Purdue Pharma, L.P. v. Recro Technology LLC
694 F. App'x 794
| Fed. Cir. | 2017Background
- Purdue Pharma L.P. appeals a Board decision in an interference proceeding regarding its ’263 and ’968 applications for hydrocodone controlled-release formulations.
- The Board concluded Purdue’s claims lack written description support under 35 U.S.C. § 112 and granted Recro Technology, LLC’s motion for judgment that the claims are unpatentable.
- The claimed dosage forms mix two multiparticulates: controlled-release (CR) and immediate-release (IR) beads, each with hydrocodone coated on inert beads, plus specified in vitro and in vivo properties.
- The dispute centers whether the specifications disclose separate IR and CR multiparticulates combined in a single dosage form.
- The Board found the spec describes IR be added by overcoating CR beads or coating the capsule, but not inert beads coated with only an IR formulation.
- The Federal Circuit affirms the Board, holding the written description requirement is not satisfied for the asserted separate IR/CR bead populations in a single dosage form.
Issues
| Issue | Plaintiff's Argument | Defendant's Argument | Held |
|---|---|---|---|
| Written description for separate IR and CR multiparticulates in one dosage form | Purdue contends the spec discloses IR-coated substrates and methods | Recro argues the disclosures describe overcoating CR with IR, not two separate bead populations | Board’s finding supported; not disclosed |
Key Cases Cited
- Ariad Pharm., Inc. v. Eli Lilly & Co., 598 F.3d 1336 (Fed. Cir. 2010) (test for written description based on possession as of filing)
- Inphi Corp. v. Netlist, Inc., 805 F.3d 1350 (Fed. Cir. 2015) (review of factual findings with substantial evidence standard)
- Novozymes A/S v. DuPont Nutrition Biosciences APS, 723 F.3d 1336 (Fed. Cir. 2013) (written description requires integrated view of the claim, not just obviousness)