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Title: Drafting Patent Specification By Ravi Bhola Partner K


1
Drafting Patent Specification
By Ravi BholaPartnerKS
PartnersBangalore
2
Contents of a Patent
  • Bibliographic Data
  • Title
  • Background Art
  • Objects of the Invention
  • Summary/Statement of the Invention
  • Detailed Description of the Invention
  • Examples Drawings
  • Claims
  • Figures/Drawings
  • Abstract

3
Background Art
  • Represents existing state of the technology in
    question
  • Talks about limitations of existing technologies
  • Reflects upon the needs for innovation in said
    technology area

4
Relevance of Good Prior Art Search
  • Determines fate of the Patent Application
  • Must disclose all relevant prior art documents in
    the patent Application and clearly distinguish
    them from the invention
  • Comprehensive search is a must
  • No search is exhaustive
  • Limitations of foreign language text
  • Search tools and databases

5
Databases
  • STN
  • Micropat
  • Elsevier
  • Delphion
  • Patent Office websites of USA, EPO, JPO etc.

6
Detailed Description of the Invention
  • Complete disclosure of the invention is a must
  • Patent granted in lieu of complete disclosure
  • Requirement of enablement
  • Supported by examples and drawings
  • Establishes that innovators are indeed in
    possession of technology
  • Envisage all possible applications achievable
    through said invention

7
Examples
  • Provides finer details of the technology
  • Establishes invention
  • Monopoly under patent is not limiting to examples
  • Monopoly can be extrapolated to reasonable extent
    beyond the scope of examples
  • Addressed to a person of Average-Skill in the art

8
Claims
  • Determines Patent Rights
  • Sets a boundary of monopoly over the technology
    for the inventor
  • Aspects of an innovation which are not claimed
    are deemed to have been disclaimed
  • Relevance of Independent and Dependent Claims

9
Claims
  • Device/Apparatus and Process Claims
  • Parameters Broad Ranges
  • Strike a balance between having broad claim
    without overlapping with prior art

10
Biotech Patents International Perspective
  • By
  • Ravi Bhola
  • KS Partners
  • Bangalore

11
Patentability
  • Broadly Uniform products processes

12
Biotechnology
  • Products (Biomolecules) DNA, RNA, Protein,
    kits, various forms of life
  • Processes culturing, immunochemical techniques,
    Molecular biology techniques, protein enzyme
    techniques, radio isotopic techniques,
    centrifugal techniques, spectroscopic techniques,
    electrophoretic techniques, chromatographic
    techniques, electrochemical techniques

13
Deposition of Biological Material
  • India deposit before filing
  • USA, Europe Japan anytime before
    acceptance/allowance of patent
  • International Depositories

14
Patentability
  • Cloning
  • allowed worldwide at molecular level
  • Not allowed for higher forms
  • Harvard Mouse
  • Dolly

15
Patentability
  • Method of treatment (USA, Japan)
  • A method of treating diabetes in a subject in
    need thereof using composition X, wherein said
    method comprises administering pharmaceutically
    acceptable amount of the composition X to the
    subject.
  • Swiss type Claims (Europe)
  • Use of composition X for manufacturing a
    medicament for treating diabetes in a subject in
    need thereof
  • In India none is allowed

16
Patentability
  • Ethical issues
  • stem cell research

17
Discovery
  • Microorganism
  • Patentable in USA, Europe Japan
  • A biologically pure culture of the
    cyclosporin-producing microbe deposited as
    provisional accession number I-1714, Collection
    Nationale de Cultures de Microorganisms, Institut
    Pasteur.
  • Human Intervention is a must in India - sec. 3
    (c) - recombinants allowed

18
Scope of Protection
  • USA Broad protection available but require
    multiple patents for independently worded claims

19
Scope of Protection
  • Europe allows multiple independetly worded
    claims in single application but more thorough
    scrutiny of patent applications

20
Scope of Protection
  • Japan Overly narrow interpretation of
    invention limits the scope of claims to specific
    examples not even slight extrapolation allowed

21
Scope of Protection
  • India Similar to Europe in terms of scope of
    protection offered not much focus on technology
    too much focus on legal formalities

22
Sequence Homology
  • US and Europe view it liberally provided some
    basic substantiation is made
  • An isolated nucleic acid sequence comprising a
    nucleotide sequence that has greater than 95
    percent sequence homology to SEQ ID NO5.
  • Japan limits the scope of the claim only that
    particular sequence which is been disclosed in
    the application
  • India somewhat similar to Japan

23
Single Nucleotide Polymorphism (SNP)
  • SNPs are not allowed in Japan, India Europe
    unless some function is assigned
  • USA has allowed SNPs in the past but is more
    cautious now.

24
IP Biotechnology - Enforcement Litigation in
India
  • By
  • Ravi Bhola
  • Partner
  • KS Partners, Bangalore

25
Usual Line of Argument
  • Plaintiff holds defendant responsible of
    infringement
  • Defendant
  • patent is invalid
  • using different technology
  • innocent infringer

26
Burden of Proof
  • Product Patent Burden sits with Plaintiff to
    establish infringement
  • Process Patent - Burden of Proof sits with the
    Defendant he is supposed to prove that his
    process is different from the patented process

27
Litigation Court Structure
  • Supreme Court
  • High Courts in every state
  • District Courts under each High Court
  • Subordinate Courts under each District Court

28
Jurisdiction
  • Suit can be filed defendant resides, carries on
    business, where infringing activities occur
  • Suit is filed with a District Court under
    ordinary circumstances
  • If counter claim in an infringement Suit is filed
    at District Court, the matter transferred to High
    Courts
  • High courts of New Delhi, Kolkata, Mumbai, and
    Chennai can hear patent cases without the matter
    first having been heard by the District Court

29
Awarding Damages
  • Successful claimant may elect between award of
    damages or account of the defendants profits
  • Assessing damages pecuniary damages suffered
    and damage to reputation are taken into account

30
Novartis Glivac Case
  • Section 3 Inventions not Patentable
  • Section 3(d) The mere discovery of a new form of
    a known substance which does not result in
    enhancement of the known efficacy of that
    substance

31
Novartiss Contention
  • Two writ petitions filed by Novartis to
    challenge
  • Validity of section 3(d)
  • Not TRIPS Complaint
  • Violates Article 14 of the Constitution of India
  • Need guidelines for section 3(d) as expression
    enhancement of known efficacy is vague and
    unclear
  • Uncontrolled discretion to Patent Controller
  • Derivatives need not be same substance

32
Novartis Case Judgement
  • TRIPS is a contract between member states
  • Dispute settlement forum exists at WTO
  • Indian Courts have no jurisdiction to decide upon
    violation of Article 27 of TRIPS
  • Article 14 of the Constitution not violated
    because section 3(d) came out of detailed
    parliamentary debate with objective to prevent
    evergreening
  • Advanced technologies exist to compare efficacy
  • Petitioner (Novartis) is a pharmaceutical giant
    and cannot plead ignorance to meaning of
    enhancement of known efficacy.
  • Both the writ petitions dismissed

33
Monsanto Vs. Coramandal
  • Plaintiff had Patent for a Phytotoxic composition
  • Defendant was able to establish that composition
    is a mere admixture (known active ingredient
    adjuvant) without any synergistic effect
  • Court held that plaintiff were merely
    camouflaging a known substance to enfold it in
    their patent
  • Court revoked the Patent

34
FDC Limited and Ors Vs. Sanjeev Khandelwal and
Ors (2007)
  • Court held that distinction between product and
    process patents should be understood.
  • Ex parte injunction can be granted if in alleged
    violation of product patent, if the plaintiffs
    have adduced the evidence of an independent
    scientist/other technical expert who has tested
    the plaintiffs and defendants product and
    arrived at an independent finding to show
    identical nature of two products
  • In the process patent cases, defendant to be
    given opportunity to explain how their process
    does not constitute infringement

35
Raj Prakash Vs. Mangat Ram (1977)
  • Simplicity of the invention is not a limitation
    for obtaining Patents
  • Court held that ..if the infringing goods are
    made with the same object in view which is
    obtained by the patented product, then a minor
    variation does not mean that there is no
    infringement. A person is guilty of infringement
    if he makes what is in substance the equivalent
    of the patented article.

36
Challenges in litigation and Enforcement
  • Lack of specialized courts
  • Documentation or rather lack of it
  • Sensitization of Judicial Officers
  • Sensitization of enforcement agencies
  • Delays in judgement

37
  • thanks for your attention
  • ravi_at_knspartners.com
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