1. Amy Yancey Lecture 23 Chapter 14 Intellectual Property in Agricultural Biotechnology: Strategies for Open Access Amy Yancey

2. Discussion Questions What is intellectual property, and how does it differ from tangible property? Discuss ways in which intellectual and tangible property rights can be transferred to third parties. What is a patent, and what are the limitations on patent rights? Contrast the “tragedy of the commons” and “tragedy of the anticommons” metaphors. How do the metaphors relate to intellectual property, particularly in agricultural biotechnology?

3. Discussion Questions What is “freedom to operate” (FTO) in the intellectual property context? What are the main issues in considering FTO when developing an improved crop variety using agricultural biotechnology? In the E8 case study, how does prior art preclude patenting? Discuss ways research scientist could use publications as a means to place inventions in the public domain. While patent law has presented opportunities to protect intellectual property in the field of biotechnology, it has also generated a struggle to reconcile public and private interests. How are the emerging models represented by PIPRA and CAMBIA trying to stimulate innovation and promote open access while avoiding the tragedies of the anticommons?

4. What is Intellectual Property If nature has made any one thing less susceptible than all others of exclusive property, it is the action of the thinking power called an idea, which an individual may exclusively possess as long as he keeps it to himself.... Inventions then cannot, in nature, be a subject of property. (However) society may give an exclusive right to the profits arising from them, as an encouragement to men to pursue ideas which may produce utility. Thomas Jefferson Congress shall have the power…To promote the Progress of Science and useful Arts, by securing for limited Times to Authors and Inventors the exclusive Right to their respective Writings and Discoveries. U.S. Constitution

5. What is Intellectual Property Legal products of your mind Forms and examples? –Copyright – Music, books… How is plagiarism related? –Trademarks – Google, Yahoo!, Apple –Trade secrets – Secret formula for Coca Cola –Plant and utility patents – Bt corn, agrobacterium, gene gun Patents are the primary IP used in ag biotech

6. What is a patent? Patent rights are a type of intellectual property (IP) that grants a government-sanctioned monopoly on an invention for a limited time. Usually 20 years from date of filing.Patent rights are a type of intellectual property (IP) that grants a government-sanctioned monopoly on an invention for a limited time. Usually 20 years from date of filing. Patent rights are negative rights. Owning a patent does not give you the right to use it, only the right to exclude others from making, using, or selling the invention.Patent rights are negative rights. Owning a patent does not give you the right to use it, only the right to exclude others from making, using, or selling the invention. Anything made by the hand of man counts. So while a law of nature, like gravity, can’t be patented, any device or system created by man that takes advantage of gravity can be patented…with some very important caveats.Anything made by the hand of man counts. So while a law of nature, like gravity, can’t be patented, any device or system created by man that takes advantage of gravity can be patented…with some very important caveats.

7. What is patentable? § 101. Inventions Patentable Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefore, subject to the conditions and requirements of this title.§ 101. Inventions Patentable Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefore, subject to the conditions and requirements of this title. Same language since 1793 (see Patent Act of 1793)Same language since 1793 (see Patent Act of 1793) Diamond v. Chakrabarty paved the way in 1980 for utility patents on living organisms (Merges & Duffy, 2002)Diamond v. Chakrabarty paved the way in 1980 for utility patents on living organisms (Merges & Duffy, 2002)

8. Other requirements The caveats. A patent must: The caveats. A patent must: Have utility Have utility Be disclosed and enabled* Be disclosed and enabled* Be novel Be novel Meet the statutory bars Meet the statutory bars Be nonobvious Be nonobvious * Important You get a monopoly—an important economic incentive. In exchange, we get to see how you did it. This is how the generics industry works.

9. How are patents different from real property? A patent provides an IP right that is geographically limited to the specific countries in which patent protection is obtained for a limited time. In tangible property, ownership is rarely limited by either geography or time. In biological research, research materials (vectors, genes, cell lines, etc.) are usually obtained under the terms of a material transfer agreement (MTA), which likely contains provisions on how the material is used. Because the MTA governs the transfer of tangible or real property the terms of the agreement typically do not contain geographic or temporal limitations and, as a result, the restrictions imposed by MTAs can become particularly problematic.

10. Innovation or stagnation? IP in Ag Biotech

11. Patents & Public Research Since the early 1980s, fundamental changes in basic and applied agricultural research have complicated public research. Historical purpose of the US LGU has changed dramatically. The primary change was the Bayh–Dole Act, which encouraged US universities to patent their innovations and license them to the private-sector. Since that time, patenting by public research institutions and universities has increased dramatically. While public-sector institutions contribute about 2.7% of patents overall, their contribution to agricultural biotechnology is nearly 24% of all patents (Graff et al. 2003).

12. Commons & Anticommons Patents on basic research tools (i.e., enabling technologies, upstream v. downstream, plant transformation tools, biotechnology tools) can create patent thickets or anticommons effects and actually hinder innovation by making it economically infeasible to bring downstream technologies to market. (Heller & Eisenberg, 1998)Patents on basic research tools (i.e., enabling technologies, upstream v. downstream, plant transformation tools, biotechnology tools) can create patent thickets or anticommons effects and actually hinder innovation by making it economically infeasible to bring downstream technologies to market. (Heller & Eisenberg, 1998) –These can be genes, transformation tools, markers, promoters, etc. –70-75% of biotechnology patents privately held The “tragedy of the commons” was coined by Garrett Hardin to explain why people overused shared resources, such as common pastures (1968). Modern examples? –Global warming –Over fishing –Western water-rights issues

13. Anticommons Anticommons effects results from scarce resources in the hands of few that are underutilized.Anticommons effects results from scarce resources in the hands of few that are underutilized. In biotechnology,In biotechnology, this relates to the proliferation and fragmentation of IP ownership, preventing any single institution or company from assembling all of the necessary rights to produce a product or downstream technology, resulting in the underuse (or nonuse) of resources.

14. Anticommons Case Study: Golden Rice Genetically enhanced rice grown in developing countries where there is a shortage of dietary vitamin A.Genetically enhanced rice grown in developing countries where there is a shortage of dietary vitamin A. Over 40 patented technologies were used to develop Golden Rice for use in developing nations.Over 40 patented technologies were used to develop Golden Rice for use in developing nations. Because it’s a humanitarian crop with no commercial value, the cost of licensing all those technologies would have prohibited Golden Rice’s development had companies not been pressured to waive their fees.Because it’s a humanitarian crop with no commercial value, the cost of licensing all those technologies would have prohibited Golden Rice’s development had companies not been pressured to waive their fees.

15. Anticommons Examples Methods for plant transformation are patented: –The ´061 Patent - Assignee: Monstanto -1999 Agrobacterium-mediated plant transformation method What is claimed is: 1. A method of transforming a corn plant cell or plant tissue using an Agrobacterium mediated process comprising the steps of…. –The ´022 Patent - Assignee: DuPont - 1992 Biolistic apparatus for delivering substances into cells and tissues in a non-lethal manner Compounded by patents on promoters, selectable markers, processes… *Photo credit: Martha Hawes, University of Arizona

16. Freedom to Operate (FTO) Navigating the IP landscape requires legal and scientific knowledge and searches of patent and literature databases to form a “freedom to operate” (FTO) opinion.Navigating the IP landscape requires legal and scientific knowledge and searches of patent and literature databases to form a “freedom to operate” (FTO) opinion. Determines if a project or the development of a product can proceed with a low likelihood that it will not infringe on existing IPDetermines if a project or the development of a product can proceed with a low likelihood that it will not infringe on existing IP OpinionsOpinions –Are not absolute –Reflect an evaluation of risk –Uncertain interpretations about patent claims –New IP may issue or be discovered later

17. Freedom to Operate (FTO) Private firms are more likely to engage in FTO searchesPrivate firms are more likely to engage in FTO searches Public and not-for-profit private institutions are becoming increasingly aware of the needPublic and not-for-profit private institutions are becoming increasingly aware of the need –Especially in research projects undertaken by universities or not-for-profit research centers for the purpose of developing new crops Material transfer agreements and suites of enabling technologies provide particular problemsMaterial transfer agreements and suites of enabling technologies provide particular problems

18. Freedom to Operate (FTO) Case Study: The E8 Gene Promoter A fruit-specific promoter from the tomato E8 geneA fruit-specific promoter from the tomato E8 gene Has been used to improve fruit quality, extend fruit shelf life, and express edible human vaccines specifically in ripening tomato fruit.Has been used to improve fruit quality, extend fruit shelf life, and express edible human vaccines specifically in ripening tomato fruit.

19. Freedom to Operate (FTO) First, clearly define the target technology.First, clearly define the target technology. In this hypothetical, the fruit specific promoter will be used exactly as described in initial publications.In this hypothetical, the fruit specific promoter will be used exactly as described in initial publications. The promoters in these publications are virtually identical.The promoters in these publications are virtually identical. Further promoter characterization identifying the location and sequence of functional elements and upstream nucleotide sequence was reported.Further promoter characterization identifying the location and sequence of functional elements and upstream nucleotide sequence was reported. Figure 14.4. A family of related tomato E8-related patents derived from the parent application USSN 448,095 [from Fenton et al. (in press)].

20. Freedom to Operate (FTO) The publications on the E8 promoter provided important prior art to subsequently filed patents and showed the general application to be in the public domain with narrower specific applications covered by patents.The publications on the E8 promoter provided important prior art to subsequently filed patents and showed the general application to be in the public domain with narrower specific applications covered by patents. The search will determine important technical legal timelines that indicate whetherThe search will determine important technical legal timelines that indicate whether –The technology infringes existing patents –Existing patents are valid –Claims are novel and nonobvious If existing patents are described in prior publications are the patents invalid?If existing patents are described in prior publications are the patents invalid?

21. Open Access

22. Emerging solutions The complex IP environment surrounding agricultural biotechnology research and development has inspired new strategies with organizations committed to lower IP barriers to new crop developments and provide open access to patented technologies.The complex IP environment surrounding agricultural biotechnology research and development has inspired new strategies with organizations committed to lower IP barriers to new crop developments and provide open access to patented technologies. Critical for small private companies and might be important for public or not- for-profit research institutions.Critical for small private companies and might be important for public or not- for-profit research institutions. Can faculty and researchers at public institutions by held liable for infringement just for doing their jobs?Can faculty and researchers at public institutions by held liable for infringement just for doing their jobs? A Federal Circuit Court of Appeals ruling in the Madey v. Duke case found academic research is not protected by the experimental use exception from patent infringement

23. Emerging solutions Most plant biotechnology laboratories routinely use patented technologies in their research without permissions.Most plant biotechnology laboratories routinely use patented technologies in their research without permissions. Although patent owners have rarely been concerned about academic research infringement in agriculture, this may be changing.Although patent owners have rarely been concerned about academic research infringement in agriculture, this may be changing. In many instances fundamental biomedical research has been challenged because of IP issues (Marshall 2002). Breast cancer gene.In many instances fundamental biomedical research has been challenged because of IP issues (Marshall 2002). Breast cancer gene. Many researchers are unfamiliar with how to find, understand, and utilize IP information, including published patents and patent applications.Many researchers are unfamiliar with how to find, understand, and utilize IP information, including published patents and patent applications. Organizations have emerged toOrganizations have emerged to –Address the inaccessibility of IP information –Provide a framework to ensure that IP does not block applications of agricultural biotechnology –Facilitate projects that can have broad humanitarian benefits.

24. Emerging solutions Several public-sector and not-for-profit agricultural research institutions developed the Public Sector Intellectual Property Resource for Agriculture (PIPRA; www.pipra.org).Several public-sector and not-for-profit agricultural research institutions developed the Public Sector Intellectual Property Resource for Agriculture (PIPRA; www.pipra.org).www.pipra.org Committed to participating and promoting strategies to manage public-sector intellectual property to support US and developing- country agriculture (Atkinson et al. 2003).Committed to participating and promoting strategies to manage public-sector intellectual property to support US and developing- country agriculture (Atkinson et al. 2003). 45 institutional members in 13 countries45 institutional members in 13 countries Among PIPRA’s core activities are:Among PIPRA’s core activities are: –Encouraging public institutions to make informed decisions about where and when to patent –Encouraging humanitarian exemptions in license language –Developing a clearinghouse of public IP information and analytical resources –Developing consolidated technology packages, or patent pools, particularly in the area of enabling technologies for plant transformation.

25. Emerging solutions CAMBIA hopes to create a new approach to technology access in agricultural biotechnology modeled after the “open source” software movement.CAMBIA hopes to create a new approach to technology access in agricultural biotechnology modeled after the “open source” software movement. The Biological Innovation for Open Society (BiOS) project is built on a broad philosophical foundation to “to democratize problem solving to enable diverse solutions to problems through decentralized innovation.”The Biological Innovation for Open Society (BiOS) project is built on a broad philosophical foundation to “to democratize problem solving to enable diverse solutions to problems through decentralized innovation.” The idea is to create a “protected commons” of enabling agricultural biotechnologies that are freely available and whose use cannot be restricted by third-party patent rights.The idea is to create a “protected commons” of enabling agricultural biotechnologies that are freely available and whose use cannot be restricted by third-party patent rights. By signing the BiOS license, a researcher or an institution agrees to contribute back to the pool, for free distribution, data on the use of the technology and the patent rights to any improvements made to the technology.By signing the BiOS license, a researcher or an institution agrees to contribute back to the pool, for free distribution, data on the use of the technology and the patent rights to any improvements made to the technology.

26. Discussion Questions What is intellectual property, and how does it differ from tangible property? Discuss ways in which intellectual and tangible property rights can be transferred to third parties. What is a patent, and what are the limitations on patent rights? Contrast the “tragedy of the commons” and “tragedy of the anticommons” metaphors. How do the metaphors relate to intellectual property, particularly in agricultural biotechnology?

27. Discussion Questions What is “freedom to operate” (FTO) in the intellectual property context? What are the main issues in considering FTO when developing an improved crop variety using agricultural biotechnology? In the E8 case study, how does prior art preclude patenting? Discuss ways research scientist could use publications as a means to place inventions in the public domain. While patent law has presented opportunities to protect intellectual property in the field of biotechnology, it has also generated a struggle to reconcile public and private interests. How are the emerging models represented by PIPRA and CAMBIA trying to stimulate innovation and promote open access while avoiding the tragedies of the anticommons?

28. Other questions or discussion points?