Bausch Health resolves IP litigation with Teva
Canadian pharmaceutical company Bausch Health and generics maker Teva have resolved their dispute over Apriso (mesalazine), a drug used to treat ulcerative colitis and Crohn's disease.
Under the terms of the agreement, which was announced on Wednesday, July 31, Bausch’s subsidiary Salix Pharmaceuticals will grant Teva a non-exclusive licence to Apriso IP, beginning October 1, 2021.
In March 2017, Salix accused Teva of infringing US patent number 8,865,688 in a lawsuit filed at the US District Court for the District of Delaware.
Teva had submitted an Abbreviated New Drug Application (ANDA) to the Food and Drug Administration, seeking approval to market a generic version of Apriso prior to the expiration of the ‘688 patent in 2030.
In response to the suit, Teva claimed that it was not infringing the patent and that the patent was invalid.
Yesterday, August 1, the parties filed a stipulated consent judgment and injunction at the Delaware court.
They agreed that without a licence or authorisation, certain claims of the ‘688 patent would be infringed by the manufacture or sale of the generic products covered by Teva’s ANDA.
Bausch will not make any financial payments or other transfers of value as part of the agreement and both parties will bear their own attorneys’ fees and costs.
In September last year, Bausch agreed to settle all IP litigation with Actavis (which is owned by Teva) over antibiotic Xifaxan (rifaximin).
Salix had sued Actavis in March 2016, alleging that the generics maker was infringing 24 patents relating to Xifaxan, after Actavis alerted Salix that it had submitted an ANDA.
Bausch granted Actavis a non-exclusive licence to the IP, beginning January 1, 2028. From 2028, Actavis will be able to either market a royalty-free generic version of Xifaxan or sell an authorised version with drug supply being provided by Salix.
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