IPR for SMEs in Pharma:Challenges & Opportunities

Conference on IPR in PharmaceuticalsBalancing Innovation & Access7th October, 2015, Ahmedabad, Gujarat

by Dr. Gopakumar G. NairGopakumar Nair AssociatesUrl: www.gnaipr.comEmail: gopanair@gnaipr.net

Status of Indian Pharma IndustryPeriod Domestic Imports Exports Research Export - Import

ratio.Domestic Mfr. to Imports ratio

Domestic to exports ratio turnover

Pre- 1970 Low High Negligible Very Low 5/95 10/90 (API) 95/5

1970-1980 + ve + ve(API)

+ ve API Process(Reverse

Engineering)

15/85 40/60 (API) 85/15

1980-1990 ++ ve + ve + ve API + Dosages processes

25/75 60/40 75/25

(APIs & Intermediates)

APIs turnover

1990-2005 +++ve +ve (APIs &

Intermediates)

++ve API + Dosages processes

NDDS

60/40APIs turnover

90/10(Dosage form)

60/40 (API/ Intermediates)

60/40

2005 onwards

+++ve ++ve (APIs / Intermediates)

++ve (Patented

formulations)

+++ve API processesNDDS

combinationsEarly NCE leads.

Me too drugs Herbals/ Nutra.

70/30(API dosage forms / API

formulations)

80/20(API patented formulation)

30/70

NCE/NME API Product Patent Process Patent ‘Me too’ derivatives – Imatinib,

Erlotinib Formulation Dosage Forms – Tablet, Capsule, etc Release Profile – Controlled, Slow etc. NDDS – ex. Transdermal Patches,

Transmucosal Drug Delivery. New Use – Aspirin (analgesic & blood

thinner)3

Famotidine

Tiotidine

Strategies for Indian Pharma• Super Generics & Value added Generics.• Sec.505 (b)(2)/ Para IV challenge/ Orphan

drugs.• Ranbaxy – Canadian Co. - Cipher – Absorica.

• Cipla –Swedish firm - Meda – Dymista.

• Lupin– Japan’s - Fujisawa – Suprax.

Source: BusinessWorld, Jan, 2014.

RESEARCH in Pharma• MSMEs

- continue with low innovation- generics.• Larger Units

- NDDS, Combinations, Processes.• Top 20 Companies- NCE Research(Drug Discovery)- Biosimilars- Vaccines( Dr. Reddys, Cadila, Glenmark, Sunpharma, Aurobindo,

Lupin, Biocon, Cipla, Wockhardt, Torrent, Jubilant Life, etc.)

Niche Models of Research in India• Discovery Research

ADVINUS (Contract Research)SUVEN (CRAM)

• Generic ResearchCiplaNatco

• Stents/ SuturesMeril

Post 2005: Generic Pharmacy of the World

+ ves:• Strong in Anti HIV/Anti Cancer Drugs.• Emerges as Leader in CRAM.• Thrust to Developed Markets.• Greenfield domestic developments.

- ves:• Intensive infringement litigations.• Damaging Regulatory Reviews/ Status.• Divergent Industry Associations/ NGO’s.• Approach on key issues such as CL, FDI, MSME role –

non uniform, irrational.

Key industry trends impacting Indian Pharmaceutical market

Source: Strategies for Indian Pharma in a volatile world, Manish Panchal, Charu Kapoor, Mansi Mahajan- TSMG.

IN THE PINK OF HEALTH? Drug-inspection systems in India and the US

INDIA• 1,200-1,500: The current strength of drug inspectors in India• 150: Number of Central drug inspectors• 20,000: Number of drug inspectors required to monitor India’s Pharma industry• 650: Staff at Central Drugs Standard Control Organization• 10,300: Number of pharmaceutical manufacturing units in India (of these 300 are big and

the rest small & medium)• Rs. 79,000 crore: The size of the domestic Pharma market by sales

UNITED STATES• 13,000 (approx) The staff of the US Food and Drug Administration• $400-500 bn: Size of the US pharma market by sales• $80 bn: Size of the US generic drug market

Source: DCGI office, industry estimates

Conclusions:• Indian Pharma must take note of faster growth in China,

Korea, Indonesia, Brazil etc.• Must resolve serious Regulatory issues and counter PICs

challenge.• Must respond strongly to TPP, SPLT, SSFFC & others.• Must ally for a balanced Patent law with BRIICS and others.• Must respond strongly to USTR actions (ITC/ super 301)• Efforts to declare India priority watch Country and to drag

India to WTO.• India must beware/ Be aware of TBT, NTB &“Q” propaganda

and take corrective measures.• India must strengthen the API sector for guaranteed &

continued support to dosage forms.• Strengthen policy support, resources & counter motivated (?)

NGOs.