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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."

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.

YouTube, eBay Decisions Raise Questions For US Copyright Law

By Drew Clark for Intellectual Property Watch
WASHINGTON, DC - Two recent court decisions against key United States internet companies - Google and eBay - are almost certain to reopen a long-standing truce between intellectual property rights-holders and website operators, over liability for the actions of users.

US Supreme Court Limits Patent Owners’ Control Over Downstream Use Of Their Inventions

By Steven Seidenberg for Intellectual Property Watch
The United States has once again chipped away at patent rights. The country's highest court recently handed down a ruling that makes it harder for patent owners to impose limits on downstream users of their inventions.

The US Supreme Court's decision in Quanta Computer Inc. v. LG Electronics Inc., however, fails to address a major issue facing patent owners and their legal counsel: Can patent owners use conditional sales or licensing agreements to impose restrictions on downstream users?

Attorneys: New USPTO Patent Appeals Rules Will Raise Costs, Accomplish Little

By Dugie Standeford for Intellectual Property Watch
New United States Patent and Trademark Office procedural rules governing ex parte appeals of rejected patent applications before the Board of Patent Appeals and Interferences (BPAI) have met with resistance from some patent attorneys, who argue they are unfair, unnecessary and will hurt smaller and foreign patent applicants. The USPTO said it adopted the rules, effective 10 December 2008, to streamline the handling of a growing number of such appeals.

Panelists: Balance Needed Between Antitrust Law, Patent Quality

By Liza Porteus Viana for Intellectual Property Watch
WASHINGTON, DC - A careful balance must be struck between ensuring the quality of the United States patent system - and the patents themselves - and antitrust law to ensure that new technologies and services can be brought to market, particularly in the pharmaceutical industry, experts said in Washington Monday.

"Imbalance can result in less competition, less innovation," Deborah Garza, deputy assistant attorney general for the Department of Justice's antitrust division, said during a meeting of the Intellectual Property Owners Association.