Gene patenting the race and the debate continue

Long before the race to sequence the human genome began, there were strong divisions among the scientific community over the patenting of sequence information.

By Editor on Feb 1, 2001

Long before the race to sequence the human genome began, there were strong divisions among the scientific community over the patenting of sequence information. And in the wake of the Human Genome Project, the race to the patent office has intensified and the debate over the validity of gene patents has become an increasingly heated one that is now being conducted in a much more public forum.

The stakes are high. Gene patenting has become a multi-million dollar business, pitting publicly funded researchers against their industry counterparts over where to draw the line on ownership rights. And adding to the confusion and controversy is a lack of international agreement on what types of gene patent claims will be approved, threatening to create a transatlantic divide on the issue.

There is an attempt by some people to use sleazy arguments in filing patents on genes, Sir Robert May, former Chief Science Officer to the U.K. government and current President of the U.K. Royal Society, told the World Economic Forum. May voiced concern that many patents fail to show utility by claiming that because one piece of a gene looks like another, it might have a similar function.

Richard Klausner, Director of the U.S. National Cancer Institute, echoed May's concerns about whether patent seekers are properly demonstrating use. The U.S. Patent and Trademark Office has moved a long way, but there is still too much ambiguity about demonstration of utility, he said.

The USPTO judges all patent applications on four criteria consistent across all fields of science and technology. The invention must be:


  • useful, meaning that the inventor must identify some useful application for the invention;
  • novel, meaning that the invention was not previously known or used before filing for a patent;
  • non-obvious, meaning that it is not an improvement that could be deduced directly from common prior knowledge; and
  • adequately described in sufficient detail to enable one skilled in the field to use it for its stated purpose (sometimes referred to as enablement).

As part of the guideline revision process, the USPTO requested comments from the public. According to the revised guidelines published in the Federal Register (Vol. 66, No. 4, pg. 1092), the agency received written comments from 35 individuals and 17 organizations.

Many of the public's comments dealt with the utility aspect of gene patents. An excerpt from the revised guidelines reads: Comment: Several comments stated that DNA should be considered unpatentable because a DNA sequence by itself has little utility. Response: A DNA sequence i.e. the sequence of base pairs making up a DNA molecule is simply one of the properties of a DNA molecule. Like any descriptive property, a DNA sequence itself is not patentable. A purified DNA molecule isolated from its natural environment, on the other hand, is a chemical compound and is patentable if all the statutory requirements are met. An isolated and purified DNA molecule may meet the statutory utility requirement if, e.g., it can be used to produce a useful protein or it hybridizes near and serves as a marker for a disease gene.

That's welcome news to companies like Human Genome Sciences (HGS) and Incyte Genomics whose bread and butter relies on gene patents. HGS currently holds 162 patents on human genes, while Incyte has more than 400 and another 6,500 applications pending approval.

William Haseltine, Chairman and CEO of HGS, believes that there has been a surge of public confusion and anxiety over gene patenting. In a statement published in Technology Review late last year, Haseltine said: The genes's being patented are not the genes in people's bodies, much less the aggregation of all genes. Rather, genes,'s as we in genomics understand them, are isolated DNA sequences and the proteins expressed by those sequences individual genes removed from the natural context of the human body and rendered useful by crafting them in specific ways for medical use. These genes are artifacts made by the hand of man, and as such, they are subject to patents.

However, critics contend that biotech companies are patenting everything they can get their hands on, whether the sequence is associated with a known gene function or not, speculating that if they can patent enough DNA sequences, at least some will lead to new drugs. And many legal experts worry that patent stacking, a number of overlapping patents on the same fragment of DNA sequence, may cause drug companies to shy away from working on a particular gene due to multiple licensing costs owed to all patent owners on a given sequence.

There are nearly as many differing opinions and concerns on both sides of the issue as there are human genes, and it's likely that the validity of gene patents will ultimately be decided case by case in courts of law. But one thing is clear, the gene patent race is far from over and the debate has only just begun.