Conserving biodiversity using patent law - Nature

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Oct 10, 2007 - The authors acknowledge the support and legal counsel of Anita Cicero and the Pharmaceutical Practice Group of Drinker Biddle & Reath LLP, ...

CORRESPONDENCE COMPETING INTERESTS STATEMENT The authors declare competing financial interests: details accompany the full-text HTML version of the paper at

© 2007 Nature Publishing Group

ACKNOWLEDGMENTS The authors acknowledge the support and legal counsel of Anita Cicero and the Pharmaceutical Practice Group of Drinker Biddle & Reath LLP, for managing the affairs of the Alliance for Biosecurity.

Gigi Kwik Gronvall1, Dennis Trent2, Luciana Borio1, Robert Brey3 & Lee Nagao4 on behalf of the Alliance for Biosecurity 1Center for Biosecurity of UPMC, University of Pittsburgh, 621 East Pratt Street, Suite 210, Baltimore, Maryland 21202, USA. 2Acambis, 38 Sidney Street, Cambridge, MA 02139, USA. 3DOR Biopharma, Inc., 1101 Brickell Avenue, Suite 7015, Miami, FL 33131, USA. 4The Pharmaceutical Practice Group, Drinker Biddle & Reath LLP, 1500 K Street, NW, Washington, DC 20005, USA. e-mail: [email protected]/

1. US Department of Health and Human Services, Food and Drug Administration. Fed. Register 67, 37988–37998 (2002). 2. US Department of Health and Human Services: Office of Public Health Emergency Preparedness. Fed. Register 72, 13109–13114 (2007).

3. US Department of Health and Human Services, Food and Drug Administration. Critical Path Opportunities List. March 16, 2004. 4. Accessed September 20, 2007. 5. Accessed September 20, 2007. 6. Accessed September 20, 2007. 7. Accessed December 19, 2006. 8. Accessed February 23, 2007. 9. US Department of Health and Human Services, Food and Drug Administration. Fed. Register 69, 25595–25596 (2004). 10. US Department of Health and Human Services, Food and Drug Administration. Fed. Register 69, 5307 (2004). 11. Food and Drug Administration. Innovation or Stagnation: Challenge and Opportunity on the Critical Path to New Medical Products. March 16, 2004. 12. Accessed September 20, 2007. 13. Accessed December 12, 2006. 14. US Food and Drug Administration: Center for Drug Evaluation and Research. FDA Project on Cancer Drug Approval Endpoints. November 14, 2006. Accessed December 12, 2006. 15. Accessed December 12, 2006. 16. Accessed September 20, 2007.

Conserving biodiversity using patent law To the editor: Humans draw immense benefits from using products and derivatives of microbes, plants and animals. And yet, the very foundation of this continuing exploitation, biodiversity, is at risk. Species and natural ecosystems are predicted to disappear in the near future at a faster rate than any time in the history of the Earth. Conservation commands far inadequate resources to halt (or slow down) this process. Here, we suggest a new approach to boost the global resources available for conservation. Organisms and their genes provide vast resources for humankind that include domesticated plants and animals, medicine, fuel, building materials and ecosystem services1,2. For instance, the venom of tropical cone snails Conus spp. may contain the largest and clinically most important pharmacopoeia of any genus3. Each species of the ~700 known species of cone snails produces 100–200 distinct toxins, so that there may be as many as 140,000 small, highly structured venom peptides, colloquially known as conotoxins4. To date only 100 conotoxins have been studied with 77% of ~2,600 research

papers focused on one compound, the ωconotoxin3,4. Conotoxins hold much promise for providing a nonaddictive pain reliever 1,000 times more powerful than morphine, and they show prospects for being potent pharmaceuticals in treating neuropathic pain, Alzheimer’s disease, Parkinson’s disease, epilepsy and clinical depression3,5. Of the first 30 peptides purified from Conus venoms, 10% reached at least phase 1 human clinical trials4. Analgesic Conus venom peptides have been attractive development candidates for drugs against severe pain at pharmaceutical and biotech companies because 26 million patients worldwide suffer from some form of neuropathic pain. The global market for neuropathic pain drugs alone is $2.5 billion and this value is expected to double by 2010 (ref. 6). Cone snails, however, and most of their coral reef habitats are endangered: four species are classified as ‘globally vulnerable’ by the World Conservation Union (International Union for the Conservation of Nature and Natural Resources, Gland, Switzerland), and more than half the ranges of 69% of cone snail


species are directly threatened by humans3,7. The resources devoted to preserve cone snail habitats is minuscule in comparison with the expected profits of conotoxin-derivative drugs; for instance, the Asian Development Bank (Manila, Philippines) funded a coral reef rehabilitation project in Indonesia, and the International Coral Reef Conservation Grant pledged $1.2 million for projects mostly in South Asia and the Caribbean8. A conservative assumption is that 1% of conotoxins will produce marketable drugs (1,400 drugs) and if each drug may take 1% of market share ($25 million/year), the estimated global market value of conotoxin-derivative drugs is ~$35 billion per year. Assuming that the grant by the Asian Development Bank ($41.3 million/15 years) and Coral Reef Conservation Grant ($1.2 million/year) represent 10% of global funds devoted to coral reef conservation relevant to cone snails, thus the total investment into cone snail conservation is ~$40 million/year, the equivalent of 0.1% market value of conotoxin-derivative drugs is invested back into conserving the source populations in nature. This meager market value versus investment ratio is reminiscent of early colonialists buying Manhattan Island from Native Americans purportedly for $24 worth of merchandise9. We suggest that using natural products without acknowledging the contribution by nature should infringe intellectual property rights. Developed societies established tight regulations to acknowledge the process of innovation and protect the rights of innovator. We argue that this concept should be extended to products and genes of organisms from the natural world. Microbes, plants and animals are produced by evolution by natural selection, and this process has lead to a magnificent diversity of species, communities and ecosystems. Converting natural products into marketable drugs by humans only represents the last step following eons of preceding steps leading to a useful product for humankind that have already been carried out by nature. We propose that inventors (individuals, groups of individuals and companies) that seek to patent nature-based products should be treated as partners (that is, ‘joint’ or ‘co-inventors’). Our rationale is that the process of natural selection itself should be acknowledged as an inventor, given that nature often contributes fundamentally to the formation of the definite and permanent idea of a patent, for instance, a pharmaceutical drug or biomimetic product. We argue that all nature-based patents that do not acknowledge evolution by natural selection as ‘co-inventor’ should be treated as invalid.


© 2007 Nature Publishing Group

CORRESPONDENCE We put forward that all patents that are based upon substantial innovation by nature should have 1% patent ownership allocated to a new global conservation organization—let’s call it Global Biodiversity Patent Fund (GBPF). This objective may be achieved in two ways. First, companies that develop patentable products from naturally occurring substances should realize their moral obligation to preserve the very source of their continuing growth—biodiversity—and voluntarily dedicate 1% of their patent right to GBPF. This move would follow an existing trend among major industries (e.g., oil and gas, mining and automotive) that are already moving toward environmentally acceptable and morally appealing standards. In addition, by funding biodiversity research and conservation, drug companies will invest in their own potential future discoveries. For instance, if the coral reef habitats were destroyed or decimated and many cone snail species went extinct, the private sector would lose the opportunity to mine these resources for potential milliondollar products. Second, to implement this model, patent laws would need to be changed to acknowledge the role of natural selection in producing the final marketable product. The origin of biotechnological inventions, such as gene sequences, must be disclosed by patent law10. This disclosure may be used to assess whether a biotechnological invention is sufficiently distinct from a natural product. In many cases this will be trivial, because for example, current EU (Brussels) patent law allows patenting a biological material that was directly isolated from its natural environment11. For products purified and further processed from a natural substance, the patentability test should include a condition when the inventive step (or nonobviousness)10 of the patent application is judged against the pure product as the latter is found in nature. This may require specifying the active ingredient of a natural product relevant to the patent application. If the inventive step that created the biologically (or pharmacologically) active component of the patent application is already exhibited by the natural substance, the patentability test would be jeopardized, unless GBPF is involved as co-inventor. In our view, this concept may only influence future patent applications, although GBPF and major drug companies should negotiate over existing patents retrospectively to settle mutually agreeable terms. Many well-known drugs were invented and produced largely by nature including >100 drugs12, and humans only contributed moderate amounts to exploit and market


these natural products compared to nature. Therefore, we view our proposal as a win-win situation both for industry and conservation. The GBPF, similar to a global nongovernmental organization like Conservation International (Arlington, VA, USA), The Nature Conservancy (Arlington, VA, USA) or the World Wildlife Fund (Gland, Switzerland), would then redistribute the funds they acquired from selling (or leasing) patented bioproducts into projects promoting knowledge about biodiversity, saving species and their habitats, and for developing environmentally sustainable societies. Because conservation biology is an emergency science, there will be immense demand for worldwide uses of these funds1,2. Let’s not make the same mistake that Manhattan’s Lenape Native Americans made in 1626. Tamás Székely1 & Alex Gaillard2

1Museum of Comparative Zoology, Harvard University, 26 Oxford Street, Cambridge Massachusetts 02138, USA. 2Department of Biology and Biochemistry, University of Bath, Bath BA2 7AY, UK. e-mail: [email protected]

1. Wilson, E.O. The Diversity of Life (Norton, New York, 1992). 2. Hunter, M.L. & Gibbs, J. Fundamentals of Conservation Biology (Blackwell, Malden, MA, 2007). 3. Chivian, E. et al. Science 302, 391 (203). 4. Olivera, B.M. J. Biol. Chem. 281, 31173–31177 (2006). 5. Pickerell, J. National Geographic News, October 16 (2003). 6. 7. Roberts, C.M. et al. Science 295, 1280–1284 (2002). 8. < nr2002242.asp> 9. 10. 11. The European Parliament & The Council of the European Union. Off. J. Eur. Comm. L213, 13–21 (1998). 12.

Why Cabilly must stand To the editor: The first line of your News story entitled ‘Industry waits for fallout from Cabilly’ in the July issue online reads, “Should the Cabilly patent fall, more than its licensees will be affected”; and it could not be more on target. Following that opening, however, the article veers widely off the mark in suggesting that an invalidation of Cabilly could be positive for the biotech industry. To the contrary, the rejection of Cabilly could have a chilling effect on the innovation the industry needs to thrive. Intellectual property and patent protections are the just rewards that make it possible for innovator companies and universities to go through the time and effort, and to spend the monetary and human resources, necessary to bring new technologies and discoveries to light. Although as Executive Vice President, Research, my primary concerns are with the direction and conclusions of the article, it is important to note that there are several factual errors as well. For example, the article fails to recognize that over a month before publication, the United States Patent Office withdrew the finality of the February rejections. The article’s statement that the Cabilly patent only has the option of an “appeal one last time to a separate board” is inaccurate, as is its inference that there is “momentum against Cabilly.”

Genentech (S. San Francisco, CA, USA) has been the pioneer in bringing monoclonal antibody (mAb) products to market with approvals in 1997 and 1998 for the first therapeutic mAb approved for treating cancer in the United States (Rituxan; rituximab) and the first mAb approved for the treatment of HER2-positive metastatic breast cancer (Herceptin; trastuzumab), respectively. Many of the mAb drugs now on the market, which have extended or enhanced the lives of millions of patients, involve the Cabilly technology that was an outgrowth of basic science and might not exist without Genentech’s contribution. From the vantage point of 2007, with the remarkable advances that have been made in the past two decades, it can be difficult to think back to the 1980s and fully appreciate the groundbreaking nature of the science that led to Cabilly patents. Engineered mAbs in general were a technology whose skeptics far outnumbered its proponents both on the scientific and regulatory level. Then as now, we made every effort to make sure that people who invested in our company recognized it was a high-risk business. We are fortunate that we have been able to deliver a return on that investment while treating millions of patients with our life-enhancing and lifesaving medicines.


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