Using Bayh-Dole Act March-In Rights to Lower US Drug Prices.

Importance: In December 2023, the Biden-Harris Administration released a proposed framework for exercising government march-in rights (effectively granting compulsory licenses for those patents to generic drug makers) under the Bayh-Dole Act on patents on taxpayer-funded drugs, which has renewed questions about whether march-in rights could promote cost savings through generic competition or harm pharmaceutical innovation.

Objectives: To determine the feasibility of using march-in rights to remove patent barriers to generic competition.

Design, Setting, And Participants: This cross-sectional study examined government funding information from multiple sources for patents listed in the Food and Drug Administration (FDA) Orange Book from 1985 to 2023.

Manual versus machine: How accurately does the Medical Text Indexer (MTI) classify different document types into disease areas?

The Medical Subject Headings (MeSH) thesaurus is a controlled vocabulary developed by the U.S. National Library of Medicine (NLM) for classifying journal articles.

Will Large Increases in the NIH Budget Promote More Meaningful Medical Innovation?

Kesselheim proposes doubling the NIH's budget to promote clinically meaningful pharmaceutical innovation. Since the effects of a previous doubling (from 1998-2003) were mixed, I argue that policymakers should couple future budget growth with investments in experimentation and evaluation.

Fixing The FDA's Orange Book.

The modern regime for balancing innovation and competition in pharmaceuticals was established through the Drug Price Competition and Patent Term Restoration Act of 1984, also known as the Hatch-Waxman Act. This regime needs updating. The process that Hatch-Waxman established for listing patents and challenging patents on the Food and Drug Administration's Orange Book is one important area for reform.

The Government and Pharmaceutical Innovation: Looking Back and Looking Ahead.

Current debates about the roles of the public and private sectors in pharmaceutical innovation have a long history. The extent to which, and ways in which, the public sector supports drug innovation has implications for assessments of the returns to public research funding, taxpayer rights in drugs, the argument the high prices are needed to support drug innovation, and the desirability of patenting publicly funded research.

The COVID-19 Innovation System.

The coronavirus disease 2019 (COVID-19) pandemic response brought forth major changes in innovation policy. This article takes stock of the key features of the COVID-19 innovation system-the network of public and private actors influencing the development and diffusion of technologies to combat the pandemic. Before the pandemic, biomedical research and development policy consisted largely of "push" funding from the public sector in support of basic research and "pull" incentives from patents to motivate private companies to invest in clinical trials and develop drugs and vaccines.

Public R&D Investments and Private-sector Patenting: Evidence from NIH Funding Rules.

We quantify the impact of scientific grant funding at the National Institutes of Health (NIH) on patenting by pharmaceutical and biotechnology firms. Our paper makes two contributions. First, we use newly constructed bibliometric data to develop a method for flexibly linking specific grant expenditures to private-sector innovations.

Indian pharmaceutical patent prosecution: The changing role of Section 3(d).

India, like many developing countries, only recently began to grant pharmaceutical product patents. Indian patent law includes a provision, Section 3(d), which tries to limit grant of "secondary" pharmaceutical patents, i.e.

The applied value of public investments in biomedical research.

Scientists and policy-makers have long argued that public investments in science have practical applications. Using data on patents linked to U.S.

Corporate Funding for Schools of Public Health: Confronting the Ethical and Economic Challenges.

We discuss the public and private sponsoring of university research and the issues it raises in a context of diminished federal funding. We consider research funding at schools of public health and why these schools have historically had weaker links to industry than have other academic units. We argue that the possibility of enhanced links with industry at schools of public health may raise specific concerns beyond those facing universities generally.

Citations in Life Science Patents to Publicly Funded Research at Academic Medical Centers.

Background: The contributions of Academic Medical Centers (AMCs) to biomedical innovation have been difficult to measure because of the challenges involved in tracing knowledge flows from their origin to their uses.

Methods: The authors examined patent citation linkages between AMC research funded by the National Institutes of Health (NIH) and patents. In prospective analyses, they examine the extent to which articles resulting from NIH grants to AMCs awarded between 1990 and 1995 were cited in drug and medical patents.

How do public health safeguards in Indian patent law affect pharmaceutical patenting in practice?

The 1995 Trade Related Intellectual Property Rights (TRIPS) agreement required developing countries to grant product patents in pharmaceuticals. Developing countries have since explored various measures to ameliorate potential negative effects of the new laws on public health. A prominent example is India, whose post-TRIPS patent laws include a provision, section 3(d), that restricts patents on incremental pharmaceutical innovations.

New evidence on the allocation of NIH funds across diseases.

Context: The responsiveness of NIH (National Institutes of Health) funding to disease burden is a long-standing issue of policy interest. Previous analyses of this issue have been hindered by data constraints, have not specified channels through which the NIH funding process could be responsive to disease considerations, and have not examined differences across NIH institutes and centers.

Methods: We collected data from the NIH's new RCDC (Research, Condition, and Disease Categorization) database on funding for 107 diseases in 2008 and linked these to data on deaths and hospitalizations for these diseases.

Accountability in patenting of federally funded research.

New data indicates substantial under-reporting of the existence of federal funding in academic biomedical patents issued since the enactment of the Bayh-Dole Act.

Evergreening, patent challenges, and effective market life in pharmaceuticals.

Observers worry that generic patent challenges are on the rise and reduce the effective market life of drugs. A related concern is that challenges disproportionately target high-sales drugs, reducing market life for these "blockbusters." To study these questions, we examine new data on generic entry over the past decade.

What are the respective roles of the public and private sectors in pharmaceutical innovation?

What are the respective roles of the public and private sectors in drug development? This question is at the heart of some policy proposals, such as those that would give the government a share of profits from drugs at least partly developed with federal research dollars. This paper provides empirical data on these issues, using information included in the patents on drugs approved between 1988 and 2005. Overall, we find that direct government funding is more important in the development of "priority-review" drugs-sometimes described as the most innovative new drugs-than it is for "standard-review" drugs.

University Software Ownership and Litigation: A First Examination.

Software patents and university-owned patents represent two of the most controversial intellectual property developments of the last twenty-five years. Despite this reality, and concerns that universities act as "patent trolls" when they assert software patents in litigation against successful commercializers, no scholar has systematically examined the ownership and litigation of university software patents. In this Article, we present the first such examination.

Academic patents and access to medicines in developing countries.

There is a widespread and growing concern that patents hinder access to life-saving drugs in developing countries. Recent student movements and legislative initiatives emphasize the potential role that research universities in developed countries could have in ameliorating this "access gap." These efforts are based on the assumption that universities own patents on a substantial number of drugs and that patents on these drugs are currently filed in developing countries.

Is Bayh-Dole good for developing countries? Lessons from the US experience.

The US Bayh-Dole Act encourages university patenting of inventions arising from publicly funded research. Lessons from three decades of US experience serve as a cautionary tale for those countries that may choose to emulate Bayh-Dole.

The anatomy of medical school patenting.

Background: Although issues related to patenting by faculty at academic medical centers have been the source of much controversy, there is little systematic evidence of the growth of these activities, their distribution among academic departments, and their relationship to faculty research efforts.

Methods: We pooled data on medical school faculty, National Institutes of Health (NIH) grant activity, and patenting to examine changes in the propensity to apply for a patent during the period from 1981 through 2000 that was subsequently granted, the distribution of these activities among departments, and the relationships between patenting and variables associated with individual faculty members. These variables included sex, academic degree, years since the last academic degree was earned, patenting by departmental peers, and NIH funding history.