625 F.3d 724
Fed. Cir.2010Background
- '291 patent claims a genus of tetra-zine derivatives for cancer treatment; temozolomide is a key claimed compound and Temodar® was FDA-approved for two brain cancers.
- Patent process began in 1982; initial office actions rejected claims for lack of utility; applicants pursued continuations and abandoned several applications.
- Ownership transferred to Cancer Research in 1991; prosecution eventually led to issuance in 1993 after altered examiner positions.
- Temozolomide received FDA approvals in 1999 and 2005; Barr filed ANDA in 2007; Cancer Research sued for patent infringement.
- District court held the patent unenforceable for prosecution laches and inequitable conduct; on appeal the Federal Circuit reversed those findings.
- Appellants seek reversal of the district court’s rulings based on the totality of prosecutorial delay and conduct evidence.
Issues
| Issue | Plaintiff's Argument | Defendant's Argument | Held |
|---|---|---|---|
| Prosecution laches based on delay and prejudice | Barr argues delay caused prejudice via intervening rights | Cancer Research argues unreasonable delay alone suffices without intervening rights | Delay not proven unlawful; no intervening rights shown; reversal on laches |
| Inequitable conduct from withholding material data | Barr shows data material and intent to deceive | Cancer Research asserts no clear intent to deceive; data publication undermines inference | District court erred; no clear intent established; inequitable conduct not proven |
Key Cases Cited
- Symbol Technologies, Inc. v. Lemelson Med., 422 F.3d 1378 (Fed. Cir. 2005) (prosecution laches requires totality of circumstances; intervening rights relevant)
- Woodbridge v. United States, 263 U.S. 50 (S. Ct. 1923) (delay in patent issuance can constitute forfeiture)
- Webster Electric Co. v. Splitdorf Electrical Co., 264 U.S. 463 (S. Ct. 1924) (unreasonable delay bar; intervening rights considered)
- Crown Cork & Seal Co. v. Ferdinand Gutmann Co., 304 U.S. 159 (S. Ct. 1938) (absence of intervening rights; no excuse required for divisional delay)
- General Talking Pictures Corp. v. Western Electric Co., 304 U.S. 175 (S. Ct. 1938) (intervening rights needed for laches in certain continuations)
- In re Bogese, 303 F.3d 1362 (Fed. Cir. 2002) (PTO forfeiture based on delay and evidence of known developments)