Patent Term Extension In Israel

1. Sanford T. Colb & Co. Intellectual Property Law Rehovot (Main office) | Tel-Aviv | Jerusalem Patent Term Extension In Israel By David Colb, Adv & Barak Mashiah, Adv

2. The term Patent Term Extension (hereinafter “PTE”) refers to the extension of the protection period which is accorded to a patent relating to a medicinal preparation or substance, beyond the 20 year protection period. • The principal grounds for enabling an extension of the protection period are as follows: • The extended period of time needed in order to obtain marketing approval for a medicinal preparation • Generic companies are, under certain conditions, permitted to carry out experimental acts during the patent period, in order to obtain a license immediately after the patent has expired, and a PTE constitutes a counter-balance to this permission. PTE- Introduction

3. Who may apply for an extension order? The applicant for registration of a basic patent.* The owner of a basic patent. The owner of an exclusive license in a basic patent or in an application to register a basic patent. What is the deadline for filing a request for grant of PTE? An application for grant of an extension order must be submitted no later than 90 days from the registration date of the medicinal preparation, even if the patent application is still pending. PTE in Israel

4. Conditions for grant of an extension order (Unofficial Translation) The Commissioner shall not grant an extension order unless all of the following conditions have been met: The substance, the process for the production or use of the substance, or the medicinal preparation that incorporates the substance or the process for the production of the medicinal preparation, or the medical equipment, was claimed in the basic patent and the basic patent remains in effect; In respect of a medicinal preparation - a medicinal preparation that incorporates the substance is registered in the Register of Medicinal Preparations; The registration referred to in Section B is the first registration which enables use of the material in Israel for medical purposes; PTE in Israel [The Israel Patents Law]

5. PTE in Israel [The Israel Patents Law] Conditions for grant of an extension order (Unofficial Translation) No extension order was granted previously in respect of the basic patent or in respect of the substance; If marketing approval has been granted in the United States of America – an extension order has also been granted for the reference patent in the United States of America, and it has not yet expired; If marketing approval has been granted in a recognized European country* – an extension order has also been granted for the reference patent in that country, and it has not yet expired; If marketing approvals have been granted in the United States of America and in at least one recognized European country – extension orders have also been granted for the reference patent in the United States of America and in that recognized European country, and they have not yet expired. *Recognized European Countries: i.e. Great Britain, Germany, Italy, France and Spain

6. PTE in Israel [The Israel Patents Law] Limitations The total period of validity of the patent, including the PTE, will not be more than 25 years from the date on which the patent application is filed. The PTE will end no more than 14 years from the earliest date on which the pharmaceutical preparation which contains the substance was licensed in one of the Recognized Countries.

7. PTE in Israel – case law Appeal Case No. 41839-10-12 Tel-Aviv District Court The relevant section of the Israel Patents Law: 64D(e) If marketing approval has been granted in the United States of America – an extension order has also been granted for the reference patent in the United States of America, and it has not yet expired; The U.S. law which determines the period of protection which is granted to a patent changed during the period of time which is relevant to this case. The determining date for the change that occurred in U.S. law was June 8, 1995, two days after the day on which the U.S. patent application was filed – June 6, 1995.

8. PTE in Israel – case law Appeal Case No. 41839-10-12 Tel-Aviv District Court The U.S. law set a de facto extension of patents, applications which were pending on June 8, 1995. The U.S. law stated that all of the patents, applications which were pending on June 8, 1995, would have a period of protection that is the greater of the twenty-year term from the day of the filing of the patent application or17 years from the day on which the patent is granted. In the words of the law: “All patents… that issued on an application that was filed before June 8, 1995, have a term that is the greater of the “twenty-year term” or seventeen years from the patent grant”. The U.S. Patent was granted on May 15, 2007. According to the U.S. law that was applicable on the day on which it was possible to request a patent term extension of the U.S. Patent, the term of the U.S. Patent was “extended” automatically, and the U.S. Patent is scheduled to expire only 17 years from the day on which the U.S. Patent was granted. In other words, on the day on which it was possible to request patent term extension of the U.S. Patent, the expiry date thereof was May 15, 2024.

9. PTE in Israel – case law Appeal Case No. 41839-10-12 Tel-Aviv District Court There was no dispute between the parties that the date on which the U.S. Patent will expire is later than the date on which the Israel Patent will expire, even if the term of the Israel Patent is extended to the maximum period permitted by law. It is clear that in view of the above-mentioned provision of the U.S. law, there was no reason or basis for requesting a patent term extension of the U.S. Patent, since the term thereof had been “automatically extended” on the basis of the law which applied in the U.S. This “automatic” extension, which was set forth in the law, extended beyond the date regarding which it had been possible to extend the term of the U.S. Patent, via a patent term extension. The Intellectual Property Adjudicator who heard the case did not agree with this argument and refused to grant the requested extension. This appeal is currently pending before the District Court.