Biotech Patenting in India by ABXt0N9

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									March 2009




  Current Status of Biotech Patenting
                In India


             Kausalya Santhanam Ph.D
                   Patent Agent
                   USPTO, IPO




                   Confidential
Patents

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

   National in scope

   Exclusionary in nature

Patentability
   Novelty

   Inventive Step (Non-obviousness)

   Industrial Application (utility)

                              Confidential
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
                                                 Process
                                                    Method of Making
                                                    Synthesis
                            Confidential
 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)




                                 Confidential
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
  patentable

 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




                                  Confidential
Biotech Inventions

What is patentable?


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




                       Confidential
Biotech Inventions

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

 SNPs
                                             Useful?
 Genetic Tests
  (screening, diagnostic)

 Proteins
                                       Enablement?
 Stem Cells                           Written Description?

                        Confidential
Biotech Inventions

Patentability
                      Utility - US



   Specific           Substantial                     Credible


         Real World     OR               Well established




         Industrial Applicability – EP and others



                          Confidential
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




                                  Confidential
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

                                Confidential
Patentability - US


Enablement Requirement

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

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


Due to unpredictable nature of biotech, enablement requirement is high




                             Confidential
Biotech Inventions
Patentability Requirements

Written Description and Enablement (35 USC § 112)
Ex:
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…
                                                                            Yes
Ex:
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)
                                   Confidential
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



Enabled?
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)



                                  Confidential
Biotech Inventions
Patentability Requirements

Outcome…

 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
    transcription


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




                                Confidential
Biotech Inventions
Patentability Requirements

Enablement
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




                                 Confidential
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



                           Confidential
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




                               Confidential
Biotech Inventions


                      Bioinformatics


    Genomics           Proteomics                 Clinical/Regulatory


                      Highthroughput
                           Tools

Data Mining    Data Analysis             Pattern        Molecular
                                        Recognition     Modeling

       Data Storage                           Predictive Tools


                         Confidential
Biotech Inventions

Bioinformatics – Challenges in Patenting

 Client oriented – Diverse needs: breadth of claims?

 Anticipate and prevent competition is difficult

 Scarce judicial precedent

 Invention obsolete?




                              Confidential
 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)




                             Confidential
Biotech Patents - India

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

 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
   Dwindling


 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
                                                        Preclinical




 Provisional           Updated Provisional/Utility           Utility/CIP           Utility

           12 months

                               12 months                     Composition and MOU     Formulation and Dose




                                              Confidential
  Portfolio Management


                                            Identification of >25 Compounds


                                         Biology
                                                                                  IP
Disease Groups           IP
                                          Chemistry
                                                                         Validation
                                                                        In vitro Studies
         Project Management
                                              Preclinical
                                         Animal Studies, Pk, Tox
Regulatory
                             Marketing
  Affairs
                                                                    Clinical
             Formulation/                                           Phase I, II
             Manufacturing


                                                                                   Licensing or Partnering deals
                                                                                             IP Audits

                                                          <2 Products


                                                                                                          - Patent Application




                                                         Confidential
IP Strategies – Related Applications

                                             Gillette

                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’




                                      Confidential
March, 2009




              Thank You!

								
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