Karen Carroll

Since the passing of the America Invents Act (AIA) and the implementation of the inter partes review (IPR) process, IPR has become a popular and important avenue for companies and individuals to challenge the validity of a patent in an administrative proceeding through the U.S. Patent and Trademark Office (USPTO). In the past five years, patent owners and challengers alike have presented new and sometimes novel challenges to the way the Patent Trial and Appeal Board (PTAB), comprised of a panel of administrative law judges that review and decide cases, conduct trial proceedings, causing the PTAB to reevaluate and tweak the process along the way. Building on the scores of changes and interpretations the PTAB has made since the first AIA trial, the USPTO provided guidance in August 2018 and more recently in July 2019 summarizing and clarifying how the PTAB handles the IPR process.  On November 20, 2019, the Patent Office issued a consolidated Office Patent Trial Practice Guide (“Practice Guide”) incorporating the updates from August 2018 and July 2019, providing practitioners with a single streamlined blueprint for the overall review process.

The U.S. Supreme Court’s 2013 ruling in Association for Molecular Pathology v. Myriad Genetics changed the landscape of what is considered patentable material in the context of genetic inventions. In the five years since Myriad, companies have pushed the boundaries of patenting certain types of genetic materials. Despite Myriad’s express statement that it was not considering “the patentability of DNA in which the order of the naturally occurring nucleotides has been altered,” the courts have not yet established the contours of how much nucleotide sequences need to be altered in order to “create something new” in order to be patentable. However, as we discuss in the next section, we expect the Court to address these questions as biotechnology companies increasingly invest resources into emerging, expensive technologies involving genes and seek to protect their investments through patents.

As the pharmaceutical industry continues to shift toward biologic-based drugs, including monoclonal antibodies, protecting the underlying technology has been and continues to be a priority for companies. As with any drug, patenting therapeutic monoclonal antibodies as early as possible in the drug development process is crucial to protect the underlying invention. In the early days of antibody discovery for therapeutic development, protection could be obtained with minimal disclosure of the actual antibody. But as the art and case law have evolved, companies now need far more data to obtain the broadest scope of protection. For that reason, it has become more of a challenge to determine the best time to file with the U.S. Patent and Trademark Office (USPTO). After the America Invents Act (AIA), it is a race to the USPTO to be the first to claim your invention, but you may lack the requisite data to enable you to obtain patent protection in the end.