1,720,958 research outputs found
Compulsory Licensing in Pharma: How it Affects Drug Prices and Accessibility
Full text linkThis review critically examines the role of compulsory licensing (CL) in the pharmaceutical industry as a tool to balance public health needs with intellectual property rights. Grounded in the TRIPS Agreement under the World Trade Organization, CL enables governments to authorize the production or import of generic versions of patented medicines without the consent of patent holders, especially during public health emergencies. Drawing from over 25 global research articles and policy analyses, the paper evaluates how CL has improved drug affordability and access in low- and middle-income countries, with case studies from Brazil, Thailand, India, and Canada. While effective in curbing monopolistic pricing and enhancing accessibility, CL’s implementation is often hampered by legal, political, and economic barriers such as retaliatory trade pressures and weak manufacturing infrastructure. The study highlights the need for international support, clearer legislation, and capacity-building to fully leverage CL as a pro-public health mechanism. It concludes that with strategic reform and equitable governance, CL can serve as a sustainable model for achieving global drug equity without undermining pharmaceutical innovatio
Understanding Evergreening of Patents in the Pharmaceutical Industry
Full text linkEvergreening is a strategic practice widely adopted by pharmaceutical companies to prolong market exclusivity of patented drugs, often through incremental innovations and secondary patents. This review explores the legal, regulatory, and ethical dimensions of evergreening, detailing various strategies such as formulation changes, new therapeutic indications, polymorph patents, and novel delivery systems. While proponents argue that these practices support continued innovation and help recover high R&D investments, critics highlight how evergreening delays generic drug entry, maintains elevated drug prices, and restricts access to affordable medicines—especially in developing nations. Drawing from international case studies and legal frameworks from the U.S., EU, India, Canada, Brazil, and South Africa, the article evaluates global responses to curb excessive patent extensions. It also presents policy recommendations, including stricter patentability criteria, shorter exclusivity extensions, and alternative innovation incentives. Ultimately, the paper emphasizes the urgent need for balanced patent reform to align pharmaceutical innovation incentives with global public health priorities and ensure equitable access to essential medicines
Biosimilar Patents Vs. Biologic Drugs: Challenges and Opportunities
Full text linkThe growing expiration of patents on biologic drugs has catalyzed the entry of biosimilars, offering a significant opportunity to lower healthcare costs and improve patient access to critical therapies, especially in fields like oncology, rheumatology, and endocrinology. However, the transition is fraught with challenges that span legal, regulatory, technical, and market domains. This review explores the complex intersection between biosimilar patents and biologic drug development, focusing on how intellectual property frameworks and global regulatory environments shape market dynamics. Key barriers include patent thickets, litigation strategies, regulatory discrepancies, and skepticism from clinicians and patients about biosimilar efficacy and safety. While biosimilars hold the promise of saving billions in healthcare expenditure, their success depends on international harmonization of regulations, education of healthcare professionals, and policy reform to discourage evergreening. The paper concludes that a balanced ecosystem—where innovation is protected but not monopolized—is essential to unlock the full potential of biosimilars in promoting equitable and sustainable healthcare globally
Patent Cliffs: What Happens When a Drug Patent Expires?
Full text linkThis review explores the concept of "patent cliffs," a critical juncture in the pharmaceutical industry where the expiration of drug patents results in abrupt revenue losses for innovator companies. When blockbuster drugs lose patent protection, generic competitors rapidly enter the market with significantly lower-priced alternatives, causing sharp declines in brand drug sales. The study delves into the multifaceted implications of this phenomenon, examining its economic, regulatory, and strategic dimensions. It highlights the role of legislation such as the Hatch-Waxman Act in accelerating generic entry and discusses how regulatory frameworks both support generic competition and enable brand protection tactics. The review also evaluates pharmaceutical companies\u27 strategic responses—including lifecycle management, authorized generics, mergers, and Rx-to-OTC switches—to extend product profitability. Importantly, the paper emphasizes how patent cliffs expose vulnerabilities in drug development pipelines and can either constrain or catalyze innovation. The analysis concludes by advocating for balanced policy reforms that protect innovation incentives while promoting market competition and public health access
The Role of Patents in Drug Innovation and Generic Competition
Full text linkThis review examines the dual role of patents in the pharmaceutical industry—serving as both catalysts for innovation and barriers to generic competition. Patents provide pharmaceutical firms with temporary market exclusivity, encouraging investment in research and development of novel drugs. However, the same patent systems can be strategically manipulated through evergreening and patent clustering to prolong monopoly periods and delay generic drug entry. This paper evaluates the economic rationale behind patent protection, analyzes the impact of regulatory policies like the Hatch-Waxman Act, and explores mechanisms such as reference pricing and Paragraph IV challenges that aim to restore competitive balance. Drawing from a wide range of empirical and theoretical studies, the article reveals the tension between fostering breakthrough innovation and ensuring timely access to affordable medicines. It concludes with a call for balanced policy reform that upholds the incentives for innovation while preventing anti-competitive practices, thereby promoting both public health goals and market efficiency in a rapidly evolving pharmaceutical landscape
Intellectual Property Rights in the Pharmaceutical Industry: Balancing Innovation and Access
Full text linkThe pharmaceutical industry operates within a delicate equilibrium between fostering innovation and ensuring equitable access to medicines. Intellectual Property Rights (IPRs), particularly patents, serve as crucial incentives that drive pharmaceutical research and development by offering commercial exclusivity to innovators. However, these protections often create barriers to the timely and affordable availability of life-saving drugs, especially in low- and middle-income countries. This review examines the multidimensional impact of IPRs on the pharmaceutical landscape, integrating perspectives from economics, ethics, public health, and international policy. The paper analyzes theoretical underpinnings such as libertarian and utilitarian frameworks, evaluates collaborative models of innovation, and addresses the contentious issues of bioprospecting and misappropriation of traditional knowledge. It also highlights ethical concerns in industry-sponsored research and discusses the shift toward open innovation and hybrid IP strategies. Ultimately, the review advocates for a more balanced and ethically grounded IPR regime—one that harmonizes commercial interests with global health equity through transparent, inclusive, and adaptive policy mechanisms
Going Beyond Counting First Authors in Author Co-citation Analysis
Full text linkThe present study examines one of the fundamental aspects of author co-citation analysis (ACA) - the way co-citation
counts are defined. Co-citation counting provides the data on which all subsequent statistical analyses and mappings
are based, and we compare ACA results based on two different types of co-citation counting - the traditional type that
only counts the first one among a cited work's authors on the one hand and a non-traditional type that takes into
account the first 5 authors of a cited work on the other hand. Results indicate that the picture produced through this non-traditional author co-citation counting contains more coherent author groups and is therefore considerably clearer. However, this picture represents fewer specialties in the research field being studied than that produced through the traditional first-author co-citation counting when the same number of top-ranked authors is selected and analyzed. Reasons for these effects are discussed
Variations on the Author
Full text link“Variations on the Author” discusses two of Eduardo Coutinho’s recent films (Um Dia na Vida, from 2010, and Últimas Conversas, posthumously released in 2015) and their contribution to the general question of documentary authorship. The director’s filmography is characterized by a consistent yet self-effacing form of authorial self-inscription: Coutinho often features as an interviewer that rather than express opinions propels discourses; an interviewer that is good at listening. This mode of self-inscription characterizes him as an author who is not expressive but who is nonetheless markedly present on the screen. In Um Dia na Vida, however, Coutinho is completely absent form the image, while Últimas Conversas, on the contrary, includes a confessional prologue that moves the director from the margins to the center of his films. This article examines the ways in which these works stand out in the filmography of a director who offers new insights into the notion of cinematic authorship
Appropriate Similarity Measures for Author Cocitation Analysis
Full text linkWe provide a number of new insights into the methodological discussion about author cocitation analysis. We first argue that the use of the Pearson correlation for measuring the similarity between authors’ cocitation profiles is not very satisfactory. We then discuss what kind of similarity measures may be used as an alternative to the Pearson correlation. We consider three similarity measures in particular. One is the well-known cosine. The other two similarity measures have not been used before in the bibliometric literature. Finally, we show by means of an example that our findings have a high practical relevance.information science;Pearson correlation;cosine;similarity measure;author cocitation analysis
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