946 F.3d 1322
Fed. Cir.2020Background:
- Hospira owns patents covering a ready-to-use dexmedetomidine formulation (Precedex Premix). Fresenius filed an ANDA to market a generic ready-to-use 4 µg/mL product; Hospira sued for infringement; Fresenius stipulated to infringement of claim 6 and defended on invalidity (obviousness).
- Claim 6 depends from claim 1 and recites a ready-to-use 4 µg/mL dexmedetomidine HCl formulation disposed in a sealed glass container that exhibits no more than about 2% loss in concentration after five months.
- Prior art included Precedex Concentrate (100 µg/mL) and a veterinary ready-to-use product (Dexdomitor), both evidencing dexmedetomidine formulations and storage in glass vials.
- At bench trial Fresenius presented stability data from more than 20 tested samples of the 4 µg/mL formulation (from Hospira’s NDA and Fresenius’s ANDA), all meeting the “about 2%” five‑month loss limitation; experts testified dexmedetomidine is chemically stable and concentration does not materially affect that stability.
- Hospira argued the tested samples post‑date the patent and were made using the patent’s Example 5 manufacturing process (nitrogen sparging, low oxygen headspace), so those data cannot show inherency in the prior art; district court rejected that and found the "about 2%" limitation inherent and claim 6 obvious; the Federal Circuit affirmed.
Issues:
| Issue | Hospira's Argument | Fresenius' Argument | Held |
|---|---|---|---|
| Whether non‑prior‑art (post‑priority) data may be used to prove a limitation is inherent in the prior art | District court improperly relied on post‑priority samples (from Hospira NDA and Fresenius ANDA) to prove inherency | Extrinsic non‑prior‑art data (including patentee’s own data) may be used to demonstrate what prior art necessarily taught | Allowed use of non‑prior‑art data; district court did not err in relying on those samples |
| Whether unclaimed manufacturing variables in the patent’s Example 5 preclude an inherency finding | Example 5 processing (e.g., nitrogen sparging) may account for observed stability, so data aren’t representative of prior‑art embodiments | Claim 6 is a composition claim (not product‑by‑process); manufacturing steps can’t be imported into the claim to avoid inherency | Court refused to import Example 5 process limitations; manufacturing variables do not bar inherency finding |
| Standard for proving inherency — did the court erroneously apply “reasonable expectation of success” instead of “necessarily present”? | District court applied lower reasonable‑expectation standard when assessing inherency | District court separately found the limitation necessarily present and then (unnecessarily) addressed reasonable expectation of success | Court: trial court conflated standards but error was harmless; inherency was established on the correct factual record |
| Whether the factual findings support a legal conclusion of obviousness | Hospira contends findings were clearly erroneous and insufficient to prove obviousness | Fresenius points to >20 samples meeting the limit and expert testimony on molecule stability; prior art taught the 4 µg/mL embodiment | Findings not clearly erroneous; inclusion of an inherent property does not avoid obviousness — claim 6 obvious and invalid |
Key Cases Cited
- In re Cuozzo Speed Techs., 793 F.3d 1268 (Fed. Cir. 2015) (to invalidate a claim covering multiple alternative embodiments, proving one embodiment invalid suffices)
- Monsanto Tech. LLC v. E.I. DuPont de Nemours & Co., 878 F.3d 1336 (Fed. Cir. 2018) (non‑prior‑art data may support an inherency finding)
- Schering Corp. v. Geneva Pharm., Inc., 339 F.3d 1373 (Fed. Cir. 2003) (prior art need not recognize a property for it to be inherent)
- Alcon Research Ltd. v. Apotex Inc., 687 F.3d 1362 (Fed. Cir. 2012) (patentee’s disclosure can establish inherency)
- Amgen Inc. v. F. Hoffman‑La Roche, Ltd., 580 F.3d 1340 (Fed. Cir. 2009) (obviousness requires a skilled artisan have a reasonable expectation of success)
- Atlas Powder Co. v. Ireco Inc., 190 F.3d 1342 (Fed. Cir. 1999) (discovery of an unappreciated property of prior art does not make the old composition patentable)
- In re Kubin, 561 F.3d 1351 (Fed. Cir. 2009) (a limitation shown by the specification to be necessarily present adds no patentable weight)
- Par Pharm. v. TWI Pharm., Inc., 773 F.3d 1186 (Fed. Cir. 2014) (inherency is a question of fact; limitation must necessarily be present as the natural result of the prior art)
- Anderson v. Bessemer City, 470 U.S. 564 (U.S. 1985) (standard for reviewing factual findings: clear‑error review)