Eli Lilly and Company, together with the Spanish subsidiary of Daiichi Sankyo, filed an ex parte preliminary injunction petition against Teva for alleged infringement of European Patent EP584952 (EP 952), which claims the use of raloxifene for treating osteoporosis.

Eli Lilly also owns European Patent EP1438957 (EP 957), which is a divisional of EP 952. Both patents – parent and divisional – essentially claim the same invention and their priority date is July 28 1992.

The divisional patent EP 957 was revoked in December 2009 by the Opposition Division of the European Patent Office (EPO) due to lack of inventive step (appeal pending). The EPO Opposition Division concluded that the use of raloxifene in the preparation of a medicament for treating osteoporosis was obvious to a skilled person in light of the teachings of a paper published in 1987. This document disclosed the effects of two anti-oestrogens (raloxifene and tamoxifen) in ovariectomised rats, showing that they inhibited the loss of mass bone density without increasing the risk of uterine cancer.

Pamplona Commercial Court No 1 decided not to issue an ex parte decision and scheduled a hearing, thus giving Teva the opportunity to oppose the preliminary injunction petition. After the hearing, the court issued a decision (dated July 14 2011) which dismissed the petition and awarded court costs in favour of Teva.

In brief, the plaintiffs claimed that the Raloxifene Teva medicament, launched in Spain, infringed the EP 952 patent. They argued that it should be presumed valid in the limited scope of preliminary injunction proceedings because it was granted by the EPO. Moreover, the plaintiffs stated that the validity of the US equivalent patent was upheld by the US courts, whereas the EPO Opposition Division decision, which revoked the divisional patent EP 957, was irrelevant since parent and divisional patents are legally independent.

Teva based its opposition on the lack of appearance of right of the plaintiffs (fumus boni iuris), arguing that the EP 952 patent clearly lacked inventive step and was therefore invalid.

Teva acknowledged that the two patents were formally independent, but pointed out the importance of the revocation of EP 957: when assessing the inventiveness of EP 957, the EPO Opposition Division concluded that the use of raloxifene for treating osteoporosis, which is the same alleged invention claimed by EP 952, lacked inventive step. Therefore, this decision was a strong indication of the invalidity of the EP 952 patent.

Likewise, Teva filed many precedent decisions, rendered in preliminary injunction proceedings in pharmaceutical patent cases, in which preliminary injunctions were dismissed due to invalidity of the asserted patent (eg, esomeprazole, finasteride, desmopressin, fluvastatin, drospirenone and tamsulosin).

The Pamplona commercial court upheld Teva's arguments, basing its decision on the following points:

  • Article 126 of the Patents Act allows a defendant to raise the invalidity of the alleged infringed patent in "all kinds of proceedings"; therefore, if the defendant challenges the validity of the patent in preliminary injunction proceedings, it must be analysed in a provisional way.
  • The patent asserted by the plaintiffs (EP 952) and its divisional patent (EP 957) claimed the same alleged invention, as the plaintiffs themselves and their experts implicitly acknowledged.
  • The EPO Opposition Division decision, which revoked the divisional patent (EP 957) due to lack of inventive step, was a strong indication of the invalidity of the parent patent (EP 952).

Consequently, in a provisional judgment the court concluded that the plaintiffs lacked the necessary fumus boni iuris, given the serious indication of invalidity of the EP 952 patent, and thus dismissed the preliminary injunction petition.

Eli Lilly and Daiichi Sankyo can appeal this decision.

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 ([email protected]).