The Paris Court of Appeal has upheld a first-instance decision, originally handed down by presiding judge Nathalie Sabotier, to reject Allergan’s request for a preliminary injunction against Mylan. This includes product recall, and Allergan obtaining damages from Mylan.
The decision suggests that, contrary to previous notions, the French courts are not the go-to jurisdiction in which a patent holder can obtain a preliminary injunction.
Mylan and Allergan go back
EP 17 54 434 concerns an eye drop treatment for glaucoma, a common eye condition where fluid build-up at the front of the eye damages the optic nerve. Allergan filed an application for EP 434 in March 2006, under the priority of US patent application 83261 of 16 March 2005. The European Patent Office granted the patent in 2009, and it is valid until 2026.
In the early 1990s, Allergan developed an ophthalmic solution to help treat glaucoma, the product Lumigan 0.3mg/ml. This contains, along with other compounds, active ingredient bimatoprost which helps reduce eye pressure. The solution also contains disinfectant preservative benzalkonium chloride (BAK). However, some observers criticised the combination of bimatoprost and BAK as causing 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 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 Mylan also obtained a marketing authorisation for its eye drops solution, the so-called Bimatoprost MylanPharma 0.1 mg/ml. The company has marketed this in France since February 2020.
First to second instance
In June 2020, after Allergan initiated proceedings, Mylan received notice of a preliminary injunction hearing at the Paris Court of First Instance. However, presiding judge Nathalie Sabotier declared a challenge against the validity of Allergan’s EP 434 for lack of inventive step, particularly taking into account the prior art. Now, following another challenge to the patent’s inventive step, the Court of Appeal has upheld Sabotier’s first analysis.
Allergan maintains that product Bimatoprost Mylan 0.1 mg/ml constitutes a generic of Lumigan 01, mg/ml. Therefore. Allergan argues, it reproduces the characteristics of claims 1, 5 and 12 of EP 434. Leaving aside arguments on validity, the company also argues that, in view of the balance of interests involved, it is seeking proportionate interim measures due to suffering significant economic damage from Mylan’s generic product.
In February 2021, the court launched the case on the merits. Now, in October, both parties will attend a case management conference as part of the ongoing case. However, the court has not yet scheduled the hearings for this part of the proceedings.
Up against the courts
EP 434 also faced two oppositions at the European Patent Office. German pharmaceutical company Ratiopharm initiated the first proceedings in February 2010, with Teva following up with a second opposition one day later. However, in 2011 the EPO rejected the opposition and maintained EP 434 in an amended form. Teva withdrew its appeal against this decision in 2017.
In 2014, the US District Court Eastern Division of Texas dismissed invalidity claims against several of Allergan’s US patents. All patents were equivalent to EP 434, which were prohibiting Mylan from marketing the corresponding generic drugs. In 2015, the court confirmed the decision on appeal. Canada also handed down a similar decision.
On the other hand, in 2018 the UK High Court of Justice annulled the English part of EP 434, based on the claims lacking inventive step.
One boutique, one full-service
Paris-based IP boutique Schertenleib led the case for Mylan, a relationship which goes back several years. Name partner Denis Schertenleib is the lead partner in the case. He is regularly active for generics pharmaceuticals companies in high-profile litigation cases. However, associates Estelle Vard and Yasmine Azzaoui have worked with Mylan on the dispute with Allergan 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, with the firm’s London office representing Allergan in the 2019 UK proceedings. Partner Yves Bizollon leads the case in Paris.
For Mylan
Schertenlieb Avocats (Paris): Denis Schertenleib (partner); associates: Estelle Vard, Marc Lauzeral, Yasmine Azzaoui
For Allergan
Bird & Bird (Paris): Yves Bizollon (partner)
SCP Grappotte Benetreau (Paris): Anne Grappotte Benetreau
Paris Court of Appeal, Paris (first chamber)
Isabelle Douillet (president); Françoise Barutel, Déborah Bohée (advisors); Karine Abelkalon (clerk)
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