Abbott GMBH & Co. v. Centocor Ortho Biotech, Inc.
| Decision Date | 04 May 2012 |
| Docket Number | Civil Action No. 09–11340–FDS. |
| Citation | 885 F.Supp.2d 491 |
| 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. |
OPINION TEXT STARTS HERE
Amy K. Wigmore, Amanda L. Major, Ali H. Shah, Pro Hac, Vice, Jacob S. Oyloe, Rachel L. Weiner, William G. McElwain, Wilmer Cutler Pickering Hale and Dorr LLP, John T. Callahan, Keiko K. Takagi, Travis B. Ribar, William J. Simmons, Sughrue Mion, PLLC, Washington, DC, Jane M. Love, Robert J. Gunther, Jr., Violetta G. Watson, Julia A. Grimes, Wilmer, Cutler, Pickering, Hale and Dorr LLP, Paula Estrada De Martin, Wilmer Hale LLP, New York, NY, William W. Kim, Wilmer Cutler Pickering Hale and Dorr LLP, Palo Alto, CA, Anne M. McLaughlin, Wilmer Hale LLP, William F. Lee, Wilmer Cutler Pickering Hale and Dorr LLP, Boston, MA, for Plaintiffs.
Barbara L. Mullin, Dianne B. Elderkin, Matthew A. Pearson, Steven D. Maslowski, Angela Verrecchio, Akin Gump Strauss Hauer & Feld LLP, Philadelphia, PA, Heather B. Repicky, Nutter, McClennen & Fish, LLP, Boston, MA, Domingo M. Llagostera, Akin Gump Strauss Hauer & Feld LLP, Houston, TX, Emily C. Johnson, Akin Gump Strauss Hauer & Feld LLP, Washington, DC, for Defendants.
MEMORANDUM AND ORDER ON MOTION FOR RECONSIDERATION
This is a patent dispute involving a pharmaceutical product. Plaintiffs Abbott GmbH & Co., KG; Abbott Bioresearch Center, Inc.; and Abbott Biotechnology Ltd. (collectively “Abbott”) seek a judgment that the drug Stelara, manufactured by defendants Centocor Ortho Biotech, Inc., and Centocor Biologics, Inc. (collectively “Centocor”), infringes its patents. Centocor seeks declarations of non-infringement and invalidity of Abbott's patents and seeks review of a decision of the Patent and Trademark Office's (“PTO”) Board of Patent Appeals and Interferences.
The Court issued its final claim construction order on May 5, 2011, and ruled on cross-motions for summary judgment relating to validity and infringement on March 9, 2012. Centocor has moved for reconsideration of two aspects of the March 9 ruling. For the following reasons, the motion will be denied. However, the Court will amend the March 9 memorandum and order to clarify its construction of the scope of certain claims of the '485 patent.1
The relevant statutory, factual, and procedural background is provided in the amended memorandum and order on the parties' cross-motions for summary judgment.
The Court has “substantial discretion and broad authority” to grant a motion for reconsideration pursuant to Fed.R.Civ.P. 59(e). Ruiz Rivera v. Pfizer Pharm., LLC, 521 F.3d 76, 81–82 (1st Cir.2008). A motion for reconsideration will be granted upon a showing of (1) a “manifest error of law,” (2) new evidence, or (3) a misunderstanding or other error “not of reasoning but apprehension.” Id.Rule 59(e) motions cannot be used to “advance a new argument that could (and should) have been presented prior to the district court's original ruling.” Cochran v. Quest Software, Inc., 328 F.3d 1, 11 (1st Cir.2003). Nor is a Rule 59(e) motion an appropriate means to “repeat old arguments previously considered and rejected.” Nat'l Metal Finishing Co., Inc. v. BarclaysAmerican/Commercial, Inc., 899 F.2d 119, 123 (1st Cir.1990).
III. AnalysisA. Written Description
The first aspect of the March 9 Order that Centocor contests is the denial of its motion for summary judgment that claims 1, 3, 4, 6–11, 15, 18, 19, and 24–26 of the '485 patent (the “p19 claims”) are invalid for failure to satisfy the written-description requirement of 35 U.S.C. § 112.2
The claims at issue are generally directed to antibodies to interleukin–12 (“IL–12”) and interleukin–23 (“IL–23”). IL–12 is composed of two smaller molecules, a p35 subunit and a p40 subunit.3 IL–23 contains the same p40 subunit that exists in IL–12, but with a p19 subunit forming its second component instead of the p35 subunit contained in IL–12. The specification of the ' 485 patent makes one reference to the p19/p40 molecule that is IL–23:
I. Binding to a Novel IL–12 Molecule
An alternative IL–12 heterodimer has been described, in which the p35 subunit is replaced by a novel p19 molecule. P19 was identified using 3D homology searching for IL–6/IL–12 family members, and is synthesized by activated dendritic cells. P19 binds to p40 to form a p 19/p40 dimer, which has IL–12–like activity, but is not as potent as the p35/p40 heterodimer in IFNã production. Antibodies which recognize p40 alone, but preferably in the context of a p70 molecule (e.g., J695 and Y61, see Example 3H) are expected to also neutralize both the p35/p40 molecules and the p19/p40 molecules.
('485 Patent, col. 111). Thus, the specification indicated the inventor's expectation that because IL–12 and IL–23 share a common p40 subunit, antibodies that bind to that subunit in IL–12 will also do so in IL–23.
In its motion for summary judgment, Centocor contended that such an expectation alone was insufficient to support claims to antibodies to antigens other than IL–12 because the patent did not disclose the structure of the p19 subunit that distinguishes IL–23. The Court denied that motion because it found that there were factual disputes as to whether the patents' disclosure of various antibodies within the scope of the p19 claims was sufficient to support the full breadth of those claims.
Centocor now contends that the Court incorrectly interpreted the scope of claims 1, 11, 15, 18, 19, and 24–26 in reaching its decision.4 Those claims provide:
1. A pharmaceutical composition comprising an isolated human antibody, or antigen-binding portion thereof, which is capable of binding to an epitope of the p40 subunit of IL–12, and further comprising an additional agent.
11. A composition of any one of claims 1–4, wherein the antibody, or antigen-binding portion thereof, dissociates from the p40 subunit of IL–12 with a Kd of 1 x 10 –10 M or less or a Koff rate constant of 1 x 10 –3 s –1 or less, as determined by surface plasmon resonance.
15. A pharmaceutical composition comprising an isolated human antibody, or antigen-binding portion thereof, which is capable of binding to an interleukin comprising a p40 subunit, and further comprising an additional agent.
18. The position [sic] of claim 15, wherein the interleukin comprises a p40 subunit and a p 19 subunit.5
19. The composition of any one of claims 15–18 wherein the antibody, or antigen binding portion thereof, binds to an epitope of the p40 subunit.
24. The composition of claim 15, wherein the antibody, or antigen binding portion thereof, dissociates from the p40 subunit of the interleukin with a Kd of 1 x 10 –10 M or less or a koff rate constant of 1 x 10–3 s –1 or less, as determined by surface plasmon resonance.
25. The composition of claim 15, wherein the antibody, or antigen binding portion thereof, neutralizes a biological activity of the interleukin.
26. The composition of claim 15, wherein the antibody, or antigen binding portion thereof, inhibits phytohemagglutinin blast proliferation in an in vitro PHA assay with an IC50 of 1 x 10 –9 M or less, or which inhibits human IFN? production with an IC50 of 1 x 10 –10 M or less.
('485 Patent, col. 381–83).
Centocor's motion concerns two sets of these claims. The first set consists of claims 15, 18, 25, and 26, which are directed to antibodies to antigens that contain a p40 subunit. Claim 15 refers to an antibody “capable of binding to an interleukin comprising a p40 subunit....” In patent claims, the term “comprising” is understood to mean “including but not limited to.” CIAS, Inc. v. Alliance Gaming Corp., 504 F.3d 1356, 1360–61 (Fed.Cir.2007).6 Claim 15 is thus directed to antibodies for interleukins that have a p40 subunit, regardless of what other subunit they may have. It is not limited to antibodies that bind to a particular epitope on those interleukins.7 Claims 18, 25, and 26 are dependent on claim 15 and do not include any limitations with respect to the epitope to which the claimed antibody must bind. Centocor is therefore correct that “[e]ach of these claims recites antibodies that bind to an antigen that has a p40 subunit, but none of these claims requires that the antibodies bind to that p40 subunit.” (Def.'s Mem. at 6).
The second set of claims at issue consists of claims 1, 11, 15, 19, 25, and 26, which are directed to antibodies that bind to a class of antigens that includes, but is not limited to, IL–12 and IL–23. Claim 1 refers to an antibody capable of binding to “an epitope of the p40 subunit of IL–12.” Claim 11 is dependent on claim 1, but limits its scope to antibodies that dissociate from the subunit at a rate that is below a particular threshold. Thus, claims 1 and 11 encompass antibodies that bind to an epitope on the p40 subunit, but are not limited to antibodies that do so while the p40 subunit is bound to the p35 subunit to form IL–12.8 The remaining claims in the second subset are also not limited to antibodies that bind to a particular interleukin. As previously noted, claim 15 claims antibodies that bind to “an interleukin comprising a p40 subunit.” Claims 19, 24, and 25 each incorporate claim 15 and add an additional limitation: claim 19 requires that the antibody bind “to an epitope of the p40 subunit,” claim 24 requires that it dissociates at a rate below a particular threshold, and claim 25 requires that it neutralize a biological activity of the interleukin. Finally, claim 26 is based on claim 25 and adds a limitation that the neutralization occur within a specified range of IC50 values.9 Thus, none of the claims in the second sets are limited to antibodies that bind to IL–12 or IL–23; rather, they claim antibodies to interleukins that share certain of the defining characteristics of those antigens.
To continue reading
Request your trial