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`UNITED STATES DISTRICT COURT
`SOUTHERN DISTRICT OF NEW YORK
`------------------------------x
`
`In re Bystolic Antitrust
`Litigation 20 Civ. 5735 (LJL)
` Oral Argument
`------------------------------x
` New York, N.Y.
` November 3, 2022
` 10:00 a.m.
`
`Before:
`
`
`HON. LEWIS J. LIMAN,
`
`
` District Judge
`
`
`APPEARANCES
`
`GARWIN GERSTEIN & FISHER LLP
` Attorneys for Plaintiffs Smith
` and Direct Purchaser Class
`BY: KIMBERLY M. HENNINGS
`
`DICELLO LEVITT LLC
` Interim Co-Lead Class Attorneys
` for End-Payor Plaintiffs
`BY: ROBIN A. van der MEULEN
` -and-
`COHEN MILSTEIN SELLERS & TOLL, PLLC
`BY: SHARON K. ROBERTSON
`
`HANGLEY ARONCHICK SEGAL PUDLIN & SCHILLER
` Attorneys for Plaintiffs CVS and Rite Aid
`BY: BARRY L. REFSIN
`
`WHITE & CASE LLP
` Attorneys for Defendants
` AbbVie, Allergan, Forest and Watson
`BY: ERIC GRANNON
` ADAM M. ACOSTA
` CELIA A. McLAUGHLIN
` J. MARK GIDLEY
`
`ALSTON & BIRD LLP
` Attorneys for Defendant Glenmark
`BY: D. ANDREW HATCHETT
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`(Case called; appearances noted)
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`THE COURT: Good morning, counsel.
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`I'm prepared to hear argument on the various motions
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`to dismiss. I've got the parties' letter setting forth the
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`agenda. Pursuant to that, the defendants will have 75 minutes
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`to argue the motion to dismiss the direct purchaser and
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`retailer plaintiffs' third consolidated amended complaint,
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`which they can split between opening and rebuttal. And the
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`plaintiffs will also have 75 minutes.
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`I'll hear first from defendants. Why don't you let me
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`know, first of all, who is arguing, and second, how long you're
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`going to spend on opening. My courtroom deputy, if you want,
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`can give you a notice at two or three minutes or five minutes,
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`whatever your preference is.
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`MR. GRANNON: Good morning, your Honor. Again, Eric
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`Grannon, White & Case, for Forest Laboratories. I'll be
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`presenting the arguments on behalf of all defendants on the DPP
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`motion to dismiss.
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`A heads-up when five minutes is left would be great.
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`THE COURT: How much time do you want to spend in your
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`direct argument and how much time do you want for rebuttal?
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`MR. GRANNON: Preferably ten minutes, but I'll see how
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`the colloquy with the Court goes.
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`THE COURT: OK.
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`MR. GRANNON: I think it's more important to get out
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`all the points.
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`THE COURT: All right. We'll give you notice after
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`you've been arguing for about an hour. Why don't I hear you.
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`MR. GRANNON: Good morning again, your Honor. We
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`appreciate the time you've allotted today, and subject to any
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`issues on your mind that you'd like to discuss up front, my
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`plan is really to spend the bulk of our time walking through a
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`discussion of the amended allegations the settlement by
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`settlement. We hope that type of a granular discussion will
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`demonstrate why the amended allegations don't nudge plaintiffs'
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`claims across the line from conceivable, plausible, in the
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`words of Twombly, and I'd like to suggest just three brief
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`points to guide our discussion about the amended allegations
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`concerning these settlements.
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`The first one, your Honor, your Honor's order of
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`dismissal from January discusses, at pages 27 through 28 of the
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`slip opinion, how Twombly made the conspicuous choice to prefer
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`false negatives over false positives due to the potentially
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`enormous extent of discovery in antitrust conspiracy cases, and
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`it's beyond the purview of any of us here today to revisit that
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`first principle. Equally important, the Supreme Court
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`subsequently decided Actavis, six years later, against
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`Twombly's settled backdrop. That means, your Honor, if it's a
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`close call, Twombly dictates that we err on the side of
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`dismissing a meritorious claim rather than run the risk of
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`allowing a nonmeritorious claim to move forward. That's a very
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`conspicuous first principle in the law, your Honor.
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`The second point that I suggest guide our discussion
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`about the settlement allegations is that Actavis is the only
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`type of antitrust violation that, by definition, requires an
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`agreed exchange of financial consideration between the alleged
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`conspirators, and indeed, Actavis specifies the direction and
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`character of that financial consideration, i.e., a large,
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`unjustified payment from the innovator to the generic, as your
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`Honor noted.
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`To illustrate the importance of that financial
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`consideration element, your Honor, and how different it is from
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`other antitrust violations, picture this. You have a lemonade
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`stand and I have a lemonade stand. We agree to each charge 50
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`cents a glass for our lemonade. We've engaged in price fixing
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`and violated the Sherman Act. Same hypothetical, except this
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`time, what if instead of agreeing on prices, we agree that
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`you'll sell only to customers on your side of the street and
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`I'll sell only on the other. We've engaged in customer
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`allocation and violated the Sherman Act.
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`In each of those examples, your Honor, you and I, as
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`the antitrust defendants, might try to point to the fact that
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`we did not, in fact, each charge 50 cents per glass or respect
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`each other's customers, but we can only point to such facts to
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`contend that no agreement was ever reached. If the agreement
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`were conceded or effectively undeniable because we had reduced
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`it to a detailed, written contract, for example, our ensuing
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`pricing behavior or which of us sold to which customers would
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`be irrelevant to whether we violated the Sherman Act, because
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`in such cases our agreement on future conduct alone would, by
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`itself, constitute the antitrust violation.
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`Actavis is different, your Honor. Actavis holds that
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`there is only a potential antitrust violation from a patent
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`settlement if that agreement includes the requisite exchange of
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`large and unjustified financial consideration going from the
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`innovator to the generic. So if the innovator and the generic
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`agree to settle and allow the generic to enter only one day --
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`just one day -- prior to patent expiration, without exchanging
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`the requisite financial consideration, it's pencils down for
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`the antitrust analysis under Actavis, just the same as if the
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`parties had agreed to permit generic entry 19 years prior to
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`patent expiration.
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`THE COURT: Is your proposition that if there is such
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`an agreement to pay a large and unjustified amount and in
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`exchange for that promise to pay the large and unjustified
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`amount the generic withholds from challenging the patent,
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`settles the action, that if the payment is not made, there is
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`no antitrust violation?
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`MR. GRANNON: Yes, but let me explain why, your Honor.
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`The reason is because it's the agreement. It's not
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`the execution of that, but it's got to be abundantly clear that
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`that's what the parties were doing. And if you have a contract
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`that says I'm going to perform X for you for X amount of
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`dollars, that doesn't establish that. You need facts to
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`determine that the contract is overvalued. So it's not just
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`the exchange of contract. Because a fairly valued business
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`transaction contemporaneous with settlement in patent
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`litigation does not state an antitrust claim, your Honor. It's
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`very important that the financial consideration that triggers
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`the potential antitrust violation is anticompetitive because
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`it's a bribe. It's got to be a bribe, your Honor.
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`THE COURT: Yes, I understand that proposition. But
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`what I was pushing on is assume that it is a bribe, but the
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`bribe is not paid. Assume that there is abundant evidence that
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`there is no consideration that the generic is getting for the
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`payment from the branded other than the agreement that it's not
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`going to go into the market at an earlier time period than the
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`expiration of the patent, but the bribe isn't paid. In that
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`instance, is there an antitrust violation?
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`MR. GRANNON: My answer to you is the same, your
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`Honor, because I think I understand what you're getting at with
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`the hypothetical. It's not the execution of the bribe, the
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`performance of that ensuing contract; it's the bribe itself and
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`the agreement. But I want to be very clear that we're not
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`talking past each other.
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`When I say bribe, I don't mean doing business at the
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`same time as settling. I mean doing large and unjustified
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`overvalued business. So if they do a fairly valued transaction
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`at the same time as settling, that's not the bribe that Actavis
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`is talking about. And it's very important to understand that
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`that regs, the exchange of the large and unjustified financial
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`consideration that's the regs that Actavis cares about, and the
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`point that Actavis uniquely requires this agreement is
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`critical, on the bribe, your Honor, is critical to a Rule 12
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`analysis here. It's critical, because in the words of Iqbal,
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`the context-specific task that requires a reviewing court to
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`draw on its judicial experience and common sense means,
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`respectfully, your Honor, that the Court is supposed to take a
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`close look and effectively the kick the tires of the alleged
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`bribe to determine the plausibility of plaintiffs' allegation
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`by asking have the plaintiffs alleged facts -- not conclusions
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`but facts -- sufficient for the Court to conclude comfortably
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`that if those facts are taken as true, the relevant business
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`arrangement is so lopsided in favor of the generic, financially
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`speaking, that there's no reasonable way to infer that the
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`innovator would have entered into the business arrangement
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`absent the patent settlement, your Honor.
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`In other words, the alleged business transaction is
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`supposed to be really bad financially from the innovator's
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`perspective, and the plaintiffs have to allege facts to
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`sufficiently give the Court a plausibility yardstick to make
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`that determination from the face of the complaint as well as
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`from the provisions of the referenced agreements if they've
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`been produced.
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`As we cite on page 5 of our reply brief, for example,
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`the complaint in Actavis alleged that the innovator was paying
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`the generic ten times what the innovator previously had paid
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`for similar services. None of us here today would feel good
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`about paying ten times more for something than we'd previously
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`paid. That's a yardstick, your Honor, and it enabled the
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`Actavis court to conclude comfortably that the complaint
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`plausibly alleged a really crappy business arrangement for the
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`innovator.
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`Now, on the flip side, your Honor, the alleged
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`business arrangement is supposed to be a plausible windfall
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`from the generic's perspective, a sufficiently large windfall
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`that the Court can comfortably conclude that if the facts
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`alleged are taken as true the windfall plausibly made the
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`generic take a dive in the patent case. This windfall to the
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`generic to take a dive in the patent litigation is equally
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`important for the plausibility determination by Rule 12, your
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`Honor.
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`Picture this, your Honor. You're an underpaid
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`baseball player with the Chicago White Sox in 1919, and after a
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`hard-fought season, you and your teammates are offered $100,000
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`to throw the World Series, which, in 1919, certainly is real
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`money. But what if the alleged bribe were only $1,000, your
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`Honor? Under Iqbal, Twombly and Actavis, the Rule 12 court has
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`to be more skeptical of the plausibility of that allegation,
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`and more skeptical still if the alleged bribe were only $100.
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`I think you take my point.
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`THE COURT: I do take your point, but my follow-up
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`question to you is what is the measure of how large the payment
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`is? It surely can't be absolute dollars, because no two cases
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`are going to be alike. No two of the drugs of the innovator is
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`going to be alike. So what is the standard that a court is to
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`apply on a motion to dismiss?
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`MR. GRANNON: Well, your Honor, as your Honor's
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`January order got to this, and I have a module for you to
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`address why we see it a little bit differently on the
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`measurement of large. But just on a very high level, it's got
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`to be some large magnitude, certainly above the innovator's the
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`litigation cost and above the fair value of the services that
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`the generic provided if there's a business transaction. And
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`that's why it's really important, your Honor, to keep in mind
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`the difference between a case where there's a business
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`transaction and just a simpler case where there's just a
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`unilateral payment of dollars for nothing. That's very
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`different.
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`THE COURT: I understand that it has to be some
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`magnitude above the fair value of the business transaction.
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`And I'm asking you these questions, because you did disagree
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`with my opinion, so I'm giving you an opportunity to argue the
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`point.
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`What is the measure of how much above the fair value
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`of the business transaction? For example, do I judge it by the
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`annual revenue that the drug is going to get? And here, the
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`annual revenue is alleged to be a billion dollars a year. Do I
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`judge it by a percentage of the fair value? Twice, three
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`times? I'm searching for what the standard is in the law.
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`MR. GRANNON: I think we can look directly to Actavis
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`itself, your Honor, and I will address that module now, since
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`you've asked the question.
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`If we go directly to Actavis at page 159 and the
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`passage that your Honor quotes at page 29 of the slip opinion,
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`the Court says, the likelihood of reverse payment bringing
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`about anticompetitive effects depends on its size, and then
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`goes on to explain, its scale in relation to the payor's
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`anticipated future litigation costs.
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`To answer your question directly, your Honor,
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`certainly at sort of the left end of the spectrum, if you start
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`with the innovator's avoiding litigation costs, it's got to be
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`some order of magnitude larger than that.
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`THE COURT: That doesn't provide the Court very much
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`help. I realize that you're quoting the Supreme Court to me.
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`MR. GRANNON: Well, then I'll try to put a little more
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`meat on those bones.
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`The court, in Actavis, again said scale. It's not
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`talking about $1 versus $1.10. The court certainly had no
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`occasion to pass on the alleged payment of single-digit or even
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`low two-digit millions, for example. They were talking about
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`hundreds of millions of dollars, and we don't have anything
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`like that here, your Honor.
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`So if you look at the rest of what it says there, it
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`says independence from other services for which it might
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`represent payment. So it's certainly got to be above, as you
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`and I understood just a moment ago, well above whatever the
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`fair value that the generic is providing. To answer your
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`question, your Honor, it's got to be a whole lot bigger than
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`avoiding litigation costs and the fair value of exchange. But
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`we don't have any facts even close to that here, your Honor.
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`But it's not $1.10 versus $1. We're talking about an order of
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`magnitude.
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`That scale of the alleged bribe is important here,
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`your Honor, and that's why it's critical for the complaint to
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`provide the Court with facts sufficient to determine whether
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`the relevant business deal is bad enough. It's got to be
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`clear, bad enough for the innovator that it's a plausible
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`windfall sufficient to bribe the generic, and I have a tweak on
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`that earlier hypothetical.
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`Suppose rather than $100,000 the allegation were that
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`Shoeless Joe and his teammates were offered a large container
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`of shiny valuable objects or federation credits, for example.
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`The complaint would be failing to provide the Court the
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`yardstick necessary to kick the tires and determine the
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`plausibility of that allegation under Iqbal, Twombly and
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`Actavis.
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`The third brief point that I'd suggest is a guidepost
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`for discussing the settlements individually is specific to this
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`case in particular, your Honor. This is not the
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`run-of-the-mill antitrust conspiracy case where alleged
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`agreements were reached only orally in some backroom at a trade
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`association meeting. The alleged anticompetitive agreements
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`were all reduced to writing, in formal, detailed contracts, and
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`the plaintiffs received all of those agreements in early
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`discovery two years ago, in November 2020, at your direction
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`during the October 26, 2020, status conference. That early
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`discovery, your Honor -- this is important -- sets this case
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`apart from many other rev-risk cases, where all the plaintiffs
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`have is a press release, for example, announcing the settlement
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`at a high level of discretion of the contemporaneous business
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`transaction. The plaintiffs in those other cases, your Honor,
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`don't have the commercial agreements to inform the allegations
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`in their complaint.
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`So, for example, Judge White, in the Northern District
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`of California, recently observed in denying, in part, a motion
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`to dismiss in a reverse-payment case: "Because the terms of
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`the settlement are not part of the record, the plaintiff and
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`the court necessarily must rely on allegations about the
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`defendant's conduct to determine whether the existence of
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`reverse payment is plausible." That case is Jacksonville
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`Police Officers v. Gilead, and it's reported at 2022 WL 3579881
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`at *7. That's not this case, your Honor.
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`Here, plaintiffs have all the agreements, and each is
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`a formal, written contract that's susceptible of objective
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`valuation -- this is a very important point, your Honor -- by
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`knowledgeable persons in the pharmaceutical industry. To state
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`a plausible claim under Twombly, Iqbal and Actavis, it's
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`incumbent upon the plaintiffs to allege the facts demonstrating
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`that each of those agreements has an objectively unjustified
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`valuation that constitutes a large, unjustified payment. To
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`provide a high-level example of what I'm saying before we turn
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`to the first settlement, imagine, your Honor, an agreement has
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`an up-front payment of, say, $5 million, and that's followed by
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`subsequent milestone payments totaling $10 million over a
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`course of five years. The antitrust plaintiff needs to allege,
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`for example, that during the relevant period in the industry,
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`up-front payments were unheard of or it was entirely outside
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`the normal course in the industry for milestone payments to be
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`spread over five years or that an up-front payment constituting
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`one-third of the contract value is far outside the normal range
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`in the pharmaceutical industry or that other companies in the
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`industry have reached comparable agreements that were far less
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`expensive.
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`Those allegations would be comparable to the ones at
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`issue in Actavis, and importantly, your Honor, none of those
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`facts were within the peculiar possession or control of the
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`defendants. The susceptiblity of the agreements here in this
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`case to objective valuation is critical and distinguishes this
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`case from other reverse-payment cases. What I'm saying flows
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`directly from Actavis and the fact-based allegations of
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`unjustified valuation that were held plausible there, but I'd
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`like to provide the Court with three quick examples of SDNY
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`cases, including one of your Honor's own statements, that
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`dismissed, under Rule 12, due to the plaintiffs' failure to
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`allege facts that reasonably could have been obtained through
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`pre-complaint investigation.
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`Very quick examples, your Honor. The first case is a
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`reported decision by Judge Seibel in 2016 called Bautista v.
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`CytoSport. The plaintiff alleged there deceptive trade
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`practices because the plaintiff purchased the defendant's
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`protein powder and "was surprised and disappointed" that the
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`container had roughly 30 percent empty space. The plaintiff,
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`Bautista, alleged that the empty space was not used to protect
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`the product, is not necessary for enclosing the product or
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`because of settling. Relying on Iqbal, Judge Seibel reasoned:
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`"Here, plaintiff provides no facts rendering plausible his
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`naked assertion that the slack filling defendant's product is
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`nonfunctional. It may be challenging for a plaintiff to
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`present such facts before discovery, but where a claim is
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`valid, it is not impossible. For example, experts in the
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`relevant field can be consulted or comparisons to similar
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`products made." And that's at 223 F.Supp.3d 182, 191.
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`In 2021, Judge Abrams relied on Judge Seibel's
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`Bautista decision to dismiss a deceptive marketing case called
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`Rivera v. S.C. Johnson. In Rivera, your Honor, the plaintiff
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`alleged that a variety of Windex marketed as environmentally
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`friendly was actually toxic based on some of its chemical
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`ingredients. But the plaintiff relied on information and
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`belief because the concentrations of the various chemical
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`ingredients in the Windex was not public. Relying on Twombly
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`and Iqbal, Judge Abrams reasoned: "The fact that the products
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`can be purchased at stores as ubiquitous as Target and tested
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`suggests that basic facts about their chemical composition is
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`not something exclusively in the control of defendant. At the
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`very least, the complaint could contain allegations as to why
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`such testing would not have been possible here -- it does not."
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`Judge Abrams then quoted portions of Judge Seibel's
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`Bautista decision, observing that "plaintiffs could have
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`consulted with experts in the field who might have been able to
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`provide even minimal support for their bald assertion that 'the
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`ingredients' likely concentrations or percentages by weight'
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`are sufficient to cause harm." 2021 WL 4392300 at *6.
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`Now, your Honor, this is important. There's no
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`question that the plaintiff in Rivera could have obtained the
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`concentrations of ingredients in discovery from S.C. Johnson,
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`but Judge Abrams held that the plaintiff did not do enough
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`pre-complaint investigation so that the case was appropriate
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`for dismissal under Rule 12.
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`The third example is your decision, your Honor,
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`Budhani v. Monster Energy, which concerned defendant's alleged
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`misrepresentation --
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`THE COURT: I know the case.
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`MR. GRANNON: -- vanilla bean extract, but just for
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`the record, your Honor, as you recall, the complaint relied on
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`the so-called gas chromatography-mass spectrometry test, which
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`your Honor found insufficient because it revealed merely that
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`vanilla from the beans contributes 49 percent of the vanilla
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`but not all or most of the flavor. After repleading, as I'm
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`sure your Honor recalls, your Honor dismissed the amended
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`complaint with prejudice because the plaintiff failed to "add
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`factual allegations regarding the amount of natural vanilla in
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`the product. Rather, plaintiff sprinkles the terms 'trace' and
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`'negligible' into the third amended complaint as if they are
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`magic words that can cure the previous complaint's deficiencies
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`and are not conclusory assertions." Obviously, you know your
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`own cite, your Honor. Again, there's no question that the
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`plaintiff in Monster Energy could have obtained the precise
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`amount of vanilla bean extract in discovery from the defendant.
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`But your Honor held that the plaintiff did not do enough
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`pre-complaint investigation so the case was appropriate for
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`dismissal under Rule 12.
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`THE COURT: Are you suggesting that -- I may be
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`jumping ahead -- but that if the plaintiff was able to put
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`forward an expert to say, listen, I've looked at the patents in
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`the Torrent agreements and those patents are worth dramatically
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`less than what was paid and this contract is unusual for a
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`contract in the industry, allegations like that might be able
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`to state a claim?
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`MR. GRANNON: I'm going to say yes, but there's a big
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`comma after that "yes," your Honor. It's not the fact that
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`it's an expert. It's not the fact that it's expert. They
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`don't have to name the expert in the complaint, your Honor.
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`What has to happen is they have to give some nod to the facts
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`that the expert would rely on to make that conclusion, your
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`Honor. It's the facts. It's not what you need in summary
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`judgment and you actually need the expert opinion. So that's a
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`very important point that I'm saying. It's the facts that if
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`they're not able to do it on their own, it can't be agreed
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`upon, all I'm saying, your Honor, is that there is a path
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`forward in the pharmaceutical industry. And that applies with
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`particular force here, your Honor -- again, because they have
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`all the agreements, and these plaintiffs, your Honor, are
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`sophisticated companies. Some of them have annual revenues
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`well beyond any defendant here. And furthermore, each of these
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`plaintiffs is a repeat, if not regular, plaintiff, on a
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`reverse-payment basis.
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`For example, plaintiff Smith Drug has been a plaintiff
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`in at least four other reverse-payment cases. And plaintiff
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`KPH has been a plaintiff in at least seven other
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`reverse-payment cases, including six pending cases, your Honor.
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`And plaintiff KPH is proceeding by assignment from McKesson,
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`whose most recent annual revenue was $264 billion. So it's not
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`exactly a widows and orphans case, your Honor. In any event, I
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`think you understand why I made those examples, but what they
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`do is they belie plaintiffs' refrain on page 1, page 2, and
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`throughout their opposition brief, and repeatedly, that without
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`discovery no antitrust plaintiff could do more.
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`With those three points, your Honor, if we're on the
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`same page with those, I'd like to start with Hetero, if you're
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`ready.
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`THE COURT: Yes.
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`MR. GRANNON: If I could draw your Honor's attention
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`to plaintiffs' opposition brief, I'd like to start with the
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`bulleted summary on page 13 of plaintiffs' opposition that
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`carries over to page 14. I'm going to address each of those
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`bullets, so it's OK if you don't have it right there. These
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`bullets basically summarize plaintiffs' argument as to why
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`their amended allegations on Hetero should suffice. And the
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`first bullet on page 13 of plaintiffs' opposition says, just
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`seven months prior to Hetero final term sheet, Forest entered
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`into an all requirements contract with Janssen covering U.S.
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`and Canadian markets that ran through December 2021 with the
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`potential for renewal, rendering it unlikely that Forest had a
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`legitimate need for additional API.
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`Now, the Court already ruled, on page 39 of your
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`Honor's January order, "alleging that Forest had been acquiring
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`API from another source, i.e., Janssen, it is insufficient to
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`raise a plausible inference that Forest had no need for another
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`source of supply or that API's supply agreement with Hetero is
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`unjustified."
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`The second bullet on page 13 of plaintiffs' opposition
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`says, Absent the need to compensate Hetero in exchange for an
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`agreement to delay generic entry, it's unlikely that Forest
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`would have decided to shift 50 percent of its requirements away
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`from a manufacturer, Janssen, that had longstanding experience
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`with Bystolic. This allegation is just a repackaging of the
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`first bullet on Forest's actual need and has literally nothing
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`to do with the unjustified valuation vel non of the Hetero term
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`sheet. Moreover, as your Honor ruled on page 40, footnote 11,
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`of your January order, having referenced the Janssen agreement
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`in their complaint, plaintiffs are charged with taking this
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`provision into account under Rule 12 -- this is very important,
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`your Honor -- the meet-or-release provision in section 4.3 of
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`the preexisting Janssen contract, not the meet-or-release
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`provision in the Hetero term sheet, your Honor, but the
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`preexisting contract with Janssen, that provision demonstrates
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`that Forest had demonstrable interest in potentially shifting
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`supply away from Janssen to an alternative supplier.
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`Now, the meet-or-release provision of the Janssen
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`contract is critical, so I want to provide a very clear
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`citation. It's Carney exhibit 3, ECF 270-3, and section 4.3 is
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`on page 27

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