One high-impact provision being debated is 12 years of dataexclusivity protection for biologics, complex medicines that treat debilitating chronic diseases.
Given the great amount of time and cost needed to develop these drugs, innovating firms must be given adequate protections on dataexclusivity to ensure they can recoup their investment and be able to continue with new drug development.
Teva, which began in 1901 as a wholesaler and importer of drugs, at first grew in part because Israel's lack of data-exclusivity laws allowed it to learn the formulas of imported drugs from the government, after their manufacturers filed the data to get regulatory approval.