The Problem with Patents

							Amy Yancey modified by Maha Krishnamurthy
         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)
  –   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 (i.e., it
   must be claimed in purified or isolated form).
     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 one of ordinary skill in the art
        Combine 2 or more references
      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:
  – 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 non-
obviousness.

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 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
      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.
                                     Figure 14.4. A family of related tomato
• Further promoter                   E8-related patents derived from the
  characterization identifying the   parent application USSN 448,095
  location and sequence of           [from Fenton et al. (in press)].
  functional elements and
  upstream nucleotide sequence
  was reported.
     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 developing-
  country 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.
   Other questions
or discussion points?