Pharmaceutical Patent Term Extensions – Israel Patent Office Considers Request to Grant Extension for Requesting Extension

scar jel

Israel Patent Application Number 217056 to Advanced Biotechnologies LTD. is titled Silicone Scar Treatment Preparation.  The patent application is still pending. According to applicant, the patent covers medical equipment marketed in Israel as Kelo-Cote Jell, Kelo-Cote Spray and Kelo-Cote UV. The products were authorized for sale in Israel from 9 June 2013 and are listed in the medical equipment register of the Ministry of Health. On 26 October 2013, the Applicant requested a three month extension to file a request for patent extension in the event that the patent application is allowed and a patent is granted.

64D. States that:

The Registrar shall not grant an extension order, unless the following conditions have been met:

(1) The material, the process for its production or its use, or the medical preparation that incorporates it or the medical equipment was claimed in the basic patent and the basic patent remains in effect;
(2) in respect of a medical preparation—a medical preparation that incorporates the material is registered in the Register of Medical Preparations under regulation 2 of the Pharmacists Regulations (Medical Preparations) 5746—1986 (hereafter: Pharmacists Regulations);
(3) the registration said in paragraph (2) is the first registration that allows the material to be used in Israel for medical purposes;
(4) no extension order was granted previously in respect of the basic patent or in respect of the material.

Section 64(O)a of the Israel Patent Law grants 60 days for filing a request for a patent term extension and this deadline was missed. HOWEVER, Section 64(O)a relates to ‘medical preparations’.

Despite the contention of the applicant that he was requesting an extension for filing a request for a pharmaceutical preparation, the Commissioner considers that the products in question are not medical preparations but rather ‘medical equipment’, and doesn’t think that the time period of Section 64(O)a of the Israel Patent Law refers to ‘medical equipment’, so there is a lacuna as to what the window for filing the request is.

Medical Equipment is certainly included in Section 64 of the Law:

“medical preparation”—any form of therapeutic drugs that underwent processing, including a preparation for use in veterinary medicine and a preparation of nutritional value intended to be injected intravenously;
“material”—the active component of a medical preparation or salts, esters, hydrates or crystal forms of that component;
“the basic patent”—the patent that protects any material whatsoever, including a process for the production of a material, use of a material, a medical preparation that incorporates a material, a process for the production of a medical preparation that incorporates a material or medical equipment that requires a license in Israel (hereafter: medical equipment).

and it would appear that the requirements to allow a proper period for filing a request for extension are analogous for ‘medical preparations’, see  Re Asta Medica Aktiengesellschaft 101537, 108704, 92904 from 2002.

Consequently, the Commissioner ruled that Applicants have three months in which to submit a request for a patent term extension of the basic patent, from the basic patent No 217056 issuing, if it eventually issues.

COMMENTS

Section 64 A defines a “medical preparation” as any form of therapeutic drugs that underwent processing, including a preparation for use in veterinary medicine and a preparation of nutritional value intended to be injected intravenously. Section 64O. States that an application for the grant of an extension order shall be submitted in the prescribed manner, after the fee has been paid and not later than 60 days from the registration day of the medical preparation under the Pharmacists Regulations.

In this ruling, Commissioner Kling has decided that these materials are medical equipment and not medical preparations, and therefore the 60 day deadline does not apply. There is no deadline for medical equipment, so he is creating one and setting it as ninety days from patent issuing and not sixty days from receiving regulatory approval.

I can see cosmetic preparations being not considered as medical preparations, but in that case they would not be considered as medical equipment either. The title of the application implies that these are preparations, if not necessarily therapeutic. Apart from the hair splitting, I fail to see the logic of granting ninety days from patent issuance for medical equipment but sixty days from regulatory allowance for medical preparations. If there is a lacuna, then the time period for medical equipment should be learned from and be the same as the period for medical preparations.

The preamble of the main claim is “A spreadable preparation for aiding in the healing of wounds”. I think this is a medical preparation and the deadline was missed, not for the first time by the agents of applicant, see here. The time frame is extendible by the commissioner, but the standard should be despite the applicant exercising Due Care. We have no indication what happened and why the application wasn’t made within 60 days.

We note that in the Novartis case then Acting Commissioner Yisrael Axelrod gave a liberal interpretation of the patent term extension rules  in accordance with the 1998 amendment and was subsequently sideways promoted to the Beer Sheva District Court, i.e. literally out into the desert, and the Knesset reworded the law to make his interpretation untenable. The intention of the Knesset was not to grant a reasonable extension under reasonable conditions, but to make it as hard as they could to get patent term extensions. Each amendment to make getting extensions easier was under US political pressure. Each amendment not under US pressure was to make it more difficult.

This is an ex-partes ruling but we suspect that if and when the patent issues, the request for an extension will be opposed and eventually the courts will have their say, if the law concerning patent term extensions is not amended AGAIN in the meantime.  It is probably the numerous amendments to this chapter of the Law under US pressure that has resulted in these “lacunae”.

In the meantime, it appears that RAFA is supplying the product in Israel. See here 

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