Lecture 23Chapter 14

Intellectual Property in Agricultural Biotechnology:Strategies for Open Access

Amy YanceyAmy Yancey

Discussion QuestionsDiscussion 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?

Discussion QuestionsDiscussion 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?

What is Intellectual PropertyWhat 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 Congress shall have the power…To promote the Progress of Science and useful Arts, by securing for limited Times to Authors Science and useful Arts, by securing for limited Times to Authors and Inventors the exclusive Right to their respective Writings and and Inventors the exclusive Right to their respective Writings and Discoveries.Discoveries.

U.S. Constitution

What is Intellectual PropertyWhat 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

What is a patent?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. 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.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, 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.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 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.man that takes advantage of gravity can be patented…with some very important caveats.

What is patentable?What is patentable?

• § 101. § 101. Inventions PatentableInventions Patentable

Whoever invents or discovers any new and useful Whoever invents or discovers any new and useful process, machine, manufacture, or composition of process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may matter, or any new and useful improvement thereof, may obtain a patent therefore, subject to the conditions and obtain a patent therefore, subject to the conditions and requirements of this title.requirements of this title.

• Same language since 1793 Same language since 1793 (see Patent Act of 1793)(see Patent Act of 1793)

• Diamond v. Chakrabarty paved the way in 1980 for utility Diamond v. Chakrabarty paved the way in 1980 for utility patents on living organisms patents on living organisms (Merges & Duffy, 2002)(Merges & Duffy, 2002)

Other requirementsOther requirements The caveats. A patent must:The caveats. A patent must:

Have utilityHave utility

Be disclosed and enabled*Be disclosed and enabled*

Be novelBe novel

Meet the statutory barsMeet the statutory bars

Be nonobviousBe nonobvious

* Important* ImportantYou get a monopoly—an important You get a monopoly—an important economic incentive. In economic incentive. In exchange, we get to see howexchange, we get to see howyou did it. This is how the genericsyou did it. This is how the genericsindustry works.industry works.

How are patents different from real How are patents different from real property?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.

Innovation or stagnation?Innovation or stagnation?IP in Ag BiotechIP in Ag Biotech

Patents & Public ResearchPatents & 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).

Commons & AnticommonsCommons & Anticommons

• Patents on basic research tools (i.e., enabling technologies, upstream v. Patents on basic research tools (i.e., enabling technologies, upstream v. downstream, plant transformation tools, biotechnology tools) can create downstream, plant transformation tools, biotechnology tools) can create patent thickets or anticommons effects and actually hinder innovation by patent thickets or anticommons effects and actually hinder innovation by making it economically infeasible to bring downstream technologies to making it economically infeasible to bring downstream technologies to market. (Heller & Eisenberg, 1998)market. (Heller & Eisenberg, 1998)

– These can be genes, transformation tools, markers, promoters, etc.These can be genes, transformation tools, markers, promoters, etc.

– 70-75% of biotechnology patents privately held70-75% 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

AnticommonsAnticommons• Anticommons effects results from scarce resources in the hands of few that Anticommons effects results from scarce resources in the hands of few that

are underutilized.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.

AnticommonsAnticommonsCase Study: Golden RiceCase Study: Golden Rice

• Genetically enhanced rice grown in Genetically enhanced rice grown in developing countries where there is a developing countries where there is a shortage of dietary vitamin A.shortage of dietary vitamin A.

• Over 40 patented technologies were Over 40 patented technologies were used to develop Golden Rice for use in used to develop Golden Rice for use in developing nations.developing nations.

• Because it’s a humanitarian crop with no Because it’s a humanitarian crop with no commercial value, the cost of licensing commercial value, the cost of licensing all those technologies would have all those technologies would have prohibited Golden Rice’s development prohibited Golden Rice’s development had companies not been pressured to had companies not been pressured to waive their fees.waive their fees.

AnticommonsAnticommonsExamples• Methods for plant transformation are patented:

– The ´061 Patent - Assignee: Monstanto -1999Agrobacterium-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 The ´́022 Patent - Assignee: DuPont - 1992022 Patent - Assignee: DuPont - 1992

Biolistic apparatus for delivering substances Biolistic apparatus for delivering substances into cells and tissues in a non-lethal mannerinto cells and tissues in a non-lethal manner

• Compounded by patents on promoters,selectable markers, processes…

*Photo credit: Martha Hawes, University of Arizona

Freedom to Operate (FTO)Freedom to Operate (FTO)• Navigating the IP landscape requires legal and Navigating the IP landscape requires legal and

scientific knowledge and searches of patent and scientific knowledge and searches of patent and literature databases to form a “freedom to literature databases to form a “freedom to operate” (FTO) opinion. operate” (FTO) opinion.

• Determines if a project or the development of a Determines if a project or the development of a product can proceed with a low likelihood that it product can proceed with a low likelihood that it will not infringe on existing IPwill not infringe on existing IP

• OpinionsOpinions– Are not absoluteAre not absolute– Reflect an evaluation of riskReflect an evaluation of risk– Uncertain interpretations about patent claimsUncertain interpretations about patent claims– New IP may issue or be discovered laterNew IP may issue or be discovered later

Freedom to Operate (FTO)Freedom to Operate (FTO)

• Private firms are more likely to engage in FTO Private firms are more likely to engage in FTO searchessearches

• Public and not-for-profit private institutions are Public and not-for-profit private institutions are becoming increasingly aware of the need becoming increasingly aware of the need – Especially in research projects undertaken by Especially in research projects undertaken by

universities or not-for-profit research centers for the universities or not-for-profit research centers for the purpose of developing new cropspurpose of developing new crops

• Material transfer agreements and suites of Material transfer agreements and suites of enabling technologies provide particular enabling technologies provide particular problems problems

Freedom to Operate (FTO)Freedom to Operate (FTO)

Case Study: The E8 Gene PromoterCase Study: The E8 Gene Promoter

• A fruit-specific promoter from the tomato A fruit-specific promoter from the tomato E8 geneE8 gene

• Has been used to improve fruit quality, Has been used to improve fruit quality, extend fruit shelf life, and express edible extend fruit shelf life, and express edible human vaccines specifically in ripening human vaccines specifically in ripening tomato fruit. tomato fruit.

Freedom to Operate (FTO)Freedom to Operate (FTO)• First, clearly define the target First, clearly define the target

technology. technology.

• In this hypothetical, the fruit In this hypothetical, the fruit specific promoter will be used specific promoter will be used exactly as described in initial exactly as described in initial publications.publications.

• The promoters in these The promoters in these publications are virtually publications are virtually identical.identical.

• Further promoter Further promoter characterization identifying the characterization identifying the location and sequence of location and sequence of functional elements and functional elements and upstream nucleotide sequence upstream nucleotide sequence was reported.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)].

Freedom to Operate (FTO)Freedom to Operate (FTO)• The publications on the E8 promoter provided important The publications on the E8 promoter provided important

prior art to subsequently filed patents and showed the prior art to subsequently filed patents and showed the general application to be in the public domain with general application to be in the public domain with narrower specific applications covered by patents.narrower specific applications covered by patents.

• The search will determine important technical legal The search will determine important technical legal timelines that indicate whethertimelines that indicate whether– The technology infringes existing patentsThe technology infringes existing patents– Existing patents are validExisting patents are valid– Claims are novel and nonobviousClaims are novel and nonobvious

• If existing patents are described in prior publications are If existing patents are described in prior publications are the patents invalid?the patents invalid?

Open AccessOpen Access

Emerging solutionsEmerging solutions• The complex IP environment surrounding agricultural biotechnology The complex IP environment surrounding agricultural biotechnology

research and development has inspired new strategies with organizations research and development has inspired new strategies with organizations committed to lower IP barriers to new crop developments and provide open committed to lower IP barriers to new crop developments and provide open access to patented technologies.access to patented technologies.

• Critical for small private companies and might be important for public or not-Critical for small private companies and might be important for public or not-for-profit research institutions.for-profit research institutions.

• Can faculty and researchers at publicCan faculty and researchers at publicinstitutions by held liable for institutions by held liable for infringement just for doing their jobs? 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

Emerging solutionsEmerging solutions• Most plant biotechnology laboratories routinely use patented technologies Most plant biotechnology laboratories routinely use patented technologies

in their research without permissions.in their research without permissions.

• Although patent owners have rarely been concerned about academic Although patent owners have rarely been concerned about academic research infringement in agriculture, this may be changing.research infringement in agriculture, this may be changing.

• In many instances fundamental biomedical research has been challenged In many instances fundamental biomedical research has been challenged because of IP issues (Marshall 2002). Breast cancer gene. because of IP issues (Marshall 2002). Breast cancer gene.

• Many researchers are unfamiliar with how to find, understand, and utilize IP Many researchers are unfamiliar with how to find, understand, and utilize IP information, including published patents and patent applications.information, including published patents and patent applications.

• Organizations have emerged toOrganizations have emerged to– Address the inaccessibility of IP informationAddress the inaccessibility of IP information– Provide a framework to ensure that IP does not block applications of agricultural Provide a framework to ensure that IP does not block applications of agricultural

biotechnologybiotechnology– Facilitate projects that can have broad humanitarian benefits. Facilitate projects that can have broad humanitarian benefits.

Emerging solutionsEmerging solutions• Several public-sector and not-for-profit agricultural research Several public-sector and not-for-profit agricultural research

institutions developed the Public Sector Intellectual Property institutions developed the Public Sector Intellectual Property Resource for Agriculture (PIPRA; Resource for Agriculture (PIPRA; www.pipra.org). ).

• Committed to participating and promoting strategies to manage Committed to participating and promoting strategies to manage public-sector intellectual property to support US and developing-public-sector intellectual property to support US and developing-country agriculture (Atkinson et al. 2003). 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 Encouraging public institutions to make informed decisions about where

and when to patentand when to patent– Encouraging humanitarian exemptions in license languageEncouraging humanitarian exemptions in license language– Developing a clearinghouse of public IP information and analytical Developing a clearinghouse of public IP information and analytical

resources resources – Developing consolidated technology packages, or patent pools, Developing consolidated technology packages, or patent pools,

particularly in the area of enabling technologies for plant transformation. particularly in the area of enabling technologies for plant transformation.

Emerging solutionsEmerging solutions• CAMBIA hopes to create a new approach to technology access in CAMBIA hopes to create a new approach to technology access in

agricultural biotechnology modeled after the “open source” software agricultural biotechnology modeled after the “open source” software movement. movement.

• The Biological Innovation for Open Society (BiOS) project is built on The Biological Innovation for Open Society (BiOS) project is built on a broad philosophical foundation to “to democratize problem solving a broad philosophical foundation to “to democratize problem solving to enable diverse solutions to problems through decentralized to enable diverse solutions to problems through decentralized innovation.” innovation.”

• The idea is to create a “protected commons” of enabling agricultural The idea is to create a “protected commons” of enabling agricultural biotechnologies that are freely available and whose use cannot be biotechnologies that are freely available and whose use cannot be restricted by third-party patent rights. restricted by third-party patent rights.

• By signing the BiOS license, a researcher or an institution agrees to 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 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 and the patent rights to any improvements made to the technology. the technology.

Discussion QuestionsDiscussion 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?

Discussion QuestionsDiscussion 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?

Other questions Other questions or discussion points?or discussion points?