Anglo-Swedish drug maker AstraZeneca Plc (AZN: Quote,AZN.L) Tuesday said a District court in New Jersey ruled that AstraZeneca's US Patent, protecting Pulmicort Respules or budesonide inhalation suspension is invalid in the US. Pulmicort Respules is a maintenance medicine used to control and prevent asthma symptoms in children aged 12 months-8 years.
The invalidity is limited to the US and will not change the revenue guidance for 2013 for a mid to high-single digit decline on a constant currency basis, the company said in a statement.
The court also ruled that the generic defendants involved in the litigation do not infringe AstraZeneca's second patent, US Patent No. 7,524,834 or the '834 patent'.
The patent No. 6,598,603, or the '603 patent', protecting Pulmicort Respules expires in 2018, with paediatric exclusivity extending into 2019. For full year 2012, Pulmicort Respules US sales totaled $136 million.
AstraZeneca had filed patent infringement lawsuits against Apotex Inc., Apotex Corp., Watson Laboratories and Breath Limited, and Sandoz, Inc., for infringement of US patents directed to methods of use and formulation and form of active ingredient, budesonide, for Pulmicort Respules.
Two of the manufacturers, Apotex and Watson/Breath, had received FDA approval and neither manufacturer launched its generic product.
AstraZeneca alleged that the defendants' generic budesonide inhalation suspension products and their use would infringe the claims of the two AstraZeneca patents. According to the defendants, each patent is invalid under the US patent laws.
Paul Hudson, executive vice president, North America said, "AstraZeneca strongly disagrees with the Court's decision. AstraZeneca has full confidence in the strength of its intellectual property rights protecting PULMICORT RESPULES."
The company said it is considering next steps, including an appeal of the Court's decision.
Teva Pharmaceutical Industries Ltd. (TEVA) has a generic Pulmicort Respules product in the market.
According to AstraZeneca, entering of additional generics into the market would materially impact royalties received on sales of Teva's generic version of Pulmicort Respules, which represented an annualized value of about $260 million in 2012, under its Core other income line.
AstraZeneca expects Core other income in 2013 to be significantly below $600 million, which will be based on additional generics entering the market. It still expects Core earnings per share to decline significantly more than revenue in 2013.
In London, AstraZeneca shares are currently trading at 3,335 pence, up 35.5 pence or 1.08 percent, on a volume of 532,329 shares.
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by RTT Staff Writer
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