On Thusday an order granting in part and denying in part the defendant’s rule 12(b)(6) motion to dismiss was issued in the case of Aortic Innovations LLC against Edwards Lifesciences Corporation, Edwards Lifesciences LLC, and Edwards Lifesciences (U.S.) Inc. The case is regarding infringement of patents for a TAVR catheterized replacement of an aortic heart valve.
Originally, the process of replacing a heart valve was performed in an open heart procedure known as a Surgical Aortic Valve Repair, which had a high degree of complications and was not recommend for high risk patients. The patents at issue in this case are directed toward improvements of the device.
The first issue raised in the 12(b)(6) motion is whether the defendants were guilty of infringement of a the ‘735 patent. The plaintiff claimed that the defendants were guilty of willful and indirect infringement of the patent, a claim that requires pre-suit knowledge of the patent being infringed. The defendant argued, and the court agreed, that the claim could not be supported because the patent being disputed was issued on the same day as the complaint was made, so there was no opportunity for the defendant to have the mens rea for willful infringement. The court also concurred that notice of a patent pending in application status does not equate with knowledge of an actual patent as a patent can be amended or restricted during the application process.
The defendants also alleged that there is no means for their employees to have infringed upon the method components of the patents at issue. The language of the method portions states a method of “actual implantation of the device into the patient” which the court held did not extend to “preparing the devices prior to insertion” which is all that the plaintiff was able to allege that the defendant’s employees were doing.
Finally, the court denied the defendants’ bid to dismiss the lack of specificity regarding the actual elements of the device patents. The plaintiffs argued and the court agreed that at this preliminary stage, the plaintiff is only required to show how it is plausible that the defendants have infringed upon the patents, and that the higher standard of line-by-line documentation of the infringement is more appropriate after fact-finding and claim construction have occurred.
Plaintiff is represented by Young, Conaway, Stargatt & Taylor. Defendants are represented by Morris, Nichols, Arsht & Tunnell.
