Reverse Payment Settlements In Pharma Industry: Revisited
|
|
- April Patterson
- 5 years ago
- Views:
Transcription
1 Portfolio Media. Inc. 860 Broadway, 6th Floor New York, NY Phone: Fax: Reverse Payment Settlements In Pharma Industry: Revisited Law360, New York (August 16, 2012, 1:02 PM ET) -- In December 2011, I wrote that despite a number of losses in different federal courts of appeal, the Federal Trade Commission continued to advocate for a rule that would make so called reverse payment settlements between branded and generic pharmaceutical companies presumptively unlawful. I also pointed out that in pharmaceutical cases, courts have not tended to use either of the traditional antitrust tests ( per se or the rule of reason ), instead adopting a scope of the patent test to review competition issues raised by patent settlements challenged under the antitrust laws.[1] Now, a pair of recent decisions, one from the U.S. Court of Appeals for the Third Circuit in its K-Dur decision[2], and one from the Eleventh Circuit in its Androgel decision[3], has caused commentators to declare a circuit split that may finally cause the U.S. Supreme Court to take interest in this issue, despite having denied certiorari several times. While the Eleventh Circuit followed its own prior precedent and other circuits in adopting the scope of the patent test, the Third Circuit adopted a quick look rule of reason. The differences in these tests are discussed below, as well as the evidence that the Third Circuit used to move away from the trend, along with the key differences in approaches future courts and parties will have to grapple with. The quick look rule of reason test adopted by the Third Circuit starts with a presumption that a reverse-payment settlement is prima facie evidence of an unreasonable restraint of trade, which can be rebutted by proof showing the payment or other benefit was for a purpose other than delayed entry or had some other pro-competitive benefit.[4] The scope of the patent test, explained most recently by the Eleventh Circuit in Androgel, takes into account the particularized regulatory and patent enforcement framework under the Hatch-Waxman Act that governs both the relationship between branded and generic competitors and generic competitors among themselves.
2 Unlike situations where no patent exists, since patents create an environment of exclusion, therefore the anti-competitive effect is already present, but is lawful. The three-step process in the scope of the patent test thus looks to: The scope of the exclusionary potential of the patent; The extent to which the challenged agreement exceeds that scope; and a Any resulting anti-competitive effects. Only if the settlement reaches beyond the reasonable scope of what is patented does the court engage in a balanced review of the reasons a settlement has been entered into, and whether the bargained-for consideration in such deals is driven by anti-competitive motives and has anti-competitive impact. The Eleventh Circuit adopted this approach in the Androgel decision; the Third Circuit rejected it in the K-Dur decision, despite an earlier Eleventh Circuit decision from 2005 on the same exact settlements upholding the very same agreements. Two days after K-Dur was decided, the Eleventh Circuit denied the FTC s petition for hearing en banc in Androgel. The following differences in the treatment by the two courts will be the subject of debate as the two cases either continue their way through the courts or, if not appealed further, in subsequent cases. 1. The Third Circuit s decision not to adhere to the finding of the Eleventh Circuit s 2005 decision upholding the exact same agreements relating to K-Dur.[5] The only real difference between the two cases factually is their procedural posture: The earlier case was brought by the settling parties against the FTC in an appeal from an FTC decision; the Third Circuit case was brought by private plaintiffs, and the FTC filed an amicus brief which the court s decision borrows from heavily. While stating merely that it found the Eleventh Circuit s Schering-Plough decision unpersuasive, the Third Circuit further cited a string of Supreme Court decisions from the 1940s that it said appear to have been overlooked by the other circuits adopting the scope of the patent test. On the other hand, a review of the full decisions and briefing in the prior decisions reveals that those same 1940 s decisions were cited by the parties or the FTC, and thus the courts did not overlook them but, rather, found them inapposite.[6] 2. The Third Circuit relied on data cited by the FTC which postdated the district court s opinion and therefore was not before it, and which has not been tested by either a Daubert motion or crossexamination. In K-Dur, the district court entered an order on March 25, 2010, adopting the 55-page Report & Recommendation of a Special Master dated Feb. 6, 2009.[7] Despite the fact that the evidentiary record closed in 2008, the Third Circuit accepted and relied on statistics cited in the FTC s appellate brief from a 2010 FTC report not considered below.[8] In that study, the FTC claimed that the category of settlements where a reverse payment is included cost consumers $3.5 billion per year.[9]
3 The Third Circuit also accepted the conclusion of the FTC from the same 2010 report that one year after market entry an average generic pharmaceutical product takes over 90 percent of the patent holder s unit sales and sells for 15 percent of the name brand product. [10] By contrast, the Eleventh Circuit considered those same statistics cited by the FTC, but did not find them pertinent to its analysis.[11] 3. The Third Circuit appears to have accepted the proposition advocated to it that under the scope of the patent standard, despite its adoption in several other circuits, there would never be a case that could succeed on the merits. Yet at least one district court within the Third Circuit two years earlier denied a motion to dismiss using the very same scope of the patent test, demonstrating that in an appropriate case, that standard can result in liability.[12] The Third Circuit cited this earlier district court decision, but nevertheless concluded that the scope of the patent test does not subject reverse payment agreements to any antitrust scrutiny. [13] By contrast to this blanket statement in K-Dur, the Eleventh Circuit recognized in Androgel that antitrust liability can be found under the scope of the patent test.[14] 4. Neither court needed to address the 2003 amendments to the Hatch-Waxman Act made by the Medicare Prescription Drug, Improvement and Modernization Act (MMA), which substantially, if not completely, eliminated any ability of first-filing generics to park 180-day exclusivity by providing for forfeiture in most circumstances that the FTC has deemed anti-competitive.[15] However, an open question remains when such cases do come to pass, whether they will be cabined in by case law dealing with a different regulatory regime that allowed for such parking. With the standard that may apply in a given case now somewhat unsettled, what then is the advice for the client or practitioner when addressing proposed settlement terms in a negotiation? Essentially, the advice has not changed from If each party documents its true expectations of its range of litigation outcomes, it will be that much easier to justify a settlement in the face of a later challenge. By its nature, the branded company is usually going to be more risk-averse and thus willing to avoid the risk of an adverse court ruling by making a payment. For one thing, it has put more at risk, with the cost of bringing a blockbuster drug to market estimated at more than $1.3 billion the generic s investment is a fraction of that. For another, generics are, on average, successful more of the time in fully litigated cases. On the flip side, a poorly capitalized generic or a brand-new firm with limited liquidity may be stabilized quicker by a settlement than a launch; indeed, without a cash payment, it may not be able to survive either the litigation or until the negotiated entry date and still be able to afford production. In that circumstance, the eventual generic output would decrease absent the payment. Even the Third Circuit recognizes that such a circumstance could be a sufficient reason to uphold a reverse payment settlement due to its overall pro-competitive effect on the market.[16] Patent strength only tells a part of the story why, other than an anti-competitive purpose, parties would agree to particular dollar amounts and dates of entry in a settlement.
4 Such alternative explanations should be documented by the parties at the time of agreement to insulate against an assumption that the payment represents an unlawful splitting of the market. Parties entering settlements should consider documenting how the agreement does not limit output or does not result in consumers paying a higher price.[17] In sum, relationships between branded and generic companies in the real world market place spawned by the Hatch-Waxman Act are far more complicated than the two variables entry date and payment that have been the focus of court decisions and FTC actions thus far. As the courts take more rigorous views of the economic forces at issue in specific cases, rather than addressing generalities, other factors will emerge. The party who has well documented an evidentiary basis for the lack of anti-competitive effects of its agreements will have more success in the forthcoming environment than one who doesn t take such care. --By David Leichtman, Robins Kaplan Miller & Ciresi LLP David Leichtman is a partner in Robins Kaplan's New York office. His practice focuses on intellectual property, antitrust, and business litigation, with a particular emphasis on the life sciences and media industries. The opinions expressed are those of the author and do not necessarily reflect the views of the firm, its clients, or Portfolio Media Inc., or any of its or their respective affiliates. This article is for general information purposes and is not intended to be and should not be taken as legal advice. [1] David Leichtman, Scrutinizing Reverse-Payment Settlements, Law 360, Dec. 16, [2] In re K-Dur Antitrust Litigation, Appeal Nos , 2078, 2079 and 4571 (3d Cir. July 16, 2012) ( K- Dur ). [3] FTC v. Watson Pharmaceuticals, Inc. et al., Appeal No (11th Cir. April 25, 2012) ( Androgel ). [4] In so holding, the Third Circuit (slip. op. at 33) purported to follow an early D.C. Circuit decision, Andrx Pharms., Inc. v. Biovail Corp. Int l, 256 F.3d 799 (D.C. Cir. 2001) (see also In re Cardizem CD Antitrust Litigation, 332 F.3d 896 (6th Cir. 2003), addressing the same agreement concerning the drug, Cardizem), but failed to recognize the special facts of that case where the agreement at issue restricted the generic from entering the market for products that went well beyond what was covered by the patent. That distinction has caused numerous other courts to reject the applicability of the Cardizem cases beyond their specific facts. See Valley Drug Co. v. Geneva Pharms, Inc., 344 F.3d 1294 (11th Cir. 2003); Schering-Plough Corp. v. FTC, 402 F.3d 1056 (11th Cir. 2005); In re Tamoxifen Citrate Antitrust Litig., 466 F.3d 187 (2d Cir. 2006); In re Ciprofloxacin Hydrochloride Antitrust Litig., 544 F.3d 1323 (Fed. Cir. 2008); Asahi Glass Co, Ltd. v. Pentech Pharms, Inc., 289 F. Supp.2d 986 (N.D. Ill. 2003) (Posner, J., sitting by designation); In re K-Dur Antitrust Litig., 2009 WL (D. N.J. Feb. 6, 2009). Even the FTC has acknowledged, begrudgingly, the likely limited applicability of the Cardizem cases. (See FTC s Petition For Rehearing En Banc, dated June 11, 2012, at 7, in Androgel litigation). [5] K-Dur, slip. op. at 22-23; compare Schering-Plough Corp. v. FTC, 402 F.3d 1056 (11th Cir. 2005), cert. denied, 548 U.S. 919 (2006).
5 [6] For example, U.S. v. Masonite Corp., 316 U.S. 265 (1942), heavily relied on by the FTC in its briefing in both K-Dur and Androgel and relied on by the Court in K-Dur involved pure price fixing between the patentee and its licensees with respect to the re-sale by the licensees of the patentee s products not even a remotely similar situation to the pharmaceutical reverse payment cases. Indeed, the Androgel court even cited to Masonite affirmatively as demonstrating the difference between a situation where the contract at issue goes beyond the exclusionary power of the statutory patent grant and one where the contract falls within it. See Androgel, slip op. at [7] K-Dur, slip. op. at 16; see id., Civ. No , Dkt. No. 758 (D.N.J. March 25, 2010), adopting id., Dkt. No. 733 (Feb. 6, 2009). [8] K-Dur, slip. op. at 16 (citing 2010 FTC study). [9] Not only was that study not before the Special Master or the District Court, but the scientific validity of the methodology used by the FTC to calculate its numbers, explained in an earlier January 2010 FTC Staff Study, has been questioned. For example, the FTC assumes all of the price savings for drugs subject to such settlements would otherwise get passed on to consumers. But there is no basis for such a conclusion. In reality, given the way that consumers pay for health insurance and medicine, the difference between the branded price and generic price is rarely as large as projected in the FTC study. Moreover, both the actual price reduction and the market share that a generic can capture in the real world are extremely variable, dependent upon such factors as: the remaining life of the patent; the number of generics on the market; the number and price of competing products on the market and their relative efficacy and safety; whether any of the competing products are generic products; whether there are any OTC alternatives; whether the branded company launches an authorized generic; the number of years the product has before other alternative treatments replace it; etc. Yet the FTC s study takes none of those variables into account. [10] K-Dur, slip op. at 16. [11] Androgel, slip op. at 5-6. As noted, this data was not tested before the District Court in either case, and numerous other studies cite to a wide range of outcomes after generic entry that hardly suggest that the FTC s numbers are anywhere close to the norm. [12] King Drug Co. of Florence, Inc. v. Cephalon, Inc., 702 F. Supp. 2d 514 (E.D. Pa. 2010). [13] K-Dur, slip op. at 26. [14] Androgel, slip op (discussing Andrx Pharmaceuticals, Inc. v. Elan Corp., 421 F.3d 1227 (11th Cir. 2005) (where the agreement at issue would have prevented generic competition after the expiration of the patent and also because the settlement allowed the generic to park its 180-day exclusivity). [15] See K-Dur, slip op. at 28 (assuming that the first generic manufacturer to file can park its 180-day exclusivity); but see Leichtman, supra note 1, describing the changes to the Hatch-Waxman Act and pointing out that none of the lawsuits brought by either the FTC or by private plaintiffs thus far have involved settlements entered into where the MMA Amendments applied. [16] K-Dur, slip op. at 33. [17] Some examples are provided in Leichtman, supra n. 1. All Content , Portfolio Media, Inc.
Pay-for-Delay Settlements: Antitrust Violation or Proper Exercise of Pharmaceutical Patent Rights?
Pay-for-Delay Settlements: Antitrust Violation or Proper Exercise of Pharmaceutical Patent Rights? By Kendyl Hanks, Sarah Jacobson, Kyle Musgrove, and Michael Shen In recent years, there has been a surge
More informationHealth Care Law Monthly
Health Care Law Monthly February 2013 Volume 2013 * Issue No. 2 Contents: Copyright ß 2013 Matthew Bender & Company, Inc., a member of the Lexis- Nexis group of companies. All rights reserved. HEALTH CARE
More informationPAYING FOR DELAY AND THE RULE OF REASON FEDERAL TRADE COMMISSION V ACTAVIS INC ET AL 1
COMPETITION LAW PAYING FOR DELAY AND THE RULE OF REASON FEDERAL TRADE COMMISSION V ACTAVIS INC ET AL 1 LIGIA OSEPCIU 2 JUNE 2013 On 17 June 2013, the Supreme Court of the United States handed down its
More informationIncreased Scrutiny of Reverse Payment Settlements: Recent Cases in E.D. of PA and 2nd Circuit Suggest Change May Be Ahead for Pharma Clients
Increased Scrutiny of Reverse Payment Settlements: Recent Cases in E.D. of PA and 2nd Circuit Suggest Change May Be Ahead for Pharma Clients By Francis P. Newell and Jonathan M. Grossman Special to the
More informationPharmaceutical Pay for Delay Settlements
Pharmaceutical Pay for Delay Settlements UCIP Seminar 12 November 2012 www.morganlewis.com Outline Background Goals of the Hatch-Waxman Act Price Effects of Generic Entry Pay-for-Delay Patent Settlements
More informationPharmaceutical Product Improvements and Life Cycle Management Antitrust Pitfalls 1
Pharmaceutical Product Improvements and Life Cycle Management Antitrust Pitfalls 1 The terms product switching, product hopping and line extension are often used to describe the strategy of protecting
More informationPENDING LEGISLATION REGULATING PATENT INFRINGEMENT SETTLEMENTS
PENDING LEGISLATION REGULATING PATENT INFRINGEMENT SETTLEMENTS By Edward W. Correia* A number of bills have been introduced in the United States Congress this year that are intended to eliminate perceived
More informationPharmaceutical Patent Settlement Cases: Mixed Signals for Settling Patent Litigation
By Margaret J. Simpson Tel: 312 923-2857 Fax: 312 840-7257 E-mail: msimpson@jenner.com The following article originally appeared in the Spring 2004 issue of the Illinois State Bar Association s Antitrust
More informationIn The Supreme Court of the United States
No. 10-762 ================================================================ In The Supreme Court of the United States --------------------------------- --------------------------------- LOUISIANA WHOLESALE
More informationProduct Improvements and Life Cycle Management Antitrust Pitfalls
Product Improvements and Life Cycle Management Antitrust Pitfalls NJ IP Law Association's 26th Annual Pharmaceutical/Chemical Patent Practice Update Paul Ragusa December 5, 2012 2012 Product Improvements
More informationCaraco V. Novo Nordisk: Antitrust Implications
Portfolio Media. Inc. 860 Broadway, 6th Floor New York, NY 10003 www.law360.com Phone: +1 646 783 7100 Fax: +1 646 783 7161 customerservice@law360.com Caraco V. Novo Nordisk: Antitrust Implications Law360,
More information5 Red Flags In Pharmaceutical Settlements
Portfolio Media. Inc. 860 Broadway, 6th Floor New York, NY 10003 www.law360.com Phone: +1 646 783 7100 Fax: +1 646 783 7161 customerservice@law360.com 5 Red Flags In Pharmaceutical Settlements Law360,
More informationIn the Supreme Court of the United States
No. 12-416 In the Supreme Court of the United States FEDERAL TRADE COMMISSION, Petitioner, v. WATSON PHARMACEUTICALS, INC., ET AL., Respondents. On Petition for a Writ of Certiorari to the United States
More informationLOUISIANA WHOLESALE DRUG CO., INC., et al., Respondents. UPSHER-SMITH LABORATORIES, INC., Petitioner, v.
Nos. 12-245, 12-265 In the Supreme Court of the United States MERCK & CO., INC., v. Petitioner, LOUISIANA WHOLESALE DRUG CO., INC., et al., Respondents. UPSHER-SMITH LABORATORIES, INC., Petitioner, v.
More informationIn re K-Dur Antitrust Litigation: Reopening the Door for Pharmaceutical Competition
Northwestern Journal of Technology and Intellectual Property Volume 12 Issue 1 Article 3 2014 In re K-Dur Antitrust Litigation: Reopening the Door for Pharmaceutical Competition Ahalya Sriskandarajah Northwestern
More informationPharmaceutical Patent Settlements: Issues in Innovation and Competitiveness
Pharmaceutical Patent Settlements: Issues in Innovation and Competitiveness John R. Thomas Visiting Scholar February 15, 2013 CRS Report for Congress Prepared for Members and Committees of Congress Congressional
More informationNo DD IN THE UNITED STATES COURT OF APPEALS FOR THE ELEVENTH CIRCUIT
No. 10-12729-DD IN THE UNITED STATES COURT OF APPEALS FOR THE ELEVENTH CIRCUIT FEDERAL TRADE COMMISSION, Plaintiff-Appellant, v. WATSON PHARMACEUTICALS, INC., et al., Defendants-Appellees. ON APPEAL FROM
More informationWE V E A L L B E E N T H E R E.
Antitrust, Vol. 23, No. 2, Spring 2009. 2009 by the American Bar Association. Reproduced with permission. All rights reserved. This information or any portion thereof may not be copied or disseminated
More informationFrom PLI s Program New Strategies Arising from the Hatch-Waxman Amendments #4888
From PLI s Program New Strategies Arising from the Hatch-Waxman Amendments #4888 New Strategies Arising From the Hatch-Waxman Amendments Practicing Law Institute Telephone Briefing May 12, 2004 I. INTRODUCTION
More informationLooking Within the Scope of the Patent
Latham & Watkins Antitrust and Competition Practice Number 1540 June 25, 2013 Looking Within the Scope of the Patent The Supreme Court Holds That Settlements of Paragraph IV Litigation Are Subject to the
More informationAntitrust and Intellectual Property: Recent Developments in the Pharmaceuticals Sector
September 2009 (Release 2) Antitrust and Intellectual Property: Recent Developments in the Pharmaceuticals Sector Aidan Synnott & William Michael Paul, Weiss, Rifkind, Wharton & Garrison LLP www.competitionpolicyinternational.com
More informationStuck in Neutral: The Future of Reverse Payments Agreements in Hatch-Waxman Litigation
Stuck in Neutral: The Future of Reverse Payments Agreements in Hatch-Waxman Litigation Alex E. Korona I. Introduction... 202 II. The Hatch-Waxman Act... 203 III. Settlement Agreements and Reverse Payments...
More informationPay-to-Delay Settlements: The Circuit-Splitting Headache Plaguing Big Pharma
Pay-to-Delay Settlements: The Circuit-Splitting Headache Plaguing Big Pharma ABSTRACT At its passage, the Hatch-Waxman Act was hailed as a much-needed step in making generic drugs more readily available
More informationCompetition Ahead? The Legal Landscape for Reverse Payment Settlements After Federal Trade Commission v. Actavis, Inc.
Berkeley Technology Law Journal Volume 29 Issue 4 Annual Review 2014 Article 6 8-1-2014 Competition Ahead? The Legal Landscape for Reverse Payment Settlements After Federal Trade Commission v. Actavis,
More informationTHE ANTITRUST LEGALITY OF PHARMACEUTICAL PATENT LITIGATION SETTLEMENTS
THE ANTITRUST LEGALITY OF PHARMACEUTICAL PATENT LITIGATION SETTLEMENTS James F. Ponsoldt W. Hennen Ehrenclou I. INTRODUCTION Several federal courts of appeal have recently ruled on the issue of whether
More informationCase 1:10-mc CKK -AK Document 31 Filed 07/13/10 Page 1 of 12 UNITED STATES DISTRICT COURT FOR THE DISTRICT OF COLUMBIA
Case 1:10-mc-00289-CKK -AK Document 31 Filed 07/13/10 Page 1 of 12 UNITED STATES DISTRICT COURT FOR THE DISTRICT OF COLUMBIA FEDERAL TRADE COMMISSION, Petitioner, v. PAUL M. BISARO, Misc. No. 10-289 (CKK)(AK)
More informationSchering-Plough and in Re Tamoxifen: Lawful Reverse Payments in the Hatch-Waxman Context
Berkeley Technology Law Journal Volume 22 Issue 1 Article 3 January 2007 Schering-Plough and in Re Tamoxifen: Lawful Reverse Payments in the Hatch-Waxman Context Jeff Thomas Follow this and additional
More informationPharmaceutical Patent Settlements A Presumption in Reverse
AUGUST 2009, RELEASE ONE Pharmaceutical Patent Settlements A Presumption in Reverse Kristina Nordlander & Patrick Harrison Sidley Austin LLP Pharmaceutical Patent Settlements A Presumption in Reverse Kristina
More informationTHE JOHN MARSHALL REVIEW OF INTELLECTUAL PROPERTY LAW
THE JOHN MARSHALL REVIEW OF INTELLECTUAL PROPERTY LAW THE PRESERVE ACCESS TO AFFORDABLE GENERICS ACT: WILL CONGRESS'S RESPONSE TO REVERSE PAYMENT PATENT SETTLEMENTS ENHANCE COMPETITION IN THE PHARMACEUTICAL
More informationIn the Supreme Court of the United States
No. 12-416 In the Supreme Court of the United States FEDERAL TRADE COMMISSION, PETITIONER v. WATSON PHARMACEUTICALS, INC., ET AL. ON PETITION FOR A WRIT OF CERTIORARI TO THE UNITED STATES COURT OF APPEALS
More informationREVERSE PAYMENT AGREEMENTS: WHY A QUICK LOOK PROPERLY PROTECTS PATENTS AND PATIENTS
REVERSE PAYMENT AGREEMENTS: WHY A QUICK LOOK PROPERLY PROTECTS PATENTS AND PATIENTS INTRODUCTION Regulating the pharmaceutical industry has proven to be precarious because of the unique landscape of the
More informationIn Re K-Dur Antitrust Litigation: Pharmaceutical Reverse Payment Settlements Go beyond the Scope of the Patent
NORTH CAROLINA JOURNAL OF LAW & TECHNOLOGY Volume 14 Issue 1 Fall 2012 Article 9 10-1-2012 In Re K-Dur Antitrust Litigation: Pharmaceutical Reverse Payment Settlements Go beyond the Scope of the Patent
More informationUNITED STATES DISTRICT COURT DISTRICT OF NEW JERSEY. This Court dismissed the complaint of Direct Purchaser Plaintiffs Louisiana Wholesale
UNITED STATES DISTRICT COURT DISTRICT OF NEW JERSEY IN RE LAMICTAL DIRECT PURCHASER ANTITRUST LITIGATION THIS DOCUMENT RELATES TO: ALL DIRECT PURCHASER ACTIONS : : : : OPINION : : No. 12-cv-995 (WHW) :
More informationIntersection of Patent Infringement and Antitrust Liability in Abbreviated New Drug Application Litigation, The
Journal of Dispute Resolution Volume 2014 Issue 1 Article 5 2014 Intersection of Patent Infringement and Antitrust Liability in Abbreviated New Drug Application Litigation, The Kevin E. Noonan Follow this
More informationSupreme Court of the United States
No. 12-416 IN THE Supreme Court of the United States FEDERAL TRADE COMMISSION, v. Petitioner, ACTAVIS, INC., ET AL. Respondents. On Writ Of Certiorari To The United States Court Of Appeals For The Eleventh
More informationWhere We Stand On Pharmaceutical Patent Settlements
Portfolio Media. Inc. 860 Broadway, 6th Floor New York, NY 10003 www.law360.com Phone: +1 646 783 7100 Fax: +1 646 783 7161 customerservice@law360.com Where We Stand On Pharmaceutical Patent Settlements
More informationNo IN THE Supreme Court of the United States. FEDERAL TRADE COMMISSION, Petitioner, v. WATSON PHARMACEUTICALS, INC., ET AL., Respondents.
No. 12-416 IN THE Supreme Court of the United States FEDERAL TRADE COMMISSION, Petitioner, v. WATSON PHARMACEUTICALS, INC., ET AL., Respondents. On Petition for a Writ of Certiorari to the United States
More informationCase 2:08-cv MSG Document 43 Filed 08/31/2009 Page 1 of 59 IN THE UNITED STATES DISTRICT COURT FOR THE EASTERN DISTRICT OF PENNSYLVANIA
Case 2:08-cv-02141-MSG Document 43 Filed 08/31/2009 Page 1 of 59 IN THE UNITED STATES DISTRICT COURT FOR THE EASTERN DISTRICT OF PENNSYLVANIA FEDERAL TRADE COMMISSION, Plaintiff, v. CEPHALON INC., Defendant.
More information1 Bret Dickey, Jonathan Orszag & Laura Tyson, An Economic Assessment of Patent Settlements
Hatch-Waxman Act Reverse-Payment Settlements FTC v. Actavis, Inc. Pharmaceutical development is an uncertain business. The process is long and laborious, resulting in research costs that are substantially
More informationPharmaceutical Patent Litigation Settlements: Implications for Competition and Innovation
: Implications for Competition and Innovation John R. Thomas Visiting Scholar January 27, 2012 CRS Report for Congress Prepared for Members and Committees of Congress Congressional Research Service 7-5700
More information2 Noerr-Pennington Rulings Affirm Narrow Scope Of Immunity
Portfolio Media. Inc. 111 West 19 th Street, 5th Floor New York, NY 10011 www.law360.com Phone: +1 646 783 7100 Fax: +1 646 783 7161 customerservice@law360.com 2 Noerr-Pennington Rulings Affirm Narrow
More informationIn Re: Tamoxifen Citrate Antitrust Litigation UNITED STATES COURT OF APPEALS FOR THE SECOND CIRCUIT. 466 F.3d 187 August 10, 2006, Decided
In Re: Tamoxifen Citrate Antitrust Litigation UNITED STATES COURT OF APPEALS FOR THE SECOND CIRCUIT 466 F.3d 187 August 10, 2006, Decided [*190] SACK, Circuit Judge: This appeal, arising [**3] out of circumstances
More information15 Hous. J. Health L. & Policy 281 Copyright 2015 Tracey Toll Houston Journal of Health Law & Policy
15 Hous. J. Health L. & Policy 281 Copyright 2015 Tracey Toll Houston Journal of Health Law & Policy PHARMACEUTICAL REVERSE PAYMENT SETTLEMENT AGREEMENTS AND A PROPOSAL FOR CLARIFYING THE APPLICATION OF
More informationDon't Overlook Pleading Challenges In State Pharma Suits
Portfolio Media. Inc. 111 West 19 th Street, 5th Floor New York, NY 10011 www.law360.com Phone: +1 646 783 7100 Fax: +1 646 783 7161 customerservice@law360.com Don't Overlook Pleading Challenges In State
More informationIN THE UNITED STATES DISTRICT COURT FOR THE DISTRICT OF NEW JERSEY
Case 3:12-cv-02389-PGS-DEA Document 152 Filed 09/14/12 Page 1 of 4 PageID: 2166 CONNELL FOLEY LLP 85 Livingston Avenue Roseland, New Jersey 07068 (973) 535-0500 WHITE & CASE LLP 1155 Avenue of the Americas
More informationREVERSE PAYMENTS: WHEN THE FEDERAL TRADE COMMISSION CAN ATTACK THE VALIDITY OF UNDERLYING PATENTS
REVERSE PAYMENTS: WHEN THE FEDERAL TRADE COMMISSION CAN ATTACK THE VALIDITY OF UNDERLYING PATENTS INTRODUCTION Settlements between brand-name and generic pharmaceutical companies that delay generic entry
More informationFTC v. Watson Pharmaceuticals: 677 F.3D 1298 (11th Cir. 2012)
DePaul Journal of Art, Technology & Intellectual Property Law Volume 23 Issue 2 Spring 2013 Article 8 FTC v. Watson Pharmaceuticals: 677 F.3D 1298 (11th Cir. 2012) Christopher Bingham Galligan Follow this
More informationFTC v. ACTAVIS: The Patent-Antitrust Intersection Revisited
Texas A&M University School of Law Texas A&M Law Scholarship Faculty Scholarship 2015 FTC v. ACTAVIS: The Patent-Antitrust Intersection Revisited Glynn S. Lunney Jr Texas A&M University School of Law,
More informationA Prescription for the Future: Reverse-Payment Settlements in the Wake of FTC v. Actavis Pharmaceuticals
Notre Dame Journal of Law, Ethics & Public Policy Volume 29 Issue 2 Symposium: Regulating Life, Disease, and Death Article 9 2015 A Prescription for the Future: Reverse-Payment Settlements in the Wake
More information15.3a1. Entry-restrictive Agreements; Exclusion or Reverse Payments
Excerpted from Herbert Hovenkamp et al., IP and Antitrust (2013 Supplement) (forthcoming) 15.3a1. Entry-restrictive Agreements; Exclusion or Reverse Payments Insofar as antitrust is concerned, among the
More informationPreemptive Use Of Post-Grant Review Vs. Inter Partes Review
Portfolio Media. Inc. 111 West 19 th Street, 5th Floor New York, NY 10011 www.law360.com Phone: +1 646 783 7100 Fax: +1 646 783 7161 customerservice@law360.com Preemptive Use Of Post-Grant Review Vs. Inter
More informationS. 214 s Inappropriate Interference With the Fundamental Right to Settle Litigation. Paul Bender Christopher A. Mohr Michael R.
S. 214 s Inappropriate Interference With the Fundamental Right to Settle Litigation Paul Bender Christopher A. Mohr Michael R. Klipper EXECUTIVE SUMMARY Patent settlement agreements with consideration
More informationA Framework to Evaluate Pharmaceutical Pay-for- Delays: A Balancing Test Based Upon Reasonableness
Kentucky Law Journal Volume 102 Issue 2 Special Feature: Medicaid Matters Article 10 2013 A Framework to Evaluate Pharmaceutical Pay-for- Delays: A Balancing Test Based Upon Reasonableness Jessica Hudson
More informationSETTLEMENTS BETWEEN BRAND AND GENERIC PHARMACEUTICAL COMPANIES: A REASONABLE ANTITRUST ANALYSIS OF REVERSE PAYMENTS
SETTLEMENTS BETWEEN BRAND AND GENERIC PHARMACEUTICAL COMPANIES: A REASONABLE ANTITRUST ANALYSIS OF REVERSE PAYMENTS Anne-Marie C. Yvon, Ph.D.* INTRODUCTION Imagine that CureCo, Inc., is the exclusive seller
More informationPayment After Actavis 100 Iowa Law Review 1 (forthcoming 2014) Michael A. Carrier *
Payment After Actavis 100 Iowa Law Review 1 (forthcoming 2014) Michael A. Carrier * One of the most pressing issues in patent and antitrust law involves agreements by which brand-name drug companies pay
More informationIN THE PAST THREE YEARS, A NUMBER
C O V E R S T O R I E S Antitrust, Vol. 22, No. 2, Spring 2008. 2008 by the American Bar Association. Reproduced with permission. All rights reserved. This information or any portion thereof may not be
More informationSeeking Disapproval: Presidential Review Of ITC Orders
Portfolio Media. Inc. 860 Broadway, 6th Floor New York, NY 10003 www.law360.com Phone: +1 646 783 7100 Fax: +1 646 783 7161 customerservice@law360.com Seeking Disapproval: Presidential Review Of ITC Orders
More informationSupreme Court of the United States
No. 12-416 IN THE Supreme Court of the United States FEDERAL TRADE COMMISSION, v. Petitioner, ACTAVIS, INC., et al., Respondents. On Writ of Certiorari to the United States Court of Appeals for the Eleventh
More informationThe EU Sector Inquiry: Implications for Patent Litigation and Settlements
The EU Sector Inquiry: Implications for Patent Litigation and Settlements Sean-Paul Brankin Crowell & Moring February 17, 2009 1 Issues from the Preliminary Report Market definition Vexatious litigation
More informationRachel A. Lewis * * J.D. Candidate, Seattle University School of Law, I want to dedicate this Comment to my
Inevitable Imbalance: Why FTC v. Actavis Was Inadequate to Solve the Reverse Payment Settlement Problem and Proposing a New Amendment to the Hatch Waxman Act Rachel A. Lewis * The law regarding reverse
More informationSome Declaratory Judgment Guidance For ANDA Litigants
Portfolio Media. Inc. 860 Broadway, 6th Floor New York, NY 10003 www.law360.com Phone: +1 646 783 7100 Fax: +1 646 783 7161 customerservice@law360.com Some Declaratory Judgment Guidance For ANDA Litigants
More informationSUPREME COURT OF THE UNITED STATES
(Slip Opinion) OCTOBER TERM, 2012 1 Syllabus NOTE: Where it is feasible, a syllabus (headnote) will be released, as is being done in connection with this case, at the time the opinion is issued. The syllabus
More informationON NOVEMBER 6, 2001, the U.S. Court of Appeals
21 Biotechnology Law Report 13 Number 1 (February 2002) Mary Ann Liebert, Inc. Brief Analysis of Recent Pharmaceutical/IP Decisions DAVID A. BALTO AMERICAN BIOSCIENCE, INC. V. THOMPSON 269 F.3D1077, 2001
More informationCase 1:18-cv AKH Document 101 Filed 10/24/18 Page 1 of 26 UNITED STATES DISTRICT COURT FOR THE SOUTHERN DISTRICT OF NEW YORK
Case 1:18-cv-04361-AKH Document 101 Filed 10/24/18 Page 1 of 26 UNITED STATES DISTRICT COURT FOR THE SOUTHERN DISTRICT OF NEW YORK In re Novartis and Par Antitrust Litigation 1:18-cv-04361-AKH This Document
More informationPleading Direct Patent Infringement Without Form 18
Portfolio Media. Inc. 860 Broadway, 6th Floor New York, NY 10003 www.law360.com Phone: +1 646 783 7100 Fax: +1 646 783 7161 customerservice@law360.com Pleading Direct Patent Infringement Without Form 18
More informationNo. IN THE Supreme Court of the United States. Petitioner, v. SCHERING-PLOUGH CORPORATION, et al.
No. IN THE Supreme Court of the United States FEDERAL TRADE COMMISSION, Petitioner, v. SCHERING-PLOUGH CORPORATION, et al. On Petition for a Writ of Certiorari to the United States Court of Appeals for
More informationIntellectual Property E-Bulletin
Issue 78 August 2012 Inside This Issue ABA Antitrust Section Intellectual Property E-Bulletin The Intellectual Property Committee is pleased to present the latest issue of our monthly E-Bulletin, providing
More information3 Tips For Understanding Price Fixing Conspiracy Liability
Portfolio Media. Inc. 860 Broadway, 6th Floor New York, NY 10003 www.law360.com Phone: +1 646 783 7100 Fax: +1 646 783 7161 customerservice@law360.com 3 Tips For Understanding Price Fixing Conspiracy Liability
More informationAntitrust/Intellectual Property Interface Under U.S. Law
BEIJING BRUSSELS CHICAGO DALLAS FRANKFURT GENEVA HONG KONG LONDON LOS ANGELES NEW YORK SAN FRANCISCO SHANGHAI SINGAPORE SYDNEY TOKYO WASHINGTON, D.C. Antitrust/Intellectual Property Interface Under U.S.
More informationReliable Analysis Is Key To Addressing Ascertainability
Reliable Analysis Is Key To Addressing Ascertainability By Stephen Cacciola and Stephen Fink; Analysis Group, Inc. Law360, New York (December 8, 2016, 11:15 AM) Stephen Cacciola Stephen Fink There has
More informationAn ANDA Update. June 2004 Bulletin 04-50
June 2004 Bulletin 04-50 If you have questions or would like additional information on the material covered in this Bulletin, please contact one of the authors: Mark R. Shanks 202.414.9201 mshanks@reedsmith.com
More informationEmerging Trend Against Nationwide Venue In Antitrust Cases
Portfolio Media. Inc. 860 Broadway, 6th Floor New York, NY 10003 www.law360.com Phone: +1 646 783 7100 Fax: +1 646 783 7161 customerservice@law360.com Emerging Trend Against Nationwide Venue In Antitrust
More informationNo.,, LOUISIANA WHOLESALE DRUG CO., AG, et al., BAYER AG AND BAYER CORP., et al.,
No.,, 10-762 IN TIlE ( urt fll Nnit h LOUISIANA WHOLESALE DRUG CO., AG, et al., Petitioners, V. BAYER AG AND BAYER CORP., et al., Respondents. ON PETITION FOR A WRIT OF CERTIORARI TO TIlE UNITED STATES
More informationPATENT TERM LIMITS, ANTI-TRUST LAW, AND THE HATCH-WAXMAN ACT: WHY DEFENSE OF A LEGALLY GRANTED PATENT MONOPOLY DOES NOT VIOLATE ANTI- TRUST LAWS.
PATENT TERM LIMITS, ANTI-TRUST LAW, AND THE HATCH-WAXMAN ACT: WHY DEFENSE OF A LEGALLY GRANTED PATENT MONOPOLY DOES NOT VIOLATE ANTI- TRUST LAWS. Christopher Fasel I. INTRODUCTION In the interest of increasing
More informationThe ITC's Potential Role In Hatch-Waxman Litigation
Portfolio Media. Inc. 111 West 19 th Street, 5th Floor New York, NY 10011 www.law360.com Phone: +1 646 783 7100 Fax: +1 646 783 7161 customerservice@law360.com The ITC's Potential Role In Hatch-Waxman
More informationFTC v. Actavis, Inc.: When Is the Rule of Reason Not the Rule of Reason?
Minnesota Journal of Law, Science & Technology Volume 15 Issue 1 Article 6 2014 FTC v. Actavis, Inc.: When Is the Rule of Reason Not the Rule of Reason? Thomas F. Cotter Follow this and additional works
More informationNo IN THE ( ourt of the: Petitioners, v. BAYER AG ~ ~D BAYER CORP., ETAL., Respondents.
No. 08-1194 OFFIUE OF 1HE CLEFI~ IN THE ( ourt of the: o I ARKANSAS CARPENTERS HEALTH AND WELFARE FUND, PAPER, A.E OF L., ETAL., Petitioners, v. BAYER AG ~ ~D BAYER CORP., ETAL., Respondents. ON PETITION
More informationPharmaceutical Formulations: Ready For Patenting?
Portfolio Media. Inc. 111 West 19 th Street, 5th Floor New York, NY 10011 www.law360.com Phone: +1 646 783 7100 Fax: +1 646 783 7161 customerservice@law360.com Pharmaceutical Formulations: Ready For Patenting?
More informationNo IN THE Supreme Court of the United States. On Writ of Certiorari to the United States Court of Appeals for the Eleventh Circuit
No. 12-416 IN THE Supreme Court of the United States FEDERAL TRADE COMMISSION, v. Petitioner, ACTAVIS, INC. ET AL., Respondents. On Writ of Certiorari to the United States Court of Appeals for the Eleventh
More informationA Back-To-Basics Approach To Patent Damages Law
Portfolio Media. Inc. 111 West 19 th Street, 5th Floor New York, NY 10011 www.law360.com Phone: +1 646 783 7100 Fax: +1 646 783 7161 customerservice@law360.com A Back-To-Basics Approach To Patent Damages
More informationTC Heartland s Restraints On ANDA Litigation Jurisdiction
Portfolio Media. Inc. 111 West 19 th Street, 5th Floor New York, NY 10011 www.law360.com Phone: +1 646 783 7100 Fax: +1 646 783 7161 customerservice@law360.com TC Heartland s Restraints On ANDA Litigation
More informationPATENT CASE LAW UPDATE
PATENT CASE LAW UPDATE Intellectual Property Owners Association 40 th Annual Meeting September 9, 2012 Panel Members: Paul Berghoff, McDonnell Boehnen Hulbert & Berghoff LLP Prof. Dennis Crouch, University
More informationA Pharmaceutical Park Place: Why the Supreme Court Should Modify the Scope of the Patent Test for Reverse Payment Deals
Journal of Intellectual Property Law Volume 20 Issue 2 Article 3 April 2013 A Pharmaceutical Park Place: Why the Supreme Court Should Modify the Scope of the Patent Test for Reverse Payment Deals David
More informationReverse Payment Settlements: A Patent Approach to Defending the Argument for Illegality
Reverse Payment Settlements: A Patent Approach to Defending the Argument for Illegality CORY J. INGLE* Abstract: This note proposes a new strategy to address the challenges of reverse payment settlements
More informationThe Role of Antitrust Principles in Patent Monopolies: The Third Circuit Applies Antitrust Scrutiny to No-AG Patent Settlements in Smithkline
Boston College Law Review Volume 58 Issue 6 Electronic Supplement Article 11 4-13-2017 The Role of Antitrust Principles in Patent Monopolies: The Third Circuit Applies Antitrust Scrutiny to No-AG Patent
More informationAntitrust Issues in the Settlement of Pharmaceutical Patent Disputes, Part III
Antitrust Issues in the Settlement of Pharmaceutical Patent Disputes, Part III Thomas B. Leary t I. INTRODUCTION Once again, I will address the issue of litigation settlements between companies that hold
More informationThe Latest On Fee-Shifting In Patent Cases
Portfolio Media. Inc. 860 Broadway, 6th Floor New York, NY 10003 www.law360.com Phone: +1 646 783 7100 Fax: +1 646 783 7161 customerservice@law360.com The Latest On Fee-Shifting In Patent Cases Law360,
More informationSupreme Court of the United States
No. 12-416 IN THE Supreme Court of the United States FEDERAL TRADE COMMISSION, v. Petitioner, ACTAVIS, INC., ET AL., Respondents. On Writ of Certiorari to the United States Court of Appeals for the Eleventh
More informationPharmaceutical Patent-Antitrust: Reverse Payment Settlements and Product Hopping
Pharmaceutical Patent-Antitrust: Reverse Payment Settlements and Product Hopping John R. Thomas Visiting Scholar October 7, 2015 Congressional Research Service 7-5700 www.crs.gov R44222 Summary Congressional
More informationDobbs V. Wyeth: Are We There Yet, And At What Cost?
Portfolio Media. Inc. 860 Broadway, 6th Floor New York, NY 10003 www.law360.com Phone: +1 646 783 7100 Fax: +1 646 783 7161 customerservice@law360.com Dobbs V. Wyeth: Are We There Yet, And At What Cost?
More informationDoes a Civil Protective Order Protect a Company s Foreign Based Documents from Being Produced in a Related Criminal Investigation?
Does a Civil Protective Order Protect a Company s Foreign Based Documents from Being Produced in a Related Criminal Investigation? Contributed by Thomas P. O Brien and Daniel Prince, Paul Hastings LLP
More informationLexmark Could Profoundly Impact Patent Exhaustion
Portfolio Media. Inc. 111 West 19 th Street, 5th Floor New York, NY 10011 www.law360.com Phone: +1 646 783 7100 Fax: +1 646 783 7161 customerservice@law360.com Lexmark Could Profoundly Impact Patent Exhaustion
More informationPTAB Approaches To Accessibility Of Printed Publication
Portfolio Media. Inc. 111 West 19 th Street, 5th Floor New York, NY 10011 www.law360.com Phone: +1 646 783 7100 Fax: +1 646 783 7161 customerservice@law360.com PTAB Approaches To Accessibility Of Printed
More informationFed. Circ. Radically Changes The Law Of Obviousness
Portfolio Media. Inc. 111 West 19 th Street, 5th Floor New York, NY 10011 www.law360.com Phone: +1 646 783 7100 Fax: +1 646 783 7161 customerservice@law360.com Fed. Circ. Radically Changes The Law Of Obviousness
More informationCase 3:14-cv MLC-TJB Document Filed 07/24/15 Page 2 of 16 PageID: 1111 TABLE OF CONTENTS INTRODUCTION... 1 BACKGROUND...
Case 3:14-cv-02550-MLC-TJB Document 100-1 Filed 07/24/15 Page 1 of 16 PageID: 1110 Keith J. Miller Michael J. Gesualdo ROBINSON MILLER LLC One Newark Center, 19th Floor Newark, New Jersey 07102 Telephone:
More informationAn Assignment's Effect On Hypothetical Negotiation
Portfolio Media, Inc. 648 Broadway, Suite 200 New York, NY 10012 www.law360.com Phone: +1 212 537 6331 Fax: +1 212 537 6371 customerservice@portfoliomedia.com An Assignment's Effect On Hypothetical Negotiation
More informationIn re Cardizem & Valley Drug Co.: The Hatch- Waxman Act, Anticompetitive Action, and Regulatory Reform
Berkeley Technology Law Journal Volume 19 Issue 1 Article 20 January 2004 In re Cardizem & Valley Drug Co.: The Hatch- Waxman Act, Anticompetitive Action, and Regulatory Reform Larissa Burford Follow this
More information'Willful Blindness' And Induced Patent Infringement
Portfolio Media, Inc. 860 Broadway, 6th Floor New York, NY 10003 www.law360.com Phone: +1 646 783 7100 Fax: +1 646 783 7161 customerservice@law360.com 'Willful Blindness' And Induced Patent Infringement
More informationWill High Court Provide Clarity On 'Clear Evidence'?
Portfolio Media. Inc. 111 West 19 th Street, 5th Floor New York, NY 10011 www.law360.com Phone: +1 646 783 7100 Fax: +1 646 783 7161 customerservice@law360.com Will High Court Provide Clarity On 'Clear
More informationPayment After Actavis
Payment After Actavis Michael A. Carrier ABSTRACT: One of the most pressing issues in patent and antitrust law involves agreements by which brand-name drug companies pay generic firms to delay entering
More information