Patent awareness particularly in Bio-science related inventions

1. Life science & IPR issues
Pankaj Kumar

2. Coverage

3. SCOPE
What is a patent ?
What is patentable?
What is not patentable?
Precautions to be taken before drafting a
specification
Contents of a specification
Claims and their interpretation
Examination practices
PCT
Budapest treaty

5. Monoclonal
Antibodies
Genetic Engineering
THIRD GENERATION BIOTECHNOLOGY
Pharma
Applications
Chemical
Applications
Patent Biotech Animal Biotech
Diagnostic Kits
Incremenatal
Knowledge of
Microbio.
Microbiological of the Late early 20th Century
SECOND GENERATION BIOTECHNOLOGY
Stone Age Empiricism
SECOND GENERATION BIOTECHNOLOGY
Molecular
Bio. & DNA
Vaccines Antibiotics Enzymes
Single Cell
Protein
Cross
Breeding
Use of
Enzymes
Alcohol
Fermentation
BIOTECHNOLOGICAL RESEARCH AREAS

6. “plants and animals in whole or any part thereof other than
microorganisms but including seeds, varieties and species and
essentially biological processes for production of propagation of plants
and animals”
e.g. Cell, Tissue, Organ
Section 3 (j):
Section 3: What are not inventions

7. ESSENTIALLY BIOLOGICAL PROCESS
Essentially biological process is defined as the one that “consists
entirely of natural phenomena such as crossing or selection”.
The decisive factor for categorizing a process as essentially
biological process or non-essentially biological process depends on
the amount of human intervention involved and its impact on the final
result.

8. BIOLOGICAL MATERIAL
The isolated (discovered) biological material does not
constitute a patentable subject matter by IPO despite the fact
it is characterized by specific utility.
The biological material genetically modified preferably
through substantial human interventions are patentable.

9. Section 3: What are not inventions
Section 3(k):
“a mathematical or business method or a computer programme per
se or algorithms”
e.g. Bioinformatics Tools

10. Section 3(p):
“an invention which in effect, is traditional knowledge or which is
an aggregation or duplication of known properties or traditionally known
component or components”
e.g. Turmeric or Neem for therapeutics
Section 3: What are not inventions

11. PATENTS : AN OVERVIEW
Patent : is a limited monopoly right
conferred by the State in consideration of
disclosure of the invention
Steers vs. Rogers :
“…what the letters patent confers is the right
to exclude others from exploiting or using
the particular invention

12. Solution/Invention
Application
Satisfaction of condition
PATENTABLE

13. 1. Introduction to IPR

14. Subjects of IP Concern IPR
Inventions like products or
process for biological
goods: recombinant items
etc
Patent
Device, tool etc: diagnostic
kits
Patent
Brand name/logo Trademark/Service-mark
Literary items Copyright
Integrated circuits Layout designs of IC
Confidential information Trade secret

15. • International Bodies –
WIPO and WTO are the two main international bodies that administer
and oversee international intellectual property obligations.
Types of IP
1. Copyrights
2. Trade Marks
3. Patents
4. Industrial Designs
5. GI
6. Lay out designs of integrated circuits
7. Protection of undisclosed information/Trade Secret according to
TRIPs agreement
8. Plant varieties
9. TK & Biodiversity
10. Utility Models

17. 2. Patentable subject matter
Criteria indicated in the Act’70
Invention (S2(1)(i))
• New product or process (“new invention”-S2(1)(l)
• Involving an inventive step (S2(1)(i)) and
• Capable of industrial application (S2(1)(ac)
“Inventions not patentable” chapter II of the Act’70
• “what are not inventions” sec.3
• “inventions relating to atomic energy not patentable” sec.4

18. 3. Prior art search & search databases
What is a prior art search?
A prior art search is undertaken to ascertain whether an invention is new
and non-obvious, or not. (satisfy patentability)
What are the benefits of a prior art search?
To begin with, a prior art search will uncover any knowledge existing prior
to the invention at hand.
This knowledge might include, but may not be limited to, patent applications,
scientific theses and industrial know-how.
Once this knowledge is obtained, an inventor will get an accurate idea of just
how novel and non-obvious the invention is. Afterwards, the inventor can,
accordingly, re-work his invention and patent application to enable the
grant of a patent for the invention. Thus, a prior art search will help
distinguish between what is already known (prior art) and what is new
(invention).
The secondary benefit of a prior art search is that an inventor can also use such
a search to understand the prevailing state of art in his field of research.
This will give an idea as to how the future scope of research could be.

19. Patent DatabasesAuthorities:
• http://www.ipindia.nic.in/
• http://patft.uspto.gov/
• http://ep.espacenet.com/
• http://www.wipo.int/pctdb/en/
Free :
• http://www.patentlens.net/
• http://www.freepatentsonline.com/
• http://www.indianpatents.org.in/db/testmaina.asp
• https://www.google.com/patents
Paid :
• http://www.delphion.com/
• http://www.delphion.com/products/research/products-
derwentcollection

20. 4. Patent specification
• Speciation may be provisional (PS) or complete (CS)
• In India the prescribed form for such specification is FORM 2
• Components of specification
• Claims

21. 5. Procedure for Patenting (office)

22. INDIAN PATENT OFFICE:
Patent Office Head Quarters at Kolkatta
Mumbai Chennai Delhi

23. INDIAN PATENT OFFICE:
Controller General
Jt. Controller Dy. Controller Asst. Controller
Examiner Examiner Examiner

24. WHAT IS AN INVENTION?
Sec. 2(1)(j)
‘Invention’ means –
a new product or process
involving an inventive step and
capable of industrial application.
(with effect from 2003)

25. INVENTION
• Fundamental research
• Improvement on existing art
• Solving unsolved problems of art/unaddressed
issues
• Different approach

26. BEFORE DRAFTING
• What is the invention ?
• Is invention patentable ?
• Is invention novel, inventive ?
• Prior art/prior disclosure ?
– Oral disclosure ?
– Prior printed publication available to the public ?
– Prior public use ?

27. BEFORE DRAFTING:
VERIFY THE FOLLOWING:
 Conduct search
 Enlist problems in prior art
 What is the problem sought to be solved by the
invention?
 What is the novelty?
 Is the solution obvious?
 Is it excluded under the Law?
 Has publication ensued?
 Ascertain the type of application -whether complete or
provisional is to be filed
 Decide the area and nature of protection- Paris
convention, PCT, ordinary application.

28. WHAT IS NOT PATENTABLE?
Inventions that cannot be patented are:
 Frivolous
 Contrary to well established natural laws
 Contrary to morality or injurious to public health (animals/plants) or to environment
 Scientific principle or abstract theory
 New property or use of a known substance
 Mere admixtures (as opposed in synergistic mixtures) and processes thereof
 Mere arrangement or rearrangement of known devices each functioning
independently of one another in a known way
 Method of agriculture or horticulture
 Treatment of human being, animals including diagnostic methods
 Plants and animals in whole or any part thereof
 Essentially biological processes
 Mathematical or business methods, computer programme per se or algorithm
 Literary, dramatic, musical or ar6tistic work
 Method of playing games
 Presentation of information

29. Composition
 Nucleic acid sequence
 Protein sequences
 Antibodies
 Small Molecules
Protectable Inventions in Biotech
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

30. 1. Genetic engineering process such as:
• A process for recombinant production of a growth hormone
• A modified interfering Ribonucleic acid molecule
• A recombinant modified virus with proper genetic intervention
• A recombinant plastid vector
2. Polypeptides such as
• Markers
• Antibodies
• Vaccines
3. Method of isolation of microorganisms from culture medium;
4. Method of mutation;
5. Host cells (if transformed with a cloning/expression vector)
6. Mutants;
7. Plasmids
PATENTABLE BIOTECHNOLOGICAL DOMAINS

31. NUCLEIC ACID/
AMINO ACID SEQUENCES
• Must be Novel
• Involve Human intervention
• Must have a Utility
• cDNAs
• Promoters
• Enhancers
• Individual exons
• Expressed Sequence Tags (ESTs); only as probes
• Diagnostic kits

32. The microorganisms are patentable, if:
• isolated,
• mutated,
• adapted and
• recombined successfully
MICRO-ORGANISMS

33. WHAT INDIAN PATENT OFFICE SAYS ABOUT
BIOTECHNOLOGICAL PATENTABILITY?
BIOTECHNOLOGICAL INVENTIONS NON PATENTABLE PATENTABLE
Living entities of natural origin √ ×
Seeds √ ×
Plants in whole or there part thereof √ ×
Plant Varieties √ ×
A method of treatment or diagnosis √ ×
A substance freely occurring in nature, if
merely found or discovered
√ ×
Any process of manufacture or production
relating to living entities
√ ×

34. Contd.
BIOTECHNOLOGICAL INVENTIONS NON PATENTABLE PATENTABLE
Micro-organisms × √
Cell line (if artificially produced) × √
Recombinant DNA, RNA, amino acid × √
Hybridoma Technology except protoplast
fusion
× √
Expressed Sequence Tags (ESTs), if it
works as a probe
× √

35. PUBLIC DOMAIN
• Public knowledge - known to persons in the
art. A part of the mental equipment of those
concerned in the art under consideration
• Common general knowledge: All available
public knowledge and all that is published

36. PUBLICATION
Kinds of publications: documents
 papers or publications should provide
unmistakable direction/disclosure of the
invention
• even single disclosure is sufficient - extent of
publication/ availability of publication-
immaterial

37. PATENT SPECIFICATION
Read by:
 Patent Office
 Licensee/Assignee
 Court
 Technical peers/skilled persons
 Competitors
 Commercial players
 General public

38. KINDS OF SPECIFICATIONS
PROVISIONAL COMPLETE
Kinds of applications:
 Conventional (Paris)
 International
 National Phase
 non-conventional
 Divisional
 Patent of addition

39. A PROVISIONAL SPECIFICATION
Pros & Cons
o when there is an Urgency
o commercial disclosure
o Submission of thesis
o Inventors/Seniors leaving the company
o Accidental disclosure
o Many competitors

40. PROVISIONAL SPECIFICATION
o A document describing the invention and need
not contain claims
o Disclose as much as possible
o Decides the date of the application
o FORM 2 “ The following specification describes the
invention”
o Specification can be amended to add new information at
the time of filing
o To be completed in 12 months
o If not- post dating to a maximum of 6 months

41. COMPLETE SPECIFICATION
 Is a techno-legal document, describing
and specifically claiming the invention
• FORM 2 “ The following specification
particularly describes and ascertains the
nature of the invention and the manner in
which it is to be performed.”

42. PATENT SPECIFICATION
Description Claims
• Description discusses the invention
• Claims define boundary of monopoly

43. WHAT IS A COMPLETE SPECIFICATION
“… specification shall fully and particularly
describe the invention and its operation or use
and the method in which it is to be performed;
discloses the best method of performing the
invention which is known to the applicant and for
which he is entitled to claim protection…”
… Section 10(4)

44. DESCRIPTION
• Description must describe the invention comprehensively
• Should fully explain the problem to be solved with example(s)
• No ambiguity
• Best mode: Should be adequate and sufficient so as to enable
a person skilled in the art to perform and repeat the
invention without inventor’s further inputs

45. DESCRIPTION
 To reflect that invention is:
– novel
– inventive
– industrially applicable
– patentable under Indian Patent Law

46. CONTENTS OF THE DESCRIPTION
• Title
• Field of the Invention
• Background of Invention
• Prior Art details
• Objects of Invention
• Statement of Invention
• Detailed description of Invention

47. • A concise statement providing the crux of the
invention
• Care should be taken to incorporate all major
aspects claimed
• Product-Process-Apparatus
TITLE

48. EXAMPLE
• Brush Vs. Cleaning Article
• Pen Vs. Writing Instrument

49.  Opening description
 More details than the title
 Provides utility
 Sometimes used as a tool for search in the absence
of abstract
FIELD OF THE INVENTION

50. BACKGROUND
Provides the technical background of the
invention

51. PRIOR ART
• Is a brief write-up of what
is known before the
invention; sets out the
problems associated with
each of the known art;
and describes the
problem proposed to be
solved by the invention
 In India, this is not
mandatory

52. PRIOR ART
Different approach
Invention

53. PRIOR ART
• Un-solved problems
• Prior art solution not working
• Describe new solution adequately

54. OBJECTS OF THE INVENTION
• Provides purpose of the invention
• Main object(s) and Ancillary object(s)
• Essential aspects and preferred/optional aspects.

55. STATEMENT OF THE INVENTION
• Statement forms the main claim

56. DETAILED DESCRIPTION OF INVENTION
• Sets out best mode of performing the invention
• Describes the invention in greater detail with
examples/illustration/tables/graphs/diagrams, etc
• Description sufficient to enable a skilled person to
put the invention into practice

57. CLAIMS
The main claim defines the essential features and the sub-claims define the
preferred / optional / additional features
The important, main properties need not be merged into the other claim.
A separate claim has to be formed for the important feature(s).
• … is the operative part of the specification
• Defines the monopoly to be conferred by the patent
• Define the metes and bounds of the invention: at the time of
infringement proceedings, only claims will be interpreted
• If you do not claim, you disclaim

58. Do’s and Don'ts
Generic expressions should be supported properly.
The names/terms used should be familiar to the PHOSITA.
Any newly coined terms/named should be clearly described.
Specification must describe the invention concisely.
Examples should explain the solution with no ambiguity.
Disclosure should be adequate and sufficient so as to enable in
the art to perform the invention.

59. Do’s and Don'ts
Chemical Invention
• Substance per se -broad coverage
• Substance can be defined in terms of
nomenclature, general formula, structural
formula, constituents, properties,
constructional or structural features, use, etc

60. Do’s and Don'ts
 Product per se
– Composition/synergy
– product with enhanced efficacy
– Describe essential ingredients of product/composition
– Ratio/percentage of the ingredients
– Their effective amounts
– Any optional/additional ingredients

61. Do’s and Don'ts
Chemical Invention
Process a) Starting materials
b) Steps of the process
c) Various parameters involved in
each step, and
d) End product.

62. Do’s and Don'ts
CHEMICAL PATENTS
Proportions: Provide a broad workable range
unless an exact amount is crucial and essential
to the success of the invention

63. Do’s and Don'ts
CHEMICAL PATENTS
Specify the class and specific chemicals used
Ex: All the oxidants that would enable the
invention, all alkali/acids that would help to
work the invention

64. DRAFTING
Fundamental research:
• PCR technique
– Specification to describe general art
– Approach adopted
– Detailed enabling process
– Best mode

65. DRAFTING
Avoid negative examples
Example;
- Vast difference in the IC 50 values of
anticancer drugs with two different hosts.
-An anticancer drug effective against a
subject may not be providing the similar
result with a subject of another genus.

66. INDEPENDENTLY-WORDED CLAIMS
• Easy to understand the invention
• Easy to search
• Easy to license
• Easy to establish infringement

67. CHARACTERIZATION IN CLAIMS
• Characterization not possible in many cases
• Need not be characterized
• Even if characterized, sub-claims need not be
restricted to characterized part

68. CHECK-LIST
VERIFY THE FOLLOWING:
 Conduct search
 Is the invention patentable?
 Has it been published?
 Ascertain whether complete or provisional is to be
filed
 Enlist problems in prior art
 What is the problem sought to be solved by the
invention?
 Is the solution obvious?
 Non-patentable items

69. CHECK-LIST
• Specific Indian requirements, such as
– Deposition, Source and origin etc.
• Collect all details, such as
– Experimental data/examples/tables/graphs
• Draft the text

70. DECODING EXAMINATION REPORT

71. Filing
12 months
Request for Examination
First Examination Report
Response
Discussion/Hearing
Acceptance/rejection
OVERALL EXAMINATION PROCEDURE

73. OBJECTIONS OF THE EXAMINATION REPORT

75. HOW TO OVERCOME THE OBJECTIONS

76. • Practice of retaining objections of International Search Report
(ISR) & International Preliminary Examination Report (IPER)
• Unity of inventions/formalities – leave to the Attorneys
• File detailed response as early as possible
• Interview with the Examiner
• Submitting expert evidence in support of Applicant’s view
• Citing precedents – Indian cases/ Foreign cases of Particular
relevance
• Grant of corresponding foreign applications, such as US/EP/JP
STRATEGIES AND TIPS

77.  Seeking hearing 10 days before the final date
 Keeping options open to file patent of addition and/or
divisional application for rectifying drafting and/or
prosecution lapses or to prolong the prosecution
 Appeal- IPAB (Intellectual Property Appellate Board) or
High Court
STRATEGIES AND TIPS

78. PROSECUTION IS A NEGOTIATION
- all the grounds of negotiation are applicable
to the prosecution
STRATEGIES AND TIPS

80. ???