Keiko K. Takagi Sughrue Mion, PLLC WRITTEN DESCRIPTION Keiko K. Takagi Sughrue Mion, PLLC © AIPLA 2015

Written Description AbbVie Deutschland v. Janssen Biotech (Fed. Cir. 2014) – clarifying the written description requirement for functionally claiming a genus Inphi Corporation v. Netlist Inc. (Fed. Cir. 2015) – what is the appropriate written description of a negative limitation? © AIPLA 2015

Written Description Standard: To satisfy the written description requirement, a patent applicant must “convey with reasonable clarity to those skilled in the art that, as of the filing date sought, he or she was in possession of the invention, and demonstrate that by disclosure in the specification of the patent.” Possession is shown by disclosure in the patent from the perspective of one of ordinary skill in the art. © AIPLA 2015

AbbVie v. Janssen Facts: Claim: A neutralizing isolated human antibody, or antigen-binding portion thereof, that binds to human IL-12 and disassociates from human IL-12 with a Koff rate constant of 1x10-2s-1 or less, as determined by surface plasmon resonance. The specification disclosed over 300 species covering a range of the claim Koff rate constant, but all were derived from a single antibody (Joe-9) with minor CDR sequence changes. © AIPLA 2015

AbbVie v. Janssen Facts: AbbVie argued that the patent discloses a representative number of antibodies covering the full range of the Koff rate. Centocor argued that the patent discloses only a family of closely related, structurally similar antibodies, which are not representative of the entire genus. © AIPLA 2015

AbbVie v. Janssen Fed. Cir. Holding: The claims were not supported because the claims attempt to claim “every fully human IL-12 antibody” that would achieve a desired result, but the patent “does not describe representative examples to support the full scope of the claims.” © AIPLA 2015

Lesson: AbbVie v. Janssen Functionally defined genus claims can be "inherently vulnerable" to an invalidity challenge for lack of written description support, especially in technology fields that are highly unpredictable. The essence of the written description requirement is that a patent applicant, as part of the bargain with the public, must describe his or her invention so that the public will know what it is and that he or she has truly made the claimed invention. © AIPLA 2015

Negative limitations: Inphi v. Netlist Negative limitations: "Negative claim limitations are adequately supported when the specification describes a reason to exclude the relevant limitation.” Santarus, Inc. v. Par Pharm., Inc., 694 F.3d 1344, 1351 (Fed. Cir. 2012). A "reason to exclude" is satisfied by an express description of the disadvantages of the excluded features, or an express description of the advantages of the claimed invention without these features. © AIPLA 2015

Facts: Technology relates to computer system memory modules. Inphi v. Netlist Facts: Technology relates to computer system memory modules. Negative limitation at issue: "DDR chip selects that are not CAS, RAS, or bank address signals" Inphi argued that the "reason to exclude" requires something more than properly describing alternative features of the patented invention. © AIPLA 2015

Inphi v. Netlist Fed. Cir. Holding: The "reason" can be provided by properly describing alternative features of the patented invention. Netlist was in "possession" of the negative limitation because the specification included a standard, a Table and Figures that distinguished between the various signal types. © AIPLA 2015

Inphi v. Netlist Lesson: The Court clarified that Santarus did not crease a heightened written description standard for negative claim limitations. But cautioned “[t]hat is not to say that in all cases, a patentee may arbitrarily dissect its invention by amending the claims in order to avoid the prior art.” © AIPLA 2015

Thank you. © AIPLA 2015