US, Europe Debate Embryonic Stem Cell Patents and Research
|Written by Gene Quinn
President & Founder of IPWatchdog, Inc.
Patent Attorney, Reg. No. 44,294
Zies, Widerman & Malek
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Posted: April 29, 2011 @ 1:12 pm
Earlier today the United States Court of Appeals for the District of Columbia vacated the preliminary injunction issued by the United States District Court for the District of Columbia preventing the federal government from funding stem cell research. The case — Sherley v. Sebelius — deals with whether federal funding of embryonic stem cell research is legal. The District Court decided in August 2010 that Congress prevented such funding and the lifting of the Bush ban by President Obama was immaterial. See District Court Injunction Opinion. In the decision on appeal, the Court of Appeals disagreed, concluding “the plaintiffs are unlikely to prevail because Dickey-Wicker is ambiguous and the NIH seems reasonably to have concluded that, although Dickey-Wicker bars funding for the destructive act of deriving an [embryonic stem cell] from an embryo, it does not prohibit funding a research project in which an [embryonic stem cell] will be used.”
Meanwhile, the patenting of stem cells is currently under attack in Europe.
According to European Union Advocate General M. Yves Bot, stem cells have the capacity to evolve into a complete human being and, therefore, must be legally classified as human embryos and must be excluded from patentability. The controversy in Europe is compounded by the fact that Article 6 of the Biotech directive 98/44/EC prohibits ”uses of human embryos for industrial and commercial purposes,” but no definition of “embryo” is provided. Further complicating the legal challenge to the patent eligibility of stem cells is the fact that in Europe patents cannot be obtained on inventions that are “contrary to ‘ordre public’ or morality…” But is it really moral not to perform research that many believe could hold promising cures for such diseases as Parkinson’s and Alzheimer’s?
Frankly, the United States Court of Appeals for the District of Columbia reached the right conclusion but to do so they needed to ignore the law. The Dickey-Wicker Amendment prohibits the use of federal funds for “(1) the creation of a human embryo or embryos for research purposes; or (2) 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…” No amount of judicial gyrations can in any intellectually honest way escape the reality that the Dickey-Wicker Amendment should rightly be determined to effectively block federal funding of stem cell research, regardless of how myopic a viewpoint that may be. In fact, Judge Karen LeCraft Henderson in dissent characterized the majority opinion of the DC Circuit as follows:
The majority opinion has taken a straightforward case of statutory construction and produced a result that would make Rube Goldberg tip his hat. Breaking the simple noun “research” into “temporal” bits, narrowing the verb phrase “are destroyed” to an unintended scope, dismissing the definition section of implementing regulations promulgated by the Department of Health and Human Services (HHS) (in case the plain meaning of “research” were not plain enough), my colleagues perform linguistic jujitsu.
While I am disappointed it required intellectual dishonesty to accomplish, I am glad that federally funded research will once again begin on stem cells. I understand the objections to embryonic stem cell research, but I simply cannot understand anyone that has a moral objection to embryonic stem cell research. We need to pursue this and other research that shows promise and not stall progress. I fail to see how is it moral to watch those with crippling diseases agonize without trying to do everything we possibly can to find cures and treatments? Simply put, I see nothing moral about watching the suffering of another human being and doing nothing.
Across the Atlantic, in Brüstle v Greenpeace eV, the Advocate General has taken a position that would create an inhospitable climate for stem cell research. Without patents to be obtained the funding would not be present for such speculative research, so if the Advocate General wins the day in Europe, which is a real possibility, embryonic stem cell research in the European Union would likely come to an abrupt stop and researchers would flee, which wouldn’t be bad for the United States, China or other countries that might be interested in picking up the slack.
The position advanced by the Advocate General, as described in a press release issued on March 10, 2011, is as follows:
[T]otipotent cells, appearing after fusion of the gametes and existing in that form only for the first days of development, have the essential characteristic of carrying within each of them the capacity to develop into a complete human being. Thus, those cells, since they represent the first stage of the human body which they will become must be legally classified as embryos, the patentability of which must be excluded. This definition therefore covers unfertilised ova into which a cell nucleus from a mature cell has been transplanted and unfertilised ova whose division has been stimulated by parthenogenesis in so far as totipotent cells would be obtained in those ways.
Similarly, the blastocyst stage of development, reached around five days after fertilisation, must also be classified as an embryo, since, according to the Advocate General, the principle of human dignity, to which the directive refers, is a principle which must be applied not only to an existing human person, to a child who has been born, but also to the human body from the first stage in its development, i.e. from fertilisation.
By contrast, pluripotent embryonic stem cells, taken in isolation, do not fall within the definition of an embryo, since, individually, they are no longer capable of developing into a complete human being. They can ‘only’ differentiate themselves into various organs forming parts of the human body. It is those cells which are concerned by the invention concerned by Mr. Brüstle’s patent, their removal from the embryo taking place at the blastocyst stage.
However, it is not possible to ignore the origin of these embryonic stem cells. The fact that they come from some stage in the development of the human body is not in itself a problem, provided only that their removal does not result in the destruction of that human body at the stage of its development at which the removal is carried out. In the opinion of the Advocate General, it must therefore be agreed that inventions relating to pluripotent stem cells can be patentable only if they are not obtained to the detriment of an embryo, be that it’s destruction or its modification.
To make an industrial application of an invention using embryonic stem cells would amount to using human embryos as a simple base material, which would be contrary to ethics and public policy.
Embryonic stem cells are cell lines, not embryos. They are derived using surplus in vitro fertilized eggs donated after fertility treatment and can be maintained indefinitely. As more than 100 established lines are now supplied through national and international cell banks, concern about commercialization of the human embryo is misplaced….
Scientists working in stem-cell medicine will not be able to deliver clinical benefits without the involvement of biological industry. But innovative companies must have patent protection as an incentive to become active in Europe. The advocate-general’s opinion therefore represents a blow to years of effort to derive biomedical applications from embryonic stem cells in areas such as drug development and cell-replacement therapy. If implemented, European discoveries could be translated into applications elsewhere, at a potential cost to the European citizen.
It is hard to ignore the fact that the debate regarding embryonic stem cell research is one that is a proxy for the abortion debate. Opponents of stem cell research talk about the potential for a human life to develop, but that is simply not true; it is factually incorrect. Where abortion is the ending of a human life to be, with stem cell research no one is talking about aborting an unborn child. The embryos that would be used are those created via in vitro fertilization and no longer needed, which means they will be discarded. So why in the world would anyone want to see an embryo destroyed for the sake of destruction but not used to allow researchers to attempt to find cures for horrible diseases? It just doesn’t make any sense, and to me is hardly taking the moral high-ground.
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About the Author
Gene Quinn is a US Patent Attorney, law professor and the founder of IPWatchdog.com. He is also a principal lecturer in the top patent bar review course in the nation, which helps aspiring patent attorneys and patent agents prepare themselves to pass the patent bar exam. Gene started the widely popular intellectual property website IPWatchdog.com in 1999, and since that time the site has had many millions of unique visitors. Gene has been quoted in the Wall Street Journal, the New York Times, the LA Times, USA Today, CNN Money, NPR and various other newspapers and magazines worldwide. He represents individuals, small businesses and start-up corporations. As an electrical engineer with a computer engineering focus his specialty is electronic and computer devices, Internet applications, software and business methods.