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by Judge Lamberth of the D.C. District Court that would negate President Obama’s executive order, issued in 2009, that repealed President Bush’s order of 2001, barring Federal funding of research on embryonic stem cells (ESCs) except on a few lines.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
Tags: biotechnology news, intellectual property, stem cells, Warren Woessner
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August 25th, 2010
In December of 2009, I argued that President Obama’s Executive Order 13505, that lifted President Bush’s 2001 Order banning the use of federal funds for embryonic stem cell (ESC) research, should be a Top Biotech Story of 2009. The Bush Order had banned all federal funding for ESC research except for research on a small number of lines that existed prior to his order. Obama’s substitute order permitted agencies like NIH to fund research on cell lines produced after the Bush ban, so long as the funding was not used to produce the lines by the destruction of embryos. NIH went on to develop guidelines for approving fundable new cell lines.
In the December 2009 post, I noted that Congress had annually enacted the so-called Dickey-Wicker amendment that banned federally-funded research that harms or destroys human embryos. The Administration tried to argue that Order 13505 did not permit funding of obtention of ESCs from embryos, but the Judge found this a distinction without a difference.
Questions remain. While Judge Lamberth (D.C.D.C.) stated that the decision was intended to restore the status quo, the status quo, e.g., the Bush Order, is long gone. Research projects using newly approved lines have been started. Even if they can be continued with private funding, it is far from clear that these “illegal” cell lines can be used at all. But what if the lines were produced abroad and sent to a U.S. lab? Would even the limited research permitted under the Bush order be fundable now? What is supposed to happen to ongoing projects that cannot find non-federal funds to keep the laboratory lights on? With patent protection for ESCs uncertain at best, the future of this research in the U.S. is cloudy at best.
Read New York Times Article on Judge Lamberth’s Decision.
Tags: biotechnology law, biotechnology news, executive order 13505, Federal Circuit, intellectual property, ip, judge lamberth, Patent Law, stem cell research, stem cells, Warren Woessner
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August 12th, 2010
On July 29th, Rep. Frank Wolf (D.-Va.) introduced H.R. 5980 that would give priority to examination of patent applications filed by U.S. universities and by their “patent holding companies.” The definition of the latter seems a bit vague, but is apparently intended to cover entities like the Wisconsin Alumni Research Foundation (WARF) that finances prep/pros of patents by University of Wisconsin inventors and licenses them to provide income to both entities. The patents are assigned to WARF when they issue. The bill would also limit the early publication of U.S. patents to their abstracts. The bill is clearly an attempt to levy an IP “tariff” on foreign inventors but, for those of us with big university practices, it is an intriguing concept (if not a good idea).
In a somewhat related news item, a group of patients afflicted with Fabry’s disease have asked The U.S. Department of Health and Human Services (DHHS) to “march in” under the provisions of the Bayh-Dole Act, and permit/require Mt. Sinai School of Medicine, the owner of two patents (U.S. Pat. Nos. 5356804 and 5580757) covering the drug Fabrazyme, to grant additional licenses to manufacture and market the drug. This request is made under the “march in” provisions of the Bayh-Dole act, which founded the entire “industry” of university technology transfer in the 80’s. It is based on the allegation that Genzyme cannot meet the need for the drug, given its recent quality control problems. During the early years of the AIDS epidemic, such requests were made regarding the few anti-HIV drugs that were then available. As far as I know, none of the prior requests were granted.
Tags: biotechnology, biotechnology law, biotechnology news, DHHS, Fabrazyme, Fabry Disease, Frank Wolf, H.R. 5980, intellectual property, ip, Patent Law, patents, WARF, Warren Woessner
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August 10th, 2010
A note from Bill Bennett of Pizzeys (Australia seems to be adopting the standard from In re O’Farrell just as the US courts are distancing themselves from it):
We have previously flagged that the APO might modify their practice in relation to the “obvious to try” standard.
We have now observed that the examiner’s manual was amended on August 2nd. (This can be found by clicking here.)
According to the APO, an invention will be obvious to try if there is a “reasonable expectation that the solution might well solve the problem”.
This appears to echo the High Court’s decision in Aktiebolaget Hässle v Alphapharm Pty Limited [2002] HCA 59, which expressly endorsed the reasoning of the US Court of Appeals for the Federal Circuit in In re O’Farrell (853 F.2d 894) as the better approach under Australian law.
The Australian Examiner’s Manual now recognises that Australian law includes the requirement that anything suggested as “obvious to try” must carry with it a “reasonable expectation of success” in order to make the invention obvious. As in US law under O’Farrell, rebuttal of the factual assertion that any anticipated success is “reasonable” may therefore help overcome objections that the invention is obvious because it was “obvious to try”.
In practice, Australian examiners may not be so bold as to assert “obvious to try” as the sole reason for a claim rejection in view of the overarching principle that the skilled person must be “directly led” to the invention for it to be obvious.
Indeed, recent examination reports are asserting that references “provide motivation to make the invention” and “directly lead the skilled person to the invention” and only then stating as a consequence of those direct leadings that a “reasonable expectation of success” has been established.
Tags: APO, Australia, Bill Bennett, intellectual property, ip, Patent Law, Pizzeys, Warren Woessner
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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.”
