Recently the Federal Circuit issued an opinion that makes big changes to the rules for construction of claims within a patent. Patentees may now have to fully describe all possible alternative embodiments in order to include them within the scope of the patent claim terms. Challenging possible infringement without such a description could also carry with it a new risk - invalidation of the original patent on enablement grounds under 35 U.S. § 112 ¶1.
These new requirements arise out of an ongoing patent infringement dispute between Liebel-Flarsheim Co. and Medrad, Inc. Liebel invented a high-pressure syringe injection system. Liebel's original patent application included the use of a pressure jacket for the system within it claim terms. However, during claim prosecution, Liebel removed all references to the pressure jacket. Liebel had become aware that Medrad had a jacketless injection system and wanted to encompass that system within its patent.
Liebel was successful. The PTO issued it a patent which contained no reference to a pressure jacket within its claim terms. Liebel then sued Medrad for patent infringement.
On a first go round Liebel successfully persuaded the Federal Circuit that it should not use specifications or described embodiments to limit the patent's claims. Liebel-Flarsheim Co. v. Medrad, Inc., 358 F.2d 898 (Fed. Cir. 2004). The Federal Circuit reviewed the patent specifications and found neither a limiting requirement of a pressure jacket or a clear disavowal of jacketless systems within the described embodiments of the invention. The Federal Circuit agreed with Liebel that its patent claims included the jacketless system and Liebel's case for infringement against Medrad stayed alive.
The victory was short lived.
In the decision released last week the Federal Circuit found that Liebel failed to show enablement of a jacketless system. The law of enablement is set forth in 35 U.S.C § 112, ¶ 1. The statute requires that the patent specifications give enough written description of the invention and the method, manner and process of making and using it so that one "skilled in the art to which it pertains" can make and use the invention. Until now, the Federal Circuit has stated that the enablement requirement is satisfied when one skilled in the art could practice the claim invention without undue experimentation after reading the specifications.
Here, Liebel argued it had met that standard because it showed one mode - a pressure jacket - for making and using the invention. Liebel cited a long string of Federal Circuit decisions in support of its position.
The Federal Circuit disagreed and found that the disclosure of the system with the pressure jacket did not allow one skilled in the art to make a jacketless system. Chiding Liebel for pressing for patent claim terms that were not "fully enabled" the court said, "The motto, ‘Beware of what one asks for," might be applicable here.'"
Is this a sea change in Federal Circuit law or just Judge Lourie's view of enablement? While not counsel of record on the briefs or at trial, we argued the case of Medtronic Surgical Navigation, Inc. v. Brain Lab before the Federal Circuit . There, Judge Lourie recently issued an opinion that, in part, also used enablement as a justification for limiting the scope of certain patent claim terms.
Either way, this is a serious development. Patent holders in litigation should consider whether they are willing to risk the validity of their patent by making aggressive claims regarding the scope of their claim terms. We also think we'll see defendants using broadly worded claims and the new standard for enablement to gain another invalidity argument.
Our advice? It looks stormy out there-you might want to bring a jacket.
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