Eli Lilly and Company is a global pharmaceutical company. Lilly was the first company to mass-produce penicillin, as well as one of the first pharmaceutical companies to produce human insulin using recombinant DNA, and today is the world’s largest manufacturer and distributor of psychiatric medications.
Teva Pharmaceutical Industries Ltd.is an international pharmaceutical company. It specializes in generic and proprietary pharmaceuticals and active pharmaceutical ingredients. It is the largest generic drug manufacturer in the world and one of the 15 largest pharmaceutical companies worldwide.
An ex parte preliminary injunction was filed against Teva for alleged infringement of European Patent EP584952 in 2008. This case was filed by Eli Lilly and Company, together with the Spanish subsidiary of Daiichi Sankyo. The patent in question claims the use of raloxifene for treating osteoporosis. Another patent owned by Eli Lilly is EP1438957, which is a divisional of EP584952. Both patents claim the same invention and their priority date is 28th July, 1992.
EPO revoked EP1438957 in December, 2009 due to lack of inventive step. 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 ovaryectomised rats, showing that they inhibited the loss of mass bone density without increasing the risk of uterine cancer.
It was decided by Pamplona Commercial Court No 1 not to issue an ex parte decision and scheduled a hearing where Teva stands on this case. After the hearing, the court issued a decision on 14th July, 2011, dismissing the petition awarding court costs to Teva.
In aforesaid case Eli Lilly had claimed that Teva was infringing EP584952 in Spain. Eli Lilly said that preliminary injunction should be issued to Teva for producing generic version of raloxifene. The plaintiff also stated that EPO has only revoked divisional application and parent application still standing tall. On this basis, Eli Lilly was asking for injunction against Teva.
To the above accusations Teva said in opposition that plaintiff lacked appearance of right and also stated that EP584952 lacked inventive step thus, it is invalid. Teva said that both patents were independent but also pointed out to the importance of the revocation of EP1438957. They said that while EPO was assessing the inventiveness, EPO said that EP1438957 lacked inventive step. The same invention was quoted in EP584952; therefore decision of EPO to revoke EP1438957 is a strong indication that EP584952 is invalid.
In the same manner Teva filed many precedent decisions, rendered in preliminary injunction proceedings in pharmaceutical patent cases, preliminary injunctions were dismissed.
The Pamplona commercial court gave decision on the following points:
· Article 126 of the Patents Act (Europe) 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 analyzed in a provisional way.
· The patent asserted by the plaintiffs EP 584952 and its divisional patent EP 1438957 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 1429957 due to lack of inventive step, was a strong indication of the invalidity of the parent patent EP 584952.
The court also concluded that the plaintiffs lacked the necessary fumus boni iuris, given the serious indication of invalidity of the EP 584952 patent, and thus dismissed the preliminary injunction petition.
In a judgment granted by Pamplona Commercial Court No 1 on 31st July, 2012, patents of Eli Lilly were revoked. This was granted on the issue where it was proved that these patents i.e. EP584952 and EP1438957 had no inventive step.
EP584952 claim an invention: the use of raloxifene for the treatment of osteoporosis. This patent protects the main indication of blockbuster drugs Evista and Optruma, which are manufactured by Eli Lilly and commercialized with its consent.
Following Teva’s arguments, the court patent due to lack of inventive step.
The decision is remarkable for two reasons:
First, the court upheld the Teva’s challenge against the impartiality and objectiveness of the two bone specialists whom Eli Lilly had appointed as experts. The experts were consultants for Eli Lilly and company. Moreover, the court emphasized that neither expert had mentioned these facts in his reports.
Secondly, the court rejected two alleged technical prejudices at the priority date of the patents, which Eli Lilly maintained would support the inventive step of the claimed invention.
The alleged technical prejudices were that:
· Raloxifene has low bioavailability, which would lead an expert to disregard the use of raloxifene to prepare a drug.
· If a compound does not produce estrogenic effects in sexual tissue, it was thought that it would not produce them in bone tissue.
Following case law from the European Patent Office Boards of Appeal, the court explained that a ‘technical prejudice’ is an opinion or preconceived idea that is widely or universally held by experts in the field, whose existence must be demonstrated by reference to textbooks or encyclopedias published before the priority date.
The court concluded that the use of raloxifene in the preparation of a drug for treating osteoporosis was obvious to a skilled person in light of a paper by Jordan et al, published in 1987. This paper disclosed the effects of two anti-oestrogens (raloxifene and tamoxifen) in ovaryectomised rats, showing that they inhibited the loss of bone density without increasing the risk of uterine cancer.