Award of Preliminary Injunction to Declaratory Judgment Defendant in the District of Delaware Offers Cautionary Tale in Opposition Strategy

District Court Judge Sue L. Robinson, U.S.D.J., of the United States District Court for the District of Delaware granted a rare preliminary injunction to the declaratory judgment defendant in a patent infringement action, highlighting the importance of presenting infringement arguments under both parties’ claim constructions and expert analysis that supports invalidity. CryoLife Inc. v. C.R. Bard Inc. et al., No. 14-559, Dkt. Entry No. 116, Mem. Order. The injunction bars sales of PerClot Topical, CryoLife’s blood-clotting powder product.

After receiving clearance from the U.S. Food and Drug Administration (“FDA”) to market its product for topical use last spring, CryoLife filed a declaratory judgment action, seeking to invalidate Medafor’s U.S. Patent No. 6,060,461 directed at a method for applying blood-clotting powders, or receive a determination of non-infringement. PerClot Topical was subsequently launched in fall 2014, in competition with Medafor’s product Arista, which was approved by the FDA in 2006.

Shortly after pleadings were completed, Medafor sought a preliminary injunction. CryoLife’s opposition focused on why it did not infringe in view of its claim construction and attorney argument that the claims were invalid over the prior art.

Applying the traditional four factor test, the court determined that a preliminary injunction was appropriate. On infringement, the court determined that since it agreed with Medafor’s proposed constructions and CryoLife failed to present an argument regarding non-infringement under Medafor’s constructions, Medafor would likely succeed in proving infringement. On invalidity, the court concluded that since CryoLife argued anticipation and obviousness based on the “barest of attorney argument,” without the benefit of expert analysis, that Medafor was also likely to succeed on of invalidity.

The court further quickly concluded that irreparable harm had been shown, noting that the record evidence demonstrated that the products are in direct competition and target similar markets. The court in a footnote also noted that: “Medafor is the owner of the ’461 patent and all the intellectual property associated with Arista, therefore, CyroLife’s contentions that Medafor cannot suffer harm are without merit.” Mem. Order at 6. In addition, the court concluded that public interest and balance of hardships favored Medafor since it faced “loss of its customer base and damage to its goodwill” should PerClot Topical remain on the market. Accordingly, the court issued the preliminary injunction, enjoining sales of PerClot Topical.

Gibbons will continue to monitor developments in granting for preliminary injunctions by district courts in the Third Circuit.

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