In a judgment issued on August 1 2011, Barcelona Commercial Court Number 4 rejected the infringement and unfair competition actions brought by Lundbeck against several companies selling generic escitalopram medicaments in Spain.
Lundbeck is the holder of Patent EP347.066 - ES2.986.891 and Supplementry Protection Certificate (SPC) 200200019 derived from it, which claims a certain manufacturing process for the active ingredient escitalopram. Escitalopram is an anti-depressant sold by Lundbeck under the trademark CIPRALEX.
Lundbeck filed a claim against various companies (Cinfa, Normon, Sandoz, ratiopharm, Stada, Actavis, Kern, Milo and Cantabria) based on the alleged infringement of its patent/SPC. Lundbeck argued that the defendants' generic products contained escitalopram manufactured using its patented process, and not exclusively by the process they had declared (a process of Indian company Dr Reddy's, which falls out of the scope of Lundbeck's patent). To support this argument, Lundbeck argued that:
- the open part of the drug master file filed by the defendants was insufficient to prove that the process used to manufacture the escitalopram in their medicaments was actually the one declared by Dr Reddy's, and that only a certificate issued by the health authorities could prove that fact;
- the presence of diol traces in the defendants' product (less than one part per million (ppm)) could not be explained if Dr Reddy's process had been used to manufacture the escitalopram, but would appear only if Lundbeck's patented process were being used;
- the optical purity of the defendants' escitalopram (99.3%) could not be achieved using Dr Reddy's process; and
- the presence of significant impurities of didesmethyl-escitalopram and desmethyl-escitalopram ('markers' of the use of Dr Reddy's process) was irrelevant, because Dr Reddy's could add them afterwards to cover up the infringement, or could be admixing escitalopram obtained using each process.
During the proceedings, Lundbeck put forward another argument relating to a new impurity , known as 'grignard'. According to Lundbeck, the presence of this impurity in the defendants' products (less than 1 ppm) also proved infringement of its patent/SPC, since this impurity was a typical marker of its own process, whose presence could not be explained if the escitalopram contained in the defendants' products had been manufactured using Dr Reddy's process alone.
However, in its August 1 2011 decision the commercial court upheld the defendants' arguments, concluding that the escitalopram in their medicaments had been manufactured exclusively using Dr Reddy's process.
The court first acknowledged that the evidence submitted by the defendants (eg, three independent expert opinions, certificates of analysis, batch production records) was sufficient to prove that the process actually used to manufacture the escitalopram in their medicaments was indeed Dr Reddy's.
The court further upheld the view of the experts appointed by the defendants, who explained that the trace amounts of impurities found in the defendants' products were insignificant and did not prove the use of Lundbeck's patented process to manufacture the escitalopram contained in them. This was supported by the fact that trace amounts of the typical impurities found using Dr Reddy's process (didesmethyl-escitalopram and desmethyl-escitalopram) were also found in Lundbeck's product, manufactured using its own patented process.
In this regard, the court concluded that, according to the evidence on file, Dr Reddy's did not use ethanol to recrystallise its escitalopram in order to eliminate significant diol traces, as Lundbeck had argued. Instead, Dr Reddy's recrystallised its escitalopram in ethyl acetate - a solvent that, according to Lundbeck itself, does not enable amounts of diol to be reduced.
With regard to the optical purity issue, the court held that, contrary to Lundbeck's initial allegations, the certificates of analysis and batch production records provided by the defendants proved that Dr Reddy's process results in escitalopram with high optical purity.
Hence, the court dismissed Lundbeck's action and awarded court costs in favour of the defendants.
Lundbeck is expected to appeal.
For further information on this topic please contact Sara Pelaz at Grau & Angulo by telephone (+34 93 202 34 56), fax (+34 93 240 53 83) or email ([email protected]).