Download The Problem with Patents - Department of Plant Sciences

Amy Yancey, Maha Krishnamurthy, Neal Stewart
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 IP
• Not ideas. Ideas are not protectable, except by
confidentiality
• Embodiments of ideas are protectable
• Intangible (intellectual property)
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Patents
Copyrights
Trademarks
Trade Secrets
• Tangible (biological materials, software)
Real Property vs. IP
• Real Property:
– Tangible (research materials such as vectors, genes,
cell lines, etc. are usually obtained under the terms of
a material transfer agreement etc.)
– Ownership is rarely limited by either geography or
time
• Intellectual Property:
– Intangible (legal products of your mind)
– IP right is geographically limited to the specific
countries in which patent protection is obtained for a
limited time
Forms of IP Protection
What is a patent?
Provides a legal right to exclude
others from:
 Making the invention
 Using the invention
 Selling or offering for sale the
invention
 Importing
the claimed invention
A document that provides a limited monopoly
Not the right to practice the invention
Types of Patents
• Utility Patent – Protects a process,
machine, manufacture, or composition.
• Design Patent – Protects an ornamental
design for an article of manufacture.
• Plant Patent – Protects an invented or
discovered asexually reproduced plant.
Utility Patents
What kinds of things are generally
patentable?
 New chemical entities, including new intermediates,
new salts, and enantiomers.
 Methods of making new compounds.
 New methods of modulating biochemical processes
which are carried out in a human, animal, or plant.
 New kits, for example, containing a new combination of
materials or of materials and equipment used for
diagnosis or treatment.
Utility Patents
What kinds of things are generally
patentable . .
Newly identified DNA, so long as it is claimed in a form
which differs from that in which it occurs naturally. “Myriad
Supreme Court Case” disallows patenting of human
genes but allows cDNAs
Newly created DNA is treated as a new chemical
compound.
 New organisms and parts of organisms such as seeds,
for example, and those containing modified DNA.
Utility Patents
What is not patentable?
Laws of nature (F = ma).
Naturally occurring things such as minerals, plants, and
unaltered organisms.
Requirements
A patent must:

Have utility

Does what it intends to do

Disclosed and enabled

Novel

Nonobvious: to someone of ordinary skill in the
art
Loss of Foreign Patent Rights
• A public disclosure of the invention without an
application on file will destroy most foreign
patent rights (US: 1 year gratis period)
• Public disclosure = public access:
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Published abstracts
Poster presentations
Online publication of manuscripts
Oral paper presentations
Grant submissions (if made available online, for
example)
– Public thesis/dissertation defense or placing it in
library
Utility Patent
The Owner
Priority Date (ie. File Date or
related application) is the
"effective date of filing" for
patent examination of
novelty and nonobviousness.
Prior art considered includes
those made available to the
public before the priority
date.
Utility Patent Claims
"comprising” open-ended term
Encompasses all the elements listed, but may also include additional,
unnamed elements.
Patent Due Diligence
1. Understand the patent claims providing protection of the
technology platform and envisioned product
2. Patent Landscape
Questions to ask?
1. Who is working in this area and are their blocking patents?
2. What part of the market does the technology IP provide protection
for?
3. Can competitors design around easily?
Tools for answers?
1. Resources: USPTO and Public PAIR (Patent Application
Information Retrieval) to view “file wrapper”
2. IP services: law firms and search firms
3. IP Tools/Databases: private solutions such as Innography, etc.
3. Map who is working on this technology/problem to
collaborate on improvements
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,
• 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 are privately held
• The “tragedy of the commons” was coined by Garrett
Hardin to explain why people overused shared
resources, such as common pastures (1968).
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
First to file
• Prior to the “first to file” law change in
2013, the USA was the last country using
the “first to invent” standard for
inventorship
• Part of the America invents Act
• It doesn’t matter who invents first—the one
who files for patent first is deemed the
inventor
The case of the solid body electric guitar—
who would have been the inventor?
• Prior to the electric guitar, the
instrument was buried in the
rhythm section
• Rickenbacker: “frying pan”
Hawaiian slide guitar: 1931
• Gibson ES-150 was the first
Spanish guitar: 1936
• Hollow body guitar had feedback
problems, which limited loudness
Who’s who in solid body electric
guitar design…
• Lester Polsfuss, aka, Les Paul: early
1940s “log” guitar and mid-to late 1940s
“clunkers” (but the clunkers were not solid)
What about Leo Fender?
• Fender Musical
Instruments sold the
first line of solid body
electric guitars in 1950
• Esquire, then
Broadcaster
(Telecaster)—first
prototype, May 1949
• Patent filed April 1951
But what about Paul Bigsby?
• Inventor of the Bigsby tremolo “whammy
bar”
• Made the first playable solid body guitar
“from scratch” for Merle Travis in 1948
Gibson Les Paul
1952
Bigsby’s “Merle Travis”
1948
Fender Stratocaster
1954
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
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–
–
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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
• 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).
• >50 institutional members in 15 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.
Other questions
or discussion points?