1. Vikram Pratap Singh Thakur
www.SiNApSEblog.com

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.  Involves living organisms
 Morals and Ethics
 Diverse fields
 Long gestation period
(c) SiNApSE, 2012

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. India , US & Europe

6.  Patentable Subject
matter
 Utility / Industrial
applicability
 Novelty
 Non-obviousness /
Inventive step
 Specification
Fig: Patent filter model
(c) SiNApSE, 2012

7. (c) SiNApSE, 2012

8.  Inclusion
 process, machine, manufacture or composition of
matter.
 Exclusion
 Laws of nature, physical phenomena, and abstract
ideas
(c) SiNApSE, 2012

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 bacteria
work of nature – not patentable subject matter
(c) SiNApSE, 2012

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.  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.  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.  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. (c) SiNApSE, 2012

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.  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.  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.  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.  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. (c) SiNApSE, 2012

21.  Lower Novelty criteria for biotech inventions
 Isolated and purified gene sequences – novel
(c) SiNApSE, 2012

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.  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.  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. (c) SiNApSE, 2012

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.  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.  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.  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.  Combined Prior Art
 Reasonable expectation of success
 Secondary considerations
 Commercial success
 Expert testimony
 Standards higher as compared to US
(c) SiNApSE, 2012

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.  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. (c) SiNApSE, 2012

34.  Higher standards than other inventions
 Require specificity
 Reduction to practice
 Examples
 Experimental data
(c) SiNApSE, 2012

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.  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.  Fiers v. Revel
 DNA coding for human fibroblast beta-interferon
 Held
▪ claiming all DNA's 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.  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.  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.  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. (c) SiNApSE, 2012

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.  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.  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.  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.  SiNApSE blog www.sinapseblog.com
 FUN IP – see IP shop @ SiNApSE blog
 Online courses - www.onlineipcourses.com
 Reading material by NLSIU
(c) SiNApSE, 2012