Tech Tourist 2.0

The battle to Patent Genes in America

It costs $1000 in Canada for a woman to find out if she has a gene associated with an increased risk for breast cancer. The same test costs $3000 in the United States.

The identity of the genes in question (BRCA1 and BRCA2) was patented in the US and only the lab that holds that patent was allowed to perform this test. They chose to charge $3000 because there was no one else in America could legally perform the test. In Canada, patents are not allowed on genes, and so any lab capable of doing so can perform the test. 

In a recent decision, the US courts have decided that genes can no longer be patented there either. If subsequent challenges to this decision fail, then this completely changes the economics of genetic discovery. This was reported by the New York Times on March 30, 2010 (REF: http://www.nytimes.com/2010/03/31/nyregion/31about.html).

While it is important to allow a path to make money from medical research if private firms are to be involved, it seems that both the Canadian standard, and the US decision are the right decision. Patents are not allowed on facts and laws of nature, such as prime numbers and elements on the period table. Until that changes, it is clear that the function of a gene is just another fact, and not an invention or process. Only inventions and processes can be patented.

This will change the economic incentive to use bioinformatic methods to do genetic research. But it will not prevent it or even discourage it; it will just shift the methods of monetizing the discovery to other areas such as tools and methods. Besides, the discovery process may soon become trivial and not worthy of assigning immensely valuable patent protection.

See also, The Economist.

Datamining in our Bioinformatic Future

The latest research suggests that we really need to look at an individual person's entire genome and the context of the specific individual to understand if they face a problem due to a new genetic defect. That is partly because just 60 out of 3 billion genes typically mutate from one generation to the next (0.00002%). Also problems can result from complex combinations of factors including heredity, mutations, environment, and nurture. (REF: San Jose Mercury News, March 10, 2010).

About a decade ago, the first human genome was decoded for about $500 million. And that was a brilliant accomplishment. Today, an individual person's genome can be decoded for $25,000. That is just on the edge of being economically useful to treat serious disease in a few people in rich countries. At this rate of development, it seems reasonable that it might soon be economically viable for large numbers of people to have their genomes decoded. The first people for whom this will make sense will be people who are sick. Later it will make sense for preventative purposes; in other words, to understand what risks exist for future disease.  Within a few years, it may cost $5,000 to decode a genome, and hundreds of thousands of wealthy and curious individuals may choose to have this done. By 2020 or 2030, costs may reach $500 to $1000, and it may become routine for individuals to have their full genome decoded. To put this in perspective, today a routine set of blood and urine tests can cost more than $1,000 in the US.

Today's $25,000 genome sequence can be produced by Complete Genomics of Mountain View, California. As reported by the New York Times (March 11, 2010), "Clifford Reid, the chief executive, said that the company was scaling up to sequence 500 genomes a month and that for large projects the price per genome would soon drop below $10,000. “We are on our way to the $5,000 genome,” he said."

The really explosive benefits, may result from combining this vast amount of genetic information into a single common database. If hundreds of thousands of genomes were available in a database, along with health histories and profiles of their associated people, then vast numbers of discoveries could be generated using existing statistical data mining techniques. We would be able to understand rare, but complex multi-gene interactions, and probabilities by looking at the genes of large numbers of cases of healthy and unhealthy individuals. The complex genetic profiles of diseases that affect just one in a thousand people could become clear.  With millions of genomes, even extremely rare diseases might become predictable or well understood. We would essentially discover and be able to predict diseases we did not even know existed.  Those with genomes in the database could even be alerted pro-actively throughout their life as new risks are discovered.  Others could benefit from the process without contributing their genomes to the discovery process.

From a legal and policy perspective, it is very important to enshine protections for individuals so that they can freely contribute their personal information to this discovery process without harming themselves. Otherwise, a great social benefit will be lost. It is important that individuals can remain anonymous. But recognizing that the data could be reverse engineered to identify an individual, it is important that laws prevent people being discriminated against on the basis of their genetic profile. This will be important in a wide range of areas, not just in the more obvious cases of health insurance policies, employment, immigration, and financial contracts.