The Israeli Ministry of Justice Initiates: Raising the Bar for Granting an Extension of Patent Protection for Pharmaceutical Products

01.09.2010

The Israeli Ministry of Justice introduced a new Bill, which includes amendments to
the Israeli Patents Law 5727-1967 (the “Patents Law”).

The Bill, which was included as part of a Memorandum of Law published on 21 September
2010, raises the bar for extending the term of patent protection for pharmaceutical products in
Israel. The Bill is subject to coordination with the Ministry of Treasury.

The Bill was published following the execution of an agreement, signed in February this year,
between Israel and the U.S. regarding the protection of intellectual property
in the pharmaceutical market in Israel.

The purpose of the Bill is to increase the verifiability for
pharmaceutical companies by reducing the number of the reference states in which the term of
granting a marketing permit may serve as basis to the calculation of the extension period in
Israel, and by providing a fast route for early examination of applications for patent extensions.
According to the Israeli Ministry Of Justice, the Bill further enhances the certainty for
pharmaceutical companies by opening the Israeli market to some generic medicines at an earlier
stage. The Israeli Ministry Of Justice further contends that such rectification of the Patents
Law will provide more certainty in planning of the required state budget to the acquisition of
pharmaceutical products and medical equipment.
The Bill includes the following substantive
amendments:

Reducing the “two states rule” list – Under the “two states rule” (Article 64D[5]-64D[6] of the
Patents Law), an extension of the patent term is granted in Israel in cases in which patent
protection extensions were granted in the United States and in one of the European states listed
in Annex 1(b) to the Patents Law regarding a specified pharmaceutical product, before a
respective patent has expired in Israel. The amendment remove Greece, Ireland, Belgium, Denmark,
Holland, Luxemburg, Portugal, Finland, and Sweden from the list, leaving only France, Italy,
England, and Germany as such potential additional European states. The extension period in Israel
is set according to the shortest extension period between the patent protection extension granted
in the United States and in one of the above European countries.

Changing the examination procedure of the extension
requests – In framework of the suggested amendments, a number of additional procedural rules were
set. For example, a time frame for the examination procedure was defined. In addition, a demand
for the submission of an early notice by the Ministry of Justice, pertaining to the acceptance of
a request for patent protection extension was set forth, as well as an early pre-grant opposition
procedure for such acceptance (on grounds different from a post grant opposition). Moreover, a
procedure for filing a pre- grant request for a patent extension term was proposed.

Clarifying which type of extensions, granted in the United States or in one of the additional
European states, may serve as reference extensions.
As mentioned, the Bill is currently at the consultation
stage. The deadline for the submission of comments regarding this Memorandum of Law is 18 October
2010. If everything proceeds according to the schedule set forth by the Ministry of Justice, we
assume that this Bill will enter into force during 2011.

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