© 2007 Anand And Anand

Pharmaceutical Patents

in India

Pravin Anand,

AIPPI Paris

5th October 2010

© 2007 Anand And Anand

Outline

• Procedural and Strategy issues– Where and when?

– Options?

– Evidence?

– Trial Design

– What to expect

• Substantive Law issues– Anticipation Obviousness and 3(d)

– Amendments

– Suppression and Public Interest

© 2007 Anand And Anand

The Indian Patent Office and its branches

Each office has its own territorial jurisdiction for receiving

-national (Domestic) applications,

-international application under PCT

-national phase applications under

PCT

-design applications (H.O.)

Jurisdiction for foreign applicants depends upon the address of service

Delhi

Mumbai

Chennai

KolkataH.O.

Each of the Patent Office is empowered to deal with all sections of Patent Act

© 2007 Anand And Anand

© 2007 Anand And Anand

Filing Vs Grant

Patent Office

India

16763552225912931991-92

12723467223912281992-93

17463869260312661993-94

17595330358917411994-95

16337036543016061995-96

9078562690116611996-97

184410155822919261997-98

18008954670722471998-99

18814824261822061999-00

13188503632421792000-01

159110592822123712001-02

137911466877226932002-03

246912613938932182003-04

1843174661383636302004-05

4320245051998445212005-06

GrantedTotalForeignIndianYear

© 2007 Anand And Anand

Top Indian Patent filing

companies

Others include : Torrent, Cadila, Cipla, Matrix Labs , Nicholas Piramal, Biocon,

Glenmark, |Hetro – new delivery systems, processes and formulations

© 2007 Anand And Anand

Top Patent recipients in 2004

US

(881)U.S. GOVERNMENT829

(1,311)(10)Sony Corporation1,30510

(1,184)(13)Toshiba Corporation1,3109

(1,893)(3)Hitachi, Ltd1,5148

(1,592)(7)Intel Corporation1,6017

(1,313)(9)Samsung Electronics Co., Ltd.1,6046

(1,707)(6)Micron Technology, Inc.1,7605

(1,759) ***(5)Hewlett-Packard Development Company, L.P. ***1,7754

(1,992)(2)Canon Kabushiki Kaisha1,8053

(1,774) **(4)Matsushita Electric Industrial Co., Ltd. **1,9342

(3,415)(1)International Business Machines Corporation3,2481

(Final Number of

Patents in 2003)

(Final Rank

in 2003) Organization*

Preliminary #

Patents in

2004*

Preliminary Rank

in 2004*

© 2007 Anand And Anand

What are not inventions -Section

3(d)

• Mere discovery of a new form of a known

substance…unless…enhancement of

known efficacy…

– Explanation: Salts, Ethers, Esters,

Polymorphs, metabolites…and other

derivatives…shall be considered same

substance unless they differ significantly in

properties with regard to efficacy

© 2007 Anand And Anand

3(d)

• Efficacy – Novartis Glivec decision (under

Appeal) – interprets as therapeutic

– Dorland Medical Dictionary – therapeutic is

curative

– Not defined technically – must have common

meaning

– Properties with regard to efficacy – Roche

Valcyte – bioavailability allows oral admin

© 2007 Anand And Anand

3(d)

• Second Medical use – mere discovery of new use of a known substance – Not Allowed

• Enantiomers – Roche Valcyte case –under appeal

• Crystalline Forms – Polymorph B –Roche Erlotinib Hydrochloride – only process claims allowed (Cadilla vs IndSwift)

© 2007 Anand And Anand

3(d)

• Prodrugs and metabolites – Roche

Valcyte

• Sustained release Forms - allowed

• Regiments, Dosages – BMS Entecavir –

low dosage formulation (BMS vs Ranbaxy)

© 2007 Anand And Anand

3(d)

• Minimal efficacy data in Specification

• May not be available on filing date

• Attempt to introduce data through

amendment (Glaverbel case)

• File data with evidence in Pre or post grant

oppositions

• Person of ordinary skill in the art

© 2007 Anand And Anand

Courts

• Supreme Court

• 23 high courts

• Over 500 district courts

• Unitary system

• Statutory and common law

– Trade secrets, phishing, meta tagging,

spamming etc all covered by common law

© 2007 Anand And Anand

Where and When and Options

• High Courts – in order of preference

– Delhi, Madras, Calcutta and Bombay,

• When – Earliest eg BMS vs Hetero

• Options – patents Ex parte rare

– Cease and Desist – get full defence

– Disadvantage – filing of cancellation before IPAB

• Simultaneous proceedings –

– Infringement and counterclaim – Post grant

– Post grant and Rectification

© 2007 Anand And Anand

Evidence

• Product purchased examined investigated

– best

• Sometimes – cannot wait

• Pharma – RTI information re DCGI

approval (Don’t annoy DCGI – arms length

enquiry)

• Export information

© 2007 Anand And Anand

Trial Design

• Witnesses –

– Novartis IPAB – avoid employees as sole

witness

– On Obviousness and S 3(d) – get

independent experts

– Expense: May develop Indian expert team

– If overseas witness record before

commissioners (3 day cross)

– Inventor – good knowledge but too emotional

© 2007 Anand And Anand

Evidence - scope

• Explain Chemistry (Drug Design)

• Prior Art (prosecution History elsewhere)

• Efficacy (properties and their effect)

• User experience

• Commercial Success

• Public Interest

– Investments in invention

– Public Access Programmes

© 2007 Anand And Anand

Burden of Proof and Estoppel

• Burden in Pre and Post grant

• Burden in invalidation proceedings

• Burden in a Suit for infringement

• Estoppel – study patents of the opponent

or defendant for concessions or

admissions

© 2007 Anand And Anand

Expectation

• Exparte injunctions rare – BMS, Philips

VCD, Philips DVD (Anton Pillar only)

• Interim injunctions rare (Roche vs Cipla

and TVS vs Bajaj)

• Time – Suit 2 to 3 years – could be faster

– 4 month orders

• Cost – USD 20 to 100,000

• Damages – high probability

© 2007 Anand And Anand

2005 – the year of Damages

• Time Magazine -16 lakhs

• Microsoft – USD 280,000

• Cartier 24 lakhs

• Nasscom 16 lakhs ( Phishing)

• Himalaya Drug 17 lakhs

• About 55 cases since

© 2007 Anand And Anand

Anticipation

• Disclosure and enablement in a single

prior art document

• Clear , Sufficient details to enable person

of ordinary skills to practice the invention

• Identifying by name, a molecule necessary

• Selection Patents

– S 91

– Novartis IPAB

© 2007 Anand And Anand

Suppression and Public interest

• Suppression – state more not less

• Public Interest –

– Pricing issues

– Investments on drug discovery

– Patient access programmes

– Donation camps, workshops to create

awareness, government information

© 2007 Anand And Anand

Recent cases

• Infringement cases– Ram Kumar vs Samsung (customs recordal)

– Bajaj vs TVS

– Roche vs Cipla

• Pre grants– Novartis, Gilead, Boehringer, Abraxis, Teva

• Post grants– Roche Valcyte

• Writs – Bayer and Syngenta (Linking argument)

© 2007 Anand And Anand

Compulsory License

Pfizer vs Natco

Roche vs Natco

Discussion paper by DIPP

© 2007 Anand And Anand

Conclusion

• Infringement complicated – Ex parte rare – don’t waste too much time on interim

– Other forums (IPAB or Patent office)

– Defendants look at world failure so bring success from other forums

– Demystify the science (eg drug discovery)

– Counter attack defendants for suppression , admissions estoppel etc

– Pharma too political – add Indian public interest dimension

• Strengths – Speed of trial and Damages and Press that should be moulded