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Genentech, Inc. v. Hospira, Inc.

United States Court of Appeals, Federal Circuit

January 10, 2020

GENENTECH, INC., Appellant
v.
HOSPIRA, INC., Appellee UNITED STATES, Intervenor

          Appeal from the United States Patent and Trademark Office, Patent Trial and Appeal Board in No. IPR2016-01837.

          Thomas S. Fletcher, Williams & Connolly LLP, Washington, DC, argued for appellant. Also represented by Paul B. Gaffney, Eden Schiffmann, Jonathan Sidhu.

          Thomas J. Meloro, Willkie Farr & Gallagher LLP, New York, NY, argued for appellee. Also represented by Alexandra Awai, Michael Johnson.

          Courtney Dixon, Appellate Staff, Civil Division,

          United States Department of Justice, Washington, DC, argued for intervenor. Also represented by Katherine Twomey Allen, Scott R. McIntosh, Joseph H. Hunt; Thomas W. Krause, Joseph Matal, Farheena Yasmeen Rasheed, Office of the Solicitor, United States Patent and Trademark Office, Alexandria, VA.

          Before Prost, Chief Judge, Newman and Chen, Circuit Judges.

          OPINION

          CHEN, CIRCUIT JUDGE.

         Genentech, Inc. appeals from the final written decision of the United States Patent and Trademark Office (Patent Office) Patent Trial and Appeal Board (the Board) holding claims 1-3 and 5-11 of U.S. Patent 7, 807, 799 (the '799 patent) unpatentable as anticipated or obvious. See Genentech, Inc. v. Hospira, Inc., No. IPR2016-01837, 2018 WL 1187484 (P.T.A.B. Mar. 6, 2018) (the '837 Decision). The Patent Office intervened in this appeal to defend the constitutionality of inter partes review (IPR) proceedings as applied to patents issued before the enactment of the America Invents Act (AIA), Pub. L. No. 112-29, 125 Stat. 284 (2011). For the following reasons, we affirm.

         Background

         Genentech owns the '799 patent, which is directed to methods of purifying antibodies and other proteins containing a CH2/CH3 region from impurities by protein A affinity chromatography. '799 patent at col. 7 ll. 50-54. Protein A affinity chromatography is a standard purification technique employed in the processing of therapeutic proteins, especially antibodies, which involves "using protein A . . . immobilized on a solid phase." Id. at col. 4 ll. 27- 30. "The solid phase may comprise a glass, silica, polystyrene, or agarose surface," such as a chromatography column resin "to which the protein A can . . . be covalently bound." Id. at col. 4 ll. 41-47. "Protein A is a useful adsorbent for affinity chromatography of proteins, such as antibodies" because protein A reversibly binds with high affinity to a specific region common to most antibodies, the CH2/CH3 region. Id. at col. 2 ll. 6-11, col. 4 ll. 20-25, 30- 31, col. 5 ll. 17-28.

         In protein A affinity chromatography, a composition comprising a mixture of the target antibody and undesired impurities often present in harvested cell culture fluid (HCCF) is placed into the chromatography column. Id. at col. 18 ll. 47-51. The target antibody binds to protein A, which is covalently bound to the chromatography column resin, while the impurities and rest of the composition pass through the column. Id. at col. 18 ll. 47-51, col. 20 ll. 6-11. Next, the antibody of interest is removed from the chromatography column, typically with a low pH wash. Id. at col. 19 ll. 45-51. The antibody is collected as it is washed from the chromatography column, then typically subjected to further purification steps, and used for therapeutic purposes after formulation. Id. at col. 19 ll. 51-63.

         While protein A affinity chromatography has been "a powerful tool . . . for purifying antibodies," it was known to have a downside. See id. at col. 20 ll. 6-12. Small amounts of the protein A that are attached to the chromatography column would "leach" (i.e., detach) from the column and contaminate the otherwise-purified antibody solution. See id. at col. 20 ll. 11-15, col. 4 ll. 48-50. Thus, further purification steps are typically employed to remove leached protein A from the antibody solution. See id. at col. 20 ll. 12-15.

         The invention of the '799 patent "concerns a method for reducing leaching of protein A . . . by reducing [the] temperature" of the "composition that is subjected to protein A affinity chromatography." Id. at col. 1 ll. 16-21. The specification discloses that "[p]referably, . . . the temperature of the composition is reduced below room temperature, for instance in the range from about 3°C to about 20°C, e.g. from about 10°C to about 18°C." Id. at col. 18 ll. 4-9. According to the patent, "[t]he temperature of the composition may be reduced prior to and/or during protein A affinity chromatography" and, in a preferred embodiment, involves "lowering the temperature of the harvested cell culture fluid (HCCF) which is subjected to chromatography." Id. at col. 18 ll. 9-16.

         Claim 1, the sole independent claim at issue, recites:

1. A method of purifying a protein which comprises CH2/CH3 region, comprising subjecting a composition comprising said protein to protein A affinity chromatography at a temperature in the range from about 10°C to about 18°C.

Id. at col. 35 ll. 44-47 (emphasis added).

         Hospira, Inc. sought IPR of claims 1-3 and 5-11 of the '799 patent. The Board instituted trial on all eight grounds of unpatentability, which all rely on WO '389[1] or van Sommeren[2] as the primary reference.

         The Board determined that all the challenged claims were unpatentable as anticipated by WO '389 or rendered obvious by WO '389 alone or in combination with other prior art references. '837 Decision, 2018 WL 1187484, at *12, *19-20. Also, the Board construed "about 18°C," and based on that claim construction, it concluded that all the challenged claims were unpatentable as anticipated by van Sommeren or rendered obvious by van Sommeren alone or in combination with other prior art references. Id. at *13, *22.

         Genentech appeals. The Patent Office intervened pursuant to 35 U.S.C. § 143 to defend against Genentech's constitutionality challenge to IPRs as applied to the '799 patent because it issued on October 5, 2010, which is before the enactment of the AIA in 2011. We have jurisdiction under 28 U.S.C. § 1295(a)(4)(A).

         Discussion

         We review the Board's legal determinations de novo, and the Board's factual findings underlying those determinations for substantial evidence. Belden Inc. v. Berk-Tek LLC, 805 F.3d 1064, 1073 (Fed. Cir. 2015). A finding is supported by substantial evidence if a reasonable mind might accept the evidence to support the finding. Consol. Edison Co. v. NLRB, 305 U.S. 197, 229 (1938).

         Anticipation is a question of fact that we review for substantial evidence. In re Rambus, Inc., 753 F.3d 1253, 1256 (Fed. Cir. 2014). Obviousness is a question of law based on underlying factual findings, including "the scope and content of the prior art, differences between the prior art and the claims at issue, the level of ordinary skill in the pertinent art, and any objective indicia of non-obviousness." Randall Mfg. v. Rea, 733 F.3d 1355, 1362 (Fed. Cir. 2013) (citing KSR Int'l Co. v. Teleflex Inc., 550 U.S. 398, 406 (2007)).

         I. Anticipation by WO '389

         The Board determined that claims 1 and 5 are anticipated by WO '389. '837 Decision, 2018 WL 1187484, at *8. WO '389 teaches a method for purifying certain antibodies of the IgG class, which are proteins comprising the CH2/CH3 region, including a step wherein HCCF is subject to protein A affinity chromatography. J.A. 511 at 2:37, 522 at 13:9-13. WO '389 Example 1 discloses a washing step after HCCF is applied to the chromatography column, whereupon the HCCF composition is washed with at least three column volumes of buffer before the antibody is eluted. J.A. 523 at 14:20-23. WO '389 teaches that "[a]ll steps are carried out at room temperature (18-25°C)." J.A. 522 at 13:13.

         Claim 1, the sole challenged independent claim of the '799 patent, requires "subjecting a composition . . . to protein A affinity chromatography at a temperature in the range from about 10°C to about 18°C." '799 patent at claim 1. The temperature range disclosed in WO '389, "18-25°C," overlaps with the claimed range of "about 10°C to about 18°C," regardless of the construction of "about 18°C." Indeed, Genentech's own proposed construction for "about 18°C" embraces temperatures up to 19°C, which further reinforces the overlap with WO '389's disclosed temperature range.

         A prior art reference that discloses an overlapping but different range than the claimed range can be anticipatory, even where the prior art range only partially or slightly overlaps with the claimed range. See Ineos USA LLC v. Berry Plastics Corp., 783 F.3d 865, 870-71 (Fed. Cir. 2015) (affirming summary judgment of anticipation of patent claims for composition with "0.05 to 0.5% by weight of at least one saturated fatty acid amide" lubricant in view of a prior art reference disclosing the same class of lubricant in an overlapping range of "0.1 to 5 parts by weight," and the parties agreed that a measurement in "% by weight" was equivalent to one in "parts by weight"). Once the patent challenger has established, through overlapping ranges, its prima facie case of anticipation, "the court must evaluate whether the patentee has established that the claimed range is critical to the operability of the claimed invention." Id. at 871; see also E.I. DuPont de Nemours & Co. v. Synvina C.V., 904 F.3d 996, 1008 (Fed. Cir. 2018) ("'where there is a range disclosed in the prior art, and the claimed invention falls within that range, the burden of production falls upon the patentee to come forward with evidence' of . . . criticality") (quoting Galderma Labs., L.P. v. Tolmar, Inc., 737 F.3d 731, 738 (Fed. Cir. 2013)). Here, the Board found that Genentech failed to establish that the claimed temperature range of "about 10°C to about 18°C" is critical to performing protein A chromatography. '837 Decision, 2018 WL 1187484, at *10-11. Genentech does not challenge the Board's finding as to criticality, and accordingly, whether or not the claimed temperature range achieves different performance results than WO '389's disclosed temperature range is not at issue on appeal. Appellee's Br. at 15.

         Aside from the overlapping range issue, the Board construed the limitation "subjecting a composition . . . to protein A affinity chromatography at a temperature in the range from about 10°C to about 18°C" as referring to the temperature of the composition prior to and/or during protein A affinity chromatography. '837 Decision, 2018 WL 1187484, at *8 (emphasis added). The Board found that WO '389's disclosed temperature range applies to all components used in the purification process, including the HCCF composition being purified. '837 Decision, 2018 WL 1187484, at *10. In that way, it found WO '389 discloses that prior to protein A affinity chromatography, the HCCF composition is at a temperature within the claimed range of "about 10°C to about 18°C." Additionally, the Board found that WO '389's disclosed composition's temperature reaches the claimed temperature range during protein A affinity chromatography. '837 Decision, 2018 WL 1187484, at *10. The Board read WO '389's teaching that "[a]ll steps are carried out at room temperature (18-25°C)" to mean that the apparatus of the chromatography column and column buffers are all within that ...


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