European Patent Office Upholds Mouse Patent

In July the European Patent Office upheld Harvard University’s patent on a genetically altered mouse. The EPO did modify the patent so that it applied only to “transgenic mice” rather than the original language of the patent which covered “transgenic rodents.”

In a press release announcing the decision, the EPO said,

As a result of an appeal decision, European patent EP 0 169 672, better-known as the “Oncomouse” patent, has been further restricted.

In 1985 the President and Fellows of Harvard College, Cambridge, Massachusetts, USA, applied for a European patent entitled “Method for producing transgenic animals”. The patent was granted in May 1992 in respect of “non-human mammalian animals” for eleven member states of the European Patent Organisation.

Seventeen oppositions against the patent, filed in 1992 and 1993, led to the decision in November 2001 to maintain the patent in respect of “transgenic rodents”. Several appeals against that decision lodged in March 2003 were heard by the Technical Board of Appeal which decided to restrict the patent further to “transgenic mice”.

Greenpeace and a number of other organizations had filed the challenges, seeking to have the EPO overturn the validity of patenting animals altogether. Jan Creamer of Great Britain’s National Anti-Vivisection Society said of the ruling,

. . .patenting life should be wrong. You’re not producing a product that will make a difference.

Harvard University’s Philip Leder, who was one of the co-creator’s of the Oncomouse, disagreed, telling The Scientist,

This is the organism that has the greatest utility. I’m pleased to have the matter resolved.

Dupont, which holds the licensing rights to the mouse, has issued 170 licenses for academic research on the mouse. It charges licensing fees for commercial uses of the patented mouse.

Source:

EPO restricts OncoMouse patent. Paula Park, The Scientist, July 26, 2004.

Technical Board of Appeal restricts “Oncomouse” patent. Press Release, European Patent Office, July 6, 2004.

Europe upholds Harvard Mouse patent. Associated Press, July 7, 2004.

Biotech Company Creates Cattle that Express Human Proteins

Biotechnology firm Hematech this month reported that it has succeeded in creating genetically modified calves that carry human genes.

The company inserts the gene for human heavy and light chain antibody genes into bovine fetal fibroblast cells. This is accomplished by knocking out both copies of the bovine immunoglobulin gene to reduce the level of bovine antibodies circulating in the blood of the animals so that detectable levels of human antibodies remain.

Another problem the company will have to face is genetically engineering the animals to prevent the possibility of transmitting prion diseases such as Mad Cow’s. The company plans on creating genetically modified cattle that lack the genes necessary to produce prion proteins. Hematech CEO James Barton told InPharma.Com,

If live animals are produced form these embryos [lacking the genes necessary to produce prion proteins] they will be prion free and thus unable to contract mad cow disease. These animals will be ideal for the production of the company’s fully human polyclonal antibodies.

Details of Hematech’s research in knocking out the bovine immunoglobulin gene is scheduled to be published in Nature Genetics.

Source:

Cattle antibody production moves a step closer. InPharma.Com, June 3, 2004.

Mayo Clinic Researchers Observe Fusing of Human, Non-Human Cells in Living Body

The Mayo Clinic announced on January 8 that its genomics researchers demonstrated for the first time that human and non-human cells could naturally mix their genetic material in a living body. According to a press release from the Mayo Clinic announcing the discovery,

In the research reported today, Mayo Clinic investigators implanted human blood stem cells into fetal pigs. The pigs look and behave like normal pigs. But cellular analysis shows they have some human blood cells, as well as some cells that are hybrid — part human, part pig — in their blood, and in some of their organs. Molecular examination shows the hybrid cells have one nucleus with genetic materials from both the human and the pig. Importantly, the hybrid cells were found to have the porcine endogenous retrovirus, a distant cousin of HIV, and to be able to transmit that virus to uninfected human cells.

Jeffrey Platt, director of the Mayo Clinic Transplantation Biology Program, said the surprising results may help explain how some viruses can jump so quickly between humans and non-humans. In a press release statement, Platt said,

What we found was completely unexpected. This observation helps explain how a retrovirus can jump from one species to another — and that may speed discovery about the origin of diseases such as AIDS and SARS. The discovery may also help explain how cells in the circulation may become part of the solid tissue.

The Mayo Clinic findings will be published in March in the online Express edition of the Federation of American Societies for Experimental Biology Journal.

Source:

Mayo researchers observe genetic fusion of human, animal cells — may help explain origins of AIDS. Press Release, Mayo Clinic, January 8, 2004.

Singapore Researchers Working on Edible Zebrafish Vaccine

Researchers at the National University of Singapore reported in September that they had produced genetically modified zebrafish that produce a vaccine for Hepatitis B in their muscles. Such research could one day pave the way for a cheaply produced, edible vaccine.

Leader researcher and zebrafish Gong Zhiyan concedes that there are still many unknowns about using genetically modified animals like this to produce vaccines. Zhiyan told The BBC,

We haven’t reached the stage yet where we know how many fish you would have to eat for a correct dose of vaccine, but based on the high levels of the protein they produce, it shouldn’t be much.

In addition, the vaccine would have to survive the passage through the digestion system and into the human bloodstream in a usable way.

To that end, the next step in this line of research will be producing and feeding these vaccine-producing zebrafish to animals to see if they confer protection from Hepatitis B when eaten.

Sources:

Edible vaccines ‘could end jabs’. The BBC, September 15, 2003.

Chinese Researchers Claim Human/Rabbit Hybrid

Chinese researchers claimed in August to have created the first human/rabbit hybrid embryo.

The researcher was carried out at Shanghai Second Medical University and details about the research was published in Cell Research, a bimonthly peer reviewed journal of the Shanghai Institute of Cell Biology.

The researchers claim they fused skin cells from a number of human source with rabbit cells that had most of their rabbit DNA removed. According to the researchers, 400 of the hybrids grew into early embryos and more than 100 survived to become blastocysts.

There are many good reasons, however, to be skeptical that the researchers actually managed to create hybrid embryos.

According to a United Press International story, the report on this research had been submitted and rejected by several more reputable journals over the past two years. The study has been rejected for publication because both the draft and the version published in Cell Research omit data that would make it possible to confirm that the researchers actually resulted in embryonic cells.

And, as UPI tactfully puts it, “researchers in China have gained a reputation for making bold claims about cloning and stem cells that, all too often, prove false.”

Sources:

Scientists Doubt Chinese Claim of Rabbit-Human Clone. United Press International, August 15, 2003.

Cloning yields human-rabbit hybrid embryo. Rick Weiss, Washington Post, August 14, 2003.

PPL Therapeutics Plans to Cull Sheep

PPL Therapeutics, which in 1996 made world news with the cloning of Dolly the sheep, announced in July that a downturn in its fortunes would lead it to cull most of its flock of 3,000 genetically modified sheep.

PPL Therapeutics produced the first transgenic sheep in 1991. The sheep are genetically modified to express recombinant Alpha-1 Antitrypsin (AAT) in their milk. AAT was to be used to treat lung disorders, but in June drug company Bayer announced that it was ending its three year partnership with PPL Therapeutics on trials of AAT.

PPL Therapeutics does plan to keep some of the sheep for possible future breeding programs.

Source:

Thousands of sheep face cull after drugs trial shelved. Ananova, July 15, 2003.

Dolly firm to cull its sheep. The BBC, July 15, 2003.

Glow In the Dark Fish First of Many Future GM Pets

The first genetically modified pet has already gone on sale in Taiwan and will likely be on sale in the United States soon. The Night Pearl is a genetically modified zebrafish that glows in the dark.

The fish grew from research conducted by HJ Tsai of the National Taiwan University. Tsai simply wanted to make the organs of fish easier to observe, and solved that problem by inserting a jellyfish gene to make the organ glow. Instead, he ended up making the entire animal glow.

Fish produce company Taikong Corporation reached an agreement to fund Tsai’s research in exchange for the right to use his techniques. Now Taikong is marketing fish that glow red and green. As might be expected, this advancement is being greeted with wildly different views.

Some, such as Keith Davenport of the UK’s Ornamental Aquatic Trade Association is outraged. Davenport told The Observer,

This is the thin end of the wedge. You could put all sorts of different genes in animals and do all sorts of damage.

Among fish dealers in the United States, however, there is the obvious excitement that these fish will be big sellers. Nevin Bailey of AquariumFish.Net told The Chicago Tribune,

If they can actually do this, it will be the greatest thing since popped corn. There’s a lot of pent-up demand [for the glow in the dark fish] . . .My gosh, if they ever made one that was red, white and blue, every Marine in the country would buy one.

Well, at least until they look at the price tag. At a $17.40 suggested retail price for each fish.

Source:

‘Fluorescent fish’ give the green light to GM pets. Robin McKie, The Observer, June 15, 2003.

Bioengineered pet fish are a reality in Taiwan. Jason Dean, Dow Jones News Service, May 12, 2003.

Australia Looks to Genetically Engineered Virus to Stop Mouse Population Explosions

Australia has a regular problem with explosions in its mouse population that occur in roughly four year cycles. The number of mice quickly increases to billions and costs Australian agriculture upwards of US $90 million in crop damage.

The problem is so severe that Australian researchers are currently investigating an exotic solution to prevent such population explosions — a genetically modified virus that renders female mice sterile.

The virus is a modified form of he herpes virus that is spread by mouse-to-mouse contact. Once it infects a female mouse, it will prevent sperm from fertilizing eggs. Researchers at Australia’s Co-operative Control of Pest Animals has shown the modified virus works in the laboratory setting, and now wants to test the virus in the field.

That, however, will have to wait for extensive testing to ensure that the virus will not jump the species barrier and infect other animals besides mice. But Australia has experience with using such solutions. It used myomatosis disease 50 years ago to control the rabbit population, and in the 1990s used the calci virus to lower rabbit populations. The calci virus killed an estimated 90 percent of the country’s rabbit population, allowing some ecosystems that were overrun by the animals to begin to recover.

Sources:

Australia invents new mousetrap with herpes virus. Reuters, April 8, 2003.

NT Queens’s Birthday Honours. ABC Rural, October 6, 2002.

Nexia Biotechnologies to Work on Nerve Gas Antidote from Goat's Milk

Nexia Biotechnologies made headlines in 2002 when it announced it had created genetically modified goats that expressed a protein unique to spiders its milk. This month Nexia announced that it would work with the Canadian military to develop a genetically modified goat that would express a powerful nerve gas antitoxin in its milk.

Its research there will focus on production of a recombinant version of butyrycholinesterace (BChE). BChE is found in small quantities in the blood of many animals, and acts as a defense against nerve agents. It binds with the components of nerve agents and renders them harmless within the blood stream. Of course in a full-fledged nerve gas attack, this small amount of naturally occurring BChE is quickly overwhelmed.

Nexia will try to create a GM goat that produces BChE in large quantities that could then be prepared as an injection which military forces could use on the battlefield to better protect themselves against nerve agents such as sarin gas.

According to Nexia, studies in animals have shown that injections of relatively large amounts of BChE have protected lab animals from such agents, but the inability to produce large quantities of it has precluded BChE from applications in human beings.

Source:

Fighting Nerve Gas: Would Use Milk of Transgenic Animals. National Post, April 2, 2003.

Protexia? – A Bioscavenger. Nexia Biotechnologies, 2003.

SCID Gene Cure May Have Leukemia Side Effect

The first disease ever cured by gene therapy was severe combined immune disorder (SCID) — the so-called “bubble boy” disease in which the immune system is so severely compromised that children have to live in near-sterile environments to avoid life threatening disease. But now, there is new evidence that the cure for SCID may increase the risk of leukemia among children receiving it.

In 2002, one of the toddlers who received SCID gene therapy as a baby came down with leukemia, and officials in France and the United States temporarily stopped the procedure. Now, a three year old who received the treatment as an infant has also come down with leukemia. As a result, the United States has suspended all 27 existing gene therapy studies have been suspended pending new risk assessments.

The potential for this sort of leukemia problem accompanies all gene therapies that use retroviruses, but this is the first time where this hypothetical risk has become actual. According to an NPR report, both of the children involved are responding well to treatment for their leukemia.

Source:

Gene therapy causes “leukemia-like side effect”. Nando Times.