Federal Funding of Stem Cell Research: Off, then On, Then Off Again, Now On, Sort Of - Fordham Intellectual Property, Media & Entertainment Law Journal
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Federal Funding of Stem Cell Research: Off, then On, Then Off Again, Now On, Sort Of

Federal Funding of Stem Cell Research: Off, then On, Then Off Again, Now On, Sort Of

The future of federally funded research involving human embryonic stem cells (hESCs or hES cells) remains in limbo following a spate of orders from the District of Columbia courts.

Federal funding of hESC research has been challenged in the courts since President Bush re-authorized in 2001 the limited funding initiated by President Clinton in January 2000.[1] However, plaintiffs have traditionally lacked standing to sue to challenge funding for stem cell research.[2] The current plaintiffs, Dr. James L. Sherley and Dr. Theresa Dreisher, however, were deemed to have standing by the D.C. Circuit Court based on a claim that they compete with hESC researchers for the same federal research grants, and so are harmed by the National Institutes of Health’s (NIH) decision to allow hESC researchers to compete with them for grant monies.[3] On August 23, D.C. District Court Judge Royce Lamberth granted plaintiffs’ motion for a preliminary injunction barring the Department of Health and Human Services from reinstating NIH funding for stem cell research.[4] The court ruled that NIH funding of hESC research violates the Dickey-Wicker Amendment to the current federal appropriations bill,[5] a “rider” attached to every annual bill since its introduction in 1996.[6]

Circuit Court’s Administrative Stay Permits Continued Federal Funding Pending Appeal of Preliminary Injunction

The Court of Appeals for the District of Columbia issued a temporary stay of Judge Lamberth’s preliminary injunction against NIH funding.[7] On Monday, September 27, the court dissolved that stay and replaced it with a long-term stay which will remain in place until the court reaches a decision on the merits of the litigation.[8]

However, there is still the matter of plaintiffs’ motion for summary judgment, on which Judge Lamberth will rule once the D.C. Circuit adjudicates the government’s appeal of the preliminary injunction.

Why Does Federally Funded hESC Research Matter?

Federally funded hESC research is important because it has formed the basis of all hESC research and continues to be the foundation upon which private and international research grows.  The original process of deriving hESCs from embryos was developed by Dr. James Thomson, a researcher at the public University of Wisconsin.[9] Dr. Thomson, along with the University of Wisconsin Alumni Research Foundation (WARF), patented the process of deriving hESCs.[10] WARF licenses its rights to U.S.-based researchers, public and private;[11] in a very basic sense, then, all U.S. hESC research derives from publicly funded research.  Similarly, other basic research into hESC line isolation, reproducibility, and therapeutic value is conducted by publicly funded researchers. Accordingly, further curtailing or altogether outlawing federal funding would erode the foundation upon which cutting-edge hESC research is based.

Secondly, federal funding of specific hESC lines is important because some lines are easier to reproduce in the laboratory setting, and some lines hold greater promise for specific therapies.  For example, researchers can reproduce the H9 line easily, making it well-suited to experiments.[12] Using other lines that are more difficult to reproduce therefore increases the cost of research,[13] and experiments which involve both private and public funding become more difficult to coordinate given funding constraints.

Finally, federal hESC funding matters because in its absence, public hESC research in the U.S. decreases substantially.  Some states, notably California, have significant hESC research programs. However, California’s program is open to commercial and public researchers, as well as reductions through state legislative action.[14] As well, other states which have funded or were considering hESC research are likely to reduce funding or elect not to fund due to the current economic climate.[15]

Implications of the Preliminary Injunction on Federally Funded hESC Research and Patents

While the NIH plans to utilize the administrative stay to process grant renewals and non-compete awards,[16] several aspects of administering and using federal hESC research grants remain impacted by the D.C. courts’ recent ‘on-again, off-again’ stem cell jurisprudence.  Among the potential implications of the appellate court upholding the injunction are:

  • The ability of grantees to receive “no-cost extensions,” in which the NIH permits expenditure of granted funds that grantees have not expended by the close of the grant period.[17]
  • Whether grantees may preserve the results and derivative products of their research.[18]
  • Whether NIH-employed scientists may use the results of publicly funded hESC research, including data and images from that research.[19]

Such questions will likely be answered by the D.C. Circuit’s ruling on Judge Lamberth’s preliminary injunction.  Regardless, these events bring further uncertainty to a research field already riddled with funding gaps and delays.

[1] Rob Stein, 13 Additional Stem Cell Lines Available for Funding, NIH Says, Wash. Post, Apr. 28, 2010, available at www.washingtonpost.com/wp-dyn/content/article/2010/04/27/AR2010042703360.html.

[2] See, e.g., Sherley v. Sebelius, 610 F.3d 69 (D.C. Cir. 2010) (dismissing vast majority of plaintiffs’ suit against new guidelines promulgated by the NIH because those plaintiffs could not allege an injury resulting from those allegations).

[3] Sherley v. Sebelius, 704 F. Supp. 2d 63 (D.D.C. 2010).  As others have noted, it was Judge Lamberth who initially dismissed plaintiff’s complaint for lack of standing.

[4] Id.

[5] Omnibus Appropriations Act 2009, Pub. L. No. 111-08, § 509, 123 Stat. 509 (2009); see also The Balanced Budget Downpayment Act, I, Pub. L. No. 104-99, § 128, 110 Stat. 128 (1996).

[6] Sherley, 704 F. Supp. 2d at 67.

[7] William McQuillen, Stem-Cell Research Ban Suspended by Appeals Court, Bloomberg News, Sept. 9, 2010, available at www.bloomberg.com/news/2010-09-09/stem-cell-research-funding-ban-suspended-during-u-s-government-s-appeal.html.

[8] Meredith Wadman, Appeals Court Grants Stay, Stem Cell Funding Continues for Now, Nature, Sept. 28, 2010, available at http://blogs.nature.com/news/thegreatbeyond/2010/09/appeals_court_grants_stay_allo.html.

[9] Sherley v. Sebelius, 704 F. Supp. 2d 63 (D.D.C. 2010).

[10] See Human ES Cell Intellectual Property: Current HESC Patents, University of Massachusetts Medical School, www.umassmed.edu/iscr/intellectualproperty.aspx (last visited Sept. 10, 2010).

[11] Id.

[12] Meredith Wadman, Stem-Cell Funding in Sight, Nature, Apr. 14, 2010, available at www.nature.com/news/2010/100413/full/464967a.html.

[13] Id.

[14] See About Us, California Institute of Research Medicine (CIRM), www.cirm.ca.gov/about-cirm (last visited Oct. 3, 2010).

[15] Among the most significant examples, California funded a decade of research at approximately $300 million annually, but this funding is available for private as well as public research.  Connecticut had funded research at about $10 million annually and other states such as New Jersey and Massachusetts have been considering hESC research funding for some years.  See Meg Tirrell and Jeffrey Young, Stem Cell Researchers Seeks Money, Law After Court Bans U.S. Funding, Bloomberg News, Aug. 25, 2010, available at www.bloomberg.com/news/2010-08-24/stem-cell-grants-worth-54-million-held-up-by-u-s-after-judge-s-decision.html; Stem Cell Research, National Conference of State Legislatures (NCSL), available at http://www.ncsl.org/IssuesResearch/Health/EmbryonicandFetalResearchLaws/tabid/14413/Default.aspx (last visited Oct. 7, 2010) (outlining state funding for hESC research); Governor Rell: State Awards $9.8 Million In Stem Cell Research Grants, Department of Economic and Community Development, June 10, 2010, available at http://www.ct.gov/ecd/cwp/view.asp?a=1104&q=461422 (example of recent funding by a state legislature).

[16] Meredith Wadman, NIH Tells Researchers to Recommence Stem Cell Work, Nature, Sept. 9, 2010, available at http://blogs.nature.com/news/thegreatbeyond/2010/09/nih_tells_its_campus_researche.html.

[17] Meredith Wadman, U.S. Department of Justice Will Appeal Stem-Cell Injunction, Nature, Aug. 25, 2010, available at http://blogs.nature.com/news/thegreatbeyond/2010/08/us_department_of_justice_will_1.html.

[18] Meredith Wadman, NIH Stops Its Own Human Embryonic Stem Cell Experiments, Nature, Aug. 30, 2010, available at http://blogs.nature.com/news/thegreatbeyond/2010/08/nih_freezes_its_own_human_embr_1.html.

[19] Id.

Aaron Scheinwald