733 F.2d 858 (Fed. Cir. 1984), 84-560, Roche Products, Inc. v. Bolar Pharmaceutical Co., Inc.

Docket Nº:Appeal No. 84-560.
Citation:733 F.2d 858
Party Name:221 U.S.P.Q. 937 ROCHE PRODUCTS, INC. Appellant, v. BOLAR PHARMACEUTICAL CO., INC., Appellee.
Case Date:April 23, 1984
Court:United States Courts of Appeals, Court of Appeals for the Federal Circuit

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733 F.2d 858 (Fed. Cir. 1984)

221 U.S.P.Q. 937




Appeal No. 84-560.

United States Court of Appeals, Federal Circuit

April 23, 1984

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John C. Vassil, New York City, argued for appellant. With him on the brief were Stephen R. Smith, J. Robert Dailey, Janet Dore, New York City, Ralph N. Del Deo and Ann G. McCormick, Newark, N.J.

Robert V. Marrow, New York City, argued for appellee. With him on the brief were Leo Salon, Joel Salon, David L. Shandalow and Jacques Catafago, New York City.

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Peter Barton Hutt and Bruce J. Brennan, Washington, D.C., were on the brief for Pharmaceutical Manufacturers Ass'n, amicus curiae.

Alfred B. Engelberg, Morton Amstar and Anthony F. LoCicero, New York City, were on the brief for Pharmaceutical Industry Ass'n as amicus curiae.

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 572 F.Supp. 255 for the Eastern District of New York held United States Patent No. 3,299,053 not infringed and denied relief. We reverse and remand.


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 use in violation of the patent laws.

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, after 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, immediately 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 pertinent facts so no testimony was necessary) and on October 11, 1983, issued a Memorandum and Order denying Roche's application for a permanent injunction. The court held that Bolar's use of the patented compound for federally mandated

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testing was not infringement of the patent in suit because Bolar's use was de minimis and experimental. The court entered judgment for Bolar on October 14, 1983, and Roche filed its notice of appeal that same day.


The district court correctly recognized that the issue in this case is narrow: does the limited use of a patented drug for testing and investigation strictly related to FDA drug approval requirements during the last 6 months of the term of the patent constitute a use which, unless licensed, the patent statute makes actionable? The district court held that it does not. This was an error of law.



When Congress enacted the current revision of the Patent Laws of the United States, the Patent Act of 1952, ch. 950, 66 Stat. 792 (codified at 35 U.S.C.), a statutory definition of patent infringement existed for the first time since section 5 of the Patent Act of 1793 was repealed in 1836. Title 35 U.S.C. Sec. 271(a) incorporates the disjunctive language of the statutory patent grant which gives a patentee the "right to exclude others from making, using, or selling" a patented invention, 35 U.S.C. Sec. 154. Congress states in section 271(a):

[W]hoever without authority makes, uses or sells any patented invention, within the United States during the term of the patent therefore, infringes the patent.

It is beyond argument that performance of only one of the three enumerated activities is patent infringement. It is well-established, in particular, that the use of a patented invention, without either manufacture or sale, is actionable. See Aro Manufacturing Co. v. Convertible Top Replacement Co., 377 U.S. 476, 484, 84 S.Ct. 1526, 1531, 12 L.Ed.2d 457, 141 USPQ 681, 685 (1964); Coakwell v. United States, 372 F.2d 508, 510, 178 Ct.Cl. 654, 153 USPQ 307, 308 (1967). Thus, the patentee does not need to have any evidence of damage or lost sales to bring an infringement action.

Section 271(a) prohibits, on its face, any and all uses of a patented invention. Of course, as Judge Learned Hand observed in Cabell v. Markham, 148 F.2d 737, 739 (2d Cir.), aff'd, 326 U.S. 404, 66 S.Ct. 193, 90 L.Ed. 165 (1945):

[I]t is true that the words used, even in their literal sense, are the primary, and ordinarily the most reliable, source of interpreting the meaning of any writing: be it a statute, a contract, or anything else. But it is one of the surest indexes of a mature and developed jurisprudence not to make a fortress out of the dictionary; but to remember that statutes always have some purpose or object to accomplish, whose sympathetic and imaginative discovery is the surest guide to their meaning.

Because Congress has never defined use, its meaning has become a matter of judicial interpretation. Although few cases discuss the question of whether a particular use constitutes an infringing use of a patented invention, they nevertheless convincingly lead to the conclusion that the word "use" in section 271(a) has never been taken to its utmost possible scope. See, e.g., Pitcairn v. United States, 547 F.2d 1106, 212 Ct.Cl. 168, 192 USPQ 612 (1976), cert. denied, 434 U.S. 1051, 98 S.Ct. 903, 54 L.Ed.2d 804 (1978) (experimental use may be a defense to infringement); United States v. Univis Lens Co., 316 U.S. 241, 62 S.Ct. 1088, 86 L.Ed. 1408 (1942) ("An incident to the purchase of any article, whether patented or unpatented, is the right to use and sell it, * * *." Id. at 249, 62 S.Ct. at 1093); General Electric Co. v. United States, 572 F.2d 745, 215 Ct.Cl. 636, 198 USPQ 65 (1978) ("[I]t can be properly assumed that as part of the bargain the seller of a device incorporating a patented combination * * * authorizes the buyer to continue to use the device so long as the latter can and does use the elements he purchased from the patentee or licensor." Id. at 784-85, 198 USPQ at 98).

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Bolar argues that its intended use of flurazepam hcl is excepted from the use prohibition. It claims two grounds for exception: the first ground is based on a liberal interpretation of the traditional experimental use exception; the second ground is that public policy favors generic drugs and thus mandates the creation of a new exception in order to allow FDA required drug testing. We discuss these arguments seriatim.


The so-called experimental use defense to liability for infringement generally is recognized as originating in an opinion written by Supreme Court Justice Story while on circuit in Massachusetts. In Whittemore v. Cutter, 29 Fed.Cas. 1120, 1121, (C.C.D.Mass.1813) (No. 17,600), Justice Story sought to justify a trial judge's instruction to a jury that an infringer must have an intent to use a patented invention for profit, stating:

[I]t could never have been the intention of the legislature to punish a man who constructed such a machine merely for philosophical experiments, or for the purpose of ascertaining the sufficiency of the machine to produce its described effects.

Despite skepticism, see, e.g., Byam v. Bullard, 4 Fed.Cas. 934 (C.C.D.Mass.1852) (No. 2,262) (opinion by Justice Curtis), Justice Story's seminal statement evolved until, by 1861, the law was "well-settled that an experiment with a patented article for the sole purpose of gratifying a philosophical taste, or curiosity, or for mere amusement is not an infringement of the rights of the patentee." Peppenhausen v. Falke, 19 Fed.Cas. 1048, 1049 (C.C.S.D.N.Y.1861) (No. 11,279). (For a detailed history and analysis of the experimental use exception, see Bee, Experimental...

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