Mitsubishi Chemical Corp. v. Barr Laboratories, Inc.
435 F. App'x 927
Fed. Cir.2011Background
- Barr infringed four claims of the ’052 patent by selling Barr’s argatroban formulation; Mitsubishi owns the patent related to argatroban solubility in ethanol–water–saccharide systems; Argatroban is a zwitterion with低 solubility at neutral pH; Yamamoto (1986) publication is the only non-English reference at issue; district court concluded Yamamoto does not anticipate the claims and that the ’052 claims are not obvious over the cited references; the court construed claim 3 as a pharmaceutical composition for injection and held Yamamoto’s disclosure too acidic for injectable use; on appeal, Barr challenges translation of Yamamoto and the anticipation/obviousness conclusions; the district court’s factual determinations about translation credibility are reviewed for clear error; the district court enabled claims 3–4 as a medicinal composition in a pharmaceutically acceptable carrier.
Issues
| Issue | Plaintiff's Argument | Defendant's Argument | Held |
|---|---|---|---|
| Whether Yamamoto anticipates claims 1–2. | Yamamoto, as translated by Cross, teaches dissolution with hydrochloric acid plus later ethanol/sorbitol. | Cross translation is unreliable; Yamamoto does not disclose the exact solvent system. | No anticipation under either construction. |
| Whether Yamamoto anticipates claims 3–4 as a pharmaceutical composition for injection. | Yamamoto discloses argatroban in a solvent system that can be used as an injectable composition. | Yamamoto’s solution is too acidic (pH 1.5–1.7) to be a pharmaceutically acceptable injectable composition. | Yamamoto does not anticipate claims 3–4; the correct construction limits to pharmaceutically acceptable injections. |
| Whether the Yamamoto translation is properly credited and whether Cross’s translation should be adopted. | Cross’s translation is corroborated and reflects standard Japanese syntax. | Other translations are equally credible; Cross litigation-specific translation should be disregarded. | District court’s translation choice affirmed; not clearly erroneous. |
| Whether the ’052 claims are enabled and properly construed to require a medicinal composition. | Spec discloses preparation of argatroban in ethanol–water with saccharide; claims cover such compositions. | Barr’s broader reading would encompass non-medicinal compositions. | Claims 3–4 are enabled and properly limited to pharmaceutically acceptable compositions. |
| Whether the claims are obvious over prior art. | Prior art does not render ethanol–water–saccharide solvent system obvious for argatroban. | Combination of references teaches the co-solvent system for solubility. | Not obvious; district court upheld nonobviousness. |
Key Cases Cited
- Hodosh v. Block Drug Co., Inc., 786 F.2d 1136 (Fed. Cir. 1986) (fact-finder’s translation credibility is a factual issue)
- Gray v. Noholoa, 214 U.S. 108 (1909) (pure questions of fact in translation credibility)
- In re Turlay, 304 F.2d 893 (CCPA 1962) (anticipation requires a clear and unambiguous teaching)
- In re Krimmel, 292 F.2d 948 (CCPA 1961) (district court’s permissible interpretation of claims)
- Forest Labs., Inc. v. Abbott Labs., 239 F.3d 1305 (Fed. Cir. 2001) (pharmaceutical composition definition and carriers)
- Schering Corp. v. Geneva Pharm., 339 F.3d 1373 (Fed. Cir. 2003) (pharmaceutical composition components and carriers)
- In re Gardner, 427 F.2d 786 (CCPA 1970) (pharmaceutical composition concept)
- Am. Med. Sys., Inc. v. Biolitec, Inc., 618 F.3d 1354 (Fed. Cir. 2010) (preparation context for preambles and claims)
- Honeywell Int’l, Inc. v. Hamilton Sundstrand Corp., 523 F.3d 1304 (Fed. Cir. 2008) (standard for appellate review of credibility determinations)