Bristol-Myers Co. v. U.S. Intern. Trade Com'n
| Decision Date | 08 December 1989 |
| Docket Number | BRISTOL-MYERS,No. 89-1530,89-1530 |
| Parties | , 15 U.S.P.Q.2d 1258, 8 Fed. Cir. (T) 187 NOTICE: Federal Circuit Local Rule 47.8(b) states that opinions and orders which are designated as not citable as precedent shall not be employed or cited as precedent. This does not preclude assertion of issues of claim preclusion, issue preclusion, judicial estoppel, law of the case or the like based on a decision of the Court rendered in a nonprecedential opinion or order. COMPANY, Appellant, v. UNITED STATES INTERNATIONAL TRADE COMMISSION, Appellee, and Gema, S.A., Kalipharma, Inc., Purepac Pharmaceutical Co., Istituto Biochimico Italiano Industria Giovanni Lorenzini, Institut Biochimique, S.A., and Biocraft Laboratories, Inc., Intervenors-Appellees. |
| Court | U.S. Court of Appeals — Federal Circuit |
Before RICH, Circuit Judge, COWEN, Senior Circuit Judge, and PAULINE NEWMAN, Circuit Judge.
Bristol-Myers Company appeals the final determination of the United States International Trade Commission in Investigation No. 337-TA-293, In re Certain Crystalline Cefadroxil Monohydrate, issued June 13, 1989, denying Bristol-Myers' request for temporary relief under 19 U.S.C. § 1337(e) (1988). We reverse.
OPINIONBristol-Myers alleged unfair acts in violation of 19 U.S.C. § 1337 (1988), based on infringement of United States Patent No. 4,504,657 by certain crystalline cefadroxil monohydrate imported into the United States, and requested that the accused goods be excluded pendente lite, as authorized by 19 U.S.C. § 1337(e)(3) (1988). Recently enacted 19 U.S.C. § 1337(e)(3) (1988) codified the Commission's authority with respect to preliminary relief:
The Commission may grant preliminary relief under this subsection or subsection (f) to the same extent as preliminary injunctions and temporary restraining orders may be granted under the Federal Rules of Civil Procedure.
On appellate review we apply the same standard as is applied to similar rulings of district courts, with appropriate deference to factual findings of the Commission. We determine whether the Commission, in its grant or denial of preliminary relief, abused its discretion, committed an error of law, or seriously misjudged the evidence. See H.H. Robertson, Co. v. United Steel Deck, Inc., 820 F.2d 384, 387, 2 USPQ2d 1926, 1927 (Fed.Cir.1987); Smith Int'l, Inc. v. Hughes Tool Co., 718 F.2d 1573, 1579, 219 USPQ 686, 691 (Fed.Cir.), cert. denied, 464 U.S. 996 (1983). Questions of law are reviewed for correctness. Surface Technology, Inc. v. United States Int'l Trade Comm'n, 801 F.2d 1336, 1340 n. 7, 231 USPQ 192, 195 n. 7 (Fed.Cir.1986). Factual findings, including factual underpinnings of legal conclusions, are reviewed to determine whether they are supported by substantial evidence. Tandon Corp. v. United States Int'l Trade Comm'n, 831 F.2d 1017, 1019, 4 USPQ2d 1283, 1284-85 (Fed.Cir.1987). See 5 U.S.C. § 706(2)(E) (1988).
The disputed product is a certain crystal form of cefadroxil monohydrate. Cefadroxil is an antibiotic of the cephalosporin family, and is in wide use due to its effectiveness against bacteria that are resistant to penicillin.
Cefadroxil was discovered by Leonard Crast, and is described and claimed in United States Patent No. 3,489,752, issued on January 13, 1970 and assigned to Bristol-Myers Company (Crast I). In Crast I the cefadroxil product is not described in any particular crystal form or degree of hydration. Its superior antibiotic properties were recognized, but the product was unsuitable for clinical studies because it could not be obtained in sufficiently pure form.
After further research, Crast and a co-worker Gottstein in 1972 produced a dimethylformamide (DMF) solvate that was a relatively pure form of the antibiotic, but was still unsuitable for human use because of toxicity of the DMF. Crast and Gottstein developed a process for removing the DMF, called the "slurrying" process, yielding a crystalline cefadroxil monohydrate that was sufficiently pure for clinical use. This crystalline monohydrate and the slurrying process are disclosed in United States Patent No. 3,985,741, issued on October 12, 1976 ("Crast II"), although the crystal form is not claimed. The product is called "the Gottstein monohydrate" in this action.
Bristol-Myers chemists Bouzard and Weber, assigned the task of developing a commercial process, developed a different process for removing the DMF from the DMF solvate, using acetonitrile and water. This process produced a further, different crystalline form of cefadroxil monohydrate, called "the old monohydrate" in this action. Subsequently Bouzard discovered that by changing the solvent system he could produce a crystalline trihydrate. The trihydrate was selected for pilot plant production, and Bristol-Myers proceeded with production and clinical trials.
Some ten months thereafter, in the course of certain aqueous stability tests of the cefadroxil trihydrate, Bouzard observed the appearance of yet another crystalline form of cefadroxil. This form is called the "new" or "Bouzard monohydrate" in this action. Since that time, Bristol-Myers has been unable to reproduce the trihydrate form. The Bouzard monohydrate and the process for preparing it are disclosed in United States Patent No. 4,504,657, issued March 12, 1985, assigned to Bristol-Myers (the '657 patent as a specific crystalline cefadroxil monohydrate, identified by its X-ray powder diffraction pattern, an accepted "fingerprint" for crystal structure.
The Bouzard monohydrate is described as an improvement over other forms of cefadroxil due to its stability, and its higher bulk density which enables production of smaller pills. The Chief Administrative Law Judge ("ALJ") found that its doses have longer effectiveness than other forms; a finding that the Commission adopted but now criticizes in its brief.
The six intervenors, all manufacturers or importers and distributors of cefadroxil in the patented crystalline form, participated in this appeal, as in the action before the Commission.
On the expedited schedule contemplated in 19 U.S.C. § 1337(e)(2) (1988), the ALJ held an evidentiary hearing on the requested temporary exclusion. We shall discuss the principal issues considered in denial of preliminary relief.
The ALJ found that the Bouzard monohydrate was not anticipated by the disclosure in Garbrecht United States Patent No. 3,781,282, issued December 25, 1973, assigned to Eli Lilly & Co. The intervenors argue that the ALJ erred.
Garbrecht describes a process for producing cephalosporin hydrates, and states in Example 7 that the cephalosporin process can be performed using different starting materials to prepare a cefadroxil product. Garbrecht does not show any specific crystalline or hydrated form of cefadroxil. There was significant agreement that Example 7 as written does not produce any crystalline monohydrate product whatsoever. At oral argument Bristol-Myers said it produces "gunk". It was vigorously disputed as to what crystal forms of cefadroxil could be or would be produced by modification of Garbrecht Example 7.
Anticipation is a factual determination and, like other Commission findings of evidentiary fact, is reviewed on the substantial evidence standard. Tandon, 831 F.2d at 1019, 4 USPQ2d at 1284-85. We have reviewed the arguments of all sides in light of the record, and conclude that substantial evidence supports the ALJ's ruling that the Bouzard monohydrate was not anticipated in the Garbrecht reference. See Richardson v. Suzuki Motor Co. 868 F.2d 1226, 1236, 9 USPQ2d 1913, 1920 (Fed.Cir.), cert. denied, 110 S.Ct. 154 (1989) ().
The parties adduced evidence as to various modifications of Example 7. This evidence was treated by the ALJ as pertinent to section 103, not section 102. These arguments are pressed by the intervenors as related to inherency as well as to obviousness. The argument of inherency is negated by the ALJ's finding that various crystal forms were obtained, depending on the process modifications made. Substantial evidence supports the ALJ's finding that the Bouzard monohydrate is not inherently formed in the Garbrecht or Crast processes. We apply the principle stated in In re Chapman, 357 F.2d 418, 422, 148 USPQ 711, 714 (CCPA 1966):
Nor can we agree that appellant's compositions are unpatentable because such a process "would inherently yield" a product substantially the same as that claimed, since that position implies that any and all products of obvious processes are unpatentable by reason of their being "inherent" results of those processes. The issue is simply obviousness of a composition of matter[.]
The Commission held that there was not substantial likelihood that the validity of the Bouzard patent would be sustained under 35 U.S.C. § 103. For purposes of this appeal, Bristol-Myers states that it accepts the ALJ's factual findings that the process steps necessary to make the Bouzard monohydrate were within the skill of the art. We take this as acceptance, for purposes of this appeal, of the ALJ's pertinent findings as to the Graham factors [ Graham v. John Deere Co., 383 U.S 1, 17-18, 148 USPQ 459, 467 (1966) ]: the scope and content of the prior art, the differences between the claimed invention and the prior art, the level of ordinary skill, and secondary considerations. We thus review the Commission's conclusion of obviousness for correctness as a matter of law, Surface Technology, 801 F.2d at 1341, 231 USPQ at 196, although we observe that all sides continue to debate the factual premises as well as their significance.
In determining the obviousness vel non of a new chemical structure, consideration is given, as appropriate on the particular facts, to the motivation or suggestion in the prior art to produce...
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Biocraft Laboratories, Inc. v. U.S. Intern. Trade Com'n
...of the '657 patent was likely to be sustained and reversed the Commission's determination. Bristol-Myers Co. v. United States Int'l Trade Comm'n, 892 F.2d 1050, 15 USPQ2d 1258 (Fed.Cir.1989) (the Commission exceeded its discretionary authority, committed an error of law, and seriously misju......