Intellectual Properties in
Biotechnology
What is Biotechnology?
Biotechnology = bios (life) + logos (study of or essence)
– Literally = the study of tools from livingthings‘
"any technique that uses living organisms (or parts of living
organisms) to make or modify products or to improve
plants or animals, for beneficial use"
Biotechnology & the Law
Branches in Biotechnology
40
30
20
10
Intellectual property rights
✓ Intellectual property (IP) is the creation of
the human mind—the intangible intellect
that can translate into tangible products.
✓ Intellectual property rights (IPR) protect
the use of these human creations.
✓ The major elements or forms of
intellectual property rights today include
i) patents
ii) utility models
iii)industrial designs
iv) trademarks and service marks
v) geographical indications
vi) layout of integrated circuits
vii) copyright
The main systems of protection for biotechnology:
➢rights in plant varieties/ genes
➢patents:
―The right to exclusively produce, use and/or market a
•Product
•Process
•Application
✓Today, IPR plays an important role in every sector and has become an
important aspect of research for Pharma and research oriented industries.
The continuous efforts of the government in policy establishment, IP
protection, infrastructure, IPR search portals and manpower made this
Industry a step ahead.
Categories of Intellectual Property
• Industrial property, which includes inventions
(patents), trademarks, industrial designs, and
geographic indications of source.
• Copyright, which includes artistic works such as
novels, poems and plays, films, musical works,
dance, artistic works such as drawings, paintings,
photographs , sculptures, and architectural
designs.
• Rights related to copyright include those of
performing artists in their performances,
producers of phonograms in their recordings, and
those of broadcasters in their radio and television
programs.
IP is important!
Legally-protected competitive advantage over
your competition
IP-driven companies:
– Procter & Gamble
– Disney
– Johnson & Johnson
– Microsoft
The Four “Flavors” of IP
➢Trademarks
➢Identify source of goods
➢Copyrights
➢Protect works of authorship
➢Trade Secrets
➢Protect processes, information
➢Patents
➢Protect processes,
compositions, devices
What You Need to Know About Patents
What legal rights do patents provide (and
not provide)? Who owns these rights?
What types of inventions are patentable?
What are the legal requirements for
patentability? What problems can arise?
What is the process for patenting an
invention? Who is an inventor?
Why are the claims so important?
What is a Patent?
A PATENT IS A BUSINESS TOOL.
In Academia: patents spur interest in
turning research results into
products that benefit the public.
Patent Examples
Animal Ear Protector
Wearable Pet Enclosure
Toy Bar Soap Slide
High Five Simulator
A Notable University Patent
Patents Provide an Exclusive Property Right
- A patent DOES NOT
confer to the owner the
right to practice the
claimed invention!
- A patent IS NOT a
“Seal of Approval of
Excellence in
Technology” from the
U.S. Patent and
Trademark Office!
A Patent is “A Contract with Society”
Inventor gives to society:
– A written description of his/her invention
that sufficiently teaches “one of ordinary
skill in the art” how to make and use the
claimed invention, and that sets forth
the “best mode” at the time of filing the
patent application.
Inventor gets from society:
– About a 20 year monopoly from the filing
date to exclude others from practicing
the claimed invention.
The “CLAIMS” are key…
Claims – provide the metes and bounds of the
right that the patent confers to exclude others
from “trespassing” on the invention:
The Claimed
Invention
Claim Terminology
“comprising”
– is synonymous with “including”,
“containing”, or “characterized by”
– is inclusive or open-ended and does
not exclude additional, unrecited
elements or method steps
Claim Analysis
Example claim:
1. A cutting device, comprising:
a metal blade having a cutting edge, and
a handle attached to the metal blade.
ANALYSIS: Any cutting device that has a metal blade
having a cutting edge, and a handle attached to
the metal blade will infringe the claim.
DO THESE INFRINGE?
Yes
? ?
Yes ?
Yes No
?
A Variety of Patentable Inventions
Machines &
Devices
Processes
Articles of
manufacture
Compositions of
matter
Note especially…
– Improvements to known technologies
– New combinations of known
technologies
– New uses of known technologies
– … are all patentable!
What is not patentable?
• Laws of nature
• Natural phenomena
• Abstract ideas
• Humans
Requirements for Patentability
(Important!) Search patents,
publications, public
Utility – it must be useful
uses (news, internet,
Novelty – it must be new * USPTO website, etc.)
Non-obviousness – it can’t be a mere
variation of what was done before
Enabling Description -- application must:
– fully disclose invention (including “best mode”
contemplated at time of filing); and
– allow a person having ordinary skill in the art to
make and use the invention
Example - Patenting Your Invention
time
Lee Taylor, et al., UH
OTTED
Obtaining Patents
Draft a patent application (use a patent
attorney)
– describe how to make and use the claimed
invention
– disclose your “best mode”
– File it with the MyIPO
Intellectual Property Agency in Malaysia
Micro-Organisms
Micro organisms can be patented
–Isolated
–Mutated
–Adapted
–Recombinant
•Mandatory deposition of the micro organism in an IPO
•Source and geographical origin to be disclosed
Recombinant Micro-Organism
Genomic Vector DNA
DNA Process and
Product Patentable
Ligate
Products
-Human insulin
Recombinant clone in plasmid vector -
Immunoglobulin
-vaccine
-Blood clotting
Protein product Micro-organism, variants
factor
-Bt-toxin
Patentable Patentable
Plant Processes
Patentable Inventions
•Processes involving plants to
increase the yield
•Genetic transformation
•Tissue culture methods
•Micro-propagation
•Somatic embryogenesis
Gene Patents
Useful Product
• Claims
• DNA of specific function/nucleotide sequence
• Protein/Polypeptide from DNA sequence (if
novel)
• Recombinant plasmid (vector)
• GM Organism containing the plasmid
• A process for the production of the product
Application of DNA sequences in
relation to patent claims
• Diagnostic -BRCA1
testing -CCR5 Receptor
• Research tools -MSP 1 Antigen
• Gene -Cystic fibrosis
Therapy -Various cancers
• Production of proteins -Human
Insulin -Epo
Gene Patent
• Human/Animal genes can be patentable if
they can be distinguished from genes as
they naturally occur in human / animal
bodies- naturally occurring genes cannot be
patented (Vary in different countries)
• First gene patent was for cystic fibrosis gene
(US 5,776,677)
Application of Patents to DNA Sequences
• As long as form in which DNA sequence is
claimed would not exist in nature without
human intervention, sequence may be subject
of a patent claim
Examples
• DNA sequence in isolated form
• DNA sequence together with another sequence
• DNA sequence that does not exist in nature
even if close to it
Process vs. Product
• Patents may be issued over DNA
sequences, on ways of making DNA
sequences, or on ways of using DNA
sequences
• A patent on the DNA sequence itself
prevents all others from making, using,
selling or importing that DNA sequence
for any industrial purpose
Research Exemptions
• Inventions may be used without fear
of infringement for
– Research
– Experiments
– Education and training
