![From QSR to QMSR: Meeting FDA’s New Requirements From QSR to QMSR: Meeting FDA’s New Requirements](https://www.fdanews.com/ext/resources/Book-Covers-NEW/From-QSR-to-QMSR-500.png?height=200&t=1714569011&width=200)
Home » Multinationals, Generics Makers Submit Rival Israeli Patent Laws
Multinationals, Generics Makers Submit Rival Israeli Patent Laws
May 20, 2005
Israel's generic drugmakers and representatives of the research-based industry have both submitted their own draft intellectual property laws to the country's legislature. It is not expected that the multinational community's favoured version will gain much ground in the Knesset. Instead, the government continues to prepare its own version, which is expected to closely follow the draft put forward by the local industry.
Local newspaper Globes claims to have obtained a copy of the generic manufacturers' draft, which would effectively eliminate patent extensions in Israel beyond the date of expiry in the US. This amendment would strongly favour local drug producers, much of whose business depends of the ability to prepare a generic version for a US launch on the date of patent expiry.
Although Israeli laws do allow for the development of generics for export during the patent term — under the so-called Teva amendment — manufacturers are threatening to move drug production to other countries for export if the laws become unfavorable. With several key blockbusters due to go off patent in the medium term, the Israeli government is unlikely to risk losing a key export industry, however genuine the threat of such action may actually be. At the same time, the backlog of hundreds of local patent extension applications filed by ethical drugmakers is expected to be resolved in light of the new amendment.
KEYWORDS Daily International Pharma Alert
Upcoming Events
-
21Oct