Presumption of Nexus Between Claims and Commercial Products May Not Apply When Unclaimed Features Are Critical

TEVA PHARMACEUTICALS v. ELI LILLY AND COMPANY

Before LOURIE, BRYSON, and O’MALLEY. Appeal from the Patent Trial and Appeal Board.

Summary: The presumption of nexus analysis requires the fact finder to consider the unclaimed features of the stated products to determine their level of significance and their impact on the correspondence between the claim and the products.

Eli Lilly challenged three patents directed to humanized antagonist antibodies in IPRs. The PTAB held that the challenged claims in all the three patents are unpatentable as they would have been obvious over various cited references. 

The Federal Circuit affirmed the PTAB’s decision after finding that there is substantial evidence to support PTAB’s finding of a motivation to combine the teachings of the references, and the potential safety and efficacy concerns would not have dissuaded a skilled artisan from making the claimed antibodies to study their therapeutic potential.

The Federal Circuit also affirmed the PTAB’s finding of no presumption of nexus between the challenged claims and the commercial products even though the PTAB articulated an incorrect standard. The Federal Circuit noted that the nexus presumption analysis requires the fact finder to consider the unclaimed features of the stated products to determine their level of significance and their impact on the correspondence between the claim and the products.  In this case, the PTAB correctly found that nexus is not presumed because the unclaimed features were critical to the functionality of the commercial products.

Editor: Paul Stewart

Written by: Hans L. Mayer & Shelley Chen