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.