Bausch targets Israeli firm in skin treatment dispute

Pharma company claims infringement of both patents that cover the blockbuster treatment | Generic version has been in motion since May last year.

Bausch Health is suing an Israel-based rival for allegedly infringing a patent covering Arazlo (tazarotene), a treatment used for skin ailments including acne and psoriasis that was issued just this week.

The pharma company filed the suit on June 21 at the US District Court for the District of New Jersey, claiming that Pedagis had violated US patent number 11,679,116 by filing its Abbreviated New Drug Application (ANDA) for the approval of a generic version of the drug.

In a letter dated May 12, 2022, sent to Bausch Americas and Bausch US, Padagis Israel notified the company it had submitted ANDA number 215393 to the US Food and Drug Administration ( FDA) seeking approval to engage in the commercial manufacture, use or sale of a generic tazarotene (0.045%) lotion.

Bausch then initiated a suit for infringement of the then-listed patent in the Orange Book for Arazlo, 11,311,482 against Padagis Israel.

On June 20, 2023, the US Patent and Trademark Office granted Baush Ireland a successor patent for its brand skin treatment product, titled Topical Compositions and Methods for Treating Psoriasis was duly and legally issued.

Bausch Ireland argued that it intends to submit information related to the ’116 patent in the Orange Book in connection with Arazlo within 30 days of its issue, and expects the FDA to list the ’116 patent in due course for NDA number 211882. 24.

The named inventors of the ’116 patent are Gordon Dow, Radhakrishnan Pillai, and Varsha Bhatt.

The company is seeking a declaratory judgment of infringement, along with relief.

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