Drafting Patent Specification By Ravi Bhola Partner K

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Drafting Patent Specification
By Ravi BholaPartnerKS
PartnersBangalore
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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

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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

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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

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Databases

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

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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

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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
  

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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

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Claims

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

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Biotech Patents International Perspective

• By
• Ravi Bhola
• KS Partners
• Bangalore

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Patentability

• Broadly Uniform products processes

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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

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Deposition of Biological Material

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

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Patentability

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

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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

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Patentability

• Ethical issues
• stem cell research

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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

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Scope of Protection

• USA Broad protection available but require
  multiple patents for independently worded claims

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Scope of Protection

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

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Scope of Protection

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

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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

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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

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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.

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IP Biotechnology - Enforcement Litigation in
India

• By
• Ravi Bhola
• Partner
• KS Partners, Bangalore

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Usual Line of Argument

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

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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

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Litigation Court Structure

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

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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

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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

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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

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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

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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

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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

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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

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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.

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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

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• thanks for your attention
• ravi_at_knspartners.com