, the impact of these statutes has been critical. In fact, many experts believe that the biotechnology industry was spawned from the close interaction between academia and industry. It is widely recognized that the Bayh-Dole Act and the FTTA continue to contribute to the global leadership of the U.S. biomedical enterprise, and governments around the world are emulating these laws in the hopes of promoting economic development in their own nations.
New products developed under this system benefit patients daily and provide hundreds of scientists with the tools required for further discovery in support of our public health mission. For example, inventions arising from the NIH intramural program alone have contributed to over 150 products on the market, including diagnostic kits, vaccines, therapeutic drugs and dozens of antibodies, cell lines and other research tools. Similarly, the transfer of technology arising from the NIH extramural program has contributed significantly to new products and fostered economic development.
To accomplish the transfer of technology, universities have relied on authorities granted to them by the Bayh-Dole Act. The Act permits the grantee to retain title to intellectual property developed with federal funds and to license its rights to for-profit entities. It should be noted that, as provided by the Act, the Government does not have any direct control over patenting and licensing activities related to discoveries resulting from NIH funded research.
Patents provide the right to exclude others from making, using, selling, offering for sale, or importing licensee is permitted to benefit from the use of the technology, or non-exclusive, when more than one licensee is permitted to benefit from such rights.
As this Subcommittee well knows, new drugs and vaccines are costly to develop, and companies are unlikely.
Whenever federal funds are used to support a new discovery by contractors and grantees, the government has a non-exclusive, royalty-free right to use the patented technology by or on behalf of the government. This would allow the government laboratories and contractors the right to use the patented technology for further research. In addition, in dealing with this invention the federal grantee or contractor must ensure that the goals of the Bayh-Dole Act—utilization, commercialization, and public availability—are implemented.
When research is funded entirely by the private sector, the government has no statutory license, and it is strictly a private matter whether, and under what terms, new intellectual property is made available to others for commercial or research purposes.
Mr. Chairman, as we have discussed with this Subcommittee before, it is not merely the existence of a patent that raises concern for the biomedical research community. The concern mostly arises when the patent holder chooses to exercise its rights through licensing or other contractual agreements many research tools may be patentable and that they are of economic value to the holder of these rights. There is also little doubt that the value to society is greatest when such research tools are made widely available to scientists.
For example,. In response to concerns from the scientific community, NIH has published guidelines on the sharing of biomedical research resources entitled "Principles and Guidelines for Recipients of NIH Research Grants and Contracts." This document helps ensure open sharing of research tools to maintain the robust research enterprise in this country.
How do issues regarding intellectual property considerations relate to research on stem cells? The issuance of patents by the U.S. Patent and Trademark Office may not necessarily have an adverse effect on continuing research and often promotes the development of new therapeutics, diagnostics and research tools, including cells. If patent owners devise a licensing and sharing strategy that will allow basic research to continue unencumbered while preserving appropriate commercial value, they will help ensure that such research tools are broadly available to the research community. The terms and conditions on the use and the transfer of material, such as these cells, would be set forth in an agreement commonly called a Material Transfer Agreement, or MTA.
MTAs are vehicles used to transfer proprietary materials between and among the for-profit and not-for-profit sectors. Most MTAs are simple, 1- to 2-page agreements. MTAs can, however, impose obligations or restrictions that the recipient to give the provider an option to exclusive rights to any new intellectual property arising from recipient's use of the material.
NIH's experience has shown, however, that conditions imposed by patent owners—whether in a license or an MTA—can be crafted to ensure both research uses and commercial development. For example, the NIH strategy is to negotiate non-exclusive licenses for its intramural technologies provides for exclusive licensees to grant sublicenses to broaden the development possibilities when necessary for the public health. Finally, NIH insists on the continuing unencumbered availability of the licensed technology to.
Over the past few years, NIH has, however, faced situations in which the patent holder was willing to allow basic research to continue only under terms that were inconsistent with our research tools principles and guidelines. To resolve such a situation, NIH negotiated acceptable terms with the patent holder so that scientists could continue to use the tools for basic research while protecting the company's commercial rights. In fact, as part of these agreements, the terms and conditions were extended to NIH grantees, should they choose to take advantage of these more favorable terms.
The experience since the inception of the guidelines has been that, while the process between not-for-profit entities has been streamlined, there is still work to be done when transfer of tools happens between the for-profit and not-for-profit sectors. We are hopeful that continued dialogue between these two constituencies will eventually result in an understanding that would permit the research enterprise to continue to flourish without undue impediments.
Finally, it is important to remind the Subcommittee that the NIH has limited authority over the patenting and licensing activities of our contractors and grantees. Therefore, with regard to the stem cell patents and patent applications, it would be appropriate to address questions to the owners and licensees of this technology as to what conditions they may apply to those who desire to use the intellectual property.
Congress has enacted legislation for recipients of federal funding that encourages the utilization, commercialization and public availability of federally funded inventions. Grantees and contractors have exercised the broad discretion awarded them by the law and sought to achieve these goals through the patenting and licensing of new inventions that arise through the use of federal funds. The government has only limited authorities over these activities. If the research is entirely funded by the private sector, the government has no statutory of a technology under terms that do not limit basic research or encumber future products. The key to the use of a technology is in the manner in which holders of existing patents exercise their rights through licensing and other contractual agreements.
Mr. Chairman, thank you for the opportunity to provide this broad background on the effects of patents and licenses on the advancement of science and medicine.
Page citation: Senate Testimony. In Stem Cell Information [World Wide Web site]. Bethesda, MD: National Institutes of Health, U.S. Department of Health and Human Services, 2006 [cited Friday, June 24, 2016] Available at <>British Pump Manufacturers' Association (BPMA) provides clarification on conformity to Building Information Modelling Level 2 (BIM).
Although the pump sector has for some time recognised the need to fulfil its commitments to BIM, there have been many different interpretations as to how this might be achieved. Recognising the confusion that seemed to prevail across the sector, and in direct response to the concerns of its members, the BPMA convened a meeting to address the issue. But given the important work that the Chartered Institution of Building Services Engineers (CIBSE) had already been conducting in this area, and acknowledging its advisory role to UK government, the BPMA solicited its help and guidance.
The initial UK meeting led to further meetings across Europe, with CIBSE and many prominent pump manufacturers in attendance. The result of these meetings was to develop a Product Data Template (PDT) which could then be populated by any pump company. By completing the PDT for their products, manufacturers can effectively produce an �electronic catalogue�, directly usable in Level 2 BIM.
The templates are written in Excel, so manufacturers will not need much BIM �know how� to be involved. Another clear advantage is that the manufacturer will only have to describe and complete a product once to serve all BIM software systems and users.
It was agreed that the master template should be owned by CIBSE, so there could be no commercial interest in its curation. All completed Product Data Templates will then be owned by the respective Pump Manufacturers. Any changes to the template will need to be agreed and approved by the pump industry across Europe and dissemination of any revised version to members will be via National Associations such as BPMA.
The purpose of this template will be to standardise the data required for a product category. As such, it is believed that this PDT for pumps will meet the requirements of the Building Services and MEPH (Mechanical, Electrical & Public Health) sectors across the European Union.(Charlestown, Nevis) – Saturday brought controversy to Culturama in the double crowning of De Inspirer in both Junior and Senior Kaiso Monarch positions in the calypso competitions.
Opinions vary greatly in the public at large about why the 14-year-old won both competitions.
Husani Parris, aka De Inspirer was allowed to compete because he showed skill beyond his years, according to Culturama Chairman Halstead “Sooty” Byron.
In the past, contestants had to be 18 to compete in the Senior Kaiso competition.
But after De Inspirer took both crowns, it fired controversy in the public. Plenty of people on Nevis were talking about this issue, but none of them wanted their names used.
“If they were going to let him compete in the Senior, then he should have