Looking Within the Scope of the Patent
|
|
- Jeffry Perry
- 5 years ago
- Views:
Transcription
1 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 Rule of Reason On June 17, 2013, the U.S. Supreme Court ruled in FTC v. Actavis, Inc. that settlements of patent infringement suits brought in response to a Paragraph IV certification under the Hatch-Waxman Act (frequently called Paragraph IV, reverse payment, or pay-for-delay settlements) are subject to the rule of reason. Writing for a five-to-three majority, Justice Breyer rejected the view adopted by the Eleventh Circuit below (as well as the Second and Federal Circuits) that settlements of Hatch-Waxman Act litigation that are within the scope of the brand s patent are per se lawful. The Court also rejected the FTC s position (also supported by the Solicitor General) that such settlements should be presumed unlawful. Instead, the Court held that such settlements must be evaluated on a case-by-case basis, under the rule of reason, to determine if the procompetitive benefits of the settlement outweigh any anticompetitive effects. The Court s decision in FTC v. Actavis, Inc. settles a long-running debate regarding the appropriate standard that should apply to Paragraph IV settlements. As the Court itself has previously noted, however, the rule of reason involves a fact-bound balancing test that does not provide the type of brightline guidance that both sides sought. Companies contemplating Paragraph IV settlements will therefore need to evaluate whether their proposed settlement s procompetitive benefits outweigh any potential anticompetitive effects resulting from the possibility of a reduction in generic competition. Whether the decision will reduce the incentives to settle costly patent litigation because of the risk of costly follow-on antitrust litigation an outcome the dissent foreshadows remains to be seen. Background on the Androgel Litigation The Hatch-Waxman Act allows branded drug owners to sue for infringement when a generic drug company makes a Paragraph IV certification that the brand company s patent is either invalid or not infringed. The typical settlement includes at least two components: (1) the brand company compensates the generic company in the form of a cash payout or other commercial benefits and (2) the generic agrees to delay its entry into the market until a later date closer to patent expiration. For more than a decade, the FTC has claimed that these settlements violate the antitrust laws by altering the incentives Congress put in place in the Hatch-Waxman Act to create generic drug competition. The Hatch-Waxman Act offered generics the opportunity to challenge invalid or non-infringed patents (in the form of a Paragraph IV certification) without the need to actually enter the market and risk litigation. To promote such challenges, the Act also provides 180 days of marketing exclusivity to the first generic filer. The Act was silent as to the settlement of the resulting infringement litigation. In practice, branded drug Latham & Watkins operates worldwide as a limited liability partnership organized under the laws of the State of Delaware (USA) with affiliated limited liability partnerships conducting the practice in the United Kingdom, France, Italy and Singapore and as affiliated partnerships conducting the practice in Hong Kong and Japan. The Law Office of Salman M. Al-Sudairi is Latham & Watkins associated office in the Kingdom of Saudi Arabia. In Qatar, Latham & Watkins LLP is licensed by the Qatar Financial Centre Authority. Under New York s Code of Professional Responsibility, portions of this communication contain attorney advertising. Prior results do not guarantee a similar outcome. Results depend upon a variety of factors unique to each representation. Please direct all inquiries regarding our conduct under New York s Disciplinary Rules to Latham & Watkins LLP, 885 Third Avenue, New York, NY , Phone: Copyright 2013 Latham & Watkins. All Rights Reserved.
2 companies have sometimes paid generics significant settlements that created incentives for the generic firm to agree to a delayed entry date and also removed any risk of an invalidity or noninfringement ruling. The FTC s position historically rested on the assumption that, because the typical pattern in litigation to enforce a strong patent is for the infringer to pay the patent owner and not the other way around, a substantial payment by the brand owner to the generic raised a suspicion that the payment was to avoid a declaration of invalidity or non-infringement of a weak patent. Thus, in the FTC s view, the payment represents a sharing of profits from an improperly prolonged monopoly protected by the patent, when the more appropriate outcome would involve elimination of the patent s exclusionary power and unrestricted new entry by one or more generics. This led the FTC to argue in the early cases that Hatch-Waxman Act settlements should be per se illegal (except for minimal payments by brand owners to compensate generics for litigation expenses). Following a string of losses in the federal appellate courts, the FTC eventually moderated its position and adopted the view that Hatch-Waxman Act settlements should be subject to a rebuttable presumption of illegality because they delay generic entry, resulting in higher prices and less choice for consumers. 1 Pharmaceutical companies long have disputed the FTC s view and contend that these settlements should be per se lawful because: (1) patent rights include the right to limit the extent and conditions under which the patent holder licenses its intellectual property (including the right to refuse to license), and (2) the efficiency and innovation of the industry (and ultimately the health of patients and economic well-being of consumers) benefit from the ability to settle in a way that provides finality and avoids both protracted and costly patent litigation as well as any follow-on antitrust litigation (equally if not more protracted and costly than patent litigation) challenging such settlements. In January 2009, the FTC filed suit against three companies, Solvay Pharmaceuticals Inc., (a brand pharmaceutical company), and Watson Pharmaceuticals and Paddock Laboratories, (both generic companies), alleging they had violated Section 5 of the FTC Act by entering into allegedly anticompetitive settlements regarding the product Androgel, a topical medication to treat male testosterone deficiency. In each settlement, in exchange for a payment, the generic companies agreed to enter the market at a later date than they would have had they prevailed in the patent suit, but an earlier date than patent expiry. The agency alleged that the Androgel patent was weak, that Solvay would likely have lost at trial, and that consumers would have benefitted from generic entry much sooner absent the settlement. The district court granted the defendants motion to dismiss because, although the settlement delayed generic entry nine years, the settlement still allowed for generic entry five years before patent expiry, and thus did not exceed the scope of the patent. 2 The Eleventh Circuit affirmed, holding that the scope of the patent standard previously adopted by the Second and Federal Circuits was appropriate unless there was evidence of sham litigation or fraud in obtaining the patent. 3 The Court noted that from the brand s perspective, no rational actor... would take [the] risk of investing more than $1.3 billion on a potential drug where [o]nly one of every 5,000 medicines tested... is eventually approved for patient use without the prospect of a big reward in the form of a guaranteed right to recoup monopoly profits. The court further observed that while agreements among competitors to eliminate competition would be barred under the antitrust laws, reverse payment cases were atypical because one of the parties [owns] a patent. This makes all the difference to the court, because the patent holder has a lawful right to exclude others from the marketplace. Shortly thereafter, in In re K-Dur Antitrust Litigation, 686 F.3d 197, 218 (3d Cir. 2012), the Third Circuit split from the Second, Eleventh, and Federal Circuits and adopted the FTC s view that reverse payment settlements should be subject to a quick-look rule of reason, under which they are presumed to be Latham & Watkins Client Alert No June 25, 2013 Page 2
3 illegal. The Supreme Court granted the FTC s petition for certiorari in the Androgel litigation on December 7, The Supreme Court s Decision The five-justice majority rejected the Eleventh Circuit s view that settlements within the scope of the brand s patent should be per se legal and concluded that the proper test for examining such settlements is the rule of reason. This reversal means that, going forward, the burden will be on the FTC or private plaintiff to show that the likely anticompetitive effects of the agreement outweigh its procompetitive benefit. The ruling contained a number of noteworthy points. First, the Court rejects the theory that the patent holder s conduct is immune from antitrust scrutiny absent evidence of sham litigation or fraud in obtaining the patent. The Court reasons that the Paragraph IV litigation put the patent s validity and preclusive scope at issue and that it would be incongruous to determine antitrust legality by measuring the settlement s anticompetitive effects solely against patent law policy, and not against procompetitive antitrust policies because both factors are relevant in determining the scope of monopoly and antitrust immunity conferred by a patent. Second, the Court is unmoved by the defendants and dissent s concern that the practical effect of allowing antitrust challenges to settlements will re-open the underlying invalidity and/or infringement litigation in order to demonstrate what would have happened to competition but for the settlement. Bottom line, the Court appears to conclude that the risks of relitigating the patent suit would be offset by the ability to root out settlements that threatened unjustified anticompetitive harm. The Court notes that a settlement which simply allowed later entry without a payment would not risk antitrust liability and leaves open the door to settlements with justified payments. Third, and finally, the Court rejects the FTC s claim that Paragraph IV settlements should be treated as presumptively unlawful under a quick look rule of reason approach. The Court concludes that the settlements do not meet the standard for a quick look approach because a settlement s anticompetitive effects depend upon its size, its scale in relation to the payor s anticipated future litigation costs, its independence from other services for which it might represent payment, and the lack of any other convincing justification. That fact-bound inquiry, the Court reasons, could not be squared with the default rule of liability required by the quick look analysis. Chief Justice Roberts authored a strong dissent joined by Justices Scalia and Thomas. The dissent characterizes the majority as announc[ing] a new rule given that the Court has historically struck a balance between antitrust and intellectual property rights with the rule that when and only when an intellectual property holder steps outside the scope of the patent, he can no longer use the patent as his defense. The dissent observes that the majority points to no case where a patent settlement was subject to antitrust scrutiny merely because the validity of the patent was uncertain. Implications Structuring Paragraph IV Settlements Going Forward. Although the Court s decision settles the longrunning debate on the legal standard that should apply to Paragraph IV settlements and permits the agencies to attack settlements that are within the scope of the patent, the Court s choice of the rule of reason standard means that the advice to brand and generic firms settling Hatch Waxman litigation does not change demonstrably: firms should continue to evaluate whether, on balance, a settlement agreement can be explained as something other than a payment from the brand to the generic to stay out of the market. Latham & Watkins Client Alert No June 25, 2013 Page 3
4 The Court identifies three aspects of Paragraph IV settlements that should receive increased scrutiny. First, the Court notes that settlements for large and unjustified amounts will raise significant questions. The Court clarifies that settlements for amounts that exceed the amount the generic would have earned had it entered the market following favorable resolution of the Paragraph IV litigation are likely to be the most problematic. Second, the Court observes that settlements with first filers are more likely to attract scrutiny. Third, settlements with a generic entry date closer to the end of patent expiry are also most likely to be problematic. To those familiar with this area, these observations are familiar and do not demonstrably alter the settlement landscape. The Court also identifies circumstances or settlement features that will diminish the likelihood of antitrust scrutiny. The Court writes favorably about potential agreements where, as part of a settlement, the brand compensates the generic for providing various services such as distribution and marketing. The decision notes that where a reverse payment reflects traditional settlement considerations, such as avoided litigation costs or fair value for services, there is not the same concern that a patentee is using its monopoly profits to avoid the risk of patent invalidation or a finding of infringement. In such cases, the parties may have provided for a reverse payment without having sought or brought about the anticompetitive consequences. This opinion arguably suggests that settlements which include these types of agreements will pass muster under the rule of reason. Finally, the Court concludes by offering some broad observations regarding the size of the payment and its connection to the other settlement terms. The Court notes the likelihood of a reverse payment bringing about the anticompetitive effects depends on its size, its scale in relation to the payor s future litigation costs, its independence from other services for which it might represent payment, and the lack of any other convincing justification. More Antitrust Litigation? A key question on the horizon is how the FTC and private plaintiffs will react to the Court s decision and what that means for assessing the risk of possible investigations and litigation arising out of settlements. At least initially, potential plaintiffs may pay increased attention to Paragraph IV settlements. The Court s decision observes that while evidence of traditional settlement considerations, such as avoided litigation costs or fair value for services may indicate that a settlement should survive rule of reason scrutiny, this possibility does not justify dismissing the FTC s complaint. This sentence could prove significant if it is meant to suggest that the Supreme Court s decision in Bell Atlantic Corp. v. Twombly, 550 U.S. 544 (2007), notwithstanding the threshold for pleading an antitrust violation based on a reverse payment settlement may be relatively low. How much deference courts will give this observation at the motion to dismiss phase will be an important development to watch. Realistically, however, the FTC will not want to create bad law and will want to bring the cases the agency is most likely to win. Since the FTC will still bear the burden of proof, only the most aggressive settlements will attract their sustained attention. Thus, while potential plaintiffs may perceive that they will have an easier time in the courts given the Court s refusal to adopt the scope of the patent test it is not evident that their case selection will change. The decision could perhaps spur more private class action litigations, given the majority s suggestion that the factors relevant to the rule of reason analysis are best evaluated following discovery. However, because private plaintiffs historically have relied on the FTC to decide for them which cases to bring, predicting whether or not the decision will have any demonstrable effect would be premature. More Intellectual Property Litigation? Perhaps the biggest unanswered question is what role a patent s questionable validity should play in antitrust litigation over Paragraph IV settlements going forward. Should the parties conduct an abbreviated trial on the merits of the patent? A full trial? Does the fact that Latham & Watkins Client Alert No June 25, 2013 Page 4
5 the parties entered into a settlement suggest that while the settlement is not presumptively unlawful, the patent is presumptively invalid? The Court notes that it is normally not necessary to litigate patent validity to answer the antitrust question given that an unexplained large reverse payment itself would normally suggest that the patentee has serious doubts about the patent s survival. This leaves unresolved, however, how courts and litigating parties should address questions that raise a closer call namely, where the payment is large, the delay is significant, but the payment and delay may very well be justified, both because of the anticipated litigation costs and also because the settlement reflects compensation for a considerable services agreement. In these cases, courts will still need to resolve how to address the fact that validity may be called into question by the antitrust action but the validity is not definitively resolved. Effects Beyond Paragraph IV Litigation. The Court s decision is also likely to factor in the analysis that the antitrust agencies and federal courts apply in evaluating antitrust claims brought against branded firms for Hatch-Waxman related conduct alleged to cause harm to generic firms. Ongoing examples of such litigation include Mylan Pharmaceuticals, Inc. v. Warner Chilcott Public Limited Company, No (E.D. Pa.), which concerns the legality of product hopping and Actelion Pharmaceuticals, Ltd. v. Apotex, No (D.N.J.), which addresses the legality of brand firms alleged exploitation of REMS programs to eliminate potential generic competition. A frequent issue in those cases is whether the branded firm s intellectual property rights should shield it from antitrust liability. The Court s broad pronouncements regarding the interplay between a brand s intellectual property rights, on the one hand, and the policies and objectives of the Hatch-Waxman Act and antitrust law, on the other, will likely cause plaintiffs in these cases to press these arguments with renewed vigor. More generally, perhaps the most significant effect of the Court s decision over the long run may be the extent to which it charts a middle ground in the long-running debate over the extent to which a defendant s rights (intellectual property or otherwise) shield it from antitrust claims. Spurred in part by the Court s decisions in Verizon Communications, Inc. v. Law Offices of Curtis V. Trinko, LLP, 540 U. S. 398, 408 (2004), and Credit Suisse Securities LLC v. Billing, 551 U.S. 264, 275 (2006), courts have had a tendency to assume that antitrust claims should yield to other bodies of law. How courts will evaluate the opinion s discussion regarding the role that antitrust law should play in analyzing an intellectual property holder s conduct in non-hatch-waxman Act contexts remains to be seen. Going forward, companies should expect, however, that the FTC and the DOJ Antitrust Division, as well as private plaintiffs, will embrace the decision in their advocacy in cases involving challenges to the conduct of intellectual property holders. If you have questions about this Client Alert, please contact one of the authors listed below or the Latham lawyer with whom you normally consult: Abbott (Tad) B. Lipsky, Jr. tad.lipsky@lw.com Washington, D.C. Amanda P. Reeves amanda.reeves@lw.com Washington, D.C. Latham & Watkins Client Alert No June 25, 2013 Page 5
6 Patrick C. English Washington, D.C. Client Alert is published by Latham & Watkins as a news reporting service to clients and other friends. The information contained in this publication should not be construed as legal advice. Should further analysis or explanation of the subject matter be required, please contact the lawyer with whom you normally consult. A complete list of Latham s Client Alerts can be found at If you wish to update your contact details or customize the information you receive from Latham & Watkins, visit to subscribe to the firm s global client mailings program. Endnotes 1 See e.g. In re Abbott Labs., No. C-3945 (F.T.C. May 22, 2000); In re Hoechst Marion Roussel, Inc., No (F.T.C. Apr. 2, 2001). 2 In re Androgel Antitrust Litig. (No. II), 687 F. Supp. 2d. 1371, (N.D. Ga. 2010). 3 FTC v. Watson Pharmaceuticals, 677 F.3d 1298, 1312 (11th Cir. 2012). Latham & Watkins Client Alert No June 25, 2013 Page 6
Pharmaceutical 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 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 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 informationReverse Payment Settlements In Pharma Industry: Revisited
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 Reverse Payment Settlements In Pharma Industry: Revisited
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 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 informationPay-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 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 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 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 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 informationLatham & Watkins Litigation Department Securities Litigation and Professional Liability Practice
Number 1312 April 4, 2012 Client Alert While the Second Circuit s formulation answers some questions about what transactions fall within the scope of Section 10(b), it also raises a host of new questions
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 informationA Response to Chief Justice Roberts: Why Antitrust Must Play a Role in the Analysis of Drug Patent Settlements
A Response to Chief Justice Roberts: Why Antitrust Must Play a Role in the Analysis of Drug Patent Settlements Michael A. Carrier* The Supreme Court s decision in FTC v. Actavis, Inc. 1 has justly received
More informationLatham & Watkins Litigation Department
Number 1391 September 12, 2012 Client Alert Latham & Watkins Litigation Department Federal Circuit Holds that Liability for Induced Infringement Requires Infringement of a Patent, But No Single Entity
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 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 informationDelaware Bankruptcy Court Confirms Lock-Up Agreements Are a Valuable Tool Not a Violation of the Bankruptcy Code
Latham & Watkins Number 1467 February 13, 2013 Finance Department Delaware Bankruptcy Court Confirms Lock-Up Agreements Are a Valuable Tool Not a Violation of the Bankruptcy Code Josef S. Athanas, Caroline
More informationClient Alert. Background on Discovery Requests under Section 1782
Number 1383 August 13, 2012 Client Alert Latham & Watkins Litigation Department Eleventh Circuit Holds That Parties to Private International Commercial Arbitral Tribunals May Seek Discovery Assistance
More informationClient Alert. Circuit Courts Weigh In on Treatment of Trademark License Agreements in Bankruptcy
Number 1438 December 12, 2012 Client Alert Latham & Watkins Finance Department Circuit Courts Weigh In on Treatment of Trademark License Agreements in Bankruptcy Recent bankruptcy appellate rulings have
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 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 informationLatham & Watkins Litigation Department
Number 866 May 14, 2009 Client Alert Latham & Watkins Litigation Department The Third Circuit Clarifies the Class Action Fairness Act s Local Controversy Exception to Federal Jurisdiction In addressing
More informationAntitrust and Intellectual Property
and Intellectual Property July 22, 2016 Rob Kidwell, Member Antitrust Prohibitions vs IP Protections The Challenge Harmonizing U.S. antitrust laws that sanction the illegal use of monopoly/market power
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 informationClient Alert. Revisiting Venue: Patriot Coal and the Interest of Justice. Background
Number 1447 January 2, 2013 Client Alert Latham & Watkins Finance Department Revisiting Venue: Patriot Coal and the Interest of Justice Steps taken by parties on the eve of filing for bankruptcy are likely
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 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 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 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 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 informationLatham & Watkins Corporate Department. The Lessons of Slayton v. American Express for Forward-Looking Statements
Number 1044 June 10, 2010 Client Alert Latham & Watkins Corporate Department Second Circuit Wades Into the PSLRA Safe Harbor The Lessons of Slayton v. American Express for Forward-Looking Statements Specific,
More informationLatham & Watkins Finance Department
Number 1147 February 17, 2011 Client Alert Latham & Watkins Finance Department The Settlement does not affirm or overturn Judge Peck s controversial decision in the US Litigation barring enforcement of
More informationIn the Supreme Court of the United States
No. 15-1055 In the Supreme Court of the United States SMITHKLINE BEECHAM CORPORATION, DBA GLAXOSMITHKLINE, ET AL., Petitioners, v. KING DRUG COMPANY OF FLORENCE, INC., ET AL., Respondents. ON PETITION
More informationFIVE YEARS AGO, THE U.S. SUPREME
C O V E R S T O R I E S Antitrust, Vol. 32, No. 3, Summer 2018. 2018 by the American Bar Association. Reproduced with permission. All rights reserved. This information or any portion thereof may not be
More informationMultidistrict Litigation, Forum Selection and Transfer: Tips and Trends Julie M. Holloway Partner, Latham & Watkins LLP
Multidistrict Litigation, Forum Selection and Transfer: Tips and Trends Julie M. Holloway Partner, Latham & Watkins LLP Latham & Watkins operates worldwide as a limited liability partnership organized
More informationSupreme Court of the United States
No. 15-1055 IN THE Supreme Court of the United States SMITHKLINE BEECHAM CORPORATION, D/B/A GLAXOSMITHKLINE; TEVA PHARMACEUTICAL INDUSTRIES LTD.; TEVA PHARMACEUTICALS, USA, Petitioners, v. KING DRUG COMPANY
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 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 informationSide Effects The Evolving Law of Reverse Payments and Its Impact on Drug Litigation
Side Effects The Evolving Law of Reverse Payments and Its Impact on Drug Litigation Side Effects The Evolving Law of Reverse Payments and Its Impact on Drug Litigation Few areas of health law have seen
More informationIn the Supreme Court of the United States
No. 15-1055 In the Supreme Court of the United States SMITHKLINE BEECHAM CORPORATION, D/B/A GLAXOSMITHKLINE, ET AL., PETITIONERS v. KING DRUG COMPANY OF FLORENCE, INC., ET AL. ON PETITION FOR A WRIT OF
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 informationLatham & Watkins Health Care Practice
Number 878 June 8, 2009 Client Alert Latham & Watkins Health Care Practice This initiative represents a continuation and expansion of interagency efforts begun more than two years ago and illustrates an
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 informationon significant health issues pertaining to their products, and of encouraging the
Number 836 March 17, 2009 Client Alert Latham & Watkins Wyeth v. Levine and the Contours of Conflict Preemption Under the Federal Food, Drug, and Cosmetic Act The decision in Wyeth reinforces the importance
More informationFTC AND DOJ ISSUE JOINT REPORT REGARDING ANTITRUST ENFORCEMENT AND INTELLECTUAL PROPERTY RIGHTS
OF INTEREST FTC AND DOJ ISSUE JOINT REPORT REGARDING ANTITRUST ENFORCEMENT AND INTELLECTUAL PROPERTY RIGHTS Interesting and difficult questions lie at the intersection of intellectual property rights and
More informationLatham & Watkins Environment, Land & Resources Department
Number 1090 October 13, 2010 Client Alert Latham & Watkins Environment, Land & Resources Department Recent Legislative Changes Affecting Pending and Future Projects Under CEQA This legislation is intended
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 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 The Supreme Court of the United States
No. 10-762 ================================================================ In The Supreme Court of the United States --------------------------------- --------------------------------- LOUISIANA WHOLESALE
More informationThe Supreme Court Decision in Empagran
The Supreme Court Decision On June 14, 2004, the United States Supreme Court issued its much anticipated opinion in Hoffmann-La Roche, Ltd. v. Empagran S.A, 2004 WL 1300131 (2004). This closely watched
More informationLatham & Watkins Litigation Department
Number 1241 September 28, 2011 Client Alert Latham & Watkins Litigation Department Practical Implications of the America Invents Act on United States Patent Litigation This Client Alert addresses the key
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 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 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 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 informationLatham & Watkins Finance Department
Number 1025 May 13, 2010 Client Alert Latham & Watkins Finance Department Pending a decision on BNY s appeal, structured transaction and derivative lawyers should carefully consider the drafting of current
More informationR U T G E R S U N I V E R S I T Y L A W R E V I E W
R U T G E R S U N I V E R S I T Y L A W R E V I E W VOLUME 67 SPRING 2015 ISSUE 3 FOREWORD AFTER ACTAVIS: SEVEN WAYS FORWARD Michael A. Carrier * The Supreme Court s decision in FTC v. Actavis is one of
More informationThe Implications Of Twombly And PeaceHealth
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 The Implications Of Twombly And PeaceHealth
More informationTrends in U.S. Patent Law: Key Decisions from the Federal Circuit
The 4 th Annual US-China IP Conference: Best Practices for Innovation and Creativity Trends in U.S. Patent Law: Key Decisions from the Federal Circuit Julie Holloway Latham & Watkins LLP October 8, 2015
More informationThe Supreme Court Appears Likely to Place the Burden of Proof in Declaratory-Judgment Actions on the Patentees
The Supreme Court Appears Likely to Place the Burden of Proof in Declaratory-Judgment Actions on the Patentees BY ROBERT M. MASTERS & IGOR V. TIMOFEYEV November 2013 On November 5, the U.S. Supreme Court
More informationFederal Circuit Provides Guidance on Methodologies for Calculating FRAND Royalty Rates, Vacating the Jury Award in Ericsson v.
In this Issue: WRITTEN BY COURTNEY J. ARMOUR AND KOREN W. WONG-ERVIN EDITED BY KOREN W. WONG-ERVIN The views expressed in this e-bulletin are the views of the authors alone. DECEMBER 1-6, 2014 Federal
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 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 informationORDER GRANTING IN PART AND DENYING IN PART MOTION TO TRANSFER OR STAY
Pfizer Inc. et al v. Sandoz Inc. Doc. 50 Civil Action No. 09-cv-02392-CMA-MJW IN THE UNITED STATES DISTRICT COURT FOR THE DISTRICT OF COLORADO Judge Christine M. Arguello PFIZER, INC., PFIZER PHARMACEUTICALS,
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 informationPatent Pending: The Outlook for Patent Legislation in the 114th Congress
Intellectual Property and Government Advocacy & Public Policy Practice Groups July 13, 2015 Patent Pending: The Outlook for Patent Legislation in the 114th Congress The field of patent law is in a state
More informationNot So Basic: Supreme Court to Revisit the Fraud-on-the Market Presumption of Reliance
Latham & Watkins Litigation Department Number 1617 November 27, 2013 Not So Basic: Supreme Court to Revisit the Fraud-on-the Market Presumption of Reliance Parties to pending securities fraud class actions
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 informationIssue Brief for Congress Received through the CRS Web
Order Code IB10105 Issue Brief for Congress Received through the CRS Web The Hatch-Waxman Act: Proposed Legislative Changes Affecting Pharmaceutical Patents Updated November 25, 2002 Wendy H. Schacht and
More informationSUCCESSFULLY LITIGATING METHOD OF USE PATENTS IN THE U.S.
SUCCESSFULLY LITIGATING METHOD OF USE PATENTS IN THE U.S. The 10 th Annual Generics, Supergenerics, and Patent Strategies Conference London, England May 16, 2007 Provided by: Charles R. Wolfe, Jr. H. Keeto
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 informationLatham & Watkins Environment, Land & Resources Department
Number 937 September 22, 2009 Client Alert Latham & Watkins Environment, Land & Resources Department The Local Controversy Exception to the Class Action Fairness Act Preston, Kaufman and Coffey An understanding
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 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 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 informationUNITED STATES DISTRICT COURT DISTRICT OF NEW JERSEY
UNITED STATES DISTRICT COURT DISTRICT OF NEW JERSEY WARNER CHILCOTT COMPANY, LLC, et al., Plaintiffs, Civil Action No. 11-6936 (SRC) v. OPINION & ORDER TEVA PHARMACEUTICALS USA, INC., Defendant. CHESLER,
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 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 informationLatham & Watkins Litigation and Finance Departments. Supreme Court Limits Reach of Non-Article III Courts Jurisdiction
Number 1210 July 5, 2011 Client Alert Latham & Watkins Litigation and Finance Departments Supreme Court Limits Reach of Non-Article III Courts Jurisdiction Under Article III, the judicial power of the
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 informationActavis and Error Costs: A Reply to Critics
theantitrustsource w w w. a n t i t r u s t s o u r c e. c o m O c t o b e r 2 0 1 4 The Antitrust Source, October 2014. 2014 by the American Bar Association. Reproduced with permission. All rights reserved.
More informationHatch-Waxman Patent Case Settlements The Supreme Court Churns the Swamp
Hatch-Waxman Patent Case Settlements The Supreme Court Churns the Swamp Kent Bernard* I. INTRODUCTION To lusty cheers of consulting economists and litigating lawyers everywhere, and the heartfelt groans
More informationEditor s Note. US Antitrust Modernization Commission. By A. Noboa Pagán.
Editor s Note. US Antitrust Modernization Commission. By A. Noboa Pagán. Since 2002, the United States Congress designated an Antitrust Modernization Commission with the task of examining whether or not
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 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 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 informationWHY THE SUPREME COURT WAS CORRECT TO DENY CERTIORARI IN FTC V. RAMBUS
WHY THE SUPREME COURT WAS CORRECT TO DENY CERTIORARI IN FTC V. RAMBUS Joshua D. Wright, George Mason University School of Law George Mason University Law and Economics Research Paper Series 09-14 This
More informationLatham & Watkins Corporate Department
Number 1171 April 7, 2011 Client Alert Latham & Watkins Corporate Department Matrixx Initiatives, Inc. v. Siracusano: Changes in Adverse Event Reporting The Court s refusal to adopt a bright-line rule
More informationRecent Patent Case Law Update. Paul Berghoff McDonnell Boehnen Hulbert & Berghoff LLP Chicago
Recent Patent Case Law Update Paul Berghoff McDonnell Boehnen Hulbert & Berghoff LLP Chicago Bowman v. Monsanto (Supreme Court) 2 Bowman v. Monsanto (Supreme Court) Patent exhaustion allows the purchaser
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 informationTHE ACTAVIS INFERENCE: THEORY AND PRACTICE
THE ACTAVIS INFERENCE: THEORY AND PRACTICE Aaron Edlin, Scott Hemphill, Herbert Hovenkamp & Carl Shapiro ABSTRACT In FTC v. Actavis, Inc., the Supreme Court considered reverse payment settlements of patent
More informationINTRODUCTION: WILLIAM HOWARD TAFT, THE ORIGIN OF THE RULE OF REASON, AND THE ACTAVIS CHALLENGE
LECTURE_INTRODUCTION_FINAL INTRODUCTION: WILLIAM HOWARD TAFT, THE ORIGIN OF THE RULE OF REASON, AND THE ACTAVIS CHALLENGE William H. Rooney & Timothy G. Fleming* The origin of the Rule of Reason can be
More informationSupreme Court Invites Solicitor General s View on Safe Harbor of the Hatch-Waxman Act
Supreme Court Invites Solicitor General s View on Safe Harbor of the Hatch-Waxman Act Prepared By: The Intellectual Property Group On June 25, 2012, the United States Supreme Court invited the Solicitor
More informationIN THE UNITED STATES DISTRICT COURT FOR THE DISTRICT OF DELAWARE MEMORANDUM ORDER
IN THE UNITED STATES DISTRICT COURT FOR THE DISTRICT OF DELAWARE THE JOHNS HOPKINS UNIVERSITY, Plaintiff, v. Civ. No. 15-525-SLR/SRF ALCON LABORATORIES, INC. and ALCON RESEARCH, LTD., Defendants. MEMORANDUM
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 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 informationClient Alert. Background
Number 1481 March 5, 2013 Client Alert Latham & Watkins Litigation Department US Supreme Court Holds That Proof Of Materiality Is Not A Prerequisite To Certifying A Securities Fraud Class Action Under
More informationWith our compliments. By Yury Kapgan, Shanaira Udwadia, and Brandon Crase
Article Reprint With our compliments The Law of Patent Damages: Who Will Have the Final Say? By Yury Kapgan, Shanaira Udwadia, and Brandon Crase Reprinted from Intellectual Property & Technology Law Journal
More information