By Kurt Buechle
On September 17, 2020, the Technical Center 1600 of the United States Patent and Trademark Office (USPTO) held its regular Biotechnology/Chemical/Pharmaceutical Customer Partnership Conference (“Conference”).
A wide range of topics was covered. The morning session included a discussion of the written description requirement under 35 U.S.C. § 112 and an overview of some of the USPTO’s fast track and pilot programs.
Daniel Kolker, the Supervisory Patent Examiner (SPE) for Group 1644, addressed the Office’s application of the written description requirement under 35 U.S.C. § 112 to antibody claims. The Office has become much more stringent on the description of antibody structure in recent years, particularly in view of the Federal Circuit’s 2017 opinion in Amgen v. Sanofi, 872 F.3d 1367. Previously, Office guidelines for evaluation of antibody claims identified the structural description of the antigen as sufficient for satisfying the written description requirement of a claim antibody that bound that antigen. A much higher standard now applies for structural description of the antibody itself, for example, the complementarity-determining regions (CDRs) that interact with the target antigen of the antibody must be disclosed. A description of the antigen, even the particular epitope sequence to which the antibody binds, is generally not sufficient to satisfy the written description requirement. The previous guidelines were suspended and the change in standard was announced in a February 22, 2018, Office Memorandum, now set forth in M.P.E.P. § 2163. Dr. Kolker discussed various antibody claim examples with respect to the current standard as shown in the corresponding presentation slides.
Two administrative patent judges, Kaylan Deshpande and David McKone, and Kery Fries of the Office of Patent Legal Administration, discussed various expedited procedures offered by the Office. These procedures include Prioritized (Track One) Examination, the COVID-19 Prioritized Examination Pilot Program, and the fast-track appeals pilot program. The requirements to qualify for these programs as well as the requirements to remain in these programs were discussed. The COV-19 Program is similar to standard prioritized examination, but is limited to small and micro entity applicants and claims have to cover a product or process subject to U.S. Food and Drug Administration (FDA) approval for use in the prevention and/or treatment of COVID-19. The fast-track appeals pilot program began in July 2020, can be requested by petition with fee once docketed with the Patent Trial and Appeal Board (PTAB), and has a cap of 125 applications a quarter. Once an appeal is granted fast-track status, there is a six-month target for a decision on appeal.
The afternoon session started with a review of the USPTO’s revised Subject Matter Eligibility Guidance and its implementation for examination of life sciences applications in Group 1600. In-house counsel from Eli Lilly gave a presentation on the effect of recent 35 U.S.C. § 101 law on pharmaceutical patents, including a review of relevant case law. Christopher Babic, the Supervisory Patent Examiner (SPE) for Group 1633, discussed several patent application initiatives including, for example, the Patents 4 Patients Cancer Immunotherapy Pilot Program, and the Quick Path Information Disclosure Statement (QPIDS) program. The cancer pilot program, which waives the petition fee for fast-track review of cancer immunotherapy-related patent applications, has been extended to June 30, 2022. QPIDS, which permits consideration of an Information Disclosure Statement subsequent to payment of the issue fee, has been implemented on a permanent basis. Dr. Peter Cooper, a staff scientist at the National Center for Biotechnology Information NLM/NIH, gave a presentation on the Basic Local Alignment Search Tool (BLAST) and other sequence searching tools. Dr. Osmat Jefferson, Director of Product Development at The Lens, an organization that has established an open platform for patent data, discussed The Lens’ open source Patseq tool for searching sequence data collected from various patent office databases.
Further information on the conference is available at: https://www.uspto.gov/about-us/events/attend-biotechnology-chemical-and-pharmaceutical-partnership-meeting-0. Selected slides from the meeting are available at: https://www.aipla.org/sandbox/uspto-bcp-blog-page-test/uspto-bcp-meetings/2020/09/29/biotech-chemical-partnership-(bcp)-meeting—sept-16-2020.