IPs on sequences. Sunil Archak

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1 IPs on sequences Sunil Archak

2 Need to ensure conducting research without infringing upon others IP rights Need to defend own IP rights against other users Justify the substantial costs involved in research by commercialization of the technology

3 Intangible property generated as a result of creativity Sell or Buy Donate Mortgage License Assign Develop Indian farmers database

4 LIMITED Jurisdiction Territorial Temporal Production Transit Market

5 Trade Secrets Patent Semi-conductor IC PVP Design Trademark Copyright GI sui generis, all others are TRIPS complying

6 IC design Control circuits Design Exterior and interior Patent Engine and parts Trademark Nissan Logo Copyright Control system & software programme

7 A method of agriculture or horticulture Inventions relating to Atomic energy Medicinal, surgical, curative, prophylactic diagnostic therapeutic or other treatment of human being Plants and animals in whole or any part thereof other than microorganisms but including seeds, varieties and species and essentially biological processes for production or propagation of plants and animals E.g. Clones and new variety of plants are not patentable. But process / method of preparing Genetically Modified Organisms are patentable subject matter

8 Today s transgenes are just the tip of the iceberg Beneath the surface is an enormous knowledge base and storehouse of tools that is growing daily for tomorrow s successes Very few plant transgenes have reached the market place yet. Thus the potential still has to be imagined

9 Regulations and policies..1 IP rights come into picture only if the product/process has practical utility immediately or in the conceivable future The ease with which genomic resources can be transported across lab/political/biological barriers makes the topic new for the legal fraternity Crossing the line!!!

10 Regulations and policies..2 IPs surrounding genomic resources are not clear for the stakeholders as yet Sequence from patented microbe Sequence from protected plant variety New utility of protected sequence Protocols and material already patented!!!

11 Regulations and policies..3 Once patents are obtained, offering protection is practically not easy! Sequence change (minor cosmetic) Sequence change (codon usage) New source of protected sequence New use of the protected sequence

12 Sequencing Cost Reductions

13 Number of known plant genes and proteins

14 IPs Commercial Products New Synthetic Species Complex Traits (Many genes) Simple Traits (Few genes) Future of owning genes and gene techs

15 High-Throughput Trait Pipeline Identify genes Transform into Model Plant Gene-Trait Associations Evaluate in Model Crop Energy Crops Switchgrass, Miscanthus, etc. Various Plant Species Arabidopsis Rice Hundreds of candidate trait genes identified Biomass yield Plant architecture Tolerance to environmental stresses Nitrogen use efficiency Disease resistance Food Crops Corn, Soybean, etc.

16 Gene-Trait Associations Drought tolerance Increased yield Heat tolerance Drought recovery Nutrient utilization Root growth Cold germination Increased biomass Shade tolerance Flowering time Stature control Salt tolerance

17 Screens for High Priority Traits Drought (including surrogates) Low Nitrogen (including surrogates) Cold and Freezing Heat (all stages) Light (e.g., shade tolerance) UV tolerance Photosynthetic efficiency Low ph and aluminum High ph Growth rate Flowering time Stay green and maturity Plant architecture Fertility Organ size Stature Stalk thickness Ozone High CO 2 High Nitrogen Carbon/Nitrogen Seed morphology Biotic, fungal Composition seed oil seed protein lignin sterols and others

18 Systems Biology of Traits Flowering: over 70 genes known with principal regulators Stresses, including disease, heat, cold, drought: 100+ genes known and pathways being assembled. Major controlling genes known Growth on limiting nitrogen: Many genes being identified

19 Central dogma!!

20 "anything under the sun made by man" is patentable The road to allowing patents on sequences began with case of Diamond v. Chakrabarty (447 U.S. 303 (1980)) Patent law in the U.S. evolved to allowing patents on many types of biotechnology products, including transgenic plants and eventually for DNA and protein sequences The rationale for concluding that DNA sequences - and by extension, protein sequences - are patentable is that the claimed sequences are human-made; they are "purified and isolated" sequences In the 1990s, the U.S. Patent Office granted many patents claiming "purified" or "isolated" nucleotide and amino acid sequences

21 "anything under the sun made by man" is patentable 2001 brought a change that severely limited the ability to obtain claims reciting sequences The USPTO released the "Utility Examination Guidelines", which set out procedures for ensuring that patent applications complied with the utility requirement of patent law A claimed invention now has to have a "specific and substantial" or a "well-established" utility The impact was huge for claims to sequences. Under these rules, a claim to "A cdna consisting of the sequence set forth in SEQ ID No: 1." is unpatentable unless there is a known function for the sequence Thus, in the United States, after a period of granting expansive patent claims, it has become increasingly more difficult to obtain patent claims to DNA or amino acid sequences

22 Broadening Claim Language in Gene Patents The claims define the scope of a patent. There are different types of claim language that are used in gene-based patents and patent applications that broaden the scope of the claim beyond the actual sequences that are disclosed in a specification Examples of different types of broadening language include the following: Hybridisation language Percent identity language Amino acid substitutions Any nucleotide sequence that encodes a given amino acid

23 US Patent No US Patent No

24 US Patent No US Patent No

25 How many sequences are accepted for examination per application? ONE! (except PCT, which allows "the international application shall relate to one invention only or to a group of inventions so linked as to form a single general inventive concept" under Rule 13

26 Indian Patent Laws on genes Section 3(c) of Indian Patent Act: mere discovery of scientific principle or the formulation or the discovery of any living/non living substance occurring in nature is not an invention. Hence, mere isolation of naturally occurring genes from animal or plant body cannot be patentable Section 3 (i): in vivo diagnostic methods are not patentable. But, diagnostic methods employing DNA primers or probes are patentable. Sequences different from naturally occurring genes/ DNA sequences that exhibit modified functions are patentable Section 3(j): plant and animals as whole, seeds and species which involve in its propagation or biological processes are not considered to be patentable ; nevertheless, artificially developed genetically engineered microorganisms, vaccines and recombinant DNA are all considered to be patentable

27 Indian Patent Laws on genes The basic fact about genes/gene products being patentable is that when a genetically engineered gene/dna/amino acid sequence is novel and holds an inventive step thereby ensuring its industrial application, the patents can be claimed as: Gene sequence/amino acid sequence. A method of expressing the above sequence. An antibody against that sequence/protein. A kit made from the antibody/sequence. Unidentified functions of gene/dna sequences and without any industrial application cannot be construed to be patentable.

28 How to search patented sequences?