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]
Mylan Faces Patent Infringement Lawsuit For Nexavar
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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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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. 2ff7e9595c
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