In a final judgment issued on April 29 2015 and served on the parties on May 13, the Supreme Court dismissed Lundbeck's extraordinary appeals in a patent infringement case regarding escitalopram, the blockbuster anti-depressant commercialised by Lundbeck as Cipralex.

Facts

Lundbeck is the holder of Patent EP0347066 - ES2986891 and Supplementary Protection Certificate (SPC) 200200019, now expired, which had a special set of claims for Spain protecting a certain manufacturing process for the active ingredient escitalopram.

In 2010 Lundbeck filed a claim against:

  • Cinfa, Normon, Sandoz, ratiopharm, Stada, Actavis, Kern, Milo and Cantabria, whose escitalopram was manufactured using a process of Dr Reddy's; and
  • Mylan and Germed, whose escitalopram was manufactured using a process of Natco.

Regarding the first set of companies, Lundbeck acknowledged that Dr Reddy's process did not infringe its patent, but argued that the defendants' generic products also contained escitalopram manufactured using the patented process and not exclusively using the process they had declared (Dr Reddy's).

Regarding the second set of companies, Lundbeck argued that Natco's process infringed its patent under the doctrine of equivalents. The main difference between the claimed process and Natco's process concerned the starting material (enantiopure ciandiol versus enantiopure bromodiol).

Lower court decisions

By means of an August 1 2011 decision (for further details please see "Infringement action against escitalopram generics is dismissed"), Barcelona Commercial Court No 4 dismissed Lundbeck's infringement action.

Lundbeck's subsequent appeal was also dismissed by the Barcelona Court of Appeal in a judgment issued on December 19 2012 (for further details please see "Appeal court dismisses Lundbeck's appeal in patent infringement case").

Regarding the first set of defendants, the Barcelona Court of Appeal declared that, according to the evidence filed by the defendants, their escitalopram was manufactured using Dr Reddy's process only and not using any other process, as Lundbeck had argued.

Regarding the second set of defendants, the court declared that Natco's process did not infringe the patent under the doctrine of equivalents because the starting material used in Dr Reddy's process was not equivalent to the starting material used in Lundbeck's process.

Supreme Court decision

Lundbeck appealed to the Supreme Court, based on a procedural infringement in relation to the first set of defendants and a material infringement in relation to the second set of defendants.

Lundbeck's arguments in relation to the alleged procedural infringement, and the Supreme Court's responses thereto, were as follows:

  • Unreasonable assessment of the evidence - the Supreme Court explained that, according to its consolidated case law, the Supreme Court can conduct further analysis of the evidence on file only in special circumstances, which were not present in the case at hand.
  • Infringement of the rules on the presumptions of law and some procedural rules - the Supreme Court found that none of the procedural rules that Lundbeck invoked had been violated and stated that Lundbeck was trying to get the court to analyse the evidence again, which is contrary to its case law.
  • Incorrect application of the rules on burden of proof - Lundbeck argued that the first set of defendants had not duly proved that their escitalopram was manufactured using Dr Reddy's process only. The Supreme Court dismissed this allegation and explained that the rules on burden of proof apply only when a fact has not been proved or remains doubtful, in order to determine which party should bear the consequences of that lack of proof. However, the Barcelona Court of Appeal had not infringed those rules because it was considered sufficiently proved that the escitalopram of the first set of defendants was manufactured using Dr Reddy's process only.

The Supreme Court also dismissed Lundbeck's cassation appeal based on a material infringement. According to Lundbeck, the Barcelona Court of Appeal infringed Article 69 of the European Patent Convention in its assessment of infringement by equivalence.

Both the Supreme Court and the Barcelona Court of Appeal held that the three protocol question test can be used to assess infringement under the doctrine of equivalents. Lundbeck argued that the court of appeal had erred in its application of the second question of this method (Was the proposed alternative obvious to the skilled person?), as the court had found that the starting material of Natco's process was not an obvious alternative to the starting material of the claimed process, because it could not be predicted that it would work satisfactorily. Lundbeck stated that the obviousness analysis of the second protocol question should be the same as that applied in the assessment of inventive step when it comes to validity. Therefore, according to Lundbeck, the question should be asked in terms of reasonable expectation of success, rather than in terms of predictability.

The Supreme Court rejected Lundbeck's argument and stated that the obviousness analysis is not necessarily the same when assessing validity (inventive step) and infringement under the doctrine of equivalents. It therefore confirmed the decision of the Barcelona Court of Appeal.

The decision is final and cannot be appealed.

For further information on this topic please contact Miguel Gil at Grau & Angulo by telephone (+34 93 202 34 56), fax (+34 93 240 53 83) or email (m.gil@gba-ip.com). The Grau & Angulo website can be accessed at www.gba-ip.com.

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