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Patent Ruling May Mean Trouble for Big Pharma

When someone seeks a patent, they must convince authorities that their inventions aren't completely apparent and are therefore worthy of protection. "Now, there is more flexibility for patent examiners in establishing that an invention is obvious," Bagley says. "And that creates more challenges for patent applicants."

Bagley says the previous strict standards had been guided by the Court of Appeals for the Federal Circuit, which hears all appeals of patent-infringement cases. Because the Supreme Court rarely hears patent cases, the appeals court "was perceived to be a mini-Supreme Court" for patent law, she says.

In recent years, however, the high court has taken renewed interest in patent law. Now, inventors "will have to be more diligent" in making claims and providing data, Bagley says.

Room for Interpretation

Bruce Downey, chairman and CEO of Barr Laboratories, said the "obviousness" standard will play a key role in the Razadyne case, as well as in upcoming legal fights over J&J's oral contraceptive TriCyclen-Lo and Bayer's (BAY) contraceptive Yasmin.

"I think the Supreme Court case has a very direct impact," Downey said in a meeting with analysts earlier this month. "It's a very significant development."

On May 11, Barr, who has contended that the J&J patent is invalid and whose dispute with the Razadyne maker has been in court since June 2005, received tentative approval from the Food and Drug Administration to market three dosage strengths of drug.
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