Who Will Cash In On Cloning?

Farms full of high-yield, milk-producing cows. Pigs providing organs perfect for human transplants. Bulls bred to help make cancer-fighting drugs. Oh, and carbon copies of your dear, departed cats and dogs.

That's the vision of companies in the business of cloning, as they grapple with a technology that still seems like science fiction but is gradually drawing closer to reality — and which could, in theory, prove highly lucrative.

Those riches loom because the potential uses for cloning cover a broad range of applications: "Cows are a walking bio-factory," says Peter Steineman, a spokesman for Wisconsin-based Infigen, Inc., which has cloned dozens of the animals.

U.S. firms that have already begun cloning animals have a lengthening list of products they're exploring, from food to organ transplants, blood-clotting medicines, cosmetic substances like collagen and more.

Cloning Products: An Interactive Look

But before cloning becomes, well, a cash cow, the major cloning firms in the U.S. must iron out a variety of political, legal and scientific problems, any of which could still help put the industry out to pasture.

For starters, the cloning industry is waiting for a government ruling defining the legal uses of clones. Additionally, three companies are embroiled in a patent dispute over a basic technique used to produce copies of animals. And then there are the ongoing practical problems with cloning, which mean that only a small fraction of cloning attempts are successful.

All told, cloning is an industry that could be going through a lengthy gestation period.

"It's hard to predict when those products are going to come," says Dr. Mark Westhusin, a professor a Texas A&M's veterinary school and a co-founder of Genetic Savings & Clone, a Texas-based firm planning to sell clones of pets to people. "It's still almost really early in the research phase, so there's no income coming from cloning yet."

FDA Approval?

To be sure, some products from cloned animals are already here. For instance, Infigen's cloned cows produce milk every day. But it's not available commercially, because the Food and Drug Administration has yet to issue a comprehensive report assessing whether or not consumer products deriving from cloned animals are safe.

Essentially, the core question facing the FDA is whether the cloned animals should be regarded as genetically engineered, and subject to FDA regulation, or whether the process should be treated like in-vitro fertilization, which is not FDA-regulated.

For its part, the FDA is waiting for a study on the subject from the National Academy of Sciences. An agency official familiar with the subject expects that to come in late spring, followed by months of FDA reviews, field interviews and discussions about the academy's conslusions. A report could emerge around the end of 2002, but the agency is trying not to tip its hand about its conclusions.

"There is a full range of options still there," says the FDA official.

Industry executives acknowledge the waiting period is necessary, but are eagerly anticipating the report's arrival.

"The uncertainty as to how the FDA may decide this is clearly a cloud over the business," says Ron Gillespie, a vice president of Cyagra, a cow-cloning subsidiary of Advanced Cell Technology (ACT) in Worcester, Mass. "Why would you want to put $20,000 into a car you may not be able to drive a year from now?"

Adds Westhusin, "It makes it difficult in terms of raising venture capital … investors are not going to put money into something if they think the FDA won't let a cloned cow be milked."

The U.S. Senate will also debate a bill in May banning human cloning but allowing the cloning of human embryos for research purposes.

Unique Way to Make Countless Copies

Still, one sign of the commercial promise of cloning is the fight over a piece of paper sitting in the U.S. Patent and Trademark Office in Washington. That would be patent number 5,945,577, which gives ACT the right to a particular way of making clones, based on the "nuclear" transfer technique.

There are a variety of ways to attempt to make clones, but this method — which involves removing the nucleus from an egg and inserting the nucleus of an adult cell, usually from the ear of a cow, for instance — is apparently worth contesting.

Cloning: Complete Coverage

Two other U.S. firms — Infigen and Geron, of Palo Alto, Calif. — say they were the first to devise the technique and should hold the patent. Both have filed an "interference" with the patent office, seeking to have ACT's patent overturned.

Geron's claim to the patent stems from the world's best-known cloned animal, Dolly the sheep, unveiled in 1996 by Scotland's Roslin Institute, which Geron took over in 1999. Infigen's first cloned animal was Gene the cow, born in 1997, while ACT's first clones — cows George and Charlie — greeted the world in 1998.

Dolly is universally recognized as the first cloned animal. But in the United States, patents don't go to the first company to create a product, or the first to file paperwork. They go to the company that can show it had begun work on the project first, leaving this case murky until the patent office conducts a further examination of the evidence.

How Well Does Cloning Work?

The financial upshot of the patent decision is that the company owning the rights to the method would then be able to license the process to other cloning firms.

Those rights could certainly be lucrative, especially if the nuclear transfer technique covered by patent number 5,945,577 remains the dominant cloning process. But scientists continue to search for new techniques, some of which could fall outside the scope of the patent — or might engender new patent disputes.

And for the cloning firms lacking the patent, the real money may not lie in selling animals in bulk quantities, but the genetic material belonging to top-of-the-breed individuals.

"Whether you're selling the clone is less of an issue than being able to sell the clone's semen, or clones embryos," says Gillespie.

Still, cloning firms can (and do) produce revenue by charging customers for each animal they produce. Cyagra, for instance, currently charges $19,950 for a clone, although you get a $10,000 refund if the process fails to produce an animal.

And that's still the likely outcome, since 100 nuclear transfers of cell materials tend to yield two live births. Moreover, scientists have raised serious questions in the last year about the health of cloned animals, many of which turn out to be overweight.

Additionally, recent cloning attempts with monkeys have fared poorly, while many scientists doubt the claims of Italian fertility specialist Severino Antinori, who said this year that a woman under his supervision is pregnant with her own clone.

Affordable Clones for All?

Nonetheless, in the area of livestock, one clone has been sold for as much as $100,000, with many others going in the $20,000-$25,000 range. If scientists are able to produce animals more efficiently, that price range will go down.

"I think it's going to be like other technologies — calculators or computers," says Westhusin. "The first ones are going to be very expensive and specific." But he adds: "As the price drops, I think there will be more people interested."

Adds Gillespie, "It becomes an issue of how many animals there are at different price points. If you get it down to $3,000 or $5,000 then you're in a whole different arena, then you have a lot of people [interested in buying clones]."

At those prices, a significant portion of the nation's estimated 60 million pet owners may yet want to buy clones to replace those departed cats and dogs.

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