Jazz Pharmaceuticals, Inc. v. Amneal Pharmaceuticals, LLC
895 F.3d 1347
| Fed. Cir. | 2018Background
- Jazz Pharmaceuticals owns a family of patents claiming a computerized, centralized system for distributing and tracking prescriptions of a "sensitive drug" (e.g., Xyrem/GHB), including an "exclusive central database," "information identifying" patients/physicians, and "periodic reports."
- Amneal (with Par) filed multiple IPR petitions challenging claims of seven Jazz patents; the PTAB instituted review on subsets of claims/grounds and issued six final written decisions finding the instituted claims obvious.
- The PTAB relied principally on four "ACA materials" (FDA advisory-committee-related transcript/slides, a preliminary FDA safety review, a sponsor briefing booklet, and a video/transcript about a proposed distribution system) that had been posted on an FDA website linked from a Federal Register notice before the patents’ critical date.
- Jazz mainly challenged the PTAB’s factual finding that the ACA materials were "publicly accessible" printed publications under pre-AIA 35 U.S.C. § 102(b), and also disputed two claim constructions ("periodic reports" and "information identifying") and the PTAB’s obviousness conclusions.
- The Federal Circuit affirmed: it held there was substantial evidence the ACA materials were publicly accessible (disseminated via Federal Register + public FDA website, available for months, aimed at interested persons with no confidentiality expectation), affirmed the PTAB’s claim constructions, and affirmed obviousness (including combining the ACA materials with Korfhage to distribute the database across multiple computers).
Issues
| Issue | Jazz's Argument | Amneal's Argument | Held |
|---|---|---|---|
| Were the ACA materials "printed publications" (publicly accessible) under § 102(b)? | The PTAB conflated constructive notice from the Federal Register with public accessibility; indexing/searchability was required and not shown. | ACA materials were widely disseminated via a Federal Register notice linking to a public FDA website, available well before the critical date and aimed at those of ordinary skill; no confidentiality expectation. | Affirmed: substantial evidence supports public accessibility (Federal Register notice + public website; broad dissemination, duration, and lack of confidentiality). |
| Proper construction of "periodic reports" | "Periodic" means only at regular, fixed intervals; PTAB’s broader construction renders term meaningless. | "Periodic" can include repeated or intermittent reports (regular or irregular); specification and prosecution history support broader meaning. | Affirmed PTAB: "periodic reports" includes reports generated at regular or irregular intervals. |
| Proper construction of "information identifying" (patients/physicians) | Specification lists identifying data; claim should require that minimum set (i.e., "contains/includes" implies particular information). | Claim language is broader and does not require all listed types; specification lists examples not limits. | Affirmed PTAB: term not limited to the exact items listed; does not require all listed types. |
| Obviousness of claims reciting a database "distributed over multiple computers" (claims 2,10 of ’988; 24,26,27 of ’963) | PTAB lacked substantial evidence of a motivation to combine ACA materials with Korfhage; KSR requires specific findings about a problem and finite predictable solutions. | Distributed databases were well-known; motivations (cost, efficiency, anticipated volume) and expert testimony supported predictable combination under KSR. | Affirmed PTAB: motivation to combine supported; implementing distributed databases was a predictable use of known systems—KSR not read to impose rigid formula. |
Key Cases Cited
- SAS Inst., Inc. v. Iancu, 138 S. Ct. 1348 (2018) (agency must decide all challenged claims when instituting IPR; relevant to partial-institution jurisdictional context)
- KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398 (2007) (obviousness: flexible approach; predictable use and common-sense motivations relevant but no rigid rule)
- Teva Pharm. USA, Inc. v. Sandoz, Inc., 135 S. Ct. 831 (2015) (claim construction: factual findings reviewed for substantial evidence; de novo review of intrinsic-evidence constructions)
- In re Gartside, 203 F.3d 1305 (Fed. Cir. 2000) (standards for substantial-evidence review of PTAB factual findings)
- In re Klopfenstein, 380 F.3d 1345 (Fed. Cir. 2004) (printed-publication/public accessibility is a fact-specific inquiry; factors include dissemination, audience, duration, confidentiality)
- Medtronic, Inc. v. Barry, 394 F.3d 1368 (Fed. Cir. 2018) (distribution at meetings and public availability bear on printed-publication analysis; indexing/searchability not always required)