Litigation

12 Months Ended

Dec. 31, 2020

Commitments and Contingencies Disclosure [Abstract]

Litigation

Litigation

Emergent BioSolutions’ Adapt Pharma subsidiaries (“Emergent”) are as follows: Emergent Devices Inc. (“EBPA”), formerly known as Adapt Pharma Inc.; Emergent Operations Ireland Limited (“EIRE”), formerly known as Adapt Pharma Operations Limited; and Emergent BioSolutions Ireland Limited (“EIR2”), formerly known as Adapt Pharma Limited.

ANDA Litigation - Teva 4mg

On or about September 13, 2016, Emergent BioSolutions’ Adapt Pharma subsidiaries EBPA and EIRE, and Opiant received a notice letter from Teva Pharmaceuticals Industries Limited and Teva Pharmaceuticals USA (collectively, “Teva”) that Teva had filed an ANDA with the FDA seeking regulatory approval to market a generic version of NARCAN® (naloxone hydrochloride) Nasal Spray 4 mg/spray before the expiration of U.S. Patent No. 9,211,253, (the “‘253 Patent”). Emergent and Opiant received additional notice letters from Teva relating to U.S.

Patent Nos. 9,468,747 (the “‘747 Patent”), 9,561,177, (the “‘177 Patent”), 9,629,965, (the “‘965 Patent”) and 9,775,838 (the “‘838 Patent”) and 10,085,937 (the “‘937 Patent”). Teva’s notice letters asserted that the commercial manufacture, use or sale of its generic drug product described in its ANDA would not infringe the ‘253, the ‘747, the ‘177, the ‘965, the ‘838, or the ‘937 Patent, or that the ‘253, the ‘747, the ‘177, the ‘965, the ‘838, and the ‘937 Patents were invalid or unenforceable. Emergent and Opiant filed a complaint for patent infringement against Teva in the U.S. District Court for the District of New Jersey with respect to the ‘253 Patent. Emergent and Opiant also filed complaints for patent infringement against Teva in the U.S. District Court for the District of New Jersey with respect to the ‘747, the ‘177, the ‘965, and the ‘838 Patents. All five proceedings were consolidated. On June 5, 2020, the U.S. District Court for the District of New Jersey ruled in favor of Teva. Emergent filed its Notice of Appeal on July 23, 2020 with the Court of Appeals for the Federal Circuit and filed its Opening Brief on November 2, 2020.

Emergent has also filed suit in the Federal Court in Canada against Teva Pharmaceuticals (on July 23, 2020). The litigation in Canada is related to Teva Pharmaceuticals’ recent filing of an abbreviated new drug submission (“ANDS”) in Canada seeking to manufacture and sell a generic form of NARCAN® Nasal Spray ahead of the expiry of the Canadian patent covering our product.

ANDA Litigation - Teva 2mg

On or about February 27, 2018, Emergent BioSolutions’ Adapt Pharma subsidiaries EBPA and EIRE, and Opiant received a notice letter from Teva that Teva had filed an ANDA with the FDA seeking regulatory approval to market a generic version of NARCAN® (naloxone hydrochloride) Nasal Spray 2 mg/spray before the expiration of U.S. Patent No. 9,480,644, (the “‘644 Patent”) and U.S. Patent No. 9,707,226, (the “‘226 Patent”). Teva’s notice letter asserted that the commercial manufacture, use or sale of its generic drug product described in its ANDA would not infringe the ‘644 Patent or the ‘226 Patent, or that the ‘644 Patent and ‘226 Patent were invalid or unenforceable. Emergent and Opiant filed a complaint for patent infringement against Teva in the U.S. District Court for the District of New Jersey. This case is currently stayed pending the outcome of the appeal of the NARCAN® Nasal Spray 4 mg/spray case.

ANDA Litigation - Perrigo 4mg

ANDA litigation between Emergent BioSolutions’ Adapt Pharma subsidiaries and Perrigo UK FINCO Limited Partnership (“Perrigo”) has been resolved through settlement. On September 14, 2018, Emergent BioSolutions’ Adapt Pharma subsidiaries EBPA, EIRE and EIR2, and Emergent’s partner Opiant received a notice letter from Perrigo that Perrigo had filed an ANDA with the FDA, seeking regulatory approval to market a generic version of NARCAN® (naloxone hydrochloride) Nasal Spray 4mg/spray before the expiration of the ‘253, ‘747, ‘177, ‘965, and ‘838 Patents, and on or about October 25, 2018, Perrigo sent a subsequent notice letter relating to the ‘937 Patent (collectively, the “Patents”). The notice letters asserted that the Patents were invalid, unenforceable, or would not be infringed by the commercial manufacture, use or sale its generic product. On October 25, 2018, Emergent and Opiant filed a complaint against Perrigo in the U.S. District Court for the District of New Jersey for infringement of the ‘253, ‘747, ‘177, ‘965, and ‘838 Patents Emergent and Opiant filed a second complaint against Perrigo on December 7, 2018, for infringement of the ‘937 Patent. On February 12, 2020, ANDA litigation with Perrigo was resolved after Emergent and Perrigo entered into a settlement agreement. Under the terms of the settlement, Perrigo has received a nonexclusive license to make, have made, and market its generic naloxone hydrochloride nasal spray. Perrigo’s license will be effective as of January 5, 2033 or potentially earlier under certain circumstances related to the outcome of Emergent’s current NARCAN® (naloxone hydrochloride) Nasal Spray ANDA litigation against Teva, or litigation against subsequent ANDA filers.

Inter Partes Review (“IPR”) Proceedings

On or about February 19, 2019, Emergent BioSolutions’ Adapt Pharma subsidiaries EBPA and EIRE, and Opiant received notice from Nalox-1 Pharmaceuticals LLC that it had filed fifteen petitions for inter partes review (“IPR”) of the '253 Patent, the '747 Patent, the '177 Patent, the '965 Patent, and the '838 Patent with the Patent Trial and Appeal Board (the “PTAB”) of the United States Patent and Trademark Office. Nalox-1’s petitions asserted that each of the foregoing patents are unpatentable as obvious in view of prior art. Three of these petitions, IPR Nos. 2019-00685, 2019-00688, and 2019-00694, were instituted on August 27, 2019, September 9, 2019, and September 11, 2019, respectively. An oral hearing for the three instituted IPR proceedings was held before the PTAB on May 19, 2020. On August 21, 2020, the PTAB issued its final written decisions for the above-listed IPRs confirming that claims of the relevant U.S. patents in the NARCAN® Nasal Spray patent portfolio are not unpatentable as obvious in view of prior art.