Big Pharma's Anticompetitive Practices Delaying Generic Entry: Has the Tide Turned?

Patent Settlements in the Pharmaceutical Industry: What Can We Learn from Economic Analysis?

Antitrust authorities in both the United States and Europe have expressed deep concern over settlements of antitrust cases in the pharmaceutical sector, settlements involving ”reverse payments” from plaintiffs to defendants, large sums paid by branded pharmaceutical companies to generic competitors in exchange for promises to stay off the market. Such ”pay-for-delay” settlements have proliferated in the United States since Federal Circuit Courts of Appeals have found them unproblematic despite the Federal Trade Commission's persistently strong position that they violate the antitrust laws. These cases arise at the intersection of three statutory regimes seeking to promote innovation, three clusters of doctrine and policy that have interacted only to reach impasse: the Patent Act, the 1984 amendment to the Food, Drug, and Cosmetic Act, and finally the Sherman Anti-Trust Act. Antitrust is a late corner to the fierce competition over patented drugs, competition that permeates the approval process in the Food & Drug Administration [FDA], competition that is restrained by these pay-for-delay settlement agreements. To set the stage, we begin with the Patent Act and its relationship to the FDA approval process. The story of pay-for-delay settlements then proceeds to the settlement agreements and their antitrust implications. We conclude that the best solution in these antitrust cases would be adoption of the FTC's approach of presumptive illegality. Together with an amendment proposed to fix the food and drug act, the presumptive illegality of pay-for-delay settlements under the antitrust laws would make the market for pharmaceuticals more price competitive, open weak patents to serious challenge, and as a result save consumers billions of dollars annually without taking from branded drug companies legitimately earned incentives to engage in research and development.

Since the Hatch-Waxman Act was enacted in 1984, generic drug companies have benefited from its provisions to facilitate approval of generic alternatives to brand-name pharmaceuticals. Upon generic entry, consumers of prescription drugs benefit from large discounts as brand manufacturers lose significant market share to these lower-priced alternatives. Over time, brand-name drug manufacturers have undertaken strategies, such as ‘product switching’ or ‘product hopping’, that may delay or prevent generic entry and protect their market share. Generic drug manufacturers, drug purchasers and antitrust authorities have begun looking to the antitrust laws to address these strategies and their impact on generic entry. This article discusses the regulatory framework under which pharmaceutical companies introduce new drugs, two prominent cases in which courts have wrestled with whether product switching violates the antitrust laws, factors that might support an antitrust claim for product switching, and the FTC's interest in challenging product switching.

Uncertainty and Reverse Payments

Contents: Preface PART I: ECONOMIC FOUNDATIONS OF COMPETITION LAW 1. Are People Self-interested? The Implications of Behavioral Economics on Competition Policy Maurice E. Stucke 2. Consumer Choice as the Best Way to Recenter the Mission of Competition Law Robert H. Lande 3. Protecting Consumer Choice: Competition and Consumer Protection Law Together Neil W. Averitt 4. Is Competition Law Part of Consumer Law? Paul L. Nihoul PART II: INDIVIDUAL JURISDICTIONS AND INTERNATIONAL PERSPECTIVES 5. Resale Price Maintenance: A Reassessment of its Competitive Harms and Benefits Marina Lao 6. The Leegin Case: A US Antitrust Chief Event versus a Storm in a European Teacup? Josef Bejcek 7. Competition Law Issues Concerning Related Markets and their Treatment under EU Competition Law Thomas Eilmansberger 8. A Comparative Look at the Competition Law Control of State-owned Enterprises and Government in China Deborah Healey 9. Australia's Criminalization of Cartels: Will it be Contagious? Caron Beaton-Wells PART III: INTELLECTUAL PROPERTY AND COMPETITION LAW 10. Patent Ambush Strategies and Article 102 TFEU Andreas Fuchs 11. Three Statutory Regimes at Impasse: Reverse Payments in Pay-for-Delay Settlement Agreements between Brand-name and Generic Drug Companies Rudolph J.R. Peritz 12. Patent Ambush and Reverse Payments: Comments Gustavo Ghidini 13. Intellectual Property in Competition: How to Promote Dynamic Competition as a Goal Josef Drexl 14. Industrial Standards and Technology Pools: A Regulatory Challenge for EU Competition Law Steven Anderman PART IV: PROMOTING COMPETITION POLICY NATIONALLY AND ACROSS BORDERS 15. International Antitrust Solutions: Discrete Steps or Causally Linked? Michal S. Gal 16. Penumbras of European Union Competition Law: External Governance, Extraterritoriality, and the Shifting Borderlands of the Internal Market Clifford A. Jones 17. The Role of Non-governmental Organizations in the Development of Competition Law Albert A. Foer Index

Data Protection and Competition Law: The Dawn of ‘Uberprotection’

Limited availability of medicines is a serious problem in fulfilling the public's right to health. The monopoly of patented medicines by patent-holding pharmaceutical companies has resulted in generic pharmaceutical companies not being able to access information about patented medicines even though the patent has expired. This certainly hinders the immediate circulation of generic versions after the patent expires. Generic medicines are important because they are easier to access, more widely available, and cheaper than patented versions of medicines. To overcome this problem, a legal means called bolar provision is regulated. Bolar provision is a permit granted by the state to generic pharmaceutical companies to use patented inventions to develop and deliver drug information without the patent owner's permission 5 (five) years before the patent protection period ends. Generic pharmaceutical companies can then market generic versions after the patent expires. The purpose of implementing Bolar provision is to provide cheap and affordable generic versions of essential drugs after the patent expires. Until this article was written bolar provisions are only regulated in Article 167 letter b of Law No. 13 of 2016 concerning patents and there are no implementing regulations specifically regulating bolar provision so that bolar provision has not been implemented. Therefore, it is important to examine how the appropriate regulations for the implementation of bolar provision. This type of research is normative legal research. The problem approach used is the legislative approach and the conceptual approach.

ABSTRACTThis article analyses antitrust enforcement practice in Russian courts in the area of competition-restricting agreements. The analysis is based on the court decision database of litigations with the Russian competition authority (the Federal Antimonopoly Service (FAS)). In the database litigations that officially started in the period 2008–2012 were included. Final court decisions were evaluated, taking into account litigation duration (sometimes up to 3 years). The database contains 400 cases, including 236 horizontal agreements and 164 other agreements (mostly vertical agreements). Based on the evidence of this database, important features and problems of the interpretation and implementation of competition law in Russia and priority areas of enforcement were identified. Antitrust policy was analysed taking into account the risks of type 1 and type 2 errors, including the problem of flexibility of prohibitions (per se vs Rule of reason (ROR) approaches), standards of proof and the problem of consistency of enforcement.

This Survey reviews EU competition law developments involving, or relevant to, intellectual property (‘IP’) rights in the period November 2018 to October 2019. The Survey covers the following: (i) the General Court’s Servier judgment on patent settlement and related agreements and market definition in the pharma sector; (ii) film copyright territorial restrictions—commitments challenged before the General Court and further commitments offered; (iii) the Commission’s Google Android Decision; and (iv) the Commission decisions in Cases AT.40428—Guess, AT.40436—Nike and AT.40432—Sanrio. In December 2018, the General Court handed down a series of parallel judgments relating to a number of patent settlements and related agreements entered into between Servier, its subsidiary Biogaran, and several manufacturers of generic pharmaceuticals (hereafter ‘generics’ or ‘generic companies’). Each of the agreements between Servier itself and the various generic companies followed (and ended) patent litigation, and each involved some limitations on the generic company’s ability to enter the market.

This study examines and analyzes anti-competitive agreements in Kosovo, North Macedonia and Albania. Also, it examines in some aspects the similarities and differences of the competition laws of the countries in question, with the competition law of the EU. It aims to achieve these basic objectives: to analyze the evolution of competition law in Kosovo, North Macedonia and Albania; to provide a clear analysis of the competition law of the countries included in the study, in terms of the prohibition of anti-competitive agreements; and compare it with the EU competition law; to analyze the behaviors of undertakings that constitute prohibited agreements in the sense of competition law; to analyze important decisions of the Competition Authorities, regarding the prohibition and punishment of anti-competitive agreements; and to consider punitive measures (fines) for violation of rules related to anti-competitive agreements. The analysis shows that there is a high alignment of the competition laws of the countries included in the study with the EU acquis, and that the challenge for the Competition Authorities remains the low number of imposed fines and their non-execution.

Playing Both Sides: Branded Sales, Generic Drugs, and Antitrust Policy

For nearly three decades, generic drug companies have relied on safety labels from the makers of brand-name medicines to warn consumers about product risks. In fact, Food & Drug Administration regulations require that generic drugs carry the same warnings and precautions as their name-brand counterparts. Now—citing issues of balanced risks for drugmakers and transparency for doctors and patients— FDA wants to change the regulations so that generic drug manufacturers will be motivated to take greater responsibility for their products. Specifically, FDA has proposed a rule change that would allow generic drug companies to independently warn consumers when important new safety information surfaces about one of their drugs. It would remove a shield from product liability claims that currently protects generics manufacturers from personal injury lawsuits. Generic drug manufacturers are not happy with the proposal. “New labeling regulations should protect patients, facilitate care, and reduce costs,” says Ralph...

The United States Food and Drug Administration guidelines for the bioequivalence (BE) testing of the generic drug products suggests that there should be an equal proportion of male and female population in the BE study. Despite this requirement, many generic drug companies do not maintain the suggested proportion of female population in their studies. Several socio-economic and cultural factors lead to lower participation of the females in the BE studies. More recently, the regulatory agencies across the globe are requesting the generic drug companies to demonstrate the performance of their drug products in the under-represented sex via additional studies. In this work, we describe the case of Dextromethorphan modified release tablets where the gender effect on the product performance was evaluated by physiologically based pharmacokinetic (PBPK) modeling approach. We have compared the drug product's performance by population simulations considering four different scenarios. The data from all-male population (from in house Pharmacokinetic [PK] BE studies) was considered as a reference and other scenarios were compared against the all-male population data. In the first scenario, we made a comparison between all-male (100% male) vs all-female (100% female) population. Second scenario was as per agency's requirements-equal proportion of male and female in the BE study. As an extreme scenario, 100% male vs 30:70 male:female was considered (higher females than males in the BE studies). Finally, as a more realistic scenario, 100% male versus 70:30 male:female was considered (lower females than males in the BE studies). Population PK followed by virtual BE was employed to demonstrate the similarity/differences in the drug product performance between the sexes. This approach can be potentially utilized to seek BE study waivers thus saving cost and accelerating the entry of the generic products to the market.

As the generic drug market tends to be saturated, the structural transformation of generic drug companies is imminent, while the high investment and high-risk attributes of innovative drug research and development aggravate the transformation difficulties. Against the backdrop of drug centralized procurement policy, considering the effect of health insurance reimbursement and market competition ferocity, this study constructs a differential game model of a secondary drug supply chain comprising two competing drug companies and a single healthcare institution. In addition, this study comparatively analyzes the optimal equilibrium strategies and supply chain profit levels of drug research and development investment and healthcare service efforts under four government subsidy modes, further discussing them along with arithmetic examples. It is found that the government's subsidy behavior markedly influenced drug companies' investment in drug research and development and healthcare institution' service cost investment. Besides, different incentives for supply chain members' decision-making and profits were noted in different markets with different competition intensities. In the low-intensity competition market, the government's subsidies to innovative drug companies generate much higher social welfare than other modes. In the high-intensity competition market, the government subsidized healthcare institution can minimize the mutually exclusive effects of subsidies on the development of innovative and generic drug companies, and eventually drive the reform and development of the entire drug industry.

The pharmaceutical industry was among the first to embrace green chemistry (GC) with many “big pharma” companies creating GC teams, adopting metrics, tools, and training to “green” drug design and manufacturing. However, little is known about GC adoption by generic drug companies and active pharmaceutical ingredient (API) manufacturers who manufacture the majority of drugs sold presently. The primary goal of this paper is to benchmark the adoption of GC by the entire pharmaceutical supply chain based on information from industry representatives leading such efforts. Data were obtained from 34 global companies participating in a survey, including 13 “big pharma”, five smaller R&D pharma, four generic pharma companies, and 12 API manufacturers (their classification is based on each company’s primary activity). Results demonstrate that time pressures to deliver new drugs and regulatory risk are the top two barriers to greater GC adoption, whereas costs savings and environmental regulations are the top two dr...