The Tragedy of the Anticommons in Biomedical Research.
Here, I present some quotations that illustrate the existence of anticommons in biomedical research. The links at the end of each quotation direct to the original text.
Report of the Commision on Intellectual Property Rights
As you can imagine, with all these different antigens, productions technologies etc, anybody who gets into this area is going to be required to take out multiple licenses. Whenever we have multiple licenses, then we have what is called “royalty stacking”, so this is a complexity where everybody wants 10% of net sales but you end up with 6 licenses. This is a problem. Then we have the complexities associated with IP, in particular patents. […]
When we started looking at patents covering MSP1, the first thing we found was that there were about 34, this later became 39, patent families describing and claiming the antigen, processing fragments, constructed DNA, production methods, delivery etc. all of this developing over about a 15 year period. We were really surprised to find this. Relatively speaking, this is a fairly large number, but it gets better. This was actually the first map (shows slide) that we generated which shows each of these 34 patent families and you will notice that the lines between them in many cases have a notation related with a question mark. We could not determine from the patent literature and from reviewing many of these patents whether or not they were in fact MSP1 and, if they were related to one another, how to actually categorise them. This is what anybody developing a malarial vaccine using MSP1 will see at first. Interestingly, we have patent families with conflicting claims, this is also known as double patenting we suspect, we have little IP heritage, in other words patents don’t tend to site backwards and forwards to one another, they tend to exist only in isolation and there are a lot of qualitative questions about scope and enforceability. […]
Regarding key learnings, this kind of very highly complex patent landscape tends to dissuade companies, in particular cases where alternate antigens may exist. It also slows access to enabling technologies. It certainly adds cost and extends lead times. You can imagine the amount of time it would take to negotiate all these various licenses. There is also something of a “tragedy of the commons” corollary where we have everybody patenting in the MSP1 area without any knowledge of what anyone else is doing and what that does is tend to disrupt the landscape rather than create a comprehensive whole.
http://www.iprcommission.org/papers/pdfs/conferences/session_7.pdf
From the USPTO itself!
Of present concern to the public is the removal of valuable research resources from the public domain. The characterization of nucleic acid sequence information is only the first step in the utilization of genetic information. Significant and intensive research efforts, however, are required to glean the information from the nucleic acid sequences for use in,inter alia , the development of pharmaceutical agents for disease treatment, and in elucidating basic biological processes. Many feel that by allowing genetic information to be patented, researchers will no longer have free access to the information and materials necessary to perform biological research. This issue of access to research tools relates to the ability of a patent holder to exclude others from using the material. Further, if a single patent holder has a proprietary position on a large number of nucleic acids, they may be in a position to “hold hostage” future research and development efforts.
No
single company or organization, however, has the resources to develop
any significant fraction of the genetic information present in an
organism. If proprietary information is not freely available or
licensed in an affordable manner, researchers will be precluded from
using these protected nucleic acids to develop new therapeutics and
diagnostics. It would be, however, shortsighted of a patent holder to
demand such a prohibitively expensive licensing agreement that would
preclude anyone else from utilizing a patented invention. Rather, an
owner of a patent is likely to make business decisions based upon
profitability, and one element of such is the ability to obtain
licensees.
http://www.uspto.gov/web/offices/pac/dapp/opla/patentpool.pdf
Bristol-Myers and Athersys Make Deal on Gene Patents (New York Times)
'You start work in a certain therapeutic area doing some screening and then a patent will issue,' said Ronald A. Pepin, a former Bristol-Myers executive who helped initiate the collaboration with Athersys. 'You're stuck. You either shut down your program or you try to get a license.' Dr. Pepin is now a vice president at Medarex, a biotechnology company that also is collaborating with Athersys.
Peter Ringrose, chief scientific officer at Bristol-Myers, has said there are more than 50 proteins possibly involved in cancer that the company was not working on because the patent holders either would not allow it or were demanding unreasonable royalties.http://query.nytimes.com/gst/fullpage.html?sec=health&res=9D01E4DE153AF93BA35752C0A9679C8B63
Patents in the Knowledge-Based Economy (National Academy of Science)
A respondent from a pharmaceutical firm expressed the firm’s frustration:
We do have frustration internally because we can’t do what we consider basic research with a cloned gene, not selling the gene, just using it to make another discovery. To be cut off from that, it sits badly. Because, at the end of the day, you are cut off from tools, from making a breakthrough discovery. Because there is a patent on the human gene, you work with the guinea pig gene, but it is not the best approach. That’s very frustrating. In a number of cases, we can’t work with this protein or this gene and it slows things down. We are looking at ways to get around this. How to not infringe their IP. And, we are coming up with ways to do that, but it involves some labor and time.
Another biotech respondent stated:
If there is a patent on manufacturing in different host cells, and certain others that don’t have a royalty, then, on the last step, you don’t make it in this cell, but over here. But that incurs some technical costs. It is a different system, you are not as familiar with the technology, but you go there because you don’t want to pay the royalty.
John P. Walsh, Ashish Arora, & Wesley M. Cohen, The Patenting of Research Tools and Biomedical Innovation, prepared for The Science, Technology and Economic Policy Board of the National Academy of Sciences 9. http://www.nap.edu/openbook/0309086361/html/314.html
Stem Cells: The Patent Landscape
In page 1 they present a classification of patents on stem cells.
Page 3: "researchers [...] may have to obtain a license to multiple blocking patents and complementary patents"
http://www.skgf.com/media/news/news.222.pdfReport of the National Institutes of Health (NIH) Working Group on Research Tools
Summary of Problems:- Many scientists and institutions involved in biomedical research are frustrated by growing difficulties and delays in negotiating the terms of access to research tools.
- The value of research tools is difficult to assess.
- Many research tools are costly to develop and have significant competitive value to the firms that own them.
- Some users of biomedical research tools have limited resources for paying up-front fees, although their use of the tools could potentially yield valuable future discoveries. License mechanisms by which tool providers seek to profit from the future discoveries of tool users often involve future royalty obligations or rights to future intellectual property that constrain future opportunities for research funding and technology transfer.
Virtually every firm that we spoke with believed that restricted access to research tools is impeding the rapid advance of research and that the problem is getting worse.
Patents on gene fragments:
"[...] the U.S. Patent and Trademarks Office had issued more than 2,000 patents covering gene sequences by the end of 1999. New applications will almost certainly require multiple DNA sequences whose patents are held by different owners".
http://ecocomm.anu.edu.au/research/papers/pdf/wp391.pdf
Towards Patent Pools in Biotechnology? by Patrick Gaulé:
Enough anecdotal evidence exists, however, to suggest that the fragmentation of rights in biotechnology is sometimes a serious concern. One of the well-known cases is malaria vaccine development, where up to 39 families were found to be potentially relevant to the development of a vaccine from the protein antigen MSP‐1 protein (IPR Commission, 2002:127).
http://cemi.epfl.ch/webdav/site/cemi/shared/misc_files/IST-vol-2-No-2-2006-Patrick-Gaule.pdf