Indivior Uk Limited v. Dr. Reddy"s Laboratories S.A.
18f4th1323
| Fed. Cir. | 2021Background:
- Indivior owns U.S. Patent No. 9,687,454 directed to orally dissolvable mucoadhesive films containing buprenorphine and naloxone; the patent claims include polymer weight-percentage limitations added by amendment.
- The patent issued as a continuation of a 2009 application (the '571 application); the central dispute is whether the challenged claims are entitled to the '571 filing date (2009).
- DRL instituted an IPR, arguing the polymer weight-percentage ranges lack written description in the '571 application, which would make U.S. Pub. 2011/0033541 (Myers) prior art that anticipates the claims.
- The PTAB found claims 1–5, 7, and 9–14 unpatentable as anticipated (concluding the '571 lacks written description for the claimed ranges) but found claim 8 (a specific 48.2 wt% polymer limitation) supported by the '571 application.
- The Federal Circuit affirmed: it held there was insufficient written description support in the '571 for the claimed ranges (so those claims are anticipated by Myers) but that substantial evidence supported written description for the single-value claim 8 (so claim 8 is entitled to the earlier date and not anticipated).
- The court applied de novo review to legal questions and substantial-evidence review to PTAB fact findings (written description and anticipation are factual questions).
Issues:
| Issue | Plaintiff's Argument | Defendant's Argument | Held |
|---|---|---|---|
| Whether claimed polymer ranges (e.g., about 40 wt%–60 wt%, 48.2 wt%–58.6 wt%) are supported by the '571 application | Indivior: Tables 1 and 5 plus para. 65 ("at least 25%"/"at least 50%") disclose the aggregate polymer levels that encompass the claimed ranges | DRL: The '571 contains only discrete examples and open language ("any desired level"); no bounded ranges or clear upper endpoints are disclosed; piecing examples together post hoc is improper | Court: Affirmed PTAB. No written description for the claimed ranges; claims not entitled to '571 date and are anticipated by Myers |
| Whether a specific polymer amount (about 48.2 wt%) in claim 8 is supported by the '571 application | Indivior: Tables 1 and 5 disclose formulations whose polymer components sum to 48.2 wt%, so a skilled artisan could derive the value | DRL: The specific total polymer wt% is not expressly stated; tables do not state total polymer weight and derivation is not immediate | Court: Affirmed PTAB. Substantial evidence supports written description for claim 8 (specific value derivable from disclosed embodiments); claim 8 entitled to '571 date and not anticipated |
Key Cases Cited
- Ariad Pharms., Inc. v. Eli Lilly & Co., 598 F.3d 1336 (Fed. Cir. 2010) (written-description test: specification must reasonably convey possession of claimed subject matter; written-description is a question of fact)
- In re Wertheim, 541 F.2d 257 (C.C.P.A. 1976) (range disclosure decisions are fact-specific; no universal rule for ranges)
- Nalpropion Pharms., Inc. v. Actavis Labs. FL, Inc., 934 F.3d 1344 (Fed. Cir. 2019) (discrete examples in tables can provide written-description support for claimed ranges)
- In re Rambus, Inc., 753 F.3d 1253 (Fed. Cir. 2014) (anticipation is a question of fact)
- In re Gartside, 203 F.3d 1305 (Fed. Cir. 2000) (substantial-evidence standard applies to PTAB factual findings)
- In re Elsner, 381 F.3d 1125 (Fed. Cir. 2004) (legal determinations reviewed de novo)
- Brenner v. Manson, 383 U.S. 519 (1966) (patent is not a hunting license; applicant must show possession of the invention)
- Consol. Edison Co. v. NLRB, 305 U.S. 197 (1940) (definition of substantial evidence standard)