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Date:

October 26, 2000

Subject:

Golden Rice Patent Issues and ISAAA Brief

 

While I have read on AgBioView a RAFI criticism of the below-described
ISAAA brief and Dr. Ingo Potrykus' response to RAFI, I do not believe that
I have seen a formal announcement of the ISSAA brief that was the subject
of those point-counterpoint messages. Hence, although I am not affiliated
with ISAAA, let me provide some information about the ISAAA brief that
sparked the exchange between RAFI and Dr. Potrykus.

R. Kryder, S. Kowalski, A. Krattiger, THE INTELLECTUAL and TECHNICAL
PROPERTY COMPONENTS of pro-VITAMIN A RICE (GoldenRICE [tm]): A Preliminary
Freedom-To-Operate Review, 56 pp. ISAAA Brief No. 20-2000 (Oct. 2000).
U.S. $ 25.00.

I have read this ISAAA Brief that discusses the patent and material
transfer issues related to the introduction of GoldenRICE [tm] into the
seed distribution chains of the developing world. The Brief is excellent
in its clear and thorough explanation of the intellectual property rights,
the source materials, and the options for obtaining intellectual property
licencing and material transfer agreements.

I believe that this ISAAA brief will become a model upon which to build
our understanding of agrobiotechnology for the developing world both at a
theoretical and a practical level about intellectual property issues and
material transfer issues. I recommend this brief highly to scientists
contemplating a project, public and private research entities thinking
about undertaking agrobiotechnology projects, governmental officials
involved in gaining access to agrobiotechnology for their nations, and all
interested in legal issues arising from agricultural biotechnology.

Drew

Drew L. Kershen
Earl Sneed Centennial Professor of Law
University of Oklahoma College of Law
=+=+=+=+=+=+=+=+=+=+=+=+=+=+=+=+=+=+=+=+

From: Prakash@tusk.edu

Readers can order the ISAAA brief on Golden Rice patent issues at
http://www.isaaa.org/briefs/Goldenrice.htm and also see the table of
contents, executive summary and some descriptive information (such as
various options ahead for developing countries and the conclusions) which
I reproduce below.

-----
ISAAA Briefs No. 20 - 2000

The Intellectual and Technical Property Components of pro-Vitamin A Rice
(GoldenRice TM ): A
Preliminary Freedom-To-Operate Review

R. David Kryder, Stanley P. Kowalski and Anatole F. Krattiger Director
(IP/TT Initiative), Management Consultant, and Executive Director (ISAAA),
respectively

Executive Summary

Introduction

Rice is a staple food for millions of people, predominantly in Asia, but
lacks essential nutritional components such as Vitamin A. This is very
important for over 180 million children and women of child bearing age who
suffer from Vitamin A deficiency in Asia alone. For this reason, an
improvement was made under an effort led by Profs. Ingo Potrykus and Peter
Beyer by inserting several genes into rice to produce an improved product
called "GoldenRiceTM". (on the trademark, see Note on Trademark and Domain
Names below). Because GoldenRiceTM has the potential to be easily
integrated into the farming systems of the world's poorer regions, the
advent of GoldenRiceTM promises to go a long way towards solving Asia's
Vitamin A deficiency problem in an effective, inexpensive, and sustainable
way.

Objectives, Limitations and Definitions

As a result of the increasing complexity of the intellectual property (IP)
framework under which the international agricultural development community
operates, the Rockefeller Foundation funded an ISAAA project to conduct a
selective Freedom-To- Operate (FTO) analysis of GoldenRiceTM with the
objectives of:

a. reviewing the IP and Technical Property (TP; or tangible property)
components associated with GoldenRiceTM; b.providing institutions
interested in distributing GoldenRiceTM with the information needed to
develop strategic options for handling the proprietary science embedded in
the product; and c.developing possible alternative strategies on how the
IP/TP constraints could be managed effectively.

Any FTO opinion is a risk management opinion and its results vary on a
country-by- country basis. It is a dynamic opinion; never a definitive
answer. Hence the present document serves as an analytical framework that
can serve as the basis of a legal FTO review. While it contains
information on ownership and statutory protection issues, it is not
intended to be a final legal opinion.

In addition, this report is not aimed at commenting on any institution's
current IP/TP strategy, but on providing relevant information to make
sound policy and strategy decisions. Neither is this study intended to
promulgate any particular approach about how to overcome the IP and TP
challenges while dealing with the proprietary science of agriculture and
plant breeding.

Proprietary Property, or proprietary science, as used throughout this
document, is comprised of: ·
IP or Intellectual Property, which has been taken to mean, without
limitation, intellectual property rights, including patent rights, plant
variety protection certificates, unpublished patent applications, and any
inventions, improvements, and/or discoveries that may or may not be
legally protectable, including all know-how, trade secrets, research plans
and priorities, research results and related reports, statistical models
and computer programs and related reports, and market interests and
product ideas; and ·

TP or Technical Property, which has been taken to mean, without
limitation, tangible property such as computer software, germplasm and the
biological materials and derivatives thereof, and related information.


Results of the Deconstruction of GoldenRice TM

Under the product deconstruction process of GoldenRiceTM, we reviewed
plant/seed source; gene constructs (TP and IP) of cloning vectors
pBin19hpc, pZPsC and pZLcyH; transformation, plant regeneration, and other
techniques; and DNA amplification technologies.

Technical Property

At least fifteen TP components went into the three different genetic
constructs; many of which were acquired by ETH-Zürich under Material
Transfer Agreements or by use licenses. Some of this complexity stems from
the product being a multi-transformant, in which three genes/enzymes
(phytoene synthase, phytoene desaturase, and lycopene cyclase) were
introduced in the carotenoid biosynthetic pathway (Figure 1 shows the flow
chart of the elements that went into one of the three constructs or
plasmids). This required three transformation vectors and the application
and use of many other processes and components. For reasons related to the
confidentiality embedded in these agreements, we are not providing details
of these agreements nor our interpretation of them in this published
version of the FTO. Determining what entity has the right to grant
licenses or sub-licenses is a relatively tedious process, one which
continually evolves as companies re-structure, sell or assign patents, or
grant licenses with or without the right to sub-license. Hence at this
stage we only identified the patents according to the original assignee
and have not determined which entity would have to be approached for
licensing the various components.

Figure 1. Flow chart of Tangible Property Transfers for pZpsC


Intellectual Property

Depending on the country where the current form of GoldenRiceTM would be
used we identified between zero and 44 patents which applied to the
product. In the USA and most countries of the European Union, around 40
patents apply. In the 10 top rice producing countries, many fewer patents
apply, namely: China (11), India (5), Indonesia (6), Bangladesh (0),
Vietnam (9), Thailand (0), Myanmar (0), Japan (21), the Philippines (1)
and Brazil (10). Similarly, in the top ten rice importing countries,
relatively few patents apply: Iran (0), Brazil (10), Nigeria (0), the
Philippines (1), Iraq (0), Saudi Arabia (0), Malaysia (0), South Africa
(5), Japan (21) and Côte d'Ivoire (10).

Recognizing that patent claims may be granted for different kinds of
inventions, claims may be worded to cover products per se, products-by-
process, uses, or processes. Whereas the first three types of claims
generally extend to the products that embed the new discoveries, "process"
claims or claims for the claimed technical procedures do not extend to the
products that are produced by the claimed processes. What is of great
importance for "process" claims is the country in which the process is
applied. If the product is made in a country where those "process" claims
have not been issued, then a license for such claimed processes are not
required.

A total of 26 of the approximately 70 patents identified in this study
contain primarily process claims thus reducing somewhat the number of
applicable patents which could inhibit FTO in a given country. A detailed
analysis on a country-by-country basis may reduce the complexity of the IP
landscape.

Discussion on Alternative IP/TP Management Strategies

Transfer and use of GoldenRiceTM , depending on the country in which it is
to be deployed, would, at a minimum, require agreements from a dozen or so
entities (public and private) for the TP transfer and use. In addition,
again depending on the country of use, between zero and 40 licenses for IP
rights would be required, from a dozen or so entities. In total,
negotiations with 12 to 20 entities might be required, again depending on
the country of release. Noteworthy is that if a regional or international
organization, such as the International Rice Research Institute (IRRI),
wishes to obtain FTO, say for national use in all developing countries in
Asia, licenses for around 30-40 patents would need to be obtained (in
addition to the resolution of TP).

All in all, the widespread release of the current version of GoldenRiceTM
will require significant licensing activity if it is to legitimately
become available to the world, either commercially or for humanitarian
purposes.

We identify and discuss the advantages and disadvantages of six
alternative strategies on how to gain FTO for GoldenRiceTM , namely:

1. Invent around current patents: Research alternative ways to develop
pro- Vitamin A rice, generating new inventions. This option, which is a
science and research based approach, leads to less reliance on other
institution's patents but is likely to be very costly and time consuming
(if at all feasible). It would arguably not constitute a wise use of
development funds.

2. Re-design constructs: Re-design each construct to reduce number of
applicable patents, whenever possible synthesize own genes to reduce
reliance on TP of others. This strategy, which is a product development
based approach, is a likely one as it may be necessary for scientific
reasons to re-design the product. It is an effective way to reduce other
institution's IP and particularly efficient if an FTO analysis is done
prior to initiation of the research. This approach would almost certainly
be the approach favored by any company as the TP issues are potentially
the most difficult ones to resolve.

3. IP/TP owners to relinquish claims: All FTO issues for all GoldenRiceTM
related activities, commercial or otherwise, are eliminated through public
(or private) statements and related activities by the certified
owners/assignees of each set of IP/TP rights for making, having made,
using, having used, importing, exporting, selling, and having sold all
GoldenRiceTM plants, plant parts, and all related products and processes.
This humanitarian strategy focuses on public perception. Some companies
(e.g. Zeneca and Monsanto) already publicly declared that they will make
their technologies available for GoldenRiceTM. This will greatly simplify
licensing negotiations although a royalty- free license may still need to
be negotiated, at least for liability/indemnity reasons. 4.Ignore all IP
and TP: All FTO issues for all GoldenRiceTM related activities, commercial
or otherwise, are ignored, and research and product development as well as
plans for general distribution proceed. This approach is a strategy that
certainly has the lowest near-term costs but may lead to long terms costs,
especially if a lawsuit ensues, and may lead to the longest delay in
product dissemination. 5.Seek Licenses for all IP and TP: All FTO issues
are resolved by the process of any party (individually or through
consortia) acquiring an appropriate (commercial or other) license from the
certified owners/assignees for each set of IP/TP rights for the
GoldenRiceTM related activities that are of interest to the licensee. This
license may be commercial in nature (a grant to make, have made, use, have
used, import, export, sell, or have sold all GoldenRiceTM plants and plant
parts and all related products and processes) or a more restrictive one as
the licensee and licensor mutually determine to be required. This
licensing approach is complex and costly, but may lead to stronger public-
private relationships whereby corporations are also willing to transfer
know-how and future biotechnology inventions. It is also the safest route
and ensures good relations with IP owners (be they from the public or
private sectors).
6.Mix of all Options (1 to 5): While research and development plans are
made to optimize the product, re-design of constructs and acquisition on
TP is planned to minimize IP and TP conflicts (OPTION 2); selected FTO
issues are removed through public (or private) rescinding of rights by
selected holders of certain IP/TP rights (OPTION 3); this i)moral high
groundld is used to leverage additional rights holders to either rescind
their claims (OPTION 3) or to reduce their demands within the context of
license negotiations (OPTION 5). In the end all remaining unrescinded
IP/TP rights can be either licensed (OPTION 5) or ignored (OPTION 4). This
strategy is again complex from the perspective of IP/TP management but
seems to be the most pragmatic and realistic. It capitalizes on the
upsides of most of the other options while reducing the risks of future
complications.

Discussion on Risk Management Strategies

Developing a sound IP management strategy is, in many ways, primarily a
matter of risk management. No one ever definitively knows who has rights
to do what with all IP, because new patents are continually being issued,
older patents expire and patent-related court settlements take place
around the world. All that any organization can do is try to comply with
the FTO opinions that they commission, establish protocols to defend (or
proactively fight) themselves, and seek whatever licenses they believe
that they need to reach their goals.

For international institutions, licensing issues are further clouded
because their donors and clients are from many different nations. Thereby
the statutory protection laws required for full FTO are as varied as their
client list. This leaves such institutions, particularly the centers of
the Consultative Group on International Agricultural Research (CGIAR) with
the challenge as to whether or not to distribute improved germplasm with
full FTO or to pass this responsibility for obtaining FTO along with their
improved germplasm, on to the client nation with a caveat regarding these
matters.

For the present FTO, we also had to make strategic decisions on how wide a
net to cast in terms of listing certain patents where it is not entirely
clear whether or not they apply to GoldenRiceTM, and whether or not to
include patent applications or only issued patents. We opted to cast a
wide net so as to provide those institutions who wish to further develop
and distribute GoldenRiceTM with a broad base of information to make sound
risk management decisions. ISAAA, through the Global IP/TT Initiative, can
be assisting institutions in developing appropriate and pragmatic IP
management options or strategies.

Conclusions

Regardless of which option discussed above or which scenario is chosen,
there are a series of tasks that should be completed in order to
adequately manage the IP/TP. These are:

1.Complete and regularly update the present FTO analysis, preferably on a
country-by- country basis. 2.Develop a scientific strategic plan (who
manages, what is to be done, which biotech and germplasm components are
to be used, where is the research to be done, who is to do the research,
what are the timelines for completion) for finalizing the current
scientific initiative. 3.Draft and negotiate a strategic plan for
distribution (who manages, what must be licensed, list of
licensors/licensees,
acceptable terms, timelines) of the finished product(s). 4.Complete a
cost/benefit analysis for the preferred options. It will be for the
developing countries, which wish to benefit from GoldenRiceTM and for the
organizations whose mandate is to assist these countries to make choices
on the best options to follow. The dominating consideration must be the
impact of GoldenRiceTM on the health and well being of rice producing and
consuming populations. These and related factors will condition the speed
and configuration of the eventual broad release of GoldenRiceTM.

National Agricultural Research Services, once they obtain access to
GoldenRiceTM, may still wish to conduct their own FTO review in order to
confirm which IP issues and TP issues are covered in their country. This
is particularly true if the recipient country foresees an export market
for its GoldenRiceTM. Additionally, any country to which they export their
GoldenRiceTM will likely present a different IP/ TP landscape.