Posts Tagged ‘stem cells’

UK National Stem Cell Network Report – The Patent Watch Landscape

Thursday, March 7th, 2013

If you have either a passing or passionate interest in stem cell patenting, this report is worth some of your time. (A link to the report can be found at the end of this post.)

The report analyzes the stem cell patent landscape from November 2008 to Oct 2009 and from November 2008 to October 2011. The “patent watch dataset” is based on patent applications published or patents issued/ granted by the PCT and in the US, EP and  UK. The top applicant of published applications is Kyoto University and the top applicant on granted patents is WARF.

However, the report goes far beyond a simple numbers game; it analyzes the therapeutic areas of research represented by the stem cell IP. The report provides topography maps of the various areas such as pluripotent cells (e.g., embryonic stem cells) that is still a very active area, as is research in the areas of hematopoietic stem cells and neural stem cells. Even more interesting is the analysis that maps collaborations between high-filing universities and their spin-offs or start-up companies, as well as established companies.

Having done some of the early IP work on pluripotent adult stem cells, I found the report as addictive as a box of chocolates – I never was sure what would be on the next page.

informatic-stemcells

Supreme Court Denies Cert. in Sherley v. Sebelius

Wednesday, January 9th, 2013

The pesky worry about a possible Supreme Court review of the ruling by the D.C. Court of Appeals affirming the Circuit Court’s dismissal of a challenge to the 2009 NIH Stem Cell Funding Guidelines – which permitted NIH funding of most stem cell research – was lifted today when the Supreme Court denied plaintiff’s petition for cert. With the re-election of President Obama, who initially lifted the ban on all but very limited stem cell research imposed by President Bush, hopefully the U.S. will return to a position of leadership and help this area of research mature.

Click here to read the story from the Stem Cell Action Coalition.

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