The Federal Circuit seems to be further confusing the already confused picture on the patenting of medical treatments. In the recently decided and non-precedential case of INO Therapeutics v. Praxair (read here), a split panel of the appeals court invalidated claims of five Mallinckrodt patents related to the use of Inomax, a form of inhaled nitric oxide to treat babies with breathing disorders, holding that they cover nothing more than an unpatentable law of nature. The use of nitirc oxide to treat such a condition is well-known in the prior art, but what the patents claimed was a method of avoiding certain complications by not treating complication-susceptible individuals.

The inventors discovered that newborns with a specific heart condition can experience excess fluid in the lungs when they are administered the drug, so the patents describe a method of using Inomax to treat breathing disorders that calls for those patients to not receive it. The court’s majority held that by not treating the at-risk patients, “the body’s natural processes are simply allowed to take place,” so the claimed invention is a law of nature that can’t be patented.

So far, seems to follow logic. However, the problem lies, as pointed out by both the majority and by dissenting judge Newman, who observed, “Today’s change of law adds to the inconsistency of this area of patent-supported innovation.”

The rub lies in the court’s previous holding in Vanda Pharmaceuticals, Inc. v. West-Ward Pharmaceuticals (read here), that a method of treatment that involved giving a lesser dose of a drug, did cover patentable subject matter. OK, not treating and treating with a lesser dose are not exactly the same things, but Judge Newman saw it in a more abstract light: “ The persistent theme of the majority’s analysis is that if a claim contains limitations that concern human physiology, ineligibility arise under Section 101….” Abstracting even further, he wrote, “The majority’s broad pronouncement of ineligibility of medical treatment that related to human physiology not only contravenes precedent, but contravenes the national interest in achieving new methods of medical treatment with the assistance of the patent incentive.”

Precisely. We are continuously in need of new medical devices, drugs, and methods of treatment. The fantastic cost of developing these innovations can only be met under a patent system whose boundaries are clear. The INO Therapeutics and Vanda decisions just make a murky picture murkier. Time for a Supreme court intervention clarifying Alice?

The Business Take -Away: It’s a mess. Alice seemed to hold out the promise of finally clearing up the decades old questions that arose in the aftermath of business method patenting. Medical research is going to have to struggle on for the time being. Companies and investors are gong to have to continue to be wary of any products or methods that are heavily patent-dependent.