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II-PIC 2017: Navigating through the Biotech patent information in India

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Vidya Subramanian (Reliance Life Sciences, India)

India has been in forefront by providing health care products at an affordable price. The success of Pharmaceutical generics showcases the significance of effective patent searching and data mining. The emerging Biotech era has posed many challenges to comprehensive patent search. The nuances in patent searching in life science domain opens a plethora of aspects that one needs to delve in seeking accurate information. The Biotech patent information remains largely scattered as opposed to the organised analysis of patents available to chemical domain. The collation of information and the complexity begins right from the structure of the molecule to the final mechanism of action of these products. A cursory review of the aspects of searching life sciences patents enables one to evolve an insightful search.

Published in: Healthcare
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II-PIC 2017: Navigating through the Biotech patent information in India

  1. 1. 12 Nov 2017 Navigating through Biotech Patent Information in India Ms Vidya Subramanian Deputy General Manager- IPR
  2. 2. 2 DISCLAIMER This presentation is purely based on my personal experience and knowledge. Any views/opinion(s) expressed during this presentation should not be taken as the views/opinion(s) of my Organization in any manner. © 2017 Reliance Life Sciences Pvt. Ltd
  3. 3. 3 Content: 1. Insights into Health care sectors- Pharma and Biopharma. 2. Advantage India – Policies & Patent aspects. 3. Patent Landscape – Pharma & Biopharma. 4. Navigating Biotech patent information in India. © 2017 Reliance Life Sciences Pvt. Ltd
  4. 4. 4 Insights into Health care sectors Pharma and Biopharma © 2017 Reliance Life Sciences Pvt. Ltd
  5. 5. 5 Indian Pharmaceutical sector ❖ The Indian pharma industry is expected to grow over 15 % p.a between 2015 and 2020. ❖ The market is expected to emerge as the 6th largest pharmaceutical market globally by absolute size. India's pharmaceutical sector will touch US$ 55 billion by 2020.
  6. 6. 6 Indian Biotech Sector ❖ India is becoming a leading destination for clinical trials, contract research and manufacturing activities which is leading to the growth of bio services sector. ❖ Protein & antibody production & fabrication of diagnostic protein chips are promising areas for investment. ❖ Stem cell research, cell engineering & cell-based therapeutics are other areas, wherein India will cash in its expertise. ❖ By FY25, India’s biotech industry is estimated to increase to USD100 billion from USD 27.58 billion in 2016. India is ranked 12th in the world in biotech and 3rd in Asia-Pacific.
  7. 7. 7 Patent Filing trends- Biotech ❖ Number of MNCs with R&D centers in India has grown from 721 in 2010 to 943 in 2016. ❖ India’s R&D ecosystem has growth at a phenomenal pace in the last 10 years. ❖ 42% of Global 500 R&D spenders have centers in India, with the figure expected to reach 49% by 2020. India is fast emerging as a global R&D hub.
  8. 8. 8 Advantage India Policies & Patent aspects © 2017 Reliance Life Sciences Pvt. Ltd
  9. 9. 9 Advantage India: Policies ❖ Patent & design applications rose at a CAGR of 3.65% & 7.13% respectively, during FY07–15. ❖ Growing IP application activity indicates increased in-house R&D & innovation in India ❖ In January 2017, “Innovate in India” a strong intellectual property framework to encourage innovation & to promote development in India. The biotechnology industry in India has immense potential to emerge as a global key player.
  10. 10. 10 Advantage India: Patent Aspects ❖ Patent Act : Non patentable inventions- under Section 3 ❖ Section 3d- prevents ever-greening ❖ Section 3e- prevents obvious combinations ❖ Section 3i - prevents medical use claims ❖ No patent term extension / exclusivity ❖ No patent linkage to regulatory approvals ❖ Option of Compulsory Licence ❖ Option of pre and post grant patent opposition ❖ Revocation of patents due to non-working Indian Patent act has provisions for faster entry of generics in health care.
  11. 11. 11 Patent Landscape Pharma & Biopharma © 2017 Reliance Life Sciences Pvt. Ltd
  12. 12. 12 Patent landscape-Pharma Patent search is more organized and structured for Pharmaceutical sector. Designing for NCE Patent data- Generics Gray area identification API- base molecule Selection from chemical classes Polymorph/ Salts/Solvates/ Purity Structure activity relationship search Key intermediates Design and check for structure/substructure Process / ROS Reaction searches / intermediates Formulation patents Formulation search Use Combinations search Dosage/ Combination/Devices
  13. 13. 13 Patent landscape- Biopharma ❖ Biotech Molecules ❖ Regulatory requirements, Gray area search ❖ Target / receptors ❖ Type of molecule- Isolated polynucleic acids, peptides and polypeptides, enzymes, microorganisms, viruses, vectors, antibodies, probes, vaccine compositions, expression systems, cell lines, plants, seeds, transgenic organisms. ❖ Technology search ❖ Sequence search Biotech field has more complex search aspects than Pharma field.
  14. 14. 14 Indian Patent Aspects- Biotech ❖ Non Patentable inventions- Indian Patent Act ❖ Section 3b - disallows Stem cell related patents ❖ Section 3c - disallows gene sequences ❖ Section 3e - prevents obvious combinations ❖ Section 3h - disallows cultivation related techniques ❖ Section 3i - prevents diagnostics, medical use ❖ Section 3j - prevents transgenic plants ❖ Section 3p - prevents protection of traditional knowledge Hindering for innovative R&D but provides commercial advantage for generic entry.
  15. 15. 15 Navigating through the Biotech patent information in India © 2017 Reliance Life Sciences Pvt. Ltd
  16. 16. 16 Framing of keywords ❖ No chemical name ❖ CAS number ❖ Initial short name : eg. D2E7 ❖ Target based search eg. VEGF Antibody ❖ Review articles of innovator ❖ Citations Keywords / search terms remains the prime area to be focused.
  17. 17. 17 Patent classification search ❖ Biotech areas : ❖ Concentrated in section A, C and G of the IPC, ❖ Certain patents in the biotechnology field might be found in sections B, D and E but are mixed with other technology domains from which they cannot be separated ❖ Example: C07K for peptides, C12N for enzymes, G01N for stem cells, Transgenic plants-A01H etc. Biotech inventions are largely inter-related.
  18. 18. 18 Equivalent patents ❖ PCT patent – national phase entry ❖ Applicant name search ❖ Inventor name search ❖ Confirming sequences in equivalent patent. ❖ Priority number search ❖ Patent Family search The equivalent patent remains the important tool for comprehensive search.
  19. 19. 19 Sequence information ❖ Sequence searches : ❖ Partial sequence in claims ❖ Check in Figures ❖ Check description for the sequence IDs ❖ Sequence listing of equivalent PCT patents ❖ Regulatory submissions ❖ Patent term extensions ❖ WHO nomenclature reports (INN) Sequence listing in the file history still remains obscure at Indian Patent office.
  20. 20. 20 Geographical source & Traditional knowledge ❖ Deposits & Geographical source ❖ Permissions from National Biodiversity Authority ❖ Need to deposit the microorganisms ❖ Traditional knowledge search ❖ Extracts ❖ Combination of ingredients in a range is not inventive. The above requirements are unique to Indian Patent Act.
  21. 21. 21 Other Aspects ❖ Technology patents ❖ Cross licence/ Exclusivity ❖ Declarations for Regulatory approvals ❖ Device related patents searches ❖ Designs patent ❖ Citation searches The additional requirements needs to be checked and aligned in the search report.
  22. 22. 22 Patent prosecution history ❖ File history retrieval ❖ Claim amendments- to overcome the rejections ❖ Check controller decision after hearing- check the claims amendment date; e.g.: Tocilizumab ❖ Check Form 8 for equivalent patents and its status ❖ No linking of divisional patents. ❖ Patent oppositions / litigation ❖ File review ❖ Track decisions & IPAB Claim amendments occur in 90% of the biotech patent applications and needs to monitored till grant.
  23. 23. 23 Databases ❖ Use of paid Databases ❖ Indian patent website- evolving ❖ Need to convert the Indian patent number of various databases to Standard form to check for status. ❖ MCPaIRS of Molecular connections- by far has extensive coverage of Indian patents ❖ Databases for Sequence related search eg STN & Scifinder ❖ Database for design patent search Paid databases helps to reconcile the reports in the standard form.
  24. 24. 24 To summarize…. ❖ Drug Substance: Target, sequence, affinity based claims ❖ Process-technology, purification, analytical methods ❖ Media: culture media, buffers ❖ Purity ❖ Formulation ❖ Combination ❖ Diagnostics methods: Screening of suitable patients, biomarkers ❖ Method of use / indication ❖ Dosing ❖ Devices Biosimilar patent landscape is more exhaustive than Pharma.
  25. 25. 25 Thank You! © 2017 Reliance Life Sciences Pvt. Ltd

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