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Pravin Anand

April 7th, 2004

Biotechnology and IPR issues

Some issues

• Why IP• What IP• The essentials• Skills• Commercialisation

•Assignments and licensing

Recent Changes

Three themes:1.In the Patent

environment2.Protection with

reference to the New Act and Traditional Knowledge

3.Enforcement

A. Environment

Knowledge of Patents reachingrural inventors

Inventors expressing Dissatisfaction with the system

1. Inventors Awareness

Letter from an Inventor

Heaviest Kite in the World

“IP is critical in this new global regime”

2.Patent Office and Government

Website of The Indian Patent Office

World Intellectual Property Day26th April 2003

B. Protection (recent Past)

– Inventions required tangible end product

– Weak Protection for Pharmaceutical, Food and Chemical Patents

– Biotechnology –protection was non existent

– Computer Software was not protected

– Enforcement climate was weak

– Non members of major International Treaties on Patents

Changes

1.Members of Paris, PCT, Budapest conventions

2.TRIPS – 1995 obligations met 4 years late by introducing EMR’s in 1999

3. TRIPS 2000 obligations met in may 2003 by Patent (Second Amendment)Act 2002 coming into force on 20.5.03

4. Interactive sessions (15 to 20) are being organised by the Government to try and make it on time

Changes

1 Request for examination can be filed with the application or deferred upto 4 years2 Disclosures of foreign applications has been made too burdensome with some time criticality3 Parallel importation4 Bolar provisions

Patent Amendments of 2002 –Pharmaceuticals , food etc

• Term of Pharma, Food, Agro-Chem Patents increased from 7 to 20 years

• License of right – repealed• Products can be patented from

2005 and EMR (Exclusive Marketing Right) in meanwhile

• Reversal of burden of proof

EMR cases

-8 EMR cases eg SKB; Hoffman LaRoche, Novartis, UP, Ranbaxy

Biotechnology

• Processes for producing living matter now allowed– Law interpreted in Dimminaco

AG– Amendment clarified

• Micro-organisms or living substances themselves still excluded

• 3rd Amendment would protect them – IMTECH established as an IDA in Chandigarh

Dimminaco ‘s case

Process for Manufacture of a live vaccine forprotecting poultry from infectious Bursitis

Traditional Knowledge (TK)

• What is TK?–At least one generation old

if passed on from generation to generation

–Knowledge wide – herbal medicines to folklore

–Communities have preserved TK and it is distinctive of them

Many legislations involved

• Patents Act:– Excludes TK as not being an

invention (S 3)– If Biological material mentioned

in application then apart from deposit requirements – source and geographical origin necessary – does not say country(S 10)

TK – hottest issue

• Biological Diversity Act 2002• No person can apply for an IPR based on a

biological resource from India without Prior consent of National Biodiversity Authority

• Can be obtained any time before sealing• NBA shall decide within 90 days• Benefit Sharing and royalty from commercial

exploitation of such IP rights

C. Enforcement

• The Litigation environment changing

• CPC amendments – a contested suit can be disposed of within 2 years now

• Shift from the need for an Injunction to damages

Franz Xaver Huemer’s case

• Injunction refused only because the Plaintiff had not used the patent in India

Thomas Brandt case (Tangibility)

• Process for opacification of a gaseous medium

• Need not be a tangible end product HC remanded –yet PO refused

• New Act makes position clear

Wet Grinder

Schneider vs Telemechanique

Injunction against JointVenture when permission toMake generation 2 productsDeclined

No Acquiescence

Philips VCD Cases

Philips VCD Compression Technology – Injunctions in Two Suits: Anton Pillers executedLicenses of US$ 200,000 in One month

Conclusion

1.From the days of the EMR amendments legislative working is more transparent and pro patents2. From the days of Thomas Brandt the Patent office has gone far3. From the days of Franz Xaver Huemerthe courts have been far stronger in favourof Patents4. Data exclusivity issues