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 for the patent, are due on the following dates:

  • 6 months prior to the expiry of the "basic patent" term
  • 6 months prior to the expiry of each year of the extension term.

Charges

The fees associated with filing a PTE application are as follows:

Personal Fees

 

Filing an application (exclusive of time) – minimum charge

US $ 825.-6

Renewals (for each annuity)

US $ 330.-

Official Fees

 

Filing an application (NIS 912.-)

US$ 192.-7

Renewal Fee – 6 months prior to the expiration of the "basic patent" term (NIS 2,450.-)

US$ 515.-6

Renewal Fee - 6 months prior to the 1st year of the Extension term) (NIS 2,940.-)

US$ 617.-6

Renewal Fee - 6 months prior to the 2nd year of the Extension term) (NIS 3,528.-)

US$ 740.-6

Renewal Fee - 6 months prior to the 3rd year of the Extension term) (NIS 4,233.-)

US$ 888.-6

Renewal Fee - 6 months prior to the 4th year of the Extension term) (NIS 5,080.-)

US$ 1,066.-6

ANNEX A:

Details and Documents to be submitted with an Application for Patent Term Extension in Israel (according to the Patent Regulations of 1998)

  1. Rule 2(a)(1) – name of the Applicant.
  2. Rule 2(a)(2) - name of those registered in the Patent Register as holding rights to the "basic patent".
  3. Rule 2(a)(3) - details of the Israeli marketing approval, including the number of registration, name of the preparation, generic name of the active ingredient, formulation of the active ingredient and dates of filing the application for marketing approval and grant thereof.
  4. Rule 2(a)(4) – number of the "basic patent", reference to the specific claims in the "basic patent" claiming the preparation, active ingredient, process of production or use thereof.
  5. Rule 2(a)(5) – (1) a list of all the countries which allow actions for obtaining regulatory approval during the term of the "basic patent" (also known as "Bolar" Countries), in which applications for Patent Term Extension relating to the active ingredient have been filed; (2) the situation of these applications. If extensions were granted in any of the aforementioned countries, please specify the date of commencement and date of termination of these extensions.
  6. Rule 2(a)(6) - name of the "Bolar" country which granted the first marketing approval for the active pharmaceutical ingredient, process of production, use or preparation including said ingredient, the name of the preparation or active ingredient as approved in that country and the date of approval.
  7. Rule 2(b)(1) – copy of the Israeli Marketing Approval.
  8. Rule 2(b)(2) – copies of the Applications for Patent Term Extensions as mentioned in item 5 and certified copies of the Grant decisions (if issued).
  9. Rule 2(b)(3) - certified copy of the first marketing approval as mentioned in item 6.
  10. Rule 2(b)(4) – three Declarations as follows:

  1. a Declaration regarding the patent, which will be prepared by us in due course.
  2. a Declaration regarding the Israeli marketing approval of the product subject of the patent. Please provide us with the details of your local agent and the person who may give said declaration therein.
  3. a Declaration regarding Applications for Patent Term Extension in other countries and the status of these Application. Enclosed please find a Declaration outline.

  1. Rule 2(b)(5) – confirmation of the payment of the official fee for filing the application (NIS 912, currently equivalent to about US$ 192).
  2. Rule 2(b)(6) – special Power of Attorney for handling the application for patent term extension, a copy of which is enclosed herewith.

DELARATION

I, ________________, of __________________________, knowing that I am to state the truth, failing which I shall be liable to the penalties prescribed by law, declare hereunder in writing as follows:

  1. I am a [state position] in ______________. In this capacity I handle various patents on behalf of ______________.
  2. Within my capacity at _________, I am also in-charge of Israeli Patent No. _____________ . In addition, I am responsible for obtaining a Patent Term Extension (PTE) for various patents in different countries, relating to [designate active ingredient]. All the facts outlined below are known to me personally within the framework of my responsibilities in ____________. All the patents mentioned below relate to [designate active ingredient].
  3. I attach herewith an Annex, which is a table listing all countries in which applications for Patent Term Extensions (referred to also as Supplementary Protection Certifications – SPC) have been applied for and granted, with respect to the patents mentioned in clause 2 above, including particulars of the patents and the relevant dates that apply to each of them.

And I further declare that all the above is true.

At ___________, this ____ day of _______________, 2004.

_____________________________
Name:
Title:

Attachment to Declaration

Annex

Granted and Applied for Patent Term Extensions of patents that relate to [designate active ingredient]

Granted Patent Term Extensions:

Country

Patent No.

Patent Expiry Date

Patent Extended until

       
       
       
       

Pending Applications for Patent Term Extensions:

Country

Patent No.

Patent Expiry Date

Patent expected to be extended until

       
       
       
       

Footnotes

1 Defined as medicinal drugs which have undergone some degree of processing and comprise drugs for human use, veterinary use, as well as nutritional compositions intended for intravenous administration.

2 The basic patent, defined in Section 64A of the law, is a patent that protects the active pharmaceutical ingredient (API), a pharmaceutical preparation comprising an API, a process for the production of an API and a process for the manufacture of the pharamceutical preparation. The basic patent may also be a patent that protects a medical equipment, the use of which requires regulatory approval. Thus, in addition to patents relating to pharmaceuticals, patents relating to such medical equipment may also be extended.

3 This term may be extended upon request and payment of the required fees.

4 This is provided by Section 64I(a) which stipulates that PTE will be effective until expiry of the PTE in a "Convention Country" (which may be a Paris Convention or a WTO member state) that permits experimental use of a patented drug during the term of the patent for the purpose of regulatory approval (of a generic version). This currently includes the U.S.A., the Ukraine and Australia (in Australia the experimental use exemption applies only during the extension term, i.e. not during the normal 20-year term of the patent, but the Patent Office’s interpretation is that Australia nevertheless qualifies as such a Convention Country). There are some countries that provide for patent term extension where experimental use to develop a generic substitute was established by case law, such as Germany and Japan. It is not clear, however, whether such countries would be regarded as "Bolar Countries" by the Israeli Patent Office.

5 Section 64J(2) stipulates that the PTE will expire no later than 14 years from the day of obtaining the marketing approval in "the Convention Country". Section 64J(3) stipulates that the PTE will expire upon expiry of the first PTE on the basic patent in "the Convention Country". Until recently, the Patent Office interpreted these restrictions to mean that the PTE in Israel would expire upon 14 years of the first marketing approval in any country that is a Paris Convention or a WTO member state, and would also expire upon expiry of a first PTE in any such country. This gave rise to PTEs of somewhat insignificant duration. In a landmark decision issued on July 23, 2003, the Deputy Registrar accepted our arguments in this matter, ruling that the correct interpretation is that this "Convention Country" is the Convention Country refeered to in Section 64I(a), namely, a Convention Country that is also a "Bolar Country" and on which the PTE application is based.".

6 Charges in addition to minimal charges are hourly based.

7 Fluctuates with the prevailing foreign exchange rate.

8 Currently including only the U.S.A, the Ukraine and Australia. There are some countries that provide for patent term extension, where experimental use to develop a generic substitute for a patented drug during the term of the patent was established by some case law, such as Germany and Japan. It is not clear, however, whether such countries would be regarded as "Bolar Countries" by the Israeli Patent Office

The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.