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This paper aims to examine whether authorized generics (AGs) have influenced prices and market shares in markets for molecules facing generic competition in South Africa. AGs (clones), which are identical to the originator brands, offer a solution for originator companies to protect their markets from independent generic (IG) competition. IG competitors have claimed that AGs have a negative impact on pricing and competition.

In a retrospective analysis, pricing and quantity data for 24 months post generic entry were extracted for oral solid dosage form products which experienced generic entry into their markets between 2005 and 2011, divided into “Authorized generic affected” and “no authorized generic” markets. A series of indices was calculated, as well as market shares of competing originator and generic products, and the number of generic competitors determined. Indices and market share data for clone affected and unaffected groups were tested at 6, 12, 18 and 24 months using unmatched t-tests, at a 95 per cent significance level.

None of the evaluated pricing indices showed a consistently significant difference existing between AG-affected and no-AG samples. The only variable for which the two samples consistently differed was market shares, with originator brands experiencing significantly more market share erosion in AG-affected markets. Pricing levels of generics and originator products as well as growth of numbers of generic competitors were similar in both AG-affected and no-AG groups.

A study of this nature on the impacts of AGs in the South African generics has not been previously published and reflects the situation particular to the country.

The Supreme Court’s decision in Federal Trade Commission v. Actavis, Inc. is a challenge to conventional antitrust analysis. Conventional civil antitrust cases are decided by a preponderance of the evidence. This means that conduct challenged under the rule of reason is only condemned if the conduct resulted in more competitive harm in the actual world than a world without the alleged violation. Under conventional analysis, the intent of the parties also plays only a supporting role in determining whether the conduct was anticompetitive. A holder of a valid patent has a right to exclude others practicing the patented technology. And, the patent holder is not assumed to have market power because it expended resources in maintaining exclusionary rights. Actavis creates doubts about these propositions in circumstances beyond the “reverse” payment settlement of a patent suit that may have delayed an alleged infringer market entry. This chapter explores whether applying Actavis logic to antitrust litigation can result in condemnation of practices where there is little chance of an anticompetitive effect, where the patent holder likely has a valid and infringed patent, where there is little reason to believe that the patent holder has market power, and where only one party, or no parties, to an agreement have an anticompetitive intent. This chapter also investigates whether Actavis creates new problems with standing analysis, damages calculations, and the balancing of efficiencies against anticompetitive effects. Nevertheless, the lower courts have begun to extend the logic of Actavis. This is apparent in the condemnation of no-Authorized-generic settlements.

The paper aims to study how global pharmaceutical companies such as Pfizer have managed the challenges of pharmaceutical patent expiry.

A case study method was applied. The best-selling brand drug over the past 10 years – Lipitor – was chosen as the case target.

For dealing with this, this paper describes all the details of the corresponding strategies of Pfizer before and after patent expiration of Lipitor. Before patent expiry, Pfizer undertook the activities of direct-to-consumer marketing, pricing strategy for competition, legal delay and me-too drug R&D. After patent expiry, Pfizer chose to carry out continuous marketing for brand, rebate strategy, authorized generics and change to over-the-counter. In addition, diversity and globalization strategy was applied before and after patent expiry.

This research provides strong implication for managing pharmaceutical products before and after patent expiry.

It is strongly recommended for both brand and generic drug companies to design strategies to meet the challenges of pharmaceutical patent expiry.

For the global pharmaceutical market, a conclusion can be drawn that, nowadays, the “patent cliff” is the most significant factor influencing decision-makers to consider futuristic policies. Further, it is also a considerably effective solution for reducing health-care costs for policymakers.

This paper contributes to the field of patent expiry management in high-tech industries such as pharmaceuticals.

The purposes of a subject index in a small information service are examined and the organizational aspects of the Big information Centre and the Small Service in relation to the descriptor level are analyzed. The advantages of co‐ordinate indexing versus the conventional hierarchical classification in meeting complex information needs are pointed out. Through an evaluation of the flexible structure of the thesauri, the lower‐level but otherwise similar vocabulary needs of the small service are discussed. The use of the UDC to effect the level transitions required to adapt the thesauri to the needs of the Small Service is examined. It is shown how an improved subject index for the Soreq book collection has been constructed by the combined use of the EURATOM Thesaurus and the UDC. Examples to illustrate the design of this index are given. In the interest of expanding the co‐operation between the small Service and big centre, the idea of a multi‐level thesaurus is proposed.

The Bureau of Economics in the Federal Trade Commission has a three-part role in the Agency and the strength of its functions changed over time depending on the preferences and ideology of the FTC’s leaders, developments in the field of economics, and the tenor of the times. The over-riding current role is to provide well considered, unbiased economic advice regarding antitrust and consumer protection law enforcement cases to the legal staff and the Commission. The second role, which long ago was primary, is to provide reports on investigations of various industries to the public and public officials. This role was more recently called research or “policy R&D”. A third role is to advocate for competition and markets both domestically and internationally. As a practical matter, the provision of economic advice to the FTC and to the legal staff has required that the economists wear “two hats,” helping the legal staff investigate cases and provide evidence to support law enforcement cases while also providing advice to the legal bureaus and to the Commission on which cases to pursue (thus providing “a second set of eyes” to evaluate cases). There is sometimes a tension in those functions because building a case is not the same as evaluating a case. Economists and the Bureau of Economics have provided such services to the FTC for over 100 years proving that a sub-organization can survive while playing roles that sometimes conflict. Such a life is not, however, always easy or fun.

The purpose of this study is to contribute towards the debate about global access to COVID-19 vaccines, therapeutics and diagnostics.

The global scramble for COVID-19 vaccine and other related pharmaceutical products have once again exposed the limitations of the Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS). High-income countries are claiming a lion’s share of the first available batches of the COVID-19 vaccine in total disregard of the consequences such approach would have on the low-income countries that lack both the manufacturing wherewithal and the financial resources to purchase the vaccine and other products needed to combat the pandemic. This paper reviews the existing TRIPS Flexibilities and analyses their limitations with respect to equitable access of pharmaceutical products in times of health emergencies. This paper then considers the unique challenges that have been brought to the fore by the COVID-19 pandemic. Finally, this paper analytically explores some options that have been proposed so far that the World Trade Organization (WTO) or governments can take in the immediate to near term to facilitate equitable access to COVID-19 pharmaceutical products and technologies. This research is non-empirical, desk-based research. It is, therefore, based on the literature review of existing body of work that is relevant to the topic under discussion. Mindful of the epistemological challenges that are always associated with desk-based research, part of the methodology of this work is to seek support from related empirical studies based on different philosophical underpinnings but that confirm the working hypothesis of this research.

This paper finds that there is still a need for a comprehensive reform of TRIPS Agreement to streamline the voluntary licencing system which is an important tool for low-income countries’ access to affordable pharmaceuticals. However, for purposes of dealing with COVID-19, WTO members should consider establishing pooled Licencing Facilities and procurement strategies via already existing political, economic or regional trade groupings.

This research is original. All sources have been acknowledged. This research synthesises different research papers and applies different viewpoints to the debate on the impact of the TRIPS Agreement on equitable access to COVID-19 vaccines, therapeutics and diagnostics.

The Federal Trade Commission (FTC) has initiated policies and legal challenges that have shaped the evolution of competition in healthcare. This chapter discusses not only discusses the current matters in healthcare competition, but it also gives a history of past issues faced by the FTC and the approaches used to resolve them. These FTC actions range from challenges to hospital mergers to preventing “reverse payments” from patent holders to generic entrants in pharmaceuticals. Ultimately the healthcare industry faces many unique regulatory and competitive aspects that, while challenging, do not require special rules.

Brand-name pharmaceutical companies have engaged in a variety of business conduct that has increased price. One of these activities involves “product hopping,” or brand switches from one version of a drug to another. The antitrust analysis of product hopping implicates antitrust law, patent law, the Hatch–Waxman Act, and state drug product selection laws, as well as uniquely complicated markets characterized by buyers different from decision makers. As a result, courts have offered inconsistent approaches to product hopping.

In this chapter, we offer a framework that courts and government enforcers can employ to analyze product hopping. The framework is the first to incorporate the characteristics of the pharmaceutical industry. It defines a “product hop” to include instances in which the manufacturer (1) reformulates the product to make the generic nonsubstitutable and (2) encourages doctors to write prescriptions for the reformulated rather than the original product.

When the conduct meets both requirements, our framework offers two stages of analysis. First, we propose two safe harbors to ensure that the vast majority of reformulations will not face antitrust review. Second, the framework examines whether the hop passes the “no-economic-sense” test, determining if the behavior would make economic sense if the hop did not have the effect of impairing generic competition. Showing just how far the courts have veered from justified economic analysis, the test would recommend a different analysis than that used in each of the five product-hopping cases that have been litigated to date, and a different outcome in two of them.