Cabazitaxel - USA

On Sep. 21, 2017, Patent Trial and Appeal Board (PTAB) issued final written decision & concluded that claims of U.S. Patent No. 8,927,592 (expiring on Apr 27, 2031) are unpatentable. The ’592 patent, titled “Antitumoral Use of Cabazitaxel,” is directed to the use of cabazitaxel in the treatment of prostate cancer, particularly metastatic castration resistant prostate cancer (“mCRPC”).

Mylan Laboratories Limited (petitioner”) filed a Petition requesting an inter partes review of claims 1–5 and 7–30 of US’592. Petitioner asserts that the subject matter of claims would have been obvious to a person of ordinary skill in the art based on the combined teachings of Winquist and TROPIC. They together disclose the same treatment protocol described in Example 1 of the ’592 patent.

The fundamental dispute between Petitioner and Patent Owner concerns the relevant standard for evaluating whether a POSA would have had a reasonable expectation of “success” in achieving the claimed method. PTAB said that, Patent Owner attempted to raise the bar for the standard of “success” required to prove obviousness. Patent Owner’s argument is misplaced because it implicitly defines “success” as a clinically effective treatment where clinical benefit outweighs potential risks to the patient in the context of a phase III clinical trial designed for FDA approval.

Petitioner, therefore, need not establish a POSA reasonably would have expected successful phase III clinical trial results, FDA approval of cabazitaxel and prednisone combination therapy, or an actual increase in patient survival, to demonstrate obviousness of claims 1 and 27. (In re Montgomery, 677 F.3d, 1375, 1380 (Fed. Cir. 2012).

With respect to the secondary considerations, PTAB concluded that Patent Owner’s secondary considerations evidence does not outweigh Petitioner’s strong evidence of obviousness.