46
32
Chapter 5: Objectives and Motivations for Generating Patent Landscape Reports
Producing a Patent Landscape Report (PLR) can be a time intensive and expensive process.
Devoting the resources necessary to generate a PLR is often tied to a business objective, e.g., where
an organization is preparing to make a significant monetary or headcount investment in developing or
moving into a technology area. Various types of organizations have different objectives that need to
be explored in order to make an informed decision about the allocation of resources to a new project
or area. For the purposes of these guidelines, the types of organizations will be either governmental
and inter-governmental, or corporate.
The approach taken to developing a PLR will differ depending on the business objectives that
necessitated the ordering of the report for an individual decision cycle. Generally speaking, PLRs
support informed decision-making. Regardless of the business objective, PLRs have developed a
specific format, and are designed to efficiently address the concerns associated with making high
stakes decisions in technologically advanced areas, with a maximum degree of confidence. For many
years decision-makers operated based on personal networks and intuition. With the institution of
patent analytics, and PLRs, it is possible for these critical decisions to be made with data-driven
approaches that deliver informed choices, and lower risk profiles.
5.1 – Objectives behind Patent Landscape Reports
The issues associated with public policy decisions, initiated by government agencies, are usually
different from the decisions that are important to corporate entities, and their stakeholders. The
analyses of patent information, and the generation of PLRs, are increasingly required by both types of
organizations, in order to understand a technological area. Understanding how the decisions differ
between these two types of entities allows the analyst to tailor their report in order to most efficiently
meet the needs of the respective audiences. In most cases, there is not much overlap between the
objectives associated with each entity, but in the cases of using PLRs to explore technology transfer,
and research and development questions there is substantial similarity in what both groups are
attempting to discover for informed decision-making.
5.1.1 – To Support Governmental Policy Discussions
At the beginning of April 2008, the World Intellectual Property Organization (WIPO) in cooperation
with the Food and Agricultural Organization (FAO) organized a Symposium on Public Policy Patent
Landscaping in the Life Sciences
36
. The stated goals for this symposium provide a succinct
explanation of how PLRs can be used as instruments to inform public policy makers as they look to
tackle technological issues.
The Symposium draws together two important trends:
• Patent information as a tool of public policy: Policymakers who deal with innovation and
access in the life sciences – concerned with agriculture and food security; public health and
pharmaceuticals; and environmental issues – have increasingly focused on the patent system.
They look for clearer, more accessible and geographically more representative information to
support key policy processes. They seek a stronger empirical basis for their assessments on
the role and impact of the patent system in relation to key areas of life sciences technology.
• Improved analytical tools and access to patent information: Rapid growth in the use of the
patent system, and in the diversity of users, has led to an explosion of raw data on patenting
36
http://www.wipo.int/meetings/en/2008/lifesciences/patent_landscaping
43
33
activities in the life sciences. This data is progressively being turned into useful information.
Availability and quality of patent information have increased. Analytical tools and
methodologies are better understood and are more widely available. And greater practical
experience has been harvested from a range of recent patent landscaping initiatives. This
trend opens up enormous practical potential for improved patent information resources for
public policymakers addressing the life sciences.
This Symposium aims to take a first step towards more systematically matching the policy needs – the
international policy agenda on public policy issues of concern in the life sciences – with the practical
capacities – the diverse resources that are now increasingly available to gather, analyze and extract
key trends and findings from patent information.
PLRs are designed to provide efficient access to a large collection of technologically focused data and
to answer key questions about what technologies are covered, which organizations own the patents
and in which countries they are held. Where previously, this data might only be available to the
technologically savvy, now it can be made available to individuals at all technological knowledge
levels. Making technological topics available to policy makers leads to better decision-making and
additional resources devoted to critical issues. Within the context of Governmental Policy discussions,
an examination of the activities associated with various jurisdictions can help identify the elements
required for preparing PLRs for these agencies.
5.1.1.1 – Global Efforts
WIPO is involved with several global efforts to enhance the availability of information on patent
activity. A WIPO Magazine article, Shedding Light on the Life Sciences: Patent Landscaping for
Public Policymakers provides excellent reasons for why these international efforts are necessary for
informed public policy discussions
37
.
Good quality information about patenting activity is an essential input for some of the most critical
international policy debates today. Yet patent information is unavoidably complex, constantly evolving,
and difficult to capture in readily accessible form for a non-specialized audience. There are real risks
associated with making judgments on the basis of limited patent landscapes without considering the
full technical and legal context. Thus the demand for reliable patent landscaping in the life sciences is
strong, and there are no shortcuts to meeting that demand.
A positive feedback loop is developing: patent informatics are delivering increasingly focused and
accessible information products for policymakers, who in turn can sharpen and distil their demands for
patent information, leading in turn to increasingly more relevant and useful support. Patent
landscaping is not a substitute for the policy debates and deliberations on the key life sciences issues
of the day. But it can inform, support and strengthen the factual basis for discussions, so assisting the
policymakers in those fields to set future directions on health, the environment and food security.
WHO’s Global Strategy and Plan of Action also identified the need to improve access to patent
information to facilitate the determination of the patent status of health products. It urges stakeholders
to:
37
http://www.wipo.int/wipo_magazine/en/2008/04/article_0005.html
60
34
•
Facilitate access to user-friendly global databases which contain public information on the
administrative status of health-related patents. This includes supporting existing efforts for
determining the patent status of health products, and to
•
Promote further development of such global databases including, if necessary, compiling,
maintaining and updating such global databases.
To date, there was no comprehensive overview of patenting activity and trends in the area of
vaccines. In the framework of policy discussions at the World Health Assemblies on vaccine local
manufacturing, WHO and WIPO jointly developed a patent landscape report
38
that provides an
overview on what is being patented in terms of selected disease targets, who is doing the patenting,
where patents are filed and on how patent policies change over time. This provided the factual
evidence and the background to support the related policy discussions.
WIPO has also worked with the World Health Organization (WHO) on understanding the patent
environment associated with essential medicines from around the world. In a summary of this work
39
,
the following details were shared:
For more than 30 years, the WHO has published a Model List of Essential Medicines, which is
updated every two years. Most countries have adopted the concept and have developed their own
national lists of essential medicines. One important question is to what extent patents protect the
essential medicines on the WHO Model List. One of the projects presented at the symposium focused
on assessing the patent status of the medicines that have been added to the WHO Model List in
recent years. The study, based on data from the US Federal Drug Administration's Orange Book,
identified relevant patent families for these medicines in countries where patent data were available.
Access to affordable generic medicines can be achieved through licensing agreements. A new
approach to increase access this way is the creation of a patent pool for antiretroviral medicines,
undertaken by the Medicines Patent Pool, a United Nations-backed organization established in
2010
40
. This requires reliable patent information, including:
1. Knowing what patents cover the products to be used;
2. What the patents exactly cover for these products;
3. Who holds the patents;
4. The countries where the patent applications have been filed and where they have bbeen
granted; and
5. The current legal status of those patents.
These are complex tasks. Many national and regional patent collections can only be consulted on-
site. Information is often not updated or incomplete, especially on the legal status. With the support of
WIPO (among others through the preparation of two patent landscape reports on Ritonavir
41
and
Atazanavir
42
, and information collected by WIPO with the support of national IP Offices), and a wide
range of national and regional patent offices, the Medicines Patent Pool has identified the legal status
38
http://www.wipo.int/patentscope/en/programs/patent_landscapes/reports/vaccines.html
39
http://www.wipo.int/edocs/mdocs/mdocs/en/who_wipo_wto_ip_med_ge_11/who_wipo_wto_
ip_med_ge_11_www_169578.pdf
40
http://www.medicinespatentpool.org
41
http://www.wipo.int/edocs/pubdocs/en/patents/946/wipo_pub_946.pdf
42
http://www.wipo.int/edocs/pubdocs/en/patents/946/wipo_pub_946_2.pdf
61
35
of key patents for selected antiretroviral medicines in low- and middle-income countries
43
.
A database
has been launched in the meantime to allow open access to this resource and the legal status
information related to these medicines
44
. The discussion raised the question of whether patent pooling
could be a general solution in cases of patent thickets, i.e. situations involving overlapping patents,
which prevent competition.
In some cases, PLRs have also an awareness raising role on the importance of the IP aspect and
patent information in policy discussions of various subject matters involving technology; and they can
also have an impact. After WIPO’s collaboration with IRENA
45
, the International Renewable Energy
Agency, and the production of a PLR on Desalination Technologies and the use of Renewable
Energies for Desalination
46
, the importance of IP and patent information became more clear to IRENA
and its stakeholders and some years later it even lead to the launch beginning of 2015 of IRENA’s
Standards and Patent Information Platform
47
.
WIPO has generated several PLRs associated with these on-going, global efforts. Additional details
on these efforts and a list of available PLRs can be found at:
http://www.wipo.int/patentscope/en/programs/patent_landscapes/index.html.
5.1.1.2 – Regional Efforts
The World Health Organization works regionally, specifically in developing countries, to ensure that
access to vital medicines is available to individuals of all economic and social backgrounds. In order
to understand the technology, and IP rights, associated with providing access to critical care, WHO
has worked with WIPO and the World Trade Organization (WTO), and looked at the patent activity
around vaccines. On February 18
th
2011, the three organizations organized a joint Technical
Symposium on Access to Medicines, Patent Information and Freedom-to-Operate
48
that provides
details on this regional effort.
In the field of vaccines, WHO is monitoring the patenting activity to identify the extent to which
vaccines and production technologies are protected by intellectual property. When patents apply, in
some cases WHO supports research on alternative technologies or negotiates licenses with the right
holders on behalf of developing country manufacturers. For most existing vaccines, patents do not
generally prevent production by competitors, but there are some notable exceptions, including reverse
genetic engineering, a key technology for the production of pandemic influenza vaccines and the
human papilloma- virus vaccine.
43
The database coverage as of June 1, 2015 can be found at
http://www.medicinespatentpool.org/wp-content/uploads/Patent-Status-Table-1June2015.xls
44
http://www.medicinespatentpool.org/patent-data/patent-status-of-arvs/
45
http://www.irena.org/
46
http://www.wipo.int/patentscope/en/programs/patent_landscapes/reports/desalination.htm
l
47
http://community.irena.org/t5/Innovation-for-Energy-Transition/LAUNCH-OF-IRENA-S-
STANDARDS-amp-PATENTS-INFORMATION-PLATFORM/gpm-p/2257
48
http://www.wipo.int/meetings/en/2011/who_wipo_wto_ip_med_ge_11/program.html
47
36
A major barrier to increasing the uptake of vaccine manufacturing in developing countries is the lack
of know-how. Thus WHO also focuses on the transfer of vaccine production technology to these
countries.
The Dengue Vaccine Initiative of the International Vaccine Institute presented a global freedom to
operate analysis with different candidates for dengue vaccines. The goal was to understand how
intellectual property may affect access to future vaccines in developing countries and to evaluate how
free developing country developers are to market their vaccines internationally.
The analysis revealed that the sponsors of vaccine candidates seem to have intellectual property
required to regulatory agency approval for their candidates and to market them. However, in the
future, problems might still arise from patent applications, which cover certain delivery mechanisms.
WIPO is also working closely with various national institutions to support them in addressing issues of
interest for various regions. For instance, WIPO is working in collaboration with the Malaysian
(MyIPO), the Malaysian Palm Oil Board and the Phillipines IP Office (IPOPHIL) on a Patent
Landscape Report on Palm Oil Production and Waste Exploitation Technologies, providing a general
overview of related technologies globally, but also with a focus on the region whose economy is
strongly active in the field.
5.1.1.3 – National Efforts
Several Intellectual Property Offices have become engaged in the field of patent analytics, e.g., the
Intellectual Property Office of the United Kingdom (http://www.ipo.gov.uk/) initiated an informatics
team in 2009 with the stated goal of “using patent data to mine, reveal, and inform, for government
and for industry”
49
. To date they have twelve PLRs listed on their reports page
50
covering topics from
stem cells to 3DTVs. They list the following national benefits to the use of patent analytics and PLRs
to both governmental and business interests in the United Kingdom:
• Innovation Policy – Providing evidence of the emerging trends in technology
• Investment Opportunity –
Identifying the technologies that could create a whole new
market
• Competitor Intelligence –
Profiling your competitors using their patent portfolios
• Knowledge Transfer –
Analyzing the flow of knowledge and collaborations
• Geographical Profiling –
Comparing markets between countries and regions
Looking at the specific objectives listed in the IPO study on the generation of energy from waste
materials, the following rationales are given:
The objectives as defined in the original project proposal are as follows:
• Provide an overall patent landscape analysis in the technology area of Energy from Waste.
• Provide analysis of the level of UK research in comparison to the rest of Europe and rest of the
world.
• Identify key active companies and key patent applications.
The objectives for Phase II were designed to focus on the UK energy from waste patent landscape,
covering:
49
http://www.ipo.gov.uk/informatics.htm
50
http://www.ipo.gov.uk/informatics-reports
42
37
• Specific technology fields: biogas / biohydrogen from waste
• Emergent technologies
• UK patent applicant types: commercial, academic, or government
• The activities of individual patent applicants and the extent to which they influence the overall
patterns in the UK
• Consolidated IPC classifications to form larger groups and produce more focused results
• Producing and interrogating a UK patent landscape map
The objective for Phase II, in particular demonstrates how the creation of PLRs can assist the
development of high impact technologies within national jurisdictions. Investing in high impact
technologies helps to establish both academic and industrial centers of excellence within a country
that often leads to an increase in the number of organizations that will establish research and
manufacturing facilities in the country.
5.1.1.4 – Technology transfer and licensing
In order to assist industries residing in their countries, several national governments have recently
started purchasing patent assets on behalf of the organizations that manufacture products in their
jurisdictions. A news story on this practice from Reuters
51
provides details on this practice:
France Brevets was launched in 2011 with 100 million euros, half from the state and half from the
Caisse des Depots, a publicly managed investor in French economic development.
Pascal Asselot, licensing director for France Brevets, said that by assembling patent pools with
intellectual property bought from French and foreign businesses, France Brevets aims to convince
other companies to sign licensing deals and pay royalties. If France Brevets can show a healthy
revenue stream, the hope is to attract sustainable private investment, Asselot said.
Korea's Intellectual Discovery, which was started in 2010 amid government fears that domestic
companies were losing key patents that could be used against them by foreign companies, has a
$140 million government commitment.
Prominent South Korean companies like Samsung Electronics Co Ltd and LG Electronics have signed
up as "shareholders," providing Intellectual Discovery with additional revenue in exchange for a
license to its patent portfolio.
Intellectual Discovery chief general manager Chant Kim compares the company to San Francisco-
based RPX Corp, which acquires patents to protect its members but doesn't initiate lawsuits.
PLRs are often used by organizations exploring technology transfer, and licensing in order to
understand what other organizations have invested in a particular area. If another organization has
invested in a technology, especially if the investment was made a few years earlier, there is a higher
likelihood that they will be receptive to hearing about new developments, and potentially acquiring or
licensing the technology.
While government agencies have shown recent interest in this area, it has been established practice
for many years for technology intensive corporate entities. Many examples abound, including Texas
51
http://www.reuters.com/article/2013/03/20/patents-nations-idUSL1N0BZ10C20130320
48
38
Instruments and Tessera, of companies that originally received most of their revenue from the sales of
physical products, but began to shift their business models to rely more heavily on revenue generated
from licensing.
5.1.1.5 – Research and development (R&D) decision-making
As was seen in the UK IPO national efforts example, the use of PLRs can influence decisions around
investments in academic and non-profit funding for the creation of economically favorable
technologies, which can increase the Gross Domestic Product of a country. Governments use PLRs
to ensure that investments in R&D will be directed to technologies and industries that will ensure their
future competitiveness in high impact areas.
Understanding patent rights also have a major impact on R&D since patents, by their nature, are a
right to exclude, and this can have a significant impact on the ability to conduct further research in an
area covered by them. Different countries allow for different Research Exemptions involving patent
rights. The Wikipedia page on Research Exemptions
52
provides the following details on the
International framework around this exemption:
Article 30 of the WTO’s TRIPs Agreement permits this type of exception:
“Members may provide limited exceptions to the exclusive rights conferred by a patent, provided that
such exceptions do not unreasonably conflict with a normal exploitation of the patent and do not
unreasonably prejudice the legitimate interests of the patent owner, taking account of the legitimate
interests of third parties.”
PLRs are an excellent method of determining which technologies have patents associated with them,
and in which countries those rights are in-force. If the initiation of R&D, in a particular region, is one of
the objectives of the report, then additional discussion of the Research Exemption law for that region
should be included.
Corporate entities are also subject to the same dynamics, when it comes to R&D decision-making and
PLRs are often generated in this sector as well to support management. A particularly good example
of this involves the so-called Safe Harbor exemptions that allow for R&D activities in association with
the generation of generic drugs. The Wikipedia page on Research Exemptions
53
discusses this
situation as well:
In patent law, the research exemption or safe harbor exemption is an exemption to the rights
conferred by patents, which is especially relevant to drugs. According to this exemption, despite the
patent rights, performing research and tests for preparing regulatory approval, for instance by the FDA
in the United States, does not constitute infringement for a limited term before the end of patent term.
This exemption allows generic manufacturers to prepare generic drugs in advance of the patent
expiration.
In the United States, this exemption is also technically called § 271(e)(1) exemption or Hatch-
Waxman exemption. The U.S. Supreme Court recently considered the scope of the Hatch-Waxman
exemption in Merck v. Integra. The Supreme Court held that the statute exempts from infringement all
uses of compounds that are reasonably related to submission of information to the government under
any law regulating the manufacture, use or distribution of drugs.
52
http://en.wikipedia.org/wiki/Research_exemption
53
Ibid
39
39
In Canada, this exemption is known as the Bolar provision or Roche-Bolar provision, named after the
case Roche Products v. Bolar Pharmaceutical.
In the European Union, equivalent exemptions are allowed under the terms of EC Directives
2001/82/EC (as amended by Directive 2004/28/EC) and 2001/83/EC (as amended by Directives
2002/98/EC, 2003/63/EC, 2004/24/EC and 2004/27/EC).
In both governmental and corporate environments PLRs are an essential tool for understanding the
competitive environment around research areas of interest, and discovering whether groups
interested in pursuing research initiatives have the freedom to do so.
5.1.2 – Business or corporate uses
While there are some overlaps between the uses of patent analytics, and PLRs for governmental
policy decision-making, the circumstances under which these tools are used for business, or
corporate situations can be somewhat different. The methods used to generate a PLR, under both
circumstances, are similar, but the implications, both in the short and long term, can vary significantly.
5.1.2.1 – Competitor monitoring
Competition is an inherently business related concept and it is nearly impossible to find a successful
industry in which there is not some form of competition between organizations looking to gain an
advantage over other companies in a space. Since businesses compete against one another,
understanding the capabilities, resources and expertise associated with a competitor becomes a key
component of corporate strategy.
These ideas are often associated with Sun Tzu, in The Art of War, when he said the following:
“If you know the enemy and know yourself, you need not fear the result of a hundred battles. If you
know yourself but not the enemy, for every victory gained you will also suffer a defeat. If you know
neither the enemy nor yourself, you will succumb in every battle”
This thinking is often applied to business strategy and is especially the case when looking at
technologically focused industries. PLRs usually answer the first question in a strategy session; does
my competitor have patent rights in any of the areas of interest? They also address the next, follow-up
question; how many do they have and in what aspects of the technology do they have coverage?
Patents can provide knowledge on levels of competitive expertise, timing, and investment, in addition
to providing a right to exclude. They are even more important in technology intensive industries since
many of the insights contained in them are only published in patents and are not described in other
types of publications.
5.1.2.2 – Technology monitoring
Corporate entities usually associate themselves with specific technological areas. In the
Pharmaceutical industry, for instance, no single company can excel in all therapeutic areas. Most
companies tend to focus on a few areas, and concentrate their efforts on those items to the exclusion
of others. There may be specific competitors, which the organization will monitor, but it is recognized
that innovation can come from unexpected sources, and as long as it covers an area of interest, the
company will be aware of these new developments regardless of their source.
Documents you may be interested
Documents you may be interested
