This document discusses research tools in molecular biology and their patenting. It defines research tools as resources used by scientists that have no immediate therapeutic or diagnostic value, including cell lines, reagents, and laboratory techniques. The document outlines three categories of research tools, examines concerns about accessing patented tools and their effects, and notes both risks and difficulties in patenting research tools.

1. PAT E N T I N G R E S E A R C H T O O L S
D R S U M I T H A J
A S S O C I AT E P R O F E S S O R
D E PA R T M E N T O F M I C R O B I O L O G Y
J B A S C O L L E G E F O R W O M E N , C H E N N A I - 1 8

2. R E S E A R C H T O O L S
• Research tools are resources used by scientists, where those resources have
no immediate therapeutic or diagnostic value.
• In biotechnology, research tools may include cell lines, monoclonal
antibodies, reagents, animal models, growth factors, combinatorial chemistry
libraries, drugs and drug targets, clones and cloning tools, methods,
laboratory equipment and machines, databases and computer software.
• The defining feature of a research tool is that its social value is realized, for
the most part, when it is used to discover a drug or therapy that is eventually
commercialized and used.

3. T H R E E B A S I C C AT E G O R I E S O F R E S E A R C H T O O L S
• Research techniques. Some gene patents cover laboratory techniques that molecular
biologists use in research, such as the Cohen–Boyer techniques (for gene-splicing) and
the polymerase chain reaction (PCR) methodology (for DNA amplification).
• Research consumables. Some gene patents cover particular enzymes or reagents that
are used in the laboratory, such as Taq polymerase (used in PCR) and restriction
enzymes (used in cloning and other applications).
• Research targets. Some gene patents cover genetic materials that are targeted in
research, for example genes for receptor proteins used in designing new drugs or
vaccines, such as the HIV-receptor CCR5.This category also includes expressed
sequence tags (ESTs) and single nucleotide polymorphisms (SNPs), which can be
targets of research or used to target other genetic materials.

4. R E S E A R C H T O O L S I N M O L E C U L A R B I O L O G Y
• ”Research tools" is not a term of art in patent law.
• No legal consequences flow from designating a particular discovery as a
research tool.
• Research tools are not categorically excluded from patent protection nor is
the use of patented inventions in research categorically exempted from
infringement liability.

5. U S E A N D L I C E N S I N G O F R E S E A R C H T O O L S
• Access to patented research tools is largely dependent on the availability
and terms of licences granted by patent holders to researchers who wish to
use them during the term of the patent.
• Licences may be exclusive or non-exclusive. For example, the Cohen–
Boyer patents held by the University of California San Francisco and
Stanford University were subject to the grant of multiple, non-exclusive
licences in return for minimal licence fees. This licensing strategy meant
that users of the invention were inclined to obtain licences, which led to
broad distribution of the technology

6. U S E A N D L I C E N S I N G O F R E S E A R C H T O O L S
• Licensing may provide rights to use research tools with the purchase of
products. This model is sometimes applied to PCR, where the Taq
polymerase that is required for PCR is purchased from a biotechnology
company licensed to manufacture and sell the enzyme. The purchase price
includes limited, non-transferable rights to use that product for research
purposes only. Further, for PCR to be authorised it may have to be
performed in thermal cyclers purchased from a licensed supplier

7. U S E A N D L I C E N S I N G O F R E S E A R C H T O O L S
• Licence agreements for the use of research tools may contain ‘reach-
through’ provisions, which give the patent holder ownership, licence rights
or royalties in relation to future discoveries made by licensed researchers.
• Reach-through licence agreements may offer advantages to both patent
holders and researchers, by permitting researchers to defer payment until
the research yields valuable results and by providing patent holders with
the opportunity to make profits from sales of downstream products, rather
than from defined, but smaller, upfront fees

8. C O N C E R N S - A C C E S S T O R E S E A R C H T O O L S
• Affects Large areas of medical research and lay down a legal barrier to the
development of a broad category of products’
• Collaboration and sharing of materials between researchers, noting that
the terms of licences or material transfer agreements ‘can be such that they
ultimately make collaboration and communication with other researchers
more difficult

9. E F F E C T S O F PAT E N T I N G R E S E A R C H T O O L S
• The effects of patenting research tools will vary.
• For example, patents are unlikely to interfere substantially with access to such research
tools as chemical reagents that are readily available on the market at reasonable prices
from patent holders or licensees.
• Many of the tools of contemporary molecular biology research are available through
catalogs under conditions that approach an anonymous market.
• Some are patented, but the patents are unlikely to interfere with dissemination. Indeed,
it might be cheaper and easier for researchers to obtain such a tool from the patent
holder or from a licensed source than it is to infringe the patent by making it themselves.

10. R I S K S O F PAT E N T I N G R E S E A R C H T O O L S
• Some research tools can only be obtained by approaching the patent
holder directly and negotiating for licenses
• The holders of patents on research tools will choose to license them on an
exclusive basis rather than on a nonexclusive basis
• Imposing "reach-through" royalties on sales of products that are
developed in part through use of licensed research tools
•

11. D I F F I C U LT Y O F PAT E N T I N G R E S E A R C H T O O L S
• The value of the license cannot be known in advance, so it is difficult to
figure out mutually agreeable license terms
• Inventions that have substantial current value as research tools but might
also be incorporated into commercial products in the future