By Kevin Noonan
Recently, patenting human DNA has been the subject of questionable legislation and alarmist opinion pieces in the U.S. Meanwhile, a team of British researchers has assessed the past, present, and likely future of gene patenting worldwide, and has come to dramatically different conclusions.
The study, by members of the Science and Technology Policy Research faculty at the University of Sussex, England, confirm the impression that gene patenting has been more extensive in the U.S. than in Europe or Japan. The authors identified a total of 15,603 patent families claiming human DNA sequences during the time period from 1980 to 2003. Of these, 5,669 patent families have one or more patents granted worldwide, and 94% of these include at least one granted U.S. patent. In contrast, only 750 of the patent families contain a granted European patent, and 494 contain a granted Japanese patent.
Once granted, most of these gene patents are maintained worldwide (92% in the U.S; 96% in Europe), indicating their continuing value to assignees. In the U.S., however, these percentages decrease as the patents mature, with only 70% of patents granted in the early 1990's being maintained in 2005 (i.e., at the third, and most expensive, maintenance fee payment).
In Europe, grant rates are actually decreasing: 45% of human gene patents filed in the 1980's were eventually granted (meaning that 55% of these patents were not granted in Europe). The grant rate fell to 8% for applications filed between 1996-2000, which may increase somewhat since some of these patent applications are pending. However, 44% of these 1996-200 vintage gene patents have been withdrawn or lapsed during pendency in Europe, a reflection of cost, long pendency, and falling grant rates.
Patent application rates are also falling in all three patent offices, as a consequence of the publication of the human genome sequence database in 2001. The authors also attribute these changes in Europe to the relatively "high hurdles" existing for human gene patents in the European Patent Office, and in the U.S. due to increased stringency with which the U.S. Patent and Trademark Office has applied the utility requirement under 35 U.S.C. 101 since 2001. This is a particular problem for U.S. patent applications filed during the explosion of DNA sequence information provided by the Human Genome Project but before promulgation of the guidelines: some U.S. applications may now be deemed insufficient to satisfy requirements not existing when the applications were filed. These decisions increase the costs and amount of disclosure required for successfully patenting human genes.
Statistics on average pendency (30-60 months in the U.S., 60-120 months in Europe and Japan) and the fact that only "well-established" assignees such as Amgen, Genentech, and the U.S. National Institutes of Health have had success in obtaining gene patents in Europe and Japan commensurate with their success in the U.S. further distinguish patenting behavior between these patent offices, despite the high numbers of applications that have been or are being filed in each.
The authors also point out that 60% of human gene patents have claims to research tools, the value of which has diminished as a result of all three patent offices disallowing so-called "reach-through" claiming. Such claims (for example, for a method of identifying a drug compound that interacts with the product of a patented gene) attempt to "reach through" the claim to capture the drug (all drugs) discovered by the patented method. All three patent offices agreed, in the Trilateral Study of 2001, that such claims were only patentable to the extent that applicants disclosed drugs discovered using the claimed method. This decision is reflected in the U.S. in the Pfizer v. University of Rochester case, and in a different context, in the Supreme Court's Merck v. Integra decision. Other DNA claims, such as those for expressed sequence tags (ESTs), have recently had their patentability, and hence their value, diminished in the U.S. (In re Fisher; see In re Fisher: EST Utility Redux and In re Fisher (Fed. Cir. 2005) summary).
The authors conclude that the fears raised by some about the negative impact of human gene patenting have been, in the event, overstated. They raise the issue of patenting specific mutations, such as the BRCA1 breast cancer gene and other single nucleotide polymorphisms, but conclude that there is insufficient evidence that there is a general problem caused by such patents. Moreover, they acknowledge that what evidence does exist indicates that the "anticommons" effects anticipated by some were exaggerated.
It can only be hoped that this sober analysis of the state of human DNA patenting has a quieting effect on the current uproar in the U.S., which is based more on politics than on science or sound public policy.
Dr. Noonan has written a number of Patent Docs articles on the issue of gene patenting, including:
- "A DNA Patenting Thought Experiment," February 16, 2007
- "Science Fiction in The New York Times," February 13, 2007
- "The Continuing Value of Biotech Patenting," February 4, 2007
- "Anti-Patent (Sullivan?) Malice by The New York Times," January 29, 2007
- "In Support of Gene Patents," December 7, 2006