Archive for the ‘Enablement’ Category

Wyeth v. Abbott Labs. – Picking Plaintiff’s Poison

Friday, June 28th, 2013

In July of 2011, I wrote a post for this blog on BSC v. J&J, a Fed. Cir. decision in which four J&J patents claiming stents eluting rapamycin, a drug that inhibits restenosis after balloon angioplasty, were held invalid for failure to meet the requirements of the written description requirement of s. 112 (1) [now s. 112(a)]. While the specification only disclosed stents releasing rapamycin, the claims used broader language, such as “rapamycin or a macrocyclic triene analog of rapamycin.” While such analogs were known, none were named in the specification. Still, J&J must have felt that they had a fighting chance, since a specification need not describe that which is known to the art.

A three-judge panel of Moore, Bryson and Gajarsa found that the claims failed to meet the WDR. However, instead of explaining why the specification read in combination with the knowledge available to the art about rapamycin analogs fails the UC v. Lilly WDR standards, Moore and Bryson relied on the deficiencies they found in the specification:

“Given the absence of information regarding structural characteristics of [rapamycin analogs] in the specification, the unpredictability of the art and the nascent state of using drug eluting stents…we affirm the [grant of SJ]. The patent laws do not reward an inventor’s invitation to other researchers to discover which of the thousands of macrocyclic lactone analogs of rapamycin could conceivably work in a drug-eluting stent.”


Edwards Lifesciences v. Corevalve – Pig Valve Implants Enabling

Monday, November 19th, 2012

In Edwards Lifesciences AB v. Corevalve, Inc. (now a part of Medtronic), Appeal No. 2011-1215-1257 (Fed. Cir. Nov. 13, 2012), Corevalve challenged the validity of US Pat. No. 5,411,552 directed to a “transcather heart valve” on the basis that the valve had only been implanted in pigs as of the effective filing date of the patent, and that not all of the experimental implants were successful. The Fed. Cir. disagreed, and Edwards provides a succinct review of the standards for enablement based on animal testing.

The panel began by reminding the parties that “[t]he enablement requirement is met if the description [in the specification] enables any mode of making and using the invention.” Johns Hopkins Univ. v. CellPro, Inc. 152 F.3d 1342, 1361 (Fed. Cir. 1998). In other contexts, this statement permits claims based on “benchtop” syntheses, even if the claimed compound or process is being produced or practiced on a pilot plant scale. “The most efficient commercial embodiment need not be disclosed. Durel Corp. v. Osram Sylvania, Inc., 256 F.3d 1298 (Fed. Cir. 2001).”