The Knesset Constitution, Law and Justice Committee today unanimously approved for its second and third readings an amendment to the Patents Law (1967) (amended 1998) to allow generic drug companies to prepare for the manufacture of generic alternatives to ethical drugs before the patents to the latter expire. As a counterweight, the Israel Patent Office will be authorized to grant five-year extensions of ethical drug patents.
International pharmaceutical companies and Israeli generic drug makers reached agreement on limiting the list of countries that extend the patents for a given drug, which will be the basis for Israel extending the patent.
Under the original wording, a patent holder may apply to extend a patent in Israel only after applying to do so in all 120 member states of the World Trade Organization (WTO), including countries with no interest in the drug. At the recommendation of Constitution, Law and Justice Committee chairman MK Michael Eitan (Likud), the number of countries was limited to 21, including the US, UK, some other European and Scandinavian states, and Australia.
A key clause in the amendment is intended to prevent harm to Israel’s interest not to lag in the distribution of generic alternatives, while also not affecting the import of the relevant ethical drug. Therefore, the patent extension granted in Israel will match the shortest among the extensions the patent holder obtained in other countries.
The Constitution, Law and Justice Committee was told that setting the marketing date for a generic drug immediately following a patent expiration makes a difference of hundreds of millions of dollars. Eitan said Israel had no intention of being the first to market a generic drug, but wanted to immediately follow the first.
The Knesset is scheduled to vote on the amendment next week, before the elections recess.
Published by Globes [online], Israel business news - www.globes.co.il - on December 13, 2005