USPTO, On “Cabilly” Patents: Merck Loses One Inter-Partes Review — But Is Allowed To Join Another…

life-mrk-cabilly-keytruda-uspto-inter-partes-2017Back in November, we reset the table on this series of patent disputes, related to the basic methods, and composition, of the immuno-oncology treatments now revolutionizing solid organ tumor therapies.

The USPTO’s PTAB has just issued its long awaited inter-partes review decision. It held that Merck’s standalone petition on the ‘415 (or “Cabilly I”) patent had been previously considered, and so denied it. However, the body allowed Merck to join a pending inter partes review filed by Amgen (and others), on the so called Cabilly II and III patents. That means this part of the wrestling match simply awaits another US PTAB decision, likely to be issued later this Spring.

So, once again, we wait for decision(s) on these fronts — in a perhaps $20 billion a year oncology revenue market, in the US alone. These same basic issues are also the subject of several pending federal suits in Delaware, and California. Here’s a bit from the latest US Patent and Trademark Appeal Board decision (a ten page PDf file):

. . . .Although Petitioner may have sound reasons for raising art or arguments similar to those previously considered by the Office, the Board weighs petitioners’ desires to be heard against the interests of patent owners, who seek to avoid harassment. See H.R. Rep. No. 112-98, pt.1, at 48 (2011) (AIA proceedings “are not to be used as tools for harassment or a means to prevent market entry through repeated litigation and administrative attacks on the validity of a patent. Doing so would frustrate the purpose of the section as providing quick and cost effective alternatives to litigation.”). All of the challenged claims require an immunoglobulin molecule. As Patent Owner notes (Prelim. Resp. 20), Axel is the only asserted reference that discloses an immunoglobulin molecule, i.e., an antibody. Axel was explicitly considered by the Office during reexamination of the ’415 patent. . . .

We determine, therefore, that Axel, the only reference that Petitioner relies upon to disclose an immunoglobulin molecule, was previously presented to, and considered by, the Office in the same substantive manner as Petitioner now advocates.

Moreover, as noted by Patent Owner, Petitioner in the instant proceeding filed a second Petition (IPR2017-00047) seeking joinder with IPR 2016-00710, which was instituted on September 8, 2016. Prelim. Resp. 28. We have instituted trial in IPR2017-00047, and joined it with IPR 2016-00710, concurrently with the instant decision. As Petitioner has agreed to abide by the Scheduling Order in IPR 2016-00710, a final written decision will be entered in that case well before a final written decision would be entered in the instant proceeding. . . .

Now you know — we will (of course) continue to monitor this. We would expect an update in the material litigation section of Merck’s forthcoming 2016 Year-end SEC Form 10-K. We begin our walk in, under cloudless but frigid skies — as wind-chills hover near minus ten. But our hearts — they be warmed. . . as a quick trip out to L.A.’s sunshine, looms for later next week. . . smile.

नमस्ते

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