Braintree Laboratories, Inc. v. Breckenridge Pharmaceutical, Inc.
688 F. App'x 905
| Fed. Cir. | 2017Background
- The ’149 patent covers aqueous hypertonic sulfate compositions and methods for inducing colonic purgation (used for colonoscopy prep). Claim 15 recites a composition "from about 100 ml to about 500 ml" that induces purgation.
- Braintree markets SUPREP (two 6-oz bottles; each diluted to 16 oz / 473 mL); brand label directs two bottles (total 946 mL) for colon cleansing.
- Breckenridge filed an ANDA to market a generic SUPREP and received a Paragraph IV notice; Braintree sued for infringement of composition claims 15 and 18 and method claims 19, 20, and 23.
- This Court previously construed “purgation” in Braintree v. Novel Labs to mean an evacuation of a copious amount of stool (less than full cleansing) and indicated a single 473 mL bottle could satisfy the volume + purgation limitations. Breckenridge stipulated that Novel’s construction of "purgation" applies here but reserved the volume-term dispute.
- The district court construed “from about 100 ml to about 500 ml” to mean the entire volume administered over the treatment period (i.e., 946 mL falls outside the range) and granted summary judgment of noninfringement, also finding Breckenridge’s ANDA label would not induce infringement under 35 U.S.C. § 271(e).
- The Federal Circuit reversed and remanded, holding Novel’s construction binds Breckenridge and that Breckenridge’s ANDA label can induce infringement because inducing purgation is within the FDA‑approved indication (colon cleansing) and is not a separate, unapproved use.
Issues
| Issue | Braintree's Argument | Breckenridge's Argument | Held |
|---|---|---|---|
| Proper construction of "from about 100 ml to about 500 ml" | It refers to the volume of the composition that induces purgation (e.g., a single 473 mL bottle). | It refers to the total volume administered over the treatment period (so 946 mL is outside the range). | Court treats Novel as binding: volume is the amount necessary to induce purgation (single bottle can meet the limitation). |
| Preclusive effect of Novel decision | Novel's construction of "purgation" and the linked volume term controls here (Breckenridge stipulated to Novel's purgation construction). | Novel did not address the specific volume term for Breckenridge; thus it is not preclusive. | Breckenridge’s stipulation binds it to Novel; Novel foreclosed the district court's contrary construction. |
| Inducement under 35 U.S.C. § 271(e) given ANDA label | The ANDA label (approved indication: colon cleansing) instructs use that induces purgation; thus it can induce infringement. | Because the claimed "inducing purgation" is not an FDA‑approved separate use, the ANDA label cannot induce infringement. | Inducing purgation is part of the approved colon‑cleansing indication; the label recommends that use, so inducement can lie. |
| Claim 23 dosing limitation ("administered in two or more doses") | Stipulated: If noninfringement motion fails, Breckenridge admits infringement of claims including 23. | District court read the limitation to require the total claimed volume (100–500 mL) to be divided among doses and thus found noninfringement. | Court declines district court’s contrary reading and notes the district decision conflicts with the parties’ stipulation; judgment for Braintree ordered on remand. |
Key Cases Cited
- Braintree Labs., Inc. v. Novel Labs., 749 F.3d 1349 (Fed. Cir.) (construed "purgation" as evacuation of a copious amount of stool; held a half‑dose bottle could meet the claim)
- Warner‑Lambert Co. v. Apotex Corp., 316 F.3d 1348 (Fed. Cir.) (ANDA label cannot induce infringement of a different, unapproved disease indication)
- Allergan, Inc. v. Alcon Labs., 324 F.3d 1322 (Fed. Cir.) (ANDA approval for one indication does not authorize inducement liability for separate unapproved method claims)
- Bayer Schering Pharma AG v. Lupin, Ltd., 676 F.3d 1316 (Fed. Cir.) (discusses when label language supplies intent to induce and limits of inducement for unapproved effects)
- AstraZeneca LP v. Apotex, Inc., 633 F.3d 1042 (Fed. Cir.) (label instructions can show affirmative intent to induce infringement)
- Blonder‑Tongue Labs., Inc. v. Univ. of Ill. Found., 402 U.S. 313 (U.S.) (due process limits preclusion of parties who were not in prior litigation)