manufacture or sale was deemed not to be an infringing use. Again, in Chesterfield v. United States, 159 F. Supp. 371 (Ct. C1. 1958), no infringement was found where the federal government conducted tests and experiments. Citing Bosnack Mack Co. v. Underwood, 73 F. 206 (C.C. 1896), the Court of Claims stated flatly, "Experimental use does not infringe." 159 F. Supp. at 375. Bolar's FDA-mandated testing clearly falls in line with the sort of commercial experiments without profit, manufacture, or sale during the patent term that the Court of Appeals holds is non-infringing.

To find infringing use there must be a benefit at the expense of the patent. In Kaz Manufacturing Co., Inc. v. Chesebrough-Pond's, Inc., 211 F. Supp. 815 (S.D.N.Y. 1962), aff'd 317 F.2d 679 (2d Cir. 1963), the court declared use to be "the commercially valuable use of which patentee could or would avail himself." The court held that as long as defendant was not helping himself to a benefit oletype secured by the patent, there was no infringement. Similarly, post-expiration advantage would not be a value secured by the patent. Furthermore, Bolar's activity cannot be connected with any benefit during the term of

the patent.

In a like vein, the de minimis doctrine would seem to apply.. Stated more fully, the law does not concern itself with small matters. In Maxon Premix Burner Co. v. Eclipse Fuel Engineering Co., 471 F.2d 308 (7th Cir. 1972), the Seventh Circuit Court of Appeals held the experimental construction of a prototype even paired with a sale was de minimis and insufficient to support an action for threatened infringement.

In the case at bar, Roche

can point to no substantial loss that would stem from Bolar's studies. The only harm Roche can point to is a violation of the principle of its monopoly.

A court should be cautious in applying the equitable remedy of a permanent injunction in patent cases, American Safety Device Co. v. Kurland Chemical Co., 68 F.2d 734 (2d Cir. 1934), particularly where, as here, there remains little more than three months to the term of the patent. This is doubly true where the case involves only a threatened infringement.

More importantly, the court cannot find a basis for holding that Bolar's limited experimental use of flurazepam hcl would constitute infringement. First, Bolar realizes no benefit during the term of the patent; its activities are in no way connected with current manufacture or sale here or abroad. Nor do its activities lessen Roche's profits during the patent's term.: Second, post-expiration delay in competition unintentionally imposed by FDA regulation is not a right or benefit granted by the patent law. This court will not act to protect a right or benefit that is without legal basis. Third, Roche can point to no substantial harm it will suffer from Bolar's FDA studies before the patent expires. Bolar's threatened activity is at best de minimis and will not support an action for infringement. If, however, it develops that Roche suffers substantial harm or loss during the patent's term, it still has available to it action at law for damages against Bolar.

Accordingly, no permanent injunction will issue and the
Parties will bear

temporary restraining order is dissolved.

Before MARKEY, Chief Judge, NICHOLS, Senior Circuit Judge, and KASHIWA, Circuit Judge.

NICHOLS, Senior Circuit Judge.

This is an appeal from a judgment entered on October 14, 1983, in which the United States District Court for the Eastern District of New York held United States Patent No. 3,299,053 not infringed and denied relief. We reverse

At stake in this case is the length of time a pharmaceutical company which has a patent on the active ingredient in a drug can have exclusive access to the American market for that drug. Plaintiff-appellant Roche Products,

Inc. (Roche), a large research-oriented

pharmaceutical company, wanted the United States district court to enjoin Bolar Pharmaceutical Co., Inc. (Bolar), a manufacturer of generic drugs, from taking, during the life of a patent, the statutory and regulatory steps necessary to market, after the patent expired, a drug equivalent to a patented brand name drug. Roche argued that the use of a patented drug for federally mandated premarketing tests is a violation of the patent laws.

use in

Roche was the assignee of the rights in U.S. Patent No. 3,299,053 (the '053 patent), which expired on January 17, 1984. The '053 patent, which issued on January 17, 1967, is entitled "Novel 1 and/or 4-substituted alkyl 5-aromatic-3H-1,4-benzodiazepines and benzodiazepine-2

ones." One of the chemical compounds claimed in the '053 patent is flurazepam hydrochloride (flurazepam hcl), the active ingredient in Roche's successful brand name prescription sleeping pill "Dalmane."

In early 1983, Bolar became interested in marketing, the '053 patent expired, a generic drug equivalent to Dalmane. Because a generic drug's commercial Success is related to how quickly it is brought on the market after a patent expires, and because approval for an equivalent of an established drug can take more than 2 years, Bolar, not waiting for the '053 patent to expire, immedi

ately began its effort to obtain federal approval to market its generic version of Dalmane. In mid-1983, Bolar obtained from a foreign manufacturer 5 kilograms of flurazepam hcl to form into "dosage form capsules, to obtain stability data, dissolution rates, bioequivalency studies, and blood serum studies" necessary for a New Drug Application to the United States Food and Drug Administration

(FDA).

On July 28, 1983, Roche filed a complaint in the United States District Court for the District of New Jersey against three parties: Bolar, Bolar's principal officer, and the importer of the infringing flurazepam hcl. Only Bolar remains a party defendant. Roche sought to enjoin Bolar from using flurazepam hcl for any purpose whatsoever during the life of the 053 patent. When Bolar stated during discovery, on August 30, 1983, that it intended immediately to begin testing its generic drug for FDA approval, Roche moved for and was granted a Temporary Restraining Order, on September 2, 1983.

On September 26, 1983, Bolar was granted a change of venue and the case was transferred to the United States District Court for the Eastern District of New York. That court consolidated Roche's motion for a preliminary injunction with the trial on the merits pursuant to Fed. R. Civ. P. 65(a)(2) (both parties had stipulated to all the