U.S. federal court invalidates Bristol hepatitis B drug patent

Bristol-Myers Squibb announced on Tuesday that a U.S. federal court had invalidated the company’s U.S. patent on its Baraclude treatment for hepatitis B.

The decision came after a challenge from Israeli drugmaker Teva Pharmaceuticals Industries, Ltd. Bristol-Meyers filed suit against Teva in 2010 to block the introduction of its own generic form of Baraclude, Reuters reports.

“We are disappointed with the court’s decision and believe it is incorrect,” Laura Hortas, a Bristol-Myers spokeswoman, said, according to Reuters.

Hortas said that the chemical patent for Baraclude lapses in February 2015. She declined to comment on whether U.S. regulators might allow Teva’s generic onto the market prior to 2015.

Mark Schoenebaum, an analyst for the ISI Group, said that the U.S. Food and Drug Administration would need to approve Teva’s marketing application prior to the introduction of the generic drug. He said that it was unclear when the FDA might act.

Schoenebaum said that Baraclude is anticipated to have U.S. sales of approximately $260 million in 2013. If the Teva generic arrives this year and hurts sales, Bristol-Myers would likely not need to lower its current forecast for full-year profit.

On Tuesday morning, Bristol-Myers shares dropped 0.6 percent at $36.69 on the New York Stock Exchange. Shares for Teva dropped 0.4 percent in Tel Aviv, Reuters reports.

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