Biotech Patenting in India by ABXt0N9


									March 2009

  Current Status of Biotech Patenting
                In India

             Kausalya Santhanam Ph.D
                   Patent Agent
                   USPTO, IPO


Commercial Attributes
 Legal monopoly limited in scope and duration (20

   National in scope

   Exclusionary in nature

   Novelty

   Inventive Step (Non-obviousness)

   Industrial Application (utility)

Protectable Inventions in Biotech

Composition                                Method of Use
                                              Treatment
   Nucleic acid sequence
                                              Diagnosis
   Protein sequences                         Screening

   Antibodies
                                       3(d) Mere discovery of
   Small Molecules                    - a new form
                                       - a new property
                                       - a new use
                                       of a known compound not patentable
Tools                                  unless
   Machines                           differ significantly with regard to efficacy

   Devices
                                                    Method of Making
                                                    Synthesis
 Biotech Inventions

 History and Facts
 Article 27 of TRIPS provides the basis for patentability

 US patent law grants patent to microorganisms when modified by human
  intervention (Diamond v Chakraborty, US Supr. Court, 1980)

 EPO has similar law with regard to patenting microorganisms

 Patentability Criteria – Novelty, Inventive step (Non-Obvious in US),
  Industrial applicability (Utility in US)

 Patenting of transgenic animals – Allowed in the US (ex: oncomouse);
  treated on a case by case basis elsewhere

 Dimminaco A.G. v Controller of Patents & Designs (Calcutta High Court, 2002)

Biotech Inventions

Indian Patent Act
 Section 3 (Patent Amendment 2003) establishes Patentability Criteria for
  microbiological processes

 Microbiological process that can be established as ‘inventions’ are

 Patentability Criteria – Novelty, Inventive step, Industrial applicability

 Biological material deposited at MTCC and Gene Bank, IMTech, Chandigarh
  - all characteristics for identification of the microbial sample
  - access to material allowed after publication of the application
  - disclose the geographical source of the biological material

 Indian law does not allow patenting of animal, whole or part

Biotech Inventions

What is patentable?

                       Purification from
                       T. aquaticus
Taq polymerase         PCR                 Obvious?
 naturally-occurring                       Useful?
                       Recombinant form
                       of Taq polymerase

Biotech Inventions

The catch…
 Expressed Sequence
  Tags (ESTs)
 Gene Fragments

 SNPs
 Genetic Tests
  (screening, diagnostic)

 Proteins
 Stem Cells                           Written Description?

Biotech Inventions

                      Utility - US

   Specific           Substantial                     Credible

         Real World     OR               Well established

         Industrial Applicability – EP and others

Patentability - US

35 USC § 112, 1st paragraph
 The specification shall contain a written description of the invention and of the
manner and process of making and using it, in such full, clear, concise, and
exact terms as to enable any person skilled in the art to which it pertains…to
make and use the same, and shall set forth the best mode contemplated by the
inventor of carrying out his invention

Three Prong requirement in the specification

   Written Description

   Enablement

   Best Mode

Patentability - US

Written Description Requirement

   A patent specification must describe an invention in sufficient detail
    that one skilled in the art can conclude that the inventor had
    possession of the claimed invention

   Possession can be shown by
    i. Actual reduction to practice
    ii. Reduction to drawings
    iii. Describe relevant identifying characteristics
         - structure
         - functional characteristics (with a correlation between structure
           and function)
         - physical characteristics
         - chemical characteristics
         - combination of the above

Patentability - US

Enablement Requirement

   Disclosure of information sufficient for the ordinary skilled
    person to make and use the full scope of the claimed

   Disclosure should facilitate the making and using [of the
    invention] without undue experimentation

Due to unpredictable nature of biotech, enablement requirement is high

Biotech Inventions
Patentability Requirements

Written Description and Enablement (35 USC § 112)
The composition of claim 1 wherein said nucleotide sequences are selected
from the group consisting of:
- the N. gonorroheae DNA insert of ATCC 53409, ATCC 53410 and
ATCC 53411 and discrete nucleotide subsequences thereof…
An isolated polypeptide comprising an amino acid sequence of SEQ ID NO: XX
selected from the group consisting of:
- a mature form of the amino acid sequence of SEQ ID NO: XX
- a variant of the mature form of an amino acid sequence of SEQ ID NO: XX
- a fragment of the mature form of the amino acid sequence of SEQ ID NO: XX

                                                                            x No
  Written Description can be satisfied by depositing the biological material (Enzo
  Biochem. Inc. v Gen-Probe Inc., Fed. Cir. 2002)
Biotech Inventions
Patentability Requirements

Enablement (35 USC § 112)

Ex: US5,756,349
Vertebrate cells which can be propagated in vitro and which are capable upon
growth in culture of producing erythropoietin in the medium of their growth in excess
of 100 U of erythropoietin per 10.sup.6 cells in 48 hours as determined by
radioimmunoassay, said cells comprising non-human DNA sequences which control
transcription of DNA encoding human erythropoietin

By Describing ‘a way’ to make EPO…
Can Amgen claim all cells that propagate in vitro comprising non-human DNA
sequence that control transcription of DNA encoding human erythropoietin?

Amgen v Hoechst (Fed. Cir. 2003)

Biotech Inventions
Patentability Requirements


 Those skilled in the art can readily use various cell cultures (vertebrate) to
  produce human EPO

 For those skilled in the art it is relatively simple to determine
  - whether a certain promoter will work within a specific vertebrate cell
  - whether a particular vertebrate cell will produce human EPO in culture
  - whether a particular promoter could be operatively linked to control the

 Publications (in the given area) that demonstrate the extent of the enabling

Biotech Inventions
Patentability Requirements

Wands Factors (In re Wands, Fed. Cir. 1988)

-   Nature of the invention
-   State of the Prior Art
-   Level of ordinary skill in the art
-   Level of predictability
-   Amount of Direction
-   Presence of working examples
-   Breadth of claims
-   Quantity of experimentation

Biotech Inventions

Gene Inventions and exemplary claims
 Nucleotide, Protein sequences

 Promoters

 Vectors

 Epitope sequences and Antibodies

 Processes used for making the protein

 Method of Use(s): diagnostic, treatment, screening

 Pharmaceutical Product

Biotech Inventions

Enabling Technologies

   Improvement Strategies
    (ex: transgenics, knock-outs)

   Gene expression methodology
    (ex: antisense, target specific expression)

   Gene expression materials
    (ex: specific promoters)

   Gene Constructs

Biotech Inventions


    Genomics           Proteomics                 Clinical/Regulatory


Data Mining    Data Analysis             Pattern        Molecular
                                        Recognition     Modeling

       Data Storage                           Predictive Tools

Biotech Inventions

Bioinformatics – Challenges in Patenting

 Client oriented – Diverse needs: breadth of claims?

 Anticipate and prevent competition is difficult

 Scarce judicial precedent

 Invention obsolete?

 Biotech Patenting

Other Issues…

 Bits and pieces: Allowing a single genomic gene to be patented
  in several ways (ex: fragments, SNPs, peptides)

 Preventing knowledge sharing (decrease in publications) and
  impeding research activities

 Social, ethical and religious issues (ex: stem cell research)

Biotech Patents - India

Indian Patent Applications Filed/Granted between 2000 to 2005 in allied

 Year                  Biotech           Chemical           Drug

 2000-01                   4/0             787/353         883/276

 2001-02                   2/0             778/483         879/320

 2002-03                  46/0             776/399         966/312

 2003-04                  23/0            2952/609         2525/419

 2004-05                1214/71           3916/573         2316192

  Source: Indian Patent Office , Annual Report 2004-2005
 Biotech Patents - India

 First Product Patent Granted (post 2005 era)
   Pegasys (Roche) – Pegylated IFNα 2a

 Increase in no. of Biotech Application Filings
   Homegrown company filings less in no.?
   Homegrown companies filed outside India pre-2005?

 Product vs Process Applications
     Process         Product

 Patent Examiners
   About 130-150

 Patent Examining Process
   Training in specific fields/art

 Oppositions
Integration of IP and Research

        Goal: Tie Applications to Appropriate Process Points

Drug Discovery                                                                     Product

 Identification           Cell Validation            Animal Validation/            Clinical

 Provisional           Updated Provisional/Utility           Utility/CIP           Utility

           12 months

                               12 months                     Composition and MOU     Formulation and Dose

  Portfolio Management

                                            Identification of >25 Compounds

Disease Groups           IP
                                                                        In vitro Studies
         Project Management
                                         Animal Studies, Pk, Tox
             Formulation/                                           Phase I, II

                                                                                   Licensing or Partnering deals
                                                                                             IP Audits

                                                          <2 Products

                                                                                                          - Patent Application

IP Strategies – Related Applications


                Building a fortress around the basic Invention/ technology

        Vacuum chamber in which                              Use of 3 staggered
             the DLC blade                               Blade getting progressively
           coating was applied                                  closer to skin

  Single point cartridge         Mach 3 Core Technology              New forward pivot design
loading system - Avoiding                                            positioning the blades in
 upside down attachment           (Diamond like Coating)            an optimal shaving position

          Indicator strip signaling                     Rubberized contour grip
           when the shaver is no                          for better handling
   longer experiencing ‘the optimal shave’

March, 2009

              Thank You!

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