Analyzing AIA reviews of Orange Book-listed patents to date – strategic considerations in filing and conducting AIA review proceedings
Attorneys from Sughrue Mion and other international law firms recently participated in the annual Symposium for Managing Pharmaceutical, Biotechnology and Chemical Patent Portfolios, hosted by the Institute of Intellectual Property Research and Development. As a member of the group from Sughrue Mion, I presented two lectures – one on strategic considerations in deciding whether to file AIA reviews of pharmaceutical patents (i.e., patents listed in the Orange Book), and a second on strategies and pitfalls in conducting an inter partes review of a pharmaceutical patent, including analysis of each of the unique final written decisions to date.
These presentations compiled key Board decisions from each stage of inter partes review proceedings and presented new statistics assessing how pharmaceutical patents have fared to date. Interestingly, while the general trends suggesting a high percentage of institution of inter partes review apply in the context of pharmaceutical patents, the high rate of unpatentability has not borne out in this technological space. In analyzing and comparing Board decisions denying institution, as well as final written decisions finding claims patentable and those finding claims unpatentable, the Board has taken a tough stance on expert support for obviousness analyses, finding claims unpatentable only with a very strong, nearly anticipating, primary reference and routinely discounting expert declarations as merely conclusory. What becomes clear after studying the Board’s decisions to date, is that much is required from expert declarations and challenging gaps in these declarations should be a focus for both petitioners and patent owners alike.
Perhaps distinct from other technological areas, in the context of pharmaceutical patents, the PTAB should not be viewed as a “death squad” for patents, but more accurately as a group of highly technical judges who will not hesitate to deny institution or grounds of unpatentability based on perceived weaknesses in expert conclusions.
Links to my presentations are provided herein and hopefully will serve as a useful resource for parties who find themselves considering filing or facing a petition for inter partes of a pharmaceutical patent.
Mr. Shackelford is an associate in the chemical patent and biotechnology / pharmaceutical practice groups, where he maintains an active patent prosecution and litigation practice.
Prior to joining Sughrue Mion, Mr. Shackelford served as Intellectual Property Fellow at Illinois Institute of Technology Chicago-Kent College of Law, where he taught IP courses for LL.M. and J.D. students and conducted research into patent claim construction. During law school, Mr. Shackelford worked as a patent prosecution law clerk at the U.S. Department of Energy, evaluating invention disclosures, responding to Office Actions, and drafting patent applications. Prior to law school, Mr. Shackelford worked at the Midwest Center for Structural Genomics as an Associate Research Scientist, where he conducted and helped develop techniques for high-throughput cloning, expression, and crystallization of target proteins.
Mr. Shackelford earned his J.D. from the IIT Chicago-Kent College of Law, where he was a member of the Moot Court Honor Society and Law Review. He received his B.S. in Biochemistry from the University of Missouri-Columbia and M.S. in Chemistry and Chemical Biology from the University of California, San Francisco. As an undergraduate and graduate research scientist, Mr. Shackelford focused his research in the area of protein chemistry, studying protein superfamilies to identify mechanisms of enzymatic function and routes through which enzymes develop new functionality.
Admitted in Illinois only. Not a member of the DC Bar. Practice limited to certain matters before federal agencies and courts.
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