Patent Term Extension in Israel – Q&A

1. Is it possible to obtain a patent term extension for a patent covering an approved drug?

The answer to this question is yes. Patent term extensions are available for medical products under Patents Law 5727-1967, Section 64. This memo is based on correction #11 to the Patents Law, dated 2014.

2. What is the maximum length of extension available, and how is it calculated?

The law distinguishes between drugs approved only in Israel and drugs approved in Israel and other jurisdictions. This Q&A relates to drugs that are approved in Israel and in other jurisdictions.

When determining patent term extension, Israeli law takes approvals and extensions in other jurisdictions into account. For this purpose, a list of “recognized states” has been compiled and consists of the following countries:

United States of America

Italy

United Kingdom

Germany

Spain

France

The maximum period of extension of a patent is 5 years. (Section 64 J(1))

The maximum period of the combined patent term and its extension may not be greater than 14 years from the first approval in one of the “recognized states”. In addition, if a corresponding patent or patent term extension is invalidated in one of the recognized states, the Israeli patent term extension will also expire. (Section 64 J(2 and 3)).

The calculation of patent term is extension in Israel is based on the shortest extension (or Supplementary Protection Certificate, SPC) granted in any of the recognized states. (Section 64 I(A)).

3. What types of patent can be extended? For example, patents with only substance claims? Or can patents with method claims, use claims, pharmaceutical composition etc. also be extended?

Substance, method of its manufacture, method of its use, compositions comprising the active ingredient, methods of manufacture of the composition, and medical device patents are all eligible for extension. (See section 64D(1))

4. Who can file a request for patent term extension? Is it only the patent owner, or can a licensee do it? Is it necessary that the patent owner and the ‘owner’ of the new drug approval are the same entity?

A patent term extension may be requested by the patent (or application) owner or exclusive licensee. (Section 64 C(A)). In the case of co-ownership, one of the co-owners may request patent term extension.

If one of the above owners or licensees requests patent term extension, the others will be added to the procedure as respondents.

5. Once the new drug approval is granted, what is the time limit for applying for a patent term extension?

A patent term extension must be applied for within 90 days of the approval of the drug. (Section 64 O)

6. What are the procedures that must be carried out in order to obtain a patent term extension?

a. The substance, method of its manufacture, method of its use, compositions comprising the active ingredient, methods of manufacture of the composition or medical device must be claimed in the patent for which a request for patent term extension is submitted.

b.  The pharmaceutical composition containing the substance for which the extension is requested must be registered according to the Pharmaceutical Regulations, Paragraph 47A.

c.  The registration mentioned in paragraph 2 must be the first registration of the substance for medical use.

d.  An extension will be granted only in a situation in which no prior extensions were granted on the patent being extended, and no prior extensions were granted in relation to the substance.

e.  An extension will be granted, in a situation in which the pharmaceutical composition was authorized in the United States of America, if a patent term extension was granted on an equivalent patent in the United States. The patent term extension must still be in force.

f.  An extension will be granted, in a situation in which the pharmaceutical composition was authorized in one of the recognized European countries, if a patent term extension (SPC) was granted on an equivalent patent in the European country. The patent term extension must still be in force.

g.  An extension will be granted, in a situation in which the pharmaceutical composition was authorized in the United States of America, and in at least one of the recognized European countries, if a patent term extension was granted both in the USA and in the in one of the recognized European countries. The patent term extensions must still be in force. (Section 64G)

h.  Fees for extension must be paid with the application.

i.  The request for extension will be published by the Israeli Patent Office. Third parties may oppose the request for extension.

7. If multiple patents cover a single product, how many of them can be extended based on a single new drug approval?

One. See answer 6.

8. If multiple approved products are covered by a single patent, how many times (or for how long) can that patent be extended based on multiple new drug approvals? Can filing divisional applications help with this?

A single patent may be extended once, even if it covers multiple drug approvals. See answer 6.

It appears that if a divisional application is filed, this patent may be extended, even though the parent application has been extended in relation to another product.

9. If a patent term extension is granted, what ‘rights’ are extended? Is it the entirety of the granted claims? Or only those claims which encompass the approved drug? Or only the portion of the claims corresponding to the approved drug?

The patent term extension extends the rights of the patent to prevent, during the period of the extension, marketing or manufacture of the approved drug, as it is claimed in the patent. The patent is only extended with respect to the approved drug. (Section 64H (D))

If you have any further questions regarding patent term extensions, please contact Senior Partner Avraham Hermon at Avraham.Hermon@JMBDavis.com.