7.22 Gene patents

The debates surrounding patents become even more controversial when we look at the area of biotechnology and genetics. How are gene patents relevant to a course on law, the internet and society? Genetic research has turned animals and plants into information maps. As James Boyle so eloquently puts it in his book Shamans, Software and Spleens, we can now deal with DNA as ‘a language to be spoken, not an object to be contemplated.’ Genetic information is primarily thought of as information. It is therefore subject to processing via the internet and to the vagaries of intellectual property laws – laws governing copyrights, patents, design, trademarks and trade secrets. It was established in a 1980 US Supreme Court case, Diamond v Chakrabarty, 447 US 303 (1980), that patenting human DNA sequences is allowed. Could we be required in future to pay someone a licence fee just for using our own DNA? This is unlikely given the prevailing values in society but we do not know what the future holds.

In February 2000, a patent on a human gene was issued to Human Genome Sciences in Maryland. The patent means that no one else can do research on the gene without permission. The company says it makes the gene available to commercial companies at a price and academic researchers at no cost. The gene makes a protein that acts as a ‘receptor’ for a virus, i.e. the virus grabs this protein to enter a cell and begin infecting the host.

Some people repeatedly exposed to the HIV virus that causes AIDS do not develop the disease. In 1995, researchers discovered that the protein (called CCR5) that acts as the virus grabber was ‘defective’ or different in these people and would not allow the virus to take hold. In isolating the gene they also discovered that if the gene was defective it produced the defective protein. Human Genome Sciences had patented the gene in the mid-1980s, although at the time they did not know what the gene could do. They had therefore isolated and identified the gene before it was known to have a role in the progression of an AIDS infection. Once the patent was granted, if anyone wanted to do research with this gene, in order to develop an AIDS treatment, they would have to pay a licence fee for the privilege. It is possible that more than one licence will be required because there have been further applications for patents in processes to produce HIV-inhibiting drugs, based on the function of this CCR5 protein.

Let us suppose that a company has developed a drug which is considered by doctors to be the only treatment available to save the life of a particular AIDS patient. What would happen to the patient if the holders of the CCR5 or related patent obtained a court order to suspend the sale of the drug because they believed it infringed their patent? This is a worst case scenario, but a similar case was the subject of litigation in the US in relation to a cancer treatment (Johns Hopkins University et al. v CellPro, which ran through various courts from 1995 to 1998). In a more recent case a US biotech company, Myriad Genetics, threatened to sue Ontario province in Canada. The company holds patents on genes that can indicate a predisposition to develop breast cancer. The Organic Consumers Association has a web page with more information. There could be a lot of money involved, but you can see that it is a lot more important than money.

Note: The development of AIDS is much more complex than I have outlined above and the CCR5 receptor is just one of the ways in which HIV is thought to infect its victims. The human body is a hugely complex system, and attributing a direct cause-and-effect (e.g. susceptibility to HIV) process to a single gene is a vast oversimplification.

Further reading: Legal jargon warning – the following links are to legal documents outlining court decisions in important internet-related patent cases.

• State Street Bank v Signature Financial Group

• Amazon v Barnes & Noble (one-click patent) (Note in the Autumn of 2007, the US Patent and Trademark Office decided to throw out Amazon's one-click patent following a challenge by Peter Calveley.)

• BT v Prodigy (hypertext linking patent)

• Rambus v Infineon

• Merc Exchange v eBay – A judge in August 2003 ordered eBay to pay $29.5 million in damages for patent infringement. The case was appealed and heard by the US Supreme Court in 2006, which ruled against Merc Exchange's request to issue an injunction preventing eBay using, for example, the electronic button at the heart of part of the dispute. It went back to a lower court which also refused the injunction in July 2007.

• In August 2003, Eolas Technologies won a patent infringement case against Microsoft. A jury awarded Eolas and joint plaintiff the University of California $520 million. Microsoft appealed through the courts and the Patent Office. After various developments in the Patent Office and bouncing up and down through the courts, in 2007 a US Supreme Court decision weakened the Eolas case somewhat and the two parties then settled out of court by August 2007, with confidentiality agreements keeping the details hidden. The patent in this dispute goes to the heart of how the Web operates and it is as yet unclear what the longer-term implications of this case might be. The True Believer and Will browser verdict snare others? provide more details.