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Trends in Patent Litigation in

India

Archana Shanker Anand and Anand 4th September, 2013 MIP- China

Introduction

• Legal System

• IP Courts and Tribunal- Litigation Process

• Recent litigation before Courts

• Procedural and Strategy issues

• Fast – track and remedies

• Recent cases

• Patent Office /IPAB Trends

(2)

Legal System

The High Courts

23 High Courts in India

Original jurisdiction

vests with 6 High Courts out of which Delhi, Bombay, Madras and Calcutta are most important

Delhi High Court handles 70% of the IP work

(3)

IP – Courts and Tribunals

TM & Patent office Intellectual Property Appellate

Board High Court

Supreme Court Writs

Infringement suits and counter claim

Appeal Revocation/ Rectification Special Leave Petition Special Leave Petition Writ petition Appeal

Patents: Pre – grant/ Post grant

TM: Show cause hearing/ opposition/

rectification Writ

(4)

Options

• High Courts – in order of preference

– Delhi, Madras, Calcutta and Bombay,

• When – Earliest eg BMS vs Hetero; Merck cases

• 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

• Customs recordal

Evidence

• Product purchased examined investigated – best

such as in telecom

• Sometimes – cannot wait

• Pharma – RTI information re DCGI approval (Don’t

annoy DCGI – arms length enquiry)

(5)

Trial design

Witnesses –

–Avoid employees as sole witness

–Inventors and independent experts

–Expense can be reduced by cross examination

through video conference facility or Local commissioners

–If overseas witness record before commissioners

(3 day cross)

How much to disclose

state more not less

Public Interest –

–Pricing issues

–Investments on drug discovery

–Patient access programmes

–Donation camps, workshops to create awareness,

(6)

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

Expectation

Exparte injunctions rare – BMS, Philips VCD,

Philips DVD (Anton Pillar only)

Interim injunctions rare (Roche vs Cipla and

TVS vs Bajaj)

Rendition of accounts/status quo orders

Undertakings – if product not launched

Time – Suit 2 to 3 years – could be faster

(7)

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

–6 months to 1 year in some cases

Cost – USD 20 to 100,000

Damages – high probability

Expectation

What is a Status Quo order

An easier order to obtain than an ex parte order Freezes things as they stand on the date of the suit.

No launch = exparte injunction

If launched in a certain market/ segment of buyers, confine sales.

(8)

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

–6 months to 1 year in some cases

Cost – USD 20 to 100,000

Damages – high probability

(9)

Recent cases

• Novartis- Supreme Court

• Infringement cases

– Ram Kumar vs Samsung (customs recordal)

– Bajaj vs TVS; Phillips

– Roche vs Cipla (patent valid / not infringed)

– BMS, Merck, Schering

• Pre grants

– Novartis, Gilead, Boehringer, Abraxis, Teva

• Post grants/ revocations

– Enercon Valcyte, Pegasys, Pfizer, Combigan, Ganfort, Lapatinib

• Writs

– Bayer and Syngenta (Linking argument)

– Pfizer

• Incremental inventions- Section 3(d) - second tier for pharmaceutical

patents

• Efficacy is “therapeutic efficacy” for pharmaceutical substances

• Coverage equivalent to disclosure in Indian patent law

• Proceedings and statements made in other jurisdictions in a different

context (before stautory Authority) – can be treated as admissions in Indian proceedings

(10)

• Lauded by the media

–Patents are anti – patients (Patents v. Patients)

• Chief Justice of India and Attorney General praise

Alam J. on Novartis (and Kasab decision)

• Innovators have become more active in the press

regarding need for patents

• Infringement action against NATCO

– A see - saw battle

• Delhi High Court granted an ex – parte injunction

• Injunction suspended based on revocation order

• Based on Supreme Court judgment, injunction restored

• Injunction vacated based on second revocation order

• Injunction restored based on stay order by IPAB

– NATCO riding on orders in CIPLA’s proceedings

• Infringement action against BDR

(11)

Bayer v. NATCO (working)

• IPAB confirms the order of the Controller

• Clarifies ‘working’ requirement – fact specific analysis based on evidence

• Rejects argument on third party sales

• Finding of prima facie case does not require hearing

The Cumulative effect

• Pharma 3(d)- efficacy is therapeutic efficacy

• Coverage is equivalent to disclosure

• Section 8- Materiality and intent: not law

• POSA- 2 different persons

– Enablement

– Obviousness

POSA not conservative and imaginative

(12)

The Cumulative effect

• If claim obvious- amendment not looked into

• Delay and conduct- Amendment

• Partial anticipation- only inventive feature looked

into

• Confusion on technical effect (lower processing time-

not technical effect)

• Monsanto case- 3(j) interpreted for the first time

Fast Track Trials

• Strict Time Lines (eg. for Written Statement)

• Admission Denial on Affidavits

• Evidence through Affidavits

• Cross Examination before Commissioner (optional)

• Limitation of witnesses and cross (hours)

(13)

FINAL ARGUMENTS Completion of pleadings Disposal of applications Admission/ denial Framing of Issues Normal 6 months – 1 year Expedited 2 – 3 months PRE – TRIAL Stages Judge Timeline TRIAL Stages Timeline Judge Evidence by affidavit Expedited 3 – 4 months Normal 1 – 2 years Stages Arguments by Plaintiff Timeline Normal 1 – 2 years Expedited Upto 6 months Judge

Reply arguments by Defendant Rebuttal (rejoinder) arguments by Plaintiff Recordal of evidence before

Commissioner or Joint Registrar (including cross)

Cross examination of foreign witness over video conference (Mattel Inc. and Anr. v Jayant Agarwalla and Ors.)

Lawyers in India Witness in U.K. Officer of the Indian High Commission The Local Commissioner

(14)

Statistics and Trends

Opposition trends

2013 2012 2011 2010 2009 2008 2007 2006 2005 Pre Grant 3 5 3 27 36 4 9 1 0 Post Grant 2 1 6 9 7 5 2 5 4 3 5 3 27 36 4 9 1 0 2 1 6 9 7 5 2 5 4 0 5 10 15 20 25 30 35 40 Opposition Trend

Pre Grant Post Grant

N

um

be

r o

(15)

Opposition Jurisdiction

Delhi Mumbai Chennai Kolkata

Pre Grant 55 12 21 3 Post Grant 11 32 16 10 55 12 21 3 11 32 16 10 0 10 20 30 40 50 60 Pre Grant, 88 Post Grant, 42

Opposition Trend: Win Rate

Total Decisions 88 Patent Rejected 45 Win % 48.9% Total Decisions 42 Patent Revoked 25 Win % 40.5%

(16)

4 0 10 1 6 9 61 11 9 6 2 0 29 13 0 10 20 30 40 50 60 70 Others FMGC Chemical Software Biotechnology Mechanical Pharmaceuticals

Post Grant Pre Grant

Number of Decisions

(17)

DELHI, HC 39% CHENNAI, HC 16% KOLKATA, HC 14% MUMBAI, HC 8% GUJARAT, HC 8% SUPREME COURT 6% UTTARAKHAND, HC 3% 6% PHARMA 24% MECHANICAL 25% ELECTRICAL / ELECTRONICS 7% SEMICONDUCTOR 4% FMGC 4% MEDICAL DDEVICE 4% SOFTWARE / HARDWARE 1% BIO-TECH 1% OTHERS 17%

(18)

2010 2009 2008 2007 2006 2005-1995 COURT 9 20 19 11 5 33 9 20 19 11 5 33 0 5 10 15 20 25 30 35

TRENDSIN SUCCESS RATE (COURT, IPAB, PATENT OFFICE)

PHARMA MECHANICAL CHEMICAL MEDICAL ELECTRONICS SEMICONDUC SOFTWARE FMGC 44.4 38.5 50 28.5 50 50 0 10 20 30 40 50 60

(19)

TOTAL NUMBEROF CASES NUMBEROF WINS SUCCESS RATE (%)

PRELIMINARY INJUNCTION 42 16 38%

PERMANENT INJUNCTION 4 2 50%

(20)

1 4 14 28 36 47 9 0 20 40 60 80 100 120 140 160 2007 2008 2009 2010 2011 2012 2013 N U MB ER OF D ECI SI O NS 1 5 19 47 83 130 139 160 140 120 100 80 60 40 20 0 C U MU LA TI V E C O U NT

NUMBEROFDECISIONSISINCREASEDOVER LASTTHREEYEARSWITH 30% INCREASEIN THEYEAR 2012 AND 43% INCREASEINTHE YEAR 2011.

47 DECISIONSIN PATENTINTHEYEAR 2012 ASCOMPAREDTO 310 DECISIONSIN THE TRADEMARK

PRABHA SRIDEVAN AND D.P.S. PARMAR, 79

S.USHAAND D.P.S PARMAR, 12 S. USHAAND S. CHANDRASHEKHARA N, 28 Z.S.NEGIAND S. CHANDRASHEKHARA N, 17 2011 2012 2013 CASES 36 34 9 36 34 9 0 5 10 15 20 25 30 35 40

PRABHA SRIDEVANAND D.P.S. PARMAR

NUMBEROFDECISIONSINPATENTCASEGIVENBY PRABHA SRIDEVANARE 79 AMOUNTINGTO 57% OFTHETOTAL DECISIONS

(21)

APPEAL (30) CONDONATIONOF DELAY (17) MISCELLANEOUS PETITION (11) OPPOSITION/PATENTABILITY /REVOCATION (50) PCT APPLICATION (11) OTHERS (20)

THEREARE 50 DECISIONS (36%) ONREVOCATIONANDPATENTABILITY. ALMOSTINALLCASESAREDECIDED BASEDONTHEINVENTIVESTEPANDANTICIPATIONENQUIRYEXCEPTONE, YAHOOCASE, WHICHISDECIDED ONTHE SECTION 3(K) GROUND

2 4 19 30 42 45 0 0 12 13 15 18 0 0 1 1 1 2 0 5 10 15 20 25 30 35 40 45 50 2008 2009 2010 2011 2012 2013 N U MB ER OF D ECI SI O NS (C U MU LA TI V E C O U NT ) CASES FOREIGN WIN

WINRATEOF FOREIGN ENTITY INREVOCATIONPROCEEDINGIS

11% (2 OUTOF 18 CASES)

YEARS 2008 2009 2010 2011 2012 2013

CASES 2 2 15 11 12 3

(22)

2 4 19 30 42 45 2 4 7 17 27 27 2 3 4 5 9 9 0 5 10 15 20 25 30 35 40 45 50 2008 2009 2010 2011 2012 2013 N U MBE R OF D EC ISI O N S (C U MU LA TI V E C O U N T ) CASES INDIAN WIN WINRATEOF FOREIGN ENTITYINREVOCATION PROCEEDINGIS 33% (9 OUTOF 27 CASES) YEARS 2008 2009 2010 2011 2012 2013 CASES 2 2 15 11 12 3 INDIAN 2 2 3 10 10 0 WINS 2 1 2 1 4 1

Conclusion

• Strategy I: Move the court ASAP to attempt a status quo order;

• Strategy II; if product marketed don’t waste time on interim injunctions- go for a fast track trial; • Strategy III: ask for damages both compensatory

and punitive and interim deposits as in Philips vs. Bhagirathi case;

• Strategy IV: Deal with voluntary license requests in a business like way

(23)

Conclusion

• Other forums (IPAB or Patent office)

• - Defendants look at world failure so bring success

from other forums

• -Demystify the science (e.g. drug discovery)

• -Counter attack defendants for suppression ,

admissions estoppel etc

• Press to be moulded

• Appeal adverse orders ( don’t let them attain

finality)

Questions?

References

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