Transcript Slide 1

The Post 2005 Patent Regime and
the Pharma-Biotech Sector:
Indian Patent Law and Policy in
making
Malathi Lakshmi Kumaran Ph. D. FNASc
[email protected]
WWW.LSLAW.IN
MHRD IPR Chair IP and Pharmaceuticals
Symposium, NLU-Jodhpur
17 March, 2012
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Brief Overview of Patent Law
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Governed by Patent Act, 1970 and Patent Rules, 2003
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India follows a first-to-file system
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In compliance with TRIPS obligations
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Product patent allowed from 2005
Judicious borrowing of patent jurisprudence from
EU/UK
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Claim Types
All fields of technology are patentable
Product Patent
 Chemicals/food
 Microorganisms
 Nucleic acid-DNA, cDNA, RNA, recombinant vector,
siRNA, RNAi
 Protein/Polypeptide
Process Patent
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A process of regeneration of plant
A process of production of transgenic
plant/A process of transformation
A process of preparation of a vaccine
A process of production of recombinant
protein- Human insulin, Immunoglobulin,
vaccine, Blood clotting factor, Bt-toxin
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Non-Patentable Subject-Matter
• Section 3 and 4: What are not inventions
 Section 3(a): Frivolous or anything contrary to well
established natural laws
 Section 3(b): Contrary to public order and morality
 Section 3(c): Discovery of living things
 Section 3(d): New forms of a known substance
 Section 3(e): Composition-mere admixture
 Section 3(i) : Method of treatment of animals and humans
 Section 3(j) : Plants, animals and parts thereof and
Essentially Biological Processes
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Section 3(c)
Section 3(c)
The mere discovery of a scientific principle or the formulation of an
abstract theory or discovery of any living or non-living substances
occurring in nature
Discovery vs. Invention
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Substance freely occurring in nature - discovery
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Substance in nature patentable when
– isolated from its surroundings and having a technical effect
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BRCA: Issues
July 29, 2011; Declaratory judgment action in Federal District Court (SDNY)
(Association for Molecular Pathology, et al. v. United States Patent and Trademark Office, et al.)
Patent claims alleged to cover natural human genes: e.g. U.S. 5,747,282
1. An isolated DNA coding for a BRCA1 polypeptide, said polypeptide having the amino acid sequence set
forth in SEQ ID NO:2.
2. The isolated DNA of claim 1, wherein said DNA has the nucleotide sequence set forth in SEQ ID NO:1.
The claim is said to be to a product of nature:
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Claimed sequence is identical to natural sequence;
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Encodes the same protein;
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Mirrors the naturally-occurring mRNA,
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Serves no new function and has no different quality from the natural sequence
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Isolating and/or purifying is not sufficient to confer patent-eligibility on a natural product;
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BRCA: Issues (cont’d…)
The Federal Circuit’s Decision
• The difference “between a product of nature and a
human made invention . . . turns on a change in the
claimed composition’s identity compared to what exists
in nature.”
• Court found that the claimed DNA sequences are
chemically different from DNA in nature
• Thus, the DNA claims are patentable subject matter
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TRIPS and Indian Patent Act
Article 27 of TRIPS
Section 3 of the Indian Patent Act-
3. Members may also exclude from
What are not inventions:
(i) any process for the medicinal, surgical,
patentability:
(a)
diagnostic, therapeutic and
curative,
prophylactic
[diagnostic,
surgical methods for the treatment of
therapeutic] or other treatment of
humans or animals;
human beings or any process for a
similar treatment of animals to render
them free of disease or to increase their
economic
products.
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value
or
that
of
their
TRIPS and Indian Patent Act
Article 27 of TRIPS
3. Members may also exclude from
What are not inventions:
patentability:
(b)
plants and animals other than
micro-organisms,
Section 3 of the Indian Patent Act-
and
(j) plants and animals in whole or any part
essentially
thereof other than microorganisms but
biological processes for the production
including seeds, varieties and species
of plants or animals other than nonbiological and microbiological processes.
However, Members shall provide for the
protection of plant varieties either by
and essentially biological processes for
production or propagation of plants and
animals.
patents or by an effective sui generis
system or by any combination thereof.
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Plant Cells/Plant Genetic Systems
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Invention embraces plant cells, plants and process for producing the plants
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Patent opposed on the grounds that grant of a patent for plant life forms and the
exploitation of the patent was contrary to morality and/or "ordre public“ [Article 53(a)
EPC], and the claims relating to plants and to processes for their production were not
patentable under Article 53(b) EPC.
Decision of the Board (T 0356/93)
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Plant cells can be cultured like bacteria and yeast using modern technology, thus, cannot
be considered to fall under the definition of a plant or of a plant variety. The plant cells are
considered to be "microbiological products" in the broad sense.
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According to the current practice of the EPO, the term "microorganism" includes not only
bacteria and yeasts, but also fungi, algae, protozoa and human, animal and plant cells, i.e.
all generally unicellular organisms with dimensions beneath the limits of vision which can
be propagated and manipulated in a laboratory. Plasmids and viruses are also considered
to fall under this definition
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Approved Biologics in Cell lines
Source: CHO Consortium, SBE Special Section
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Proteins produced in Plant cell culture
Source: Stephen Hellwing, Jurgen Drossand,
Richard M Twyman & rainer Fischer; Nature
Biotechnology, Volume 22, Number 11, Nov
2004
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Secondary metabolites in Plant Tissue Culture
Source: Mulabagal Vanisree, Chen-Yue Lee,
Shu-Fung Lo, Satish Manohar Nalawade,
Chien Yih Lin, and Hsin-Sheng Tsay; Bot. Bull.
Acad. Sin (2004) 45:1-22
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EP Enlarged Board of Appeal:
Novartis/Transgenic Plant
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Invention embraces plant varieties but not targeted to plant varieties
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Interrelationship between UPOV and EPC – no dual protection
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Art. 53(b) interpreted to establish demarcation to prevent dual protection
Decision of the Board (G 1/98)
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A claim to a (genetically modified) plant or animal is not excluded from
patentability even if this claim encompasses a plant (animal) variety, provided
that the invention is not restricted to a single plant (animal) variety.
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Plant varieties obtained by means of genetic engineering do not fall outside
the exclusion from patentability under Article 53(b) of EPC
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Patent granted to Novartis for anti-pathogenic transgenic plants and
processes for producing the transgenic plants
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Patentability of
Human Embryonic Stem Cell Culture
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Case no. :G 0002/06
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Decision: 25 November 2008
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Applicant: Wisconsin Alumni Research Foundation (WARF)
Questions before the Enlarged Board of Appeal
1. Does Rule 23d(c) [now 28(c)] EPC forbid the patenting of claims directed to
products (here: human embryonic stem cell cultures) which - as described in the
application — at the filing date can be prepared exclusively by a method which
necessarily involves the destruction of the human embryos from which the said
products are derived, if the said method is not part of the claims?
2. If answer to question 1 is no, does Article 53(a) EPC forbid patenting such claims?
3. Is it of relevance that after the filing date the same products could be obtained
without having to recur to a method necessarily involving the destruction of human
embryos (here: eg derivation from available human embryonic cell lines)?
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EP Technical Board of Appeal: Patentability of
Transgenic Animals (Oncomouse)
Claims in question
1. A method for producing a transgenic non-human mammalian animal having an
increased probability of developing neoplasms, said method comprising
chromosomally incorporating an activated oncogene sequence into the genome of a
non-human mammalian animal.
19. A transgenic non-human mammalian animal whose germ cells and somatic cells
contain an activated oncogene sequence as a result of chromosomal incorporation
into the animal genome, or into the genome of an ancestor of said animal, said
oncogene optionally being further defined according to any one of claims 3 to 10.
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Art. 53(b) of EPC – Exclusion for animal variety from patentability.
Technical Board of Appeal (T 19/90)
 Art. 53(b) language does not include animals in general, only animal varieties
 Harvard application – for animal variety? – rodents
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THANK YOU
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