Italy: PI granted against everolimus generic medicinal products for use for breast cancer

Background

The patent enforced by Novartis is EP ‘246, entitled “Rapamycin derivative for the treatment of a solid tumor associated with deregulated angiogenesis”, a second medical use patent in EPC 2000 form, claiming everolimus with an aromatase inhibitor for the treatment of hormone receptor positive breast tumors.
In particular, in May 2020 several Novartis companies filed an application on the basis of EP ‘246 seeking PI against Ethypharm and Avas[1].

Ethypharm and Avas had obtained a full label MA for everolimus (i.e. they did not carve out a combination of everolimus in combination with exemestrane for use in breast cancer) and had participated in some tenders for the supply of everolimus.

Ethypharm and Avas asked for the dismissal of the PI application for lack of the requirements provided by law:

• the “fumus boni iuris” requirement, alleging that EP ‘246 is not prima facie valid;
• the “periculum in mora” requirement, submitting that Novartis (i) was not suffering irreparable damages and (ii) waited for several months from the launch of Everolimus Ethypharm before filing PI proceedings.

In the first instance PI proceedings the Judge appointed a Court Technical Expert (“CTE”) to assess the validity and infringement of EP ‘246.

The first instance PI decision

In the decision published on 13 July 2021, the Judge (agreeing on the conclusion of the CTE) recognized the prima facie validity of EP ‘246.

The CTE considered groundless the added matter objection raised by Ethypharm / Avas, pointing out that the skilled person, in order to arrive at claim 1 of EP ‘246 starting from the embodiment disclosed in the original application (WO ‘019), would only have to select everolimus from the compounds according to that invention and such selection would have been clearly directed towards everolimus since the latter was the most preferred compound in the description of WO ‘019.

Additionally, the CTE considered unfounded the insufficiency objection, noting that even if EP ‘246 does not contain experimental data specifically relating to the use of everolimus in combination with an aromatase…