Indian Patent Law

Udai SJC on May 05, 2007
Nitin Gupta

Intellectual Property
“Intellectual Property is the Property, which has been created by exercise of Intellectual Faculty” • • • • • • Patent Industrial Design Trademark Copyright Geographical Indication Layout design of industrial circuits

Patent
• Set of exclusive rights
– Given to the inventor – By the state – For a fixed period of time

• In exchange of Public disclosure of certain details of the invention that is
– Novel – Has an inventive step – Capable of industrial application

• Including the right
– To prevent others from making/using/selling the invention

• But not necessarily the right
– To make/use/sell the invention

Patent v/s Copyright
• Copyright
– – – – Original works of authorship Protects the form of expression, not the subject matter Longer duration (life+70) Automatically granted

• Examples
– Art – Software

Another way to protect your creation

And one more, if you are an emperor

Money  Industry  Patents

Indian Patent Office
• Administered by
– Office of the Controller General of Patents, Designs & Trade Marks (CGPDTM) – ~300 examiners – Headoffice Kolkata – Patents now granted in 2-3 years

Patent Applications in India
9000 8000 7000 Number of Applications 6000 5000 4000 3000 2000 1000 0 19 7071 19 7576 19 8081 19 8485 19 8586 19 8687 19 8788 19 9889 19 8990 19 9091 19 9192 19 9293 19 9394 19 9495 19 9596 19 9697 19 9798 19 9899

Domestic Foreign

Year

US received 288K patent applications in 1999

Patent Validity

• A patent is valid if
– satisfies common requirements – not proven invalid

Patent Opposition
• Pre-grant Opposition
– Patent applications are published – Non-compliance – Non/wrong-disclosure

• Post-grant Opposition
– Within 12 months of grant of a patent – Misconduct, public display, non-patentable

Patent Infringement

• A patent is not infringed until proven otherwise
– onus on the patent owner

Compulsory License
• After three years of patent, anyone can request a license from the govt. on these grounds – That the reasonable requirements of the public with respect to the patented invention have not been satisfied – That the patented invention is not available to the public at reasonably affordable price – Export of pharmaceuticals to poor countries

Not Patentable

• • • • • • • •

Atomic energy Traditional knowledge Scientific principle Abstract theory Discovery of natural substances New form of a known substance Mixture of known compounds Methods of agriculture

History of Indian Patent System
1856 1911 1972 1975 1999 1999, 2002, 2004, 2005 The Act of 1856 on protection of invention Indian patents & designs act Patents act (act 39 of 1970) – only process patents | 14 year, 7 year (food/drug) India joins WIPO India signs TRIPS (after joining WTO) – 10 year “ultimatum” starting from 1995 Amendments -Product patents | 20 years patent period | EMR | Burden of Proof

http://ipindia.nic.in/ipr/patent/history.htm

TRIPS
• Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS) • WTO • Formulated 1986-1994 • Uniform patent regime in 147 member countries

Indian Patent Act of 1970
Only process not product patents in food, medicines, chemicals Term of patents 14 years; 5-7 in chemicals, drugs

TRIPS
Process and product patents in almost all fields of technology Term of patents 20 years

Compulsory licensing and license of right Several areas excluded from patents (method of agriculture, any process for medicinal surgical or other treatment of humans, or similar treatment of animals and plants to render them free of disease or increase economic value of products) Government allowed to use patented invention to prevent scarcity

Limited compulsory licensing, no license of right Almost all fields of technology patentable. Only area conclusively excluded from patentability is plant varieties; debate regarding some areas in agriculture and biotechnology

Very limited scope for governments to use patented inventions

How TRIPS came into being
• • • • • • • • Until 1989, India opposed IPR policies in GATT US pressure – Restrictions on Indian food exports Liberalization – early 1990s Both Congress and BJP favoring globalization in late 1990s Need for FDI Indian companies becoming stronger – demand patents Industry bodies lobbying for patents CSIR supporting patents

Effect on India Pharma Companies
Force Indian companies to innovate Increase competition Indian companies don’t have enough funds for R&D Not a level playing field

Western companies may partner Indian companies already with Indian companies to sell selling those, as generics  their drugs Western companies not interested in tropical diseases! -opportunity for Indian companies

Ranbaxy’s Patent Filings
180 160 140 120 100 80 60 40 20

170 146 86 24 32
2000

49
2001 2002 2003 2004

0 1999

Effect on Patients
Encouragement for Expensive medicine development of new drugs No Generics  availability affected

AIDS
• Gilead: Tenofovir
– $5718 / patient / year

• Cipla: Tenvir
– $ 700 / patient / year – Plans to make available for $350 in Africa

• Gilead granted patent, Cipla fighting • Gilead licensed Tenofovir to some Indian companies in 2006 for low price

Cancer: Novartis
• • • • • • • • Gleevec: $26,000/yr, Generic: 1/10th price Gleevec invented in 1993 India rejected patent application in 1995 Novartis produced a minor variant Granted exclusive marketing rights In 2005, Patent amendment prohibits minor variants – In 2006, Novartis lost the rights Filed petition again – still ongoing Novartis claims it is giving away free to 99% patients in India
– Mere publicity.. Only for few months.

Effect on Agriculture
Protection to genetically modified seeds Protection to plant varieties Expensive seeds They used to be protected by milder PVP laws

Summary

• Good in long term, bad in short