In the United Kingdom, multiple generic competitors initiated invalidity lawsuits seeking revocation of Bayer’s key dosing patent protecting Xarelto 10, 15, and 20 mg (EP 1845961, the ‘961 patent; set to expire January 19, 2026) at the UK High Court (UKHC).
In late March 2024, the UKHC granted Bayer’s request for a preliminary injunction against multiple generic competitors based on the ‘961 patent until a decision on its validity was made. On April 12, 2024, the UKHC ruled the UK part of the ‘961 patent invalid for lack of inventive step. Later that day, the preliminary injunction (PI) was extended until April 29, 2024, to allow Bayer time to seek permission to appeal before the UK Court of Appeal (CoA).
Fast forward to May 16, 2024, the UK Court of Appeal held a hearing in Bayer’s appeal against the ‘961 patent revocation. The focus was on whether the correct legal standard was applied by the UKHC in assessing inventive step. Following the hearing, the Court of Appeal decided to dismiss Bayer’s appeal, signaling an imminent order to lift the PIs.
The Court of Appeal is expected to promptly issue an order lifting the injunctions against competitors and to publish its written appeal decision in the coming weeks. Consequently, generic competition for 10, 15, and 20 mg Xarelto is expected to begin in the UK.
It’s unlikely that Bayer would be permitted to further appeal on a point of law to the UK Supreme Court.
Stay tuned for further updates as this complex legal saga continues to unfold.
