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...
When Relying upon Scientific Test Data in its Petition, the Petitioner Must Provide Sufficient Information to Permit the PTAB to Evaluate the Data and its Reliability

When Relying upon Scientific Test Data in its Petition, the Petitioner Must Provide Sufficient Information to Permit the PTAB to Evaluate the Data and its Reliability

By Jennifer Chheda, Ph.D. and Cary Miller, Ph.D. On November 14, 2016, the PTAB issued a Final Written Decision upholding Paragon Bioteck, Inc.’s patent, U.S. Patent No. 8,859,623 B1 (the “’623 patent”), relating to a method of using an ophthalmic composition for...