On September 15, 2021, the Barcelona Court of Appeal upheld the rejection of a preliminary injunction (IP) request filed by Sanofi against Mylan for alleged patent infringement, concerning a biosimilar product to insulin glargine. With this decision, the Court updated and strengthened its current doctrine regarding the urgency requirement in IP patent cases.
In general, two conditions must be met in order to grant IP in a patent infringement case:
- prima facie validity and patent infringement; and
- danger of delay (i.e. justification of urgency, in order to avoid irreparable damage during the duration of the main proceedings on the merits).
In some decisions, the Court has considered that the “urgency” would arise directly from the risk of the beginning or continuation of the infringement of the patent, that is to say from the risk of launching on the market or of continuing the commercialization of the patent. allegedly infringing product during the life of the patent. However, in other decisions, notably in recent years, the Court has recognized that the above would not suffice as such, and that a real and specific risk must be justified in each particular case.
Sanofi is the holder of European patent 2,346,552, which does not claim a pharmaceutical invention, but an injectable drug delivery device, such as a syringe or a pen, with certain technical characteristics. Although Sanofi markets two injectable insulin glargine pens, they are not embodiments of the patent. A third, Lilly, has been selling an injectable insulin glargine biosimilar since 2015.
In September 2020, Mylan began marketing its insulin glargine biosimilar as a pre-filled pen for injection (Semglee). Sanofi, which had sued Mylan for patent infringement, asked a PI asking the court to ban the marketing of Semglee, believing that its injectable pen would include all the features of the device claimed in the patent. Regarding the urgency, Sanofi alleged that it would be inherent in patent infringement as such. Also, Sanofi added that since in the proceedings on the merits it could only claim a royalty for the sales that Mylan could make on its product (due to the lack of exploitation of the patent), such sales would cause prejudice. irreparable to its activity.
In turn, Mylan referred to the doctrine of the Barcelona Court of Appeal, that a real and specific risk must be justified in each particular case, and argued that this was not the case for de many reasons. In this regard, Mylan pointed out that insulin glargine is in the public domain, and that Sanofi could not tie the sales of its drugs to the patent, as its injectable pens are not an embodiment of the invention. Mylan also pointed out that Sanofi’s failure to work the patent would eliminate the urgency in this specific case. In addition to all of the above, it also argued that, in any event, its product was priced the same as that of Sanofi and Lilly, and that sales data did not predict a significant drop in sales of Sanofi due to the marketing of another biosimilar insulin glargine.
At first instance, Barcelona Commercial Court No. 1 rejected Sanofi’s IP claim, although it did so on other grounds and did not consider the questions of danger of delay. Sanofi has appealed the decision.
The Barcelona Court of Appeal dismissed Sanofi’s appeal, thus upholding the rejection of PI’s claim. On this occasion, the Court specifically addressed the dispute between the parties concerning the urgency.
In its decision of September 15, 2021, the Court referred to previous decisions and explained that, although the approach to urgency was debated within the Court due to its case-by-case nature, the criterion which has prevailed for some time now is that, as such, the marketing of the counterfeit product is not sufficient. On the contrary, a specific risk must be justified in each particular case.
Applying this approach to the case at hand, the Court concluded that there was no urgency. In this regard, it argued that Sanofi could not allege a possible loss of market share for its drugs since it did not have a monopoly on insulin glargine: the claimed patent did not relate to the drug, but to a administration device. Also, the Court declared that the fact that Sanofi could only claim a royalty on the sales of Mylan because of the lack of exploitation of the patent on its part constituted a legal limitation which could not be invoked as prejudice or prejudice. .
This decision is final.
For more information on this topic, please contact NÃºria Ribera to Grau & Angulo by phone (+34 93 202 34 56) or email ([emailÂ protected]). The Grau & Angulo website can be accessed at the address www.ga-ip.com.