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New Rules On Generic Biological Medicines Under US Congressional Debate

By Liza Porteus Viana for Intellectual Property Watch
When Biotechnology Industry Organization CEO Jim Greenwood meets with members of the United States Congress to talk to them about follow-on biologics, he brings a graphic model of an aspirin and a DVD showing the complex molecules of a biologic drug. He uses these visuals to help explain the differences between traditional chemical drugs and newer, cutting-edge biological ones being used in many breakthrough therapies for cancer, multiple sclerosis, HIV/AIDS, and other diseases.

The differences between traditional chemical drugs and biological ones is the crux of the debate going on in the United States as Congress and the Food and Drug Administration (FDA) try to create a regulatory pathway that gives consumers greater access to cheaper, generic biological drugs, but still spurs innovation and protects innovator patent claims.

"When the legislation was introduced at the beginning of this Congress, most pundits expected that we'd oppose it," said Greenwood, a former House representative from Pennsylvania, told Intellectual Property Watch. "But that was a mistake the pharmaceutical industry made in the '80s - trying to resist the notion you could safely make generics …our view at BIO is that we need to follow the science, and science says you can make follow-on biologics that can be safe and can save the consumer money and therefore we support it."

Europe May Put ACTA Back On Faster Track

By Monika Ermert for Intellectual Property Watch Despite earlier statements by European negotiators that the planned Anti-Counterfeiting Trade Agreement (ACTA) would need time for fine-tuning, nations seem to accept a fast track movement now. ACTA has been mentioned as an…

Modalities Text On IP Issues Floated At WTO Available Here

A confidential text, dated 30 June and available here, and circulated recently among some World Trade Organization members reveals an attempt to consolidate separate proposals on the protection of geographical indications, biodiversity and traditional knowledge.

Intellectual Property: A Means To An Access And Benefit-Sharing End?

By Kaitlin Mara
Intellectual property is a useful leveraging tool for developing countries eager to see the creation of a global access and benefit-sharing regime on genetic resource use, said a recent panel on biodiversity protections in international law.

"Benefit-sharing was viewed as an integral part of the main bargain between developed and developing countries" when the Convention on Biological Diversity (CBD) was first formed, said Timothy Hodges, a Canadian official who co-chairs an access and benefit-sharing working group under the CBD.

WIPO Development Committee Makes Careful Progress On Implementation

By William New Members of the new World Intellectual Property Organization Committee on Development and Intellectual Property (CDIP) this week are negotiating implementation of agreed changes to WIPO practices intended to ensure they are development-friendly. Perhaps predictably, countries with the…