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Intellectual Property Issues in Managing Clinical Trial


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Title: Intellectual Property Issues in Managing Clinical Trial

Annual Meeting of American Intellectual Property
Law Association (AIPLA), 2011
Biotechnology Patenting in India and Related Issues
May 13, 2011 San Francisco
Rajashree Sharma Partner-Corporate Law Group New
Delhi, India
  • Roadmap
  • Introduction
  • Evolution of Indian Patents Act
  • Biotechnology Scope of Patent Law in India
  • A summary overview on biotechnology patenting
    activity in India
  • Biotechnology Patent Prosecution Guidelines
    Basic Considerations
  • Patentability of Biological Material (s)
  • Patentability of Micro-organism (s)
  • Patent law and Conservation of Biological
    Diversity (CBD)
  • Patent law and Traditional Knowledge
  • Biotech patent jurisprudence in India
  • Conclusion

  • 1. Introduction
  • Biotechnology is a culmination of human
    intervention and natural processes
  • Ever since a genetically engineered
    micro-organism was
  • granted patent, the field of biotechnology
    gained enormous significance
  • Evolution of patent law on biotechnology dates
    back to
  • seventh century
  • Global adoption of the patent system started in
    Venice as the first patent law was enacted in
  • The requirements enshrined in the Venetian
    Statute such as utility, novelty and
    non-obviousness are still the basis of modern
    patent law around the world
  • Cont.

  • Introduction
  • Under the patent regime around the world the
    significance of biotechnology and its inventions
    are recognized and protected
  • The TRIPS-level patent protection is an
    incentive mechanism to enhance biotechnology
    innovation in India
  • Patent protection on novel biotechnology products
    can be obtained by prosecuting the patent
    applications in an articulate manner
  • The trend of filing biotechnological patents in
    India has a
  • steady growth
  • 2007-08-2774
  • 2008-09 -1884
  • 2009-10-2700

  • 2. Evolution of Indian Patents Act
  • British rulers enacted the first ever patent law
    in India- the Act VI of 1856 based on the British
    patent law of 1852
  • Consolidated Indian Patents and Designs Act, 1911
    was enacted after several modifications in 1859,
    1872 and 1888.
  • The Patents Act 1970 was enacted highlighting
    universally accepted requirements of
    patentability such as novelty, inventive step and
    industrial application.
  • The Indian Patents Act, 1970. The patents granted
    under the Act are operative in the whole of
  • Patents Act, 1970
    Patents Rules, 2003
  • 1999
    Amended in

  • 2002

  • 2005 (product)

  • 3. Biotechnology Scope of Patent Law in India
  • Indian patent practice and jurisprudence with
    respect to
  • the patenting of biological materials are
    relatively new
  • and thus not so well settled and/or uniform.
  • The Indian Patents Act, 1970 as in force, does
  • describe, in an inclusive manner, what is
  • under biotechnology discipline. Rather, Section 3
  • includes a list of inventions considered not
  • Additional hurdles like mandatory disclosure of
  • material, prior approval from the Biodiversity
    Board and
  • access benefit issues under the Indian Patent
    regime exist.
  • Cont..

  • Biotechnology Scope of Patent Law in India
  • Apart from TRIPS consisting criteria, Indian
    patent law has a long list of exceptions to
  • e.g., frivolous, simple combination of known
  • methods for curative prophylactic treatments
    traditional knowledge considered as not
  • New requirement not found in TRIPS - New use of
    a known substance considered non-patentable.
    Salts, Esters, ethers, Polymorphs, Metabolites,
    Pure form, Particle size, Isomers, mixtures of
    isomers, complexes, composition, derivatives too
    are considered non-patentable unless they
    differ significantly in properties with regard to
    efficacy or if they do not result in the
    enhancement of known efficacy of the substance
  • New requirement not found in TRIPS - mere
    admixture e.g., root-nodule bacteria of
    leguminous plants, use in combination does not
    improve natural functioning
  • non disclosure of origin and source of
    biomaterial - widens the scope of grounds for
    opposition and revocation

  • 4. A summary overview on biotechnology patenting
    activity in India
  • Mostly foreign application, however considerable
    increase in Indian applications
  • To translate the discovery into a patentable
    subject matter, the discovered component must be
    substantially changed through human intervention
    into a form in which it does not occur in nature,
    or employed in a process resulting into technical
    advancement and/or economic significance
  • Inventions filed for grant of patent recombinant
    DNA molecule, recombinant vaccine, monoclonal
    antibodies, recombinant therapeutic molecules,
    diagnostic kits, recombinant vectors, Isolated
    Nucleic acid encoding a gene, Method of
    preparation of recombinant hormones, DNA related
    inventions such as preparing plasmids, vectors
    etc, bioleaching, biotransformation, biological
    treatment of waste, gene and somatic cell
    therapy, pluripotent stem cells derived from
    regenerative tissue, recombinant microbes
    expressing chimeric HIV protein, regulation of
    cell mediated immune response, recombinant
    interleukin IL-18 inhibitors, plastid
    transformation vectors, Waste water and sewage
    treatment using microorganism, conjugate vaccine
    against cholera and tetanus, peptide based
    immunotherapy for atherosclerosis, mixed cell
    gene therapy, bone regeneration by gene therapy
    and treatment of flower.

  • I. Non-Patentable Inventions
  • Ordre public and morality exception - Section 3
    (b)- . As per the section an invention would not
    be patentable if it is immoral or against public
    order, harmful to human, animal or plant life or
    harmful to environment.
  • Discovery of living things or non living
    substances in nature - Section 3 (c)
  • Plants and animals in whole or any parts thereof
    other than micro-organisms but including seeds,
    varieties and species - Section 3 (j)
  • Essentially biological processes for the
    production or propagation of plants and animals
    Section 3 (j)
  • Any Process for the medicinal, surgical,
    curative, prophylactic, diagnostic or therapeutic
    or other treatment of human beings or animals to
    render them free of disease or to increase their
    economic value or that of their products
    Section 3(i)
  • New use or new property of known substance
    Section 3(d)
  • Methods of agriculture or horticulture Section
  • Traditional knowledge Section 3(p)

  • II. Patentable Inventions
  • Modified Microorganism and process therefor.
  • Isolated nucleic acids encoding gene, first time
    isolation of a molecule novel peptides, peptide
    analogs, proteins, vaccines, antibodies, Primers,
    and cDNA
  • Recombinant DNA, RNA, Amino Acids, antibodies,
     oligonucleotides, primers, and genes, and
    Process therefor
  • DNA related inventions such as preparing
    plasmids, vectors etc.
  • Composition/formulation thereof.
  • Bioprobes, Biosensors
  • Diagnostic/Equipment kits, Research Tools
  • Cell lines-A cell line is patentable if
    artificially produced
  • Hybridoma technology patents are also allowed on
    hybridoma technology, but not on protoplast
    fusion (on ethical issues).
  • Expressed sequence tags (ESTs), can be patented
    if it has a use, such as if it works as a probe
  • Cont..

  • II. Patentable Inventions
  • Methods of enzyme Purification.
  • Environment cleaning using biological materials
    such as solid or liquid waste (industrial/domestic
    ) treatment, water treatment, mitigation of air
    pollution, bio-remediation.
  • Treatment of plants.
  • Process for preparing product using modified or
    known organism (extraction, fermentation etc.)
  • Biological material such as rDNA, plasmids are
    patentable provided they are produced by
    substantive human intervention
  • Processes for producing chemical and biological
    substances using microorganisms including lower
    plants and animals are patentable

  • 5. Biotechnology Patent prosecution
  • Guidelines Basic Considerations
  • No formal bio-guidance with regard to
    biotechnological patent application
  • Some reference in Manual of Patent Practice and
    Procedure (MPPP) is there however inadequate
  • No mention of gene or DNA in the Patents Act
  • The biological material such as recombinant DNA,
    plasmids and processes of manufacturing thereof
    are patentable provided they are produced by
    substantive human intervention
  • Gene sequences, DNA sequences without having
    disclosed their functions are not patentable for
    lack of inventive step and industrial
  • Cloning human beings or animals, processes for
    modifying the germ line, genetic identity of
    human beings or animals, uses of human or animal
    embryos for any purpose are not patentable as
    they are against public order and morality
  • Cont..

  • 5. Biotechnology Patent prosecution
  • Guidelines Basic Considerations
  • During prosecution, the establishment of the
    biological function of a biotech invention, it is
    preferable to include biological experimental
    data / efficacy data both in vitro as well as
    in vivo to support the efficacy of a claimed
    invention over the prior art
  • The specific sequence IDs of the genetic material
    being claimed must have been described
    sufficiently in the accompanying description so
    as to enable a person skilled in the art to
    identify and work upon such material (submission
    of SEQ ID in electronic as well as in paper form
    is also mandatory). Insufficient disclosure as
    well as enablement objections could be raised.
  • Additionally, the reference to more than one SEQ
    IDs requires establishing unequivocally that more
    than one sequence of IDs is so correlated with
    another that they constitute a single inventive
  • Cont

  • 5. Biotechnology Patent prosecution
  • Guidelines Basic Considerations
  • A. Types of Objections Raised under First
    Examination report
  • Objections relating to non compliance of criteria
    for patentability such as lack of novelty and/or
    obviousness community/folklore knowledge
    available, non-sufficient disclosure
    non-compliance of Biological Diversity Act
    requirements lack of functional aspects and
    information required under Section 8 of the Act
  • B. Few Examples of Objections Raised Generally
  • Claims do not sufficiently define the invention
  • Distinguishing features as compared to prior art
    given are not clear
  • Disclosure is insufficient
  • SEQ should be filed in electronic form
  • Claims fall under section 3(i)
  • Claims fall under section 3(j).
  • Obtaining permission from NBA
  • Disclosure of deposition of biological material
    used in the invention
  • Invention that falls under 2(1)(j)
  • Use claims (generally not considered, need
    skilful wording ).

  • Cont..

  • 5. Biotechnology Patent prosecution
  • Guidelines Basic Considerations
  • C. Some examples of allowed claims in biotech
  • Novel Modified Microorganism-The present
    invention relates to a modified microorganism
    comprising a mutation that disrupts the
    expression of the nucleotide sequence defined
    herein as SEQ ID No. 15. It also relates to
    bacterial genes and proteins, and their uses.
    More particularly, it relates to their use in
    therapy, for immunization and in screening for
  • Nucleic Acid Molecule-A nucleic acid molecule
    comprising a sequence of nucleotides that encodes
    an HPV31 L1 protein as set forth in SEQ ID No. 4,
    the nucleic acid comprising sequence of
    nucleotides as set forth in SEQ ID NO 2 or SEQ
    ID NO. 3 wherein the sequence being
    codon-optimized for high level expression in a
    yeast (P-237941)
  • Cell Line-A method of producing human oral
    cancer cell line which comprises .

  • 5. Biotechnology Patent prosecution
  • Guidelines Basic Considerations
  • D. Some examples of rejected claims in biotech
  • Claims related to Methods for identifying tumors
    that are
  • responsive to treatment with anti-ErbB2antibodies.
  • determination that the patient suffers from
    cancer (such as,
  • Castration- Resistant Prostate Cancer-CRPC or
    ovarian cancer)
  • that is positive for HER2 phosphorylation, the
    patient will
  • receive a loading dose of 840 mg of rhuMAb 2C4 on
    day 1 of
  • cycle 1 (first 21-day treatment period), followed
    by 420 mg on
  • day 1 of each subsequent 21-day cycle, as
    continuous intravenous
  • infusion. Applicant submitted that improvement
    lies in new
  • amounts of rhuMAb (420 and 840 mg)
  • The controller refused the application under
    section 3(d) (new use of known substance) as
    being dosage and 3(i) method of treatment that
    the said MAb are already known as described in
    the description.

  • 6. Patentability of Biological Material (s)
  • (Disclosure and Enablement Requirements) Section
    10(4) of the Patents Act, 1970 (as in force)
  • If the invention mentions a new biological
    material in the specification and such material
    is not available to public, the applicant has to
    deposit said biological material in the
    International Depository Authority recognized
    under Budapest Treaty before filing of the
  • SEQ
  • Functional aspects of biologics for ex.
    application / use of biologics Source of material
    (in case generic material is not used)
  • Geographical origin (in case generic material is
    not used)
  • CBD compliance prior approval of NBA is
    necessary for applying for patent and for
    material transfer
  • ( The disclosure is mandatory only if any
    specific material imparting the
  • specific property is required to work the
    invention. In case the material
  • such as proteins/peptides/amino acids prepared
    synthetically can substitute
  • the live material to work the invention,
    appropriate statements may be
  • incorporated in the specification.)

  • 7. Patentability of Micro-organism (s)
  • Microbiological inventions include new products,
    processes, uses and compositions involving
    biological materials
  • Inventions cover methods to isolate and obtain
    new organisms, improve their character, modify
    them and find their new and improved uses.
  • New micro-organisms isolated for the first time
    from the natural surrounding can only be patented
    if they differ in character from the known
    micro-organisms and find a new or improved use or
    function. Claims to micro-organisms have been
    allowed on the grounds that they are the products
    of micro-biological processes
  • In the Dimminaco AG vs. Controller of Patents,
    the Calcutta High Court held in 2002 that a
    patent on a micro-organism is valid. The court
    ruled that the Act did not preclude a living end
    product from being patented. As a result, a large
    number of patents have been granted to
    microorganisms since then

  • 8. Patent law and Conservation of Biological
  • ABS Issues Biotechnology Patents
  • Mandatory disclosure in patent application of
    source and geographical origin of biological
    material and traditional knowledge used in
    invention(S.10(4)(d) of Indian Patents Act, 2005
  • Amended Patents Act also provides for pre-grant
    opposition and revocation of granted patents of
    grounds of non-disclosure or wrongful disclosure
    of source or geographical origin of biological
    resources and traditional knowledge (S.25(1)
  • NBAs prior approval is required before seeking
    patent based on biological material and TK
    obtained from India Sec 6(1).
  • Gate - keeping in accessing biological resources
  • ABS provisions in Biodiversity Act, 2002. Several
    guidelines have come up from time to time w.r.t.

  • 9. Patent law and Traditional Knowledge
  • Section 3(p) excludes from patentability an
    invention which, in effect, is traditional
    knowledge or which is an aggregation or
    duplication of known properties of traditionally
    known component or components.
  • disclosure requirements mandate inclusion of the
    source and geographical origin of biological
    material used in the claimed invention, and
    interested parties may oppose or petition to
    revoke an Indian patent on the ground that the
    invention claimed therein is anticipated having
    regard to the knowledge, oral or otherwise,
    available within any local or indigenous
    community in India or elsewhere . . .
  • Access to its the online database contains
    translations of manuscripts and textbooks in five
    languages Traditional Knowledge Digital Library
    (TKDL), that contains translations of manuscripts
    and the online database textbooks in five
  • Cont

  • Patent law and Traditional Knowledge
  • Prior art enablement
  • The TKDL allows examiners to compare patent
    applications with existing traditional knowledge
  • New patent applications need to demonstrate
    significant improvements and inventiveness
    compared to prior art in their field. If the
    medical use of an herb is a traditional practice,
    and thereby public knowledge, it is considered
    prior art under regulations.
  • The patent applicant may still be granted a
    patent on a new method for industrial-scale
    production of the active ingredient of the herb,
    for example, if this process is new and inventive
  • example-jeevani, a medicine based on
    the traditional medicinal knowledge, an extract
    of arogyappacha plant Trichopus zeylanicus

  • 10. A. Biotech patent jurisprudence in
  • Dimminaco AG v Controller of Patents and Designs
  • Dimminaco AG filed a process patent application
    for a vaccine for infectious bursitis in poultry.
    It claimed a lyophilized microorganism
  • Application rejected on the grounds the vaccine
    involved processing of certain microbial
    substances this was only a natural process
    devoid of any manufacturing activities
  • On appeal, the Calcutta high court considered the
    dictionary meaning of manufacture and
    substance and reversed the decision passed by
    the controller.
  • The Court held that law does not bar processes
    where the end-product is living
  • cont

  • 10. A. Biotech patent jurisprudence in India
  • Dimminaco AG v Controller of Patents and Designs
  • No statutory bar to accept a manner of
    manufacture as patentable even if the end
    product contains a living organism.
  • One of the common test is vendibility test (In
    other words the product should be a commercial
  • The MPPP states that a living entity of
    artificial origin such as micro-organism, or
    vaccines are considered patentable
  • This landmark judgment opens up new opportunities
    for obtaining patents related to live
    microorganisms subject to fulfilling basic
    criteria for patenting
  • cont..

  • Biotech patent jurisprudence in India
  • B. Speaking Roses International Inc. vs.
    Controller-General of Patents And Anr.
  • Speaking Roses international Inc., had on
    September 19, 2002, applied for a patent for
    providing an image on an Organic Product, being
  • The first ground of rejection was that the
    application was in contravention of Section 3(j)
    of the Patents Act, 1970. As per sub-clause (j),
    such exclusion extends to Plants and animals in
    whole or any part thereof other than
    micro-organisms but including seeds, varieties
    and species and essentially biological processes
    for production or propagation of plants and
  • The court held that the patent sought was not for
    any flowers or organic products, but for
    providing an Image on an organic product. Hence
    it was not a plant that was being sought to be
  • Image was to be created by a mechanical process
    and not a biological one. Therefore, the claim
    did not fall within the scope of the aforesaid

Patent grant Procedure
Early publication on request
  • WITHIN 48 MONTHS FROM filing date

3rd Party Representation


Decision of Controller
Appellate Board
  • 11. Conclusion
  • The patenting of biological material are
    relatively new to India.
  • Standardized practice has yet to be
    satisfactorily established with respect to
    patenting or non-patenting of biological
  • If a claim of an invention is related to a novel
    and inventive and modified genetic material,
    wherein such genetic material is identified by
    its protein or amino acid sequences at least in
    the description and in the claims, such genetic
    material is capable of industrial application,
    then the Patent Office generally accepts such
    invention as patentable
  • Inventions are subject to the fulfillment of the
    relatively broad criteria.
  • Patenting of biological material in India is
    still decided on a case-by-case basis.
  • cont..

  • 11. Conclusion
  • Indias post-TRIPS patent laws include certain
    provisions to make biotechnology patenting more
  • The allowable claims disclosed in the preceding
    slide that the biotech patent can be obtained in
    diverse areas provided
  • To grant a patent the description/enablement
    requirements be complied with and prosecute
  • India being one of the bio-diversity rich
    countries, it would, thus, be prudent to reap
    the due benefits from its rich bio-resources
    with an enabling provision for patent protection
    in biotechnological innovations and inventions

Ms. Rajashree Sharma
1101-1104, Kailash Building, 26,
Kasturba Gandhi Marg, New Delhi-110001
Tel 91-11-43621000 (100 Lines) Extn. 208
Mob 91-11-9811882548
Fax 91-11-23357721
Amendments of use treatment claims HEPATITIS C
  • 1. Original claims were 59. During prosecution
    we deleted certain claims and merged and amended
    Use/ treatment claims in to 1 claim and
    restricted the claims to 19 only. Further, with
    the help of omnibus claim we covered a novel
    nucleic acid and a pharmaceutical composition
    thereof substantially as described in the
    specification with reference to examples,
    drawings and sequence.
  • A nucleic acid as claimed in preceding claims and
    a pharmaceutical composition thereof is useful
    for treating or preventing HCV infected subjects.
  • Claims amended in appln. for vaccines for
    staphylococcal infection
  • 3. A pharmaceutical composition, comprising
    protein as claimed in previous claims in an
    effective amount in the range of 1 to 1000 µg
    preferably to 5 to 500 µg and more preferably 10
    to 100 µg and pharmaceutically and
    physiologically acceptable carrier to be used as
    a vaccine in managing Staphylococcal infections.
  • 4. A vaccine comprising of protein of amino acid
    sequence of SEQ ID No 3,4, or 5, a method for
    producing the same and the pharmaceutical
    composition thereof useful for managing
    staphylococci associated infections substantially
    such as herein described.

  • Response to the objection on biological material
  • PATENT NO. 232694
  • Objection
  • In page 8 of the complete specification you have
    mentioned the accession number of the protein but
    have not mentioned the date anywhere as u/s 3 (p)
    and 10(4) (d) you have to mention the date of
    accession within the prescribe time and also
    mention with u have obtained permission from NBA
    for the material claimed.
  • Response
  • With regard to your fresh objection raised vide
    your mail dated February 20, 2009, we humbly wish
    to submit that according to Section 10 (d) (ii),
    the application shall be completed by depositing
    the material to an international depository
    authority if the applicant mentions a biological
    material in the specification which may not be
    described in such a way as to satisfy clause (a)
    and (b), and if such material is not available to
    the public. We feel that the protein should not
    be considered as biological material for
    depositing as such. Moreover, in view of the
    disclosure of SEQ, the requirement may be
    considered as complied with.

  • Table Depicting Some of the Biotech Patents
    Granted in India

236079 370/MUM/2004 Reliance Life Sciences Pvt. Ltd. Method for synthesis of human recombinant insulin with improved process efficiency
231288 168/MAS/1999 Indian Institute of science A method of treating sunflower plants
228492 1882/DELNP/2004 Pfizer Products Inc. "Polynucleotide molecule comprising a nucleotide sequence that is the streptomyces avermetilis avec allele
228182 2554/CHENP/2005 Monsanto Technology LLC. DNA constructs and methods to enhance the production of commercially viable transgenic plants
218516 740/CHENP/2004 Istituto di Ricerchi di Biologia Molecolare P. Angeletti spa Hepatitis c virus vaccine
213334 423/MUMNP/2004 N-ZYME BIOTEC GMBH Method for production of recombinant proteins in microorganisms

  • Table Depicting Some of the Biotech Patents
    Granted in India

213289 826/MUM/2002 Cadila Healthcare Limited Recombinant DNA molecule encoding a novel human interferon alpha 2b like polypeptide method for producing it in pichia and its use
208063 IN/PCT/2001/58/CHE Novo Nordisk A/S A method for preparing a yeast strain
199578 566/DEL/2002 University of Delhi A process of obtaining recombinant lambdoid bacteriophage and the resultant novel phage display system"
210988 IN/PCT/2001/01140/MUM Meristem Therapeutics Chimeric expression promoters originating from commelina yellow mottel virus and cassava vein mosaic virus
235741 1274/DEL/2002 DBT A pair of oligonucleotide primers for specific amplification of the hupb gene of mycobacterium species"
246612 507/MUMNP/2007 Biointex Composition for use against one or more pathogens able to cause diseases to vegetal material/plant

  • Table Depicting Some of the Biotech Patents
    Granted in India

218518 1353/CHE/2004 Kerala Forest Research Institute A bio-pesticide based on nucleopolyhedrovirus for the management of teak pest hyblaea puera
227691 3456/DEL/2005 "Biofertilizer cum biofungicide/biobactericide composition b5"
224221 183/MUMNP/2004 Speaking Roses International Inc. Providing an image on an organic product, wherein the organic product is plant, flower, fruit or portion thereof.
243799 1908/delnp/2005 Lee, Young-Min genetically stable jev cdna based on Japanese encephalitis virus (jev)"
246347 1598/del/2003 All India Institute of Medical Sciences oligonucleotides for detection of Leishmaniasis and methods thereof"
96972 96972 The Maharaja Sayajirao University Of Baroda improvements in or relating to the purification of sewage and like organic wastes by employment of activated sludge