Posts Tagged ‘Enablement’

The Unacknowledged Role of Section 112 in the Myriad Decisions

Saturday, November 30th, 2013

Guest post from Paul Cole, Lucas & Co., UK; introduction by Warren Woessner.

In this interesting note, Paul Cole explores the possible effect on the Fed. Cir. and Supreme Court’s decisions about the patent-eligibility  of “genomic DNA” of the arguable failure of the claims to meet the written description and enablement requirements of section 112. He also considers whether or not the Court’s ruling ultimately will have any real effect on Myriad’s testing business. Finally, he raises the question of the effect of the decision on progress dependent on work  involving non-human DNA sequences.

A representative Myriad patent considered by the Supreme Court in the above proceedings covered isolated DNA coding for the wild-type BRCA1 gene. However, it disclosed only a partial sequence of the gene and did not disclose its isolation as a free-standing molecule. For those reasons a claim which on reasonable interpretation covered the wild-type gene was open to objection on the grounds of lack of written description and lack of enablement, which objections though not formally in issue were readily apparent to a knowledgeable reader.  (The entire post can be downloaded below.)


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).”