Archive for the ‘Written Description Requirements (WDR)’ Category

Abbvie V. Janssen Biotech –Written Description Requirement Road Map

Monday, July 7th, 2014

The recent decision in Abbvie Deutschland v. Janssen Biotech and Centorcor Biologics, App. No. 2013-1338, -1346 (Fed. Cir. , July 1, 2014) deserves more attention than it has received. (A copy of the decision is available at the end of this post.) The appeal was by Abbvie from a District Court decision entering a judgment of invalidity of Abbvie’s patents on fully humanized antibodies (Abs) to IL-12. Although Abbvie won an interference involving its U.S. Patent No. 6,914,128, a jury found both patents invalid inter alia as failing the written description requirement (“WDR”) of s.112, para. 1.

The “modern” WDR as created in UC v. Lilly and applied in decisions such as U. of Rochester v. Searle and Ariad v. Lilly has been a potent patent-killer, particularly when functional claims are asserted. That is just what Abbvie attempted, e.g.:

Claim 29. A neutralizing isolated human antibody…that binds to human IL-12 and disassociates from human IL-12 with a koff rate constant of 1×10(-2)s(-1) or less, as determined by surface plasmon resonance. See slip. op p.7.

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GlaxoSmithKline v. Banner Pharmacaps – Written Description Requirement 101

Monday, March 3rd, 2014

In a short opinion dated February 24, 2014 (App. Nos. 2013-1593, -94, -95, -98), a Fed. Cir. panel made short work of the defendants’ attempt to invalidate a Glaxo claim in U.S. Pat. No. 5,565,467, to dutasteride “or a pharmaceutically acceptable solvate thereof” on the basis that the term “[dutasteride] solvate” failed to meet the written description requirement (“WDR”). The district court construed a “solvate” of this steroidal drug to mean “a complex formed by dutasteride in which dutasteride is reacted or from which it is precipitated or crystallized.”

While the parties agreed that dutasteride “is the molecule identified before ‘or a pharmaceutically acceptable solvate thereof’,” the panel noted that the defendants failed to argue that there was an inadequate description of “pharmaceutically acceptable” – this term had been construed to mean “suitable for use  when administered to the recipient thereof as a pharmaceutical”- and hinted that its ruling might have been different had the defendants adopted this approach, rather than arguing simple lack of an adequate disclosure of enough species to support the genus of dutasteride solvates.

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Sanofi-Aventis v. Pfizer – Possession and Appreciation Trump Structure

Wednesday, November 6th, 2013

On Tuesday, the Fed. Cir. affirmed a finding by the Board that Pfizer was entitled to an earlier priority date for a claim to  cDNA encoding the IL-13 receptor protein (Sanofi-Aventis v. Pfizer, Inc., App. No. 2012-1345 (Fed. Cir. November 5, 2013). (A copy can be found at the end of this post.) Pfizer was the junior party in a pre-AIA interference, and was required to show conception plus reduction to practice prior to Sanofi’s filing date.  While both applications demonstrated physical possession of the sequent and, in fact, contained the correct sequence, Pfizer argued that it was entitled to an earlier date of invention based on its actual possession of the cDNA combined with a sequence “only” containing eight errors in an 1135 nucleotide sequence.

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Synthes v. Spinal Kinetics – When “Structure” is Not Enough

Monday, November 4th, 2013

A guest post from Domenico Ippolito of Schwegman Lundberg & Woessner, P.A.

Synthes USA, LLC v. Spinal Kinetics, Inc., 2013-1047, -1059, (Fed.Cir. Oct 29, 2013) concerns a medical device patent, but addresses issues common to all patents.  The primary issue was whether Synthes’ claims on a synthetic intervertebral implant (i.e., a spinal disc) were supported by a sufficient written description.  The question had been submitted to a jury, which determined that the written description requirement was not met.  The patentee requested JMOL from the district court judge (Judge Whyte, of the Northern District of California), but the court found substantial evidence supporting the jury’s decision.  The basis of the court’s opinion was that the patent described only a system in which the center layer of the disc was attached to the outer layers via “grooves” penetrating from the circumference of the outer layers, but the claims were directed to “openings.”  Thus, a reasonable jury could find that the claims directed to openings lacked adequate support.

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