Author: Jacob S. SherkowPublisher:
ISBN:
Category :
Languages : en
Pages : 2
Book Description
An imminent US Supreme Court ruling should resolve one of the thorniest legal issues facing pharmaceutical companies today.
Federal Trade Commission V. Actavis, Inc. and Reverse-Payment Or Pay-for-Delay Settlements
Author: Jacob S. SherkowPublisher:
ISBN:
Category :
Languages : en
Pages : 2
Book Description
An imminent US Supreme Court ruling should resolve one of the thorniest legal issues facing pharmaceutical companies today.
Reverse Payments
Author: Daryl LimPublisher:
ISBN:
Category :
Languages : en
Pages : 0
Book Description
On its face, the United States Supreme Court's opinion in Federal Trade Commission (FTC) v. Actavis seemed to contain the elements of a straightforward antitrust indictment: a dominant drug company paid potential rivals millions of dollars not to compete at the cost of public access to cheaper medicine. The interests of these rivals, once aligned with those of the public, have been twisted to align with its former rival and current paymaster. According to an FTC report, these settlements cost consumers $3.5 billion a year. The Court likened these settlements to cases involving market division arrangements, hardcore offenses normally weeded out under a per se standard of illegality. However, it ultimately opted for a rule of reason approach. Lower courts were to balance benefits and anticompetitive harms, taking into consideration the size and scale of the payment in relation to the patent owner's anticipated litigation costs and any auxiliary services it received from the generic drug company. Large and unexplained payments could be used as a proxy for market power and anticompetitive harm, sparing lower courts the need for complex, costly and time-consuming inquiries into issues of patent validity and infringement.While the Hatch-Waxman Act makes it lucrative for generic challenges to induce settlements, the fact that the European Union faces similar issues in cases such as Lundbeck, Les Laboratoires Servier and others even without similar legislation is evidence that reverse payments occur outside the setting of the Act. Looking ahead, parties to a reverse payment will need to negotiate with a view that their agreement will be scrutinized by antitrust agencies and courts. Since at least 2005, settlements have evolved beyond cash payments to include other forms of consideration. Courts must now articulate how cross-licensing, service agreements and offers to delay authorized generic launches are to be assessed. Carelessly applied, Actavis could open litigation floodgates, dampening R&D by current and prospective patent owners. With the prospect and payoffs of settlement now tightened, generics could also be less willing to develop cheaper alternatives or challenge patents to bring such alternatives to market. In the United States where patent litigation is considerably higher than in Europe, these risks are more real and the consequences more dire. Beyond reverse payments, Actavis provides a rare and precious opportunity to move the dialogue on the interface between the patent and antitrust laws beyond mere platitudes. Most patent and antitrust stakeholders agree that both regimes seek to promote competition and innovation. An enduring disagreement remains, however, as to how these goals should be operationalized. The fierce rift between the majority and dissent vividly illustrates this: should we give primacy to visible marketplace rivalry or allow more latitude for private ordering between the settling parties? The true legacy of Actavis lies in the promise of catalyzing those from the patent and antitrust spheres into moving towards a realistic compromise on how the rules that affect them both should look like and function. Through debate, experimentation and refinement innate in the common law, future cases can craft pieces that will form a coherent analytical framework for the interface between patent and antitrust laws. The effort must be supported by constituents clear-headed enough to look beyond traditional prejudices, who are able to translate economic insights into workable legal rules, and who recognize that failure would mean that law at the interface will look a lot like the current state of American politics - divided, dysfunctional and a hotbed for empty rhetoric.
The Antitrust Enterprise
Author: Herbert HOVENKAMPPublisher: Harvard University Press
ISBN: 9780674038820
Category : Law
Languages : en
Pages : 392
Book Description
After thirty years, the debate over antitrust's ideology has quieted. Most now agree that the protection of consumer welfare should be the only goal of antitrust laws. Execution, however, is another matter. The rules of antitrust remain unfocused, insufficiently precise, and excessively complex. The problem of poorly designed rules is severe, because in the short run rules weigh much more heavily than principles. At bottom, antitrust is a defensible enterprise only if it can make the microeconomy work better, after accounting for the considerable costs of operating the system. The Antitrust Enterprise is the first authoritative and compact exposition of antitrust law since Robert Bork's classic The Antitrust Paradox was published more than thirty years ago. It confronts not only the problems of poorly designed, overly complex, and inconsistent antitrust rules but also the current disarray of antitrust's rule of reason, offering a coherent and workable set of solutions. The result is an antitrust policy that is faithful to the consumer welfare principle but that is also more readily manageable by the federal courts and other antitrust tribunals.
Actavis and Error Costs
Author: Aaron S. EdlinPublisher:
ISBN:
Category :
Languages : en
Pages : 0
Book Description
The Supreme Court's opinion in Federal Trade Commission v. Actavis, Inc. provided fundamental guidance about how courts should handle antitrust challenges to reverse payment patent settlements. In our previous article, Activating Actavis, we identified and operationalized the essential features of the Court's analysis. Our analysis has been challenged by four economists, who argue that our approach might condemn procompetitive settlements. As we explain in this reply, such settlements are feasible, however, only under special circumstances. Moreover, even where feasible, the parties would not actually choose such a settlement in equilibrium. These considerations, and others discussed in the reply, serve to confirm the wisdom of the Actavis inference, in which the observation of a large reverse payment serves as a “surrogate” for patent-case weakness and therefore for lost competition.
Drug Wars
Author: Robin FeldmanPublisher: Cambridge University Press
ISBN: 131673949X
Category : Law
Languages : en
Pages : 165
Book Description
While the shockingly high prices of prescription drugs continue to dominate the news, the strategies used by pharmaceutical companies to prevent generic competition are poorly understood, even by the lawmakers responsible for regulating them. In this groundbreaking work, Robin Feldman and Evan Frondorf illuminate the inner workings of the pharmaceutical market and show how drug companies twist health policy to achieve goals contrary to the public interest. In highly engaging prose, they offer specific examples of how generic competition has been stifled for years, with costs climbing into the billions and everyday consumers paying the price. Drug Wars is a guide to the current landscape, a roadmap for reform, and a warning of what is to come. It should be read by policymakers, academics, patients, and anyone else concerned with the soaring costs of prescription drugs.
Understanding Actavis
Author: Bryan GantPublisher:
ISBN:
Category :
Languages : en
Pages : 0
Book Description
In FTC v. Actavis, Inc., the Supreme Court held that a large, unexplained “reverse payment” from an infringer to a patentee in connection with a patent settlement could sometimes raise antitrust concerns, but that “traditional” settlement forms would not. Lower courts have since struggled to apply this standard, at times expressing open frustration with what they perceive as Actavis's lack of guidance. Actavis seems inscrutable, however, only when courts fail to faithfully apply the framework the Court adopted.To understand Actavis, a court must first understand the inference on which it relied. Because Actavis addressed patent settlements entered prior to any determination of the patent's validity, the Court sought to use the patentee's willingness to make a large, unexplained payment as a basis from which to infer possible patent weakness and thus the potential for anticompetitive effect. This inference provides the framework by which to apply Actavis, as to support such an inference a reverse payment must be: (1) a sacrifice by the patentee -- rather than the normal, mutually-beneficial integrative bargaining so critical to the resolution of complex disputes; (2) large enough in the context of the settlement to suggest patent weakness; and (3) “unusual” rather than “traditional” under the considerations explained in Actavis.
Pay-for-delay Deals
Author: United States. Congress. Senate. Committee on the Judiciary. Subcommittee on Antitrust, Competition Policy, and Consumer RightsPublisher:
ISBN:
Category : Competition
Languages : en
Pages : 132
Book Description
Generic drug entry prior to patent expiration an FTC study
Author: Publisher: DIANE Publishing
ISBN: 1428951938
Category :
Languages : en
Pages : 129
Book Description
ANDA Litigation
Author: Kenneth L. DorsneyPublisher: American Bar Association
ISBN: 9781614384786
Category : Biotechnology
Languages : en
Pages : 0
Book Description
Examining the intersection between the statutory and regulatory scheme governing approval of generic pharmaceuticals and U.S. patent law in the context of Paragraph IV ANDA litigation, this comprehensive guide focuses on current and developing law as well as litigation strategies and tactics. This ready roadmap begins with an explanation of the Hatch-Waxman Act, its implementation, and litigation. Other topics include preparing and trying the case, post-trial issues and appeals, remedies, settlement, antitrust implications, and litigation of pharmaceuticals outside the U.S.
FTC Reverses Administrative Law Judge Decision, Finding Section 5 Violation for Reverse-Payment Settlement (Impax).
Author: Michael A. CarrierPublisher:
ISBN:
Category :
Languages : en
Pages : 0
Book Description
In FTC v. Actavis, the Supreme Court ruled that settlements by which brand drug companies pay generics to delay entering the market could violate antitrust law. In In the Matter of Impax Laboratories, the FTC offered its first elaboration upon this framework. On behalf of all 5 members, Commissioner Noah Joshua Phillips wrote an opinion that was comprehensive, thoughtful, and consistent with Actavis.This piece discusses the opinion. And it offers five observations on it, regarding 1) the longstanding bipartisan FTC consensus challenging pay-for-delay settlements, 2) the comprehensiveness of the opinion, 3) the Commission's impatience on several occasions with the ALJ and Impax, 4) the recognition of the harm from multiple types of anticompetitive conduct (settlements and product hopping) in combination, and 5) the FTC's balanced approach. The Impax ruling presents a model for future analyses of pay-for-delay settlements.