Abbott GmbH & Co. v. Centocor Ortho Biotech, Inc.
971 F. Supp. 2d 171
D. Mass.2013Background
- This is a patent infringement suit over antibodies targeting IL-12 (Stelara) involving Abbott and Centocor.
- The ’128 and ’485 patents were alleged to be invalid for written description, enablement, and obviousness.
- Jury trial in 2012 found the claims invalid on three grounds; Centocor did not contest infringement at trial.
- Abbott renewed its JMOL on written description, enablement, and obviousness; motion denied.
- Court analyzes whether the patents’ disclosure adequately describes a genus of antibodies and whether the full scope is enabled and non-obvious.
- Stelara is an antibody binding IL-12 produced by Centocor; two methods exist to make fully human antibodies (phage display, transgenic mice).
Issues
| Issue | Plaintiff's Argument | Defendant's Argument | Held |
|---|---|---|---|
| Written description sufficiency for genus claims | Abbott argues the disclosure fails to describe a representative genus. | Centocor contends the disclosed antibodies are representative of the genus. | Denied; jury's verdict supported by substantial evidence. |
| Enablement of full genus scope | Abbott asserts the specification does not enable Stelara-equivalent antibodies. | Centocor argues non-enablement of full genus, given Stelara’s distinct features. | Denied; jury reasonably found non-representativeness and lack of enablement. |
| Obviousness of claims as to IL-12 antibodies | Abbott contends claims were not obvious in view of prior art. | Centocor asserts prior art would lead skilled artisans to achieve the claimed antibodies. | Denied; substantial evidence supported obviousness under the law. |
| Representativeness of disclosed species | Abbott claims disclosed species are representative of the genus. | Centocor contends disclosed species are non-representative given structural/functional differences. | Denied; evidence supported non-representativeness and unreliability of Stelara as a sole exception. |
| Visualization/recognition requirement application | Argues the visualized/recognized standard should not apply to functional genus claims. | Defendant contends the standard applies to genus disclosure. | Denied; court found law supports applying the standard to determine genus discernibility. |
Key Cases Cited
- Ariad Pharmaceuticals, Inc. v. Eli Lilly & Co., 598 F.3d 1336 (Fed.Cir.2010) (defines written-description tests for a genus and representative species)
- Carnegie Mellon Univ. v. Hoffmann-La Roche Inc., 541 F.3d 1115 (Fed.Cir.2008) (discloses representative species vs structural features in genus claims)
- Regents of the Univ. of Cal. v. Eli Lilly & Co., 119 F.3d 1559 (Fed.Cir.1997) (addressed disclosure of representative species in a genus)
- Genentech, Inc. v. Novo Nordisk A/S, 108 F.3d 1361 (Fed.Cir.1997) (enablement and genus disclosures considerations)