Archive for the ‘Stem Cells/Cloning’ Category

Appellate Court Ruling Permits Continued NIH Funding of Embryonic Stem Cell Research

Tuesday, September 4th, 2012

On August 24th, the D.C. Cir. ruling dismissing the suit brought to block any federal funding of embryonic stem cell research was affirmed. Stem cell researchers can breathe a bit more easily, and keep the lights on in their labs – for the next few months at least.

Read short article here.

Sherley v. Sibelius – The Undead Threat To Stem Cell Funding

Thursday, April 26th, 2012
Green Energy Sources

When a three judge panel of the US Court of Appeals for the D.C. Cir. dismissed a preliminary injunction obtained by plaintiffs in April 2011, and the lower court judge then  dismissed plaintiffs’ suit to block the Administration’s guidelines permitting funding for embryonic stem cell research as violative of the Dickey-Wicker amendment banning funding that might destroy or harm a human embryo, I thought the issue had been laid to rest. However, plaintiffs – not the Government – have now appealed to the appeals court, arguing that the prior ruling overturning the injunction banning hESC research is not binding on the present panel.

The earlier panel had ruled that the  Dickey-Wicker amendment, that is tacked onto some bill sure to pass Congress each year, is ambiguous in view of the more precise policies urged by the Administration and the NIH, regulating hESC research. The plaintiffs argued that the earlier panel ruling simply involved injunctive relief and should not be “the law of the case” regarding the merits of their suit. Defendants and amici argued that the panel effectively analyzed the merits of the suit: the conflict or congruence between Dickey-Wicker and the NIH policy resuming funding for stem cell research.

If the current panel does not agree that it is bound by the earlier panel’s analysis and sides with the (anti-hESC research) plaintiffs, this case will wend its way to the Supreme Court. However, if the Administration changes in November, and a new Administration reinstates the “Bush ban,” the appeal will be moot. Those who support hESC research should hope that the stem cell researchers can get some grants funded and new cell lines approved  in the next six months or so. A pro-science door that has been open for about three years may be about to close.

Read the article from Regenerative Medicine Forum

Prior posts on this subject can be found here:

July 28, 2011

May 2, 2011

EU High Court Bans Patents on Cells Requiring Processing Human Embryos

Tuesday, October 18th, 2011

Defining “human embryos” broadly, The Court of Justice of the European Union has ruled that pluripotent stem cells derived from human embryos and totipotent stem cells derived from blastocysts are not patentable if they are obtained by destroying human embryos or using them “as base material”, at any point in the  production of the stem cells. The definition of “human embryo” was also extended to cover enucleated oocytes that may incorporate nuclear material from other cells or be induced to divide by parthenogenesis. The later essentially bans “adult cell cloning” for research on the early stage cells, e.g., if it involves destruction of resultant “embryo.” Individual pluripotent stem cells were not included in that concept, e.g., neuronal stem cells, since they cannot develop into a human being. But since they are obtained by disassembling a blastocyst, this is a distinction without a difference. For a refresher on the science, see W. Woessner, JPTOS, 83, 830 (November 2001).

The EU decision was based on Article 72(2) of TRIPS which stipulates that Members may exclude from patentability inventions, the prevention of the commercial exploitation of which is necessary to protect ordre public or morality. Thus, Greenpeace and its friends have accomplished what organizations with similar political (if not religious) leanings have failed to accomplish in their attempts to ban Government funding for embryonic stem cell research in the U.S.  Of course, such court battles will be refocused by the AIA. Sec. 33 bans patents with claims “directed to or encompassing a human organism.” This provision is retroactive to all pending applications, but not to issued patents. How broadly the term “human organism” will be defined is still an open question but, groups supporting a very broad definition will be encouraged by this decision.

The only exception “to the non-patentability of uses of human embryos for industrial and commercial purposes concerns only invention  for therapeutic or diagnostic purposes which are applied to the human embryo and are useful to it.” This exception would seem to permit some types of gene therapy or other medical treatments aimed at correcting genetic defects in the developing embryo. As noted above, this decision, which involved the isolation of pluripotent stem cells, does not purport to ban human cloning, so long as birth results – the embryo would not be harmed by such a procedure. This type of research, termed “therapeutic cloning” has not been banned in Europe. The charter of Fundamental Rights of the European Union prohibits reproductive cloning. In the U.S., the “Dickey-Wicker Amendment” to the annual HHS appropriations bill bars Federal funding for the creation of a human embryo for research purposes or for research in which human embryos are destroyed.  In 2010, HR 4808 was introduced by Diana DeGette (D-CO) to expressly permit funding for embryonic stem cell research, but it has not been passed.

Judgement of the Court – October 18th, 2011

District Court Dismisses Stem Cell Ban Suit

Thursday, July 28th, 2011

On July 27, in Sherley v. Sibelius, Judge Royce Lamberth reversed himself, and dismissed the 2010 lawsuit that initially led to a freeze on Government funding for human embryonic stem cell research, conducted under the terms of the 2009 NIH Guidelines. His decision tracks the reasoning of  an April 29th decision by the Court of Appeals that lifted the injunction that he had imposed on the implementation of the Guidelines (See, my post of May 2, 2011: “Appeals Court Overturns Stem Cell Ban”).  The Guidelines had been formulated to implement President Obama’s executive order 13505 that, in turn, lifted Bush’s 2001 Executive Order banning such funding.

The Court of Appeals had found that the preliminary injunction was improperly granted and the Guidelines were not in conflict with the 1996 Dickey-Wicker Act, banning funding for certain research involving human embryos. The plaintiffs’ counsel, Steven H Aden of the Alliance Defense Fund, a pro-life “legal alliance of Christian attorneys”,  was quoted by the WSJ as considered their options for appeal, and called embryonic stem cell research “illegal and unethical” in a story on the ADF website.