Challenges in IPI due to globalization of IPR

Amritha M. S.2010-09-115

Indian pharmaceutical industry

• One of the most successful industries in India

• Ranks 3rd in volume of production • Dept. of Pharmaceuticals, Ministry of

Chemicals and Fertilizers: “total turnover between 2008-09 :

$21 billion”• Grown from $0.3 billion in 1980

What is a patent?

Patent No patent

One producer Multiple producers

No competition Competition

High prices of imported medicines

Low prices of locally produced medicine

Brief history

• Western style patent legislation Patent And Design Act, 1911 “Recognized product patent in addition to

process patent”

Post independence high prices of medicines, because of patent law carried over from British rule

Monopoly: Product patents to MNCs meant that Indian domestic producers could not manufacture

Know How: No capacity to manufacture, foreign companies established and prospered

Unaffordable: Highest prices in the world, highly dependence for import

•

Indian pharma Industry virtually non-existent

Indian Patents Act, 1970 Legal reform aimed at Local production

No product patent for medicines - process patent term- 7yrs - 3 yrs from date of sealing patent- “ Compulsory Licensing” (requirement of the public not satisfied at reasonable price)

• Developing alternative cost effective manufacturing process for molecules already invented and patented

• 1970 – 2005: Indian generic companies become the “pharmacy of the developing world”

• The absence of patent barriers allowed generic Companies to innovate simpler treatment - fixed dose combinations

Reverse Engineering

Treat ulcerPatented $9000/kgGeneric version - $50/kg

Little investment in R&DMedicine at affordable pricesCompetition among Indian mfrs.MNC – backoutStrong domestic industryExporter

TRIPS – Globalization of IP

• April 15, 1994 - signed GATT• Bring Indian Patent Law in compliance with TRIPS• Amendment – 1999, 2002, 2004• TRIPS mandate - introduce product patent• India took 10 yrs

January 1, 2005

• - amendment enacted - “grants 20 yr monopoly for new applications”

• Mail box provision Applications from 1-1-1995 should also be considered Will be examined only on 1-1-2005

Growing control of MNC Threat to domestic marketDownfall for generic companiesReverse engg. no longer possibleIncreased treatment costHigher drug price

Pre-19701970 TRIPS - 2005

Post - TRIPS

?GROWTH

Alternatives to reduce price

1. Patent opposition

2. Compulsory licensing

Patent opposition

Gleevec treat myeloid leukemia

Patented- Rs. 1,20,000/patient/monthGeneric - Rs. 8,000/patient/month

• Novartis filed an application for patent in 1998, during which India did not grant patents on medicines.

• Therefore, Novartis was granted EMR (Exclusive Marketing Rights) for 5 years.

After 2005, the drug was reviewed for product patent and opposed based on pre grant opposition due to the following reasons:

• Prior publication in Canada and the US• High cost of drug limiting public access• No inventive step involved (making salt from

base)• No enhancement in the therapeutic efficacy • In 2006, the Chennai patent office rejected the

patent application.• 2013 - HC rejected application

Compulsory licensing

Anticancer Nexavar by BAYER

Rs. 2,80,000/month

Generic version by NATCO

Rs. 8,800/month

The first ever compulsory license in India was given to Natco in 2013 to manufacture the generic version.

Challenges

• Acquisition of Indian Companies by MNC - capture marketing and distribution network - restrict the use of flexibilities e.g. Ranbaxy- Daichii

• Launching of generic companies in India by MNCs. “high drug price ”

2. Pitfalls to R&D

a). Commitment of huge investmentwithout any returns for 8-10 years

• Ranbaxy, Dr. Reddy’s Lab - 5-10% of revenue

b). Drug discovery hindered by lack of qualified scientists

- Disconnection between curriculum and industry - Lack academic collaboration

3. Key Indian law safeguard: Evergreening• The basic patents on Nevirapine

(NVP) were applied for by Boehringer Ingelheim in November 1990, and are due to expire in November 2010. 

• BI also applied for a patent on the hemihydrate form of NVP, used in the suspension in 1998, which is due to expire 2018.

• Additionally, BI applied for a patent on the extended release formulation of nevirapine in 2008, which is due to expire in 2028.

• India has a specific provision in its patent law that does not grant patents on minor changes to existing medicines.

Result – Prevent Evergreening(Novartis case)

• CPAA files first pre-grant opposition

• In January 2006, the patent on imatinib mesylate, (Gleevec) was rejected in India on the grounds that it only represented a new form of a known substance and therefore was not an innovation and not patentable under Indian law.

• the selection of a salt of the active ingredient with the purpose to improve bioavailability is known in pharmaceutical art. It is common knowledge in the pharmaceutical field that salts result in different solubility and, therefore, in different bioavailability.

Efforts to stop evergreening

Not all patent applications are valid. Many patent applications are for a new

use of an old drug, or simply for derivatives of old drugs or combinations of old

drugs. (TRIPS requires patent protection for ‘inventions’) E.g. AIDS drug patent applications:1. a fixed dose combination of lamivudine/zidovudine

used in the treatment of HIV/AIDS: not a new invention but simply the combination of two existing drugs. Status of application - Withdrawn

2. tenofovir disoproxil fumarate (TDF), a key AIDS drug: forming a salt (fumaric acid) out of an existing compound (tenofovir disoproxil), is common practice within the pharmaceutical industry, and should not be considered a new invention. Status of applications - Opposed

II. Any person can oppose the grant of a patent application

5. High price

Patented Hepatitis treatment in India Pegylated interferon alfa 2a

Rs. 14,700 per injection (180 mcg)

Patented cancer drug sorafenib

• Rs. 2,80,000 per month/per patient