Patentability of biotech inventions us, europe and india


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Patentability of biotech inventions us, europe and india

  1. 1. Vikram Pratap Singh Thakur
  2. 2.  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
  3. 3.  Involves living organisms Morals and Ethics Diverse fields Long gestation period (c) SiNApSE, 2012
  4. 4.  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
  5. 5. India , US & Europe
  6. 6.  Patentable Subject matter Utility / Industrial applicability Novelty Non-obviousness / Inventive step SpecificationFig: Patent filter model (c) SiNApSE, 2012
  7. 7. (c) SiNApSE, 2012
  8. 8.  Inclusion  process, machine, manufacture or composition of matter. Exclusion  Laws of nature, physical phenomena, and abstract ideas (c) SiNApSE, 2012
  9. 9.  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
  10. 10.  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
  11. 11.  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
  12. 12.  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
  13. 13.  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
  14. 14. (c) SiNApSE, 2012
  15. 15.  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
  16. 16.  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
  17. 17.  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
  18. 18.  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
  19. 19.  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
  20. 20. (c) SiNApSE, 2012
  21. 21.  Lower Novelty criteria for biotech inventions Isolated and purified gene sequences – novel (c) SiNApSE, 2012
  22. 22.  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
  23. 23.  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
  24. 24.  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
  25. 25. (c) SiNApSE, 2012
  26. 26.  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
  27. 27.  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
  28. 28.  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
  29. 29.  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
  30. 30.  Combined Prior Art Reasonable expectation of success Secondary considerations  Commercial success  Expert testimony Standards higher as compared to US (c) SiNApSE, 2012
  31. 31.  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
  32. 32.  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
  33. 33. (c) SiNApSE, 2012
  34. 34.  Higher standards than other inventions  Require specificity  Reduction to practice  Examples  Experimental data (c) SiNApSE, 2012
  35. 35.  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
  36. 36.  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
  37. 37.  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
  38. 38.  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
  39. 39.  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
  40. 40.  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
  41. 41. (c) SiNApSE, 2012
  42. 42.  No statutory provisions relating to morality USPTO examination guidelines  No patents relating to human beings ▪ Against US Constitution - prohibits slavery (c) SiNApSE, 2012
  43. 43.  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
  44. 44.  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
  45. 45.  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
  46. 46.  SiNApSE blog FUN IP – see IP shop @ SiNApSE blog Online courses - Reading material by NLSIU (c) SiNApSE, 2012