United States District Court in New Jersey ruled that AstraZeneca’s patent protecting Pulmicort Respules in the U.S. is invalid.
The decision deals another blow to the pharmacutical company that plans to eliminate 1,200 jobs in north Wilmington in coming years as it works to get new drugs into its pipeline to replace others that have gone off patent.
The court further ruled that the generic defendants involved in the litigation do not infringe AstraZeneca’s second patent.
“AstraZenca strongly disagrees with the Court’s decision,” said Paul Hudson, executive vice president, North America. “AstraZeneca has full confidence in the strength of its intellectual property rights protecting Pulmicort Respules. AstraZeneca is considering next steps, including an appeal of the court’s decision.”
The decision is limited to the US and has no impact on the validity of patents related to the drug in other countries. This decision will not change AstraZeneca’s revenue guidance for 2013, which is that the company anticipates a mid to high-single digit decline in revenue on a constant currency basis.
Sales in 2012 for Pulmicort Respules US sales were $136 million. In the event that additional generics enter the market, this would materially impact royalties received on sales of Teva’s generic version of Pulmicort Respules valued at $260 million annually. The asthma drug is inhaled.
Subject to additional generics entering the market, guidance for other income in 2013 could put the number significantly below $600 million. The company still expects core earnings per share to decline significantly more than revenue in 2013.
At the trial AstraZeneca claimed that the defendants’ products and their use will infringe the claims of the two AstraZeneca patents, should those defendants market their generic products in the US. The defendants denied that they will infringe and asserted that each patent is invalid under the US patent laws.
