Abbott GmbH & Co. v. Centocor Ortho Biotech, Inc.

• Decision Date: 04 May 2012
• Docket Number: Civil Action No. 09–11340–FDS.
• Citation: 870 F.Supp.2d 206
• Court: U.S. District Court — District of Massachusetts
• Parties: ABBOTT GMBH & CO., KG; Abbott Bioresearch Center, Inc.; and Abbott Biotechnology Ltd., Plaintiffs, v. CENTOCOR ORTHO BIOTECH, INC., and Centocor Biologics, Inc., Defendants.

870 F.Supp.2d 206

ABBOTT GMBH & CO., KG; Abbott Bioresearch Center, Inc.; and Abbott Biotechnology Ltd., Plaintiffs,
v.
CENTOCOR ORTHO BIOTECH, INC., and Centocor Biologics, Inc., Defendants.

Civil Action No. 09–11340–FDS.

United States District Court,
D. Massachusetts.

May 4, 2012.

[870 F.Supp.2d 210]

William F. Lee, Wilmer Hale LLP, Boston, MA, for Plaintiffs.

AMENDED MEMORANDUM AND ORDER ON CROSS–MOTIONS FOR SUMMARY JUDGMENT
SAYLOR, District Judge.

This is a patent infringement action involving a class of antibodies developed to treat certain auto-immune diseases. Plaintiffs Abbott GmbH & Co., KG; Abbott

[870 F.Supp.2d 211]

Bioresearch Center, Inc.; and Abbott Biotechnology Ltd. (collectively “Abbott”) and defendants Centocor Ortho Biotech, Inc and Centocor Biologics, Inc. (collectively “Centocor”) are pharmaceutical companies. Abbott and Centocor have both developed antibodies capable of treating diseases associated with the overproduction of a naturally-occurring protein in the human body called interleukin–12 (“IL–12”). Abbott seeks a judgment under 35 U.S.C. § 271 that its U.S. Patent No. 6,914,128 (the “'128 patent”) and U.S. Patent No. 7,504,485 (the “'485 patent”) are infringed by the drug Stelara, which Centocor manufactures. Centocor seeks declarations that Stelara does not infringe the patents and that the patents are invalid under 35 U.S.C. §§ 102, 103, and 112.

The parties are simultaneously before this Court on an appeal of a decision of the United States Patent and Trademark Office (“PTO”) Board of Patent Appeals and Interferences (“BPAI”) regarding essentially the same subject matter. On December 12, 2007, the BPAI declared an interference between Abbott's '128 patent and Centocor's pending Patent Application No. 10/912,994 for Stelara. That proceeding was instituted to determine priority of invention as between the parties and whether the '128 patent claimed material that was unpatentable under 35 U.S.C. §§ 102, 103, and 112. On August 6, 2009, the BPAI ruled for Abbott on these issues. Centocor has petitioned for judicial review of the interference decision pursuant to 35 U.S.C. § 146.

This Court conducted a Markman hearing in the infringement action and issued its final claim construction decision on May 5, 2011, 2011 WL 1791684. The parties have now filed multiple cross-motions for summary judgment on the issues of validity and infringement.¹

I. Background

This case concerns the interrelation of two statutory causes of action as well as questions of infringement involving application of the claim construction to technical subject matter. A brief review of the relevant statutory, factual, and procedural background is therefore warranted.

A. Statutory Background1. Infringement Actions Under 35 U.S.C. § 271

Two statutes, 35 U.S.C. § 271 and 281, provide a patentee with a cause of action for damages and injunctive relief for patent infringement. Infringement analysis is a “two-step process in which the court first determines, as a matter of law, the correct claim scope, and then the fact-finder compares the properly construed claim to the accused device to determine, as a matter of fact, whether all of the claim limitations are present, either literally or by a substantial equivalent in the accused device.” IEX Corp. v. Blue Pumpkin Software, Inc., 122 Fed.Appx. 458, 464 (Fed.Cir.2005).

Because “an invalid patent cannot be infringed,” Viskase Corp. v. American Nat'l Can Co., 261 F.3d 1316, 1323 (Fed.Cir.2001), a defendant in an infringement action may assert invalidity as an affirmative defense. However, a granted patent is “presumed valid,” 35 U.S.C. § 282, and

[870 F.Supp.2d 212]

this presumption may be rebutted only by “clear and convincing evidence,” Microsoft Corp. v. i4i Ltd. P'ship, ––– U.S. ––––, 131 S.Ct. 2238, 2242, 180 L.Ed.2d 131 (2011). See also Anderson v. Liberty Lobby, Inc., 477 U.S. 242, 255, 106 S.Ct. 2505, 91 L.Ed.2d 202 (1986) (holding that “the clear-and-convincing standard of proof should be taken into account in ruling on summary judgment motions”).

2. Interference Proceedings and Judicial Review Under 35 U.S.C. § 146

The Director of the PTO is authorized to declare and conduct interference proceedings by 35 U.S.C. § 135. The statute provides, in relevant part:

Whenever an application is made for a patent which, in the opinion of the Director, would interfere with any pending application, or with any unexpired patent, an interference may be declared.... The [BPAI] shall determine questions of priority of the inventions and may determine questions of patentability. Any final decision, if adverse to the claim of an applicant, shall constitute the final refusal by the [PTO] of the claims involved, and the Director may issue a patent to the applicant who is adjudged the prior inventor ....

35 U.S.C. § 135(a).² At the beginning of an interference, the BPAI defines one or more “counts.” 37 C.F.R. § 41.203(b). A count is “the Board's description of the interfering subject matter that sets the scope of admissible proofs on priority.” 37 C.F.R. § 41.201. It “corresponds to a patentable invention” and “may be identical to a single claim at issue or may be broader than the particular claims at issue.” Slip Track Sys., Inc. v. Metal–Lite, Inc., 304 F.3d 1256, 1263 (Fed.Cir.2002). The party that was first to file an application describing and enabling the “count” declared in the interference is designated the “senior party,” and the second the “junior party.” The junior party bears the burden of proving priority by a preponderance of the evidence. 37 C.F.R. § 41.207(a); Rexam Indus. Corp. v. Eastman Kodak Co., 30 Fed.Appx. 983, 985 (Fed.Cir.2002).

Once an interference is properly declared, a priority determination is mandatory. See Guinn v. Kopf, 96 F.3d 1419, 1421–22 (Fed.Cir.1996). A patentability determination, if fairly raised and fully developed before the BPAI, is “nearly mandatory.” In re Gartside, 203 F.3d 1305, 1317 (Fed.Cir.2000); see also Perkins v. Kwon, 886 F.2d 325, 328–29 (Fed.Cir.1989) (interpreting the phrase “may determine questions of patentability” to require a determination unless patentability is not placed at issue); Koninklijke Philips Elecs. N.V. v. Cardiac Sci. Operating Co., 590 F.3d 1326, 1334 (Fed.Cir.2010) (citing Perkins, 886 F.2d at 328).

Once the BPAI has rendered a final decision, Section 146 of the Patent Act authorizes an aggrieved party to seek review of that decision in federal district court. The statute provides:

Any party to an interference dissatisfied with the decision of the [BPAI] on the interference, may have remedy by civil action.... Such suit may be instituted against the party in interest as shown by the records of the [PTO] at the time of the decision complained of, but any party in interest may become a party to the action.... Judgment of the court in favor of the right of an applicant to a patent shall authorize the Director to issue such patent on the filing in the [PTO] of a certified copy of the judgment

[870 F.Supp.2d 213]

and on compliance with the requirements of law.

35 U.S.C. § 146. “District court review of an interference proceeding under Section 146 is an equitable remedy of long standing.” General Instrument Corp. v. Scientific–Atlanta, Inc., 995 F.2d 209, 214 (Fed.Cir.1993).

An action in district court pursuant to Section 146 takes the form of a “hybrid appeal/trial de novo proceeding in which the PTO record is admitted on motion of either party [but] may be supplemented by further testimony.” Human Genome, 552 F.Supp.2d at 468 (quoting General Instrument, 995 F.2d at 212). To the extent that no new evidence is presented in the Section 146 action, the district court reviews the factual findings of the BPAI for “substantial evidence,” the standard applicable to review of agency fact-finding under the Administrative Procedure Act. Dickinson v. Zurko, 527 U.S. 150, 152, 119 S.Ct. 1816, 144 L.Ed.2d 143 (1999). However, if the parties do introduce new evidence in the form of live testimony before the district court, its review of the BPAI's determinations is de novo. Winner Int'l Royalty Corp. v. Wang, 202 F.3d 1340, 1345 (Fed.Cir.2000). Although it has some aspects of a trial, a Section 146 action “is not a new claim, but an authorized phase of the interference proceeding that is conducted by the PTO and is subject to judicial review.” Vas–Cath, Inc. v. Curators of the Univ. of Mo., 473 F.3d 1376, 1382 (Fed.Cir.2007); Rexam Indus. Corp. v. Eastman Kodak Co., 182 F.3d 1366, 1370 (Fed.Cir.1999) (stating that a Section 146 action is “derivative of the interference conducted in the PTO.”).

B. Factual Background

The following facts are undisputed except where otherwise noted.

1. Human IL–12 and Recombinant Antibodies to It

IL–12 is a member of a family of naturally occurring human proteins, called cytokines. It assists the immune system by binding to receptors on the surfaces of certain cells as part of the body's inflammation response to infection. Structurally, IL–12 is composed of two smaller molecules, a p35 subunit and a p40 subunit.³

In some individuals, the body can over-produce IL–12, causing auto-immune diseases such as psoriasis, where the body's immune system chronically targets healthy human tissue instead of foreign contaminants. One way of treating such diseases is by inhibiting or blocking the effects of IL–12 through the use of antibodies. Antibodies are proteins that attach themselves to a target molecule—called an “antigen” for that antibody—by binding with a portion of that antigen called an “epitope.” The immune system produces antibodies that typically target antigens such as viruses, foreign bacteria, or other foreign substances, but an antibody may also target a non-foreign antigen such as IL–12.

The ability of an antibody to bind to a specific antigen is determined by its molecular structure. All antibodies share a general structure consisting of two identical “heavy” chains and two identical “light”...