On August 15, 2022, the Knesset (Israel Parliament) approved, in a first reading, a bill amending the Israeli Patents Law by introducing SPC manufacturing and stockpiling waivers. We have previously elaborated on the proposed bill here.
A Supplementary Protection Certificate (“SPC”), also known as patent term extension (“PTE”), is available in Israel, in certain circumstances, to cover a pharmaceutical product or a medical device protected by a basic patent. In a nutshell, a basic patent is a patent that protects an active pharmaceutical ingredient (API), a process for manufacturing an API, its use or a pharmaceutical product containing an API, or a medical device for which regulatory approval is required in Israel. A SPC is available only for the first regulatory approval allowing use of an API in a pharmaceutical product in Israel.
Essentially, the Israeli Patents Law provides that, subject to certain conditions, a SPC order shall remain valid for a period equal to the shortest extension afforded to the reference patent in a “Recognized Country” (which term is defined to mean Italy, the UK , Germany, Spain, France and the US). Nonetheless, the period of an extension SPC order cannot exceed five years beyond the twenty-year statutory patent term.
In addition, the overall period of the basic patent and any SPC order therefor shall expire no later than fourteen years from the date marketing approval is first received in a Recognized Country. Moreover, the SPC order shall expire no later than the first date on which the extension period granted to the reference patent in a Recognized Country, in which marketing approval has been obtained, is due to expire, or the date of revocation of any reference patent , whichever is the earlier.
The Proposed Amendment
The Patents Law, in its current form, provides that the holder of a SPC may prevent any person from marketing – or manufacturing for the purpose of marketing – a medical device or a pharmaceutical product that contains an API, provided that the API, its manufacturing Process or its use, or the pharmaceutical product or its manufacturing process, are claimed in the basic patent.
The bill specifically refers to Regulation (EU) 2019/933 of the European Parliament and of the Council of 20 May 2019 which allows for certain activities to be carried out during the period of supplementary protection.
It has therefore been proposed to amend the Patents Law, by adding exceptions that would not be considered an infringement of the SPC. Within this context: (i) the manufacturing of a pharmaceutical product or a medical device in Israel, for the purpose of exporting same outside Israel; and (ii) the manufacturing of any such product in Israel, no earlier than six months prior to the expiry of the SPC, for the purpose of marketing the same in Israel, provided that actual delivery of the product is done following the expiry of the SPC .
In addition, any related act deemed necessary for such manufacturing purposes will similarly be allowed. However, the exception shall not apply to the importation of products into Israel for the mere purpose of repackaging, re-exporting or storing the imported product.