U.S. Court finds patent covering AstraZeneca’s anti-cholesterol drug Crestor®, is valid and enforceable in ANDA litigation

The United States District Court for the District of Delaware ruled in favor of firm clients AstraZeneca and Shionogi Pharmaceuticals, finding that the FDA Orange Book listed patent for the active ingredient in their blockbuster anti-cholesterol drug, Crestor®, is valid and enforceable—preserving market exclusivity for Crestor® into 2016.  The patent was challenged in these Abbreviated New Drug Application litigations by eight generic pharmaceutical companies.  Judge Farnan ruled that the novel rosuvastatin inventions claimed in the patent would not have been obvious to one of ordinary skill in the art.  Judge Farnan further found that the failure to submit certain prior art during the prosecution of the patent application was not the result of an intent to deceive the United States Patent and Trademark Office.  Instead, Judge Farnan credited AstraZeneca and Shionogi’s witnesses and evidence that innocent mistakes resulted in the non-submission of the prior art and ruled that the patent is enforceable.