The Post 2005 Patent Regime and the Pharma-Biotech

The Post 2005 Patent Regime and the Pharma-Biotech

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 LAKSHMIKUMARAN & SRIDHARAN Brief Overview of Patent Law Governed by Patent Act, 1970 and Patent Rules, 2003 India follows a first-to-file system

In compliance with TRIPS obligations Product patent allowed from 2005 Judicious borrowing of patent jurisprudence from EU/ UK LAKSHMIKUMARAN & SRIDHARAN 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 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 LAKSHMIKUMARAN & SRIDHARAN 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 LAKSHMIKUMARAN & SRIDHARAN 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 Substance freely occurring in nature - discovery

Substance in nature patentable when isolated from its surroundings and having a technical effect LAKSHMIKUMARAN & SRIDHARAN 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: Claimed sequence is identical to natural sequence;

Encodes the same protein; Mirrors the naturally-occurring mRNA, Serves no new function and has no different quality from the natural sequence Isolating and/or purifying is not sufficient to confer patent-eligibility on a natural product; LAKSHMIKUMARAN & SRIDHARAN BRCA: Issues (contd) The Federal Circuits Decision The difference between a product of nature and a human made invention . . . turns on a change in the

claimed compositions 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 LAKSHMIKUMARAN & SRIDHARAN 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 surgical

curative, prophylactic [diagnostic, methods for the treatment of humans or therapeutic] or other treatment of animals; human beings or any process for a similar treatment of animals to render them free of disease or to increase their economic products. LAKSHMIKUMARAN & SRIDHARAN value

or that of their TRIPS and Indian Patent Act Article 27 of TRIPS 3. Members may also exclude from patentability: (b) plants and animals other than micro- Section 3 of the Indian Patent ActWhat are not inventions: organisms, and essentially biological processes (j) plants and animals in whole or any part for the production of plants or animals other

thereof other than microorganisms but than microbiological including seeds, varieties and species processes. However, Members shall provide for and essentially biological processes for the protection of plant varieties either by production or propagation of plants and non-biological and

patents or by an effective sui generis system or animals. by any combination thereof. LAKSHMIKUMARAN & SRIDHARAN Plant Cells/Plant Genetic Systems Invention embraces plant cells, plants and process for producing the plants 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)

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. 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 LAKSHMIKUMARAN & SRIDHARAN Approved Biologics in Cell lines Source: CHO Consortium, SBE Special Section LAKSHMIKUMARAN & SRIDHARAN

Proteins produced in Plant cell culture Source: Stephen Hellwing, Jurgen Drossand, Richard M Twyman & rainer Fischer; Nature Biotechnology, Volume 22, Number 11, Nov 2004 LAKSHMIKUMARAN & SRIDHARAN 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 LAKSHMIKUMARAN & SRIDHARAN EP Enlarged Board of Appeal: Novartis/Transgenic Plant

Invention embraces plant varieties but not targeted to plant varieties Interrelationship between UPOV and EPC no dual protection Art. 53(b) interpreted to establish demarcation to prevent dual protection Decision of the Board (G 1/98) 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. Plant varieties obtained by means of genetic engineering do not fall outside

the exclusion from patentability under Article 53(b) of EPC Patent granted to Novartis for anti-pathogenic transgenic plants and processes for producing the transgenic plants LAKSHMIKUMARAN & SRIDHARAN Patentability of Human Embryonic Stem Cell Culture Case no. :G 0002/06 Decision: 25 November 2008

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)? LAKSHMIKUMARAN & SRIDHARAN 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. 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 LAKSHMIKUMARAN & SRIDHARAN THANK YOU LAKSHMIKUMARAN & SRIDHARAN

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