Judge Robinson grants motion to dismiss in part, grants preliminary injunction

In CryoLife, Inc. v. C.R. Bard, Inc. et al., C.A. No.  14-559-SLR (D. Del. Mar. 10, 2015), Plaintiff CryoLife, Inc. (“CryoLife”) filed a declaratory judgment action against Defendants C.R. Bard, Inc. (“Bard”), Davol, Inc. (“Davol”), and Medafor, Inc. (“Medafor”) (collectively, “Defendants”), seeking a declaration that U.S. Patent No. 6,060,461 (“the ’461 patent”) is invalid and not infringed.  Defendants  moved to dismiss the declaratory judgment for lack of subject matter jurisdiction and failure to state a claim. As to subject matter jurisdiction, Judge Robinson found that there was no “dispute that Medafor is the assignee of the ’461 patent and that Medafor has not granted a written license to Bard or Davol.”  Judge Robinson thus explained that “[e]ven though CryoLife argues that Davol is an implied exclusive licensee, it has offered no evidence that Medafor transferred any of its rights to either Bard or Davol.” CryoLife’s identification of certain facts were insufficient to establish that “Medafor could not sue Cryolife for infringement without joining Bard and/or Davol.” Accordingly, Judge Robinson concluded that the court did not have subject matter jurisdiction over Bard and Davol, and granted Defendants’ motion in that regard.

Judge Robinson then addressed Defendants’ motion to dismiss for failure to state a claim. Judge Robinson found that “CryoLife identifie[d] . . . . specific statutory sections regarding invalidity (§§ 102, 103, and/or 112) and provide[d] examples of invalidating prior art.” Further, “Cryolife also allege[d] a lack of written description.” Id. Judge Robinson also explained that “[w]hile the amended complaint does not identify the relevant statutory sections for indirect infringement or use the terms ‘induced infringement’ or ‘contributory infringement,’ Cryolife has pled that there is no direct or indirect infringement.” Judge Robinson therefore denied Defendants’ motion to dismiss for failure to state a claim.

Following the filing of CryoLife’s declaratory judgment action, Medafor filed a counterclaim for infringement and moved for a preliminary injunction. Finding Medafor to have carried its burden, Judge Robinson granted Medafor’s motion for a preliminary injunction. The patent at issue—the ’461 patent—is titled “Topically Applied Clotting Material.” In 2006, Medafor received FDA approval for ARISTA®, an “innovative hemostatic power that is used to control bleeding when conventional methods are ineffective.” On the other hand, CryoLife was “seeking FDA approval to market PerClot for surgical indications (‘PerClot Surgical’) and received FDA approval of its lnvestigational Drug Exemption application on March 27, 2014.”

Addressing the claim limitations at issue, Judge Robinson concluded that “Medafor’s constructions are consistent with the specification” and that “CryoLife has offered no non-infringement arguments using Medafor’s constructions.”  Judge Robinson therefore concluded Medafor showed “a likelihood of success on infringement.” Judge Robinson was unpersuaded by CryoLife’s invalidity arguments, explaining that “CryoLife argues, without expert testimony or declarations, that certain prior art anticipates or, in combination, renders the asserted claims obvious. CryoLife supports its anticipation and obviousness arguments with reference to a table

of invalidity contentions and the barest of attorney argument.” Judge Robinson also found that Medafor carried its burden demonstrating the remaining prerequisites for a preliminary injunction, explaining that “[t]here is sufficient record evidence that Cryolife’s PerClot product is in direct competition with Medafor’s Arista product and that these products are targeted to the same customers and hospitals.” According to Judge Robinson, Medafor made “persuasive arguments for the loss of its customer base and damage to its goodwill.”

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