Israel’s less stringent intellectual property (IP) laws are, today, helping create a conducive business environment for Indian generic players, according to trade experts who further added that Israel’s IP laws are less stringent than other countries such as the European Union (EU) and USA.
Under Israeli law, patent protection is granted to inventors from all countries for a term of 20 years. The governing law for patent protection in Israel is the Patent Law 5727-1967261, which has been amended several times. Patent applications are filed with the Israel Patent Office (“ILPO”), the body that controls and governs the patent registration procedure, for the purpose of registration.
“Patent term extensions are granted in Israel to make up for the lost time due to delayed market approvals. Patent term extensions are granted by reference to the extension period granted for a corresponding patent in a reference country. Such period must be shorter than or equal to the shortest period granted in such reference country. The reference countries are USA, UK, France, Germany, Spain, and Italy. Pharmaceuticals containing a new chemical entity may be granted a 6-and-a-half-year period of marketing exclusivity of up to 6.5 years from the first registration in a recognized country (i.e., US, EU, etc.),” informs Sumanta Choudhury, advisor, Pharmaceuticals Export Promotion Council of India (Pharmexcil).
As per the Israel’s IP laws, pre-grant opposition is allowed by the ILPO wherein the application can be opposed within a time period of 3 months which is non-extendable. The pre-grant opposition procedure is similar to a procedure for litigation in courts and may last for 2 to 3 years or even longer in some cases.
“The pre-grant opposition period may provide generic manufacturers with an avenue to oppose patents in Israel. However, the time period for such opposition is limited. Hence, India may also consider whether it is useful to discuss the possibility of expanding this period with the Israeli Government,” Choudhury suggests.
There are exceptions to the grant of certain kinds of patents. For example, patents are not granted on any method of therapeutic treatment on the human body. However, the following types of “therapeutic treatment on the human body” are protected like products or compositions used for the treatment of the human body, purpose-limited product or composition claims (formerly, Swiss-type claims). Such claims provide adequate protection and are also recognized for primary, secondary and any subsequent medical indications of an active ingredient, diagnostic or detection methods, cosmetic (non-therapeutic) treatment.
The ILPO relies on the examination results, particularly for prior art citations, of parallel applications in the leading examination jurisdictions (Europe and the US). In this context, it is important to note that the applicant claiming priority in its patent application submitted in Israel, must submit the application within 12 months after the previous application was submitted. In addition, the ILPO conducts an independent prior art search and examines the application on various other grounds (for example, unity of invention, sufficient support for the claimed invention, and so on).
“An ILPO report specifies that after a patent application is filed, it usually takes a few years i.e., 24 to 35 months until the examination commences. The examination period, thereafter, ranges between 12 to 20 months approximately, depending on the field of invention (approximately 18 months in case of pharma). The examination time includes the time taken from the first examination till the final decision of acceptance or refusal or abandonment is given. The average time taken from the filing of application till the end of examination is 42 months. However, this time period does not take into account the time for conducting opposition proceedings,” experts inform.
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