Viatris and Schertenleib invalidate Allergan glaucoma treatment patent

Following pharmaceutical company Allergan making an infringement claim against Viatris, the Paris Judicial Court has invalidated a patent owned by the former which covers an eye-drop treatment for glaucoma (case no. RG 21/02570). The condition leads to fluid building up at the front of the eye, which damages the optic nerve.

Allergan sought PI

Allergan filed an application for EP 1 754 434 in March 2006, which the European Patent Office granted in 2009. The patent is valid until 2026. In the early 1990s, Allergan developed ophthalmic solution Lumigan 0.3mg/ml to help treat glaucoma, which contains active ingredient bimatoprost. The solution also contains disinfectant preservative benzalkonium chloride (BAK). However, some suggested that the combination of bimatoprost and BAK caused side effects in patients, such as eye inflammation.

EP 434 covers a composition containing a lower concentration of bimatoprost and a higher concentration of BAK, as contained in product Lumigan 0.1mg/ml. The European Medicines Agency (EMA) granted Allergan Ireland a marketing authorisation for Lumigan 0.1 (no. EU/1/02/205/003-004) in January 2010.

Since May 2010, Allergan France has marketed Lumigan 0.1 mg/ml in France on this basis. However, in April 2017 Viatris also obtained a marketing authorisation for its eye drops solution, the Bimatoprost MylanPharma 0.1 mg/ml. The company has marketed this in France since February 2020.

Claim characteristics

But Allergan had already stumbled in July 2021. The Paris Court of Appeal upheld a first-instance decision to reject Allergan’s request for a preliminary injunction against Viatris due to a challenge to the patent’s validity. Allergan maintains that product Bimatoprost Mylan 0.1 mg/ml constitutes a generic of Lumigan 01, mg/ml. Therefore, Allergan argued, it reproduces the characteristics of claims one, five and 12 of EP 434.

Following the PI proceedings, Allergan then brought infringement proceedings against Viatris, which the defendant counterclaimed via invalidity due to lack of inventive step. With regards to the inclusion of BAK, Viatris claimed that the invention is an obvious dosage adjustment for a person skilled in the art.

In November 2023, the Paris Judicial Court heard the case on the merits, dismissing the infringement claims and finding patent claims one, five and 12 invalid. According to the judgment, in Italy a preliminary injunction issued against Viatris on the basis of EP 434 was overturned on appeal. In the US and Canada, courts rejected the invalidity applications against the corresponding local patents.

Firms in Paris

Paris-based IP boutique Schertenleib led the case for Viatris, a relationship which goes back ten years when the company operated under the Mylan name. Name partner Denis Schertenleib, who leads alongside Ombeline Degrèze-Péchade in the case, also acted in the 2021 PI proceedings. Of the associates, Yasmine Azzaoui and Marc Lauzeral have worked on the dispute since it began.

Allergan and Bird & Bird have a long-running relationship, with the full-service international firm working for the pharmaceutical company in numerous disputes. The interplay between Bird & Bird’s European teams remains strong; the firm’s London office represented Allergan in the 2019 UK proceedings, in which the patent was also invalidated.

Yves Bizollon, who is of counsel at the firm, leads the PI case in Paris. Partner Thierry Lautier handled the proceedings on the merits. Lautier joined the Bird & Bird team in September 2023 from the Paris office of Reed Smith.

For Viatris
Schertenlieb Avocats (Paris): Denis Schertenleib, Ombeline Degrèze-Péchade (both partners); associates: Marc Lauzeral, Yasmine Azzaoui, Nevyn Fournel, Stella Signoroni, Célia Benmesbah; Alix Daubé (legal practitioner and biologist)

For Allergan
Bird & Bird (Paris): Thierry Lautier (partner); of counsel: Yves Bizollon; associate: Marylis Clerc

Paris Judicial Court, third chamber (second section), France
Irène Benac, Véra Zederman (both vice president); Arthur Courillon-Havy (judge); Quentin Curabet (registrar)