Obama 2012 Budget Proposal Reduces Exclusivity For Biologics

Shortly after passage last year of the US healthcare reform act called for a regulatory pathway to bring follow-on biologic drugs, or biosimilars, to market with 12 years of data exclusivity for brand-name producers, the Obama administration has proposed to reduce that time to its original 7 years, according to sources. The move, contained in the 2012 budget proposal, is expected to allow lower priced generic versions of drugs to enter the market sooner, a benefit to consumers.

WTO GI Discussions Gather Speed, Parties Watchful Until Negotiations

The international protection of wines and spirits named after geographical locations has seen renewed attention at the World Trade Organization since the beginning of the year as part of a push to conclude the Doha Round of trade liberalisation. Legal effects and costs of a register for such wines and spirits were addressed last week.