Opinion
Master 20-1076-CFC
07-05-2022
In re Seroquel XR (Extended Release Quetiapine Fumarate) Antitrust Litigation This Document Relates to: All Actions
Carmella P. Keener, COOCH AND TAYLOR, P.A., Wilmington, Delaware; Bruce E. Gerstein, Joseph Opper, Kimberly M. Hennings, Daniel Litvin, GARWIN GERSTEIN & FISHER LLP, New York, New York; Peter R. Kohn, Joseph T. Lukens, FARUQI & FARUQI, LLP, Philadelphia, Pennsylvania; David F. Sorensen, Caitlin G. Coslett, BERGER MONTAGUE PC, Philadelphia, Pennsylvania; Stuart E. Des Roches, Amanda Hass, Chris Letter, Dan Chiorean, Thomas J. Maas, ODOM & DES ROCHES, LLC, New Orleans, Louisiana; Susan C. Segura, Erin R. Leger, David C. Raphael, Jr, SMITH SEGURA RAPHAEL & LEGER, LLP, Alexandria, Louisiana; Russell A. Chorush, HEIM PAYNE & CHORUSH, LLP, Houston, Texas Interim Lead Counsel for the Direct Purchaser Class and Counsel for Plaintiff J M Smith Corporation d/b/a Smith Drug Company. Michael J. Barry, GRANT & EISENHOFER P.A, Wilmington, Delaware; Robert G. Eisler, Deborah A. Elman, Chad B. Holtzman, GRANT & EISENHOFER P.A, New York, New York Interim Co-Lead Counsel for the Proposed End-Payor Class and Counsel for Plaintiff Law Enforcement Health Benefits, Inc. Sharon K. Robertson, Donna M. Evans, Matthew W. Ruan, COHEN MILSTEIN SELLERS & TOLL PLLC, New York, New York Interim Co-Lead Counsel for the Proposed End-Payor Class and Counsel for Plaintiff Mayor and City Council of Baltimore, Maryland Michael J. Barry, GRANT & EISENHOFERP.A., Wilmington, Delaware; Jayne A. Goldstein, SHEPHERD, FINKELMAN, MILLER & SHAH, LLP, Media, Pennsylvania Interim Co-Lead Counsel for the Proposed End-Payor Class and Counsel for Plaintiffs Fraternal Order of Police, Miami Lodge 20, and Insurance Trust Fund J. Clayton Athey, Jason Wayne Rigby, PRICKETT, JONES & ELLIOTT, P.A., Wilmington, Delaware; Barry L. Refsin, Alexander J. Egervary, Caitlin V. McHugh, HANGLEY ARONCHICK SEGAL PUDLIN & SCHILLER, Philadelphia, Pennsylvania; Monica L. Kiley, Eric L. Bloom, HANGLEY ARONCHICK SEGAL PUDLIN & SCHILLER, Harrisburg, Pennsylvania Counsel for Plaintiffs CVS Pharmacy Inc., Rite Aid Corp., and Rite Aid Headquarters Corp., J. Clayton Athey, Jason Wayne Rigby, PRICKETT, JONES & ELLIOTT, P.A, Wilmington, Delaware; Scott E. Perwin, Lauren C. Ravkind, Anna T. Neil, KENNY NACHWALTER, P.A., Miami, Florida Counsel for Plaintiff Walgreen Co., The Kroger Co., Albertsons Companies Inc., Hy-Vee, Inc., and H-E-B, L.P. Heidi M. Silton, Jessica N. Servais, LOCKRIDGE GRIND AL NAUEN P.L.L.P., Minneapolis, Minnesota Additional Counsel for Pipe Trades Services MN Welfare Fund and the Proposed End-Payor Class Peter Safirstein, SAFIRSTEIN METCALF LLP, New York, New York Additional Counsel for Plaintiff Sergeants Benevolent Association Health & Welfare Fund and the Proposed End-Payor Class Archana Tamoshunas, TAUS, CEBULASH & LANDAU, LLP, New York, New York Additional Counsel for Plaintiff Mayor and City Council of Baltimore, Maryland and the End-Payor Proposed Class Lee Albert, Brian D. Brooks, GLANCY, PRONGAY, & MYRRAY, New York New York Counsel for The Uniformed Firefighters' Association of Greater New York Security Benefit Fund and the Retired Firefighters' Security Benefit Fund of the Uniformed Firefighters Association Robert J. Kriner, Jr., Tiffany Joanne Cramer, CHIMICLES SCHWARTZ KRINER & DONALDSON-SMITH LLP, Wilmington, Delaware; Dianne M. Nast, Joseph N. Roda, Michael D. Ford, NASTLAW, Philadelphia, Pennsylvania; Michael L. Roberts, Stephanie E. Smith, ROBERTS LAW FIRM US, PC, Little Rock, Arkansas Counsel for PlaintiffKPH Healthcare Services Inc. Daniel M. Silver, Alexandrea M. Joyce, MCCARTER & ENGLISH, LLP, Wilmington, Delaware; John E. Schmidtlein, Benjamin M. Greenblum, Colette T. Connor, Thomas S. Fletcher, Akhil K. Gola, WILLIAMS & CONNOLLY, Washington, District of Columbia Counsel for Defendant AstraZeneca Pharmaceuticals L.P., AstraZeneca L.P. and AstraZeneca UK Ltd. Arthur G. Connolly, III, Alan Richard Silverstein, CONNOLLY GALLAGHER LLP, Wilmington, Delaware; Christopher J. Marino, James E. Gallagher, DAVIS MALM & D'AGOSTINE, P.C., Boston, Massachusetts Counsel for Defendant Handa Pharmaceuticals LLC. Jack B. Blumenfeld, Michael J. Flynn, MORRIS, NICHOLS, ARSHT & TUNNELL LLP, Wilmington Delaware; Stephen J. McIntyre, O'MELVENY & MYERS LLP, Los Angeles, California; Brett J. Williamson, O'MELVENY & MYERS LLP, Newport Beach, California; Ben Bradshaw, O'MELVENY & MYERS LLP, Washington, District of Columbia Counsel for Defendant Par Pharmaceuticals Inc. John W. Shaw, Karen E. Keller, Nathan Roger Hoeschen, SHAW KELLER LLP, Wilmington Delaware; Thomas J. Lang, Christina E. Fahmy, Peter M. Boyle, KILPATRICK TOWNSEND & STOCKTON LLP, Washington, District of Columbia Counsel for Defendant Accord Healthcare Inc.
Carmella P. Keener, COOCH AND TAYLOR, P.A., Wilmington, Delaware; Bruce E. Gerstein, Joseph Opper, Kimberly M. Hennings, Daniel Litvin, GARWIN GERSTEIN & FISHER LLP, New York, New York; Peter R. Kohn, Joseph T. Lukens, FARUQI & FARUQI, LLP, Philadelphia, Pennsylvania; David F. Sorensen, Caitlin G. Coslett, BERGER MONTAGUE PC, Philadelphia, Pennsylvania; Stuart E. Des Roches, Amanda Hass, Chris Letter, Dan Chiorean, Thomas J. Maas, ODOM & DES ROCHES, LLC, New Orleans, Louisiana; Susan C. Segura, Erin R. Leger, David C. Raphael, Jr, SMITH SEGURA RAPHAEL & LEGER, LLP, Alexandria, Louisiana; Russell A. Chorush, HEIM PAYNE & CHORUSH, LLP, Houston, Texas
Interim Lead Counsel for the Direct Purchaser Class and Counsel for Plaintiff J M Smith Corporation d/b/a Smith Drug Company.
Michael J. Barry, GRANT & EISENHOFER P.A, Wilmington, Delaware; Robert G. Eisler, Deborah A. Elman, Chad B. Holtzman, GRANT & EISENHOFER P.A, New York, New York
Interim Co-Lead Counsel for the Proposed End-Payor Class and Counsel for Plaintiff Law Enforcement Health Benefits, Inc.
Sharon K. Robertson, Donna M. Evans, Matthew W. Ruan, COHEN MILSTEIN SELLERS & TOLL PLLC, New York, New York
Interim Co-Lead Counsel for the Proposed End-Payor Class and Counsel for Plaintiff Mayor and City Council of Baltimore, Maryland
Michael J. Barry, GRANT & EISENHOFERP.A., Wilmington, Delaware; Jayne A. Goldstein, SHEPHERD, FINKELMAN, MILLER & SHAH, LLP, Media, Pennsylvania
Interim Co-Lead Counsel for the Proposed End-Payor Class and Counsel for Plaintiffs Fraternal Order of Police, Miami Lodge 20, and Insurance Trust Fund
J. Clayton Athey, Jason Wayne Rigby, PRICKETT, JONES & ELLIOTT, P.A., Wilmington, Delaware; Barry L. Refsin, Alexander J. Egervary, Caitlin V.
McHugh, HANGLEY ARONCHICK SEGAL PUDLIN & SCHILLER, Philadelphia, Pennsylvania; Monica L. Kiley, Eric L. Bloom, HANGLEY ARONCHICK SEGAL PUDLIN & SCHILLER, Harrisburg, Pennsylvania
Counsel for Plaintiffs CVS Pharmacy Inc., Rite Aid Corp., and Rite Aid Headquarters Corp.,
J. Clayton Athey, Jason Wayne Rigby, PRICKETT, JONES & ELLIOTT, P.A, Wilmington, Delaware; Scott E. Perwin, Lauren C. Ravkind, Anna T. Neil, KENNY NACHWALTER, P.A., Miami, Florida
Counsel for Plaintiff Walgreen Co., The Kroger Co., Albertsons Companies Inc., Hy-Vee, Inc., and H-E-B, L.P.
Heidi M. Silton, Jessica N. Servais, LOCKRIDGE GRIND AL NAUEN P.L.L.P., Minneapolis, Minnesota
Additional Counsel for Pipe Trades Services MN Welfare Fund and the Proposed End-Payor Class
Peter Safirstein, SAFIRSTEIN METCALF LLP, New York, New York
Additional Counsel for Plaintiff Sergeants Benevolent Association Health & Welfare Fund and the Proposed End-Payor Class
Archana Tamoshunas, TAUS, CEBULASH & LANDAU, LLP, New York, New York
Additional Counsel for Plaintiff Mayor and City Council of Baltimore, Maryland and the End-Payor Proposed Class
Lee Albert, Brian D. Brooks, GLANCY, PRONGAY, & MYRRAY, New York New York
Counsel for The Uniformed Firefighters' Association of Greater New York Security Benefit Fund and the Retired Firefighters' Security Benefit Fund of the Uniformed Firefighters Association
Robert J. Kriner, Jr., Tiffany Joanne Cramer, CHIMICLES SCHWARTZ KRINER & DONALDSON-SMITH LLP, Wilmington, Delaware; Dianne M. Nast, Joseph N. Roda, Michael D. Ford, NASTLAW, Philadelphia, Pennsylvania; Michael L. Roberts, Stephanie E. Smith, ROBERTS LAW FIRM US, PC, Little Rock, Arkansas
Counsel for PlaintiffKPH Healthcare Services Inc.
Daniel M. Silver, Alexandrea M. Joyce, MCCARTER & ENGLISH, LLP, Wilmington, Delaware; John E. Schmidtlein, Benjamin M. Greenblum, Colette T. Connor, Thomas S. Fletcher, Akhil K. Gola, WILLIAMS & CONNOLLY, Washington, District of Columbia
Counsel for Defendant AstraZeneca Pharmaceuticals L.P., AstraZeneca L.P. and AstraZeneca UK Ltd.
Arthur G. Connolly, III, Alan Richard Silverstein, CONNOLLY GALLAGHER LLP, Wilmington, Delaware; Christopher J. Marino, James E. Gallagher, DAVIS MALM & D'AGOSTINE, P.C., Boston, Massachusetts
Counsel for Defendant Handa Pharmaceuticals LLC.
Jack B. Blumenfeld, Michael J. Flynn, MORRIS, NICHOLS, ARSHT & TUNNELL LLP, Wilmington Delaware; Stephen J. McIntyre, O'MELVENY & MYERS LLP, Los Angeles, California; Brett J. Williamson, O'MELVENY & MYERS LLP, Newport Beach, California; Ben Bradshaw, O'MELVENY & MYERS LLP, Washington, District of Columbia
Counsel for Defendant Par Pharmaceuticals Inc.
John W. Shaw, Karen E. Keller, Nathan Roger Hoeschen, SHAW KELLER LLP, Wilmington Delaware; Thomas J. Lang, Christina E. Fahmy, Peter M. Boyle, KILPATRICK TOWNSEND & STOCKTON LLP, Washington, District of Columbia
Counsel for Defendant Accord Healthcare Inc.
MEMORANDUM OPINION
COLM F. CONNOLLY, CHIEF JUDGE.
Table of Contents
I. BACKGROUND ............................................................................................. 4
A. Legal Framework .................................................................................. 4
B. Facts ...................................................................................................... 9
II. LEGAL STANDARDS ................................................................................. 16
A. Rule 12(b)(6) ....................................................................................... 16
B. Rule 12(b)(l) ....................................................................................... l 7
III. DISCUSSION ............................................................................................... 17
A. The Direct Purchasers' Federal Antitrust Claims ............................... 18
1. Whether the Direct Purchasers' Claims are Barred by § 15b .. 18
2. Whether the Direct Purchasers Have Pleaded Antitrust Standing 27
a. The Handal AstraZeneca Settlement Agreement.. .......... 28
b. The Accord/AstraZeneca Settlement Agreement .......... 33
B. The End-Payors' State Law Claims .................................................... 40
1. Antitrust Claims ........................................................................ 41
a. Article III Standing ........................................................ 42
b. Antitrust Standing .......................................................... 45
1) Florida (Counts II and III) ....................................... 46
2) Illinois (Counts I-III) ............................................... 46
3) Maryland (Counts I-III) .......................................... 50
4) Massachusetts (Counts III and IV) .......................... 52
5) Utah (Counts I-III) .................................................. 53
c. Intra-State Effects ........................................................... 54
2. Consumer Protection Claims .................................................... 55
a. Adequacy of Pleadings ................................................... 55
b. State-Specific Requirements .......................................... 56
1) Illinois ...................................................................... 5 6
2) New York ................................................................. 57
3) Minnesota ................................................................ 5 9
4) Missouri ................................................................... 60
5) Nevada ..................................................................... 61
6) North Carolina ......................................................... 61
3. Unjust Enrichment Claims ....................................................... 62
a. Adequacy of Pleadings ................................................... 62
b. Claims under Laws of States that Follow Illinois Brick 63
c. Unjust Enrichment Claims in States with an Adequate Statutory Remedy ..................................................................... 65
d. State-Specific Requirements .......................................... 66
1) Georgia, Kentucky, and Pennsylvania .................... 66
2) West Virginia ........................................................... 66
IV. CONCLUSION ............................................................................................. 67
These three separately consolidated antitrust actions have been coordinated for discovery and pretrial proceedings pursuant to a stipulated order. D.I. 134 at 3. The actions arise out of agreements to settle patent litigation over extended-release quetiapine fumarate, an anti-psychotic drug sold by Defendants AstraZeneca Pharmaceuticals LP and AstraZeneca LP (collectively, AstraZeneca) under the brand-name Seroquel XR®. Two of the consolidated actions are class actions brought by pharmaceutical wholesalers (the Direct Purchasers) and by union health and welfare funds and municipalities (the End-Payors). The third consolidated action consists of three cases filed by pharmaceutical retailers (the Retailers). All the operative complaints allege that AstraZeneca, Handa Pharmaceuticals LLC, Par Pharmaceuticals, Inc., and Accord Pharmaceuticals, Inc. were original or successor parties to unlawful noncash “reverse payment” agreements that settled certain patent lawsuits and delayed and suppressed competition among sellers of generic versions of Seroquel XR®. Plaintiffs claim that, as a result of these agreements, they paid directly or indirectly supracompetitive prices for branded and/or generic versions of Seroquel XR®.
The operative complaints in the Direct Purchasers' and Retailers' actions each allege five counts under sections 1 and 2 of the Sherman Act, 15 U.S.C. §§ 1, 2. See D.I. 135 ¶¶ 180-87, 197-203 (alleging violations of § 1 in Counts 1 and 3); D.I. 135 ¶¶ 188-96, 204-11, 212-17 (alleging violations of § 2 in Counts 2, 4, and 5); 20-1086, D.I. 1 ¶¶ 159-65, 175-80 (alleging violations of § 1 in Counts 1 and 3); 20-1087, D.I. 1 ¶¶ 161-67, 177-82 (same); 20-1089, D.I. 1 ¶¶ 158-64, 174-79 (same); 20-1086, D.I. 1 ¶¶ 166-74, 181-89, 190-95 (alleging violations of § 2 in Counts 2, 4, and 5); 20-1087, D.I. 1 ¶¶ 168-76, 183-90, 191-96 (same); 20-1089, D.I. 1 ¶¶ 165-73, 180-87, 188-93 (same). The operative complaint in the EndPayors' action alleges a series of state law antitrust, consumer protection, and unjust enrichment claims. D.I. 136 ¶¶ 233-95.
All the operative complaints name AstraZeneca, Handa, and Par as defendants; the operative complaints in the Retailers' actions also name Accord as a defendant in two counts. For ease of reference, I will refer at times to AstraZeneca, Handa, Par, and Accord collectively as “Defendants.”
Pending before me are (1) AstraZeneca, Handa, and Par's motion to dismiss pursuant to Federal Rule of Civil Procedure 12(b)(6) the Consolidated Amended Complaint filed by the Direct Purchaser Plaintiffs, D.I. 137; (2) AstraZeneca, Handa, Par, and Accord's motion to dismiss pursuant to Rule 12(b)(6) the three complaints filed by the Retailer Plaintiffs, D.I. 141; and (3) AstraZeneca, Handa, and Par's motion to dismiss pursuant to Rules 12(b)(1) and 12(b)(6) the Second Consolidated Amended Complaint filed by the End-Payor Plaintiffs, D.I. 139. (Accord states in its briefing that it joins the first motion. D.I. 144 at 1. AstraZeneca UK Ltd. is named as a movant in all three motions, but it is not a named defendant in the Direct Purchasers' complaint. D.I. 135 at 1.)
I. BACKGROUND
A. Legal Framework
The antitrust claims in this case arise out of Abbreviated New Drug Application or “ANDA” litigation and implicate patent law and the so-called Hatch-Waxman Act amendments to the Federal Food, Drug, and Cosmetic Act (FDCA), 21 U.S.C. § 301 et seq. Judge Sirica helpfully summarized in King Drug Company of Florence v. Smithkline Beecham Corporation, 791 F.3d 388 (3d Cir. 2015), how patent law intersects with the Hatch-Waxman amendments to create ANDA litigation:
A patent... is an exception to the general rule against monopolies and to the right to access to a free and open market. The Constitution's Patent Clause itself reflects a balance between the need to encourage innovation and the avoidance of monopolies which stifle competition without any concomitant advance in the “Progress of Science and useful Arts.” [U.S. Const, art. I, § 8, cl.8.] In turn, from their inception, the federal patent laws have embodied a careful balance between the need to promote innovation and the recognition that imitation and refinement through imitation are both necessary to invention itself and the very lifeblood of a competitive economy. A patent, consequently, is a special privilege designed to serve the public purpose of promoting the “Progress of Science and useful Arts.” [Id.]
With the Drug Price Competition and Patent Term Restoration Act of 1984, commonly known as the HatchWaxman Act, Congress attempted to balance the goal of making available more low[-]cost generic drugs with the value of patent monopolies in incentivizing beneficial pharmaceutical advancement. The Act seeks to
accomplish this purpose, in part, by encouraging manufacturers of generic drugs to challenge weak or invalid patents on brand name drugs so consumers can enjoy lower drug prices. The resulting regulatory framework has the following four relevant features identified by the Supreme Court in [Federal Trade Commission v.] Actavis, [570 U.S. 136, 140-44 (2013)].
First, a new drug-that is, a pioneer, “brand-name” drug-cannot be introduced until it is approved by the Food and Drug Administration (“FDA”). A New Drug Application (“NDA”) requires the applicant to submit, among other things, full reports of investigations which have been made to show whether or not such drug is safe for use and whether such drug is effective in use, as well as comprehensive information about the drug. This reporting requirement entails “a long, comprehensive, and costly testing process.” [Id. at 142].
Second, the Hatch-Waxman Act facilitates the development of generic drugs by allowing an applicant to file, for new drugs shown to be “bioequivalent” to a drug previously approved by the FDA, 21 U.S.C. § 355(j)(2)(A)(iv), a less onerous and less costly “Abbreviated New Drug Application” (“ANDA”) in lieu of an NDA. The ANDA process “allow[s] the generic to piggy-back on the pioneer's approval efforts . . ., thereby furthering drug competition.” Actavis, (citing Caraco Pharm. Labs., Ltd. v. Novo Nordisk A/S, [566 U.S. 399, 405] (2012)).
Third, Hatch-Waxman “sets forth special procedures for identifying, and resolving, related patent disputes.” Id. [at 143]. A new drug applicant must list information on any patents issued on the drug's composition or methods of use. If the FDA approves the new drug, it publishes this information, without verification, in its Orange Book. In turn, any manufacturer filing an ANDA to produce a generic version of that pioneer drug must consult the
Orange Book and “assure the FDA that [the] proposed generic drug will not infringe the brand's patents.” [Caraco, 566 U.S. at 406]. As relevant here, the manufacturer may tender that assurance with a “paragraph IV” certification that the relevant listed patents are “invalid or will not be infringed by the manufacture, use, or sale of the [generic] drug.” 21 U.S.C. § 355(j)(2)(A)(vii)(IV). But filing a paragraph IV certification means provoking litigation, because the patent statute treats paragraph IV certification as a per se act of infringement, see 35 U.S.C. § 271(e)(2)(A). The patentee then has an incentive to sue within 45 days in order to trigger a 30-month stay of the FDA's potential approval of the generic “while the parties litigate patent validity (or infringement) in court. If the courts decide the matter within that period, the FDA follows that determination; if they do not, the FDA may go forward and give approval to market the generic product.” Actavis, (citing 21 U.S.C. § 355(j)(5)(B)(iii)).
“Fourth, Hatch-Waxman provides a special incentive for a generic to be the first to file an Abbreviated New Drug Application taking the paragraph IV route.” [Id.] From when it first begins marketing its drug or when a court enters judgment finding the challenged patent invalid or unenforceable, the first-filing generic enjoys a 180-day period of exclusivity during which no other generic manufacturer can enter the market. See 21 U.S.C. § 355(j)(5)(B)(iii), (iv). This exclusivity period belongs to first-filing ANDA applicants alone and is nontransferable. See id. § 355(j)(5)(D); Actavis, [570 U.S. at 143-44]. The period does not, however, prevent the brand-patentee from marketing its own “authorized generic.”Id. at 394-96 (footnotes, most citations, and most internal quotation marks omitted). (An “authorized generic”-often referred to as “AG”-is simply the term used to describe an approved brand name drug that is marketed without the brand name on its label. See FDA List of Authorized Generic Drugs, Food & Drug Admin. (Apr. 1, 2022), https://www.fda.gov/drugs/abbreviated-new-drug-application-anda/fda-list-authorized-generic-drugs.)
In Actavis, the Supreme Court held that agreements between first-filer generics and brand manufacturers to settle ANDA cases may in certain circumstances give rise to antitrust claims. In reaching this conclusion, the Court rejected the Eleventh Circuit's so-called “scope of the patent” rule that immunized such agreements “‘from antitrust attack so long as [their] anticompetitive effects fall within the scope of the exclusionary potential of the patent.'” 570 U.S. at 141 (quoting FTC v. Watson Pharmaceuticals, Inc., 677 F.3d 1298, 1312 (11th Cir. 2012)). The Court held specifically in Actavis that a settlement agreement pursuant to which a brand manufacturer pays a first-filer generic manufacturer a “large and unjustified” sum in exchange for the generic's agreement to relinquish its patent invalidity and noninffingement claims and delay its entry into the market “can sometimes violate the antitrust laws.” 570 U.S. at 141, 158. Such agreements are referred to as “reverse payment” agreements because they require the patentee to pay the alleged infringer, and not the other way around. They raise antitrust .. concerns because they remove from the market the risk of competition that arises from expected litigation outcomes. The Court explained in Actavis that an “unexplained large reverse payment” that is inconsistent with traditional settlement considerations, such as avoided litigation costs,
would normally suggest that the patentee has serious doubts about the patent's survival. And that fact, in turn, suggests that the payment's objective is to maintain supracompetitive prices to be shared among the patentee and the challenger rather than face what might have been a competitive market-the very anticompetitive consequence that underlies the claim of antitrust unlawfulness.570 U.S. at 157.
In King Drug, the Third Circuit held that Actavis's holding is not “limited to reverse payments of cash.” 791 F.3d at 403. At issue in King Drug was a “no-AG” settlement agreement whereby a brand manufacturer agreed to relinquish its right to produce an AG drug to compete with a first-filer generic's drug during the 180 days of first-filer market exclusivity. The Court explained that the 180-day exclusivity period was “possibly worth several hundred million dollars” and “where the bulk of the first-filer's profits lie.” Id. at 404 (internal quotation marks omitted). It held accordingly that “no-AG” agreements can “fall[] under Actavis's rule because [they] may represent an unusual, unexplained reverse transfer of considerable value from the patentee to the alleged infringer and may therefore give rise to the inference that [they are] a payment to eliminate the risk of competition.” Id. at 394.
B. Facts