By: Patent Attorneys Dr. Hadassa Waterman, Head of the Biotech Department and Dr. David Mencher, of Ehrlich & Fenster of Ehrlich Group<\/p>\n
Current USPTO guidelines for antibody-based inventions (see \u201cGuidelines\u201d1<\/sup>) have overturned the long-standing \u201cantibody exception\u201d to the 112 Written Description requirement for correlation between structure and function defining the boundaries of a group (genus) of individual items (species).\u00a0 Previously, disclosure of \u201ca fully characterized antigen\u201d, defined by \u201cstructure, formula, chemical name, physical properties\u201d\u00a0or<\/strong><\/b>\u00a0\u201cdeposit in public depository\u201d constituted sufficient support for 112 Written Description requirement for claiming any antibody binding that antigen (\u201clock-and-key\u201d definition- see Noelle v Lederman, 20042<\/sup>).\u00a0 Recent Federal Court rulings, however, have led the USPTO to eliminate the \u201cantibody exception\u201d to the 112, 1st<\/sup>\u00a0Paragraph requirement for \u201cpossession of the invention\u201d (see Abbvie v Janssen, Fed. Cir. 20143<\/sup>\u00a0and Amgen v Sanofi, Fed Cir 20174<\/sup>), in step with more than a decade of precedential decisions and USPTO policy regarding written description of nucleic acids (Fiers v Revel v Sugano, Regents of Univ of Calif v Eli Lilly & Co, Enzo Biochem, Inc v Gen-Probe, Inc. and Amgen, Inc. v Hoechst Marion Russel, Inc.).\u00a0 The immediate result is that the \u201cnewly characterized antigen test\u201d is now officially irrelevant, even when antibody preparation is routine and more than one antibody has been disclosed.<\/p>\n What, then, constitutes a valid written description of antibodies?\u00a0 Structural details (i.e. amino acid sequence) of the functional portion (e.g. binding sites, paratopes) conferring binding specificity (e.g. affinity, dissociation constant), for example, complementarity-determining regions (CDRs) of the (heavy- and light-) variable chains suffice if provided for a representative number of species for the claimed genus.<\/p>\n Disclosure (at the time of filing) of a correlation between structural elements and the function they determine in the antibody is a powerful means for establishing a valid written description under 112, 1st<\/sup>\u00a0Paragraph.\u00a0 Elucidation of the structure (e.g. by X-Ray Crystallography) of a target (e.g. antigen) binding site common to a \u201crepresentative number\u201d of antibodies or binding peptides (species) can provide evidence of \u201cpossession\u201d, under 112, 1st<\/sup>\u00a0Paragraph, of the group (genus) of antibodies.\u00a0 What is a \u201crepresentative number\u201d?\u00a0 Although presently undefined by court decisions, our review of the few recently issued US antibody patents indicates that detailed data correlating structure and function from no less than 5 individual members (species) of a group (genus) of antibodies is required to define the genus (group).<\/p>\n Additional data that could possibly support \u201cpossession of the invention\u201d for written description of antibodies or binding peptides under 112, 1st<\/sup>\u00a0Paragraph includes deposit of hybridomas, detailed description of the epitope of the antigen, detailed affinity kinetics and\/or cross-reactivity common to the group (genus) of antibodies, and biological assays characterizing the group (genus) of antibodies.<\/p>\n In short, it is evident that today, in light of the new guidelines, it is critical to provide much more data, at the time of filing, in order to achieve a broad scope of protection for claims reciting antibodies either as a composition or in a process (e.g., methods of diagnosing and treating).<\/p>\n Although USPTO policy regarding written description under 112, 1st<\/sup>\u00a0Paragraph now seems to have reached an extreme in its swing away from allowing claims in antibody and binding peptide inventions, experience reminds us that in the past similar \u201cpendulum motion\u201d of USPTO guidelines with respect to other requirements for claim validity [obviousness (USC 103), patent eligibility (USC 101)], has been followed (over time) by definition, clarification and moderation as courts review the impact of new policies.<\/p>\n References:<\/strong><\/b><\/p>\n By: Patent Attorneys Dr. Hadassa Waterman, Head of the Biotech Department and Dr. David Mencher, of Ehrlich & Fenster of Ehrlich Group Current USPTO guidelines for antibody-based inventions (see \u201cGuidelines\u201d1) have overturned the long-standing \u201cantibody exception\u201d to the 112 Written Description requirement for correlation between structure and function defining the boundaries of a group (genus) … <\/p>\n\n