Santarus, Inc. v. Par Pharmaceutical, Inc.
694 F.3d 1344
| Fed. Cir. | 2012Background
- Santaru s owned Phillips patents on uncoated benzimidazole PPI formulations; Santarus licensed MO patent rights and sells Zegerid®. Par filed ANDA seeking a generic; district court found infringement but held claims obvious or lacking written description; inequitable conduct defense thrown against all patents but court found no clear intent to deceive; on appeal, issue was obviousness and priority with respect to multiple patents; opinion affirms some rulings and reverses others, remanding for further proceedings.
- The patents trace to the '737 priority, which disclosed non-enteric forms with buffering; '346, '772, '885, '988 patents cover non-enteric solid dosages with buffering agents; prior art Pilbrant and Lamers discussed in evaluating obviousness.
- Court addressed inequitable conduct, concluding failure to prove intent by clear and convincing evidence; not overturned here as lacking.
- The panel held that certain claims would have been obvious over prior art, including the '737 patent disclosures, and affirmed some invalidity findings while reversing others related to the '772 patent written description.
- The decision remands for further proceedings consistent with this opinion, with mixed affirmances, reversals, and remand.
Issues
| Issue | Plaintiff's Argument | Defendant's Argument | Held |
|---|---|---|---|
| Inequitable conduct proven? | Par shows intent to deceive; district court credibility. | Phillips hidden material; deliberate withholding. | Inequitable conduct not proven. |
| Written description for no sucralfate? | Specification supports exclusion of sucralfate. | Need explicit contraindication in description. | Reversed; no written description issue. |
| Obviousness of claimed non-enteric solid dosage forms? | 737 discloses non-enteric forms; overlaps; unexpected results. | Enteric coating taught away; obvious overall. | Claims found obvious in most groups; some exceptions remanded. |
| Priority and reliance on parent CIP disclosures? | Common subject matter should carry parent date. | Parent disclosures cannot invalidate CIPclaims. | Panel erred; priority rules preserved; remand. |
| Effect of Pilbrant/Lamers on various claims? | Some limitations taught by Pilbrant; ratios overlap. | Pilbrant teaches away from non-enteric forms. | Obviousness found for many claims; some claims not obvious. |
Key Cases Cited
- Therasense, Inc. v. Becton, Dickinson & Co., 649 F.3d 1276 (Fed.Cir.2011) (inequitable conduct requires intent to deceive)
- KSR Int'l Co. v. Teleflex, Inc., 550 U.S. 398 (Supreme Court 2007) (obviousness standard; common sense)
- In re Johnson, 558 F.2d 1008 (CCPA 1977) (claims may be narrowed during prosecution)
- In re Kao, 639 F.3d 1057 (Fed.Cir.2011) (inherent properties cannot render nonobviousness without new teaching)
- Pilbrant, n/a (n/a) (discussed as prior art evaluating non-enteric forms; not a case)
- Lamers v. Absorption of omeprazole in Zollinger-Ellison syndrome is accelerated by alkali, Lamers et al., 26 Gut 1134-1135 (1985) (teaching on absorption with alkali; used in obviousness analysis)