On July 29th, the Federal Circuit handed down its decision in the much-discussed Association for Molecular Pathology v. U.S. Patent and Trademark Office (commonly known as the “Myriad Genetics” case). The Federal Circuit split the baby — finding Myriad’s isolated BRCA DNA claims patentable, but its method claims for analyzing patients for mutations in these genes unpatentable.
On the 26th of July, the FDA’s Center for Drug Evaluation and Research (CDER) published a draft report entitled “Identifying CDER's Science and Research Needs.” The document describes seven major regulatory science needs CDER believes are important to its mission.
Of most interest here, the seventh category CDER identifies is “Enhance Individualization of Patient Treatment.” This document amplifies the themes recently sounded in the FDA’s Draft Guidance Concerning In Vitro Companion Diagnostic Devices that was released a few weeks ago. In short, CDER is emphasizing the importance of, and encouraging further research into, qualifying different biomarkers for making decisions concerning dosing, patient selection for efficacy, and patient exclusion for safety. Clearly, CDER has the expectation that many clinical trials and approved treatment regimens will have one or more integrated diagnostic genetic tests and that personalizing treatments will lead to better patient outcomes. But, as suggested in the report, large public/private collaborations will be necessary to identify novel biomarkers and to develop the tools to properly validate them for clinical use.
On July 14, the FDA issued a new draft guidance concerning in vitro companion diagnostic devices (“IVD companion diagnostic devices”). As explained in its press release, such IVD companion diagnostic devices are already in use to identify patients that are most likely to benefit from certain therapeutic products, such as some monoclonal antibodies.
The draft guidance focuses on an integrated approach to approval of therapeutic products and their IVD companion diagnostics. Much of the guidance addresses simultaneous review of a new biologic (or drug) and a companion test, particularly where safe and effective use of the treatment depends on the companion test. The guidance is clear evidence that the FDA appreciates the importance that personalized medicine will assume in the coming years.
In an article posted on July 1, The Generics and Biosimilars Initiative (GaBI) presents an interesting Venn diagram of the partnerships among the players vying for the prospective biosimilars market:
The diagram clearly shows how the lines between innovator companies and generic companies is breaking down in the rush to develop biosimilars to the blockbuster biologics which are coming off patent in the next few years.