Brigham & Women's Hospital Inc. v. Teva Pharmaceuticals USA, Inc.
761 F. Supp. 2d 210
D. Del.2011Background
- BWH, NPS, and Amgen sue Teva, Teva, and Barr for infringement of four cinacalcet-related patents: the '068, '003, '244, and previously the '146; the court later dismisses claims relating to the '146 patent.
- Representative claims across the asserted patents cover cinacalcet and its salts, methods of treating hyperparathyroidism, and compositions of calcimimetic compounds.
- The parties stipulate that the proposed generic product would infringe the asserted claims, and ANDAs were filed with the FDA; the litigation focuses on patent validity and enforceability.
- The '541 patent (disclosed plant for making R-enantiomers) is later alleged to anticipate or render relevant information material to the '244 patent prosecutors.
- A key procedural posture is that the court issues findings of fact and conclusions of law after a bench trial, addressing inequitable conduct, double patenting, and anticipation.
- The patents at issue were prosecuted by a four-member committee, with disclosure practices at the heart of the inequitable conduct and double patenting defenses.
Issues
| Issue | Plaintiff's Argument | Defendant's Argument | Held |
|---|---|---|---|
| Whether the '068 and '003 patents are unenforceable due to inequitable conduct | Defendants: non-disclosure of copending '244 to examiners shows intent to deceive | Defendants: failure to disclose shows intent to deceive | No inequitable conduct proven; no clear and convincing intent to deceive shown |
| Whether the '068 and '003 patents are invalid for obviousness-type double patenting over the '244 patent | Genus '068/'003 valid but species '244 extends term improperly | Term alignment causes unjust timewise extension | Not invalid for double patenting; term alignment does not unjustly extend protection |
| Whether the '541 patent anticipates the '244 patent | '541 discloses genus that anticipates cinacalcet | Cinacalcet is not at once envisaged due to non-preferred substituents | Not anticipated by the '541 patent; cinacalcet not within the at-once-envisage subclass described in '541 |
| Whether the '541 patent duty to disclose was violated in the '244 prosecution | Plaintiffs breached no duty; no deception shown | Defendants argue duty to inquire was breached | No clear and convincing evidence of inequitable conduct; no withholding of '541 proven |
Key Cases Cited
- Star Scientific, Inc. v. R.J. Reynolds Tobacco Co., 537 F.3d 1357 (Fed. Cir. 2008) (clear and convincing evidence required to prove intent to deceive; one-way disclosure insufficient to show intent)
- Li Second Family Ltd. Partnership v. Toshiba Corp., 231 F.3d 1373 (Fed. Cir. 2000) (materiality requires substantial likelihood examiner would consider reference important)
- Akron Polymer Container Corp. v. Exxel Container, Inc., 148 F.3d 1382 (Fed. Cir. 1998) (later-filed copending application can be material to an earlier copending one)
- Dayco Prods., Inc. v. Total Containment, Inc., 329 F.3d 1358 (Fed. Cir. 2003) (one examiner's view of related prosecution can be material to another examiner's review)
- In re Berg, 140 F.3d 1428 (Fed. Cir. 1998) (anticipates or supports obviousness determinations for genus-to-species relations)