the growing consensus in the antitrust treatment of pharmaceutical settlement agreements david a....
TRANSCRIPT
The Growing Consensus in the Antitrust Treatment of
Pharmaceutical Settlement Agreements
David A. Balto The FDA Symposium Cambridge, MA
August 23, 2007
2
Consensus?
• Agreements within patent right are permissible
• Impossible to determine patent validity post hoc
• Patents are NOT “probabilistic” rights
• Reverse payments are not “red flags”
3
Continuing risks?
• Continuing FTC Vigilance and Possible Litigation
• Proposed Legislation
• Second Circuit decision in Cipro
• Continued litigation: K Dur, Cipro, Plavix, Provigil
4
Patent Settlement Cases: Emerging Themes
• Courts have had a tendency to give greater deference to settlement agreements, see e.g.:
• In re Tamoxifen Citrate Antitrust Litigation, 429 F.3d 370 (2d. Cir. 2005)
• In re Ciprofloxacin Hyrochloride Antitrust Litigation, 261 F. Supp.2d 188 (E.D.N.Y., May 20, 2003)
• Valley Drug Company v. Geneva Pharmaceuticals, Inc., 344 F.3d 1294 (11th Cir. 2003)
• Asahi Glass Co. Ltd., v. Pentech Pharmceuticals, Inc., 2003 WL 22462405 (N.D. Ill. Oct. 29, 2003)
• In re Cardizem CD Antitrust Litigation, 332 F.3d 896 (6th Cir. 2003)
• Schering Plough Corp. v. FTC, 402 F.3d 1056 (11th Cir. 2005)
5
What are Exclusion Payment Settlements?
• Parties enter into an interim or final settlement• Exclusion Payment (or reverse payment)
– Generic agrees to refrain from going to market until a date certain and
• Settlement includes payment or other consideration from the brand to the genericSettlement may include agreements that generic:– Will not go to market with any non-infringing product– Will not relinquish its rights to the 180-day exclusivity.
6
Different Approaches
Per Se Illegal: In re Cardizem, 332 F.3d 896 (6th Cir. 2003)
Rule of Reason: Schering Plough v. FTC, 402 F.3d 1056 (11th Cir. 2005);
Valley Drug v. Geneva, 344 F.3d 1294 (11th Cir. 2003)
Per Se Legal? Tamoxifen Citrate Antitrust Litig., 429 F.3d 370
(2d Cir. 2005)
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FTC approach
• We can’t and should not litigate the underlying patent
• Patent is not an absolute right; its a probablistic right – the opportunity to exclude
• Reverse payments distort the generics incentives to bargain for the earliest possible entry date
• The existence of a nontrivial reverse payment suggests competition was compromised and there was a more procompetitive settlement
8
FTC’s Settlement Cases
• Abbott/Geneva (2000) - consent order• Hoechst/Andrx (2001)- administrative
litigation and consent order• Schering/Upsher-Smith/AHP- administrative
litigation, reversed by 11th Circuit• Bristol-Myers Squibb (BuSpar) (2002)-
consent order
9
The Problem with Exclusion Payment Patent Settlements
• Entry is later than would be expected absent the payment
• Sharing supracompetitive profits, not the patent, secures the delay
• The best evidence is the parties’ actions, the competitive landscape, and the settlement terms
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Incentive to Pay for Delay
Monopoly
Incumbent’sProfits
Payment to
Entrant
Incumbent’s Profits
Retained MonopolyExpected Competition
Entrant’s Profits
Consumer Savings
Incumbent’s Profits
11
FTC approach: Settlement “Red Flags”
• Payments from patent holder to alleged infringer and generic’s agreement not to market its product.
• Restrictions on generic’s entry with non-infringing products
• Restrictions on generic’s ability to relinquish 180-day exclusivity
12
Impact of Antitrust Investigations
1992 - 1999
5 Settlements without a payment
9 Settlements with a payment
2000 - 2001
0 Settlements with a payment
6 Settlements without a payment
Late 1999:InvestigationsBecome Public
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Notification of Agreements
Medicare Modernization Act, P.L. 108-173, Title XI
– Requires notification to FTC + DOJ
– Agreements between “brand name” manufacturers and generic applicants (with par. IV certification) regarding
• (1) Manufacture, marketing or sale of brand name or generic or
• (2) 180-day exclusivity
– Agreements between generic applicants (with par. IV certification)
• Regarding the 180-day exclusivity period
– Within 10 business days after execution and before commercial marketing of generic drug
– Subject to $11,000 per day civil penalty
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Types of Agreements that Must Be Filed
• Agreements, including settlements, “interim settlements,” stipulations
– To stay off the market for any period of time, including
– In exchange for extending a briefing schedule
– Pending a court decisionto avoid the need for a temporary restraining order
– Transfer of ANDA
– Introduction of authorized generic
– Production
– Co-promotion
– 180-day exclusivity
15
Agreements Reported in 2004
• FTC Report March 2005• 17 agreements reported• 11 resolved a patent dispute between the
brand and the generic -None of those 11 included both a payment to
the generic and a restraint on generic’s entry• 3 involved agreements between generic
competitors
16
Agreements Reported in 2005
20 Agreements Filed
Brand-Generic Agreements
Interim Agreements During Brand-Generic
Patent Litigation
No generic marketing
pending courtdecision
Generic-Generic Agreements
Final Settlements of Brand-Generic Patent Litigation
Stay litigationand be boundby result with
first filer
Settlements Involving and ANDA
1st Filer
OtherSettlements
SettlementsInvolving a
Subsequent Filer
141
11
416
5
55
17
Agreements Filed Pursuant to the Medicare Modernization Act
Breakdown of Final Settlements by Type of Payment – FY 2005
Generic Receives Royalties for Co-
promoting Brand Product
Royalty to the Brand
Compensation to Both Parties (Royalty to the Brand)
Brand Agrees Not to Launch a Generic During
the 180-day Exclusivity
Generic Receives Rights to Launch Authorized Generics
for Unrelated Products
No Restriction on Generic EntryRestriction on Generic Entry
Payment to the Generic
No Payment
11 Brand-Generic Agreements Filed
74
22331
1 11
No Payment
18
Agreements Filed Pursuant to the Medicare Modernization Act
Overall Breakdown of Agreements Filed under the MMA in FY 2006
46 Agreements Filed
Brand-Generic Agreements
Interim Agreements During Brand-Generic
Patent Litigation
Generic-Generic Agreements Other
8136
8
Final Settlements of Brand-Generic Patent Litigation
Settlements Involving and ANDA
1st Filer
OtherSettlements
SettlementsInvolving a
Subsequent Filer
4
28
1311
19
Agreements Filed Pursuant to the Medicare Modernization Act
Breakdown of Final Settlements by Type of Payment – FY 2006
Generic Received Payment as Part of “Side
Deal”
Royalty to the Brand
Payment to Generic
Brand Agrees Not to Launch a Generic During
the 180-day Exclusivity and/or sold litigation
expenses
Generic Receives only saved litigation expenses
No Restriction on Generic EntryRestriction on Generic Entry
Payment to the Generic
No Payment
28 Brand-Generic Agreements Filed
820
143146
1 310
No Payment
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• BUT HOW DOES THEORY SELL IN THE COURTS?
21
Valley Drug (11th Cir. 2003)• Eleventh Circuit overturned the District Court
- Lower court had ruled that Geneva’s agreement with Abbott Laboratories not to sell or distribute a generic version of Abbott’s hypertension drug Hytrin was a per se violation of the antitrust laws
• In its decision, 11th Circuit Court rejected 6th Circuit ruling in Cardizem based on similar facts
• 11th Circuit ruled that Abbott’s patent covering terazosin hydrochloride, the compound underlying Hytrin, already gave it the right to exclude others from making, using or selling the drug
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22
Valley Drug
• Reasons for rejecting the per se condemnation- Automatic per se condemnation will chill settlements - Existence of payments between brand and generic
firms are not automatic violation of antitrust laws - Restricting settlement options will increase cost of
patent enforcement - Automatic per se condemnation may impair
incentives for disclosures and innovation - Courts must look at circumstances, details, and logic
of restraint before condemning agreements
23
Valley Drug
• “[b]y restricting settlement options, which would effectively increase the cost of patent enforcement,”
• a per se rule barring reverse payment settlements “would impair the incentives for disclosure and innovation.”
24
Valley Drug• District Court’s failure to consider exclusionary power
of Abbott patent fatally undermined its antitrust analysis and ultimate per se condemnation of agreements
- Test should be whether conduct/restraint is within the scope of the patent
- Within the scope of the patent- no antitrust liability- Outside the scope of the patent- per se or rule of reason treatment based on
underlying facts behind the restraint
• Remanded case for further fact finding and consideration of Plaintiff’s challenges to provisions of the agreements, including a prohibition against Geneva’s marketing of “any” generic terazosin product
25
Valley Drug Three Part Test
1. “The scope of the exclusionary potential of the patent.”
2. “The extent to which the agreements exceed that scope.”
3. “The resulting anticompetitive effects.”
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Valley Drug Remand First, “the exclusionary scope of the ‘207 patent” must be examined in
order to determine “the extent of the protections afforded to Abbott”
Second, the court must evaluate “the likely outcomes” of the underlying patent litigation, including the likelihood of patent validity issue.
Lastly, the court must determine whether the settlement represented a “reasonable implementation of the protections afforded by the ‘207 patent, in light of the applicable law, then pending litigation, and the general policy justifications supporting settlements of intellectual property disputes.” Id at 1295-96
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Valley Drug Remand
On remand find agreement per se illegal“While [Abbott and Geneva] could have
structured their Agreement in a less restrictive way that reasonably implemented Abbott’s patent protections, they instead agreed to a restraint that surpassed that which the patent would have allowed.”
In re: Terazosin Hydrochloride Antitrust Litigation, 352 F. Supp.2d 1279, 1318-19 (S.D. Fla. 2005)
28
Schering v. FTC (11th Cir. 2005)
• Settlement of patent suit – Schering manufacturers K-Dur 20– Patent expires in 2006– Upsher files ANDA in 1997– Schering sues for infringement—parties settle
• Upsher allowed to enter market in 2001• Schering pays Upsher $60 million• Upsher licenses rights to 6 products to Schering
– Payment to stay off market between Schering and ESI Lederle
29
Schering v. FTC
• ALJ dismisses complaint / FTC staff appeals to full commission
• Commission agrees that settlement harmed consumers by eliminating generic competition– But for Schering’s payment, there was
another settlement that would have been reached that would have resulted in earlier entry
30
Schering – 11th Circuit
• Reverses FTC in 7 weeks; court referred to the Commission as:
• “naive” (p. 34)• “myopic” (p. 37)• “inflexible” (p. 39),• and asked the FTC to be “mindful” of the law
and policy going forward (p. 43).
31
Schering-Plough v. FTC(11th Cir. 2005)
• FTC relied on the “untenable supposition that without a payment there would have been a settlement with earlier entry.
• “Although the exclusionary power of a patent may seem incongruous with the goals of antitrust law, a delicate balance must be drawn between two regulatory schemes….
[Antitrust law…cannot discounts the
rights of the patent holder.”
• “The proper analysis not turns to whether…the challenged agreements restrict competition beyond the exclusionary effects of the patent.”
• See also Andrx Pharms. v. Elan Corp. (11th Cir. 2005) – reversing dismissal on pleadings
32
FTC- Schering
• First, according to the Commission, “[i]f there has been a payment from the patent holder to the generic challenger, there must have been some offsetting consideration.”
• Second, the Commission concludes “that the quid pro quo for the payment was an agreement by the generic to defer entry beyond that date that represents an otherwise reasonable litigation compromise.”
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Schering- 11th Circuit
“The Commission’s opinion requires the conclusion that but for the payments, the parties would have fashioned different settlements with different entry dates…The Commission rationalizes its decision not to consider the exclusionary power of the patent by asserting that the parties could have attained an earlier entry with out the role of payments.”
“There is simply no evidence in the record, however, that supports this conclusion”
34
Schering – 11th Circuit• Patent settlements are beneficial – therefore conditions of settlement
are legal if ancillary to the settlement– Court eschews what it characterizes as per se illegality for reverse payments– Settlements save costs of litigation and satisfy risk averse litigants– Courts should hesitate to second guess aspects of settlements
• “The proposition that the parties could have ‘simply compromised’ on earlier entry dates is somewhat myopic, given the nature of patent litigation and the role that reverse payments play in settlements.”
• “[w]ithout any evidence to the contrary, there is a presumption that the 743 patent is a valid one, which gives Schering the ability to exclude those who infringe on its product.”
• Size does not matter - "the size of the payment, or the mere presence of a payment, should not dictate the availability of a settlement remedy."
35
FTC v. Schering-Ploughcert. denied (Sup. Ct. 2006)
FTC: “This case puts into sharp focus an issue that is fundamental to antitrust doctrine in the Hatch-Waxman context: whether a branded drug seller can buy protection from potential generic competition so long as the competition excluded falls within the nominal scope of a non-sham patent claim.”
DOJ: “This case…does not present an appropriate opportunity for this Court to determine the proper standards for distinguishing legitimate patent settlements, which further the important goals of encouraging innovation and minimizing unnecessary litigation, from illegitimate settlements that impermissibly restrain trade in violation of the antitrust laws.”
36
FTC / DOJ Amicus (2004)
Is there a conflict between Cardizem and Valley Drug:
The better reading of the Sixth Circuit’s opinion is that it does not deem illegal per se every settlement agreement that includes a reverse payment in exchange for the exclusion from the market of an allegedly infringing product…If construed {otherwise} the court of appeals’ decision would be erroneous.
Brief for the United States Amicus Curiae, at 12, Andrx Pharm., Inc. v. Kroger Co., (S. Ct. July 2004), No. 03-779 (emphasis added)
1
37
Cipro III
• Bayer holds patent on Cipro, expiring in December 2003• Barr files ANDA for generic Cipro in 1997 – Bayer sues
for patent infringement• Bayer pays $49 million to settle suit and keep Barr’s
product off the market• Barr agrees to change ANDA IV status of generic Cipro
application to ANDA III• Bayer makes quarterly payments (reverse payments) to
Barr, totaling nearly $400 million over 5 years
In re Ciprofloxacin Hydrochloride Antitrust Litigation, __ F. Supp.2d__, 2005 WL 736604 (E.D.N.Y. Mar. 31, 2005)
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Cipro• Direct and indirect purchasers sue for damages
under Sherman Act § • Cipro II – Agreements not per se illegal
– Parties did not place restrictions outside the scope of the patent
– Large settlement amount may reflect risk aversion of patent holder rather than belief in the patent’s invalidity
• Cipro III – Agreement withstands rule of reason scrutiny – 3-step Valley Drug inquiry– Court need not engage in post hoc determination of
potential validity of underlying patent
39
Cipro
“Unless and until the patent is shown to have been procured by fraud, or a suit for its enforcement is shown to be objectively baseless, there is no injury to the market cognizable under existing antitrust law, as long as competition is restrained only within the scope of the patent.” Cipro III, 2005 WL 736604 at *18
40
Cipro – Litigant risk aversion
“[T]he fact that Bayer paid what in absolute numbers is a handsome sum to Barr to settle its lawsuit does not necessarily reflect a lack of confidence in the ‘444 Patent, but simply the economic realities of what was at stake.” Cipro III, 2005 WL 736604 at *22
41
Cipro (EDNY 2005)
No post facto inquiry:• “it is inappropriate for an antitrust court, in determining the
reasonableness of a patent settlement agreement, to conduct an after the fact inquiry into the validity of the underlying patent. Such an inquiry would undermine any certainty for a patent litigants trying to settle their disputes.
• In addition, exposing the parties to a patent settlement agreement to treble antitrust damages simply because the patent is later found to be invalid would overstep the bright-line rule adopted by the Supreme Court in Walker Process.”
42
Cipro
No “public property right “ in requiring litigation
“This concept of a public property right in the outcome of private lawsuits does not translate well into the realities of litigation, and there is no support in the law for such a right. There is simply no legal basis for restricting the rights of patentees to choose their enforcement vehicle (i.e., settlement versus litigation).”
43
Cipro
“ Requiring parties to a lawsuit either to litigate or negotiate a settlement in the public interest, at the risk of treble damages is, as a practical matter, tantamount to establishing a rule requiring litigants ‘to continue to litigate when they would prefer to settle’ and ‘to act as unwilling private attorneys general and to bear the various costs and risks of litigation.” Slip op. at 38-39
44
Cipro
Reverse payments can not demonstrate illegality: • "the FTC's now vacated rule that exclusion payments
beyond litigation costs are always illegal should be rejected because it ignores the justified needs of the patent holder in the face of the risks of litigation, especially in an arena where it is well-known that courts are far from error free. The test for determining the validity of the so-called reverse or exclusion or exit payment and the only question remaining is whether the Agreements constrained competition beyond the scope of the patent claims." Slip p. at 57-58.
45
In re Tamoxifen Citrate Antitrust Litig.(2d Cir. Nov. 2005, amended Aug. 2006)
• The terms of the settlement enlarge the scope of the patent monopoly, or
• The patent was procured by fraud or the underlying infringement lawsuit was objectively baseless
Unique facts not likely to be repeated given changes in FDA, patent law
Settlement after trial included reverse payments and made Barr an “authorized generic”
Settlements even with large reverse payments, are in public interest, will violate the antitrust laws only if
46
Tamoxifen
• the central criteria to the “legality of a patent settlement agreement is whether it ‘exceeds’ the ‘scope of the patent protection.’”
• The plaintiff “must show that the settlement litigation was a sham, i.e., objectively baseless, before the settlement can be considered an antitrust violation”
• The plaintiff must allege facts that, if proven, would establish the settlement agreement provided the defendants have benefits that exceeded the scope of the Tamoxifen patent
47
Tamoxifen: Plus factor?
• In the Hatch-Waxman context, the balance of risk and benefits is totally different.
• Alleged infringer has little costs or risks; brand name manufacturer has substantial risks
• Due to asymmetries of risk reverse payments are to be expected
48
Tamoxifen: Reverse payment
• “there is something on the face of it that does seem ‘suspicious’ about a patent holder settling patent litigation against a potential generic manufacturer by paying that manufacturer more than either party anticipates the manufacturer would earn by winning the lawsuit”
• But patent holder faces great risks “it might therefore make some economic sense for the patent holder to pay some portion of that difference to the generic manufacturer to maintain the patent-monopoly market for itself. And if that amount exceeds what the generic manufacturer sees as its likely profit from victory, it seems to make obvious economic sense for the generic manufacturer to accept such a payment if it is offered.”
49
FTC v. Warner-Chilcott• Allegations:
– Barr planned to introduce generic W-C Ovcon oral contraceptive
– W-C plan to switch patients to new chewable product delayed
– W-C paid Barr $20 M to be available as second supplier, not complete
– A “naked agreement not to compete”
• Defenses:
– Product market includes all oral contraceptives
– Introductions of generic would end sampling and discounts, not lead to lower prices
– Exclusive supply agreement was procompetitive
50
Latest Word from the FTC• “Where a patent holder makes a payment to a challenger to induce it to agree
to a later entry that it would otherwise agree to, consumers are harmed either because a settlement with an earlier entry date might have been reached, or because continuation of the litigation without settlement would yield a greater prospect of competition.”
FTC Testimony Before U.S. Senate Special Committee on Aging (July 20, 2006)
• “We should think about a two-pronged approach: first look for appropriate enforcement cases which may create a clearer split in the circuits; second, encourage Congress to act.”
FTC Commissioner Jon Leibowitz (Apr. 24, 2006)
• It’s apparent that drug companies aren’t especially worried about the FTC threat since they continue to negotiate new patent settlements. But ‘they do so at their own peril.”
FTC Chariman Deborah Majoras (Sep. 1, 2006)
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Pending Legislation
• Three approaches– Absolute ban on “exclusion payments” i.e.,
“anything of consideration”– Ban with exceptions, e.g., litigation costs– Spector proposal – antitrust review by patent
court judge– -S.316– H.R. 1432, H.R. 1902
52
Pending Legislation
• Would amend FTC Act to make it an “unfair method of competition” to agree to settle litigation if the ANDA filer
– receives “anything of value” and
– agrees “not to research, develop, manufacture, market, or sell the ANDA product for any period of time”
• OK if “value paid” is “no more than the right to market the ANDA” before patent expiration
• Sens. Kohl, Leahy, Grassley + Schumer
• FTC: “we strongly support the intent behind S. 3582…would welcome the opportunity to work with Congress:
S. 316 “Preserve Access to Affordable Generics Act”
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The emerging consensus
• Public Policy Favors Patent Settlements
• Settlements within the scope of the patent are legal
• Patents are presumed legal• The existence and size of the reverse
payment is irrelevant
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Principle I: Public Policy Favors Patent Settlements
• “The efficiency-enhancing objectives of a patent settlement are clear, and public policy strongly favors settlement of disputes without litigation.” Schering v. FTC, 402 F.3d 1056, 1072-73 (11th Cir. 2005).
• “[R]estricting settlement options, which would effectively increase the cost of patent enforcement…would impair the incentives for disclosure and innovation.” Valley Drug v. Geneva Pharms., Inc., 344 F.3d 1294, 1308 (11th Cir. 2003).
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“In the context of patent litigation,…the anticompetitive effect [of a pioneer-generic settlement agreement] may be no more broad than the patent’s own exclusionary power.” Schering, 402 F.3d at 1064.
Principle II: Settlements Within Scope of Patent are Legal
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Principle II: Settlements Within Scope of Patent are Legal
Courts consider settlements that allow for entry on or before the patent expiration date and involve only those products that are claimed by the patent to be per se legal.– Schering, 402 F.3d at 1064-65– Valley Drug, 344 F.3d at 1310– In re Ciprofloxacin Hydrocloride Antitrust Litig, 363 F. Supp.
2d 514, 540 (E.D.N.Y. 2005) (Cipro III)– Asahi Glass Co. v. Pentech Pharms., Inc., 289 F. Supp. 2d
986, 994 (N.D. Ill. 2003) (Posner, J.)
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“[A patentee] enjoys the presumption of validity that attaches to an issued patent, is entitled to defend the patent’s validity in court, to sue alleged infringers, and to settle with them, whatever its private doubts, unless a neutral observer would reasonably think either that that patent was almost certain to be declared invalid, or the defendants were almost certain to be found not to have infringed it.” Asahi Glass, 289 F. Supp. 2d at 993.
Principle III: Patents are Presumed Valid
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Principle III: Patents are Presumed Valid
• Courts reject view that patents confer probabilistic rights. Asahi Glass, 289 F. Supp. 2d 992-93.
• Courts are unwilling to conduct post hoc investigations into validity. Cipro III, 363 F. Supp. 2d at 539; Asahi Glass, 289 F. Supp. 2d at 992.
• Even subsequent invalidity of a patent is “insufficient to render the patent’s potential exclusionary effects irrelevant to the antitrust analysis.” Valley Drug, 344 F.3d at 1309.
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Principle IV: The Size of a Reverse Payment is Irrelevant
• No plaintiff has successfully based antitrust liability on the size of the payment.
• Courts are rejecting the claim that the size of a payment is evidence of exclusionary intent– Schering, 402 F.3d at 1075.– Cipro III, 363 F. Supp. 2d at 539– Tamoxifen
• Settlements are evaluated based on parties’ understanding at the time of settlement. Asahi Glass, 289 F. Supp. 2d at 991.
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• “[A reverse payment] does not necessarily reflect a lack of confidence in the [patent], but simply the economic realities of what was at stake.” Cipro III, 363 F. Supp. 2d at 539.
• “[T]he FTC’s now-vacated rule that exclusion payments beyond litigation costs are always illegal should be rejected because it ignores the justified needs of the patent holder in the face of risks of litigation.” Id. at 539-40.
Principle IV: The Size of a Reverse Payment is Irrelevant
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7 11 2 7 $237million
$1.5billion
CASES DAMAGES PAIDTOTAL DAMAGES
RISKS OF ANTITRUST LITIGATIONPatent Settlement Cases v. Intellectual Property Cases
Antitrust Settlement Litigation
Intellectual Property Litigation
62
High Risk
• Naked payments from patent
holder to infringer• Belt and suspenders approach• Agreements not to market other non-infringing
products• Restrictions on generics’ ability to relinquish
180-day exclusivity• Other controls on generic
competition – market division, price fixing
IN HOT WATER!
63
Moderate Risk
• Legitimate side agreement– Earlier entry on other drugs– Generic – branded supply
agreement– Upsher/Schering arrangement
• Noerr-Pennington Protection– Secure court approval– FTC/State involvement
• Assure entry by later generics
ROCKY WATERS
64
Totally Safe
• Early Entry Date
• Small payment for cost of litigation
SMOOTH SAILING!
65
Practical Considerations• Do you want to trade patent litigation for antitrust litigation?
– Risk of action by FTC, disadvantaged competitor, direct/indirect purchasers
– Who picks forum?
• FTC “Red Flags”
– Payments from patent holder to alleged infringer/”anything of value”
– Restrictions on generic entry with non-infringing product or generic’s ability to relinquish 180-day exclusivity
– Restrictions on introduction of “authorized generic”
• FTC “Safe Harbor”
– Compromise time of entry without payment to infringer
– Payment of less than $2 million or expected litigation costs
– Royalties (what about sole license, supply agreement?)
• What would happen in absence of agreement?
– Timing of likely entry, impact on other entrants
– Efficiencies: avoiding litigation, payment to cash-starved generic
66
Practical Considerations• License Terms
– Exclusive, sole or non-exclusive; royalty terms
– Market entry on a date certain; impact of pediatric exclusivity
– Supply arrangements, joint promotion
• Side Deals
– Cross license other products; other business dealings
• Form of Settlement
– Admissions of infringement and/or validity
– Dismissal with or without prejudice
– Settlement agreement in court order
– Cooperation during FTC review; effect if FTC questions/challenges agreement
• Uncertainties
– Likelihood of success in litigation, generic entry “at risk,” FDA approval, next generation products, authorized generic
– Legal landscape unsettled – courts v. FTC. what is “anything of value”?
67
Questions?
David A. Balto2600 Virginia Avenue, NW
Suite 1111Washington, DC 20037