Recently, the Patent Trial and Appeal Board issued its first set of final written decisions in three inter partes reviews relating to molecules in the large molecule biopharma space (IPR2013-00534, IPR2013-00535 and IPR2013-00537). Biosimilar companies will no doubt be looking to these decisions as a roadmap for clearing patent landscapes for their own biosimilar products in the coming years.

While all of the challenged claims in all three patents at issue in the three IPRs were found invalid, this set of decisions should be viewed in its appropriate context. While many of the claims at issue are representative of later generation molecular biology claims, this should be tempered in light of the results seen in other large biomolecule IPRs and recent trends in the U.S. Patent and Trademark Office's institution in the biotechnology space (TC1600). While there are situations where IPRs can be highly successful, there are clearly situations where careful thought should be given prior to pursuing an IPR approach....

Originally published in Law360 on April 8, 2015.