Secondary Indicia of Greater Value in Bio/Pharma
The submission of objective evidence of non-obviousness is rarely effective in the predictable arts (i.e., mechanical/electrical). This is because such evidence must have a “nexus” to the claimed invention. And, as the most common secondary indicia is “commercial success,” rarely do broadly drafted patent claim elements so cleanly coincide with sales results. Long-felt but unsolved need is a further secondary consideration that is less prevalent in the predictable arts as it is in more traditional, laboratory driven industries. Nexus is a significant hurdle in the predictable arts.
On the other hand, patent claims in the unpredictable arts, such as new drug formulations can have an especially compelling nexus to market appeal and unfilled need. Where a drug is an improvement over existing formulations, or an altogether new treatment, commercial success and long, unmet need are easily tied to the specific formulations of the claims. For this reason, secondary indicia of non-obviousness is a far more compelling rebuttal to a patentability challenge of the USPTO’s Patent Trial & Appeal Board (PTAB).
Given the modest, but growing rate of PTAB challenges in the unpredictable arts, petitioners should be wary of challenging especially popular drug formulations.
Last week, in Phigenix Inc. v. Immunogen Inc. (IPR2014-00676), in finding for the Patentee, the Board explained (here):
. . . Patent Owner cites substantial evidence of objective indicia of non-obviousness in relation to claim 8, which is directed to the T-DM1/Kadcyla® commercial product. PO Resp. 34–60 (citing evidence regarding T-DM1 and unexpected superior results as compared to closest prior art compositions, fulfilling a long-felt and unmet need, praise in the field, and commercial success). For example, Patent Owner provides evidence that T-DM1 fulfilled a long-felt, unmet need for an immunoconjugate capable of targeting a solid tumor in patients without excessive toxicity. Id. at 46–57 (citing, for example, Ex. 2103 ¶¶ 24–48; see id. at ¶¶ 26–28 (citing exhibits including Ex. 2062) (discussing numerous clinical trials testing ability of immunoconjugates to treat solid tumors before March 2000, where “none of these immunoconjugates proved safe and effective for treating solid tumors”); Ex. 2134 ¶ 106 (citing exhibits). Patent Owner also provides evidence regarding the commercial success of T-DM1/Kadcyla® . PO. Resp. 57–60 (citing, for example, Ex. 2131 (testimony by Mr. Jarosz, analyzing sales and prescription data, and marketing and promotional efforts relating to Kadcyla® )). In view of the specific components recited in claim 8, i.e., a specific antibody, linker, and toxin, which are the same as those in T-DM1/Kadcyla® (PO. Resp. 35 (citing Ex. 2025, 14), we are persuaded that Patent Owner establishes a sufficient nexus in relation to the cited objective evidence of nonobviousness.
Given that it is not currently possible to provide a fulsome presentation of such evidence prior to PTAB institution, (i.e., due to current restraints on new testimonial evidence in Patentee preliminary response filings, soon to change) one would expect that the rate of claim cancellation in Bio/Pharma to be less pronounced as compared to the predictable arts. This difference in ultimate success rates is already reflected in the lower institution for predictable (70%) vs. unpredictable arts (50%).