Delaware Patent Litigation Report : Delaware Intellectual Property Lawyer & Attorney : Morris James Law Firm : Delaware Patent Litigation Report

The Court issues its opinion (as revised) following a bench trial.  Plaintiffs brought this action against several defendants alleging infringement of the patent-in-suit relating to rosuvastatin and its salts which are compounds useful in the treatment of hypercholesterolemia, hyperlipoproteinemia and atherosclerosis.  Defendants submitted ANDAs to the FDA. All but one defendant admits that they infringe claims 6 and 8 but they argue invalidity and unenforceability.  Defendants have also challenged the standing of one of the plaintiffs to sue for infringement.  The remaining defendant (Apotex) contends that it did not engage in an infringing act in the first instance, because it did not "submit" the ANDA.  The Court finds that defendant’s intention to market and sell its generic rosuvastatin calcium products in the United States, coupled with its actions in connection with the ANDA submission and its designation as the U.S. agent, satisfy the legal standard for liability as an ANDA "submitter" under Section 271(e) (2) (A).  As for the standing issue, defendants contend that AstraZeneca LP does not own the patent-in-suit, does not possess an exclusive license to the patent, and is not an exclusive marketer.  AstraZeneca LP urges the Court to expand the second category of recognized plaintiffs to include NDA holders and their authorized agents.  However, the Court is not persuaded AstraZeneca Pharmaceuticals LP holds no interest in and does not have any exclusionary rights in the patent-in-suit and therefore it has no standing to bring or join in this infringement action.
Next defendants contend that members of the Patent Department at plaintiff failed to disclose to the PTO two highly material prior art patent applications as well as a European Search Report.  Defendants have no direct evidence of intent to deceive the PTO, but urge the Court to infer such intent. While the circumstances raised by defendants could be suggestive of deceptive intent, the Court cannot conclude that to be the case.
On obviousness, defendants contend that the testimony and evidence at trial creates a prima facie showing based on the prior art.  However, plaintiffs introduced compelling evidence that significant work was needed to develop rosuvastatin.  In addition, the first and third Graham factors, concerning the scope and content of the prior art and the differences between the prior art and the claimed subject matter, weigh in plaintiffs’ favor.  Moreover, there was much skepticism in the industry concerning the safety of rosuvastatin.
Finally, defendants contend that plaintiffs cannot establish infringement because it is invalid as improperly reissued.  Defendants argue that there were no errors in the original patent that warranted reissue.  In the Court's view, the error in the original patent was not in failing to claim rosuvastatin but in unknowingly claiming subject matter broader than rosuvastatin which is an error that is properly remedied by reissue.