The Israeli Ministry of Justice has proposed changes to Israel's patent term extension (PTE) laws that significantly enhance generics' ability to launch at risk. Although the proposal ostensibly offers Israeli generics the same benefits afforded to European generics, the proposal does not include the safeguards found in the European regulations.
The Israeli proposal offers generics the advantages of the May 2019 amendments to the EU Supplementary Protection Certificate Regulations without the safeguards to prevent misuse. Specifically, the amendment will enable generics to produce generic drugs for export during the PTE period, and to produce and store generic drugs during the last six months of the protection period for sale after the PTE's expiration. Nevertheless, the Israeli proposal does not include any of the EU safeguards intended to prevent generic products from entering the Israeli market prior to the expiration of the PTE.
Unlike the EU regulations, the Israeli proposal does not require generics to notify Israeli authorities or the innovator company of the generic manufacture of a PTE-protected drug. EU notification requirements oblige generics to provide at least three months' advance notice prior to any generic manufacturing to specify whether the generic drug is being produced for storage or export and to provide information on generic drug marketing authorisation in the export country. The Israeli proposal also does not require generics to label exported generic drugs produced with export-only marking.
This will lead to a situation in which generics can produce PTE-protected drugs almost at will, with little, if any, oversight. Generics can easily misuse the protection exemptions to surprise innovators with a local at-risk launch that floods the Israeli market with large quantities of a generic drug at a moment's notice.
The proposal's weakening of PTE rights advances Israel's pro-generic policies. In this regard, Israel already limits PTE periods to the shortest protection period granted out of the United States, the United Kingdom, France, Germany, Spain and Italy. Israel's PTE law contains significant procedural obstacles that ensure the PTE process is challenging for innovators (eg, limited time extensions and time-sensitive requirements to submit foreign PTE or supplementary protection certificates). Further, in contrast with the European Union and the United States, drug market exclusivity is restricted to new chemical entities (eg, small molecules) and limited to a maximum of six-and-a-half years from the drug's first foreign marketing authorisation. Biologics are not granted any market exclusivity in Israel.
As highlighted above, this one-sided proposal, which the Israeli Justice Ministry states will have no detrimental impact on any groups, is especially challenging to innovators. Although the proposal is still subject to approval by Parliament, its potential to further erode non-patent drug exclusivity means innovators need to take immediate note. If the proposal is ratified, innovators will need to be particularly vigilant to ensure they are prepared for potential launch at risk and export by Israeli generics during the PTE period.
For further information on this topic please contact Ephraim Heiliczer or Zeev Pearl at Pearl Cohen by telephone 972 3 303 9000 or email ([email protected] or [email protected]). The Pearl Cohen website can be accessed at www.pearlcohen.com.