The Federal Circuit has upheld the Patent Trial and Appeal Board’s finding that a patent directed towards making oxycontin less soluble, and therefore harder for abusers to inject, was “obvious,” even though it is undoubtedly an improvement of great usefulness.
Purdue Pharma, makers of oxycontin, one of America’s most abused drugs, claimed the addition of two gelling agents, polyethylene oxide, or PEO, and hydroxypropylmethylcellulose, or HPMC in USPN 9,034,376 (read here). These agents have two effects; slowing the absorption in the intestinal tract, giving a longer-lasting dose form; and causing the pills to turn to a difficult to inject gelatinous form if an abuser tries to dissolve them in water for injection. Both PEO and HPMC could be found as gelling agents in prior art, but as successfully argued by Purdue (read here) not claimed in the combination patented by Purdue, and not in a solid dosage form with specified viscosity requirements. A competitor of Purdue petitioned for a review of the grant by the Patent Trial and Appeal Board, who invalidated the patent on the grounds of obviousness, and now the Federal Circuit has upheld the invalidation.
The Federal Circuit (read here) gave little credence to Purdue’s arguments, adopting the position of the Board’s expert; “According to Dr. Timko, “[a]n experienced formulator, at the time of the invention, would be aware of all of these things and would formulate their dosage form accordingly.” This could be seen as a rebuke towards the recent findings of “reasonable expectation of success” (link to Luper website here), but the prior art relied on by the Court disclosed relatively few gelling agents, and the evidence that they were all well-know was considerable.
THE BUSINESS TAKE-AWAY: While “long-felt need” is a respected argument against obviousness, it is always a long-shot and must be well-documented. The evidence showed that the solution to this “need” was actually known and practiced, in forms very close to that patented by Purdue, for many years. The fact that Purdue’s formulation may have been useful, is not the same thing as answering a “long-felt need.” Also, a convincing “no reasonable expectation for success: argument, the less well-know the combined elements are, and a prior art disclosure that is truly a laundry list of all possibilities, increases the chances for success.