytase genes in yeast systems″

Synopsis:  Huvepharma claims infringement of the '150, '063, and '232 patents.  Plaintiff claims that beginning in the 2003 time frame, Defendants contracted with Fermic S.A. de C.V. in Mexico to manufacture Phyzyme phytase products in Mexico, followed by manufacturing Phyzyme phytase products at a second location in Europe which was also imported by Defendants and/or their predecessors-in-interest into the United States.

View the complaint here.

Genentech, Inc. v. Amgen Inc.
1-18-cv-00924; filed June 21, 2018 in the District of Delaware (Wilmington)

• Plaintiffs: Genentech, Inc. and City of Hope
• Defendant: Amgen Inc.

Claim: Infringement of Patent Nos.:

• 6,121,428: ″Protein recovery″
• 6,242,177: ″Methods and compositions for secretion of heterologous polypeptides″
• 6,331,415: ″Methods of producing immunoglobulins, vectors and transformed host cells for use therein″
• 6,407,213: ″Method for making humanized antibodies″
• 6,417,335: ″Protein purification″
• 6,489,447: ″Protein purification″
• 6,586,206: ″Methods for making recombinant proteins using apoptosis inhibitors″
• 6,620,918: ″Separation of polypeptide monomers″
• 6,627,196: ″Dosages for treatment with anti-ErbB2 antibodies″
• 6,870,034: ″Protein purification″
• 7,371,379: ″Dosages for treatment with anti-ErbB2 antibodies″
• 7,449,184: ″Fixed dosing of HER antibodies″
• 7,501,122: ″Treatment with anti-ErbB2 antibody combinations″
• 7,846,441: ″Treatment with anti-ErbB2 antibodies″
• 7,892,549: ″Treatment with anti-ErbB2 antibodies″
• 7,923,221: ″Methods of making antibody heavy and light chains having specificity for a desired antigen″
• 7,993,834: ″Detection of ErbB2 gene amplification to increase the likelihood of the effectiveness of ErbB2 antibody breast cancer therapy″
• 8,044,017: ″Protein purification″
• 8,076,066: ″Gene detection assay for improving the likelihood of an effective response to a HER2 antibody cancer therapy″
• 8,314,225: ″Heavy chain mutant leading to improved immunoglobulin production″
• 8,357,301: ″Chromatography equipment characterization″
• 8,425,908: ″Treatment with anti-ErbB2 antibodies″
• 8,440,402: ″Gene detection assay for improving the likelihood of an effective response to a HER2 antibody cancer therapy″
• 8,460,895: ″Method for producing recombinant proteins with a constant content of pCO₂ in the medium″
• 8,512,983: “Production of proteins in glutamine-free cell culture media″
• 8,574,869: ″Prevention of disulfide bond reduction during recombinant production of polypeptides″
• 8,691,232: ″Extending time to disease progression or survival in cancer patients″
• 8,710,196: ″Protein purification″
• 8,771,988: ″Protein expression from multiple nucleic acids″
• 9,047,438: ″Chromatography equipment characterization″
• 9,080,183: ″Promoter″
• 9,249,218: “Protein purification″
• 9,428,766: “Protein expression from multiple nucleic acids″
• 9,487,809: ″Decreasing lactate level and increasing polypeptide production by downregulating the expression of lactate dehydrogenase and pyruvate dehydrogenase kinase″
• 9,493,744: ″Methods for viral inactivation and other adventitious agents″
• 9,714,293: ″Production of proteins in glutamine-free cell culture media″
• 9,868,760: ″Protein purification″

Synoposis:  Genentech has multiple patents on Herceptin®, its manufacture, and its use for the treatment of HER2-positive breast cancer.  Plaintiffs claim that Amgen is seeking FDA approval of a biosimilar version of Herceptin® called ABP 980 with the same label indications and usage as Herceptin®.  Plaintiffs allege infringement based upon Amgen's submission of its aBLA for ABP 980.  Plaintiffs also seek a declaratory judgment.  Genentech claimed patent infringement and Defendant expressed concern that complaint contained confidential information.  Complaint was sealed on June 25, 2018, a redacted version of the Complaint was filed on July 2, 2018.

View redacted complaint here.

Astellas Pharma Inc. v. Aurobindo Pharma Ltd.
1-18-cv-00932; filed on June 25, 2018 in The District of Delaware (Wilmington)

• Plaintiffs: Astellas Pharma Inc.; Astellas Pharma U.S., Inc.; Astellas Ireland Co., Ltd.; and Astellas Pharma Europe Ltd.
• Defendant: Aurobindo Pharma Ltd.

Claim:  Infringement of U.S. Patent No.:

• 6,017,927: ″Quinuclidine derivatives and medicinal composition thereof″

Synopsis:  Astellas Pharma Inc. claims infringement the ′927 patent.  Astellas Pharma U.S., Inc. holds approved NDA No. 21518 for VESIcare® tablets in 5 mg and 10 mg strength tablet dosage forms, which contain the active ingredient solifenacin succinate.  Aurobindo India submitted ANDA No. 206817 seeking FDA approval to engage in the commercial manufacture, use, offer for sale, sale, and/or importation of generic solifenacin succinate 5 mg and 10 mg tablets, for the treatment of overactive bladder prior to the expiration of the ′927 patent.  Aurobindo India's ANDA submission included a certification that, in Aurobindo India's opinion, the claims of the ′927 patent are invalid.

View the complaint here.

Celgene Corp. v. Sandoz Inc.
3-18-cv-11026; filed on June 26, 2018 in the District of New Jersey (Trenton)

• Plaintiff: Celgene Corp.
• Defendant: Sandoz Inc.

Claim: Infringement of U.S. Patent Nos.:

• 6,962,940: ″(+)-2-[1-(3-Ethoxy-4-methoxyphenyl)-2-methylsulfonylethyl]-4-acetylaminoiso indoline-1,3-dione: methods of using and compositions thereof″
• 7,208,516: ″Methods of the treatment of psoriatic arthritis using (+)-2-[1-(3-ethoxy-4-methoxyphenyl)-2-methylsulfonylethyl]-4-acetylaminoi- soindoline-1,3-dione″
• 7,427,638: ″(+)-2-[1-(3-ethoxy-4-methoxyphenyl)-2-methylsulfonylethyl]-4-acetylaminois- oindoline-1,3-dione:, and methods of synthesis and compositions thereof″
• 7,659,302: ″Methods of using (+)-2-[1-(3-ethoxy-4 methoxyphenyl)-2-methylsulfonylethyl]-4 acetylaminoisoindoline 1,3-dione″
• 7,893,101: ″Solid forms comprising (+)-2-[1-(3-ethoxy-4-methoxyphenyl)-2-methylsulfonylethyl]-4-acetylaminoi- soindoline-1,3-dione, compositions thereof, and uses thereof″
• 8,455,536: ″Methods of using (+)-2-[1-(3-ethoxy-4-methoxyphenyl)-2-methylsulfonylethyl]-4-acetylaminoi- soindoline 1,3-dione″
• 8,802,717: ″Methods of treating arthritic conditions using (+)-2-[1-(3-ethoxy-4-methoxyphenyl)-2-methylsulfonylethyl]-4-acetylaminoi- soindoline 1,3-dione″
• 9,018,243:  ″Solid forms comprising (+)-2-[1-(3-ethoxy-4-methoxyphenyl)-2-methylsulfonylethyl]-4-acetylaminoi- soindoline-1,3-dione, compositions thereof, and uses thereof″
• 9,872,854: ″Methods for the treatment of psoriatic arthritis using apremilast″

Synoposis:  Celgene Corp. claims infringement of the ′940, ′516, ′638, ′302, ′101, ′536, ′717, ′243, and ′854 Patents.  Celgene makes and sells OTEZLA® (apremilast) 10 mg, 20 mg, and 30 mg tablets for treatment of adult patients with active psoriatic arthritis as well as patients with moderate to severe plaque psoriasis who are candidates for phototherapy or systemic therapy.  OTEZLA® is the first approved pharmaceutical product to contain apremilast and was granted five years of regulatory exclusivity for a new chemical entity, which expires on March 21, 2019.  Plaintiff alleges Sandoz submitted ANDA No. 211658 to obtain approval to engage in the commercial manufacture, use, offer for sale, sale, or importation into the United States of generic apremilast tablets prior to the expiration of the patents-in-suit.  Celgene claims infringement and Sandoz counters that the patents-in-suit are invalid, unenforceable, or would not be infringed.

View the complaint here.

Related matters:

• Celgene Corp. v. Macleods Pharmaceuticals Ltd.
3-18-cv-11212; filed on June 28, 2018 in the District of New Jersey (Trenton)
Infringement of the ′638 patent

• Celgene Corp. v. MSN Laboratories Private Ltd.
3-18-cv-11213; filed June 28, 2018 in the District of New Jersey (Trenton)
Infringement of the ′638 patent

• Celgene Corp. v. Prinston Pharmaceutical Inc.
3-18-cv-11216; filed on June 28, 2018 in the District of New Jersey (Trenton)
Infringement of the ′638 patent

• Celgene v. Teva Pharmaceuticals USA, Inc and Actavis LLC
3-18-cv-11215; filed June 28, 2018 in the District of New Jersey (Trenton)
Infringement of the ′940, ′516, ′638, ′302, ′101, ′536, ′717, ′243, and ′854 patents

• Celgene v. Aurobindo Pharma Ltd. and Aurobindo Pharma USA, Inc.
3-18-cv-11219; filed June 28, 2018 in the District of New Jersey (Trenton)
Infringement of the ′940, ′516, ′638, ′302, ′101, ′536, ′717, ′243, and ′854 patents

• Celgene Corp. v. Emcure Pharmaceuticals Ltd. and Heritage Pharmaceuticals Inc.
3-18-cv-11218; filed June 28, 2018 in the District of New Jersey (Trenton)
Infringement of the ′638 and ′854 patents

• Celgene Corp. v. Annora Pharma Private Ltd. and Hetero USA Inc.
3:18-cv-11220; filed on June 28, 2018 in the District of New Jersey (Trenton)
Infringement of the ′638 and ′854 patents

• Celgene Corp. v. Torrent Pharmaceuticals Ltd.
3-18-cv-11156; filed on June 27, 2018 in the District of New Jersey (Trenton)
Infringement of the ′638, ′101, and ′854 patents

• Celgene Corp. v. Shilpa Medicare Ltd.
3-18-cv-11157 filed on June 27, 2018 in the District of New Jersey (Trenton)
Infringement of the ′638, ′101, and ′854 patents

• Celgene Corp. v. Glenmark Pharmaceuticals Ltd.
3:18-cv-11158; filed on June 27, 2018 in the District of New Jersey (Trenton)
Infringement of the ′940, ′516, ′638, ′302, ′101, ′536, ′717, ′243, and ′854 patents

• Celgene Corp. v. Dr. Reddy's Laboratories, Inc.
3-18-cv-11269; filed on June 29, 2018 in the District of New Jersey (Trenton)
Infringement of the ′940, ′638, ′302, ′101, ′536, and ′243, patents

• Celgene Corp. v. Unichem Laboratories, Ltd.
3-18-cv-11268; filed on June 29, 2018 in the District of New Jersey (Trenton)
Infringement of the ′940, ′638, ′302, ′101, ′536, and ′243, patents

• Celgene Corp. v. Zydus Pharmaceuticals USA, Inc.
3-18-cv-11267; filed on June 29, 2018 in the District of New Jersey (Trenton)
Infringement of the ′940, ′638, ′302, ′101, ′536, and ′243, patents

• Celgene Corp. v. Alkem Laboratories Ltd.
3-18-cv-11265; filed on June 29, 2018 in the District of New Jersey (Trenton)
Infringement of the ′940, ′638, ′302, ′101, ′536, and ′243 patents

• Celgene Corp. v. Cipla Ltd.
3-18-cv-11262; filed on June 29, 2018 in the District of New Jersey (Trenton)
Infringement of the ′940, ′516, ′638, ′302, ′101, ′536, ′717, ′243, and ′854 patents

• Celgene Corp. v. Amneal Pharmaceuticals LLC
3-18-cv-11358; filed on July 03, 2018 in the District of New Jersey (Trenton)
Infringement of the ′940, ′638, ′302, ′101, ′536, and ′243 patents

• Celgene Corp. v. Aurobindo Pharma Ltd.
1-99-cv-de807; filed on July 3, 2018 in the District of Delaware (Wilmington)
Infringement of the ′940, ′516, ′638, ′302, ′101, ′536, ′717, ′243, and ′854 patents

 

Xlear, Inc. v. Whole Foods Market
2-18-cv-00518 filed in the District Court of Utah (Central) on June 28, 2018

• Plaintiff: Xlear
• Defendant: Whole Foods Market

Claim: Infringement of Patent Nos.:

• 6,054,143: ″Xylitol delivery″
• 6,258,372: ″Xylitol nose spray″
• 6,599,883: ″Nasal delivery of xylitol″

Synopsis:  Xlear is the assignee of all rights, title, and interest in the ′143, ′372, and ′883 patents.  Plaintiff has recently become aware that Defendant has sold, is selling, or offering to sell nasal sprays containing xylitol through its stores and its website.  Plaintiff alleges that the Defendants' nasal sprays (1) instruct and actively induce users to nasally administer an effective amount of xylitol/xylose in solution; (2) contain xylitol in amounts that infringe; and (3) products, packaging and/or websites provide instruction on the method that users of its products should follow to nasally administer an effective amount of xylitol/xylose to the nasopharynx of a human.  Plaintiffs thus claim that Defendant infringes either literally, equivalently or contributorily one or more claims in the patents at issue.

View the complaint here.

Gilead Sciences, Inc. v. Strides Pharma Inc.
3-18-cv-11134 filed in the District Court of New Jersey (Trenton) on June 27, 2018

• Plaintiffs: Gilead Sciences, Inc and Emory University
• Defendants: Strides Pharma, Inc. and Strides Pharma Global PTE Ltd.

Claim: Infringement of Patent Nos.:

• 6,642,245: ″Antiviral activity and resolution of 2-hydroxymethyl-5-(5-fluorocytosin-1-yl)-1,3 oxathiolane″
• 6,703,396: ″Method of resolution and antiviral activity of 1,3-oxathiolane nuclesoside enantiomers″
• 8,592,397: ″Compositions and methods for combination antiviral therapy″
• 8,716,264: ″Compositions and methods for combination antiviral therapy"
ª 9,457,036: ″Compositions and methods for combination antiviral therapy″
• 9,744,181: ″Compositions and methods for combination antiviral therapy″

Synopsis:  Gilead is the holder of NDA No. 21-752 which relates to tablets containing 200 mg of emtricitabine and 300 mg of tenofovir disoproxil fumarate.  The tablets are prescribed and sold under the trademark Truvada® for the treatment of HIV-1 infection in adults.  The ′397, ′264, ′036, and ′181 patents are assigned to Gilead and the ′245 and ′396 Patents to Emory, Gilead is a licensee with enforcement rights.  Defendant submitted ANDA No. 091055 seeking approval to engage in the commercial manufacture, use, sale and/or importation of tablets containing 200 mg of emtricitabine and 300 mg tenofovir disoproxil fumarate for the purpose of treating HIV infection.  Plaintiffs claimed infringement of the patents noted, Defendants countered that the issued patents were either not valid or not infringed.

View the complaint here.

Life Sciences Court Report

    By Bryan Helwig --

About Court Report:  Each week we will report briefly on recently filed biotech and pharma cases, and a few interesting cases will be selected for periodic monitoring.

Fresenius Kabi USA, LLC v. Eurohealth International Sarl
1-18-cv-00835; filed June 1, 2018 in the District Court of Delaware

• Plaintiffs: Fresenius Kabi USA, LLC and Fresenius Kabi Deutschland GmbH
• Defendant: Eurohealth International Sarl

Claim: Infringement of U.S. Patent Nos.
• 9,248,229: ″Packaging System for Oxygen-Sensitive Drugs″
• 9,731,082: ″Drug Container″

Synopsis: Fresnius claims infringement of the ′082 and ′229 patents.  Fresenius owns all rights, title, and interest in the '082 and '229 patents.  Fresenius is the holder of NDA No. 019034 for Dilaudid® Injection.  Eurohealth submitted amendments to ANDA No. 202159 to engage in the commercial manufacture, use, importation, offer for sale, or sale of generic Deluadid® Injection.

View the complaint here.

Cipla Ltd. v. Eli Lilly and Company
1-18-cv-01671; filed June 1, 2018 in the Southern District of Indiana, Indianapolis Division

• Plaintiffs: CIPLA Ltd. and CIPLA USA, Inc.
• Defendants: Eli Lilly and Company and ICOS Corp.

Claim: Infringement of U.S. Patent Nos.
• 6,821,975: ″Beta-carboline drug products″
• 7,182,958: ″β-Carboline Pharmaceutical Compositions″

Synopsis: Cipla seeks a declaratory judgment that the ′975 and ′958 patents are invalid.  ICOS is the assignee of the ′975 and ′958 patents.  Lilly is the exclusive licensee of both patents.  The patents are associated with submitted NDA No. 022332.  Cipla was not the first generic drug manufacturer to file an ANDA directed to tadalafil tablets in the 20 mg dosage strength.  Cipla sent Lilly and ICOS notice of Cipla's Paragraph IV certification with ANDA No. 210255.  Cipla's Notice Letter initiated a 45-day statutory period during which Defendants did not file an action against Cipla for infringement of the '975 or '958 patents.  Cipla believes the patents are an impediment to entry into the market.  As a subsequent ANDA filer, Cipla's ANDA for 20 mg tadalafil tablets cannot be approved by the FDA until the first ANDA filer's 180-day exclusivity period is either forfeited or runs out.  As of the date of this Complaint, the '975 and '958 patents are the only two remaining unexpired patents listed on the Orange Book for NDA No. 022332.  As such, there are no patents barring the first ANDA filer from entering the market.  Additionally, no first ANDA filer has entered the market.  Cipla seeks a declaratory judgment to allow entry into the market.

View the complaint here.

Astellas Parma Inc. v. Cipla Ltd.
1-18-cv-00844; filed June 5, 2018 in the District of Delaware

• Plaintiffs: Astellas Pharma Inc.; Astellas Pharma U.S., Inc.; Astellas Ireland Co., Ltd.; and Astellas Pharma Europe Ltd.
• Defendant: Cipla Ltd.

Claim: Infringement of U.S. Patent No.
• 6,017,927: ″Quinuclidine derivatives and medicinal composition thereof″

Synopsis: Astellas claims infringement of the ′927 patent.  Astellas Pharma U.S., Inc. holds approved NDA No. 21518 for VESIcare® tablets in 5 mg and 10 mg strength tablet dosage forms, which contain the active ingredient solifenacin succinate.  VESIcare® is indicated for treatment of overactive bladder with symptoms of urge urinary incontinence, urgency, and urinary frequency.  Cipla submitted ANDA No. 209839 for generic solifenacin succinate 5 mg and 10 mg tablets, as a pharmaceutical composition in an oral dosage form for the treatment of overactive bladder prior to the expiration of the '927 patent.  In response, Plaintiffs filed for patent infringement.

View the complaint here.

Biozone Laboratories, Inc. v. Next Step Laboratories Corp.
1-18-cv-03296; filed June 5, 2018 in the Eastern District of New York (Brooklyn)

• Plaintiff: Biozone Laboratories, Inc.
• Defendants: Next Step Laboratories Corp. and Richard Rigg

Claim: Infringement of U.S. Patent Nos.
• 6,610,322: ″Self forming, themodynamically stable liposomes and their applications″
• 6,958,160: ″Self forming, thermodynamically stable liposomes and their applications″
• 6,495,596: ″Compounds and methods for inhibition of phospholipase A2 and cyclooxygenase-2″
• 6,998,421: ″Compounds and methods for inhibition of phospholipase A₂ and cyclooxygenase–2″
• 7,150,883: ″Self forming, thermodynamically stable liposomes and their applications″
• 7,718,190: ″Self forming, thermodynamically stable liposomes and their applications

Synopsis: BioZone claims infringement of patents ′322, ′160, ′596, ′421, ′883, and ′190.  The Patents-in-Suit cover BioZone’s proprietary QuSome® and Inflacin® proprietary technologies.  Plaintiffs claim Defendants directly and indirectly infringe, by offering to sell QuSomes Products according to the claims of the patents-in-suit.

View the complaint here.

H. Lundbeck A/S v. MSN Laboratories Private Ltd.
1-18-cv-00853; filed June 7, 2018 in the District of Delaware (Wilmington)

• Plaintiffs: H. Lundbeck A/S, Takeda Pharmaceutical Co. Ltd., Takeda Pharmaceuticals U.S.A., Inc., Takeda Pharmaceuticals International AG, and Takeda Pharmaceuticals America, Inc.
• Defendants: MSN Laboratories Private Ltd., MSN Pharmaceuticals, Inc., and MSN Pharmachem Private Ltd.

Claim: Infringement of U.S. Patent No:
• 9,861,630: ″1-[2-(2,4-dimethylphenylsulfanyl)-phenyl]piperazine as a compound with combined serotonin reuptake, 5-HT.sub.3 and 5-HT.sub.1A activity for the treatment of cognitive impairment″

Synopsis: Plaintiffs claim infringement of the ′630 patent.  Plaintiff H. Lundbeck is the assignee and owner of the ′630 patent.  Lundbeck granted Takeda Japan an exclusive license to the ′630 patent.  Takeda Japan issued sublicenses to its subsidiary Plaintiffs.  Takeda USA is the holder of New Drug Application ("NDA") No. 204447 for TRINTELLIX® tablets (5 mg, 10 mg, 15 mg, and 20 mg dosage strengths) containing the active ingredient vortioxetine hydrobromide for the treatment of Major Depressive Disorder.  Defendants have submitted ANDA No. 211101 to FDA, or caused ANDA No. 211101 to be submitted to FDA, under 21 U.S.C. § 355(j), in order to obtain approval to engage in the commercial manufacture, use, or sale of vortioxetine hydrobromide tablets as purported generic versions of TRINTELLIX® tablets prior to the expiration of the ’630 Patent.

View the complaint here.

Purdue Pharma LP v. Ascent Pharmaceuticals, Inc.
1-18-cv-00855; filed June 7, 2018 in the District Court of Delaware (Wilmington)

• Plaintiffs: Purdue Pharma L.P., Purdue Pharmaceuticals L.P., P.F. Laboratories, Inc., Rhodes Technologies, and Grünenthal GmbH
• Defendant: Ascent Pharmaceuticals, Inc.

Claim: Infringement of U.S. Patent Nos:
• 8,309,060: ″Abuse-proofed dosage form″
• 9,060,976: ″Pharmaceutical formulation containing gelling agent″
• 9,073,933: ″Oxycodone hydrochloride having less than 25 PPM 14-hydroxycodeinone″
• 9,149,533: ″Tamper resistant pharmaceutical formulations″
• 9,522,919: ″Oxycodone compositions″
• 9,675,610: ″Abuse-proofed dosage form″
• 9,861,582: ″Pharmaceutical formulation containing gelling agent″

Synopsis: Plaintiffs claim infringement of the ′060, ′976, ′933, ′533, ′919, ′610, and ′582 patents.  Plaintiffs have approved NDA No. 022272 in the 10 mg, 15 mg, 20 mg, 30 mg, 60 mg and 80 mg dosage strengths.  Defendant filed ANDA No. 211178 seeking approval to engage in the commercial manufacture, use, or sale of Defendant's ANDA Products, a generic product based on the Reference Listed Drug OxyContin®, which is the subject of approved NDA No. 022272.  Plaintiffs sued for patent infringement.

View the complaint here.

Teijin Ltd. v. MSN Laboratories Private Ltd.
1-18-cv-00881; filed June 7, 2018 in the District Court of Delaware (Wilmington)

• Plaintiffs: Teijin Ltd., Teijin Pharma Ltd., and Takeda Pharmaceuticals U.S.A., Inc.
• Defendants: MSN Laboratories Private Ltd. and MSN Pharmaceuticals, Inc.

Claim: Infringement of U.S. Patent Nos:
• 7,361,676: ′Solid preparation containing single crystal form″
• 8,372,872: ″Methods for concomitant treatment of theophylline and febuxostat″
• 9,107,912: ″Methods for concomitant treatment of theophylline and febuxostat″

Synopsis: Plaintiffs claim infringement of the ′676, ′872, and ′912 patents.  Plaintiffs own the patents noted.  In addition, Takeda holds NDA No. 21-856 for oral tablets containing 40 mg or 80 mg of the active ingredient febuxostat.  Takeda markets and sells these tablets in the United States under the brand name Uloric®.  MSN certified in ANDA No. 210461 that the claims of 7 the patents-in-suit are invalid, unenforceable, or would not be infringed by the commercial manufacture, use, offer for sale, or sale of MSN’s Generic Products.  Plaintiff claims the Defendant infringes the claims of the ′676, ′872, and ′912 patents.

View the complaint here.

Court Report

        By Sherri Oslick --

About Court Report:  Each week we will report briefly on recently filed biotech and pharma cases.

Horizon Therapeutics, Inc. v. Lupin Ltd. et al.
1:16-cv-04438; filed July 21, 2016 in the District Court of New Jersey

• Plaintiff:  Horizon Therapeutics, Inc.
• Defendants:  Lupin Ltd.; Lupin Pharmaceuticals Inc.

Infringement of U.S. Patent Nos. 9,254,278 ("Methods of Therapeutic Monitoring of Nitrogen Scavenging Drugs," issued February 9, 2016) and 9,326,966 (same title, issued May 3, 2016) following a Paragraph IV certification as part of Lupin's filing of an ANDA to manufacture a generic version of Horizon's Ravicti® (glycerol phenylbutyrate oral liquid, used as a nitrogen binding agent for chronic management of adult and pediatric patients ≥ 2 years of age with urea cycle disorders that cannot be managed by dietary protein restriction and/or amino acid supplementation alone).  View the complaint here.

Allergan, Inc. v. TWi Pharmaceuticals, Inc. et al.
2:16-cv-00820; filed July 21, 2016 in the Eastern District of Texas

• Plaintiff:  Allergan, Inc.
• Defendants:  TWi Pharmaceuticals, Inc.; TWi Pharmaceuticals USA, Inc.

Allergan, Inc. v. TWi Pharmaceuticals, Inc. et al.
1:16-cv-00620; filed July 20, 2016 in the District Court of Delaware

• Plaintiff:  Allergan, Inc.
• Defendants:  TWi Pharmaceuticals, Inc.; TWi Pharmaceuticals USA, Inc.

The complaints in these cases are substantially identical.  Infringement of U.S Patent Nos. 8,629,111 ("Methods of Providing Therapeutic Effects Using Cyclosporine Components," issued January 14, 2014), 8,633,162 (same title, issued January 21, 2014), 8,642,556 (same title, issued February 4, 2014), 8,648,048 (same title, issued February 11, 2014), 8,685,930 (same title, issued April 1, 2014), and 9,248,191 (same title, issued February 2, 2016) following a Paragraph IV certification as part of TWi's filing of an ANDA to manufacture a generic version of Allergan's Restasis® (cyclosporine ophthalmic emulsion, 0.05%, used to treat dry eye).  View the Delaware complaint here.

AstraZeneca AB et al. v. Aurobindo Pharma Ltd. et al.
3:16-cv-04414; filed July 20, 2016 in the District Court of New Jersey

• Plaintiffs:  AstraZeneca AB; Aktiebolaget Hassle; AstraZeneca LP; Zeneca Inc.
• Defendants:  Aurobindo Pharma Ltd.; Aurobindo Pharma USA Inc.

Infringement of U.S. Patent Nos. 6,369,085 ("Form of S-omeprazole," issued April 9, 2002) and 7,411,070 (same title, issued August 12, 2008) following a Paragraph IV certification as part of Aurobindo's filing of an ANDA to manufacture a generic version of AstraZeneca's Nexium 24HR® (esomeprazole magnesium, used for the treatment of gastroesophageal reflux disease).  View the complaint here.

Valeant Pharmaceuticals Luxembourg S.A.R.L. et al. v. Actavis Laboratories UT. Inc. et al.
2:16-cv-04344; filed July 15, 2016 in the District Court of New Jersey

• Plaintiffs:  Valeant Pharmaceuticals Luxembourg S.A.R.L.; Valeant Pharmaceuticals North America LLC
• Defendants:  Actavis Laboratories UT. Inc.; Actavis, Inc.; Allergan PLC

Infringement of U.S. Patent No. 6,670,335 ("Fluorouracil-Containing Formulation," issued December 30, 2003) following a Paragraph IV certification as part of Actavis' filing of an ANDA to manufacture a generic version of Valeant's Carac® (fluorouracil 0.5% cream, used to treat multiple actinic or solar keratoses of the face and anterior scalp).  View the complaint here.

Shionogi Inc. et al. v. Actavis Laboratories UT, Inc.
1:16-cv-00606; filed July 14, 2016 in the District Court of Delaware

• Plaintiffs:  Shionogi Inc.; Concordia Pharmaceuticals Inc.
• Defendant:  Actavis Laboratories UT, Inc.

Infringement of U.S. Patent Nos. 6,793,931 ("Ectoparasite Asphyxiator Compositions and Methods for their Applications," issued September 21, 2004) and 7,294,342 (same title, issued November 13, 2007) following a Paragraph IV certification as part of Actavis' filing of an ANDA to manufacture a generic version of Shionogi's Ulesfia® (benzyl alcohol lotion, 5%, for the topical treatment of head lice infestation in patients 6 months of age and older).  View the complaint here.

Actavis Elizabeth LLC v. Novartis Corp. et al.
1:16-cv-00604; filed July 13, 2016 in the District Court of Delaware

• Plaintiff:  Actavis Elizabeth LLC
• Defendants:  Novartis Corp.; Novartis Pharmaceuticals Corp.; Novartis AG; Novartis Pharma AG

Declaratory judgment of noninfringement of U.S. Patent No. 9,283,209 ("Oral Formulations of Deferasirox," issued March 15, 2016) based on Activis' Paragraph IV certification as part of its filing of an ANDA to manufacture a generic version of Novartis' Jadenu® (deferasirox, used for the treatment of chronically elevated levels of iron in the blood caused by repeated blood transfusions).  View the complaint here.

Helsinn Healthcare S.A. v. Zydus Pharmaceuticals (USA) Inc. et al.
3:16-cv-04239; filed July 13, 2016 in the District Court of New Jersey

• Plaintiff:  Helsinn Healthcare S.A.
• Defendants:  Zydus Pharmaceuticals (USA) Inc.; Cadila Healthcare Ltd.

Infringement of U.S. Patent Nos. 7,947,724 ("Liquid Pharmaceutical Formulations of Palonosetron," issued May 24, 2011), 7,947,725 (same title, issued May 24, 2011), 7,960,424 (same title, issued June 14, 2011), 8,598,219 (same title, issued December 3, 2013), and 8,729,094 (same title, issued May 20, 2014) following a Paragraph IV certification as part of Zydus' filing of an ANDA to manufacture a generic version of Helsinn's Aloxi® (palonosetron hydrochloride intravenous solution, used to prevent chemotherapy induced nausea and vomiting).  View the complaint here.

DSM IP Assets, B.V. et al. v. Lallemand Specialties, Inc. et al.
3:16-cv-00497; filed July 13, 2016 in the Western District of Wisconsin

• Plaintiffs:  DSM IP Assets, B.V.; DSM Bio-Based Products & Services B.V.
• Defendants:  Lallemand Specialties, Inc.; Mascoma LLC

Infringement of U.S. Patent No. 8,795,998 ("Fermentative Glycerol-Free Ethanol Production," issued August 5, 2014) based on defendants' manufacture and sale of certain  transgenic yeast cells, including their TransFerm Yield+ product.  View the complaint here.

Court Report

        By Sherri Oslick --

About Court Report:  Each week we will report briefly on recently filed biotech and pharma cases.

Tris Pharma Inc. v. Actavis Elizabeth LLC et al.
1:16-cv-00603l; filed July 12, 2016 in the District Court of Delaware

• Plaintiff:  Tris Pharma Inc.
• Defendants:  Actavis Elizabeth LLC; Actavis Inc.

Infringement of U.S. Patent Nos. 8,202,537 ("Modified Release Formulations Containing Drug-Ion Exchange Resin Complexes," issued June 19, 2012), 8,287,903 ("Orally Effective Methylphenidate Extended Release Powder and Aqueous Suspension Product," issued October 16, 2012), 8,999,386 ("Methylphenidate Extended Release Chewable Tablet," issued April 7, 2015), and 9,295,642 (same title, issued March 29, 2016) following a Paragraph IV certification as part of Actavis' filing of an ANDA to manufacture a generic version of Tris' QuilliChew ER® (methylphenidate hydrochloride extended-release chewable tablets, used to treat ADHD in children 6 years and above).  View the complaint here.

Imprimis Pharmaceuticals, Inc. v. Alcon Pharmaceuticals Ltd. et al.
3:16-cv-01794; filed July 11, 2016 in the Southern District of California

• Plaintiff:  Imprimis Pharmaceuticals, Inc.
• Defendants:  Alcon Pharmaceuticals Ltd.; Alcon Research, Ltd.

Declaratory judgment of noninfringment of U.S. Patent Nos. 6,716,830 ("Ophthalmic Antibiotic Compositions Containing Moxifloxacin," issued April 6, 2004) and 7,671,070 ("Method of Treating Ophthalmic Infections with Moxifloxacin Compositions," issued March 2, 2010) based on Imprimis' manufacture and sale of certain ophthalmic products.  View the complaint here.

Gilead Sciences, Inc. et al. v. Aurobindo Pharma Ltd. et al.
1:16-cv-04178; filed July 8, 2016 in the District Court of New Jersey

• Plaintiffs:  Gilead Sciences, Inc.; Emory University
• Defendants:  Aurobindo Pharma Ltd.; Aurobindo Pharma USA Inc.

Infringement of U.S. Patent Nos. 6,642,245 ("Antiviral Activity and Resolution of 2-Hydroxymethyl-5-(5-fluorocytosin-1-yl)-l,3-oxathiolane," issued November 4, 2003), 6,703,396 ("Method of Resolution and Antiviral Activity of 1,3-Oxathiolane Nucleoside Enantiomers," issued March 9, 2004), 8,592,397 ("Compositions and Methods for Combination Antiviral Therapy," issued November 26, 2013), and 8,716,264 (same title, issued May 6, 2014) following a Paragraph IV certification as part of Aurobindo's filing of an ANDA to manufacture a generic version of Gilead's Truvada® (emtricitabine and tenofovir disoproxil fumarate, used for the treatment of HIV-1 infection in adults).  View the complaint here.

Merck Sharp & Dohme Corp. v. Genentech, Inc. et al.
2:16-cv-04992; filed July 7, 2016 in the Central District of California

• Plaintiff:  Merck Sharp & Dohme Corp.
• Defendants:  Genentech, Inc.; City of Hope

Declaratory judgment of invalidity and noninfringement of U.S. Patent No. 7,923,221 ("Methods of Making Antibody Heavy and Light Chains Having Specificity for a Desired Antigen," issued April 12, 2011) based on Merck's manufacture and sale of its Keytruda® product (pembrolizumab, used to treat patients with unresectable or metastatic melanoma, and for the treatment of patients with metastatic or PD-L1 positive, non-small cell lung cancer, as determined by an FDA-approved test, with disease progression on or after platinum-containing chemotherapy) and/or Merck's anticipated manufacture and sale of its bezlotoxumab products (to be used for the prevention of Clostridium difficile infection recurrence).  View the complaint here.

AstraZeneca AB v. Apotex Corp. et al.
1:16-cv-00583; filed July 7, 2016 in the District Court of Delaware

• Plaintiff:  AstraZeneca AB
• Defendants:  Apotex Corp.; Apotex Inc.

Infringement of U.S. Patent No. RE44,186 ("Cyclopropyl-Fused Pyrrolidine-Based Inhibitors of Dipeptidyl Peptidase IV and Method," issued April 30, 2013) following a Paragraph IV certification as part of Apotex's filing of an ANDA to manufacture a generic version of AstraZeneca's Onglyza® (saxagliptin hydrochloride, used as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus).  View the complaint here.

Court Report

        By Sherri Oslick --

About Court Report:  Each week we will report briefly on recently filed biotech and pharma cases.

Takeda Pharmaceutical Co. Ltd. v. Lee
1:16-cv-00852; filed July 1, 2016 in the Eastern District of Virginia

Review and correction of the patent term adjustment calculation made by the U.S. Patent and Trademark Office for U.S. Patent No. 8,900,638 ("Solid Preparation Comprising Alogliptin and Metformin Hydrochloride," issued December 2, 2014).  View the complaint here.

Alcon Pharmaceuticals Ltd. et al. v. Imprimis Pharmaceuticals, Inc.
1:16-cv-00563; filed June 30, 2016 in the District Court of Delaware

• Plaintiffs:  Alcon Pharmaceuticals Ltd.; Alcon Research, Ltd.
• Defendants:  Imprimis Pharmaceuticals, Inc.

Infringement of U.S. Patent Nos. 6,716,830 ("Ophthalmic Antibiotic Compositions Containing Moxifloxacin," issued April 6, 2004) and 7,671,070 ("Method of Treating Ophthalmic Infections with Moxifloxacin Compositions," issued March 2, 2010) based on Imprimis' manufacture and sale of moxifloxacin ophthalmic products, similar to Alcon's Vigamox® (moxifloxacin hydrochloride, used to treat bacterial conjunctivitis).  View the complaint here.

Horizon Therapeutics, Inc. v. Par Pharmaceutical, Inc.
1:16-cv-03910; filed June 30, 2016 in the District Court of New Jersey

Infringement of U.S. Patent Nos. 9,095,559 ("Methods of Therapeutic Monitoring of Nitrogen Scavenging Drugs," issued August 4, 2015), 9,254,278 (same title, issued February 9, 2016), and 9,326,966 (same title, issued May 3, 2016) following Par's filing of an ANDA to manufacture a generic version of Horizon's Ravicti® (glycerol phenylbutyrate oral liquid, used as a nitrogen binding agent for chronic management of adult and pediatric patients ≥ 2 years of age with urea cycle disorders that cannot be managed by dietary protein restriction and/or amino acid supplementation alone).  View the complaint here.

Genzyme Corp. et al. v. Zydus Pharmaceuticals (USA) Inc.
1:16-cv-03905; filed June 30, 2016 in the District Court of New Jersey

• Plaintiffs:  Genzyme Corp.; Sanofi-Aventis U.S. LLC
• Defendant:  Zydus Pharmaceuticals (USA) Inc.

Infringement of U.S. Patent Nos. 7,897,590 ("Methods to mobilize progenitor/stem cells" issued March 1, 2011) and 6,987,102 ("Methods to mobilize progenitor/stem cells" issued January 17, 2006) following a Paragraph IV certification as part of Zydus' filing of an ANDA to manufacture a generic version of Genzyme's Mozobil® (plerixafor solution for injection, used in combination with granulocyte-colony stimulating factor to mobilize hematopoietic stem cells to the peripheral blood for collection and subsequent autologous transplantation in patients with non-Hodgkin's lymphoma and multiple myeloma).  View the complaint here.  [NB: The complaint was later voluntarily dismissed without prejudice.]

Genzyme Corp. et al. v. Amneal Pharmaceuticals LLC
2:16-cv-03892; filed June 29, 2016 in the District Court of New Jersey

• Plaintiffs:  Genzyme Corp.; Southern Research Institute; Sanofi-Aventis U.S. LLC
• Defendant:  Amneal Pharmaceuticals LLC

Infringement of U.S. Patent No. 5,661,136 ("2-Halo-2'-Fluoro ARA Adenosines as Antinoplastic Agents," issued August 26, 1997) following a Paragraph IV certification as part of Amneal's filing of an ANDA to manufacture a generic version of Genzyme's Clolar® (clofarabine injection, used to treat acute lymphoblastic leukemia).  View the complaint here.

Court Report

        By Sherri Oslick --

About Court Report:  Each week we will report briefly on recently filed biotech and pharma cases.

Genzyme Corp. et al. v. Zydus Pharmaceuticals (USA) Inc.
1:16-cv-00540; filed June 29, 2016 in the District Court of Delaware

Plaintiffs:  Genzyme Corp.; Sanofi-Aventis U.S. LLC
Defendant:  Zydus Pharmaceuticals (USA) Inc.

Infringement of U.S. Patent Nos. 7,897,590 ("Methods to mobilize progenitor/stem cells" issued March 1, 2011) and 6,987,102 ("Methods to mobilize progenitor/stem cells" issued January 17, 2006) following a Paragraph IV certification as part of Zydus' filing of an ANDA to manufacture a generic version of Genzyme's Mozobil® (plerixafor solution for injection, used in combination with granulocyte-colony stimulating factor to mobilize hematopoietic stem cells to the peripheral blood for collection and subsequent autologous transplantation in patients with non-Hodgkin's lymphoma and multiple myeloma).  View the complaint here.

Janssen Pharmaceutica N.V. v. Xellia Pharmaceuticals ApS
1:16-cv-00554; filed June 29, 2016 in the District Court of Delaware

Infringement of U.S. Patent No. 6,407,079 ("Pharmaceutical Compositions Containing Drugs Which Are Instable or Sparingly Soluble in Water and Methods for Their Preparation," issued June 18, 2002) following a Paragraph IV certification as part of Xellia’s filing of an NDA (under § 505(b)(2) of the Food, Drug and Cosmetic Act) to manufacture a generic injectable voriconazole product, which relies upon the NDA filed for Janssen's Sporanox® (itraconazole, used for the treatment of certain fungal infections).  View the complaint here.

BTG International Ltd. et al. v. Glenmark Pharmaceuticals Inc., USA et al.
2:16-cv-03743; filed June 24, 2016 in the District Court of New Jersey

Plaintiffs:  BTG International Ltd.; Janssen Biotech, Inc.; Janssen Oncology, Inc.; Janssen Research & Development, LLC
Defendants:  Glenmark Pharmaceuticals Inc., USA; Glenmark Pharmaceuticals SA; Glenmark Pharmaceuticals Ltd.

Infringement of U.S. Patent No. 8,822,438 ("Methods and Compositions for Treating Cancer," issued September 2, 2014) following a Paragraph IV certification as part of Glenmark’s filing of an ANDA to manufacture a generic version of Janssen's Zytiga® (abiraterone acetate, used in combination with prednisone for the treatment of patients with metastatic castration-resistant prostate cancer).  View the complaint here.

Gilead Sciences, Inc. et al. v. Aurobindo Pharma Ltd. et al.
1:16-cv-03722; filed June 23, 2016 in the District Court of New Jersey

Plaintiffs:  Gilead Sciences, Inc.; Emory University
Defendants:  Aurobindo Pharma Ltd.; Aurobindo Pharma USA Inc.

Infringement of U.S. Patent Nos. 6,642,245 ("Antiviral Activity and Resolution of 2-Hydroxymethyl-5-(5-fluorocytosin-1-yl)-l,3-oxathiolane," issued November 4, 2003) and 6,703,396 ("Method of Resolution and Antiviral Activity of 1,3-Oxathiolane Nucleoside Enantiomers," issued March 9, 2004) following a Paragraph IV certification as part of Aurobindo’s filing of an ANDA to manufacture a generic version of Gilead's Emtriva® (emtricitabine, used for the treatment of HIV-1 infection in adults).  View the complaint here.

Abbvie Inc. et al. v. Medimmune Ltd.
2:16-cv-00322; filed June 22, 2016 in the Eastern District of Virginia

Declaratory judgment of invalidity of U.S. Patent No. 6,248,516 ("Single Domain Ligands, Receptors Comprising Said Ligands Methods for Their Production, and Use of Said Ligands and Receptors," issued June 19, 2001) relating to AbbVie's marketing and sale of its Humira® product (adalimumab, used to treat rheumatoid arthritis, juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis, Crohn's disease and plaque psoriasis).  View the complaint here.

Court Report

        By Sherri Oslick --

About Court Report:  Each week we will report briefly on recently filed biotech and pharma cases.

Eli Lilly and Company et al. v. Apotex Inc. et al.
1:16-cv-00475; filed June 22, 2016 in the District Court of Delaware

• Plaintiffs:  Eli Lilly and Company; Eli Lilly Export S.A.; Acrux DDS Pty Ltd.
• Defendants:  Apotex Inc.; Apotex Corp.

Eli Lilly and Company et al. v. Apotex Inc. et al.
1:16-cv-01512; filed June 20, 2016 in the Southern District of Indiana

• Plaintiffs:  Eli Lilly and Company; Eli Lilly Export S.A.; Acrux DDS Pty Ltd.
• Defendants:  Apotex Inc.; Apotex Corp.

The complaints in these cases are substantially identical.  Infringement of U.S. Patent Nos. 8,419,307 ("Spreading Implement," issued April 16, 2013), 8,177,449 (same title, issued May 15, 2012), 8,435,944 ("Method and Composition for Transdermal Drug Delivery," issued May 7, 2013), 8,807,861 (same title, issued August 19, 2014), 8,993,520 (same title, issued March 31, 2015), 9,180,194 (same title, issued November 10, 2015), and 9,289,586 ("Spreading Implement," issued March 22, 2016) following a Paragraph IV certification as part of Apotex's filing of an ANDA to manufacture a generic version of Eli Lilly's Axiron® (testosterone metered transdermal solution, used to treat males for conditions associated with a deficiency or absence of endogenous testosterone). View the S.D. Indiana complaint here.

Noven Pharmaceuticals, Inc. v. Actavis Laboratories UT, Inc.
1:16-cv-00465; filed June 20, 2016 in the District Court of Delaware

Infringement of U.S. Patent No. 8,231,906 ("Transdermal Estrogen Device and Delivery," issued July 31, 2012) following a Paragraph IV certification as part of Actavis' filing of an ANDA to manufacture a generic version of Noven's Minivelle® (estradiol transdermal system, used for the treatment of moderate to severe vasomotor symptoms due to menopause and for the prevention of postmenopausal osteoporosis). View the complaint here.

UCB, Inc. et al. v. Aurobindo Pharma Ltd. et al.
1:16-cv-00451; filed June 17, 2016 in the District Court of Delaware

• Plaintiffs:  UCB, Inc.; UCB Biopharma SPRL; Research Corporation Technologies, Inc.; Harris FRC Corp.
• Defendants:  Aurobindo Pharma Ltd.; Aurobindo Pharma USA, Inc.; Aurobindo Pharma USA, Inc.; Aurobindo Pharma Ltd.

UCB, Inc. et al. v. Hetero USA Inc. et al.
1:16-cv-00452; filed June 17, 2016 in the District Court of Delaware

• Plaintiffs:  UCB, Inc.; UCB Biopharma SPRL; Research Corporation Technologies, Inc.; Harris FRC Corp.
• Defendants:  Hetero USA Inc.; Hetero Labs Ltd.

The complaints in these cases are substantially identical. Infringement of U.S. Patent No. RE38,551 ("Anticonvulsant Enantiomeric Amino Acid Derivatives," issued July 6, 2004) following a Paragraph IV certification as part of defendants' filing of an ANDA to manufacture a generic version of UCB's Vimpat® (lacosamide, used as adjunctive therapy in the treatment of partial-onset seizures in people with epilepsy aged 17 years and older). View the Aurobindo complaint here.

Shire Orphan Therapies LLC et al. v. InnoPharma Inc.
1:16-cv-00456; filed June 17, 2016 in the District Court of Delaware

• Plaintiffs:  Shire Orphan Therapies LLC; Sanofi-Aventis Deutschland GmbH
• Defendant:  InnoPharma Inc.

Infringement of U.S. Patent No. 5,648,333 ("Peptides Having Bradykinin Antagonist Action," issued July 15, 1997) following a Paragraph IV certification as part of InnoPharma's filing of an ANDA to manufacture a generic version of Shire's Firazyr® (icatibant, used to treat acute attacks of hereditary angioedema in adults 18 years of age and older). View the complaint here.

United Therapeutics Corp. et al. v. Actavis Laboratories FL, Inc.
3:16-cv-03642; filed June 17, 2016 in the District Court of New Jersey

• Plaintiffs:  United Therapeutics Corp.; Supernus Pharmaceuticals, Inc.
• Defendant:  Actavis Laboratories FL, Inc.

Infringement of U.S. Patent Nos. 7,417,070 ("Compounds and Methods for Delivery of Prostacyclin Analogs," issued August 26, 2008), 7,544,713 (same title, issued June 9, 2009), 8,252,839 (same title, issued August 28, 2012), 8,349,892 ("Solid Formulations of Prostacyclin Analogs issued January 8, 2013), 8,410,169 ("Compounds and Methods for Delivery of Prostacyclin Analogs," issued April 2, 2013), 8,497,393 ("Process to Prepare Treprostinil, the Active Ingredient in Remodulin®," issued July 30, 2013), 9,050,311 ("Compounds and Methods for Delivery of Prostacyclin Analogs," issued June 9, 2015), 8,747,897 ("Osmotic Drug Delivery System," issued June 10, 2014), and 9,278,901 ("Compounds and Methods for Delivery of Prostacyclin Analogs," issued March 8, 2016) following a Paragraph IV certification as part of Actavis' filing of an ANDA to manufacture a generic version of UTC's Orenitram® (treprostinil, used to treat pulmonary arterial hypertension). View the complaint here.

Court Report

        By Sherri Oslick --

About Court Report:  Each week we will report briefly on recently filed biotech and pharma cases.

Janssen Biotech, Inc. v. Celltrion Healthcare Co., Ltd. et al.
1:16-cv-11117; filed June 14, 2016 in the District Court of Massachusetts

• Plaintiff:  Janssen Biotech, Inc.
• Defendants:  Celltrion Healthcare Co., Ltd.; Celltrion, Inc.; Hospira, Inc.

Infringement of U.S. Patent No. 7,598,083 ("Chemically Defined Media Compositions," issued October 6, 2009) based on defendants' alleged control of the development of cell culture media, used to manufacture of defendants' infliximab biosimilar, a biosimilar to Janssen's Remicade® (infliximab, used to treat rheumatoid arthritis, ulcerative colitis, Crohn's disease, ankylosing spondylitis, psoriatic arthritis, and plaque psoriasis).  View the complaint here.

Janssen Biotech v. Hyclone Laboratories
1:16-cv-00071; filed June 14, 2016 in the District Court of Utah

Infringement of U.S. Patent No. 7,598,083 ("Chemically Defined Media Compositions," issued October 6, 2009) based on HyClone's development of cell culture media, supplied to Celltrion and Hospira to manufacture an infliximab biosimilar, a biosimilar to Janssen's Remicade® (infliximab, used to treat rheumatoid arthritis, ulcerative colitis, Crohn's disease, ankylosing spondylitis, psoriatic arthritis, and plaque psoriasis).  View the complaint here.

Novartis Pharmaceuticals Corp. et al. v. Breckenridge Pharmaceutical Inc.
1:16-cv-00431; filed June 13, 2016 in the District Court of Delaware

• Plaintiffs:  Novartis Pharmaceuticals Corp.; Novartis AG
• Defendant:  Breckenridge Pharmaceutical Inc.

Infringement of U.S. Patent Nos. 5,665,772 ("O-alkylated Rapamycin Derivatives and Their Use, Particularly as Immunosuppressants," issued September 9, 1997), 8,410,131 ("Cancer Treatment," issued April 2, 2013), and 8,778,962 ("Treatment of Solid Tumors with Rapamycin Derivatives," issued July 15, 2014) following a Paragraph IV certification as part of Breckenridge's filing of an ANDA to manufacture a generic version of Novartis' Afinitor® (everolimus, used for the treatment of: postmenopausal women with advanced hormone receptor-positive, HER2-negative breast cancer in combination with exemestane after failure of treatment with letrozole or anastrozole; adults with progressive neuroendocrine tumors of pancreatic origin that are unresectable, locally advanced or metastatic; adults with advanced renal cell carcinoma after failure of treatment with sunitinib or sorafenib; adults with renal angiomyolipoma and tuberous sclerosis complex, not requiring immediate surgery; and pediatric and adult patients with tuberous sclerosis complex who have subependymal giant cell astrocytoma that requires therapeutic intervention but cannot be curatively resected).  View the complaint here.

LEO Pharma A/S et al. v. Perrigo UK FINCO Limited Partnership et al.
1:16-cv-00430; filed June 10, 2016 in the District Court of Delaware

• Plaintiffs:  LEO Pharma A/S; LEO Laboratories Ltd.; LEO Pharma, Inc.
• Defendants:  Perrigo UK FINCO Limited Partnership; Perrigo Co.

Infringement of U.S. Patent Nos. 6,432,452 ("Anti-Cancer Compounds," issued August 13, 2002), 6,787,161 (same title, issued September 7, 2004), 6,844,013 ("Methods of Stimulating the Immune System," issued January 18, 2005), 7,410,656 ("Anti-Cancer Compounds," issued August 12, 2008), 8,278,292 ("Therapeutic Compositions," issued October 2, 2012), 8,372,827 (same title, issued February 12, 2013), 8,372,828 (same title, issued February 12, 2013), 8,377,919 (same title, issued February 19, 2013), 8,536,163 (same title, issued September 17, 2013), 8,716,271 (same title, issued May 6, 2014), and 8,735,375 (same title, issued May 27, 2014) following a Paragraph IV certification as part of Perrigo's filing of an ANDA to manufacture a generic version of LEO Pharma's Picato® ( ingenol mebutate gel, used  for the topical treatment of actinic keratosis).  View the complaint here.

Purdue Pharma, L.P. v. Collegium Pharmaceutical, Inc.
1:16-cv-11091; filed June 10, 2016 in the District Court of Massachusetts

• Plaintiff:  Purdue Pharma, L.P.
• Defendant:  Collegium Pharmaceutical, Inc.; Collegium Pharmaceutical, Inc.

Infringement of U.S. Patent No. 9,155,717 ("Pharmaceutical Formulation Containing Irritant," issued October 13, 2015) based on Collegium's filing of an NDA (under § 505(b)(2) of the Food, Drug and Cosmetic Act) to manufacture its Xtampza ER product (oxycodone myristate), comparable to Purdue Pharma's OxyContin® (controlled release oxycodone hydrochloride, used to treat pain).  View the complaint here.

Aurobindo Pharma USA Inc. et al. v. Apicore US LLC et al.
1:16-cv-03358; filed June 9, 2016 in the District Court of New Jersey

• Plaintiffs:  Aurobindo Pharma Usa Inc.; Aurobindo Pharma Ltd.; Auromedics Pharma LLC
• Defendants:  Apicore US LLC; Mylan Institutional LLC

Declaratory judgment of non-infringement and invalidity of U.S. Patent Nos. 7,662,992 ("Process for Preparation of Isosulfan Blue," issued February 16, 2010), 8,969,616 (same title, issued March 3, 2015), and 9,353,050 (same title, issued May 31, 2016) based on Aurobindo's filing of an ANDA to manufacture a 1% strength isosulfan blue for injection.  View the complaint here.

Court Report

        By Sherri Oslick --

About Court Report:  Each week we will report briefly on recently filed biotech and pharma cases.

Orexo AB et al. v. Actavis Elizabeth LLC et al.
1:16-cv-00397; filed May 27, 2016 in the District Court of Delaware

• Plaintiffs:  Orexo AB; Orexo US, Inc.
• Defendants:  Actavis Elizabeth LLC; Actavis Inc.

Infringement of U.S. Patent No. 9,259,421 ("Abuse-Resistant Pharmaceutical Composition for the Treatment of Opioid Dependencen" issued February 16, 2016) following a Paragraph IV certification as part of Actavis' amendment of its ANDA to manufacture a generic version of Orexo's Zubsolv® (buprenorphine hydrochloride and naloxone hydrochloride sublingual tablets, used the maintenance treatment of opioid dependence and for the induction of buprenorphine maintenance therapy in patients suffering from opioid dependence).  View the complaint here.

Alvogen Pine Brook LLC v. Noven Pharmaceuticals, Inc. et al.
1:16-cv-00395; filed May 27, 2016 in the District Court of Delaware

• Plaintiff:  Alvogen Pine Brook LLC
• Defendants:  Noven Pharmaceuticals, Inc.; Hisamitsu Pharmaceutical Co., Inc.

Declaratory judgment of noninfringement of U.S. Patent Nos. 6,841,716 ("Patch," issued January 11, 2005) and 8,231,906 ("Transdermal Estrogen Device and Delivery," issued July 31, 2012) based on Alvogen's filing of an ANDA to manufacture a generic version of Noven's Minivelle® (estradiol transdermal system, used for the treatment of moderate to severe vasomotor symptoms due to menopause and for the prevention of postmenopausal osteoporosis).  View the complaint here.

AbbVie Inc. v. Amneal Pharmaceuticals, LLC et al.
1:16-cv-00398; filed May 27, 2016 in the District Court of Delaware

• Plaintiff:  AbbVie Inc.
• Defendants:  Amneal Pharmaceuticals, LLC; Amneal Pharmaceuticals of New York, LLC

Infringement of U.S. Patent Nos. 7,148,359 ("Polymorph of a Pharmaceutical," issued December 12, 2006) and 7,364,752 ("Solid Dispersion Pharmaceutical Formulations," issued April 29, 2008) following a Paragraph IV certification as part of Amneal's filing of an ANDA to manufacture a generic version of AbbVie's Norvir® (ritonavir, used to treat human immunodeficiency virus (HIV) infection).  View the complaint here.