BIOTECHNOLOGY PATENTING ISSUES IN by 761BJA

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									      Biotechnology Patenting In
        India and Related Issues

Rajashree Sharma, Corporate Law Group
            New Delhi. India
1. Introduction

Biotechnology is a culmination of human intervention and natural processes. Biotechnology is
not new but exists since ancient times and its progress has been witnessed through many
centuries. The term “biotechnology” is defined broadly to include not only the old
biotechnology such as the traditional method of manufacturing fermented products but also
the new biotechnology represented by genetic engineering and recombinant technology.

In earlier days fermentation technology was used to produce and preserve goods for a long time.
Biotechnology proved itself to be in the field of miracles when it produced genetically modified
or non-natural living organisms. Genetic engineering is capable of manipulating living organisms
and making such organisms to perform and function in a way different from the natural ones.

Ever since a genetically engineered micro-organism was granted patent, the field of
biotechnology gained enormous significance and patents have been granted on genetically
engineered plant and human genetic material. Though evolution of patent law on biotechnology
dates back to seventh century, the global adoption of the patent system started in Venice as the
first patent law was enacted in 1494, which regarded as the foundation for the world’s patent
system. 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.

Earlier nobody thought that biotechnology could manipulate either plant or animal or human
being and therefore none thought of the need for evolving a comprehensive law on
biotechnology for regulation. However, as biotechnology has progressed in various generations
at different times and this field mandated a comprehensive legal framework for proper regulation,
TRIPS agreement provided protection and regulation of various biotechnology inventions as well.
Under the patent regime around the world the significance of biotechnology and its inventions
are recognized and protected. The biotech inventions could be patented following the
patentability criteria; however there exists complexity of manipulating of living forms hence
need special attention.

This paper will examine and analyze the effectiveness of TRIPS-level patent protection as an
incentive mechanism for enhanced biotechnology innovation in India and how to enhance patent
protection on novel biotechnology products by prosecuting the patent applications in an
articulate manner in the Indian Patent Office. The trend of filing biotechnological patents in
India has a steady growth as in 2008-09 the total filing was 1884, 2009-10 the total biotech
application is about 2700, however the highest filing recorded so far is 2774 in 2007.

2. Evolution of Indian Patents Act

British rulers enacted the first ever patent law in India the Act VI of 1856 on protection of
inventions based on the British patent law of 1852. After several modifications in 1859, 1872
and 1888, the consolidated Indian Patents and Designs Act, 1911was enacted and offered patent
protection to the inventions. In the light of changing socio-politico scenarios in India there were
moves to consolidate the patent law by bringing up a new legislation and the outcome is the



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enactment of Patents Act 1970. The Patents Act 1970 highlights the invention that satisfies the
universally accepted requirements of patentability such as novelty, inventive step and industrial
application. The Patents Act 1970 had undergone several amendments in 1999, 2002 and finally
the Patents (Amendment) Act 2005 (hereinafter referred to as the Patents Act) with introduction
of product patents on substances capable of use as medicine, drug, or food could be obtained
when India completed implementation of TRIPS required amendments to its Act. Further
considerable changes have been made in the patenting procedure through the introduction of
Patent Rules, 2003 further amended in 2005 and 2006, resulting in new practice and procedure.
The Patents Act does not specify which are patentable, but it illustrates subject matters that are
not patentable. The Patents Act enacted in 1970 does not mention anything about biotechnology
invention. Judicial pronouncements in the US and EU and suitable intervention by judiciary led
to amendments of patent laws in these countries as efforts were made to grant patents to biotech
inventions. The same approach gained significance in India as well. India’s patent third laws
were amended in 2002 to explicitly include biochemical, biotechnological, and microbiological
processes within the definition of potentially patentable chemical processes. However, the formal
bio-guidance is the need of the hour as biotechnology is gaining momentum in India. The
requirement of submission of working of patents in India is another salient feature of the Indian
Patents Act.
This paper will discuss the effectiveness of patent protection to enhance biotechnology
innovation in India. The paper further overviews expanding biotechnology patenting activity in
India and Provisions of India’s current patent laws particularly relevant to biotechnology
inventions with the watershed judicial decisions for biotechnology patenting in India.
.
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. There are several outstanding
deficiencies within the substantive law that needs addressing. Apart from narrow standards of
patentability, biotech products are faced with certain additional hurdles like mandatory
disclosure of biological material, prior approval from the Biodiversity Board and access &
benefit issues under the Indian Patent regime.

While TRIPS does not allow exclusion of inventions that are novel, non-obvious and industrially
applicable en masse, the Indian law has a long list of exceptions to patentability:

   a. TRIPS consistent - naturally Occurring components, animate or inanimate from
      biological material or their parts; process to obtain such components; isolation of live
      material, genetically modified or transgenic organism, cell parts; process for the isolation
      and modification; use/application of biological material;

   b. TRIPS consistent - plants and animals as a whole or parts thereof; varieties of plants and
      animals, seeds, essentially biological processes of propagation;

   c. Criteria not found in TRIPS – e.g., frivolous, simple combination of known elements;




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   d. Criteria inconsistent with TRIPS – e.g., Inventions based on methods of agriculture,
      horticulture; methods of business; methods for curative & prophylactic treatments;
      traditional knowledge considered as not patentable.

   e. 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’.

   f. New requirement: not found in TRIPS - mere admixture – e.g., root-nodule bacteria of
      leguminous plants, use in combination does not improve natural functioning;

   g. New requirement: not found in TRIPS - additional disclosure of source and origin
      biological materials for grant of patent (Further amendments to section 25 (j) & Section
      64 (p) of 1970 Act - non disclosure of origin and source of biomaterial - widens the scope
      of grounds for opposition and revocation)

   h. Restriction on scope of Patentability - Encompassing bio-chemical bio- technological
      and micro-biological processes in chemical processes by way of explanation for the
      purpose of product patent.

Its pertinent to mention that in order to give effect to TRIPS Article 27(3) (b), a sui generis law
Protection of Plant Variety and Farmer’s Rights Act 2001 has been passed to provide for
effective system for protection of the rights of plant breeders (PBRs) and farmers and to
encourage the development of new varieties of plants.

The Indian Patents Act does not describe, in an inclusive manner, what is patentable. Rather,
Section 3 includes a list of inventions considered not patentable. In respect of biotechnology
inventions, the Indian Patents Act 1970 as amended till date specifies under Section 3(a) to
3(e), 3(h) to 3(j) and 3(p), inventions that will not be considered as a patentable
subject matter in India. However, Clauses 3(c) to 3(d), 3(i) to 3(j) and 3(p) are important in the
context of patentability of biotechnological inventions. Clause 3(c) states that “The mere
discovery of a scientific principle or the formulation of an abstract theory or discovery of any
living thing or nonliving substances occurring in nature” will not be considered as patentable
invention. This provision of non-patentability is common to patent laws of other countries. The
Clause 3(j) states that “Plants and animals in whole or any part thereof other than
microorganisms including seeds, varieties and species and essential biological processes for
production or propagation of plants and animals as non-patentable invention”. This provision
differs from the patent laws of countries like the US, the European Union, and Japan, who
follow liberal patent standards and where patents are also granted to genetically modified
organisms and plant varieties. This exception of non-patentability is allowed as per TRIPS
Agreement provided member countries provide alternate effective system for protection of
plant varieties (sui generis system).

4. A summary overview on biotechnology patenting activity in India



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Though inventions in this biotechnology category filed were mostly of the foreign origin but
there was considerable increase in Indian applications. Inventions were mostly in the field of
recombinant DNA molecule, recombinant vaccine, monoclonal antibodies, recombinant
therapeutic molecules, diagnostic kits, stem cells, 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.

As, in other jurisdictions, in India too, the subject matter claimed as the invention, must be new,
non-obvious, industrially applicable and requires sufficient disclosure. When the existence of a
new compound or element in nature is discovered, one can not obtain a patent on it because the
form as it exists in nature is not new. Further 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.

Following are some instances of non patentable subject matter per se; however fulfilling certain
criteria like functions the biotechnological inventions are patentable.

   I. Non-patentable inventions
       A. 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.
       B. Discovery of living things or non living substances in nature - Section 3 (c)
       C. Plants and animals in whole or any parts thereof other than micro-organisms but
          including seeds, varieties and species - Section 3 (j)
       D. Essentially biological processes for the production or propagation of plants and
          animals– Section 3 (j)
       E. 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)
       F. New use or new property of known substance – Section 3(d)
       G. Methods of agriculture or horticulture – Section 3(h)
       H. Traditional knowledge – Section 3(p)

   II. Patentable inventions

       A. The MPPP regards claims to ‘genetically modified Gene Sequence/Amino Acid
          Sequence, a method of expressing the sequence, an antibody against the




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            protein/sequence, a kit containing such antibody/sequence as having a single
            inventive concept and capable of being granted a patent
       B.   Gene sequences, DNA sequences without having disclosed their functions are not
            patentable for lack of inventive step and industrial application
       C.   Living entities of artificial origin such as micro-organism, vaccines are patentable
       D.   Biological material such as rDNA, plasmids are patentable provided they are
            produced by substantive human intervention
       E.   Processes for producing chemical and biological substances using microorganisms
            including lower plants and animals are patentable
       F.   Modified Microorganism & process therefor
       G.   Process for modification/ isolation of microbes.
       H.   Isolated nucleic acids encoding gene, first time isolation of a molecule; novel
            peptides, novel peptide analogs, proteins, vaccines, antibodies, recombinant:
            DNA, RNA, Amino Acids, antibodies, primers, recombinant oligonucleotides and
            primers, genes and process therefor; DNA related inventions such as preparing
            plasmids, vectors etc.; composition/formulation thereof.
       I.   Cell lines-A cell line is patentable if artificially produced.
       J.   Hybridoma technology: patents are also allowed on hybridoma technology, but not on
            protoplast fusion.
       K.   rDNA, cDNA, r-RNA, r-antibodies
                a.      Expressed sequence tag’s, or ESTs, are small fragments of genetic
                        material
                b.      obtained by reverse transcriptions of messenger RNA (mRNA) from
                        expressed
                c.      genes. The gene sequence, or expressed sequence tags (ESTs), can be
                        patented if it
                d.      has a use, such as if it works as a probe.

       L.   Bioprobes, biosensors
       M.   Diagnostic/Equipment kits, Research Tools
       N.   Methods of enzyme Purification.
       O.   Environment cleaning using biological materials such as solid or liquid waste
       P.   (industrial/domestic) treatment, water treatment, mitigation of air pollution, bio-
       Q.   Remediation
       R.   Treatment of plants.

5. Biotechnology Patent Prosecution: Guidelines & Basic Considerations

There is no formal bio-guidance as of yet with regard to biotechnological patent application.
Some reference in Manual of Patent Practice and Procedure (MPPP) is there and guidelines with
regard biotechnological inventions are inconsistent and inadequate. Pertinently there is no
mention of word gene or DNA in Patents Act, 1970, nonetheless, MPPP serves as an informal
written guidance for the examiners/Practitioners and is not a binding document. 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




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sequences without having disclosed their functions are not patentable for lack of inventive step
and industrial application.

Further, MPPP provides that the processes for 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.

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. Furthermore, an isolated but not
modified living entity is not substantially different from the form in which it existed in the nature
are non patentable under sec 3(c). However, mere isolation of a living thing or a part thereof
from its natural environment without a modification by genetic engineering or otherwise that
improves properties or increases efficacy of the claimed invention over the existing form or a
biological material or a part thereof is isolated in the desired form from its natural environment,
such material is no longer a living thing occurring in nature as envisaged in s. 3(c) of the Patents
Act. Additionally, quite often the material obtained by the process of isolation is in a raw state
and thus needs to be processed further e.g. purified by physical or chemical treatment to render it
industrially applicable. It can therefore be argued that the isolated material is not necessarily a
“merely discovered living thing”. First time isolation of a component from biological material is
patentable.

If sequences of biologics included with claims, to obtain broadest possible protection, it might
not be prudent to include such specific references to SEQ IDs in the main claim. However, in the
event that compliance with such a requirement is mandatory during the final stage of the
prosecution of an application, such a reference could then be merged in the main claim, as
broadly as possible in order to secure the eventual acceptance of such an application. 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 form is also
mandatory). Otherwise, 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 concept.

       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
             A. Claims do not sufficiently define the invention;
             B. Distinguishing features as compared to prior art given are not clear;
             C. Disclosure is insufficient;
             D. SEQ should be filed in electronic form;



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      E.   Claims fall under section 3(i);
      F.   Claims fall under section 3(j).
      G.   Obtaining permission from NBA
      H.   Disclosure of deposition of biological material used in the invention
      I.   Invention that falls under 2(1)(j)
      J.   Use claims (generally not considered).

C. Some examples of allowed claims in biotech inventions

      1. Micro-organism per se:-A recombinant microorganism, which is a
         microorganism having ability to produce 16-position hydroxyl macrolide
         compounds represented by the formula (I): (wherein R represents a hydrogen
         atom or hydroxyl group), and, which comprises: (a) DNA encoding wholly or
         partially a polypeptide participating in biosynthesis of the macrolide
         compounds represented by the formula (II)

      2. 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

      3. Protein:-A sublingually highly effective hypoglycaemic polypeptide-k, from
         seeds of Momordica charantia L. (bitter gourd), prepared by a process which
         comprises, splitting the seeds of Momordica Charantia L (bitter gourd)
         washing thoroughly the splitted seeds with water to remove contaminants,
         treating the splitted seeds with solvent consisting of hexane and acetone (3:1),
         grinding the said seeds to obtain powder, treating the said powder of seeds
         with, hexane and acetone solvents (3:1), dissolving the residual mass in
         aqueous acetone (water and acetone 80:20), adjusting pH upto 9.5 by adding
         ammonium hydroxide, separating the supernatant kyer from the mixture,
         treating the supernatant layer with sulphuric acid by adjusting the pH upto 3 to
         obtain the flocculent precipitate of polypeptide-k.

      4. Cell Line:-A method of producing human oral cancer cell line which
         comprises:

            a. Subjecting oral squamous cell carcinoma from the floor of mouth to the
               step of biopsy in Hanks Balanced Salt Solution (HBSS) as a buffer
               supplemented with antibiotics (Penicillin and streptomycin) and
               amphotericin B;
            b. Cutting the treated tissue of step (a) into smaller pieces;
            c. Washing the cut tissues with solution of antibiotics;
            d. The washed tissues being introduced into tissue culture flasks having a
               medium comprising DMEM and media 199 in a ratio of 2:1
               supplemented with fetal bovine serum (FBS) and growth supplements



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                       such as herein described to allow the growth of cells comprising
                       fibroblast cells which grow earlier than the epithelial cells;
                    e. Removing the fibroblasts cells from the culture to obtain a cell line
                       comprising essentially of epithelial cells.

       D. Some examples of rejected claims in biotech inventions

                    1. Claims related to Methods for identifying tumors that are responsive to
                       treatment with anti-ErbB2 antibodies After 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.
                    2. Invention related to a method for in vitro production of isolated
                       langerhans islets endocrine cells free from fibroblasts so as to be suitable
                       for transplantation. The process discloses the steps of culturing and
                       proliferation the cells and back and forth aspiration to separate fibroblast
                       from the cells, which will be capable of differentiating into insulin
                       producing, cells


The applicant argued the case on following grounds:
That the process is novel and has utility as fibroblast free langerhans islets are useful in the
enhanced production of insulin to control diabetes.
Kolkata High Court has already allowed patenting of a substance containing living organisms.
Indian Patent law does not bar the grant patent for such invention
The Controller refused the application under section 15 on the following grounds:
1. The end product of the process is nothing but a cluster of cells or piece of tissues of human
body.
2. The invention claimed is not patentable under section 3(I) as a method of treatment of human
being, since langerhans islets are freshly taken from the body of patient in order to treat them to
remove fibroblast so as to increase secretion of insulin.
3. The principles laid down in Kolkata High Court are not applicable as the end product of the
process of present invention are not commercial entity and cannot be passed on from one person
to another upon the transaction of purchase or sale.

6. Patentability of Biological Material(s)
(The Enablement Requirement in the Disclosure)




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Mandatory disclosure is required in patent application of source and geographical origin of
biological material used in invention - Sec.10 (4) (d) of Indian Patents Act, 2005. In case of
patent applications involving biological material such as DNA, a recombinant vector, or cells or
invention related to genes that may not be described in such a way as to satisfy the enablement
and best mode requirements and if such material is not available to the public, submission and/or
deposition of biological material to an International Depository Authority (IDA) under the
Budapest treaty is required if adequate disclosure is not possible - Sec.10 (4) (ii). The disclosure
is mandatory 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 submissions may help to overcome the
objection. The law 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 - Sec. 25(1) & Sec. 64

The Microbial Type Culture Collection (MTCC) at the Institute of Microbial Technology
(IMTECH) in Chandigarh is the IDA in India. However the scope of this IDA is limited because
it is not equipped to accept deposits of “cell lines, cyanobacteria, viruses etc. Biological deposits
of such materials would presumably need to be made in IDAs located outside of India, resulting
in increased cost and administrative complexity for domestic biotechnology firms.

National Biodiversity Authority’s prior approval is required for accessing biological material by
foreigners/NRIs (Sec. 3) as well as before seeking patent based on biological material and TK
obtained from India Sec 6(1) of Biodiversity Act 2002

7. Patentability of Micro-organism (s)

Guidelines were formulated for examination of the patent applications involving micro-
organisms from the point of view of substantial human intervention and utility.

Microbiological inventions include new products, processes, uses and compositions involving
biological materials. These inventions cover methods to isolate and obtain new organisms,
improve their character, modify them and find their new and improved uses.

Patenting of new micro-organisms is based on their differences with the characteristics & uses of
micro-organisms as available in the prior art. Known micro-organisms are restricted to new uses,
wherever patent law permits such a protection. The same is the case with genetically modified
micro-organisms. Genes and gene products are treated similar to chemical compositions.

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




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Universally, as practiced by most patent offices, 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.


8. Patent law and Conservation of Biological Diversity (CBD)

India enacted the Biological Diversity Act to address the issues of prior informed consent,
disclosure and access and benefit sharing. This Act primarily aims at regulating access to
biological resources and associated traditional knowledge so as to ensure equitable sharing of
benefits arising out of their use.

All matters relating to requests for access by foreign individuals, a non-resident Indian,
institutions or companies ( that are not incorporated or registered in India; or incorporated or
registered in India with foreign participation in its share capital or management), and all matters
relating to transfer of results of research to any foreigner is dealt with by the NBA. Section 3
provides that all foreign national require approval from NBA for obtaining Biological Resources
or knowledge associated with it and Section 4 provides that Indian individuals/entities to seek
approval before transferring knowledge / research and material relating to any biological
resources (occurring in or obtained from India) to foreign individuals, non-resident Indians,
institutions or companies ( that are not incorporated or registered in India; or incorporated or
registered in India with foreign participation in its share capital or management). NBA, may
consult the Biodiversity Management Committees (BMC) or any other expert committee
constituted for this purpose and thereafter grant approval under Section 19 subject to such terms
and conditions it may deem fit.

In case of Collaborative projects (covered by Section 5 of Biological Diversity Act) that are
either approved by the Government or conforms to the policy guidelines formulated by the
Government, no further approval is required from NBA.

For flora such as bacterial or fungal strains habitant from reserved and protected forests, notified
sanctuaries and national parks are regulated by Indian Forest Act, 1927 and Wildlife Protection
Act, 1972. The Indian Forest Act and Forest (Conservation) Act deal with management of forests
and conservation of forest land respectively. Wildlife (Protection) Act is for the protection of
wild animals, birds and plants, and basically aims at protecting, propagating or developing
wildlife or its environs through national parks, sanctuaries etc. In addition, the Act has a
provision to prohibit picking and uprooting etc. of specified plants.

In the Biological Diversity Act, ‘Biological resources’ mean plants, animals and micro-
organisms, their genetic material and by-products with actual or potential use or value. Human
genetic material is outside the purview. However, extracts of bacterial and fungal strains and all
value added products are not encompassed in the definition of ‘biological resources’ and thus do
not require approval of the NBA. The Indian collaborating company of a foreign entity is only
required to give prior intimation to the concerned State Biodiversity Board about obtaining such
material for commercial purposes. The fees payable for export permits will be regulated by



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EXIM policies. Please note that additional permission is required from the Director General of
Foreign Trade for import and export of certain biological material.

The Biological Diversity Act forbids an application for any IPR in or outside India without prior
approval of NBA. The Gate keeping for this is envisaged at several stages:
              1) Section 6(1) provides that prior approval of NBA is necessary before
                 applying for any kind of IPRs (in or outside India)based on any research or
                 information on a biological resource obtained from India.
                 Such approval, however, is not required where IPR rights relating to
                 protection of plant varieties are applied for [Section 6(3)]. This is because in
                 such cases, it is the Plant Varieties and Farmers' Rights Authority, established
                 under the Protection of Plant Varieties and Farmers' Rights Act, 2001, which
                 grants the right and determines the benefit sharing. This Authority, in turn,
                 endorses the grant of right to NBA;
              2) In case of Patents, one can procure such approval after the publication of the
                 patent application and before the grant of patent.
              3) In case of assignment of IP rights to third persons, the persons who have been
                 granted approval for access to biological resource and associated knowledge
                 may transfer the same by taking approval from NBA.

While granting such permission, the NBA is most likely to impose benefit sharing conditions
such as monetary benefit like royalty, joint ventures, technology transfer product development.
The parameters involved for payment of such compensation are extent of use, sustainability
aspect, impact and expected outcome levels, short term and long term benefits etc.

NBA drafted new guidelines on access and benefits sharing particularly on International Regime
on Access and Benefit Sharing; Evolving sui generis system for the protection of Traditional
Knowledge and Amendments to the Biological Diversity Act, 2002 and Biological Diversity
Rules, 2004 and opened for public hearing. The final draft is yet to be released.

9. Patent law and Traditional Knowledge

The TRIPS Agreement has some provisions having limited application to the protection of
Traditional Knowledge. The obligation to protect geographical indications can be used to protect
traditional knowledge if associated with the indication used for production and sale of goods. It
is made clear that a given quality, reputation or other characteristics of the goods essentially
attributable to its geographical origin are to be considered in identifying the geographical
indications for protection.

 India’s current Patents Act includes several provisions aimed at traditional knowledge outside
the realm of patenting. 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.” This exclusion is but one of several provisions
inserted into the new Act in an effort to prevent the exercise of proprietary rights in India’s
genetic resources and indigenous knowledge. As mentioned above, the Act’s disclosure
requirements mandate inclusion of the source and geographical origin of biological material used



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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 . . .

The government of India has granted the EPO &USPTO, access to its Traditional Knowledge
Digital Library (TKDL). The European Patent Office, for instance, has set aside its original
intention to grant patents in at least two cases, while 33 applications were withdrawn by the
applicants themselves. Council of Scientific & Industrial Research claims that around 400
applications pending in various other patent offices have also been similarly challenged. Loaded
with ancient medical knowledge, the online database contains translations of manuscripts and
textbooks in five languages (500-5000 year old texts on Ayurvedic cure & herbal remedies are
documented), including English. Access to the 30-million-page database helps to correctly
examine patent applications relating to traditional knowledge. With the TKDL, examiners have
improved access to background information at an early stage of patent examination. Prominent
cases of patent disputes include a US patent on the wound-healing properties of turmeric
(revoked in 1997) as well as an anti-fungal product from the Indian Neem tree (revoked in 2008).
Both herbal practices were evidence of traditional knowledge and the patents were rescinded. In
both instances, the Indian government needed to prove that the patented methods were not novel
and were based on traditional knowledge. The process to challenge the granted patents proved
lengthy and cumbersome as some traditional knowledge had only been documented in Sanskrit
or other ancient writings and thus required extensive translation. Agreements with regard to
TKDL with offices in Japan and New Zealand are round the corner.

       A. 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.

           If an applicant seeks to patent the medicinal use of an herb listed in the TKDL,
           examiners conduct a thorough investigation. In some cases this leads to a reduction of
           the scope of the patent or its refusal.

           However, 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 zeylanicusused] as
           immunomodulator as well as for energy and vitality). There are about 6 patents
           granted on jeevani and Tropical Botanical Garden and Research Institute (TBGRI),
           the patent holder shared the royalty through ABS with the local tribe)

10. Biotech patent jurisprudence in India
       A. Dimminaco A.G. v. Controller




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In India there is no substantial case law development with regard to the biotechnology
inventions in India as the industry is in an infant stage. The leading biotechnology
patent law decision of the Indian courts is the A.G. v. Controller of Patents, Designs
& Trade Marks (in 2002), where for the first time, and utility of a biotech invention
was demonstrated. The invention related to a process for preparation of infectious
bursitis vaccine. The vaccine was useful for protecting poultry against contagious
bursitis infection. Initially the Patent office rejected the patent application on the
ground that the claim did not constitute an invention. But the utility of the invention
was not disputed. Although this decision was issued more than twenty years after the
U.S. Supreme Court’s decision in Diamond v. Chakrabarty, Indian commentators
view it as epoch making as by this decision, the court overturned a long-standing
policy of the Indian Patent Office to refuse such process claims, thus opening the
door to biotechnology patenting in India much as the Chakrabarty decision did in the
United States.

The Assistant Controller of patent observed that “in India till date, no patent had been
granted for any process of preparing a living organism. In the Controller’s view, if
such a process became patentable, “there will be further problems as foreign
sophisticated technologies will have to be patented in India. The Assistant Controller
also contended that the framers of India’s Patents Act, 1970, had relied on the 1959
recommendation of the government commissioned Iyengar Committee that
“invention” should be defined narrowly. Appellant Dimminaco countered that the
Patent Office had not cited any anticipatory prior art against the claimed process, nor
had it questioned the utility of the end-product vaccine. Therefore, the process should
be held a patentable “manner of manufacture” coming within the Patent Act’s
enumerated categories of inventions. After summarizing the parties’ respective
arguments, the Calcutta High Court considered the scope of “manner of manufacture”
under section 2(i)(j) of the Patents Act, 1970, and noted that the word “manufacture”
was not defined in the Patents Act. In such cases, the court explained, the dictionary
meaning of “manufacture” or its usage “in the particular trade or business must be
accepted. Further, in order to decide whether a particular process of manufacture
“ought to be patented or not, “one of the most common tests is the vendibility test.
This test is satisfied “if the invention results in the production of some vendible item
something which can be passed on from one man to another upon the transactions of
purchase and sale claimed method was a patentable invention because the dictionary
meaning of the word manufacture does not exclude the process of preparing a
vendible commodity which contains a living substance. Where, as in this case, the
Patents Act, 1970, provided no definition of “manufacture,” then “the dictionary must
be accepted. The Assistant Controller had legally erred “by holding that merely
because the end product contains a live virus, the process involved in bringing out the
end product is not an invention.

In overturning the Assistant Controller’s decision, the court held that there was
evidence that the Indian Patent Office had already granted a few biotechnology
process patents producing a living end product. The Assistant Controller had “not
acted on correct principles” by rejecting Dimminaco’s application on the ground that



                                    13
   it could not be called a “manner of manufacture” because it involved a living virus in
   the end-product. The Indian Patent Office appears to have adopted Dimminaco’s
   teaching that the fact that an invention is living (or produces a living product) does
   not automatically exclude it from patentability. The MPPP states that a “living entity
   of artificial origin such as micro-organism, or vaccines are considered patentable,
   although higher life forms such as plants or multi-cellular animals, whether of natural
   or artificial origin, are not. Moreover, biological material such as recombinant DNA,
   Plasmids and processes of manufacturing thereof are patentable provided they are
   produced by substantive human intervention. In addition, the processes relating to
   micro-organisms or producing chemical substances using such micro-organisms are
   patentable.

B. Speaking Roses International Inc. vs. Controller-General of Patents And Anr.

   The Petitioners, viz. Speaking Roses international Inc., had on September 19, 2002,
   applied for a patent for “providing an image on an Organic Product, being
   flowers”. Subsequently, they were given the First Examination Report (FER) as well
   as the Second Examination Report (SER), both of which they had replied to and
   complied with. However, by an order the Respondent had rejected said application on
   the following 5 major grounds. 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 animals.” This sub-clause thus
   does not allow grant of patent for plants or for any biological processes for production
   or propagation of plants. 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 patented. Furthermore, such 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       Section3(j).

   The second ground of objection was that 3 other inventors, had been previously
   granted patents for identical purpose and in light of that fact, the Petitioners’ claim
   lacked the necessary inventive step to qualify for a patent. The Petitioners, however,
   argued that their product was substantially different from those of the patentees as the
   Petitioners, had been using a pad/roller as a transfer medium, which resulted in no
   such damage. Again, another inventor marked the image by cutting and altering over
   the surface of the flower by a computer-controlled laser beam, which caused
   alterations of the material of the organic product and subsequent quick deterioration.
   However, the Petitioners' process of pad printing did not cause any such alteration.
   The court held that that the Petitioners were the first to have applied for the process
   they have claimed a patent for and hence the requirements of inventive step and
   novelty stood satisfied.

   The remaining 3 grounds of objection included the allegations that the Petitioners'
   claim does not sufficiently define the invention, lack of clarity of the title of the



                                        14
           patented product and the inconsistency of the title with the claims made by the
           Petitioners. Regarding these, the Court was of the opinion that the Petitioners
           intended to obtain a patent on the mechanical process of imprinting the message by
           way of pad printing on an organic product and the hence the title of their application,
           being for “Providing an image on an Organic Product”, appeared to be precise,
           concise and definite. The court observed that the Petitioners’ illustrative explanation
           of the method appeared to be in perfect consistency with their claim for a method
           patent as against a product patent. Moreover, the summary of the invention, provided
           by the Petitioners in the application, renders well defined methods of the invention as
           the type of images to be imprinted upon specifically illustrated organic products and a
           clear object of the exercise in its entirety and the objection with regard to the title and
           claims inconsistency also met with a similar fate.

           The Court also held that the Petitioners do not require amending their claims under
           such circumstances and refused to consider further objections of the Respondent
           regarding the feasibility of expanding the scope of the claim. At the end the court
           observed that a patent application could not be rejected merely on the ground that
           only one of the assignees of the patent had filed the application. Finally, the Court set
           aside the Respondent’s order of rejection of the patent.

11. Conclusion

As stated hereinbefore, the issues that relate to 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 inventions. However, 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. Therefore, the inventions are subject to the fulfillment of the
relatively broad criteria. It is noteworthy to mention that the patenting of biological material in
India is still decided more often on a case-by-case basis.

India’s post-TRIPS patent laws include several provisions that make biotechnology patenting
more attractive as a basis for competitive advantage. The Dimminaco decision likewise signifies
greater judicial and administrative appreciation of the importance of biotechnology patenting. It
is apparent from the allowable claims disclosed hereinbefore, that the biotech patents can be
obtained in diverse areas provided the description/enablement requirements be complied with
and prosecuted articulately.

Furthermore, India being one of the bio-diversity rich countries, it would, thus, be prudent to
protect biotechnological inventions as that would help Indian biotechnology research to compete
globally. India needs to reap the due benefits from its rich bio-resources with an enabling
provision for patent protection in biotechnological innovations and inventions.




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Bibliography

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          22. The protection, conservation and effective management of traditional knowledge
              relating to biological diversity rules, 2009



                                             16
23. Indian Patent Law, Office Procedures and Examination Practice for
Biotechnology Patent Applications Dr. K.S. KARDAM Deputy Controller of Patents
& Designs Indian Patent Office




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