Patenting Biotech inventions in India

1. Patenting in India: Biotech
PANKAJ KUMAR
IPR Trainer and the Facilitator
http://in.linkedin.com/in/IPConsultant
8003099120

2. Composition
 Nucleic acid sequence
 Protein sequences
 Antibodies
 Small Molecules
Protectable Biotech Inventions in India
Method of Use
 Treatment
 Diagnosis
 Screening
Tools
 Machines
 Devices
Process
 Method of Making
 Synthesis
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

3. Patents
Attributes:
 Legal monopoly
 Exclusionary in nature
Criteria for Patentability:
Article 27 of TRIPS provides the basis for patentability
 Novelty
 Inventive Step (Non-obviousness)
 Industrial Application (utility)
Limitation:
National in scope
Limited term of 20 years

4.  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
 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)
History of patenting biotech Inventions

5.  Section 3 (Patent Amendment Act 2003) establishes Patentability Criteria for
microbiological processes
 Microbiological process that can be established as ‘inventions’ are
patentable
 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
Indian Patent Act: Biotech Inventions

6. • Definition of “Invention” – Section 2(j)
– Product or process
– New, inventive step and industrial application
• Inventive step - Section 2(j(a)) (2005)
– Identification of a feature of an invention –
“Claims”
– Finding out whether there is “technical
advancement” or “economic significance” or both
in the feature of the invention
– Examining whether it is obvious to a “person
skilled in the art”

7. Is improvement patentable?
“It is important to bear in mind that
in order to be patentable
an improvement on something known before or
a combination of different matters already known,
should be
something more than a mere workshop
improvement; and
must independently satisfy the test of invention or
an “inventive step”.
To be patentable the improvement or the
combination must produce a new result, or a
new article or a better or cheaper article than
before”

8. • Inventive step
• “The expression “does not involve any inventive
step” used in Section 26 (1)(e) of the Act and its
equivalent word “obvious”, have acquired special
significance in the terminology of patent law. The
“obviousness” has to be strictly and objectively
judged”.
• Need for higher standards of patentability
– Need to read higher standards in section 2(j) & (ja)
– Need to read section 2(j), (ja) and section 3 (d) & (e)
together
• Broaden/shrink the public domain?

9. • What are not inventions - Section 3
– “an invention”
• Frivolous or contrary to well-established natural law
• Public order or morality
• In effect traditional knowledge
– Mere discovery
• Scientific principles
• Abstract theory
• Living thing or non-living substance occurring in nature

10. • Improvements – inventive step? (3 (d, e & f))
– Mere discovery of
• new form of known substance – does not result in
enhanced efficacy
• new property or new use of a known substance
– Mere use of a known process, machine or
apparatus unless results in new product or new
reactant
• Explanation – unless they differ significantly in
properties with regard to efficacy

11. • Improvements – inventive step?
– Mere admixture – only resulting in aggregation of
properties
– Mere arrangement or rearrangement or duplication
of known devises each functioning independently

12. • Excluded subject matter
– Method of agriculture or horticulture
– Plants and animals – including seeds, varieties
– Mathematical or business methods
– Computer program per se or algorithms
– Mere scheme or rule or method of performing
mental act or method of playing games

13. Biotech Inventions
What is patentable?
Taq polymerase
naturally-occurring
Purification from
T. aquaticus
PCR
Recombinant form
of Taq polymerase
Novel?
Obvious?
Useful?

14. Biotech Inventions
The catch…
 Expressed Sequence
Tags (ESTs)
 Gene Fragments
 SNPs
 Genetic Tests
(screening, diagnostic)
 Proteins
 Stem Cells
Novel?
Obvious?
Enablement?
Written Description?
Useful?

15. Patent 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
Requirement in the specification for the patent application

16.  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
Written Description Requirement

17.  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
Enablement Requirement

18. 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…
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
Written Description can be satisfied by depositing the biological material (Enzo
Biochem. Inc. v Gen-Probe Inc., Fed. Cir. 2002)
Written Description and Enablement in Biotech Inventions
Patentability Requirements
Yes
x No

19.  Nucleotide, Protein sequences
 Promoters
 Vectors
 Epitope sequences and Antibodies
 Processes used for making the protein
 Method of Use(s): diagnostic, treatment, screening
 Bio-Pharmaceutical Product
Biotech Inventions

20.  Improvement Strategies
(ex: transgenics, knock-outs)
 Gene expression methodology
(ex: antisense, target specific expression)
 Gene expression materials
(ex: specific promoters)
 Gene Constructs
Biotech Inventions
Enabling Technologies

21. 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.?
 Product vs Process Applications
Process Product
 Oppositions

22. Thank You!