I’ve written previously about sequential PTAB challenges to the same patent, but the dispute between Coherus Biosciences Inc. and AbbVie Biotechnology Ltd. has engendered six Inter Partes Review proceedings against the same Humira patent, four of which are pending and awaiting institution decisions. Coherus’s aggressive use of PTAB proceedings to challenge Humira patents shows that biosimilar applicants may be able to eliminate at least some patent disputes without participating in the patent dance of the Biologics Price Competition and Innovation Act (BPCIA).
The Humira Patent At Issue
The Humira patent at issue is U.S. Patent 9,085,619. Only claims 16–19, and 24–30 are challenged. Independent claim 16 recites:
16. An aqueous pharmaceutical formulation comprising:
(a) an anti-tumor necrosis factor alpha antibody comprising a light chain variable region (LCVR) having a CDR3 domain comprising the amino acid sequence of SEQ ID NO:3, a CDR2 domain comprising the amino acid sequence of SEQ ID NO:5, and a CDR1 domain comprising the amino acid sequence of SEQ ID NO: 7, and a heavy chain variable region (HCVR) having a CDR3 domain comprising the amino acid sequence of SEQ ID NO:4, a CDR2 domain comprising the amino acid sequence of SEQ ID NO: 6, and a CDR1 domain comprising the amino acid sequence of SEQ ID NO:8, wherein the concentration of the antibody is 50 to 200 mg/ml; and (b) water;
wherein the formulation does not comprise a buffering system.
The January 2017 IPR Petitions
Coherus filed the first four IPR petitions on January 31, 2017.
The petition filed in IPR2017-00822 asserted anticipation by WO 2006/138181 (“Gokarn PCT”) (published December 28, 2006) and obviousness over the Gokarn PCT and the 2003 Humira® Label.
The petition filed in IPR2017-00823 asserted anticipation by US 2016/0319011 (“Gokarn ‘011”) which claims priority to U.S. Provisional Application 60/690,582, filed June 14, 2005 .
The petition filed in IPR2017-00826 asserted obviousness in view of the 2003 Humira® Label, Fransson & Espander-Jansson, J. Pharm. Pharmacol., 48:1012-1015 (1996), and the 2005 Gamimune ® Label.
The petition filed in IPR2017-00827 asserted obviousness in view of the 2003 Humira® Label, Fransson and Gorkan ‘011, and obviousness over Gorkarn ‘011 in view of the 2003 Humira® Label.
The March 2017 IPR Petitions
Coherus filed the next two IPR petitions on March, 2, 2017.
The petition filed in IPR2017-01008 asserted obviousness in view of the 2003 Humira® Label, Fransson and Gorkan ‘011, and obviousness over Gorkarn ‘011 in view of the 2003 Humira® Label.
The petition filed in IPR2017-01009 asserted obviousness in view of the 2003 Humira® Label, Fransson, and the 2005 Gamimune ® Label.
On April 11, 2017, the PTAB granted Coherus’s unopposed motions to dismiss IPR2017-00826 and IPR2017-00827 without prejudice. Coherus essentially replaced IPR2017-00826 and IPR2017-00827 with IPR2017-01008 and IPR2017-01009.
The Patent Owner Preliminary Responses
AbbVie has filed Patent Owner Preliminary Responses in the four pending IPR proceedings. In addition to arguing against the proposed findings on the merits, AbbVie argued in IPR2017-00823 and IPR2017-01008 that Coherus failed to establish that Gokarn ‘011 can be cited as of its priority date. In particular, AbbVie asserted that Coherus did not show that the “Gokarn Provisional provides written description support for both (1) the subject matter relied on in Gokarn ‘011 to allege anticipation and (2) at least one claim of Gokarn ‘011. ”
(See Dynamic Drinkware and this article for a discussion of requirement (2))
Other Humira IPR Proceedings
Coherus successfully challenged three other Humira® patents in IPR proceedings decided in May: U.S. Patent 8,889,135, U.S. Patent 9,017,680, U.S. Patent 9,073,987. AbbVie has appealed those PTAB decisions to the Federal Circuit.
Who Needs To Dance?
Coherus’s aggressive use of PTAB proceedings shows that biosimilar applicants may be able to resolve at least some patent disputes without participating in the BPCIA patent dance. However, since AbbVie claims to have over 100 patents in its Humira® estate, Coherus may not be able to eliminate all patent issues within the patent office.
