Intellectual property (IP) restrictions rarely impose significant burdens on biomedical research, but there are reasons to be apprehensive about their future impact on scientific advances in this area, says a new report from the National Academies' National Research Council. The nation's policy-makers, courts, and health and patent officials should take appropriate steps to prevent the increasingly complex web of IP protections from getting in the way of potential breakthroughs in genomic and proteomic research. For example, Congress should consider legislation that would allow scientists to conduct research on patented inventions in order to discover novel uses or improvements without fear of liability for patent infringement. And should the rare case arise in which restricted access works against the interests of public health, courts should follow legal precedents and allow the provision of products or services that the public needs, while awarding compensation to particular inventors for the use of patented material....The U.S. Patent and Trademark Office (USPTO) has been inundated with requests for patents on genes, gene fragments, proteins, and methods to study or produce them. Because thousands of genes or proteins can now be examined simultaneously, there is a real possibility that a thicket of restrictions could impede scientific progress by blocking access to previous findings.
Furthermore, a federal appellate court recently rejected the claim that the so-called "experimental use" legal defense shields academic research from patent infringement liability. In the future, academic and other nonprofit research institutions may feel compelled to protect themselves and their scientific investigators from liability by trying to regulate investigators' behavior, the report says....It is rare for research to be stopped, significantly delayed, or redirected because of intellectual property mandates, the survey found. On the other hand, failure to comply with requests for the exchange of biomedical research material, patented or not, is common in both the public and private sectors....The National Institutes of Health should continue to encourage the free exchange of material and data among its grantees and contractors. Additionally, NIH should require these individuals to comply with the agency's guidelines for obtaining and disseminating biomedical research resources and for licensing genomic inventions. Industries and nonprofit institutions should standardize and streamline their processes for exchanging biological material or data.
NIH also should adapt and extend the "Bermuda Rules," which were created in 1996 by scientists involved in the publicly funded human genome project. The rules instruct genomics researchers to share their data in a free public database called GenBank. They should be extended to include protein-structure data that NIH-funded centers generate for large projects in genomics, the report says. Researchers in both the public and private sectors should make this information freely available in the Worldwide Protein Data Bank, a project overseen by a consortium of international research groups....Copies of Reaping the Benefits of Genomic and Proteomic Research: Intellectual Property Rights, Innovation, and Public Health will be available this fall from the National Academies Press.
Posted by
Peter Suber at 11/18/2005 01:25:00 PM.
The open access movement:
Putting peer-reviewed scientific and scholarly literature
on the internet. Making it available free of charge and
free of most copyright and licensing restrictions.
Removing the barriers to serious research.
