SOURCE: Wolf Greenfield

August 15, 2005 10:16 ET

Personalized Medicine Creates New Patent Opportunities and Dangers, Wolf Greenfield Lawyer Tells Conference

BOSTON, MA -- (MARKET WIRE) -- August 15, 2005 -- The dawning personalized-medicine revolution will require companies to take new strategies when patenting drugs and diagnostics, Edward R. Gates of Wolf, Greenfield & Sacks, P.C., a Boston intellectual property law firm, told the Drug Discovery Technology & Development World Congress here.

"There's going to be a huge opportunity to impact the industry through innovative intellectual-property strategies," said Gates, a senior attorney in the firm's biotechnology practice.

Spurred by the sequencing of the human genome, personal medicine posits that some drugs work for only some people because of genetic differences. For instance, only 30% of the population may have a genetic marker that makes a drug highly effective.

Developing new drugs, companies might be able to run a smaller trial by selecting only patients with the right makeup. This could lead to speedier FDA approval, slash costs and spell the end of the "blockbuster" model for drug development, Gates said.

Makers of existing drugs could benefit even more. Suppose it's learned that a popular drug helps just 60% of the population. The company could file a new patent, make a label change, and possibly win an extra 20 years of exclusivity, he pointed out.

"Anyone Can Infringe"

Patents directed to personalized medicine inventions must be aimed at all the potential infringers, which include chipmakers, software users, pharmacists, diagnostic companies, clinical labs, drug manufacturers, reagent suppliers, distributors and more, he said.

Patenting a personalized drug may not be the primary strategy. "The best protection may be to patent the genetic chip that does the test," Gates said.

International patent law poses complications. Even if a drug is intended for domestic use only, offshoring could complicate matters. For instance, a company might have blood samples analyzed in India. Patent strategies must take this into account.

A potential problem is that case law in Europe precludes patenting some of the types of inventions based on personalized medicine that are patentable here in the US. But diagnostics are patentable there.

"Most pharmaceutical companies aren't involved in diagnostics, which are handled by separate companies. With personalized medicine, that will all change," Gates predicts.

The personalized medicine revolution is in its infancy, and solving IP challenges will likely be a conundrum for some time.

"Crafting solutions will take creativity, taking into account what the FDA requires, what label changes are permitted and who might benefit commercially from the invention," he said.

Wolf Greenfield in Boston (www.wolfgreenfield.com) is one of the most experienced law firms specializing in intellectual property law, including patents, trademarks, copyrights, licensing, trade secrets and related litigation.

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