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

12 Nov 2017

Navigating through

Biotech Patent Information in India

Ms Vidya Subramanian

Deputy General Manager- IPR

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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

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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.


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Insights into Health care sectors

Pharma and Biopharma


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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.

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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.

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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.

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Advantage India

Policies & Patent aspects


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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.

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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.

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Patent Landscape

Pharma & Biopharma


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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

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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.

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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.

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Navigating through the

Biotech patent information in India


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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.

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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.

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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.

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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.

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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.

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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.

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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.

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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.

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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.

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Thank You!


Healthcare

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