Irina Vainberg, Ph.D.

The ‘156 patent discloses methods of treating and/or preventing metabolic diseases, particularly diabetes, in patients for whom metformin therapy is inappropriate due to intolerability or contraindication against metformin, e.g., renal disease, metabolic acidosis, congestive heart failure. Defendants alleged that the asserted claims are patent ineligible because the claims recite a natural law. Plaintiffs argued claims of the ’156 patent are directed towards methods of treating the targeted patient population with metabolic diseases using non-naturally existing DPP-IV inhibitors, which alter the natural state of the body in a new and useful way, and hence do not fall within the natural phenomena exception… Superficially, this decision may appear to be consistent with Mayo – methods of treatment claims that manipulate natural biological processes are considered to be directed to patent ineligible subject matter under § 101. However… it is not perfectly clear that the treatment claims of the patent-at-issue are directed to a law of nature or an abstract idea. Claim 1 is directed to an active practical application of a compound for treatment… The decision also appears at odds with the USPTO Subject Matter Eligibility Examples.