By order issued on June 18, 2017, in summary proceedings brought by Teva against Mylan and Synthon for the alleged infringement of EP 2 361 924 (covering a manufacturing process for the active ingredient glatiramer acetate), the Court of Milan revoked the interim measure granted inaudita altera parte (i.e. without the defendants have been previously heard), which initially ordered Synthon and Mylan to refrain from carrying out further regulatory steps intended to obtain the pricing and reimbursement of the defendants’ Copemyl.

Findings of the Court

The Court of Milan held that, in principle, the patent owner may seek an immediate injunction against the generic manufacturer to the effect that no other regulatory activities are performed to the purpose of the pricing and reimbursement of a generic product. In the case at issue, the Court noted that the order was not addressed against the competent authority (AIFA) but was restricted to the defendants. Therefore the defendants’ objection of lack of jurisdiction of the civil court was dismissed.

The Court stated that

the ordinary protection contemplated by the law (the appeal before the competent administrative court against the marketing authorisation allegedly granted in breach of the law), this being a measure granted only ex post, may not effectively satisfy the need of protection of the patent owner (due to the immediate impact of the decision in terms of market alteration and of the prices that are associated to the grant of the marketing authorisation, which cannot be easily determined and compensated on a later stage)”.

However, the Court narrowly construed the requirements for the grant of the order to halt the regulatory procedure. According to the Court, it must be proved that an irreparable damage would have been caused to the patent holder, even if he were to wait for the time needed for the Judge to perform an investigation on the merits, including the performance of a technical investigation by an independent expert. In the case at issue, the Court found that the balance of convenience was in favour of the defendants and revoked the order initially granted.

That said, the Court drew different conclusions as to the urgency requirement for the grant of an injunction on an urgent basis upon investigation on the merits by a technical expert. The Judge noted that the patent holder would likely suffer an irreparable damage, if he had to wait for the conclusion of ordinary proceedings, since the required additional time would have irremediably altered the market conditions.

The Court eventually rejected Teva’ petition on the merits, based on the assessment carried out by the court-appointed expert of the patent validity and infringement.

Comment

It may appear that the circumstances that are sufficient to meet the urgency requirement for the grant of an interim injunction are not the same as those for obtaining an immediate order to halt the regulatory procedure. To this purpose, the patent owner should prove that – as a consequence – he would suffer an irreparable damage to the pricing and reimbursement and to the launch of the generic product, even in the relatively short timeframe needed for the Judge to deliver a decision on a summary basis.

To this purpose, the patent owner should prove that he would suffer an irreparable damage, i) as a consequence of the pricing and reimbursement decision and ii) to the launch of the generic product, even in the relatively short timeframe needed for the Judge to deliver a decision on a summary basis.

Finally, it is worth mentioning that the court liquidated the reimbursement of legal fees based on an estimate of the actual value of the case, which is unusual for Italian practice. The ordinary practice is that the value at dispute in patent matters is deemed to be undetermined and is therefore set at a figurative medium value (regardless of the actual value of the disputed patent being clearly higher as it was in the case at issue). This new approach led, in the present case, to substantially higher legal fees to be reimbursed by the losing party. It is to be seen whether this approach will be followed by the court of Milan in the future.