• Save
Patentability of biotech inventions   us, europe and india
Upcoming SlideShare
Loading in...5

Patentability of biotech inventions us, europe and india






Total Views
Views on SlideShare
Embed Views



0 Embeds 0

No embeds



Upload Details

Uploaded via as Microsoft PowerPoint

Usage Rights

© All Rights Reserved

Report content

Flagged as inappropriate Flag as inappropriate
Flag as inappropriate

Select your reason for flagging this presentation as inappropriate.

  • Full Name Full Name Comment goes here.
    Are you sure you want to
    Your message goes here
Post Comment
Edit your comment

Patentability of biotech inventions   us, europe and india Patentability of biotech inventions us, europe and india Presentation Transcript

  • Vikram Pratap Singh Thakur www.SiNApSEblog.com
  •  Broad - (WIPO)  any technology that uses living organisms Narrow and limited - (United States Office of Technology Assessment)  techniques using living organisms to make or modify products and to improve plants or animals Economic view - (OECD)*  include techniques using living organisms for production of knowledge, goods or services Different organizations – Different meaning – scope of field is not clear – challenging in applying patent principles*Organisation for Economic Co-operation and Development (c) SiNApSE, 2012
  •  Involves living organisms Morals and Ethics Diverse fields Long gestation period (c) SiNApSE, 2012 View slide
  •  The modification may cause harm The results of such inventions may prove to be harmful to human beings Man does not have the right to play god by modifying living organisms Protection would stifle research and prevent access to medical treatment. Counter Argument  High investment  Long time (c) SiNApSE, 2012 View slide
  • India , US & Europe
  •  Patentable Subject matter Utility / Industrial applicability Novelty Non-obviousness / Inventive step SpecificationFig: Patent filter model (c) SiNApSE, 2012
  • (c) SiNApSE, 2012
  •  Inclusion  process, machine, manufacture or composition of matter. Exclusion  Laws of nature, physical phenomena, and abstract ideas (c) SiNApSE, 2012
  •  Funk Bros. Seed Co. v. Kalo Inoculant Co.  mixed culture of Rhizobium bacteria capable of simultaneously inoculating the seeds of plants  Mere aggregation of species  produced no new bacteriawork of nature – not patentable subject matter (c) SiNApSE, 2012
  •  Diamond v. Chakrabarty  a single genetically modified Pseudomonas bacterium ▪ four different plasmids - degrading four different oil components  Patent rejected – product of nature – living organism  SC: Product of nature - whether the invention in question involves a hand of man? (c) SiNApSE, 2012
  •  Mayo v. Prometheus  use of thiopurine drugs to treat autoimmune diseases ▪ Administration of drug – assessment of metabolite levels – determination of appropriate dosage ▪ Federal circuit – patentable ▪ Supreme court – reversed ▪ processes are just extensions of co-relations that exist in nature and do not add anything to those relationships. ▪ Assessment based on biological co-relations by doctors cannot according to the court considered sufficient to take the processes outside the scope of laws of nature exclusion. (c) SiNApSE, 2012
  •  Inclusion  Any invention Exclusions  Contrary to public order or morality  Living Organisms ▪ Plants and Animals  Human cells and cell lines  Human Cloning and Chimeras Oncomouse / Harvard mouse case ▪ genetically altered mouse ▪ Involved inserting an activated oncogene to develop cancer Non human multicellular organisms – patentable subject matter (c) SiNApSE, 2012
  •  Inclusion  Product or process Exclusion  Public order or morality  Discovery of any living things  Genetically modified multicellular organisms ▪ Plants and animals and their parts thereof  human beings and embryonic stem cells are not patentable  methods of medical treatment (c) SiNApSE, 2012
  • (c) SiNApSE, 2012
  •  Specific  well defined and particular benefit - is specific to the subject matter claimed Substantial  real world use – use in current form Credible  believable to PHOSITA based on the totality of evidence and reasoning provided (c) SiNApSE, 2012
  •  re Fisher  Five purified nucleic acid sequences that encodes proteins and protein fragments in maize plants  Several uses of Expressed Sequence Tags (ESTs) ▪ use as a molecular marker, ▪ primer ▪ other general uses  Court: ▪ Genes encoded by EST - had no known functions – not useful ▪ Utility – not general - directed to a particular disease or aspect. (c) SiNApSE, 2012
  •  Capable of being industrially produced Max-Planck/BDP1 Phosphatase  Brain Derived Phosphatase  Board ▪ vague and speculative indication of possible objectives ▪ that might or might not be achievable by carrying out further research ▪ was not sufficient for fulfillment of the requirement of industrial applicability  industrial applicability - satisfied - "practical" application -disclosed. (c) SiNApSE, 2012
  •  Human Genome Sciences Inc v Eli Lilly  Protein - Neutrokine-α, and its gene sequence  SC: ▪ gene sequence coding for the protein has industrial applicability even if the specific use of the protein is not known ▪ protein - a class of ligands - uses generally known - sufficient utility.  Lowering of heightened standards ▪ Maturity in the field – increases predictability – removes speculation (c) SiNApSE, 2012
  •  Industrially applicable  Make  Use  Repeat / reproduced Standard principles apply to biotech inventions Patent Manual  Disclose functions of gene sequences and DNA sequences to satisfy requirements (c) SiNApSE, 2012
  • (c) SiNApSE, 2012
  •  Lower Novelty criteria for biotech inventions Isolated and purified gene sequences – novel (c) SiNApSE, 2012
  •  Amgen v. Chugai  a gene was a chemical compound, albeit a complex one and is therefore patentable  Conception of a chemical compound requires, inventor to : ▪ define and distinguish from other materials ▪ describe how to obtain it ▪ conception of a generalized approach for screening a DNA library that may be used to identify and clone the Erythropoetin (Epo) gene of unknown constitution was not conception of a "purified and isolated DNA sequence" encoding human EPO ▪ Conceived, if reduced to practice for purposes of novelty (c) SiNApSE, 2012
  •  Novelty determination for biotech inventions is relatively low Isolated Gene Sequences Relaxin case  process for obtaining H2-relaxin, the DNA encoding it, their chemical structure and use of the protein  Board ▪ isolation of a gene of a known protein for the first time through conventional methods would make the gene sequence novel ▪ natural existence of genes would not anticipate their isolation ▪ Isolated genes are different from their natural counterparts (c) SiNApSE, 2012
  •  No explicit provisions for novelty of biotech inventions Biotech inventions – inherently product of nature – present in Living organisms - construed as discoveries Patent Manual - patentable  recombinant DNA  Plasmids  processes of manufacturing Provided: involve substantive human intervention (c) SiNApSE, 2012
  • (c) SiNApSE, 2012
  •  Non-obviousness standards - different from the generally accepted principles  Lack of maturity in the field – lower standards  Reasonable expectation of success – lower standards (c) SiNApSE, 2012
  •  Hybritech v. Monoclonal  Immunometric Assays Using Monoclonal Antibodies  Patent non-obvious - despite a lot of prior art – combined prior art not obvious  Importance of secondary indicia ▪ commercial success ▪ unexpected advantages ▪ praise from experts of the diagnostic kits made by Hybritech (c) SiNApSE, 2012
  •  In re Deuel  isolated and purified DNA and cDNA molecules encoding heparin-binding growth factors (HBGFs)  Prior art ▪ Bohlen reference disclosing a group of protein growth factors ▪ Maniatis reference and a general gene cloning method  Court ▪ Invention could not be conceived based on the teachings in the references ▪ until the claimed molecules were actually isolated and purified ▪ Highly unlikely for PHOSITA to contemplate the invention ▪ What cannot be conceived cannot be obvious. (c) SiNApSE, 2012
  •  In re Kubin’s  Invention ▪ an amino acid sequence of Natural Killer Cell Activation Inducing Ligand, also referred to as NAIL - activation of the Natural Killer cells - instrumental in fighting tumors and viruses  Prior art ▪ Valiante’s patent which discloses a receptor protein called p38 receptor – found to be essentially same as NAIL ▪ Joseph Sambrook’s Laboratory Manual on Cloning - provided information with regard to conventional techniques to isolate and sequence any gene  Board ▪ Obvious  Federal Circuit ▪ Affirmed ▪ motivation to seek ▪ reasonable expectation of success (c) SiNApSE, 2012
  •  Combined Prior Art Reasonable expectation of success Secondary considerations  Commercial success  Expert testimony Standards higher as compared to US (c) SiNApSE, 2012
  •  R. v. Chiron - with inventive step of a DNA molecule  DNA molecule comprising a specified nucleotide sequence encoding insulin-like growth factor II (IGF-II)  lack of sufficient information in prior art can be supplemented by the knowledge of PHOSITA  Board – lacked inventive step ▪ reasonable likelihood of success – obvious ▪ Proved by prior art information, experiments, expert testimony and so on ▪ low expectation of success – non obvious (c) SiNApSE, 2012
  •  No differing standards  Reasonable expectation of success – same standards  Predictability of the field – same standards Patent Manual  Isolated gene sequences and protein sequences - patentable  Economic significance easy to prove ▪ application in drugs and diagnostics (c) SiNApSE, 2012
  • (c) SiNApSE, 2012
  •  Higher standards than other inventions  Require specificity  Reduction to practice  Examples  Experimental data (c) SiNApSE, 2012
  •  Amgen v. Chugai  DNA sequences encoding Erythropoietin  Court ▪ claims have to be adequately supported by the written description ▪ stating a few gene analogs would not support a claim over all gene analogs of a protein (c) SiNApSE, 2012
  •  Regents of the University of California v. Eli Lilly & Co  Recombinant plasmids and microorganisms that produce human insulin  Disclosure of structure of a few species in a genus would not be sufficient to support a claim of the entire genus ▪ Unless ▪ substantial features of the genus, and ▪ substantial common physical characteristics were described (c) SiNApSE, 2012
  •  Fiers v. Revel  DNA coding for human fibroblast beta-interferon  Held ▪ claiming all DNAs that achieve a result without defining what means would do so was not in compliance with the description requirement ▪ it was an attempt to preempt the future before it had arrived. (c) SiNApSE, 2012
  •  Much higher standards than other inventions Weyershaeuser Case  microbiologically produced reticulated cellulose  board ▪ disclosure should be sufficiently clear such that it can be enabled by PHOSITA without undue burden on that person (c) SiNApSE, 2012
  •  R v. Genentech case  amino acid sequence and DNA sequences of interferon-gamma  Board ▪ patent application relating to a gene would be enabling even if the experimentation required is burdensome, so long as undue experimentation is not required ▪ deposit of biological materials is not compulsory – if application can be enabled based on written description (c) SiNApSE, 2012
  •  Described completely in the specification to enable a PHOSITA to be able to carry out the invention by reading the specification Deposit of biological materials at a recognized depository (c) SiNApSE, 2012
  • (c) SiNApSE, 2012
  •  No statutory provisions relating to morality USPTO examination guidelines  No patents relating to human beings ▪ Against US Constitution - prohibits slavery (c) SiNApSE, 2012
  •  Provides prohibitions Invention not against public order or morality Cases:  Harvard Mouse Case ▪ genetically modified mouse – morality concern - patentable ▪ Benefit to human outweighs suffering to animal (c) SiNApSE, 2012
  •  Provides strong prohibitions Not patentable  public order or morality  Causes serious prejudice to human, animal or plant life or health or to the environment Patent Manual  Against public order or morality ▪ 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 (c) SiNApSE, 2012
  •  All requirements can broadly be classified under 3 stages Stage 1 – Pre-search stage  Subject matter  Utility Stage 2 - Patentability assessment search and analysis  Novelty  Non-obviousness Stage 3 - Application drafting and filing  Specification ▪ Written description ▪ Enablement (c) SiNApSE, 2012
  •  SiNApSE blog www.sinapseblog.com FUN IP – see IP shop @ SiNApSE blog Online courses - www.onlineipcourses.com Reading material by NLSIU (c) SiNApSE, 2012