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AZ loses Pulmicort Respules protection in US

Court also denied AZ’s request for a permanent injunction

AstraZeneca AZ headquarters London UK 

AstraZeneca (AZ) was dealt a major blow by a US court after a key patent protecting its Pulmicort Respules product was invalidated.

Generic drugmaker Actavis responded to the ruling by immediately launching its own version of the Pulmicort Respules (budesonide), an inhalation suspension formulation of the corticosteroid that is used as a maintenance treatment for asthma. 

Not only did the US District Court for the District of New Jersey rule that AZ's patent (No. 7,524,834) on the product was invalid, but it also denied AZ's request for a permanent injunction, clearing the path for the launch of generic copies.

The latest ruling is a massive setback for AZ as well as Teva, which has had rights to sell an authorised generic under an exclusive license which dates back to 2009. All told, sales of the branded and generic versions of the product were around $1.1bn in the 12 months ending June 30 2014, according to Actavis, which secured FDA approval for its version in August 2012.

AZ's executive vice president for North America Paul Hudson said in a statement that it "strongly disagrees with the court's decision" and was "considering our legal options, including an appeal."

The patent had not been due to expire until 2018, and AZ had carried out paediatric trials that it hoped would extend its intellectual property (IP) rights on the product until 2019.

AZ has been fighting to protect its Pulmicort Respules franchise for several years, with infringement proceedings filed against Apotex, Watson Laboratories (now Actavis), Breath Ltd and Novartis' Sandoz unit. It is expected that other generic drugmakers will move quickly to launch their own versions of the drug.

Last April, the same court ruled that another of AZ's patents on the drug (No. 6,598,603) was invalid while concluding that the generic drugmakers defending the litigation were not infringing the patent. The following October, the US Court of Appeals for the Federal Circuit reversed the latter decision and referred the case back to the District Court.

Actavis and AZ may be in opposition in the courts and marketplace for Pulmicort Respules, but recently reached an agreement in which Actavis will sell a portfolio of respiratory drugs sold in the US and Canada to AZ for $700m. 

Article by
Phil Taylor

16th February 2015

From: Sales

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