Genzyme Therapeutic Products Ltd. Partnership v. Biomarin Pharmaceutical Inc.
825 F.3d 1360
| Fed. Cir. | 2016Background
- Genzyme owned two patents ('410 and '226) claiming biweekly intravenous administration of human acid α‑glucosidase (GAA) to treat Pompe disease (reducing or arresting glycogen accumulation).
- Biomarin petitioned for inter partes review (IPR) asserting obviousness based on combinations of prior art including a Duke press release, Reuser, Barton, van der Ploeg ’88, van Hove, and later-cited in vivo studies (van der Ploeg ’91 and Kikuchi).
- The PTAB instituted review on selected obviousness grounds, conducted a trial where both parties introduced evidence (including debate over use of in vivo studies), and issued final written decisions finding the challenged claims obvious.
- Genzyme appealed, asserting (1) APA/notice violation because the Board relied on references not listed in the institution decisions (in vivo studies), (2) erroneous claim constructions of the ‘‘whereby’’ clause, (3) failure to make an explicit person‑of‑ordinary‑skill finding, and (4) lack of substantial evidence supporting a reasonable expectation of success.
- The Federal Circuit affirmed: it held Genzyme had notice and opportunity to respond to in vivo evidence, the Board’s claim constructions were reasonable (broadest reasonable interpretation), omission of an explicit POSA finding was harmless, and substantial evidence supported obviousness.
Issues
| Issue | Genzyme's Argument | Biomarin's Argument | Held |
|---|---|---|---|
| APA / notice: Board reliance on references not in institution decision (Kikuchi, van der Ploeg '91) | Institution decision must identify all prior-art evidence the Board will rely on; use of in vivo refs denied Genzyme fair notice | New evidence may arise in IPR trial; Genzyme had actual notice and opportunity to respond; Board may cite extra references to show state of the art | Affirmed: no APA violation — Genzyme had notice/opportunity; Board properly used in vivo refs to describe state of the art |
| Claim construction — whether ‘‘whereby’’ clause changed between institution and final decisions | Board changed construction midstream (impermissible) | Board used same construction in institution and final decisions: whereby is result of administering an effective amount | Affirmed: no change in construction; clause treated as result of administration |
| Scope of ‘‘whereby’’ clause — must glycogen reduction be in skeletal muscle? | Whereby should require reduction in skeletal muscle (therapeutically meaningful) | Claims do not specify organ; broadest reasonable interpretation covers reduction anywhere in patient | Affirmed: clause not limited to skeletal muscle; broad reading consistent with specification/prosecution history |
| Failure to make explicit POSA finding | Board erred by not specifying level of ordinary skill | Parties proposed nearly identical POSA definitions; prior art itself reflects appropriate level | Affirmed: no reversible error — proposed POSA definitions converged and outcome unaffected |
| Substantial evidence / reasonable expectation of success | Expert testimony was subjective/hindsight; no reasonable expectation clinical success in humans | Prior art (in vitro and in vivo animal studies), production methods, GAA half‑life, and Gaucher dosing supported expectation of success and routine optimization of dose/schedule | Affirmed: substantial evidence supports reasonable expectation of success and obviousness |
Key Cases Cited
- Dell Inc. v. Acceleron, 818 F.3d 1293 (Fed. Cir.) (APA notice and opportunity principles in PTO adjudications)
- Belden v. Berk‑Tek LLC, 805 F.3d 1064 (Fed. Cir.) (agency may not change theories in midstream; parties may address new evidence in IPR)
- Ariosa Diagnostics v. Verinata Health, Inc., 805 F.3d 1359 (Fed. Cir.) (Board may cite additional prior art to show state of the art)
- In re Cuozzo Speed Techs., LLC, 793 F.3d 1268 (Fed. Cir.) (IPR claim construction uses broadest reasonable interpretation)
- Okajima v. Bourdeau, 261 F.3d 1350 (Fed. Cir.) (failure to state POSA explicitly is not reversible error when prior art reflects appropriate level)
- Boston Carrier, Inc. v. ICC, 746 F.2d 1555 (D.C. Cir.) (agency not required to give exhaustive bill of particulars at institution stage)
- Pub. Serv. Comm’n of Ky. v. FERC, 397 F.3d 1004 (D.C. Cir.) (adequate notice of issues to be considered at hearing is critical to due process)