Routine Trial-and-Error Approach to Protein Formulation Is Not Sufficient to Establish Obviousness Absent a Reasonable Expectation of Success in Achieving the Claimed Formulation

Routine Trial-and-Error Approach to Protein Formulation Is Not Sufficient to Establish Obviousness Absent a Reasonable Expectation of Success in Achieving the Claimed Formulation

By Raffaella Faraoni, Ph.D. and J. Patrick Elsevier, Ph.D. On December 22, 2016, in a final written decision in IPR2015-01537, the PTAB rejected an obviousness challenge brought by Momenta Pharmaceuticals, Inc. against a patent owned by Bristol-Myers Squibb directed...