Coalition for Affordable Drugs Succeeds in Invalidating Gattex Patent Claims​

In a final written decision, the Board found claims of a patent directed to a stabilized formulation of GLP-2 unpatentable under 35 U.S.C. § 103(a). "That the inventors of the ’866 patent discovered that a particular GLP- 2 analog performs best with a certain combination of amino acid and sugar, namely histidine and mannitol, does not persuade us by itself that the subject matter of the claims of the ’866 patent is nonobvious. The preponderance of evidence of record shows that the identification of the optimal sugar and amino acid to add to a formulation for stability purposes was nothing more than routine experimentation. Here, in addition to the disclosures of [a 1999 journal paper] and [U.S. patent '216], we credit the testimony of [petitioner's declarant] and his analysis of publications authored by [patent owner's expert] that describe 'rational' design choices for excipients in lyophilized protein formulations in order to optimize the formulation. . . .Thus, we are not persuaded that this is a case where there were 'numerous parameters' to try so as to support a conclusion of nonobviousness. . . . [T]he use of histidine and mannitol in protein formulation was disclosed in the prior art and the experimentation needed to confirm the successful application with GLP-2 analogs was 'nothing more than [the] routine application of a well-known problem-solving strategy, . . . "the work of a skilled [artisan], not of an inventor."'"

Petition for Inter Partes Review by Coalition for Affordable Drugs II, LLC, IPR2015-01093 (PTAB October 21, 2016, Order) (Snedden, APJ)