A new decision closes the door to patent term extension for early-registered pharmaceuticals.

Case summary: Wyeth Vs. Teva Pharmaceutical Industries Ltd. and Dexel Ltd. An Application for an Extension Order – Patent No. 70390

The Israeli Deputy Registrar of Patents has recently rendered a decision in which he rejected an application for a patent term extension order where the pharmaceutical preparation protected under the patent was registered in the Israeli Register of Drugs well before the Amendment to the Patent Law, which allows such extensions, entered into force. At this time it is not known whether the decision will be appealed.

Background:
On February 26, 1998 Amendment No. 3 to the Israeli Patent Law - 1967 came into force. The Amendment allows experimental use for the purpose of obtaining a regulatory approval, prior to the expiration of the patent. On the other hand, the Amendment enables patent owners, under the terms and conditions prescribed therein, to apply for the extension of the patent protection term (beyond the basic period of twenty years). An application for an extension order must be filed within sixty days from the registration date of the pharmaceutical preparation in the Israeli Register of Drugs (under certain conditions. this sixty days term may be extended).

In addition, a Transitional Provision to Amendment No. 3 states that an application for an extension order in respect of a pharmaceutical preparation that was registered in the Register of Drugs within sixty days prior to the entry into force of Amendment No. 3 may be filed within sixty days calculated as of the date on which the Amendment came into force.

The facts:
Wyeth, the applicant, has a patent the active ingredient of which was registered in the Register of Drugs in April 1996, i.e., approximately two years before Amendment No. 3 came into force. Wyeth submitted an application for an extension order on November 28, 2003, several days before the expiration of the twenty years patent protection period and approximately seven years after the registration of the pharmaceutical preparation in the Register of Drugs.

Two generic pharmaceutical companies, Teva Pharmaceutical Industries Ltd. and Dexel Ltd. were allowed by the Registrar, at their request, to join the proceeding and file arguments against Wyeth's application.

The decision:
The Registrar ruled that:
• The language of the Transitional Provision to Amendment No. 3 is very clear. The Provision has a retroactive validity only in respect of products which were registered in the Israeli Register of Drugs within the sixty days preceding the date on which the Amendment came into force (namely, only between December 26, 1997 and February 26, 1998). The ruling is categorical in that patents covering products which were approved for use in Israel and registered prior to December 26, 1997, are not eligible for patent term extension and that therefore the term of patents such as Wyeth's patent cannot be extended.

• The intent of the Israeli legislator, when enacting Amendment No. 3, was not to create a symmetric balance between the ethical drug industry and the generic industries. Rather, Amendment No. 3 takes into consideration additional economical and public interests, such as the prices of medicines in Israel and the influence of Amendment No. 3 on the public health system.

• Finally, the Deputy Registrar held that the Transitory Provision to Amendment No. 3 does not violate the Israeli constitutional Basic Laws.