Washington

The first patents on the technology used to clone Dolly the sheep were issued last week, three years after its inventors published news of Dolly's birth (see Nature 385, 810–813; 1997).

The two British patents, issued on 19 January to the Roslin Institute and the two government agencies that supported its work, cover a broad variety of applications of the cloning technology, but exclude human reproductive cloning. In all, the patents cover 58 claims to methods of producing cloned non-human animals, human cell lines and early human embryos, and to the animals, embryos and cell lines produced in this way.

Other patents have already been issued for cloning technology that differs from the Roslin method, but covering only animals. The Roslin patents cover the cloning and growth of a human embryo to the level of the blastocyst, an early embryonic stage.

Separately, the US Patent and Trademark Office has issued a notice of allowance for a patent application on Roslin's cloning technology, also called nuclear-transfer technology. A US patent on the technology is therefore likely to be issued within months.

The US patent is limited to techniques for cloning non-human mammals, but the inventors are expected to follow this up with an application encompassing human uses.

“This is the first time anyone has had a patent issue on a nuclear-transfer technology that would cover its use in human cells,” says David Earp, vice-president of intellectual property at Geron Corporation of Menlo Park, California. He says this puts his company in a “dominant position”.

Geron, which last year acquired Roslin Bio-Med, a company set up by the Roslin Institute to develop its cloning technology (see Nature 399, 92; 1999), holds an exclusive licence on the Roslin patents and underlying technology, with one exception — PPL Therapeutics Ltd holds a licence to use the technology to produce certain human proteins in the milk of ruminants and rabbits.

Geron hopes to combine the cloning and stem-cell technologies to develop therapies for a range of diseases from diabetes to Parkinson's disease.

The idea is to use nuclear-transfer technology to produce a genetically identical embryonic stem cell from a patient's own cell, then to cause the cell to differentiate into the kind needed for therapy — pancreatic cells in diabetes, for instance, or dopamine-producing neurons in Parkinson's disease. The potential therapeutic applications leave Earp “excited”. “There are huge medical advances at our fingertips,” he says.

Trouble ahead? Protestors have criticized the issuing of patents for cloning technology. Credit: MAFF/PA

The patents were criticized last week from various sides. “Organizations, including charities, may not have the money to pay to use this patent technology,” Vivienne Nathanson, head of science and ethics at the British Medical Association, told BBC Television. “So this could inhibit medical research.”

“It's going to break the health-care system,” adds Jeremy Rifkin, who heads the Washington-based Foundation on Economic Trends. “If Geron and Roslin can get a lock on stem cells and [cloned] embryonic cells, they then have total control over future medical developments in this area of research.”

Rifkin says he is distressed by the UK patent office's “chilling” and “unconscionable” decision to grant a patent on the earliest form of human life. He argues that patents should pertain only to inventions, not to naturally existing entities, such as humans. The decision, he says, is “an absolutely transparent violation of the patent statutes in virtually every country. This is something my attorneys are going to move on immediately with formal legal protests in the UK.”

But Arthur Caplan, director of bioethics at the University of Pennsylvania, says Roslin has rightfully won the patents. “They've got the products and the uses as well as the technique.” He adds: “It's time to shift the issue to a discussion of what responsible [patent] ownership is.”

Geron's Earp says the company has “absolutely no intention” of inhibiting medical research. “We want to openly encourage as many people as possible to do basic research” using cloning and stem-cell technologies.