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| [1] | UNITED STATES COURT OF APPEALS FOR THE FEDERAL CIRCUIT |
| [2] | Appeal No. 84-560 |
| [3] | 1984.CFC.40491 <http://www.versuslaw.com>;
733 F.2d 858 |
| [4] | Decided: April 23, 1984. |
| [5] | ROCHE PRODUCTS, INC. APPELLANT, v. BOLAR PHARMACEUTICAL CO., INC., APPELLEE |
| [6] | Appealed from: United States District Court for the Eastern District of
New York. |
| [7] | John C. Vassil, of New York, New York, argued, for Appellant. With him
on the brief were Stephen R. Smith, J. Robert Dailey, Janet Dore, Ralph
N. Del Deo and Ann G. McCormick. |
| [8] | Robert V. Marrow, of New York, New York, argued, for Appellee. With him
on the brief were Leo Salon, Joel Salon, David L. Shandalow and Jacques
Catafago. |
| [9] | Peter Barton Hutt and Bruce J. Brennan, of Washington, District of Columbia,
were on the brief for Pharmaceutical Manufacturers Association, Amicus Curiae. |
| [10] | Alfred B. Engelberg, Morton Amstar and Anthony F. LoCicero, of New York,
New York, were on the brief for Pharmaceutical Industry Association as Amicus
Curiae. |
| [11] | Markey, Chief Judge, Nichols, Senior Circuit Judge, and Kashiwa, Circuit
Judge. |
| [12] | Nichols |
| [13] | NICHOLS, Senior Circuit Judge. |
| [14] | 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. |
| [15] | I |
| [16] | 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. |
| [17] | 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." |
| [18] | 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). |
| [19] | 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. |
| [20] | 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 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. |
| [21] | II |
| [22] | 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. |
| [23] | III |
| [24] | A |
| [25] | 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. § 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. § 154. Congress
states in section 271(a): |
| [26] | Whoever without authority makes, uses or sells any patented invention,
within the United States during the term of the patent therefore, infringes
the patent. |
| [27] | 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, 12 L. Ed. 2d 457
, 84 S. Ct. 1526
, 141 U.S.P.Q. (BNA) 681, 685 (1964); Coakwell v. United States, 178 Ct.
Cl. 654, 372 F.2d 508, 510, 153 U.S.P.Q. (BNA) 307, 308 (1967). Thus, the
patentee does not need to have any evidence of damage or lost sales to bring
an infringement action. |
| [28] | 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): |
| [29] | It 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. |
| [30] | 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, 212 Ct. Cl. 168, 547 F.2d 1106, 192 U.S.P.Q.
(BNA) 612 (1976), cert. denied, 434 U.S. 1051
, 54 L. Ed. 2d 804
, 98 S. Ct. 903
(1978) (experimental use may be a defense to infringement); United States
v. Univis Lens Co., 316 U.S. 241
, 86 L. Ed. 1408
, 62 S. Ct. 1088
(1942) ("An incident to the purchase of any article, whether patented
or unpatented, is the right to use and sell it, * * *." Id. at 249);
General Electric Co. v. United States, 215 Ct. Cl. 636, 572 F.2d 745, 198
U.S.P.Q. (BNA) 65 (1978) ("It 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 U.S.P.Q. (BNA) at 98). |
| [31] | 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. |
| [32] | B |
| [33] | 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, 1 Gall.
429, 29 F. 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: |
| [34] | It 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. |
| [35] | Despite skepticism, see, e.g., Byam v. Bullard, 1 Curt. 100, 4 F. 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." Poppenhusen v. Falke, 19 F. 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 Use as an Act of
Patent Infringement, 39 J. Pat. Off. Soc'y 357 (1957).) Professor Robinson
firmly entrenched the experimental use exception into the patent law when
he wrote his famous treatise, W. Robinson, The Law of Patents for Useful
Inventions § 898 (1890): |
| [36] | § 898. No Act an Infringement unless it Affects the Pecuniary Interests
of the Owner of the Patented Invention. |
| [37] | The interest to be promoted by the wrongful employment of the invention
must be hostile to the interest of the patentee. The interest of the patentee
is represented by the emoluments which he does or might receive from the
practice of the invention by himself or others. These, though not always
taking the shape of money, are of a pecuniary character, and their value
is capable of estimation like other property. Hence acts of infringement
must attack the right of the patentee to these emoluments, and either turn
them aside into other channels or prevent them from accruing in favor of
any one. An unauthorized sale of the invention is always such an act. But
the manufacture or the use of the invention may be intended only for other
purposes, and produce no pecuniary result. Thus where it is made or used
as an experiment, whether for the gratification of scientific tastes, or
for curiosity, or for amusement, the interests of the patentee are not antagonized,
the sole effect being of an intellectual character in the promotion of the
employer's knowledge or the relaxation afforded to his mind. But if the
products of the experiment are sold, or used for the convenience of the
experimentor, or if the experiments are conducted with a view to the adaptation
of the invention to the experimentor's business, the acts of making or of
use are violations of the rights of the inventor and infringements of his
patent. In reference to such employments of a patented invention the law
is diligent to protect the patentee, and even experimental uses will be
sometimes enjoined though no injury may have resulted admitting of positive
redress. [Emphasis supplied, footnotes omitted.] |
| [38] | The Court of Claims, whose precedents bind us, on several occasions has
considered the defense of experimental use. See Ordnance Engineering Corp.
v. United States, 84 Ct. Cl. 1, 32 U.S.P.Q. (BNA) 614 (1936), cert. denied,
302 U.S. 708
, 37 U.S.P.Q. (BNA) 842, 82 L. Ed. 547
, 58 S. Ct. 28
(1937); Chesterfield v. United States, 141 Ct. Cl. 838, 159 F. Supp. 371,
116 U.S.P.Q. (BNA) 445 (1958); Douglas v. United States, 181 U.S.P.Q. (BNA)
170 (Ct. Cl. Tr. Div. 1974), aff'd, 206 Ct. Cl. 96, 510 F.2d 364, 184 U.S.P.Q.
(BNA) 613, cert. denied, 423 U.S. 825
, 46 L. Ed. 2d 41
, 96 S. Ct. 40
(1975); Pitcairn v. United States, 212 Ct. Cl. 168, 547 F.2d 1106, 192 U.S.P.Q.
(BNA) 612 (1976), cert. denied, 434 U.S. 1051
, 54 L. Ed. 2d 804
, 98 S. Ct. 903
(1978). Bolar concedes, as it must, that its intended use of flurazepam
hcl does not fall within the "traditional limits" of the experimental
use exception as established in these cases or those of other circuits.
Its concession here is fatal. Despite Bolar's argument that its tests are
"true scientific inquiries" to which a literal interpretation
of the experimental use exception logically should extend, we hold the experimental
use exception to be truly narrow, and we will not expand it under the present
circumstances. Bolar's argument that the experimental use rule deserves
a broad construction is not justified. |
| [39] | Pitcairn, the most persuasive of the Court of Claims cases concerning
the experimental use defense, sets forth the law which must control the
disposition of this case: "tests, demonstrations, and experiments *
* * [which] are in keeping with the legitimate business of the * * * [alleged
infringer]" are infringements for which "experimental use is not
a defense." 547 F.2d at 1125-1126
, 192 U.S.P.Q. (BNA) at 625. We have carefully reviewed each of the other
Court of Claims cases, and although they contain some loose language on
which Bolar relies, they are unpersuasive. The Ordnance Engineering case
provides no guidance concerning the boundaries of an appropriately applied
experimental use rule other than flatly stating that a device must have
been "built for experimental purposes." In Chesterfield, the court's
flat declaration that "experimental use does not infringe" is
pure obiter dictum. See Pitcairn, 547 F.2d at 1125
, 192 U.S.P.Q. (BNA) at 625. Douglas has no precedential value here since
the Court of Claims never affirmed the part of the trial judge's opinion
dealing with experimental use; moreover, Trial Judge Cooper's well-reasoned
analysis of the experimental use rule concluded that no case had permitted
a pattern of systematic exploitation of a patented invention for the purpose
of furthering the legitimate business interests of the infringer. The authority
of Trial Judge Cooper's views rests on his reputation as a fine patent lawyer,
and on their own intrinsic persuasiveness. |
| [40] | Bolar's intended "experimental" use is solely for business reasons
and not for amusement, to satisfy idle curiosity, or for strictly philosophical
inquiry. Bolar's intended use of flurazepam hcl to derive FDA required test
data is thus an infringement of the '053 patent. Bolar may intend to perform
"experiments," but unlicensed experiments conducted with a view
to the adaption of the patented invention to the experimentor's business
is a violation of the rights of the patentee to exclude others from using
his patented invention. It is obvious here that it is a misnomer to call
the intended use de minimis. It is no trifle in its economic effect on the
parties even if the quantity used is small. It is no dilettante affair such
as Justice Story envisioned. We cannot construe the experimental use rule
so broadly as to allow a violation of the patent laws in the guise of "scientific
inquiry," when that inquiry has definite, cognizable, and not insubstantial
commercial purposes. |
| [41] | C |
| [42] | Bolar argues that even if no established doctrine exists with which it
can escape liability for patent infringement, public policy requires that
we create a new exception to the use prohibition. Parties and amici seem
to think, in particular, that we must resolve a conflict between the Federal
Food, Drug, and Cosmetic Act (FDCA), 21 U.S.C. §§ 301-392 (1982), and the
Patent Act of 1952, or at least the Acts' respective policies and purposes.
We decline the opportunity here, however, to engage in legislative activity
proper only for the Congress. |
| [43] | The new drug approval procedure which existed between 1938 and 1962 was
relatively innocuous and had little impact on the development of pioneer
prescription new drugs. Section 505 of the FDCA, ch. 675, 52 Stat. 1052
(1938), required the manufacturer of a pioneer new drug to submit to the
FDA a New Drug Application (NDA) containing information concerning the safety
of the drug. If the FDA did not disapprove the new drug within 60 days after
it received the NDA, marketing could begin. |
| [44] | The provisions of the Drug Amendments of 1962, Pub. L. No. 87-781, 76
Stat. 780, caused a substantial increase in the time required for development
and approval of a pioneer new drug. Beginning in 1962, the amended Section
505 (codified at 21 U.S.C. § 355 (1982)) required an NDA to contain proof
of efficacy (effectiveness) as well as safety, and required the FDA affirmatively
to approve the NDA rather than just to permit marketing by inaction. A recent
study indicated that it now can take on average from 7 to 10 years for a
pharmaceutical company to satisfy the current regulatory requirements. National
Academy of Engineering, The Competitive Status of the U.S. Pharmaceutical
Industry 79-80 (1983). |
| [45] | Because most FDA-required testing is done after a patent issues, the remaining
effective life of patent protection assertedly may be as low as 7 years.
Id., citing Statement of William M. Wardell to the Subcommittee on Investigations
and Oversight of the Committee on Science and Technology, U.S. House of
Representatives, Feb. 14, 1982, at 14. Litigation such as this is one example
of how research-oriented pharmaceutical companies have sought to regain
some of the earning time lost to regulatory entanglements. They gain for
themselves, it is asserted, a de facto monopoly of upwards of 2 years by
enjoining FDA-required testing of a generic drug until the patent on the
drug's active ingredient expires. |
| [46] | Bolar argues that the patent laws are intended to grant to inventors only
a limited 17-year property right to their inventions so that the public
can enjoy the benefits of competition as soon as possible, consistent with
the need to encourage invention. The FDCA, Bolar contends, was only intended
to assure safe and effective drugs for the public, and not to extend a pharmaceutical
company's monopoly for an indefinite and substantial period of time while
the FDA considers whether to grant a pre-marketing clearance. Because the
FDCA affected prevailing law, namely the Patent Act, Bolar argues that we
should apply the patent laws to drugs differently. |
| [47] | Simply because a later enacted statute affects in some way an earlier
enacted statute is poor reason to ask us to rewrite the earlier statute.
Repeals by implication are not favored. See, e.g., Mercantile National Bank
v. Langdeau, 371 U.S. 555
, 565, 9 L. Ed. 2d 523
, 83 S. Ct. 520
(1963). Thus, "courts are not at liberty to pick and choose among congressional
enactments, and when two statutes are capable of co-existence, it is the
duty of the courts, absent a clearly expressed congressional intention to
the contrary, to regard each as effective." Morton v. Mancari, 417
U.S. 535
, 551, 41 L. Ed. 2d 290
, 94 S. Ct. 2474
(1974). There is no affirmative obligation on Congress to explain why it
deems a particular enactment wise or necessary, or to demonstrate that it
is aware of the consequences of its action. See Harrison v. PPG Industries,
Inc., 446 U.S. 578
, 592, 64 L. Ed. 2d 525
, 100 S. Ct. 1889
(1979). Rather, because "laws are presumed to be passed with deliberation,
and with full knowledge of all existing ones on the same subject,"
T. Sedgwick, The Interpretation and Construction of Statutory and Constitutional
Law 106 (2d ed. 1874), we must presume Congress was aware that the FDCA
would affect the earning potentiality of a drug patent, and chose to permit
it. Although arguably Title 21 and Title 35 are not laws on the "same
subject," we note that during Congress' deliberations on the 1962 amendments
to the FDCA, it considered the relationship and interaction of the patent
laws with the drug laws. See S. Rep. No. 1744, 87th Cong., 2d Sess., reprinted
in 1962 U.S. Code Cong. & Ad. News 2884, 2911-2915. |
| [48] | It is the role of Congress to maximize public welfare through legislation.
Congress is well aware of the economic and societal problems which the parties
debate here, and has before it legislation with respect to these issues.
See H.R. 3605, 98th Cong., 1st Sess. (1983) ("Drug Price Competition
Act of 1983") (amending 21 U.S.C. § 355(b) to allow faster marketing
of new generic drugs equivalent to approved new drugs); S. 1306, 98th Cong.,
1st Sess. (1983) ("Patent Term Restoration Act of 1983") (amending
35 U.S.C. § 155 to add to the patent grant a period of time equivalent to
that lost due to regulatory delay), Cong. Rec. S. 6863 (daily ed. May 17,
1983), 26 Pat. Trademark & Copyright J. (BNA) 87-88 (May 26, 1983).
No matter how persuasive the policy arguments are for or against these proposed
bills, this court is not the proper forum in which to debate them. Where
Congress has the clear power to enact legislation, our role is only to interpret
and apply that legislation. "It is not our job to apply laws that have
not yet been written." Sony Corp. of America v. Universal City Studios,
Inc., 464 U.S. 417
, 456, 78 L. Ed. 2d 574
, 104 S. Ct. 774
, 796, 220 U.S.P.Q. (BNA) 665, 684, 52 U.S.L.W. 4090
, 4100 (1984). We will not rewrite the patent laws here. |
| [49] | IV |
| [50] | The district court refused to grant a permanent injunction against Bolar
because it believed the law did not require that it find infringement of
the '053 patent. Since we hold that there is infringement, Roche is entitled
to a remedy. We are not in a position, however, to decide the form of that
remedy. |
| [51] | Roche requested us, at first, to remand this case to the district court
with instructions to enter a permanent injunction against infringement by
Bolar. After the main briefs were filed, but before oral argument, the '053
patent expired. This case is not moot, however, because although the initially
requested order no longer is necessary, other remedies can be fashioned
to give Roche relief against Bolar's past infringement. Roche requests,
for example, an order to confiscate and destroy the data which Bolar has
generated during its infringing activity, citing, Pfizer, Inc. v. International
Rectifier Corp., 217 U.S.P.Q. (BNA) 157 (C.D. Cal. 1982) (granting an injunction
of that nature to remedy infringement done in contempt of a court order). |
| [52] | Statute provides the basis for Roche's request for injunctive relief,
35 U.S.C. § 283: |
| [53] | The several courts having jurisdiction of cases under this title may grant
injunctions in accordance with the principles of equity to prevent the violation
of any right secured by patent, on such terms as the court deems reasonable. |
| [54] | Section 283, by its terms, clearly makes the issuance of an injunction
discretionary: the court " may grant " relief " in accordance
with the principles of equity." The trial court thus has considerable
discretion in determining whether the facts of a situation require it to
issue an injunction. The scope of relief, therefore, is not for us to decide
at the first instance, nor is this the time or place for a discourse on
the "principles of equity." |
| [55] | Whether an injunction should issue in this case, and of what form it should
take, certainly depends on the equities of the case. Bolar, Roche, and amici
Pharmaceutical Manufacturers Association and Generic Pharmaceutical Industry
Association, each detail the "catastrophic" effect our decision
for either party will have on the American public health system. It is true
that it "is a principle of general application that courts, and especially
courts of equity, may appropriately withhold their aid where the plaintiff
is using the right asserted contrary to the public interest," Morton
Salt Co. v. Suppiger Co., 314 U.S. 488
, 492, 86 L. Ed. 363
, 62 S. Ct. 402
(1941), reh'g denied, 315 U.S. 826
, 86 L. Ed. 1222
, 62 S. Ct. 620
(1942). Since "the standards of the public interest, not the requirements
of private litigation, measure the propriety and need for injunctive relief
in these cases," Hecht Co. v. Bowles, 321 U.S. 321
, 331, 88 L. Ed. 754
, 64 S. Ct. 587
(1944), rev'g Brown v. Hecht Co., 78 U.S. App. D.C. 98, 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. |
| [56] | 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 Roche 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. The destruction of material in Pfizer, Inc., was ordered
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 predicates
established. |
| [57] | 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 relief of a harsh,
or even a mild, character is gone. |
| [58] | 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
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 II, 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. |
| [59] | After discovering some loopholes in the statute, in light of the legislative
history, Justice Douglas continued at 329: |
| [60] | 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 discretion which guides the determinations of courts
of equity." Meredith v. Winter Haven, 320 U.S. 228
, 235 [88 L. Ed. 9
, 64 S. Ct. 7].
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. |
| [61] | 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, having, 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. |
| [62] | The application of historic equity principles to the case at bar is in
the first instance for the district court. |
| [63] | V |
| [64] | Conclusion |
| [65] | 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. |
| [66] | REVERSED AND REMANDED. |
| [67] | Disposition |
| [68] | Reversed and Remanded. |
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