Centocor Ortho Biotech, Inc. v. Abbott Laboratories
636 F.3d 1341
| Fed. Cir. | 2011Background
- Centocor and NYU sued Abbott for infringement of the '775 patent on anti-TNF-α antibodies.
- Jury held Abbott liable for willful infringement and awarded over $1.67 billion in damages; asserted claims 2, 3, 14, 15 require human variable regions.
- Abbott moved for JMOL on invalidity, noninfringement, damages, and willfulness; district court granted JMOL on willfulness but denied others.
- The central issue on appeal is whether the 1994 CIP applications provide adequate written description for fully-human, A2-identified, high-affinity antibodies.
- The district court did not grant JMOL on invalidity, so the appellate court reviews written description de novo with substantial-evidence standard for the jury.
- The court focuses on whether Centocor’s 1994 CIP disclosure reasonably conveys possession of fully-human, high-affinity, neutralizing antibodies with A2 specificity.
Issues
| Issue | Plaintiff's Argument | Defendant's Argument | Held |
|---|---|---|---|
| Whether the 1994 CIP applications adequately described fully-human, A2-specific antibodies. | Centocor possessed written description for human variable regions and A2 specificity in 1994. | The 1994 CIP disclosure lacks any fully-human antibody or human variable region; only a chimeric antibody and general references exist. | No; lack of adequate written description in 1994 CIP. |
| Whether the specification enables a person of ordinary skill to recognize possession of the claimed antibodies. | The 1994 CIP shows plans and tools capable of yielding fully-human antibodies; the claims are supported by description of properties and benchmarking against A2. | The specification does not describe a single fully-human, high-affinity, neutralizing antibody with A2 specificity; it is merely a plan to search. | No; insufficient constructive possession in the disclosure. |
| Whether applying PTO antibody-guideline reasoning from Noelle supports written description here. | Noelle-like reasoning allows description of a well-characterized antigen to support antibodies; protein TNF-α is well characterized. | Noelle is distinguishable; here full human variable regions were not disclosed and routine production was not demonstrated in 1994. | No; Noelle guidance does not render the 1994 CIP adequate. |
| Whether Centocor’s broader claims to fully-human antibodies exceed the disclosure in the specification. | The claims describe properties that were disclosed or anticipated by the specification and prior art. | The claims recite antibodies not described or enabled by the 1994 CIP; scope exceeds disclosure. | Yes; claims exceed the disclosure. |
Key Cases Cited
- Ariad Pharm., Inc. v. Eli Lilly & Co., 598 F.3d 1336 (Fed.Cir. 2010) (written description requires possession and is a factual question)
- Carnegie Mellon Univ. v. Hoffmann-La Roche Inc., 541 F.3d 1115 (Fed.Cir. 2008) (possession shown by disclosure; mere plan not enough)
- PIN/NIP, Inc. v. Platte Chem. Co., 304 F.3d 1235 (Fed.Cir. 2002) (written description requires description of the invention as claimed)
- Noelle v. Lederman, 355 F.3d 1343 (Fed.Cir. 2004) (antibody example; broad antibody claims require sufficient disclosure of the antigen)
- Regents of the Univ. of Cal. v. Eli Lilly & Co., 119 F.3d 1559 (Fed.Cir. 1997) (mere plan to obtain claimed invention is insufficient for written description)