Interested in Patent Term Extensions for medical device in Israel? Be ready for prompt action
The medical device industry is one of the most important and innovative sectors in Israel. The Israeli regulatory regime covering medical devices is governed by the Medical Devices Law, 2012 (“the Medical Device Law”) and the Medical Device Regulations (Registration of a Medical Device and the Renewal Thereof), 2013. However, the Medical Device Law is not yet formally in force, since the enactment of further regulations is still required. However, in practice, the principles of the Medical Device Law are applied by the Ministry of Health, in accordance with certain administrative circulars.
A recent amendment to the Israeli Patent Regulations with respect to Patent Term Extension (“PTE”) orders in Israel (“the Amendment”) includes a reference, among others, to PTEs applicable to medical devices. The Amendment is expected to be signed by the Minister of Justice and published in the near future. The Amendment raises considerable issues concerning the interface between the Patents Law and the Medical Device Law. We therefore believe that appropriate attention should be paid, in particular by patent holders in the field of medical devices, who may become eligible to apply for PTE under certain circumstances.
The Israeli Patents Law allows, in appropriate cases, for PTE to be applied for and obtained based on a "Basic Patent" that protects a medical device which requires registration in Israel. The Amendment provides that an application for PTE in the field of medical devices must be filed within 90 days of registration of the protected device. The application must contain certain details, be supported by an affidavit and accompanied by the appropriated documentation, all intended to demonstrate that the application fulfils the substantial requirements as set out in the Patents Law. The affidavit must include, among others, details of the marketing authorization of the medical device in Israel, as well as particulars with respect to PTEs and marketing authorizations requested for or granted with respect to said medical device in all the recognized countries (the U.S., Italy, England, Germany, Spain and France). If the marketing authorization was requested only in Israel, the applicant must submit any additional information demonstrating that the marketing authorization in Israel was sought, and then handled, in good faith and diligently.
We would like to draw your attention to the transitional provision of the Amendment applicable to medical devices which provides that, with respect to inventions for which marketing authorization for a medical device was granted prior to the Amendment, the deadline for filing an application for PTE (which, as aforesaid, is 90 days from registration of the protected device), will commence 30 days following publication of the Amendment. In the appropriate circumstances, filing an application for PTE, or a motion to extend the deadline for filing such application, may be recommended within said timeframe.