Download Biotech Patenting in India - PHARMACEUTICALS EXPORT

March 2009
Current Status of Biotech Patenting
In India
Kausalya Santhanam Ph.D
Patent Agent
USPTO, IPO
Confidential
Patents
Commercial Attributes
Legal monopoly limited in scope and duration (20
years)


National in scope

Exclusionary in nature
Patentability

Novelty

Inventive Step (Non-obviousness)

Industrial Application (utility)
Confidential
Protectable Inventions in Biotech
Composition

Nucleic acid sequence

Protein sequences

Antibodies

Method of Use
Small Molecules
Tools

Machines

Devices

Treatment

Diagnosis

Screening
3(d) Mere discovery of
- a new form
- a new property
- a new use
of a known compound not patentable
unless
differ significantly with regard to efficacy
Process
Confidential

Method of Making

Synthesis
Biotech Inventions
History and Facts
 Article 27 of TRIPS provides the basis for patentability
 US patent law grants patent to microorganisms when modified by human
intervention (Diamond v Chakraborty, US Supr. Court, 1980)
 EPO has similar law with regard to patenting microorganisms
 Patentability Criteria – Novelty, Inventive step (Non-Obvious in US),
Industrial applicability (Utility in US)
 Patenting of transgenic animals – Allowed in the US (ex: oncomouse);
treated on a case by case basis elsewhere
 Dimminaco A.G. v Controller of Patents & Designs (Calcutta High Court, 2002)
Confidential
Biotech Inventions
Indian Patent Act
 Section 3 (Patent Amendment 2003) establishes Patentability Criteria for
microbiological processes
 Microbiological process that can be established as ‘inventions’ are
patentable
 Patentability Criteria – Novelty, Inventive step, Industrial applicability
 Biological material deposited at MTCC and Gene Bank, IMTech, Chandigarh
- all characteristics for identification of the microbial sample
- access to material allowed after publication of the application
- disclose the geographical source of the biological material
 Indian law does not allow patenting of animal, whole or part
Confidential
Biotech Inventions
What is patentable?
Purification from
T. aquaticus
Taq polymerase
PCR
naturally-occurring
Recombinant form
of Taq polymerase
Confidential
Novel?
Obvious?
Useful?
Biotech Inventions
The catch…
 Expressed Sequence
Tags (ESTs)
Novel?
Obvious?
 Gene Fragments
 SNPs
Useful?
 Genetic Tests
(screening, diagnostic)
 Proteins
Enablement?
Written Description?
 Stem Cells
Confidential
Biotech Inventions
Patentability
Utility - US
Specific
Real World
Substantial
OR
Credible
Well established
Industrial Applicability – EP and others
Confidential
Patentability - US
35 USC § 112, 1st paragraph
The specification shall contain a written description of the invention and of the
manner and process of making and using it, in such full, clear, concise, and
exact terms as to enable any person skilled in the art to which it pertains…to
make and use the same, and shall set forth the best mode contemplated by the
inventor of carrying out his invention
Three Prong requirement in the specification

Written Description

Enablement

Best Mode
Confidential
Patentability - US
Written Description Requirement

A patent specification must describe an invention in sufficient detail
that one skilled in the art can conclude that the inventor had
possession of the claimed invention

Possession can be shown by
i. Actual reduction to practice
ii. Reduction to drawings
iii. Describe relevant identifying characteristics
- structure
- functional characteristics (with a correlation between structure
and function)
- physical characteristics
- chemical characteristics
- combination of the above
Confidential
Patentability - US
Enablement Requirement

Disclosure of information sufficient for the ordinary skilled
person to make and use the full scope of the claimed
invention

Disclosure should facilitate the making and using [of the
invention] without undue experimentation
Due to unpredictable nature of biotech, enablement requirement is high
Confidential
Biotech Inventions
Patentability Requirements
Written Description and Enablement (35 USC § 112)
Ex:
The composition of claim 1 wherein said nucleotide sequences are selected
from the group consisting of:
- the N. gonorroheae DNA insert of ATCC 53409, ATCC 53410 and
ATCC 53411 and discrete nucleotide subsequences thereof…
Yes
Ex:
An isolated polypeptide comprising an amino acid sequence of SEQ ID NO: XX
selected from the group consisting of:
- a mature form of the amino acid sequence of SEQ ID NO: XX
- a variant of the mature form of an amino acid sequence of SEQ ID NO: XX
- a fragment of the mature form of the amino acid sequence of SEQ ID NO: XX
x No
Written Description can be satisfied by depositing the biological material (Enzo
Biochem. Inc. v Gen-Probe Inc., Fed. Cir. 2002)
Confidential
Biotech Inventions
Patentability Requirements
Enablement (35 USC § 112)
Ex: US5,756,349
Vertebrate cells which can be propagated in vitro and which are capable upon
growth in culture of producing erythropoietin in the medium of their growth in excess
of 100 U of erythropoietin per 10.sup.6 cells in 48 hours as determined by
radioimmunoassay, said cells comprising non-human DNA sequences which control
transcription of DNA encoding human erythropoietin
Enabled?
By Describing ‘a way’ to make EPO…
Can Amgen claim all cells that propagate in vitro comprising non-human DNA
sequence that control transcription of DNA encoding human erythropoietin?
Amgen v Hoechst (Fed. Cir. 2003)
Confidential
Biotech Inventions
Patentability Requirements
Outcome…
 Those skilled in the art can readily use various cell cultures (vertebrate) to
produce human EPO
 For those skilled in the art it is relatively simple to determine
- whether a certain promoter will work within a specific vertebrate cell
- whether a particular vertebrate cell will produce human EPO in culture
- whether a particular promoter could be operatively linked to control the
transcription
 Publications (in the given area) that demonstrate the extent of the enabling
disclosure
Confidential
Biotech Inventions
Patentability Requirements
Enablement
Wands Factors (In re Wands, Fed. Cir. 1988)
-
Nature of the invention
State of the Prior Art
Level of ordinary skill in the art
Level of predictability
Amount of Direction
Presence of working examples
Breadth of claims
Quantity of experimentation
Confidential
Biotech Inventions
Gene Inventions and exemplary claims
 Nucleotide, Protein sequences
 Promoters
 Vectors
 Epitope sequences and Antibodies
 Processes used for making the protein
 Method of Use(s): diagnostic, treatment, screening
 Pharmaceutical Product
Confidential
Biotech Inventions
Enabling Technologies

Improvement Strategies
(ex: transgenics, knock-outs)

Gene expression methodology
(ex: antisense, target specific expression)

Gene expression materials
(ex: specific promoters)

Gene Constructs
Confidential
Biotech Inventions
Bioinformatics
Genomics
Proteomics
Clinical/Regulatory
Highthroughput
Tools
Data Mining
Data Analysis
Data Storage
Pattern
Recognition
Molecular
Modeling
Predictive Tools
Confidential
Biotech Inventions
Bioinformatics – Challenges in Patenting
 Client oriented – Diverse needs: breadth of claims?
 Anticipate and prevent competition is difficult
 Scarce judicial precedent
 Invention obsolete?
Confidential
Biotech Patenting
Other Issues…
 Bits and pieces: Allowing a single genomic gene to be patented
in several ways (ex: fragments, SNPs, peptides)
 Preventing knowledge sharing (decrease in publications) and
impeding research activities
 Social, ethical and religious issues (ex: stem cell research)
Confidential
Biotech Patents - India
Indian Patent Applications Filed/Granted between 2000 to 2005 in allied
areas
Year
Biotech
Chemical
Drug
2000-01
4/0
787/353
883/276
2001-02
2/0
778/483
879/320
2002-03
46/0
776/399
966/312
2003-04
23/0
2952/609
2525/419
2004-05
1214/71
3916/573
2316192
Source: Indian Patent Office , Annual Report 2004-2005
Biotech Patents - India
 First Product Patent Granted (post 2005 era)
Pegasys (Roche) – Pegylated IFNα 2a
 Increase in no. of Biotech Application Filings
Homegrown company filings less in no.?
Homegrown companies filed outside India pre-2005?
 Product vs Process Applications
Process
Product
 Patent Examiners
About 130-150
Dwindling
 Patent Examining Process
Training in specific fields/art
 Oppositions
Integration of IP and Research
Goal: Tie Applications to Appropriate Process Points
Drug Discovery
Identification
Provisional
Product
Cell Validation
Animal Validation/
Preclinical
Updated Provisional/Utility
Utility/CIP
Clinical
Utility
12 months
12 months
Composition and MOU
Confidential
Formulation and Dose
Portfolio Management
Identification of >25 Compounds
Biology
IP
Disease Groups
IP
Chemistry
Validation
In vitro Studies
Project Management
Preclinical
Animal Studies, Pk, Tox
Regulatory
Affairs
Marketing
Formulation/
Manufacturing
Clinical
Phase I, II
Licensing or Partnering deals
IP Audits
<2 Products
- Patent Application
Confidential
IP Strategies – Related Applications
Gillette
Building a fortress around the basic Invention/ technology
Vacuum chamber in which
the DLC blade
coating was applied
Single point cartridge
loading system - Avoiding
upside down attachment
Use of 3 staggered
Blade getting progressively
closer to skin
Mach 3 Core Technology
(Diamond like Coating)
Indicator strip signaling
when the shaver is no
longer experiencing ‘the optimal shave’
Confidential
New forward pivot design
positioning the blades in
an optimal shaving position
Rubberized contour grip
for better handling
March, 2009
Thank You!