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24.09.2009 -

German Federal Court of Justice Confirms Patentability of Escitalopram

Following the hearing on 10 September 2009, the German Federal Court of Justice (Bundesgerichtshof) confirmed in its judgment of the same day the validity of the Supplementary Protection Certificate DE 103 99 030 issued for the active ingredient escitalopram (case docket Xa ZR 130/07). Hence, the antidepressant Cipralex® of the Danish pharmaceutical company H. Lundbeck A/S will continue to enjoy protection in Germany until June 1, 2014.

Generics companies such as Neolab Ltd., Alfred E. Tiefenbacher GmbH & Co. KG, Teva Pharmaceutical Industries Ltd. and Mylan dura GmbH attacked the German part of EP 0 347 066 granted for the active ingredient escitalopram by filing separate nullity actions at the Federal Patent Court in 2005 through 2007. Arrow International Ltd. even joined the fight for a while as an intervenor. The generics companies based their cases on more than 200 prior art documents, expert opinions and test reports.

The nullity actions prevailed in the first instance before the Federal Patent Court of Germany when this Court decided that the active substance escitalopram lacks novelty and that the method for its production was not based on inventive step. The grounds given for this were that the substance citalopram was already known and that the skilled person could have recognized this was composed of two enantiomers (S-citalopram and R-citalopram). The Court stated that it was “easily” possible for the person skilled in the art to separate the substance, thus achieving the pharmaceutically more effective S-enantiomer (escitalopram). He only had to apply textbook knowledge to do so. The stereospecific synthesis of the patent in suit was obvious to the skilled person, in the opinion of this Court.

The nullity proceedings involved not only the European patent as such, but also the SPC, i.e. DE 103 99 030, granted for the active substance escitalopram on the basis of “Council Regulation (EEC) 1768/92 concerning the creation of a supplementary protection certificate for medicinal products”. Patent protection can be extended by up to five years with an SPC for new pharmaceutical products if the possibility for the effective use of the patent has been considerably reduced due to much time having lapsed between the filing of the patent application and grant of a market authorization. This was the case for escitalopram: The first European market authorization for escitalopram was not granted until more than 12 years after the European patent application was filed. Thus, at the start of the market launch, the patentee was left with a term of less than 8 years for the patent. The SPC granted extended patent protection for the active substance escitalopram for an additional 5 years until 1 June 2014.

As the premise behind the validity of an SPC is that the underlying patent is also valid, the Federal Patent Court also revoked the SPC granted on the basis of the underlying patent in its first-instance decision of August 2007.

Lundbeck, however, prevailed in the end at the Federal Court of Justice. Since the patent has in the meantime expired, the parties unanimously declared in the hearing of 10 September 2009 the lawsuit to be resolved as far as the patent was concerned. Thus, the dispute concerned henceforth only the validity of the SPC that was granted for the patent and is of such commercial importance. The Federal Court of Justice dismissed the nullity actions attacking this. Consequently, the Federal Court of Justice has confirmed by its final decision the validity of the SPC for escitalopram.

This constitutes the first decision by the Court of Justice regarding the question of patentability of an enantiomer. This was decided in the present proceedings in favor of patentee. By dismissing the lawsuits against the SPC, a decision was issued for the first time in Germany by the highest court ruling that an enantiomer can be a different product, within the terms of Regulation 1768/92, than the chiral compound as such. The nullity plaintiff Teva had denied this for escitalopram. Teva asserted that, within the terms of Regulation 1768/92, escitalopram is the same product as citalopram and that therefore the SPC for escitalopram had to be revoked.

The Federal Court of Justice did not accept this line of argument, as is apparent from its judgment. On the contrary, it considers the basic patent for escitalopram to be valid and it has also established that within the terms of Regulation 1768/92, escitalopram is a different product than citalopram. Thus, it has ruled that the SPC was legitimately granted.

The escitalopram preparation Cipralex® is, commercially speaking, Lundbeck’s most important product by far. Cipralex®, which is distributed in the USA under the trademark Lexapro®, is the most often prescribed non-generic antidepressant in Europe and the USA. It generates an annual turnover of more than 1 billion Euros and is being distributed in 93 countries. More than 160 million patients have been treated with this product.

Lundbeck is one of many pharmaceutical research companies that are being represented by Hoffmann · Eitle in patent disputes with generics companies. The team at Hoffmann · Eitle that worked on this case thus gained an important victory by prevailing in this first of many nullity cases pending at the Federal Court of Justice against pharmaceutical patents that were granted for enantiomers.

Issuance of the grounds of the Federal Court of Justice for this judgment can be expected in the next few weeks.

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