United States v. Glaxo Group Ltd.

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United States v. Glaxo Group Ltd.
Seal of the United States Supreme Court.svg
Argued November 9, 1972
Decided January 22, 1973
Full case nameUnited States v. Glaxo Group Ltd.
Citations410 U.S. 52 ( more )
93 S. Ct. 861; 35 L. Ed. 2d 104; 1973 U.S. LEXIS 26; 176 U.S.P.Q. (BNA) 289; 1973 Trade Cas. (CCH) ¶ 74,323
Case history
Prior328 F. Supp. 709 (D.D.C. 1971); probable jurisdiction noted, 405 U.S. 914(1972).
Holding
When a patent is directly involved in an antitrust violation, the Government may challenge the validity of the patent.
Court membership
Chief Justice
Warren E. Burger
Associate Justices
William O. Douglas  · William J. Brennan Jr.
Potter Stewart  · Byron White
Thurgood Marshall  · Harry Blackmun
Lewis F. Powell Jr.  · William Rehnquist
Case opinions
MajorityWhite, joined by Burger, Douglas, Brennan, Marshall, Powell
DissentRehnquist, joined by Stewart and Blackmun
Laws applied
Sherman Act

United States v. Glaxo Group Ltd., 410 U.S. 52 (1973), [1] is a 1973 decision of the United States Supreme Court in which the Court held that (1) when a patent is directly involved in an antitrust violation, the Government may challenge the validity of the patent; [2] and (2) ordinarily, in patent-antitrust cases, “[m]andatory selling on specified terms and compulsory patent licensing at reasonable charges are recognized antitrust remedies.”

Contents

Background

Imperial Chemical Industries (ICI) and Glaxo Group Ltd. (Glaxo) each owned patents covering various aspects of the antifungal drug griseofulvin. [3] They “pooled” the patents (that is, cross-licensed one another), subject to express licensing restrictions that the chemical from which the “finished” form of the drug (tablets and capsules) was made must not be resold in bulk form. ICI and Glaxo licensed three “brand name” drug companies to make and sell the drug in finished form only. The purpose of this restriction was to keep the drug chemical out of the hands of small companies that might act as price-cutters, and the effect was to maintain stable, uniform prices.

The Department of Justice Antitrust Division sued, alleging violations of § 1 of the Sherman Act and also alleging that the patents were invalid. The district court granted summary judgment against the defendants on the antitrust charges, but dismissed the invalidity claims on the ground that the Government lacked standing to challenge patent validity. The district court also denied the Government’s request for mandatory selling of the bulk chemical and compulsory licensing, on reasonable terms. The Government then appealed to the Supreme Court.

Opinion of the Court

Justice Byron White wrote the majority opinion for the Court Justice White Official.jpg
Justice Byron White wrote the majority opinion for the Court

Justice Byron White wrote the 6-3 majority opinion for the Court. Justice William Rehnquist wrote a dissenting opinion in which Justices Potter Stewart and Harry Blackmun joined.

Standing

The Court observed that the defendants had been adjudged to be antitrust violators. The Court said that while “we do not recognize unlimited authority in the Government to attack a patent by basing an antitrust claim on the simple assertion that the patent is invalid,” whether the patents are valid or invalid could significantly affect what remedies were appropriate. Therefore, when the Government presents substantial claims for relief, a court should entertain the Government’s validity challenge.

Relief

The Court noted that mandatory sales and reasonable royalty compulsory licensing were “well established forms of relief when necessary to an effective remedy, particularly where patents have provided the leverage for or have contributed to the antitrust violation adjudicated.” Here, the evidence showed that the patents “gave the appellees the economic leverage with which to insist upon and enforce the bulk-sales.” Reasonable royalty licensing was necessary to assure competitive access to the input factor for production of the drug. In addition, both mandatory sales of “bulk-form griseofulvin on reasonable and nondiscriminatory terms’ and grants of “patent licenses at reasonable-royalty rates to all bona fide applicants’ were necessary in order to "’pry open to competition’ the griseofulvin market that ‘has been closed by defendants' illegal restraints.’"

Subsequent developments

The Glaxo case was brought, initially, as a test case on government standing to challenge patent validity—a vehicle for overturning or at least limiting the 1897 decision of the Supreme Court in United States v. Bell Tel. Co. [4] Substantively, Glaxo was one of a series of antitrust challenges against patent license restrictions on the sale of bulk drugs. Such restrictions were used to keep the bulk chemical form of drugs out of the hands of generic drug houses and other potential price-cutters, so that "finished" drug prices could be maintained at high levels. (The Supreme Court's statement of the facts in its Glaxo opinion explains this point. [5] )

The defendants asserted no health and safety or other factual defenses. The district court then granted three summary judgment motions in the government's favor on the issue of antitrust violation, granted the defendants' motion to dismiss the patent validity challenges, and denied any significant relief. [6] The case then went to the Supreme Court on a record consisting of legal briefs and supporting affidavits, without live testimony: there had not been a single day of trial in the usual sense—nothing but legal argumentation. [7]

After the Supreme Court's decision, the government found itself possessed of a new power to challenge antitrust defendants' patents. However, the government did not rush to exploit this power. It appears that only one reported decision has involved a patent validity challenge based on the doctrine of the Glaxo case. [8]

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Besser Mfg. Co. v. United States, 343 U.S. 444 (1951), is a 1951 patent–antitrust decision of the United States Supreme Court in which the Court upheld a ruling that the dominant U.S. manufacturer of concrete block–making machines violated the antitrust laws when it acquired its two principal competitors, bought important patents, made bad–faith threats of patent infringement suits, and entered into patent licensing agreements in which the parties were given veto powers over any prospective additional licensees. The Supreme Court approved the district court's grant of compulsory, reasonable–royalty licensing of the patents and compulsory sales of patented machines, holding that such relief "is a well–recognized remedy where patent abuses are proved in antitrust actions, and it is required for effective relief."

<i>United States v. Krasnov</i>

United States v. Krasnov, 143 F. Supp. 184, was a 1956 district court patent–antitrust decision that the United States Supreme Court affirmed per curiam without opinion. The district court granted the Government's summary judgment motion because it concluded:

That the defendants in combination controlled the market and had the ability to and did drive competitors from the business of manufacturing knitted fabric slip covers is abundantly clear from the record. That the defendants in combination fixed and maintained prices is likewise crystal clear. That the defendants in combination and cross-licensing created a situation in the industry which, particularly by agreement for joint action respecting the patents, effectively hindered newcomers in the field, is also established beyond peradventure of doubt. That the harassing suits against competitors, previously discussed in some detail, were designed as and were actually only harassing suits is clear from an examination of the correspondence between the parties and the Court feels that such conclusion in inescapable from an objective analysis of the documents. All of these actions taken in concert constitute a clear violation of the Sherman Anti-Trust Act and the Government has established to the satisfaction of the Court that the combination and conspiracy above referred to represents an unreasonable restraint of trade and commerce among the several states of the United States in the manufacture and sale of ready-made furniture slip covers, is unlawful, and in violation of Section 1 of the Sherman Anti-Trust Act. Further, the Government, in the opinion of the Court, has effectively demonstrated that the defendants combined and conspired not only to restrain trade unreasonably but also to monopolize trade and commerce among the several states of the United States in the manufacture and sale of ready-made furniture slip covers, in direct violation of Section 2 of the Sherman Anti-Trust Act. The Court also feels that by documentary proof the Government has established that the defendants have used patent rights unlawfully in instituting, effectuating and maintaining the aforesaid combination and conspiracy which likewise constitutes a clear violation of the Sherman Anti-Trust Act.

Bulk-sale restrictions—also known as bulk-sale restraints, finished-form limitations, and dosage-form limitations—are, as the term is used in United States antitrust case law, clauses in patent licenses that provide that the licensee shall make and sell the licensed product only in "finished pharmaceutical form" or "dosage form", not in bulk. Bulk form is the form in which drug chemicals are manufactured by chemical or other processes. These clauses are found primarily in pharmaceutical product licenses and are used to keep active drug ingredients out of the hands of generic manufacturers and price-cutters.

Hartford-Empire Co. v. United States, 323 U.S. 386 (1945), was a patent-antitrust case that the Government brought against a cartel in the glass container industry. The cartel, among other things, divided the fields of manufacture of glass containers, first, into blown glass and pressed glass, which was subdivided into: products made under the suction process, milk bottles, and fruit jars. The trial court found the cartel violative of the antitrust laws and the Supreme Court agreed that the market division and related conduct were illegal. The trial court required royalty-free licensing of present patents and reasonable royalty licensing of future patents. A divided Supreme Court reversed the requirement for royalty-free licensing as "confiscatory," but sustained the requirement for reasonable royalty licensing of the patents.

References

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  1. United States v. Glaxo Group Ltd., 410 U.S. 52 (1973). PD-icon.svg This article incorporates public domain material from this U.S government document.
  2. This overruled or further limited United States v. Bell Tel. Co. , 167 U.S. 224 (1897), which held that the United States lacked standing to challenge the validity of its issued patents “on the mere ground of error of judgment” in issuing them. The United States had standing to seek to invalidate patents, however, on grounds of fraudulent procurement and also as a defense to a charge of patent infringement.
  3. ICI had patents on the dosage form of the drug. Glaxo had patents on manufacturing patents.
  4. 167 U.S. 224 (1897). That decision had held that the United States lacked standing to challenge its own grant, because of the doctrine of legal estoppel.
  5. See Glaxo, 410 U.S. at 63.
  6. See Glaxo, 410 U.S. at 56.
  7. Glaxo, 410 U.S. at 56 n.5.
  8. United States v. Ciba-Geigy Co., 508F. Supp.1157 (D.N.J.1979). See also United States v. FMC Corp., 717 F.2d 775 (3d Cir. 1983) (government has no standing to invalidate patent for failure to file copy of interference settlement).

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