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U.S. District Court Examines Standard For Granting Preliminary Injunctive Relief

CryoLife, Inc., v. C.R. Bard, Inc., et al.
No. 14-559 (United States District Court for the District of Delaware, March 10, 2015)
by Richard J. Medoff, Law Clerk
Semmes, Bowen & Semmes (www.semmes.com)

Available at: http://www.ded.uscourts.gov/sites/default/files/opinions/slr/2015/march/14-559.pdf

In CryoLife, Inc., v. C.R. Bard, Inc., et al., a case involving a motion for a preliminary injunction in a patent infringement action, the United States District Court for the District of Delaware concluded that the movant met its burden to establish each of the four (4) elements required for the court to grant preliminary injunctive relief. Thus, Judge Sue L. Robinson granted the movant's motion for a preliminary injunction.

By way of factual background, on April 28, 2014, plaintiff CryoLife, Inc. ("CryoLife") filed a declaratory judgment action against defendants C.R. Bard, Inc., Davol, Inc., and Medafor seeking a declaration that U.S. Patent No. 6,060,461 ("the 461 patent") was invalid and not infringed. All parties involved in the case were biomedical companies. The 461 patent, titled "Topically Applied Clotting Material," was filed on February 8, 1999 and issued May 9, 2000. Representative independent claim 32 on the 461 patent ("claim 32") stated:

A method for enhancing the formation of clots in a wound of an animal where blood is present, the method comprising the steps of: applying porous particles having average diameter dimensions of from about 0.5 to 1000 micrometers to at least a portion of said wound where blood is present in said wound; applying pressure to said porous particles in said wound; and allowing said porous particles to remain in contact with said blood in said wound while clotting initiates in said wound.

Medafor received U.S. Food and Drug Administration ("FDA") approval in 2006 for ARISTA® AH ("Arista"), an "innovative hemostatic powder that is used to control bleeding when conventional methods are ineffective." In April 2014, CryoLife received FDA clearance to market PerClot Topical ("PerClot"), its similar powdered hemostat product for topical use.

On August 25, 2014, Medafor, the owner of the 461 patent, filed a counterclaim against CryoLife for patent infringement. On September 19, 2014, Medafor filed a motion for a preliminary injunction.

The court began its analysis by noting that “the decision to grant or deny ... injunctive relief is an act of equitable discretion by the district court," eBay, Inc. v. MercExchange, LLC, 547 U.S. 388, 391 (2006), and that “the grant of such relief is considered an ‘extraordinary remedy’ that should be granted only in ‘limited circumstances.’” Kos Pharma., Inc. v. Andrx Corp., 369 F.3d 700, 708 (3d Cir. 2004). The court explained that “a party seeking preliminary injunction relief must demonstrate: (1) a reasonable likelihood of success on the merits; (2) the prospect of irreparable harm in the absence of an injunction; (3) that this harm would exceed harm to the opposing party; and (4) the public interest favors such relief.” See, e.g., Sciele Pharma Inc. v. Lupin Ltd., 684 F.3d 1253, 1259 (Fed.Cir.2012); Antares Pharma., Inc. v. Medac Pharma., Inc., Civ. No. 14-270, 2014 WL 3374614, at *2 (D. Del. July 10, 2014). The court further explained that “the burden lies with the movant to establish every element in its favor or the grant of a preliminary injunction is inappropriate." P.C. Yonkers, Inc. v. Celebrations, the Party and Seasonal Superstore, LLC, 428 F.3d 504, 508 (3d Cir. 2005); McKeesport Hosp. v. Accreditation Council for Graduate Med. Educ., 24 F.3d 519, 523 (3d Cir. 1994).

Regarding the first factor, CryoLife contended that the issue of infringement turned on the construction of two limitations in claim 32 - the limitation "porous particles," and the limitation, "allowing said porous particles to remain in contact with blood while clotting initiates." First, CryoLife proposed that the limitation "porous particles" should be construed as "substantially spherical materials, e.g., beads, comprising voids or channels open to the surface that are sufficient to act as a molecular sieve by allowing blood liquid and low molecular weight blood components to be adsorbed onto the surface and/or absorbed into the surface of the particles." Medafor proposed construing this limitation according to the plain and ordinary meaning, that is, "particles containing pores." The court began its analysis by noting that the 461 patent's specification regarding this point explained that "[t]he terms particles and beads are not intended to denote any substantive difference in size, shape or performance of materials ... , but are merely alternative terms." The court then found that Medafor's construction was consistent with the specification because the specification did not use the term "sphere" or "spherical," and because CryoLife's proposed construction "improperly import[ed] additional limitations 'open to the surface' and 'molecular sieve' into the claim."

Second, CryoLife proposed that the limitation, "allowing said porous particles to remain in contact with blood while clotting initiates," be construed as, "upon contact with blood, the particles must remain intact and remain in contact with blood while clotting initiates." Medafor proposed using the plain and ordinary meaning, that "the particles physically touch the blood while clotting begins in the wound." The court began its analysis on this issue by noting that the 461 patent's specification regarding this point explained that "[t]he particle application should enable direct contact of the particles with the flow of blood, preferably without any non-clotting intermediate film or material between the blood at the site of the wound and the clotting particles." Interpreting this limitation, the court again sided with Medafor and found that Medafor's construction was consistent with the specification because the specification did not use the term "intact" to describe the particles. Accordingly, the court concluded that Medafor had shown a likelihood of success on infringement, as CryoLife had failed to offer any non-infringement arguments using Medafor's constructions.

Next, CryoLife argued, "without expert testimony or declarations," that the 461 patent was invalid on two (2) distinct grounds. First, CryoLife argued the 461 patent was invalid because "certain prior art anticipates or, in combination, renders the asserted claims obvious." The court, however, rejected CryoLife's obviousness argument, citing Mytee Prods., Inc. v. Harris Research, Inc., and noting that CryoLife supported its obviousness argument with only "the barest of attorney argument." 439 Fed. App'x 882, 886 (Fed. Cir. 2011) (concluding that summary judgment of nonobviousness was proper when defendant relied on "nothing more than 'conclusory assertions, gross generalities, and unsupported assumptions made by counsel"' to provide a "reason why a person of ordinary skill would have been motivated to combine the references."). Second, CryoLife argued the 461 patent was invalid because it "failed to provide adequate written description support for Medafor's proposed construction of 'porous particle,' therefore, such construction is indefinite." The court rejected this argument as well, citing the lack of any expert testimony or declarations, and noting that "attorney argument is not evidence." Accordingly, the court concluded that Medafor had shown a likelihood of success of arguing against CryoLife's invalidity arguments.

Finally, the court considered the remaining prerequisites for preliminary injunction relief and concluded that the "balance of the hardships and the public interest weigh[ed] in Medafor's favor." In reaching that conclusion, the court first noted that there was "sufficient record evidence" that CryoLife's PerClot product was in "direct competition" with Medafor's Arista product, and that both products were targeted at the same customers and hospitals. Additionally, the court found that Medafor had made "persuasive arguments" related to the "loss of its customer base and damage to its goodwill.” For those reasons, the court concluded that Medafor had also carried its burden to demonstrate the remaining prerequisites for preliminary injunction relief. Accordingly, the court granted Medafor's motion for a preliminary injunction.