Abbott GmbH & Co. v. Centocor Ortho Biotech, Inc.
870 F. Supp. 2d 206
D. Mass.
2012

Background

  • Abbott and Centocor sue each other over IL-12 antibodies; Abbott asserts infringement of the '128 and '485 patents by Stelara (ustekinumab).
  • PTO BPAI interference between Abbott's '128 patent and Centocor's Stelara application; BPAI ruled for Abbott on priority, validity, and patentability issues in 2009.
  • Court conducted Markman claim construction in infringement action; multiple cross-motions for summary judgment on validity and infringement were filed.
  • IL-12/IL-23 biology: antibodies target IL-12/IL-23; SPR-based Kd measurements and receptor-binding assays used to characterize binding and neutralization.
  • Stelara approved by FDA; Abbott contends Centocor’s product infringes, Centocor seeks noninfringement and invalidity challenges.
  • Key statutory framework includes 35 U.S.C. § 271, § 146, and the interplay between judiciary and PTO in interference/priority proceedings.

Issues

Issue Plaintiff's Argument Defendant's Argument Held
Whether BPAI interference precludes later validity defenses Abbott argues BPAI decision precludes Centocor from raising invalidity. Centocor argues BPAI decision may have issue preclusion effect, especially with Section 146 pending. BPAI decision not binding final judgment; §146 pending allows validity issues to proceed.
Indefiniteness of the Kd/surface plasmon resonance (SPR) claims Abbott contends Kd/SPR language sufficiently definite as intrinsic property with standard methods. Centocor argues ambiguity due to SPR conditions (surface density/flow rate) affecting Kd value. Kd claims are sufficiently definite; Abbott granted summary judgment on definiteness.
Written description for the functional genus claims Abbott asserts disclosed 50 antibodies provide sufficient representative species. Centocor contends lack of common structural features/representative species for genus. Disputes over adequacy of written description for genus claims; summary judgment denied.
Prior art under 102(g)(2) for Joe antibodies and Stelara Abbott argues Joe antibodies are not prior art; joint inventors preclude separate prior art. Centocor contends Joe antibodies conceived earlier as separate inventive entity and Stelara anticipates. Joe antibodies are not prior art; Abbott granted summary judgment on that point; Stelara priority/anticipation issues remain disputed.
Infringement of specific claims by Stelara Stelara infringes multiple '128 and '485 claims, including 29, 32, 64 and 1-4, 6-9, 11, 15-19, 24. Stelara does not infringe or lacks certain limitations (e.g., koff, RBA constraints) as to some claims. Infringement found for several claims (29, 32, 64; 1-4, 6-9, 11, 15-19, 24) but not for claim 30; other noninfringement arguments denied or pending.

Key Cases Cited

  • IEX Corp. v. Blue Pumpkin Software, Inc., 122 Fed.Appx. 458 (Fed.Cir.2005) (two-step infringement analysis; claim scope then comparison)
  • Microsoft Corp. v. i4i Ltd. P’ship, 131 S. Ct. 2238 (2011) (clear and convincing standard for validity rebuttal)
  • Ramallo Bros. Printing, Inc. v. El Dia, Inc., 490 F.3d 86 (1st Cir. 2007) (Ramallo requirements for issue preclusion in patent cases)
  • Blonder-Tongue Labs., Inc. v. University of Ill. Found., 402 U.S. 313 (U.S. 1971) (non-mutual estoppel and preclusion in patent validity)
  • Winner Int’l Royalty Corp. v. Wang, 202 F.3d 1340 (Fed.Cir.2000) (hybrid of appeal and trial de novo; de novo review variables)
  • Beacon Theatres, Inc. v. Westover, 359 U.S. 500 (U.S. 1959) (Seventh Amendment rights when mixing equitable and legal claims)
  • Parklane Hosiery Co. v. Shore, 439 U.S. 322 (U.S. 1979) (preclusion where earlier equitable decision affects later legal action)
  • Streck, Inc. v. Research & Diagnostic Sys., Inc., 665 F.3d 1269 (Fed.Cir.2012) (concurrent §146 actions; preclusion interplay described)
  • Ariad Pharm., Inc. v. Eli Lilly & Co., 598 F.3d 1336 (Fed.Cir.2010) (written description standard for genus claims in biotech)
  • Carnegie Mellon Univ. v. Hoffmann-La Roche Inc., 541 F.3d 1114 (Fed.Cir.2008) (written description and possession requirement for inventions)
  • Noelle v. Lederman, 355 F.3d 1343 (Fed.Cir.2004) (written description when structure of claimed antibody or antigen lacking)
  • Alonzo v. In re Alonso, 545 F.3d 1015 (Fed.Cir.2008) (representative species within a dense genus; written description context)
  • Honeywell Int’l, Inc. v. Intl. Trade Comm’n, 341 F.3d 1332 (Fed.Cir.2003) (indefiniteness when multiple measurement methods yield different results)
  • Wellman, Inc. v. Eastman Chem. Co., 642 F.3d 1355 (Fed.Cir.2011) (consistency of industry standards to define measurement boundaries)
  • Star Scientific, Inc. v. R.J. Reynolds Tobacco Co., 655 F.3d 1364 (Fed.Cir.2011) (definiteness of environmental/controlled- environment process)
  • Enzo Biochem v. Gen-Probe Inc., 323 F.3d 956 (Fed.Cir.2002) (written description and enablement standards for patents)
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