ILPTO Update: Impact of cancellation of first product registration on validity of the IL PTE 

According to a recent controversial District Court judgment (Wyeth v. The Manufacturers’ Association of Israel), even when switching to a new generation product comprising the active ingredient, it is still necessary to maintain in force the original product registration on which the IL PTE was based (the first registration permitting the use of the active ingredient for medical purposes in Israel) to prevent the revocation of the IL PTE.

Wyeth obtained a PTE in Israel based on the registration for Conbriza (bazedoxifene) which is indicated for postmenopausal osteoporosis. The combination drug Duavive, comprising bazedoxifene and conjugated estrogens, was subsequently registered in Israel and replaced Conbriza. The registration for Conbriza was accordingly cancelled at Wyeth’s request.

The IL PTE provisions provide that the PTE order expires upon cancellation of the registration of the drug. The IL Manufacturers’ Association, acting for the local generic industry, petitioned to revoke the PTE order for bazedoxifene among others on the grounds that the first registration for bazedoxifene was cancelled. The Patents Commissioner correctly rejected this assertion. The Commissioner held that the cancellation of the registration would lead to the revocation of the PTE order only if on the date of its cancellation, no other registration for a drug comprising bazedoxifene was listed in the IL Drug Registry. The Commissioner acknowledged that strict literal reading of the PTE provisions would lead to the result advocated by the Manufacturers’ Association. However, such outcome does not serve the legislative purpose, would lead companies to unnecessarily maintain older product registrations and may stifle innovation.

The District Court reversed on appeal. The court held that the letter of the law should be followed and that the cancellation of the original registration, on which the PTE was based, automatically leads to the revocation of the IL PTE order. In our opinion, the District Court judgment is fundamentally wrong and may have been prompted by insufficient arguments at the appeal stage relating to the regulatory framework of drug registrations in Israel. In view of the judgment, when switching to a new generation product comprising the active ingredient, it is necessary to maintain in force the original product registration on which the PTE order was based to prevent the revocation of the IL PTE. In order to prevent the exposure of the IL PTE to revocation, please feel free to consult with us before cancelling the original product registration or allowing it to lapse.

This update article is provided for general information only and is not in lieu of legal advice. Please contact us directly for any required advice on specific matters.