- Law corporations
- Related paperwork
- Astepro Allergy accredited for over-the-counter use in June
- Bayer, Meda say Apotex’s generic infringes patents
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(Reuters) – Bayer Healthcare and Viatris’ Meda Pharmaceuticals have sued Canadian generic drugmaker Apotex in Delaware federal court docket, alleging its proposed generic model of Astepro Allergy nasal spray infringes its patents.
The U.S. Food and Drug Administration approved Bayer’s Astepro Allergy for nonprescription use in June. Bayer has mentioned it’s the first over-the-counter, steroid-free antihistamine allergy spray within the U.S.
The Thursday complaint requested the U.S District Court for the District of Delaware to delay FDA approval of Apotex’s generic drug till the final Astepro patent expires in 2028, and to dam Apotex from making it earlier than then. The lawsuit additionally initiates a 30-month keep of the approval course of below the Hatch-Waxman Act.
Meda obtained FDA approval for the prescription model of Astepro in 2009. Bayer spokesperson Chris Loder mentioned in an announcement that the corporate licenses the patents from Meda and has the appropriate to implement them towards alleged infringers.
Apotex did not instantly reply to a request for remark. Viatris additionally did not instantly reply, nor did Bayer’s attorneys Dov Grossman of Williams & Connolly and Jack Blumenfeld of Morris Nichols Arsht & Tunnell, or Meda’s attorneys Brandon White of Perkins Coie and Jennifer Ward of Wilson Sonsini Goodrich & Rosati.
Bayer and Meda’s swimsuit follows Apotex’s submitting of an Abbreviated New Drug Application for FDA approval of its generic drug. An ANDA asserts that the related drug patents are invalid or wouldn’t be infringed by the generic drug, and opens the applicant to infringement claims from the patent proprietor.
The criticism says Apotex informed the FDA that the related components of the patents had been invalid.
The case is Bayer Healthcare LLC v. Apotex Inc, U.S. District Court for the District of Delaware, No. 1:21-cv-01429.
For Bayer: Dov Grossman of Williams & Connolly and Jack Blumenfeld of Morris Nichols Arsht & Tunnell
For Meda: Brandon White of Perkins Coie and Jennifer Ward of Wilson Sonsini Goodrich & Rosati