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equitable reliet of a harsh, or even a mild, character is

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Counsel are equally mistaken in their apparent belief that once infringement is established and adjudicated, injunction must follow. In Hecht Co. V. Bowles, supra, the statute, unlike the one we have here, was seemingly mandatory 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 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.

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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.

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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.

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ORPHAN DESIGNATIONS

PURSUANT TO SECTION 525

F THE

ORPHAN CRIUJE ACT PL. 37-414)

Through June 30, 1984

Docket No. 848-0102

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