Merck’s Ezetrol and Patent Term Extension in Israel
Patent Term Extension in Israel
Under Israeli Patents Act (Patents Act), a petition for patent term extension (PTE) must be submitted no later than 90 days from the date of regulatory approval of a drug. However, patent term extension is available only for a “basic” patent. A basic patent is a patent that protects a pharmaceutical compound (API), a process for making the API, use of an API or a pharmaceutical product containing an API, a process for making a pharmaceutical compound containing the API or a medical device that requires regulatory approval in Israel. As a result of such a broad definition, a number of patents may cover a product for which PTE is sought. As a result, each of these patents may qualify as a “basic” patent. While a patentee can select which basic patent to extend, only one basic patent can be extended for each product.
The Israeli Patent Office will extend the term of protection of a basic patent if the following conditions are met:
A PTE petition is filed in good faith;
The API, the process of its manufacture, its use, the pharmaceutical composition containing the API, or the medical device are claimed in the basic patent and the basic patent is in force;
The pharmaceutical composition is registered according to the Pharmacists’ Ordinance;
The registration is “the first regulatory approval permitting use of the compound in Israel for pharmaceutical purposes”;
If a pharmaceutical composition is registered in the U.S., a PTE in Israel will only be available if a “patent of reference” was also extended in the U.S. A “patent of reference” is any patent that protects the pharmaceutical product or medical device claimed in a “basic” Israeli Patent, regardless of whether or not it corresponds to the basic Israeli Patent; and
If a pharmaceutical composition is registered in any of the countries listed in Part B of the Addendum (namely, Italy, Britain, Germany, Spain and France), a PTE in Israel will only be available if a “patent of reference” has been extended in at least one of these countries.
The PTE period is calculated according to the following guidelines:
The period of extension will not exceed five years;
The overall period of the patent and the extension must end no later than 14 years from the earliest date in which a regulatory approval was obtained in any of the recognized countries (namely, U.S., Italy, UK, Germany, Spain and France);
The period of extension will be equal to the shortest period of extension granted to a “reference” patent in any of the recognized countries; and
Regardless, a PTE will expire no later than the first expiry date of a PTE of any “reference” patent in any of the recognized countries.
In Israel, the main principle is that a PTE will be granted for a period equal to the shortest duration of a PTE granted in any recognized countries. In addition, the extension period cannot exceed five years and the overall patent and extension period cannot exceed 14 years from the date of the earliest regulatory approval in any of the recognized countries.
Israeli Patent No. 110956
Israeli Patent No. 110956 (‘956 patent) covers Merck’s drug Ezetrol ((3R,4S)-1-(4-fluorophenyl)-3-[(3S)-3-(4-fluorophenyl)-3-hydroxypropyl]-4-(4-hydroxyphenyl)azetidin-2-one), a cholesterol lowering drug. In many parts of the world, Ezetrol is marketed as Zetia.
The ‘956 patent was initially extended for a period of 1,014 days pursuant to Amendment No. 3 of the Patents Act. Under Amendment No. 3 the Israeli PTE was not linked to the shortest PTE or SPC in reference countries but to the PTE or SPC elected by the patentee. Amendment No. 7 introduced for the first time the mechanism which calls for linkage to the shortest PTE/SPC in reference countries. According to Amendment No. 7, the duration of the Israeli PTE order was linked to the shortest PTE/SPC period (meaning the number of days of extension) and to the expiration date of any PTE/SPC in a Recognized Country. The Association of Generic Manufacturers (Association) petitioned to shorten the PTE period according to Amendment No. 7 of the Patents Act. Specifically, the Association argued that according to the transitional provisions, Amendment No. 7 applied retrospectively in connection with PTE orders entered before this amendment came into force.
The Commissioner granted the Association’s petition. Specifically, the Commissioner linked the PTE period of the‘956 patent to the period of the U.S. PTE and shortened the PTE period to 496 days (which was the U.S. PTE period) instead of 1,014 days (the original PTE period). The “reference” U.S. PTE was granted approximately one year after the grant of the Israeli PTE.
Merck challenged the constitutionality of the transitional provisions applying Amendment No. 7 retrospectively. The District Court rejected Merck’s arguments. Nonetheless, the court granted Merck’s alternative basis for the appeal. Based on the legislative history and the language of the statute, Merck distinguished between linkage to the PTE period (number of days) and linkage to the expiry date of the reference PTE/SPC. Specifically, Merck argued:
With respect to the linkage to the PTE period, only a reference PTE/SPC already granted at the date of grant of the Israel PTE will be eligible to shorten the PTE period; and
With respect to the linkage to the expiration date, any reference PTE/SPC will count, regardless of whether it is granted before or after the grant of the IL PTE.
The court agreed this interpretation. As a result, the U.S. PTE order (granted after the Israeli PTE) was no longer relevant and the Israeli PTE was extended by additional 9 months (based on linkage to the German PTE).
The court’s decision that the period of the Israel PTE could only be linked to the period of a reference PTE/SPC granted until the grant date of the Israeli PTE could have important consequences.