IP Law Daily LifeNet Health’s $35M verdict stands in soft tissue graft patent infringement suit
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Friday, September 16, 2016

LifeNet Health’s $35M verdict stands in soft tissue graft patent infringement suit

By Greg Hammond, J.D.

A jury’s finding that a tissue repair products developer’s tissue grafts infringed an organ procurement organization’s patent and award of nearly $35 million in damages remains undisturbed. The U.S. Court of Appeals for the Federal Circuit affirmed denial of the developer’s motion for a new trial and renewed motion for judgment as a matter of law, finding that there was substantial evidence to support the jury’s determination and that the patent’s non-removal limitation did not relieve the developer of direct infringement (LifeNet Health v. LifeCell Corp., September 16, 2016, Prost, S.).

LifeNet Health owns U.S. Patent No. 6,569,200 (the ’200 patent), issued on May 27, 2003, and entitled "Plasticized Soft Tissue Grafts, and Methods of Making and Using Same." The patent relates to methods of improving the preservation of soft tissue grafts, resulting in lesser chance of the graft failing upon transplantation. Following trial, a jury found that the ’200 patent was infringed by LifeCell and was not invalid. The district court denied LifeCell’s motion for a new trial and renewed motion for judgment as a matter of law, which LifeCell appealed.

Claim construction. The district court had found that no further construction was needed for the limitation "said one or more plasticizers are not removed from [an] internal matrix of [the] plasticized soft tissue graft prior to transplantation." LifeCell argued that the district court’s failure to resolve a legal dispute concerning the scope of that limitation constituted error under O2 Micro International Ltd. v. Beyond Innovation Technology Co., 521 F.3d 1351 (Fed. Cir. 2008)—in which the Federal Circuit held that when the parties raise an actual dispute regarding the proper scope of claims, the court, not the jury, must resolve that dispute. However, in light of LifeCell’s failure to sufficiently request further construction of the relevant limitation leading up to and during trial, the Federal Circuit concluded that LifeCell failed to properly raise an O2 Micro issue.

Direct infringement. Based on the non-removal limitation and under the law of divided infringement, LifeCell next argued that it could not be liable for direct infringement regardless of how that limitation was construed, because the non-removal limitation could not be met until an independent third party—such as a surgeon—actually prepared and used the accused products. The court rejected this argument, finding that preceding language in each asserted claim stated that the relevant plasticizers were already part of the tissue graft. Further, the court found that the non-removal limitation clarified that the recited plasticizer has not been removed and, because the plasticizer is biocompatible, can remain in the internal matrix of the tissue graft during transplantation. This limitation was therefore met without action by a third party, and it consequently did not relieve LifeCell of direct infringement.

Indefinite claims. LifeCell also asserted that because the non-removal limitation described a method of use while the remainder of claims 1-4 described an apparatus, those claims were indefinite for covering both an apparatus and a method of using that apparatus. This argument was also rejected, however, because the non-removal limitation defines a property of the recited plasticizer in that the plasticizer is biocompatible and does not need to be removed from the internal matrix before transplantation in the context of apparatus claims 1-4, so no later action by a user of the tissue graft would be necessary. The claims consequently did not mix an apparatus with a method of using that apparatus.

"Plasticized soft tissue graft." LifeCell separately argued that the lower court erred in its construction of "plasticized soft tissue graft." The district court construed this limitation to require, among other things, that "free and loosely bound waters of hydration in the tissue have been replaced with one or more plasticizers." LifeCell argued that the lower court mistakenly failed to also require that the tissue graft be "dehydrated" in the sense that the tissue could only have "low residual moisture." The appellate court rejected this argument, agreeing with LifeNet that "dehydration," as the word is used in the ’200 patent, merely meant that some of the water has been replaced with plasticizer and that the lower court’s construction already included that understanding.

The case is No. 2015-1549.

Attorneys: Constantine L. Trela, Jr. (Sidley Austin LLP) for LifeNet Health. John M. Desmarais (Desmarais LLP) for LifeCell Corp.

Companies: LifeNet Health; LifeCell Corp.

MainStory: TopStory Patent FedCirNews

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