The Bayh-Dole Act of 1980 grants universities the right to elect to take title in any patent application and patent that was made by their researchers with the support of the Government, e.g., NIH. 35 USC s. 200 et seq. This clears the path for universities and other non-profit institutions to license the patents, potentially exclusively, to commercial entities (like big Pharma) that, hopefully will fund further research and eventually bring a drug to market. Prior to 1980, the Government kept title, and was responsible for licensing such technology. However, due to a lack of resources and red tape, most Government-funded inventions never saw “the light of day.”
Posts Tagged ‘NIH’
On April 29th, in Sherley v. Sebelius, the U.S. Court of Appeals for the D.C. Cir., (a copy is available at the end of this post) overturned the injunction imposed by the district court, which had blocked the implementation of the 2009 NIH Guidelines on finding research using human embryonic stem cells. 74 Fed. Reg. 32170(2009). The Guidelines, in turn, had been formulated to implement President Obama’s executive order 13505 that lifted President Bush’s executive order banning such funding. The suit, brought by two researchers working with adult stem cells, argued that the Guidelines were in conflict with the 1996 Dickey-Wicker Act, which banned funding for both research that would create human embryos for research purposes or would destroy human embryos. For more background, see my post of Sept. 1, 2010.
The Court found that preliminary injunction was improperly granted “because Dickey-Wicker is ambiguous and the NIH seems reasonably to have concluded that, although [D-W] bars funding for the destructive act of deriving an ESC from an embryo, it does not prohibit funding a research project in which an ESC will be used.” In other words, if some other unfunded entity disassembles an unwanted embryo obtained with informed consent of the donor from an in vitro fertilization clinic and provides the ESCs to a researcher, the researcher can obtain federal funding to study them. Since establishing the Guidelines, the NIH has approved additional ESC lines for federal funding. While this is good news for researchers working with embryonic stem cell lines approved under the NIH Guidelines, the underlying suit will continue to threaten the administration’s more liberal view of stem cell research.
The lists of the top pharma/biotech stories for 2009 that I have been seeing online focus mostly on the rise of biosimilars, the spate of mergers and the plurality of Hatch-Waxman litigations that have grabbed the headlines almost daily, along with the policies of the new PTO Director and attacks on gene- and business-method patenting.
Let’s not forget one major policy shift that President Obama initiated early in the year that may do more for the health of our citizens than the gut-shot health care reform bill stumbling toward further compromise. On March 9, 2009, President Obama signed Executive Order 13505 that lifted a more than eight-year ban on Federal Funding for research on embryonic stem cells.
Prior to the order, U.S. researchers could conduct research on ESCs with private funds, but this research had to be strictly segregated from any resources made available by the feds. In other words, an instrument bought with private funds could not be set on a lab bench built with federal funds. This problem is not entirely remedied by the Executive Order since Congress continues to attach an amendment to general funding bills that prohibits the use of federal funds to destroy or harm human embryos. In other words, researchers can now use ESCs, but they can’t make them from scientific scratch.
Still, this is an important step forward to enhance the ability of U.S. researchers to contribute and complete in this new and increasingly promising area. In August, the NIH issued guidelines which it will use in deciding if grant applications for stem cell research are fundable, and in approving ESC lines not previously approved for use in research. The stem cells must have been derived from embryos in excess of clinical need for in vitro fertilization, they must be voluntarily donated by the “parents,” and not bought or sold. Also, the human embryos cannot be the result of cloning experiments. See, http://stemcells.nih.gov.
In early December, NIH approved, inter alia, the use of 11 cells produced at Harvard using private funding. This is significant, since there are an estimated 700 ESC lines in the worldwide research community, and research on most of them may well be fundable now. Reports of phase I/II clinical trials using ESCs to treat a wide range of mostly hopeless conditions are frequent already. A very recent news story reported that a Scottish researcher plans to use ESCs in an attempt to treat stroke victims. Let’s hope that executive order 13505 and the NIH regulations open the floodgates for both new business opportunities and, more importantly, new hope for the new year.