Transcript The Problem with Patents - Department of Plant Sciences

Lecture 23
Chapter 14
Intellectual Property in Agricultural Biotechnology:
Strategies for Open Access
Amy Yancey
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?
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?
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
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
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 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.
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.
• 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)
Other requirements

The caveats. A patent must:

Have utility

Be disclosed and enabled*

Be novel

Meet the statutory bars

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.
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.
Innovation or stagnation?
IP in Ag Biotech
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).
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)
– 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
Anticommons
•
•
Anticommons effects results from scarce resources in the hands of few that
are underutilized.
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.
Anticommons
Case Study: Golden Rice
•
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.
•
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.
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
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.
• Determines if a project or the development of a
product can proceed with a low likelihood that it
will not infringe on existing IP
• Opinions
–
–
–
–
Are not absolute
Reflect an evaluation of risk
Uncertain interpretations about patent claims
New IP may issue or be discovered later
Freedom to Operate (FTO)
• Private firms are more likely to engage in FTO
searches
• Public 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
problems
Freedom to Operate (FTO)
Case Study: The E8 Gene Promoter
• A 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.
Freedom to Operate (FTO)
• First, clearly define the target
technology.
• In this hypothetical, the fruit
specific promoter will be used
exactly as described in initial
publications.
• 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.
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)
• 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 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?
Open Access
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.
•
Critical for small private companies and might be important for public or notfor-profit research institutions.
•
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
Emerging solutions
•
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.
•
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.
•
Organizations 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.
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).
• Committed to participating and promoting strategies to manage
public-sector intellectual property to support US and developingcountry agriculture (Atkinson et al. 2003).
• 45 institutional members in 13 countries
• 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.
Emerging solutions
• 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 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.
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?
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?
Other questions
or discussion points?