where the plaintift is using the right asserted contrary to the public interest," Horton Salt Co. v. Suppiger Co., 314 U.S. 42S, 492 (1941), reh'g denied, 315 U.S. 826 (1942). Since "the standards of the public interest, not the requirements of private litigation, measure the propriety and need for injunctive relief for injunctive relief in these cases," Hecht Co. v. Bowles, 321 U.S. 321, 331 (1944), rev'g Brown v. Hecht Co., 137 F.2d 689 (D.C. Cir. 1943), we remand this case to the district court for further proceedings to consider what this interest is and what measures it calls

for.

There are other aspects here that might make a tribunal reluctant to select, within the scope of its discretion, relief along the harsher side of the possible scale. The case clearly was regarded by both sides as a test. The good faith with which Bolar acted is undisputed, at least before us. Bolar says it did nothing

clandestine, but notified Koche what it was going to do at all times before doing it, so Roche could act promptly to defend what it believed to be its rights. The case may be unlike Pfizer, Inc., supra, in that Bolar scrupulously obeyed all court orders while they were in effect, or So it says, whereas in Pfizer, Inc., the infringer acted in defiance of court decrees. Pfizer, Inc., was ordered

The destruction of material in

after everything milder had

proved useless. If other measures can be made sufficient, one might well be reluctant to order destruction of the - records of research and tests that may embody information that would contribute to the health and happiness of the human race. All this is, of course, for the district judge to consider so far as he finds the factual predi

cates established.

The actual infringing acts are said to have all occurred in the relatively brief period between vacation of the lower court's restraining order and the expiration of the patent. Counsel for Roche was candid in explaining that he pushed so hard for the harsh relief he did because he thought any money damages would have to be nominal. The correctness of this belief has not been briefed or argued, and we hesitate to state a firm position, but tentatively, at least, we are skeptical. It is clear that the

economic injury to Roche is, or is threatened to be, substantial, even though the amount of material used in the tests was small. If the patent law precludes substantial damages, there exists a strange gap in the panoply (in its proper meaning, a suit of armor) of protection the patent statutes place around an aggrieved and injured patentee. The district judge, before getting into the issue of equitable relief, must determine if he can deal with the case by adequate money damages. If he can, the predicate for

equitable relietot a harsh, or even a mild, character is

Counsel are equally mistaken in their apparent belief that once infringement is established and adjudicated, an injunction must follow. In Hecht Co. V. Bowles, supra,

the statute, unlike the one we have here, was seemingly mandatety by its language that once a violation was shown, an injunction must follow, and the D. C. Circuit had SO held. But the circumstances made an injunction somewhat repugnant. Hecht Co., an an unquestionably legitimate and long-established District of Columbia retailer, had got tangled up in the price control regulations of World War 11, and its employees had in good faith unwittingly committed some violations. The situation was ironic in that the Hecht Co. had been a leader in extending the patriotic cooperation of the retail trade in application of the unpopular but necessary retail price controls, and had itself offered its own operation for study as illustrating the problems and how they could be solved..

After discovering some loopholes in the statute, in light of the legislative history, Justice Douglas continued at 329:

We

are dealing here with the requirements of equity practice with a background of several hundred years of history. Only the other day we stated that "An appeal to the equity jurisdiction conferred on federal district courts is an appeal to the sound discre

tion which guides the determinations of courts of equity." Meredith v. Winter Haven, 320 U.S. 228, 235. The historic injunctive process was designed to deter, not to punish. The essence of equity jurisdiction has been the power of the Chancellor to do equity and to mould each decree to the necessities of the particular case. Flexibility rather than rigidity has distinguished it. The qualities of mercy and practicality have made equity the instrument for nice adjustment and reconciliation between the public interest and private needs as well as between competing private claims. We do not believe that such a major departure from that long tradition as is here proposed should be lightly implied.

While two justices declined to join in the opinion, none expressed themselves in favor of affirming the D. C. Circuit. In short, if Congress wants the federal courts to issue injunctions without regard to historic equity principles, it is going to have to say so in explicit and even shameless language rarely if ever to be expected from a body itself made up very largely of American lawyers, haying, probably, as much respect for traditional equity principles as do the courts. If an injunction was not mandatory in Hecht Co. v. Bowles, the more permissive statutory language here makes it a fortiori that an injunction is not mandatory now.

The application of historic equity principles to the case at bar is in the first instance for the district

court.

V

Conclusion

The decision of the district court holding the '053 patent not infringed is reversed. The case is remanded with instructions to fashion an appropriate remedy. Each party to bear its own costs.

This is in response to a recent request by Mr. Dave Beier of your Subcommittee staff for information on orphan drugs and approved generic antibiotics.

Since 1962 approximately 350 generic antibiotic applications have been approved. Of those 350 approved applications, 150 have been approved with more than one strength.

With respect to orphan drugs, I am pleased to provide the following information:

- 33 requests for orphan drug designations have been received
since October 1983;

- 16 of the designations have been approved (see enclosed list);

- 15 new drug applications (NDA's) for orphan drugs have been
received since January 1983;

- 7 NDA's for orphan drugs have been approved for the following
conditions:

1. Chronic urea-splitting urinary infections.

2. Dissolution of radiolucent gallstones in poor surgical
risk patients.

3. Testicular cancer.