On Wednesday, August 31, the U.S. Court of Appeals for the Federal Circuit issued an important decision in the life sciences realm regarding the patentability of immunotherapy treatment protocols and associated clinical studies.  In Classen Immunotherapies, Inc. v. Biogen Idec, et al ., Appeal No. 2006-1634, -1649 (Fed. Cir., Aug. 31, 2011), the court ruled that two patent claims directed to immunizing patients according to a given schedule are eligible for patent protection but that a third patent claim, which was directed to a method of determining whether a given immunization schedule is effective (in essence, a clinical study or literature search), is not eligible for patenting.  The decision is potentially important for any company or organization that conducts clinical trials or that develops medical therapies and protocols.

All three patent claims were based on the inventor's thesis that the schedule of infant immunizations against infectious diseases (such as measles) can affect the occurrence of diabetes, asthma, and other chronic immune-mediated disorders later in life.  The patent owner alleged that these claims are infringed when, for example, a doctor or researcher reads the medical literature, selects an immunization schedule, and immunizes a patient according to that schedule so as to minimize the risk of immune-mediated disorders later in life.   The case does not concern whether the thesis or protocol is scientifically valid but rather only whether the practical application of that thesis qualifies for patent protection.

Each patent claim at issue recites correlation steps (e.g., screening, determining, and/or comparing), which are commonly found in biotechnology and other life sciences patents.  Although the claims appear superficially alike, the court distinguished them for patent eligibility purposes.  The two immunization claims--which, of course, require the physical step of immunizing patients--qualify for patent protection because they are "directed to a specific, tangible application."  The third claim, however, simply involves collecting and comparing data (i.e., mere mental steps) and thus cannot be patented.

The Classen decision comes in the wake of two other recent Federal Circuit decisions in this area, Prometheus Labs., Inc. v. Mayo Collaborative Services and Association for Molecular Pathology et al. v. U.S. Patent & Trademark Office. (more commonly known as ACLU v. Myriad).  Prometheus is scheduled for Supreme Court review this fall.  Myriad may very well follow.  Together, these three decisions will provide a map of what is and what is not patentable in the life sciences realm.