FTC v. Actavis (Supreme Court 2013) /media/docs/2013/03/12-416.pdf
The Supreme Court today heard oral arguments in the reverse-payment pharmaceutical case of FTC v. Actavis. The FTC is asking the court to rule that it is impermissible for a pharmaceutical company to pay a potential competitor to stay out of the market – even when shrouded as a patent litigation settlement. This case stems from the Hatch-Waxman Act that encourages a generic manufacturer to step forward and challenge a patentee’s patent rights. In a number of cases, branded manufacturers have offered various incentives to the first-filing generic to end its challenge. These are termed “reverse payments” because the patentee is offering the incentive (money) rather than the usual patent infringement case where the patentee is expecting to be paid.
The FTC challenged a settlement between Solvay and Actavis where Solvay paid around $30 million per year to generic companies to keep generic versions of Androgel off the market.
The question asked by the cert petitions:
Whether reverse-payment agreements are per se lawful unless the underlying patent litigation was a sham or the patent was obtained by fraud (as the court below held), or instead are presumptively anticompetitive and unlawful (as the Third Circuit has held).
The following are a few notes from oral arguments. USDOJ Deputy Solicitor Malcolm Stewart began with the government’s basic premise:
MR STEWART: As a general matter, a payment from one business to another in exchange for the recipient’s agreement not to compete is an paradigmatic antitrust trust violation. . . . Reverse payments to settle Hatch-Waxman suits are objectionable for the same reasons that payments not to compete are generally objectionable. They subvert the competitive process by giving generic manufacturers an incentive to accept a share of their rival’s monopoly profits as a substitute for actual competition. . . . [T]he point here is that the money is being given as a substitute for earning profits in a competitive marketplace.
Some think of patent law as an exception to antitrust law and a number of courts have basically exempted would be collusive or anticompetitive conduct because the activity was conducted under the a patent shield. Justice Scalia focused on this point:
JUSTICE SCALIA: Mr. Stewart, do you have a case in which the patentee acting within the scope of the patent has nonetheless been held liable under the antitrust laws for something that it’s done acting within the scope of the patent?
MR. STEWART: Yes, if you adopt Respondent’s conception of what it means to act within the scope of the patent. And let me explain. When the Respondents say that the restrictions at issue here are within the scope of the patent, what they mean is that the goods that are being restricted are arguably encompassed by the patent and the restriction doesn’t extend past the date when the patent expires.
That’s all they mean. And if that were the exclusive test, the defendants in Masonite, in New Wrinkle, in Line Material, they would all have been off the hook, because all of those cases involved restrictions on trade in patented goods during the period that the patent was in effect, and yet, the Court found antitrust liability in each of these.
Answering that same question in his presentation, Jeff Weinberger disagreed:
MR. WEINBERGER: The answer to that question is no. All of the cases that have found violations of the antitrust laws based on a patent-based restraint do so because the object of the agreement, the restraint that’s being achieved in the agreement, is beyond the scope that could be legitimately achieved with a patent.
The incentive for a patentee to pay a generic challenger to keep off the market is at least partially governed by the chance that the patentee would lose the infringement litigation. At its core, this case should really about whether antitrust officials should take-into account the fact that a patent is likely-invalid or not-infringed when judging anticompetitive behavior. However, neither party supports that approach:
MR. WEINBERGER: The patent g[ives] the patent holder the legal right to exclude. So unless there’s a reason, there’s some reason to believe that it couldn’t reasonably assert that patent, it’s entitled to monopoly profits for the whole duration of the patent.
…
[Earlier] JUSTICE KENNEDY: And one way [to judge anticompetitive behavior] is to assess the validity or the strength of the infringement case?
MR. STEWART: We would say that that’s not a way
JUSTICE KENNEDY: That’s my concern, is your test is the same for a very weak patent as a very strong patent. That doesn’t make a lot of sense.
MR. STEWART: Well, [our proposed] test is whether there has been a payment that would tend to skew the parties’ choice of an entry date, that would tend to provide an incentive … for the generic to agree to an entry date later than the one that it would otherwise insist on. Now, it probably is the case that our test would have greater practical import in cases where the parties perceive the patent to be [invalid].
JUSTICE KENNEDY: Why wouldn’t that determination itself reflect the strength or weakness of the patent so that the market forces take that into account?
MR. STEWART: [unable to give a direct answer]
…
MR. WEINBERGER: I think our patent system depends upon the notion that you don’t evaluate from the perspective of the antitrust laws a patent restraint based upon whether you could have proved in a litigation that that patent was infringed.
. . .
JUSTICE SCALIA: You can’t possibly figure it out, can you, without assessing the strength of the patent? … And to say you can consider every other factor other than the strength of the patent is to leave out the the elephant in the room.
MR. WEINBERGER: I agree with that, Justice Scalia. I don’t think that an alternative test — the only alternative test that could be fashioned that would — that would make sense is one based on strength of the patent. But there are so many reasons that that is an undesirable result that I — I don’t think it’s the way this Court should go.
Justice Breyer was also clearly frustrated with the FTC’s proposed “overcomplicated” test as well as with the patentee’s insistence that reasonable invalidity and non-infringement arguments be ignored in the antitrust analysis.
MR. WEINBERGER: I’ve obviously given a lot of thought to whether there is any kind of an intermediary test that works, and I don’t believe there is.
As per his usual Justice Scalia found some amount of fault with Congress as well:
JUSTICE SCALIA: I have the feeling that what happened is that Hatch-Waxman made a mistake. It did not foresee that it would produce this kind of payment. And in order to rectify the mistake the FTC comes in and brings in a new interpretation of antitrust law that did not exist before, just to make up for the mistake that Hatch-Waxman made, even though Congress has tried to cover its tracks in later amendments, right, which -which deter these, these — these payments? . . . So, why should we overturn understood antitrust laws just to — just to patch up a mistake that Hatch-Waxman made?
In the end, the basic question for decision seems to be whether or not to presume that a reverse payment is anticompetitive. With Justice Alito’s recusal, I’m looking for a 4-4 tie that would simply reinforce the current circuit split.
More from Lyle Denniston and Lisa Larrimore Ouellette.