Arti K. Rai

Synthetic Biology: Caught between Property Rights, the Public Domain, and the Commons

Synthetic biology presents a particularly revealing example of the difficulty of assimilating a new technology into the conceptual limits around existing intellectual property rights.

Finding Cures for Tropical Diseases: Is Open Source an Answer?

The Tropical Disease Initiative will be a Web-based, community- wide effort where scientists from the public and private sectors join together to discover new treatments

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.

Pathways Across the Valley of Death: Novel Intellectual Property Strategies for Accelerated Drug Discovery

Drug discovery is stagnating. Government agencies, industry analysts, and industry scientists have all noted that, despite significant increases in pharmaceutical R&D funding, the production of fundamentally new drugs - particularly drugs that work on new biological pathways and proteins - remains disappointingly low. To some extent, pharmaceutical firms are already embracing the prescription of new, more collaborative R&D organizational models suggested by industry analysts. In this Article, we build on collaborative strategies that firms are already employing by proposing a novel public-private collaboration that would help move upstream academic research across the valley of death that separates upstream research from downstream drug candidates. By exchanging trade secrecy for contract-based collaboration, our proposal would both protect intellectual property rights and enable many more researchers to search for potential drug candidates.

Bayh-Dole reform and the progress of biomedicine

A method for the hydrolysis of only the lacto-N-biosidic (Gal beta 1-3GlcNAc beta 1-) linkages at the non-reducing termini of sugar compounds, characterized by the use of glycosidase that is specific for only the lacto-N-biosidic linkage in said sugar compounds. And disclosed is a reagent for use in hydrolysis of only the lacto-N-biosidic linkage at the non-reducing termini of sugar compounds.

A Kernel for Open Source Drug Discovery in Tropical Diseases

Background Conventional patent-based drug development incentives work badly for the developing world, where commercial markets are usually small to non-existent. For this reason, the past decade has seen extensive experimentation with alternative R&D institutions ranging from private–public partnerships to development prizes. Despite extensive discussion, however, one of the most promising avenues—open source drug discovery—has remained elusive. We argue that the stumbling block has been the absence of a critical mass of preexisting work that volunteers can improve through a series of granular contributions. Historically, open source software collaborations have almost never succeeded without such “kernels”. Methodology/Principal Findings Here, we use a computational pipeline for: (i) comparative structure modeling of target proteins, (ii) predicting the localization of ligand binding sites on their surfaces, and (iii) assessing the similarity of the predicted ligands to known drugs. Our kernel currently contains 143 and 297 protein targets from ten pathogen genomes that are predicted to bind a known drug or a molecule similar to a known drug, respectively. The kernel provides a source of potential drug targets and drug candidates around which an online open source community can nucleate. Using NMR spectroscopy, we have experimentally tested our predictions for two of these targets, confirming one and invalidating the other. Conclusions/Significance The TDI kernel, which is being offered under the Creative Commons attribution share-alike license for free and unrestricted use, can be accessed on the World Wide Web at http://www.tropicaldisease.org. We hope that the kernel will facilitate collaborative efforts towards the discovery of new drugs against parasites that cause tropical diseases.

Proprietary science, open science and the role of patent disclosure: the case of zinc-finger proteins

A closer look at the large patent estate now covering both the engineering and use of zinc-finger proteins.

PHARMACOGENETIC INTERVENTIONS, ORPHAN DRUGS, AND DISTRIBUTIVE JUSTICE: THE ROLE OF COST-BENEFIT ANALYSIS

With the human genome mapped, and with the mapping of more than one hundred animal genomes in progress, the amount of genetic data available is increasing exponentially. This exponential increase in data is having an immediate impact on the process of drug development. By using techniques of information technology to manipulate data regarding the genes, proteins, and biochemical pathways associated with various diseases, scientists are beginning to be able to design drugs in a systematic fashion. In the context of any given disease, scientists look to see whether a gene, a protein for which the gene codes, or another protein in the relevant biochemical pathway could be the “target” biological molecule, the “knocking out” of which would halt or slow the diseases progression. Once a target molecule has been identified and characterized structurally, drug therapies that would be likely to knock out this target can be identified and tested systematically. The merger of information technology and genetic technology has changed the process of pharmaceutical development so much that a new term—bioinformatics—has been coined to describe this new approach to such development.

Open Source Research — the Power of Us

Academic and industrial scientific research operate on powerful and complementary models, consisting of some mix of competitive funding, peer review, and limited inter-laboratory collaboration. Enormous successes have arisen from both models. Yet there are clear failures to deliver results in certain areas, such as the provision of drugs for some of the most prevalent of human diseases. Is there a mechanism of research that is not wholly dependent on funding for its operation nor on traditional peer-reviewed articles for its propagation? Open source methods have delivered tangible benefits in the computer science community. We describe here efforts to extend these principles to science generally, and in particular biomedical research. Open source research holds great promise for solving complex problems in areas where profit-driven research is seen to have failed. We illustrate this with a specific problem in organic chemistry that we think will be solved substantially faster with an open source approach.

Use Patents, Carve-Outs, and Incentives — A New Battle in the Drug-Patent Wars

The Hatch–Waxman Act aims to strike a balance between the innovation incentives provided by patents and the greater access provided by generic drugs. Now the tactical landscape in the drug-patent wars has shifted again, with a recently decided Supreme Court case.