shutterstock_1124671937_jhvephoto
JHVEPhoto / Shutterstock.com
2 August 2019AmericasSarah Morgan

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.

Did you enjoy reading this story?  Sign up to our free newsletters and get stories like this sent straight to your inbox.

Already registered?

Login to your account

To request a FREE 2-week trial subscription, please signup.
NOTE - this can take up to 48hrs to be approved.

Two Weeks Free Trial

For multi-user price options, or to check if your company has an existing subscription that we can add you to for FREE, please email Adrian Tapping at atapping@newtonmedia.co.uk


More on this story

Americas
14 May 2020   A Californian judge has thrown out an attorney’s whistleblower lawsuit alleging Bausch Health Companies fraudulently obtained a patent for its ulcerative colitis drug Apriso.
Big Pharma
13 September 2021   Canadian pharma firm Bausch Health has agreed to settle an antitrust suit where it was accused of holding an illegal monopoly on the diabetes drug Glumetza.
Big Pharma
20 June 2023   Pharma giant claims infringement of two patents | Hyderabad-based rival’s letter offering details of proposed generic allegedly lacked certain required details.

More on this story

Americas
14 May 2020   A Californian judge has thrown out an attorney’s whistleblower lawsuit alleging Bausch Health Companies fraudulently obtained a patent for its ulcerative colitis drug Apriso.
Big Pharma
13 September 2021   Canadian pharma firm Bausch Health has agreed to settle an antitrust suit where it was accused of holding an illegal monopoly on the diabetes drug Glumetza.
Big Pharma
20 June 2023   Pharma giant claims infringement of two patents | Hyderabad-based rival’s letter offering details of proposed generic allegedly lacked certain required details.

More on this story

Americas
14 May 2020   A Californian judge has thrown out an attorney’s whistleblower lawsuit alleging Bausch Health Companies fraudulently obtained a patent for its ulcerative colitis drug Apriso.
Big Pharma
13 September 2021   Canadian pharma firm Bausch Health has agreed to settle an antitrust suit where it was accused of holding an illegal monopoly on the diabetes drug Glumetza.
Big Pharma
20 June 2023   Pharma giant claims infringement of two patents | Hyderabad-based rival’s letter offering details of proposed generic allegedly lacked certain required details.