Regulatory Exclusivity Rights and Medicines

This chapter provides a detailed analysis of the rules that govern the award of regulatory exclusivity rights, which focuses on the EU law. It talks about the arrangements around Northern Ireland that will incentivize the UK and EU to stay in close alignment in heavily regulated product markets, such as pharmaceuticals. It also sets out an overview of the law surrounding the full and abridged generic marketing authorization applications from an exclusivity perspective. The chapter covers some of the seminal judicial decisions, which demonstrate the legal challenges and decisions that have shaped the current position. It provides a summary of the basics of data and market exclusivity in the EU.

The COVID-19 Pandemic: Stress Test for Intellectual Property and Pharmaceutical Laws

The COVID-19 pandemic poses a challenge to certain standards in patent law as well as in pharmaceutical law. This paper discusses questions as to whether and under what conditions government-ordered or privately claimed compulsory licensing can contribute to controlling the pandemic. The existing obstacles and conflicts under the current legal framework, such as a lack of international harmonization and a lack of coherence between patent law (compulsory licensing) and pharmaceutical law (data protection), are outlined and discussed. A possible solution could lie in a modernization of relevant legal provisions to create an internationally harmonized balance between the public interest in using important patents in the present and in future emergency situations and the interest of patent owners and data and market exclusivity holders in allowing exemptions within clearly defined limits. The article concludes with a discussion of conditions that may influence possible solutions.

Market Exclusivity of the Originator Drugs in South Korea: A Retrospective Cohort Study

Introduction: Generic entry is a well-known driver of competition and cost containment.Objectives: We aim to measure the market exclusivity of originator drugs and to determine what influences the entry of generics in South Korea.Methods: A list of originator drugs approved by the authority from 2000 to 2013 and their corresponding generics were paired. An event history model was applied for a statistical estimation for the duration until generic entry and to identify abbreviating or prolonging factors on the duration.Results: A total of 2,061 pairs of originator and generics were identified. The market exclusivity for the originator drugs, including NDAs and non-NDAs, has not notably changed. However, competition among non-NDAs was less common than we expected. We found delayed time to entry of generics in the long run, particularly for non-NDAs in injection forms and biologics, and this finding is partially associated with market attractiveness.Conclusion: The authority should address the delayed availability of certain types of generic drugs. The government could provide information on off-patent pharmaceuticals with no generic competition, designate their corresponding submissions as prioritized in the review process, and provide additional market exclusivity when entering the market via a long period of exclusivity.

Prescribing originality: investigating the impact of original knowledge on patent quality in the pharmaceutical sector

PurposeThis paper examines the relationship between the originality of a pharmaceutical innovation and its patent quality. Greater patent quality has been shown in the extant literature to enhance market value, which better enables firms to recoup research and development (R&D) expenditures incurred during the innovation process. Understanding how originality improves patent quality can assist policymakers, when determining the optimal length of pharmaceutical patent protection and/or market exclusivity.Design/methodology/approachThe relationship between originality and patent quality is empirically investigated using a tobit, as well as a zero-inflated negative binomial, estimation approach to account for prevalence of patents receiving zero forward citations. Moderating effects of joint innovation, innovation by a university researcher and innovation by an established innovator on originality are also considered.FindingsThere is a robust and positive relationship between patent originality and quality in the pharmaceutical sector. This relationship is positively moderated by joint patent ownership with a university. As such, innovators that target originality in new drug development (especially those collaborating with universities) should, according to extant literature, see greater increases in their market value.Originality/valuePolicymakers can use information on the originality of a new drug to discern the optimal length of market exclusivity needed to enable the innovator to recoup expenditures related to R&D. Better predictions of the timing for which firms can recoup R&D expenditures will equip policymakers with knowledge about the appropriate timing to introduce competition into the market, which is critical to reducing the price of pharmaceuticals to consumers.

The Expiry of Humira® Market Exclusivity and the Entry of Adalimumab Biosimilars in Europe: An Overview of Pricing and National Policy Measures

Background: From October 2018, adalimumab biosimilars could enter the European market. However, in some countries, such as Netherlands, high discounts reported for the originator product may have influenced biosimilar entry.Objectives: The aim of this paper is to provide a European overview of (list) prices of originator adalimumab, before and after loss of exclusivity; to report changes in the reimbursement status of adalimumab products; and discuss relevant policy measures.Methods: Experts in European countries received a survey consisting of three parts: 1) general financing/co-payment of medicines, 2) reimbursement status and prices of originator adalimumab, and availability of biosimilars, and 3) policy measures related to the use of adalimumab.Results: In May 2019, adalimumab biosimilars were available in 24 of the 30 countries surveyed. Following introduction of adalimumab biosimilars, a number of countries have made changes in relation to the reimbursement status of adalimumab products. Originator adalimumab list prices varied between countries by a factor of 2.8 before and 4.1 after loss of exclusivity. Overall, list prices of originator adalimumab decreased after loss of exclusivity, although for 13 countries list prices were unchanged. When reported, discounts/rebates on originator adalimumab after loss of exclusivity ranged from 0% to approximately 26% (Romania), 60% (Poland), 80% (Denmark, Italy, Norway), and 80–90% (Netherlands), leading to actual prices per pen or syringe between €412 (Finland) and €50 – €99 (Netherlands). To leverage competition following entry of biosimilar adalimumab, only a few countries adopted measures specifically for adalimumab in addition to general policies regarding biosimilars. In some countries, a strategy was implemented even before loss of exclusivity (Denmark, Scotland), while others did not report specific measures.Conclusion: Even though originator adalimumab is the highest selling product in the world, few countries have implemented specific policies and practices for (biosimilar) adalimumab. Countries with biosimilars on the market seem to have competition lowering list or actual prices. Reported discounts varied widely between countries.

Promoting Competition in Drug Pricing: A Review of Recent Congressional Legislation

Brand-name prescription drug manufacturers use various strategies to extend their market exclusivity periods by delaying generic or biosimilar competition. Recent Congressional legislation has targeted four such tactics. We analyze these proposals and assess their likely effect on competition in the U.S. drug market.