Patent Term Extension

The patent term extension (PTE) legal framework in Israel is complex. The PTE provisions, as part of the Israeli Patent Law of 1976, have been amended several times in the past decade. Consequently, PTE provisions lack clarity and at times create ambiguity in this field. The PTE provisions are implemented by the PTE Regulations, which were amended recently in 2017.

Israeli PTE orders are only available for pharmaceuticals which contain an active ingredient that was registered for the first time in the Israeli Pharmaceutical Registry. Israeli PTE orders are also available for medical devices if all applicable conditions are met.

One of the main complexities of the Israeli PTE regime is that issuance of an Israeli PTE order is influenced, inter alia, by a drug’s marketing approval and the issuance of corresponding PTE and/or SPCs outside of Israel – namely, in the US and five European countries (Italy, Germany, the United Kingdom, Spain and France). In particular, if a marketing approval was issued for a drug in the US and/or one of the European countries, an Israeli PTE order will be issued only if a corresponding US PTE and/or SPC was issued as well. Furthermore, the duration of the Israeli PTE order is calculated on the basis of the corresponding PTE and SPCs and the expiry of the order is also influenced by the status of these foreign term extensions.

The Reinhold Cohn Group has extensive understanding and vast experience in all aspects of PTE, including preparation and examination of PTE applications, legal advice, litigation and representation before various legal entities, which allows the Reinhold Cohn Group to analyze and examine each case in depth and provide the most suitable legal advice that allows the best interest of the pharmaceutical industry.

In addition, the close cooperation with the Attorneys at law of Gilat, Bareket & Co. creates a unique and effective platform for offering top quality services to each and every client.

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