AstraZeneca wins Crestor ruling
UK pharmaceutical company AstraZeneca has won an appeal court ruling to block the sale of generic versions of its cholesterol medicine Crestor in the US until July 2016.
On Friday 14 December, the US Court of Appeals for the Federal Circuit upheld a 2010 ruling by the US District Court of Delaware that a ‘314 patent covering the main ingredient of Crestor, rosuvastatin, is valid and enforceable, and that it has been infringed by companies selling generic versions of the drug.
In a statement, a spokesperson for AstraZeneca said the company is pleased with the ruling, adding: “the decision reaffirms the strength of the intellectual property protecting Crestor.”
Rosuvastatin was discovered by scientists at Japan’s Shionogi University in 1991. AstraZeneca patented the product in partnership with the university in 1992 and in 2003, the drug was approved for sale. It is now AstraZeneca’s biggest selling product and last year, the company reported Crestor sales of $6.6 billion.
In 2007, eight generic pharmaceuticals companies (Apotex, Aurobindo, Cobalt, Mylan, Par, Sandoz, Sun and Teva) challenged the patent on the grounds of obviousness, claiming that rosuvastatin was merely an improvement on a similar chemical compound patented by Sandoz in 1990.
They also alleged that the patent was unenforceable due to inequitable conduct, as staff at Shionogi had neglected to submit three documents relating to the patent to the US Patent and Trademark Office (USPTO) during prosecution.
The Delaware court rejected these claims and found in favour of AstraZeneca. The generic companies appealed but in last week’s 2-1 decision, judges at the Court of Appeal upheld the district court’s finding that the patent is “valid, enforceable and infringed.” All companies excluding Apotex admitted infringement.
Melissa Hunter-Ensor, a patent attorney at Edwards Wildman in Boston, said that the decision was an important victory for AstraZeneca, but that the courts were in danger of favouring pharma at the expense of generics.
“The generics had argued that AstraZeneca's patent was unenforceable due to inequitable conduct. In siding with AstraZeneca, the Federal Circuit adopted a very narrow reading of deceptive intent.
“Consistent with the Court's decision in Therasense [ in which judges ruled that deceitful intent must be proved if using an inequitable conduct defense] the decision raises the bar for generics seeking to use inequitable conduct to invalidate a patent,” she said.
The generic companies can now ask the full court to reconsider the decision, or appeal to the US Supreme Court.
To read the judgement, click here.
