By Ian Millhiser on
Jun 18, 2013 at 3:00 pm
Chief Justice John Roberts
(Credit: AP)
In 2000, a pharmaceutical
company named Solvay obtained a patent for a drug called
“AndroGel,” which is used to treat men with low testosterone
levels. Shortly thereafter, several of Solvay’s competitors sought to market
generic versions of the same drug, claiming that Solvay’s patent for the
testosterone replacement gel was invalid. These claims were never resolved,
however, due to a settlement agreement where Solvay agreed to pay its
competitors millions of dollars if they abandoned their efforts to cut into
Solvay’s monopoly until August of 2015. This settlement, according to the
Federal Trade Commission, was an agreement by generic drug manufacturers “to
share in Solvay’s monopoly profits, abandon their patent challenges, and
refrain from launching their low-cost generic products to compete with AndroGel
for nine years.”
In other words, the FTC
alleged, Solvay got to keep charging monopoly rates for its drug. Its
competitors got a cut of the profits. And consumers got the shaft, in the form
of higher drug prices.
Thanks to the Supreme Court’s
decision yesterday in FTC v. Actavis, an FTC lawsuit challenging
this settlement will move forward. Conservative Justices Antonin Scalia and
Clarence Thomas, however, joined an opinion by Chief Justice John Roberts that
would have given the Court’s effective blessing to the AndroGel settlement
(Justice Samuel Alito was recused from the case).
The legal issue in the case
involves a complex question of what happens when federal antitrust law runs
headlong into federal patent law. On the one hand, allowing a company to simply
pay its competitors not to enter the market would defeat the entire purpose of
antitrust law and open the door to monopolies in every marketplace. On the
other hand, the whole point of patents is to give inventors a temporary
monopoly in order to encourage them to pursue their inventions. Drug companies
would have little incentive to create new drugs if their discoveries could be
poached immediately after they are created.
Yet, patent law does not
allow someone to unilaterally proclaim that they invented a product and then change
monopoly prices for it. As Justice Breyer explains in the majority opinion, “a
valid patent excludes all except its owner from the use of the protected
process or product,” Breyer’s opinion explains, “[b]ut an invalidated patent
carries with it no such right.” The whole point of cases like the FTC’s lawsuit
is to prevent pharmaceutical companies from giving a wink and a nod to each
other’s more doubtful patent claims in order to squeeze more money from
consumers.
The dissent, which seems to
presume that the patent at issue in this case is valid, rests largely on a
desire not to upset “the public policy in favor of settling.”
As it turns out, there is a
disinterested study available which shines light on whether the majority or the
dissent’s approach will be better for consumers. In 2011, the nonpartisan
Congressional Budget Office conducted a study on the budgetary impact of the Preserve
Access to Affordable Generics Act, which would have created a strong
legal presumption against settlements such as the one that occurred in this
case. The CBO determined that restricting such settlements, where a drug
company pays its competitors not to enter the generic drug market, “reduce[s]
total expenditures on prescription drugs in the United States, on net, by about
$11 billion over the 2012-2021 period.” Federal programs alone would
save $4 billion. As CBO explained, restricting arrangements similar to the
AndroGel settlement would “accelerate the entry of generic drugs affected by
the bill by roughly 17 months, on average,” thus enabling consumers to buy
cheaper generic drugs that much sooner.
Admittedly, this bill cast
a more skeptical eye on these settlements than Justice Breyer’s opinion does in Actavis.
Nevertheless, this CBO report is strong evidence that the conservatives’
approach to these cases would have ultimately led to higher prices for
consumers and windfall profits for drug companies.
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