Nuvo Pharm. (Ireland) Designated Activity Co. v. Dr. Reddy's Labs. Inc.
923 F.3d 1368
Fed. Cir.2019Background
- Dr. Plachetka (assigned to Pozen/Nuvo) patented coordinated-release oral tablets combining an NSAID (naproxen) coated to delay release until gastric pH ≥3.5 and an acid inhibitor (PPI, e.g., esomeprazole/omeprazole) with at least a portion uncoated for immediate release. Claims recite uncoated PPI ‘‘effective to raise gastric pH to at least 3.5.’
- Nuvo markets Vimovo, an embodiment of the patents. Several generics (Dr. Reddy’s, Mylan, Lupin) filed ANDAs seeking to market generic versions; Nuvo sued for infringement. Generics defended on obviousness and §112 (enablement and written description) grounds.
- At bench trial the district court found the asserted claims (’907 and ’285 patents) nonobvious and enabled, and that the specification adequately described the claimed inventions; it granted summary judgment of noninfringement as to one Dr. Reddy’s product (p / t claim construction of “essentially any NSAID”).
- On appeal the Federal Circuit reviewed the written-description issues for clear error and focused primarily on whether the specification adequately describes the claimed therapeutic efficacy of uncoated PPI (i.e., its ability to raise gastric pH to ≥3.5).
- The specification lacked experimental data or a technical explanation showing uncoated PPI actually achieves the claimed pH increase; the prior art taught away from uncoated PPI effectiveness and the inventor admitted only a ‘‘general concept’’ at filing.
- The Federal Circuit concluded the specification does not demonstrate possession of the claimed effective uncoated PPI and invalidated the asserted claims for lack of adequate written description; Nuvo’s cross-appeal re: noninfringement was dismissed as moot.
Issues
| Issue | Nuvo (Plaintiff) Argument | Generics (Defendant) Argument | Held |
|---|---|---|---|
| Whether the specification provides adequate written description for the claimed therapeutic efficacy of uncoated PPI (ability to raise gastric pH ≥3.5). | Claims and spec recite effective amounts; teaching how to make/use the formulations and claim language suffice; efficacy need not be separately proven; inherency supports efficacy. | The spec contains no data, theory, or disclosure showing uncoated PPI is effective; prior art taught away; mere recital of claim terms is insufficient. | Held: Spec fails §112 ¶1 written description. The patentee did not show possession of effective uncoated PPI; claims invalid. |
| Whether teaching how to make/use (enablement) or reciting claim language can substitute for written description of efficacy. | Teaching make/use satisfies the requirement; enablement and written description overlap enough here. | Enablement is distinct from written description; making/using does not prove inventor possessed the claimed efficacy. | Held: Make/use (enablement) is insufficient to satisfy written description where the specification lacks disclosure showing inventor possessed claimed efficacy. |
| Whether the claimed efficacy is inherent in the disclosed formulations (inherency). | The claimed efficacy is necessarily inherent in the disclosed formulation; Allergan and related precedent support inherency without explicit data. | Inherency not established; there is no record evidence that uncoated PPI necessarily raises pH to ≥3.5. | Held: Inherency not established here; doctrine inapplicable. |
| Whether Nuvo’s cross-appeal of district court summary judgment of noninfringement (construction of "essentially any NSAID") remains viable after invalidation. | Nuvo argued the phrase does not bar small amounts of immediately released NSAID and the SJ was improper. | Dr. Reddy’s argued the claim precluded any immediate-release NSAID and SJ was correct. | Held: Moot — cross-appeal dismissed because claims invalidated. |
Key Cases Cited
- Allergan, Inc. v. Sandoz Inc., 796 F.3d 1293 (Fed. Cir.) (inherent properties can support written description when inevitable and undisputed)
- Enzo Biochem, Inc. v. Gen–Probe Inc., 323 F.3d 956 (Fed. Cir.) (mere verbatim repetition of claim language in spec may not satisfy written description)
- Centocor Ortho Biotech, Inc. v. Abbott Labs., 636 F.3d 1341 (Fed. Cir.) (written description requires showing inventor possessed the claimed invention)
- Ariad Pharm., Inc. v. Eli Lilly & Co., 598 F.3d 1336 (Fed. Cir.) (written description distinct purpose; inventor must show possession)
- Univ. of Rochester v. G.D. Searle & Co., 358 F.3d 916 (Fed. Cir.) (written description focuses on scope and possession, not just make-and-use)
- Alcon Research Ltd. v. Barr Laboratories, Inc., 745 F.3d 1180 (Fed. Cir.) (written description satisfied where spec included unexpected results, exemplary formulations, and supporting data)
- Yeda Research & Dev. Co. v. Abbott GmbH & Co. KG, 837 F.3d 1341 (Fed. Cir.) (doctrine of inherent disclosure may satisfy written description in narrow circumstances)
- In re ’318 Patent Infringement Litig., 583 F.3d 1317 (Fed. Cir.) (testing not always required to support therapeutic claims)
- Amgen Inc. v. Sanofi, 872 F.3d 1367 (Fed. Cir.) (written description determinations are highly fact-specific)