The United States Court of Appeals for the District of Columbia Circuit stayed the order of the D.C. District Court that had nullified President Obama’s executive order restoring Federal funding for research on embryonic stem cells (ESCs) as conflicting with the Congressional amendment attached to a bill each year that bars Federal funding for research that would destroy human embryos. The Court of Appeals did not provide any opinion on the merits, but the stay permits NIH-funded ESC research projects in the U.S. to continue, and permits the NIH to continue to disburse funds to projects it had funded under the Obama order. Of course, the stay will only last until a decision on the merits, which itself is sure to be appealed, but this may provide time for a legislative fix favored by supporters of ESC research. Earlier posts on this judicial/legislative battle appear below (Sept. 1st and August 25th).
Archive for September, 2010
Stem Cell Funding Ban Stayed by D.C. Cir.
Monday, September 13th, 2010Savior or Candidate for “Worst Patentee”? Nutriset
Wednesday, September 8th, 2010
Last Sunday’s New York Times magazine had a provocative article about Plumpy’nut, a nutritive peanut paste that is foil-packaged so it does not need refrigeration. When eaten by malnourished children it can “cure” them in a relatively brief period of time. It is being touted as nearly a miracle food for countries in Africa or Central America, since peanuts are a cheap commodity in many of these countries and the product also does not require reconstitution with water.
However, Nutriset, a French company, is described as having patented this product essentially world-wide, and is characterized as aggressively defending its patents. (A copy of the U.S. patent is available at the end of this post.) Apparently, it has licensed the product in two African countries, but wants to make it in France. The advantages to, not just the health, but the economies of third-world countries, if they could manufacture and package the product locally, are clear. In fact, one organization has built a “factory” in Haiti and is making the product there. (Probably no Fed. Cir. equivalent to worry about.)
While recipes are notoriously difficult to patent in the U.S., it can be done, and the article reports that there is a U.S. patent on Plumpy’nut, which doesn’t expire until 2017. It is apparently the subject of an inter partes reexamination request, and so may not be around long. But if it is cancelled, the plot only thickens. The author speculates that big food companies, like General Mills or Cargill, may want to get into the business of manufacturing this or similar supplements and selling them to relief organizations, who would do the distribution. This may benefit a lot of children but it won’t do much for economic development in these countries and ultimately, may just provide lots of older and larger stomachs that need to be filled with something more substantial than fortified peanut butter.
USPTO Issues “2010 KSR Guidelines Update”
Tuesday, September 7th, 2010
On September 1st, the Office of Patent Legal Administration (I didn’t know there was one) issued 17 pages in the Fed. Reg. (Vol. 75, 53643) updating its obviousness guidelines. (A copy of the guidelines is found at the end of this post.) The Update is mostly a meaty analysis of 22 post-KSR Fed. Cir. decisions, 12 of which are in the pharma/biotech area and nine of which deal with the principles of “structural obviousness.” The Guidelines state that apart from using the TSM test as a rationale “to support an obviousness determination,” the 2007 KSR Guidelines identified six other rationales that can also be used: (1) Combining prior art elements according to known methods to yield predictable results; (2) simple substitution of one known element for another to obtain predictable results; (3) use of a known technique to improve similar devices, methods, or products in the same way; (4) applying a known technique to a known device, method or product ready for improvement to yield predictable results; (5) “obvious to try”; and (6) known work in one field of endeavor may prompt variation of it for use in either the same field or a different one based on design incentives or other market forces if the variations are predictable to POSA.
The structural obviousness decisions are either used to illustrate “substituting one known element for another” or “obvious to try.” All the decisions are summarized by “teaching points,” some of which are simply put too broadly. For example, the teaching point for Aventis Pharma v Lupin, 499 F.3d 1293 (Fed. Cir. 2007) is: “A chemical compound would have been obvious over a mixture containing that compound as well as other compounds where it was known or the skilled artisan had reason to believe that some desirable property of the mixture was derived in whole or in part from the claimed compound, and separating the claimed compound from the mixture was routine in the art.”
INJUNCTION BARRING ESC RESEARCH FUNDING APPEALED
Wednesday, September 1st, 2010
The Justice Department has appealed the injunction levied by Judge Lamberth of the D.C. District Court that would negate President Obama’s executive order, issued in 2009, that repealed President Bush’s order of 2001, barring Federal funding of research on embryonic stem cells (ESCs) except on a few lines. In my previous post, I reviewed some of the history of these executive orders. Repealing the Obama order has thrown the ESC research community into turmoil, as it is not even clear if research permitted under the restrictive Bush order can be funded, or even continued. This is because the basis for the Judge’s order is his belief that the Obama order conflicts with the Congressional amendment, renewed each year, that absolutely bars the use of Federal funds to support research that would destroy human embryos, even those that would be discarded by fertility clinics with the permission of all of the parties involved in their “creation.”
The best hope is probably the legislative fix proposed by Representative Diana DeGrette, who was able to get a bill permitting funding for ESC research passed by the House and the Senate twice during the Bush years. Each time, the President vetoed it. She has stated that she intends to offer the bill again, and hopes for (relatively) quick passage this fall.
Reuters – Justice Department Appeals Injunction on Stem Cell Funding
