Monday, August 23, 2010

Judge Lamberth enjoins Obama stem cell guidelines on ESC

CNN reports:

A U.S. district judge granted a preliminary injunction [23 August 2010] to stop federal funding of embryonic stem cell research that he said destroys embryos, ruling it went against the will of Congress.
The ruling by Judge Royce C. Lamberth was a blow to the Obama administration, which last year issued guidelines to allow federal funding for embryonic stem cell research.
Lamberth's ruling said all embryonic stem cell research involves destroying embryos, which violates the Dickey-Wicker Amendment included in federal spending bills.
"The Dickey-Wicker Amendment unambiguously prohibits the use of federal funds for all research in which a human embryo is destroyed," Lamberth's ruling said. "It is not limited to prohibit federal funding of only the 'piece of research' in which an embryo is destroyed. Thus, if ESC [embryonic stem cell] research is research in which an embryo is destroyed, the guidelines, by funding ESC research, violate the Dickey-Wicker Amendment."

to californiastemcellreport-->

While Ric talks about the Republican federal government, note the decision by Judge Royce C. Lamberth blowing away via the Dickey-Wicker Amendment the Obama guidelines. As to iPS cells, they were developed outside the US without Federal funding and have a variety of patents covering use.

[As of midnight (Eastern) on Aug. 23, calstemsupport didn't publish my comment. Work on iPS cells evolved independently of CIRM and federal funding.]

On the intellectual property status of iPS, see previous IPBiz post

The patent world of iPS (stem cells): Yamanaka, Bayer, and iZumi

See also iZumi's plans to capitalize on iPS cells, Nature Biotechnology 27, 590 - 591 (2009)

[Not likely that this will be covered on californiastemcellreport]

Within coverage by the New York Times [U.S. Judge Rules Against Obama’s Stem Cell Policy ]:

Mr. Aden, the plaintiff’s lawyer, said Judge Lamberth would have to clarify whether President Bush’s rules were legal.

[of the previous standing issue]

But the Court of Appeals reversed that ruling last year, saying the two researchers could be harmed by the new policy since they worked exclusively with adult stem cells and would face increased competition for federal financing under the new policy. After the appeals court ruling, all but Dr. Sherley and Dr. Deisher were dropped as plaintiffs to the suit.

Yes, the opinion gets into Chevron deference:

Defendants argue that the Dickey-Wicker Amendment is ambiguous. Specifically, they
argue that the term “research” is ambiguous, and that, as a result, their interpretation of research
should be entitled to Chevron deference. See Chevron U.S.A., Inc., v. Natural Resources Defense
Counsel, Inc., 467 U.S. 837, 843 (1984). Defendants’ argument fails.

The Court elaborated:

Congress has spoken to the precise question at issue—whether federal funds may be used
for research in which an embryo is destroyed. The Dickey-Wicker Amendment provides that no
federal funds shall be used for “research in which a human embryo or embryos are destroyed,
discarded, or knowingly subjected to risk of injury or death greater than that allowed for research
on fetuses in utero under 45 C.F.R. § 46.204(b) and section 498(b) of the Public Health Service
Act (42 U.S.C. 289g(b)).” Pub. L. No. 111-8, § 509(a)(2). Thus, as demonstrated by the plain
language of the statute, the unambiguous intent of Congress is to prohibit the expenditure of
federal funds on “research in which a human embryo or embryos are destroyed.” Id.
Contrary to defendants’ argument, the term “research” as used in the Dickey-Wicker
Amendment has only one meaning, i.e., “a systematic investigation, including research
development, testing and evaluation, designed to develop or contribute to generalizable
knowledge.” 45 C.F.R. § 46.102(d); see also Random House Dict. (listing the first definition of
research as “diligent and systematic inquiry or investigation into a subject in order to discover or
revise facts, theories, applications, etc.”).


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