Transcript Patents

Patents
Business of Biotechnology
BIT 120
Definition Patent
Government grants which provide inventors with right
to exclude others from practicing invention for 20
years.
Sole owners, producers and sellers of product/process
•Date back to 1374 (Venice)
•Original version of US Constitution
•Farmers ‘own’ plant varieties
Stimulates invention/industry???
Intellectual Property Rights
A. Patents
B. Trade Secrets
private information about procedures and
formulations
C. Copyrights
authorship of published works
D. Trademarks
words or symbols that identify a product
What can be patented?
Machines
Processes
Compositions of Matter
(genetically engineered microorganisms)
Asexually reproduced plants
Biological Materials -Purified or Synthesized
DNA, RNA, plasmids, enzymes
Typically a patent can not be granted for anything that is a
‘product of nature’
Requirements
Novel
Useful
Not Obvious
Patent Application must include
• list of claims about invention and how it
is to be used
•detailed description
Differences Between Countries
A. Timing of Exclusive Rights
Now international agreement:
Patent limited to 20 years from date of filing
[Takes 2-5 years to grant a patent]
[1 year after a publication to apply for patent]
B. tPA
US approved broad application
UK rejected
Japan approved narrow application
Challenging a Patent
A. Patent Appeals Board
B. Lawsuit
Thomas Edison
“a patent is an invitation to a lawsuit”
Notable Patents
1971
Ananda Chakrabarty
Oil-eating bacteria
1st organism to be patented
NOT genetically engineered (No new DNA)
Transformed bacteria with plasmids which contained
genes responsible for breakdown of oil
Controversy: U.S. Patent and Trademark Office
rejected initially because “living things were not
patentable
Notable Patents
1988
DuPont Co.
Oncomouse
First patent for living animal
Transgenic Mouse which contained oncogenes
from other species
Still Humans could not be patented!!!!!
13th Amendment of Constitution
Notable Patents
1974 Cohen/Boyer
Restriction Enzymes
to insert foreign genes
$45 million to Stanford/U Cal
1991 Craig Venter
Individual Human genes
(ESTs)
DENIED
First time request was made for legal rights of a
naturally occuring product
No function for these genes had been established
Partially sequenced cDNAs
Notable Patents
1991
Systemix, Inc.
Hemapoeitic Stem cells
Procedure to Isolate cells
First normal, non-engineered human cells/tissue patent
Royalties
Certain Percentage of All sales paid to ‘Patentee’
Licensing Agreements need to be set up
PATENT PRIORITY
Given to first to invent – (not to
file) – so documentation so
IMPORTANT!
See handout on patents
Business of Biotechnology
Steps of Commercialization
1. Ideas
2. Scientific Development/Market Research
3. First Production Capabilities
4. Testing and Approval
5. Marketing/Final Production
Market Research
Is there a market for this drug/process?
What sales will be generated?
Will market grow? Shrink?
Investment Capital
Facilities
Scientists/Expertise
Equipment
Money put up by venture capitalists
or
Funded by ‘Chemical’ division of Pharma Co.
Investors ‘make’ their money by
sharing in profits
owning stock when company goes public
Genentech
First Biotech Co. to offer shares to public
1980
$35 - $89 20 minutes