English High Court invalidates Symbicort patent
English High Court Justice Philip James Sales has found a patent covering AstraZeneca’s bestselling drug Symbicort invalid after a challenge by Israeli generic drug maker Teva.
The patent at issue, European patent 1,085,877, covers a combination of the drugs formoterol and budesonide in a single inhaler for the treatment of asthma, and AstraZeneca’s combination inhaler product Symbicort.
This technology is referred to as SMART (single inhaler maintenance and relief treatment) technology in the scientific literature.
Symbicort is one of AstraZeneca’s biggest selling products, generating sales of more than $1.8 billion in the first half of 2014.
Teva moved to revoke the patent last year, seeking a European launch of its budesonide and formoterol inhaler DuoResp Spiromax. It received European marketing authorisation for the product in April.
In May, AstraZeneca filed against Teva, accusing it of infringing the ’877 patent with its BiResp Spiromax and DuoResp Spiromax products.
It argued that its patent is valid, and that the idea of having a treatment for asthma for both maintenance and relief in a single inhaler is novel and was not obvious at the patent’s priority date of June 1998.
However, it made a conditional application to amend the patent claims if the patent were found to be invalid, which the UK Intellectual Property Office objected to.
In his ruling yesterday (September 2), Sales found the patent to be invalid and rejected AstraZeneca’s amended claims.
The ’877 patent is currently the subject of opposition proceedings in the European Patent Office. The case is under appeal after the Opposition Division found the patent to be invalid on the ground of obviousness.
Rob Koremans, Teva’s president and chief executive for global specialty medicines, described the ruling as a “big step” for the company.
AstraZeneca told LSIPR in an emailed statement: “AstraZeneca is disappointed with the judgment, which was amended between being handed down in draft and final form. AstraZeneca will seek leave to appeal against the judgment.”
