Patent Term Extension Matters in Israel

Author:Mr Yafit Avital
Profession:Reinhold Cohn & Partners
 
FREE EXCERPT
Originally published January 2004

The Israeli Patents Law - 1967 (hereinafter "the Law") allows for the extension of the term of patents for medicinal compositions1 and medical devices. The Law (as amended in 1998) stipulates, that those entitled to file an application for patent term extension (hereinafter: "PTE") are the proprietors of a "basic patent"2 and the holders of an exclusive license. The Law further stipulates that an application for patent term extension must be filed within 60 days from the grant of the marketing approval from the Ministry of Health.

Information and Documents

The information and documents required for filing a PTE application as required by the Patent Regulations are specified in the attached ANNEX A.

Procedure

Filing of an application for PTE.

Official letter by the Patent Office, acknowledging the filing of the application and specifying the filing date thereof.

If certain documents are missing, or the application is defective in any way, an Office Action will issue to which a response is usually due within 2 months.3

Once the PTE application is found to meet all the provisions of the Law, a notice will be published in the official Gazette on the intention to issue an Extension Order (hereinafter: "the Notice").

Any party may lodge an opposition to the application by filing a Notice of Opposition at the Patent Office, within 3 months from publication of the Notice.

If no opposition is filed within said term, or if an opposition was filed but cancelled or ultimately refused by the Registrar or by the Court, the Extension Order will issue.

Duration of the Extension Term

The duration of the PTE in Israel is based on the corresponding term in a country that permits PTE, on the one hand, and also experimental use of a patented drug during the term of the patent in order to develop a generic substitute, on the other hand (a "Bolar Country"4). The PTE in Israel will then be granted until the date of expiry of the extended term in the Bolar country. However, notwithstanding the above, the PTE shall expire on the earlier of the following dates:

5 years from the expiry of the "basic patent" (i.e. 25 years from the filing date of the patent application in Israel).

14 years from the first date of obtaining marketing approval in the "Convention Country"5.

Expiry date of the Extension Order in the "Convention Country"5.

Date of cancellation of the Israeli marketing approval.

Date of cancellation or amendment of the "basic patent", in such a manner that the patent no longer covers the marketable product that is the subject of the PTE.

On the dates that renewals were due and were not paid.

Renewals

Renewal fees, beyond those normally paid...

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