AstraZeneca Plc (AZN), the U.K.’s second- biggest drugmaker, said it may appeal a U.S. court ruling that invalidated a patent on its Pulmicort Respules asthma treatment and cleared the way for generic competition.
The drugmaker “strongly disagrees with” the ruling by the federal court in New Jersey that also said a second patent wasn’t being infringed by producers of a generic version of the treatment. Actavis Inc. (ACT), whose generic form of the corticosteroid has been approved by the U.S. Food and Drug Administration, said separately that it will begin selling its version immediately.
AstraZeneca “has full confidence in the strength of its intellectual property rights,” Paul Hudson, executive vice president of North America, said in the London-based company’s statement.
The ruling, which AstraZeneca said is restricted to the U.S., doesn’t change the drugmaker’s forecasts for this year of a mid- to high-single-digit decline in revenue excluding currency shifts and core earnings per share to fall significantly more than revenue, the company said. The invalidated patent covered the drug’s delivery method, while the second patent involved its formulation.
Generic competition will mean that royalty payments AstraZeneca receives from Teva Pharmaceutical Industries Ltd. (TEVA) will decline from $260 million last year, the U.K. company said. AstraZeneca struck an agreement with Teva in 2008 allowing the Petach Tikva, Israel-based company to sell a generic version of the drug beginning in December 2009 in exchange for an undisclosed lump sum and royalty payments.
Pulmicort Respules patents expire in 2018, with protection of the children’s version extending to 2019, AstraZeneca said.
Actavis plans to begin marketing 0.25- and 0.5-milligram units of its asthma drug immediately, the Parsippany, New Jersey-based company said yesterday in a statement.
Another generic copy, from Apotex Inc., was approved in the U.S., though the Toronto-based drugmaker has been blocked from selling the product after AstraZeneca won an injunction.
AstraZeneca will lose patent protection on some of its best-selling drugs by 2016, including cholesterol treatment Crestor, which had sales of $6.3 billion last year.
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