Can a Patent Term be Extended in Israel on the Basis of a Patent Term Adjustment in the US?

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Most patents are renewable up to 20 years from filing. The exception is basic pharmaceutical patents which may be renewed until 25 years from filing to ensure at least 14 years of post regulatory approval in Bolar countries.

The Israel Law relating to pharmaceutical extensions is complicated and has been amended several times. It is based on the Hatch Watchman Act in the US, and was legislated in Israel under a great deal of pressure from the United States. The Amendment itself has been amended a couple of times. Because of the large sums of money involved, drug development companies are willing to spend a small fortune to obtain extensions and Unipharm and Teva frequently oppose such extension periods.

Novartis applied for an extension for IL 154465 titled IL-1BETA BINDING MOLECULES AND USE THEREOF IN THE PREPARATION OF PHARMACEUTICAL COMPOSITIONS AND MEDICAMENTS.

The active ingredient is known as Canakinub, and this received regulatory approval in October 2010 under the trade name ILARIS.

In this instance, regulatory approval preceded allowance of the patent so Applicant requested an extension of the period for requesting an extension of the patent as defined in Section 61(XV). The patent was granted on 1 March 2011 and following this, the patentee requested an Extension.

It transpired that requests for extensions were filed in the US and in most of the European countries that can be used as the basis for a request for patent term extension as detailed in Appendix B to the amendment.

In the US, there are Patent Term Extensions (PTEs) which may be used as the basis for requesting a corresponding extension in Israel. But there are also Patent Term Adjustments (PTAs) which are not to be confused with Parents and teachers Associations considered different things entirely. The PTA is granted to compensate for delays attributed to patent office tardiness in the USPTO. They do not have anything to do with ensuring a term of enforcement from regulatory approval.

In this instance, the Patent Term Adjustment exceeded the theoretical Patent Term Extension so no Patent Term Extension was granted. In other words, there was regulatory approval in the US which starts the clock for usage. However, the corresponding US Patent never was extended by a PTE. The Israel Examiner therefore rejected the request to grant a PTE in Israel as there was no PTE in the US to consider under Section 64(IV)5.
Novartis were not happy with this decision and requested a hearing before the Commissioner on 17 February 2015. They submitted written arguments on 22 June 2015, a hearing was held on 22 July 2015, and on 11 August 2015 a supplementary affidavit was submitted by a Ms Leslie Fisher (maybe that should be Lesley?).

After the 11 amendment to the Israel Patent Law of 27 April 2014, Novartis requested an extension based on the Notice of Final Determination:

“A determination has been made that U.S. patent No. 7,446,175, claims of which cover the human biologic product Ilaris® (canakinumab), is eligible for patent term extension under U.S.C. § 156. The period of extension has been made determined to be 0 days.

The period of extension, if calculated using the Food and Drug Administration determination of the length of the regulatory review period published in the Federal Register of December 9, 2010 (75 Fed. Reg. 76739), would be 205 days.

Because the patent term adjustment awarded to U.S. Patent No. 7,446,175…of 1,131 days extends the original expiration date to September 24, 2024, which is beyond the 14 year exception of 35 U.S.C. 156(c)(3), the term extension is 0 days…”

(the underlying is by the Commissioner Assa Kling (we suspect that Novartis would have preferred not to draw attention to it).

Essentially what happened was that the US patent was in force for over 14 years due to the Patent Term Adjustment, so no Patent Term Extension was required.

The commissioner noted that the PTE was zero days and that section 64(I) of the Law states explicitly that an Extension of the basic patent relied upon has to be for one day or more and that this is referred to in the US as a Patent Term Extension (PTE) and in Europe a Supplementary Protection Certificate (SPC).

The Applicant has a different understanding of the correct interpretation of the Law based on its purpose and the legislative’s intent and argued that there was a lacuna. However, the differences between PTEs and PTAs was discussed in a ruling concerning a patent term extension for IL 181673 to Genetech.

The law, the previous decision and common sense implies that if the drug has patent protection of 14 years from first regulatory approval it does not deserve a patent term extension in Israel. Furthermore, the Commissioner referenced the understanding reached between Israel and the United States

“A reference PTE which results from marketing authorization delays means any period extending the Basic Patent by one or more days, up to the maximum period allowed under the Patent Act.
“…However, if a reference PTE has not been granted (either as an interim or final PTE Order) in the United States and at least one EU reference country prior to the expiration of the underlying Basic Patent in Israel, then no PTE (interim or final) shall be granted in Israel in respect of that Basic Patent.”

This supports the Law as formulated and the Commissioner’s understanding.
The rejection of the request for a Patent Term Extension in Israel was upheld despite the Applicant having been given an opportunity to present his case before the commissioner as per section 152 of the Law.
COMMENT
I am convinced by the ruling. I suspect it may be appealed though.

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