<nettime> "HuMouse" to Put Limits on BIO-IPR

[Soenke Zehle <soenke.zehle@web.de>]

This sure is a nice piece of IPR-activism, I think. Also check Rifkin's
other project (Treaty of the Genetic Commons) at
http://www.foet.org/Treaty.htm
Soenke

Patently Provoking a Debate
Los Angeles Times, 12 May 2002
(via http://http://pqasb.pqarchiver.com/latimes)

Two friends seek rights to a theoretical human-mouse, thought up to
force limits on patenting human life.

By AARON ZITNER, Times Staff Writer

WASHINGTON -- Nearly 10 years ago, a friend called Stuart Newman with an
intriguing challenge: Could he think up a new form of life that would be
scientifically useful and possible to patent--yet so disturbing that the
public would recoil?

And so Newman, a New York medical school professor, proposed a "humouse",
a part-human, part-mouse creature that could be made with existing lab
techniques and would help companies test for the toxic effects of new drugs.
He even typed up a fake press release claiming a trademark for the
"humouse" name.

Newman's proposal was far more than a whimsical exercise. Today, the U.S.
Patent and Trademark Office is in the final stages of deciding whether he
can patent his idea. Win or lose, the result could be exactly what the
humouse was designed to accomplish: prodding Congress and the courts to
place new limits on manipulating and patenting human life.

For the patent office, the humouse raises some awkward issues. For 22 years,
the office has granted patents on a wide array of living organisms and
elements of life. Human genes have been patented. So have human cells.
Patents have gone to animals made with bits of human DNA so scientists
can study cancer and other diseases.

But the patent office has drawn a line at claims on human embryos and human
beings themselves, saying that Congress, which writes the patent laws,
excluded them from the range of things that can be patented. Although
Congress has never spoken directly on the subject, the patent office says
it infers the ban on these patents from such doctrines as the 13th
Amendment ban of slavery.

Some patent experts doubt that this stance is legally sound. Now the humouse
is forcing the patent office to defend its position. And in five years of
sparring over Newman's application, the office appears to concede that it
has little or no legal authority to stop what would clearly be a
controversial development: the patenting of human embryos.

The case will probably wind up in the courts, which could decide whether
patent rights to human life--and to new methods of making human life --
can be owned and controlled by private hands.

Novel Plan for Raising Moral Objections

Newman has never made a humouse and says he probably never would. In fact,
he and his patent partner, technology critic Jeremy Rifkin, have deep moral
objections to manipulating human life and oppose patenting any living
organisms. They believe that federal law does not sufficiently limit
scientific work with human embryos and human life, and their humouse is
intended to change just that.

Patent law does not require them to make a humouse, but they must show it
can be done. Newman says he could take an embryo from one species, either
man or mouse, and inject it with embryonic cells from the other species. The
result would be an animal with cells from both species scattered throughout
and working cooperatively. A similar technique was used in the early 1980s
to make a sheep-goat hybrid, dubbed a "geep," though no one is known to have
tried a similar cross-species mix with humans.

"There really is no boundary on what you can do with human life. There's no
natural stopping point," Newman said. "That troubles me. I think it will
ultimately lead to genetically engineered human beings made for sale."

Making the humouse would be legal under federal law, as long as no taxpayer
money was used and certain administrative rules were followed.

By asking for a patent on the very thing they find unethical, Newman and
Rifkin believe they will provoke tighter limits on what can be made and
patented. If the patent office awards them a patent on something widely
considered monstrous, Congress could be pressured to draw new laws on
patenting life. And if the office rejects their patent, Newman and Rifkin
would gain standing to appeal in the federal courts.

They are happy to go to court. A judge's denial of a humouse patent would
probably bar patents on all human-animal hybrids and possibly on human
embryos. And even if they win a patent in court, they expect a public outcry
that also could force Congress to act.

So far, patent examiners have denied the humouse patent on grounds that it
"embraces a human being" and human beings cannot be patented. But how,
Newman and Rifkin ask, does the patent office know that a human-animal
combination is human?

"This is the first test of what constitutes a human being in the age of
biotechnology," Rifkin said. "When we can engineer life, answering these
questions becomes an angst-laden struggle."

Experts See Important Implications

Patent experts say the humouse case could be important for three reasons.

First, no court has ruled on whether human embryos can be patented, or
whether a mix of human and animal material remains, in a legal sense, human.
This lack of legal clarity is becoming more important as scientists push to
understand embryos and the medically promising stem cells that grow inside
them.

A Massachusetts company, Advanced Cell Technology Inc., is trying to produce
and patent human stem cells made by merging human DNA with cow eggs,
creating a human-cow embryo. A Chinese scientist is working with
human-rabbit combinations. Cow and rabbit eggs are far cheaper than human
eggs, and producing stem cells with them could prove more inexpensive and
efficient.

Second, the patent office has allowed thousands of claims on genes, cells
and animals over the last two decades. By raising the question of what can
be patented, Newman and Rifkin hope to undermine some of those patents.

Finally, the patent dispute is part of a political struggle to define the
legal and moral status of the human embryo. President Bush has barred
Federal funding for experiments that destroy embryos for their stem cells,
and he has devoted two speeches to arguing that embryo destruction is
unethical in research. Within weeks, the Senate is expected to vote on
whether it should be legal to create human embryos through cloning.

Still, cloning and stem cell research are legal today. Congress has not said
embryos are so privileged that they deserve protection from privately funded
researchers.

Yet the patent office argues that human embryos are equivalent to human
beings, which puts them beyond the reach of patent claims. "No question,
they're in a very strange status," said George Annas, a bioethicist at
Boston University. "They're not the same as mouse embryos, but we haven't
really decided how different they are."

"There is tremendous symbolism here," said R. Alta Charo, professor of law
and medical ethics at the University of Wisconsin Law School. "Patents
stand for the idea that somebody invented something. For those who are
religious, it smacks of hubris to say that human beings were invented.
They were invented by God."

1980 Case Allows Patents for Organisms

At one time, the patent office believed living organisms could not be
patented. That put the office in accord with people such as Newman, a
developmental biologist at New York Medical College in Valhalla, N.Y. He
believes that patents on life are an "incursion of private property and
private ownership into the realm of nature, into what should be common
property."

But the patent office was forced to change its policy in 1980 after it
turned down a patent application from General Electric for a bacterium that
had been genetically engineered to "eat" oil spills.

General Electric appealed to the Supreme Court, in a case called Diamond vs.
Chakrabarty. Only one "friend of the court" brief was filed arguing that
life should not be patented. It was written by Jeremy Rifkin and his
colleagues.

The Supreme Court, however, said in a 5-4 ruling that Congress had
authorized patents on "anything under the sun that is made by man." And
because the GE microorganism was man-made and not naturally occurring,
the court ruled that it qualified for a patent.

It was the first Supreme Court ruling to endorse patents on living
organisms. Eventually, the patent office began issuing patents on a barnyard
of more complex animals -- genetically engineered mice, pigs and cows.
Rifkin thought this went far beyond the authority laid out by the court.

"I wanted to revisit the question of what is legally patentable and what
is not," said Rifkin, president of the Foundation on Economic Trends in
Washington. "But you can't bring litigation against the patent office. They
have utter discretion, and you can't challenge them from the outside. The
only way to be a player is to apply for a patent."

And so Rifkin called Newman to ask what invention might make their case
best -- and bring as much publicity as possible along the way.

After considering the humouse, Newman and Rifkin later broadened their idea
to include human combinations with chimpanzees, baboons and other animals.
They filed a patent application in 1997, with Newman as inventor and
Rifkin as a co-owner.

Patent Office Explains Basis for Rejection

In 1999, two years after receiving the humouse application, the patent
office issued a preliminary rejection. Patent examiner Deborah Crouch said
the human-animal hybrid "embraces a human being"--and so did not qualify
for a patent.

When Newman and Rifkin pressed the office to identify a law that bars human
embryo patents, a second examiner, Deborah Clark, wrote that patents on
embryos and human beings would clash with the 13th Amendment's ban on
slavery.

A patent is good for 20 years and allows the holder to prevent anyone else
from using an invention. Because of this, Clark wrote, "the patented human
being could conceivably be excluded by the patentee from 'using' himself,
i.e. self-employment, an absurdity that reinforces the conclusion that
Congress did not intend to allow patenting of human beings."

In addition, a patent conveys the right to bar anyone else from making the
patented invention. If that invention were a human being or viable embryo,
Clark argued, the patent holder could stop that person from copying
himself -- in other words, from reproducing.

Some patent lawyers question these arguments. Roe vs. Wade, after all, holds
that embryos at their earliest stages are not constitutionally protected as
human beings, suggesting that the patent office should not equate embryos
with people. And the 13th Amendment argument is "just nonsense," Charo said,
because a person, once born, has all the rights of citizenship, including
the right to a work life free of patent restrictions.

But even if the patent office had the power to bar patents on human embryos,
Newman and Rifkin said in written responses, how did the office classify a
human-animal hybrid as human?

Clark pointed to the hypothetical case of a person who received a pig heart.
This would mix two species, but the result was clearly human, she said.

But Rifkin and Newman argue that their creatures, composed of cells from two
species scattered throughout, are wholly different from a human.

In the patent office's most recent rejection notice, in August 2000, Clark
included a passage that Rifkin, Newman and others took as a clear indication
that the office has no authority to reject claims on human embryos.

Congress has not spoken directly to embryo patents, and neither has the
Supreme Court, the patent examiner wrote. "In the absence of clear
legislative intent and guidance from the courts," she added, "it is
incumbent on the office to proceed cautiously."

"She's conceding that they don't have explicit authority to reject this
application as 'embracing a human being,'" said Patrick Coyne, the lawyer
for Newman and Rifkin. But the office is rejecting the application anyway
"so the issue can be decided in court," he said. "To just give it to us
would open the floodgates to these kinds of patents." The patent office
would not comment.

Patent examiners told Newman and Rifkin to expect a final rejection of their
application more than a year ago, but instead the office sent it to a
"quality review" process, which usually take two weeks.

Rejection Could Preclude New Products

For the biotechnology industry, the humouse case is serious business.
Without strong patent protections, the industry says, investors will not
risk money to develop new products. And Rifkin and Newman aim to narrow
the scope of what elements of life can be patented.

Rifkin and Newman claim that denying their patent throws many existing
patents into question. They ask how the patent office can reject a
mouse-animal hybrid because of its human qualities while not also rejecting
all-human stem cells, which come from embryos and can grow into any part of
the body.

One of the most sensitive questions is whether patents can cover human
embryos that have been engineered to carry certain traits. Although the
Biotechnology Industry Assn. says it does not support the patenting of human
embryos, pressure may grow from individual biotech companies.

"If you had a system where the embryo could be used to generate cells for
therapeutic use, then there could be a compelling reason to want a patent,"
said Elizabeth Howard, a patent lawyer in Palo Alto with the firm Orrick,
Herrington & Sutcliffe.

In particular, Howard said, scientists will try to modify human embryos to
produce stem cells that can be transplanted into patients without resulting
in tissue rejection, a common problem in transplants today.

Scientists say they also want to create human embryos to study disease. Many
people carry genes that raise their risk of breast cancer, colon cancer,
Alzheimer's disease and other ailments. Through cloning, scientists could
take a cell from one of these people and use it to create an embryo that
also would have the disease genes. Stem cells from that embryo could offer
clues to mechanisms of the disease.

Some scientists consider this work so promising that they have cited it in
asking Congress not to outlaw human cloning in medical research.

But some people fear that researchers will not only want to make embryos and
stem cells this way but also patent them. With so many disease genes to
study, companies could eventually ask for separate patents on each type of
embryo they created. Companies already patent and sell mice, rats and other
animals that have been engineered to model various human diseases.

Opponents of human cloning, in fact, have run radio advertisements that play
up the prospect of embryo patents, in an attempt to persuade the Senate to
outlaw the technique.

"It hearkens back to slavery," said Douglas Johnson, legislative director of
the National Right to Life Council, which sponsored the ads. "You would have
biotechnology companies owning a class of members of the species Homo
sapiens and selling them because of particular genetic traits that are
deemed useful in drug testing or experimentation."

Ultimately, Congress may have to decide what life forms are proper material
for patenting. The Supreme Court invited such an action in its Chakrabarty
ruling 22 years ago, noting that lawmakers "may choose to craft a statute
specifically designed for such living things."

"Both the majority and minority probably thought Congress would have to say
something after that decision, but Congress hasn't said a thing," said
Annas, the Boston University bioethicist. "It's Congress' job to say what
the limits are of patent law, and it's time for Congress to do that."

But resolving the question would require a compromise between lawmakers who
consider embryos equivalent to humans and those who hope to use them to make
stem cells and tissues for patients.

"We as a society are ambivalent about the moral status of the embryo," said
Arthur L. Caplan, a bioethicist at the University of Pennsylvania. "That's
why this has been going on for a long time, and why no one wants to try to
sort it out."

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