Ethical Concerns Block Patents of Useful Embryonic Advances

Antonio Regelado and Meera Louis
The Wall Street Journal
August 20, 2001

As the science of cloning and embryonic stem cells advances at a breathtaking pace, universities and companies are seeking sweeping patent claims over the new technologies. In the US , patent applications in these two areas have jumped 300% in just the last year.

But ethical prohibitions embodied in patent law in the US and Europe are preventing scientists from securing patents on some pioneering biological inventions.

At issue in the US is the 13th Amendment to the Constitution, which abolished slavery. Patent documents show that the legal prohibition against owning humans has complicated efforts by Geron Corp. and closely held Advanced Cell Technology Inc. to patent medical uses of human cloning technology.

On the other side of the Atlantic, where mistrust of biotechnology runs deeper, the European Patent Office has put the whole field of embryonic stem cells on hold. Christian Gugerell, director of biotechnology at the European Patent Office, says his examiners are delaying issuing patents related to embryonic stem cells until an ethics committee established by the European Commission issues recommendations on topics that include the definition of a human.

Patent records indicate that a cat-and-mouse game has emerged between scientists and patent examiners. Scientists want to make the broadest claims they can. Patent offices want to restrict them. So, top cloning groups have filed strings of applications to probe for loopholes that would allow them to protect some useful aspects of human cloning, in particular "therapeutic cloning" of embryos. With therapeutic cloning, scientists hope to create an embryo-stage clone of a living patient, harvest its stem cells and transplant them back into the patient.

These applications are testing legal limits and setting the stage for what many expect will be an eventual legal challenge to allow patents to cover human reproductive cloning as well. Todd Dickinson, who was commissioner of the US Patent and Trademark Office during the Clinton administration, and is now a lawyer in private practice, believes the "no-humans" rule could end up in the courts. "There are going to be some very important inventions that will test the limitations of this principle," he says. But having a patent on an invention doesn't mean it can be used. Congress is currently considering legislation to ban all forms of human cloning in the U.S.

In the meantime, patent offices are receiving applications on cloning technology that cover its use in all animals. That was the case with the initial application filed by the Roslin Institute in Scotland and scientist Ian Wilmut, who created Dolly the sheep. Since humans are animals, the US Patent Office rebuffed the application, saying: "It is patent office policy not to allow claims to humans." The patent was issued once the disclaimer "non-human" was inserted.

Since lawyers always draft claims as broadly as possible, the intent in such cases is often ambiguous. But in other instances, like an application from Tufts University pending in Europe, the patent clearly states its intention of covering the creation of cloned people. "It's something to think about very hard before you go in with a claim in that area," says Nick Bassil, the attorney for the Roslin Institute. "If you do file a patent application, you are nailing your colors to the mast." Due to an oddity of British law, Roslin did win a patent on cloned human embryos up to 14 days old, but it is valid only in the U.K.

A review of Patent Office documents shows how companies such as Advanced Cell Technology, of Worcester, Mass., have tried to finesse the US Patent Office stance. The company is developing a strong intellectual property on cloning based on patents licensed from the University of Massachusetts. Its chief executive, Michael West, has said he intends to begin creating cloned human embryos for therapeutic purposes at any time.

But the company's initial patent application, filed January 10, 1997, had some problems--including a description of harvesting transplant tissues from cloned "embryos, fetuses or offspring, including human." A spokesman for the Patent Office says the agency not only forbids patents on human beings, but also on any method for making them. The reason is that the owner of a patented "process" can prevent anyone else from importing products made using the technique. With cloning, that could lead to human clones born overseas being legally denied entry into the U.S.

After examiners rejected its claims, Advanced Cell's lawyer, Robin Teskin of Pillsbury Winthrop, McLean, Va., found a way to tweak the patent's language to protect the therapeutic cloning process. In a patent approved last May, No. 6,235,970, rights are given to stem cells taken from cloned embryos, not the embryos themselves.

Such a patent may never be allowed in Europe, where a 1998 directive on biotechnology inventions from the European Parliament outlawed patenting of processes for cloning humans and modifying the genetics of the human species, as well as any commercial uses of embryos.

According to Greenpeace Germany, such patent applications are piling up anyway, with 56 filed just in 2000. The list was compiled in part by Christoph Then, a former veterinarian who since 1992 has crusaded against all patents on life forms, which he calls "against ethical borders and the history of European culture." One he has been fighting: A patent granted to the University of Edinburgh and the Australian company Stem Cell Sciences Pty. Ltd. for the genetic engineering of animals that had no "non-human" disclaimer.

German Greenpeace went public with the discovery in February 2000. Patent examiners conceded the error, and Stem Cell Sciences voluntarily proposed changes to the language of the patent. Still, Mr. Then has asked for the entire patent to be revoked.

"It caused a big stink," says Peter Mountford, chief executive of Stem Cell Sciences. "But from our perspective it was an oversight; we were happy to provide the reassurance that we are not at all interested in germ-line engineering of humans."

The situation is so novel that sometimes it's the scientists who are talking the patent offices out of questionable stances. For instance, when James Thomson of the University of Wisconsin filed an application to claim the human embryonic stem cell, the US Patent Office rejected his application twice. Its reasoning: Dr. Thomson had not shown his cells could truly form every type of human tissue, the key quality of such a stem cell.

But Dr. Thomson and his attorneys successfully appealed. They argued the only way to satisfy examiners' demands would be to insert stem cells into a living human embryo--and show they could grow to form part or all of an adult body. In effect, they argued, the examiners "would condition patent protection on evidence that the invention will work to create live recombinant humans."

The lawyers urged the appeals board to rethink the "ethical, moral, and legal" issues raised by "encouraging such experimentation." The Patent Office conceded the point, and issued the patent, number 6,200,806, last March.