AstraZeneca Fights Appeal Against Makers of Generic Drugs

San Diego – AstraZeneca appeared in front of the U.S. Court of Appeals for the Federal Circuit on Wednesday October 5th, 2011 to defend against claims that its multi-billion dollar cholesterol fighting drug Crestor was too obvious to receive patent protection. That action was originally heard by the Delaware District Court in June 2010. That court found that generic drug makers including Mylan, Teva, Sun, Aurobindo, Par, Watson, and Sandoz failed to prove that Crestor was an obvious invention at the time it was patented.

The case originated when AstraZeneca brought a patent infringement action against several makers of generic drugs after the generics applied for approval to market their own identical versions of Crestor before the patent term was set to expire in 2016. In the original action, the generics defended by attacking the initial issuance of the patent as well as a subsequent reissue. Primarily, the generics claimed that the invention of the drug Crestor was too obvious to receive a patent.

To receive patent protection, an invention must be useful, novel, and non-obvious. An invention is obvious if, at the time of invention, others skilled in the art would find the invention an obvious improvement of the prior art. Instead, to receive a valid patent, the invention must involve a minimum level of creativity not obvious to someone skilled in the industry.

On appeal, aside from arguing that the drug was an obvious extension of the prior art, the generic drug makers argue that the original patent was intentionally drawn too broadly, in order to receive over-reaching patent protection. They also claim that the more narrowly drawn reissued patent did not cure these defects. In addition, the generics allege that original patent applicant, Shionogi (from whom AstraZeneca licenses the Crestor patent), withheld crucial documents from the USPTO in the patent application process.

The generic drug companies failed to prove these allegations before the District Court judge in the original suit and appealed to the U.S. Court of Appeals for the Federal Circuit, which held oral arguments in the case on October 5, 2011. The case comes with high stakes, both for AstraZeneca and the generic companies. Crestor achieved worldwide sales amounting to over five billion dollars in 2010, with over 2.6 billion dollars in the United States. The market for the drug is only expected to increase as AstraZeneca reaches the termination of the 20 year patent term in 2016.