CAFC Outlines Most Common Faults in Secondary Indicia Showing

The efficacy of objective evidence of non-obviousness (i.e., secondary indicia) hinges on the ability to demonstrate a "nexus" between the evidence and the subject patent claims. This is because such evidence cannot be accorded substantial weight absent a nexus to the claimed invention.  As pointed out in a previous post a compelling showing of nexus is more likely in the unpredictable arts where specific formulations, dosages and the like are more readily correlated to such secondary indicia as commercial success and long-felt but unsolved needs.

Recently, in Merck & Cie v.Gnosis S.p.A., (here) the Federal Circuit affirmed the Patent Trial & Appeal Board's (PTAB) nexus analysis in an unpredictable art. In Merck, the Court agreed that patentee's secondary indicia lacked a nexus to the claims of U.S. patent 6,011,040 (methods of using folates  to decrease levels of homocysteine) and, in the process, outlined some of the more common deficiencies in such evidence— illustrating the difficulties in presenting a nexus even in specific formulation claims. 

At the outset of any nexus analysis is the fundamental requirement that not just any aspect of a patent claim be linked to secondary indicia, but that it be a novel aspect of the claim.  Where objective indicia results from something other than what is both claimed and novel in the claim, there is no nexus to the merits of the claimed invention. Stated another way, for commercial success, the most common of secondary indicia, if commercial success is due to an element in the prior art, no nexus exists.

In Merck the nexus was identified as specific mixture of L-5-MTHF.  Yet, the commercial success evidence was found to depend on products that included a combination of active ingredients, not just  L-5-MTHF.  In finding this evidence unpersuasive the Court explained:

For example, the Cerefolin® product combines L-5-MTHF with specific quantities of riboflavin (vitamin B2), cyanocobalamin (a form of vitamin B12), and pyridoxine hydrochloride (a form of vitamin B6). Merck failed to establish that the commercial success of these products was due to the claimed method—using L-5-MTHF and “at least one B-vitamin”—as opposed to the specific formulations in the mixed products. Indeed, a Pamlab executive stated that the success of two of these products was due to the “unique combination” of their ingredients.

The Court also sided with the Board's decision not give weight to secondary indicia of copying an industry praise based on the same failure to establish a nexus with the novel feature of the claim.  As to evidence of licensing, the Court pointed out that licensing must be specific to the subject patent:

Although Merck successfully licensed the ’040 patent to Pamlab, the licensing agreement also covered several other patents. One of those patents claims the stable form of L-5-MTHF used in Pamlab’s products more precisely than the ’040 patent. See U.S. Patent No. 6,441,168. A Pamlab executive explained that Pamlab desired this stable form “[b]ecause of its uniqueness and its novel properties,” and touted the ingredient as “[o]ne particular differentiator that makes our product unique.”  It is therefore difficult to determine the extent to which the licensing agreement was a result of the novel features in the ’040 patent, as opposed to the other patents involved. In light of this ambiguity, the Board’s finding that the evidence of licensing should not be afforded much weight was reasonable.

Lastly, as to long-felt but unresolved need, the Court agreed that no nexus was shown here either. 

Finally, Merck alleges that the ’040 patent resolved a long-felt but unmet need for a supplemental therapy for treating MDD. As mentioned, however, substantial evidence supports the Board’s finding that the prior art disclosed the use of 5-MTHF to treat depression associated with folate deficiencies, such as MDD. Merck’s argument that the ’040 patent met a long-felt need for MDD treatment, therefore, is not sufficiently connected with the novel elements of the asserted claims.

At the close of its analysis the majority pointed out that its affirmance rested on the review of the Board's decision for substantial evidence (i.e., more than a mere scintilla), and that different fact finders may have come to a different conclusion. This statement should serve as a reminder to fully develop the record on such factual determinations before the agency.