Braintree Laboratories, Inc. v. Novel Laboratories, Inc.
749 F.3d 1349
Fed. Cir.2014Background
- Braintree markets SUPREP bowel prep; '149 patent teaches a small-volume hypertonic saline composition (100-500 mL) causing purgation without clinically significant electrolyte shifts.
- Novel filed ANDA under Hatch-Waxman for a generic SUPREP copy and challenged the '149 patent in district court for infringement.
- District Court construed two key terms: “purgation” and “clinically significant electrolyte shifts,” and granted summary judgment of infringement.
- District Court later held that the ANDA could induce infringing use with a 946 mL (two-bottle) regimen, potentially infringing under the district court’s construction.
- On appeal, court reversed in part: held purgation construction was correct but erred on the electrolyte-shifts construction; remanded for factual findings on infringement under the corrected construction.
- The court affirmed the patentability—claims not anticipated, not obvious, and not indefinite.
Issues
| Issue | Plaintiff's Argument | Defendant's Argument | Held |
|---|---|---|---|
| Construction of ‘purgation’ | Novel argues purgation means cleansing. | Braintree argues purgation is evacuation of copious stool, not necessarily full cleansing. | Reversed district court; purgation meaning adopted as evacuation of copious stool, not requiring full cleanse. |
| Construction of ‘clinically significant electrolyte shifts’ | Specification supports a broader, inventor-defined lexicography. | District Court’s conjunctive construction aligns with “untoward effects.” | Reversed district court; defined as alterations outside normal range or with untoward effects. |
| Infringement under volume limitation | One-bottle theory can infringe if any subset (473 mL) falls within 100-500 mL. | FDA-approved dose is two-bottle regimen totaling 946 mL; one-bottle regimen not approved; no infringement. | Remanded for factual findings; majority’s one-bottle view rejected; volume must reflect total approved dose. |
| Invalidity (anticipation, obviousness, indefiniteness) | Hechter anticipates; prior art would render claims obvious; term ‘copious’ indefinite. | Braintree’s arguments fail under the prior art and claim construction; no indefiniteness. | Not invalid; claims not anticipated, not obvious, and not indefinite. |
| Preamble term ‘a patient’ scope | According to law, ‘a’ means one or more; infringement can occur for any patient in the population. | Majority adopts a population-wide reading that limits infringement. | Dissent in Part agrees with plaintiff on plain meaning; remand for correct application of volume and infringement scope. |
Key Cases Cited
- 01 Communique Lab., Inc. v. LogMeIn, Inc., 687 F.3d 1292 (Fed. Cir. 2012) (‘a’ means one or more in open-ended claims; exceptions rare)
- SanDisk Corp. v. Kingston Tech. Co., Inc., 695 F.3d 1348 (Fed. Cir. 2012) (meaning of indefinite articles in claims)
- TiVo, Inc. v. EchoStar Commc’ns Corp., 516 F.3d 1290 (Fed. Cir. 2008) (claim construction principles; deference and standard)
- Rowe v. Dror, 112 F.3d 473 (Fed. Cir. 1997) (preamble and use of claims; when limiting)
- Phillips v. AWH Corp., 415 F.3d 1303 (Fed. Cir. 2005) (intrinsic evidence governs claim construction)
- Markman v. Westview Instruments, Inc., 517 U.S. 370 (U.S. 1996) (claim construction is a matter of law)
- KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398 (Sup. Ct. 2007) (obviousness analysis standard)
- Allergan, Inc. v. Alcon Labs., Inc., 324 F.3d 1322 (Fed. Cir. 2003) (ANDA infringement framework; FDA-approved dose relevance)
- Bayer Schering Pharma AG v. Lupin, Ltd., 676 F.3d 1316 (Fed. Cir. 2012) (FDA approval governs asserted uses in ANDA context)