BRISTOL-MYERS' CEFADROXIL IMPORT EXCLUSION REQUEST DENIED

BRISTOL-MYERS' CEFADROXIL IMPORT EXCLUSION REQUEST DENIED -- for a second time -- in a Dec. 18 advisory opinion from International Trade Commission Administrative Law Judge Janet Saxon. The opinion contradicts a Dec. 8 Washington, D.C. federal appeals court ruling that Bristol-Myers Squibb's cefadroxil monohydrate patent "is likely to be sustained" ("The Pink Sheet" Dec. 18, T&G-4). Saxon's ruling, however, supports her earlier decision, on June 13, that Bristol's request for a ban on the import of generic cefadroxil should not be granted on the grounds that the patent is likely to be held invalid. * Saxon found that Bristol's Bouzard crystalline cefadroxil monohydrate patent would have been "obvious" to a bench chemist of "ordinary skill." The '657 patent was filed March 16, 1982. The ITC judge wrote that a skilled chemist, motivated to create commercially viable, pure and high-yielding product, could have through experimentation arrived at the Bouzard product. She stated that a chemist could have produced the Bouzard monohydrate by modifying two different Bristol patents: the Garbrecht patent ('282) which discloses a process for making purified cephalosporins and the expired Crast patent ('741), which covered cefadroxil in any form. Saxon also concluded that "indirect evidence" supporting the validity of the narrower Bouzard patent, i.e. commercial success of Bristol's Duracef antibiotic and the failure of others to make the product, is "inadequate to overcome the substantial direct evidence that the product claimed would have been obvious." Biocraft and Purepac were co-respondents in the ITC investigation; Zenith also has an approved ANDA for the product but has delayed marketing until disposition of the case. The administrative law judge's opinion will be forwarded to the full ITC commission, which must decide by March 15 whether cefadroxil importation should be banned. Because Purepac and Biocraft are currently marketing the product, an adverse decision will expose them to a claim for damages by Bristol-Myers Squibb. Any decision made by the full commission is subject to appeal in the federal circuit court. In a Dec. 18 press release, Biocraft commented that it is "gratified with the result" and "will continue to market" generic cefadroxil. Court documents show that Biocraft had accrued gross sales of $6.7 mil. for generic cefadroxil from the beginning of March through mid-April. A Bristol-Myers Squibb spokesperson said Dec. 18 that the company was "surprised" that Saxon ignored the appellate ruling that the patent is valid.