United States v. Glaxo Group Ltd.
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''United States v. Glaxo Group Ltd.'', 410 U.S. 52 (1973), is a 1973 decision of the
United States Supreme Court The Supreme Court of the United States (SCOTUS) is the highest court in the federal judiciary of the United States. It has ultimate appellate jurisdiction over all U.S. federal court cases, and over state court cases that involve a point o ...
in which the Court held that (1) when a
patent A patent is a type of intellectual property that gives its owner the legal right to exclude others from making, using, or selling an invention for a limited period of time in exchange for publishing an enabling disclosure of the invention."A p ...
is directly involved in an
antitrust Competition law is the field of law that promotes or seeks to maintain market competition by regulating anti-competitive conduct by companies. Competition law is implemented through public and private enforcement. It is also known as antitrust l ...
violation, the Government may challenge the validity of the patent; and (2) ordinarily, in patent-antitrust cases, " ndatory selling on specified terms and compulsory patent licensing at reasonable charges are recognized antitrust remedies."


Background

Imperial Chemical Industries Imperial Chemical Industries (ICI) was a British chemical company. It was, for much of its history, the largest manufacturer in Britain. It was formed by the merger of four leading British chemical companies in 1926. Its headquarters were at M ...
(ICI) and Glaxo Group Ltd. (Glaxo) each owned patents covering various aspects of the antifungal drug
griseofulvin Griseofulvin is an antifungal medication used to treat a number of types of dermatophytoses (ringworm). This includes fungal infections of the nails and scalp, as well as the skin when antifungal creams have not worked. It is taken by mouth. C ...
. 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 The United States Department of Justice Antitrust Division is a division of the U.S. Department of Justice that enforces U.S. antitrust law. It has exclusive jurisdiction over U.S. federal criminal antitrust prosecutions. It also has jurisdic ...
sued, alleging violations of § 1 of the
Sherman Act The Sherman Antitrust Act of 1890 (, ) is a United States antitrust law which prescribes the rule of free competition among those engaged in commerce. It was passed by Congress and is named for Senator John Sherman, its principal author. Th ...
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 Byron "Whizzer" Raymond White (June 8, 1917 April 15, 2002) was an American professional football player and jurist who served as an associate justice of the U.S. Supreme Court from 1962 until his retirement in 1993. Born and raised in Color ...
wrote the 6-3 majority opinion for the Court. Justice William Rehnquist wrote a dissenting opinion in which Justices
Potter Stewart Potter Stewart (January 23, 1915 – December 7, 1985) was an American lawyer and judge who served as an Associate Justice of the United States Supreme Court from 1958 to 1981. During his tenure, he made major contributions to, among other areas, ...
and
Harry Blackmun Harry Andrew Blackmun (November 12, 1908 – March 4, 1999) was an American lawyer and jurist who served as an Associate Justice of the Supreme Court of the United States from 1970 to 1994. Appointed by Republican President Richard Nixon, Blac ...
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 In software engineering, a test case is a specification of the inputs, execution conditions, testing procedure, and expected results that define a single test to be executed to achieve a particular software testing objective, such as to exercise ...
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.'' 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.) 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. 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. 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. 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).


References


External links

{{DEFAULTSORT:United States V. Glaxo Group Ltd. United States Supreme Court cases United States Supreme Court cases of the Burger Court United States antitrust case law United States patent case law 1973 in United States case law GSK plc litigation Standing (law) Legal doctrines and principles