The PTAB is not often persuaded by objective evidence of non-obviousness, i.e., secondary considerations, when the scope and content of the prior art includes all of the features recited in the claims. However, a pair of recent PTAB decisions, Innopharma Licensing, Inc. v. Senju Pharmaceutical Co., LTD., IPR2015-00902, Paper 90, and IPR2015-00903, Paper 82 (PTAB July 28, 2016), provides a rare example where the PTAB completely changed its mind after instituting the IPRs. The decisions offer the same message, and this post focuses on the decision in IPR2015-00902, where the PTAB found all of the challenged claims of U.S. Patent No. 8,669,290 not obvious over the applied prior art references based on the objective evidence of non-obviousness.
The ‘290 patent is directed generally to a nonsteroidal anti-inflammatory drug (NSAID) to treat inflammation and reduce eye pain in patients after cataract surgery. The claimed invention relates to an aqueous liquid formulation comprising two components: (1) bromfenac (an NSAID), and (2) tyloxapol in an amount sufficient to stabilize the bromfenac. The parties did not dispute that the invention is embodied by the commercial product, Prolensa.
The introduction during trial of additional evidence beyond just the evidence from public documents can sometimes get the panel to change its mind. So, be prepared!
The primary pieces of prior art together disclosed all of the features recited in the claims. In particular, the Ogawa patent disclosed all of the claimed features except for the use of tyloxapol in an amount sufficient to stabilize the bromfenac. The Sallmann patent disclosed an aqueous ophthalmic preparation that included tyloxapol used to stabilize diclofenac potassium salt (an NSAID). Additional background art included various discussions of tyloxapol and bromfenac. Based on these asserted pieces of prior art, the PTAB in its institution decision initially found a reasonable likelihood that the petitioner would prevail in its obviousness challenge and, thus, instituted inter partes review (IPR).
Following institution and during trial, the patentee presented additional evidence and arguments that the claimed invention was nonobvious. In particular, the patentee presented evidence that the use of tyloxapol in an amount sufficient to stabilize the bromfenac as recited in the claims provided unexpected results relative to the teachings of the prior art, and directly contributed to the commercial success and industry acclaim of Prolensa. The PTAB found as significant the patentee’s evidence that the bromfenac’s chemical stability is “44% better” when using tyloxapol than the preparation taught by Ogawa. Also important was the “counterintuitive” discovery that formulation stability actually improved when using less of the tyloxapol stabilizer, rather than more. The PTAB was further persuaded by the patentee’s evidence that the novel use of the tyloxapol also directly provided the benefits that caused Prolensa to increase its market share (i.e., commercial success) and receive industry acclaim. In sum, the patentee was able to persuasively show to the PTAB not only the unexpected nature of the technical effects obtained by using tyloxapol, but also direct links (a nexus) between those technical effects, the consumer benefits in the commercial product, and the industry acclaim and commercial success arising of the commercial product.
These IPRs are good examples of how objective evidence of secondary considerations (e.g., long-felt but unsolved need, failure of others, unexpected results, commercial success, copying, licensing, and industry praise) can be used to help a patentee overcome an initially unfavorable institution decision. The patentee may succeed in changing the minds of the PTAB panel that initially decided to institute the IPR if a the patentee can demonstrate there exists a strong, direct relationship between the novel features of the invention and the objective evidence of non-obviousness, for example, by showing how the novel feature provides an unexpected technical effect that is in turn directly tied to other objective evidence of non-obviousness.
These decisions also provide a good reminder that a patentee should not give up after receiving an unfavorable institution decision. The introduction during trial of additional evidence beyond just the evidence from public documents can sometimes get the panel to change its mind. So, be prepared!