Chapter 16: Biotechnology

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23 Οκτ 2013 (πριν από 3 χρόνια και 11 μήνες)

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Chapter 16: Biotechnology

Patent Issues and Other Controversies

David Bankston

The Use of Biological
Processes
and Materials…

To Help Solve Problems and
Satisfy
Needs

Intro to Biotech

What is Biotech?

What does a Biotech company
do?

Human Genome Project


Started 1990 (DOE & NIH)


“Map Out” Reference Sequence of DNA


3 Billion+ Base Pairs (BP)


3,000 BP / 1 Gene


Largest Gene 2.4 Million BP


1 of ~25,000 Genes


99.9% of BP same in EVERYONE!

Biotech Patent

March 31, 1981
Ananda

Chakrabarty

patented a new
single cell life
form


A
live, human
-
made micro
-
organism is patentable
subject matter
under
U.S.C.S.
ß

101


*FIRACT CASE*
(
Ass'n

for Molecular Pathology v. United States PTO,
2011)


Even
with the patent, No commercial success


Public Opinion (Fear
)

Bioengineered Plants, Animals, & Humans

How far up the ladder of
life should proprietary
rights through patents
be allowed?

Biotech Patent News

Biological Safety Concerns


(
rBGH
)
recombinant
Bovine Growth
Hormone

Milk threatens health


Ecological Fears

Large Fish for consumption good, but bad on environment

Herbicide
-
resistant cross
-
pollinization


International Concerns?

Cartagena Protocol on
Biosafety


Acknowledges a country's right to regulate bio
-
engineered organisms, subject to existing
international
obligations



Does not require product labeling

USA Labeling Agencies

Bioengineered Food/Fuel

Cloning Concerns

Genetic Testing

FIRACT


Ass'n

for Molecular Pathology v. United States
PTO


Background:
On March 31, 1981,
Ananda

Chakrabarty

patented an
isolated DNA
sequences.
Myriad Genetics
patented isolated DNA sequences
BRCA1 and BRCA2 Genes
& Method for screening potential cancer
therapeutics

FIRACT


Ass'n

for Molecular Pathology v. United States
PTO


Decided: July 29,
2011


I. Declaratory Judgment Jurisdiction


Do
the Plaintiffs have standing to exercise declaratory judgment jurisdiction over this case
?



II. Patentable Subject
Matter

-

Composition
Claims: Isolated DNA Molecules


Does
Myriad's composition claims to isolated DNAs provide eligibility for patentability
?



III
. Method Claims


A. Methods of "Comparing" or "Analyzing" Sequences


Does
Myriad's method claims to comparing or analyzing gene sequences
provide
eligibility for patentability?






B. Method of Screening Potential Cancer Therapeutics


Does
Myriad's method claim to screening potential cancer therapeutics
via changes in cell growth rates provide eligibility for patentability
?


FIRACT


Ass'n

for Molecular Pathology v. United States
PTO



Take
-
Home Message




Federal Court
U
pheld

U.S.C.S. 101


Isolated DNA is patent
-
eligible subject matter



D
iagnostic Methods


Functional & Palpable
A
pplications