Appeals Court Overturns Stem Cell Ban

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.

Sherley – 4-29-11 Documents and Order

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Patent System Fosters Eugenics – What Next?

USA TODAY ran a provocative article yesterday (April 26, 2011) on the “dark past” of the respected journal Annals of Human Genetics, in which its editor, Andres Linares did a mea culpa for the role of the journal, founded in 1925 and then called Annals of Eugenics, in promoting racial purity and preventing inferior races and social classes from reproducing. I was startled to find that the patent system was tied into the story as a part of “modern genetics today [that] still suffers from the same blind spots that fostered eugenics.” Along with the evils of “[s]tudies that ascribe genes to explain complex character traits” that are promoted by geneticists, are:

“Scientists seeking patent rights over their patient’s genes, a hotly contested area of current law because of the argument patent rights don’t extend to natural products.”

Apart from the fact that this could have been taken from an ACLU Myriad press release, what does the patent system have to do with eugenics? A better choice for criticism might have been: Scientists seeking to develop therapies for genetic disorders by introducing repaired DNA into a patient’s genome – although the “gene therapies” under trial  today are not experiments in eugenics, any more than is patenting a “healthy” or a “defective” gene. But, to borrow from  David Letterman, I wouldn’t give the patent system’s problems to a monkey on a rock.

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Where Will the Burden Fall – Microsoft v. i4i Argued Before the Supreme Court

Find below a recent article from Robins, Kaplan, Miller & Ciresi L.L.P. regarding Advanced Patent Trial Strategies (APaTS).

i4i APaTS Special

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H.R. 1249 Voted Out Of Committee: No Grace Period For You!

You may well be tired of hearing about the contending amendments, but I must note that the House version of the America Invents Act was voted out of Committee after being amended to reinstate the section of 102 that limits the exceptions for inventor activity within one year of filing to publications and disclosures, while not including the inventor’s “public use” or “on sale” activity in the grace period. The upshot is that the bill that will reach the House floor for a vote is identical in this section as it appears in S. 23, which the Senate passed. Amendments can still be made before the House votes, but the odds of having a broadly protective grace period are getting long. As Hal Wegner has repeatedly noted and Matt Osenga have pointed out in his useful note, “(Lack of) Grace Period in America Invents Act”, 102(b) currently provides that public use or sale (by anyone) is only a problem if it takes place more than one year prior to the date of application for the patent. Under the amended bill, an inventor’s (or anyone else’s) offer for sale one day prior to filing a patent application would be a bar to obtaining a patent (even if the inventor had made an “excepted disclosure” 363 days earlier).  This is getting as hard to follow as a double-jointed rattle snake, but it may be as dangerous to early-stage developers. At least there is some rattling going on.

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