Category IP-Watch Briefs

Research Groups Seek Stronger Protections In EU Copyright Reform Proposal

European lawmakers should boost protections for researchers and educators in the European Commission proposal for a directive on copyright in the digital single market, five research organisations said today. Among other things, lawmakers and policymakers must rethink the provisions on text and data mining as well as the exception for use of works in digital and cross-border teaching, they said.

US Food And Drug Administration Issues Equivalence Guideline For Biosimilars Producers

Biotherapeutic medicines are made out of living organisms and cannot be replicated. No generic medicines, which are exact copies of the reference product, can be made. The generic equivalent of a biotherapeutic would be biosimilars, which are highly similar products. The United States Food and Drug Administration has issued a guide to help producers to prove how close their biosimilars are to the biotherapeutics.