LifeNet Health v. LifeCell Corporation

Docket No. 2015-1549

September 16, 2016

Brief Summary: DC decision denying LifeCell’s motion for a new trail and JMOL following jury finding of infringement and no invalidity affirmed (based on DC’s claim construction).

Summary: LifeCell appealed from DC denial of its motion for a new trial and judgment as a matter of law (JMOL) following the jury finding of infringement ($34+ million in damages) and no invalidity regarding LifeNet’s US 6,569,200 directed to “plasticized” soft tissue grafts for transplantation. The plasticized grafts are described as avoiding problems associated with the usual freeze-drying of tissues before transplantation. Claims 1-4 are directed to a “plasticized soft tissue graft” where the “plasticizers are not removed from [the] internal matrix of said plasticized soft tissue graft prior to transplantation into a human” (the “non-removal limitation” was added during prosecution to overcome a prior art rejection). Claims 7, 8 and 10 are method claims and include the same limitation. The DC declined to construe “not removed”, finding that to be “unnecessary” since it “is easily understood…to have its plain meaning that no plasticizers are removed prior to transplantation” (agreeing with LifeCell). And LifeCell’s motion for SJ that the claims were invalid as indefinite for including a method step in an apparatus claim was denied. LifeCell unsuccessfully argued for non-infringement based on evidence showing that its process removes “as much as 50% of the plasticizer” before transplantation. The FC panel opinion explained that it reviews denial of JMOL under the law of the regional circuit (Voda, FC 2008) which here is the Fourth Circuit in which review is “for abuse of discretion ‘and will not be reversed save in the most exceptional circumstances’” (Minter, 4th 2014). The FC panel first found LifeCell “fail[ed] to properly raise an O2 Micro issue” (FC 2008, “[w]hen the parties raise an actual dispute regarding the proper scope of…claims, the court, not the jury, must resolve that dispute” but “not necessarily…whenever further claim construction could resolve the parties’ dispute”, becoming dissatisfied “with [one’s] own proposed construction” does not suffice) because it “fail[ed] to sufficiently request further construction…leading up to and during trial” (Lazare Kaplan, FC 2010). In FN1, the FC panel opinion explains that it also saw no error with the construction under Phillips (FC 2005) due to prosecution history estoppel. It also found “there was substantial evidence to support the jury’s determination that plasticizer is not removed ‘from the internal matrix’ of the accused tissue grafts before translplantation” and that the DC “did not err in denying JMOL or a new trial on non-infringement”. LifeCell also argued it could not be liable for direct infringement (apparatus claim requires that each and every limitation set forth in the claim appear in the accused product” (Cross Med., FC 2005); method claim must be “performed by or attributable to a single entity” (BMC, FC 2007; Akamai, FC 2015 (may be attributed to third party performance in some circumstances)) because the non-removal limitation cannot be met “until an independent third party, such as surgeon actually prepares and uses the accused products”. The FC panel disagreed because “the non-removal limitation is satisfied by the grant from the moment it is manufactured unless and until the plasticizer is removed”. It also found the claim does “not mix an apparatus with a method of using that apparatus” since “no later action by a user of the tissue graft is necessary.” And it concluded the record showed “substantial evidence to support a jury finding” that the prior art does not disclose the claimed grafts (“The ultimate issue on this record was a classical factual dispute that the jury was free to resolve in LifeNet’s favor.” Kinetic Concepts, FC 2012)). Thus, the DC decision was affirmed.

This entry was posted in Claim Construction, Negative Limitations, Prosecution History Estoppel. Bookmark the permalink.

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