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9/16/2013
1
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
• Conclusion
9/16/2013
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
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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
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4
Procedural and Strategies-Where and When and 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)
• Export information
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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, government information
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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
– 6 months to 1 year in some cases
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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.
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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
Recent litigation before Courts
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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
9/16/2013
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 – Delhi High Court granted an ex – parte injunction
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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
• No evidence for simple inventions
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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)
• Heavy Costs if Delay
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13
FINAL ARGUMENTS
Admission of suit 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)
Stages of Litigation
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
Trial over video conference
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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
Nu
mb
er o
f
9/16/2013
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%
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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
Technology Wise Trend
Post Grant Pre Grant
Number of Decisions
TRENDS IN PATENT COURT CASES
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17
DELHI, HC 39%
CHENNAI, HC 16%
KOLKATA, HC 14%
MUMBAI, HC 8%
GUJARAT, HC 8%
SUPREME COURT 6%
UTTARAKHAND, HC 3%
OTHERS 6%
COURT WISE DECISIONS ON PATENT CASES
PHARMA 24%
MECHANICAL 25%
CHEMICAL / MATERIAL ENGINEERING
13%
ELECTRICAL / ELECTRONICS 7%
SEMICONDUCTOR 4%
FMGC 4%
MEDICAL DDEVICE 4%
SOFTWARE / HARDWARE 1%
BIO-TECH 1%
OTHERS 17%
SUBJECT WISE COURT DECISIONS
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18
YEAR WISE TRENDS ON PATENT CASES (COURT, IPAB, PO)
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
TRENDS IN SUCCESS RATE (COURT, IPAB, PATENT OFFICE)
PHARMA MECHANICAL CHEMICAL MEDICAL DEVICE
ELECTRONICS SEMICONDUC
TOR SOFTWARE FMGC
COURT 44.4 38.5 50 28.5 50 50
44.4
38.5
50
28.5
50 50
0
10
20
30
40
50
60
9/16/2013
19
SUCCESS RATE IN INFRINGEMENT CASES (COURT DECISIONS)
TOTAL NUMBER OF CASES NUMBER OF WINS SUCCESS RATE (%)
PRELIMINARY INJUNCTION 42 16 38%
PERMANENT INJUNCTION 4 2 50%
TRENDS IN IPAB CASES
9/16/2013
20
1 4 14
28
36
47
9
0
20
40
60
80
100
120
140
160
2007 2008 2009 2010 2011 2012 2013
NU
MB
ER O
F D
ECIS
ION
S
1 5
19
47
83
130
139
160
140
120
100
80
60
40
20
0
CU
MU
LATI
VE
CO
UN
T
NUMBER OF DECISIONS IS INCREASED OVER LAST THREE YEARS WITH 30% INCREASE IN THE YEAR 2012 AND 43% INCREASE IN THE YEAR 2011. 47 DECISIONS IN PATENT IN THE YEAR 2012 AS COMPARED TO 310 DECISIONS IN THE TRADEMARK
TRENDS: PATENT CASES IN IPAB
PRABHA SRIDEVAN AND D.P.S.
PARMAR, 79
S.USHA AND D.P.S PARMAR, 12
S. USHA AND S. CHANDRASHEKHARA
N, 28
Z.S.NEGI AND S. CHANDRASHEKHARA
N, 17
2011 2012 2013
CASES 36 34 9
36 34
9
0
5
10
15
20
25
30
35
40 PRABHA SRIDEVAN AND D.P.S. PARMAR
NUMBER OF DECISIONS IN PATENT CASE GIVEN BY PRABHA SRIDEVAN ARE 79 AMOUNTING TO 57% OF THE TOTAL DECISIONS OVERALL IN 6YEARS, 139 DECISION IN PATENT CASES ARE PRONOUNCED BY IPAB
DECISION DISTRIBUTION BY JUDGES
9/16/2013
21
APPEAL (30)
CONDONATION OF DELAY (17)
MISCELLANEOUS PETITION (11)
OPPOSITION/PATENTABILITY
/REVOCATION (50)
PCT APPLICATION (11)
OTHERS (20)
THERE ARE 50 DECISIONS (36%) ON REVOCATION AND PATENTABILITY. ALMOST IN ALL CASES ARE DECIDED BASED ON THE INVENTIVE STEP AND ANTICIPATION ENQUIRY EXCEPT ONE, YAHOO CASE, WHICH IS DECIDED ON THE SECTION 3(K) GROUND
ISSUE WISE DECISION TRENDS
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
NU
MB
ER O
F D
ECIS
ION
S (C
UM
ULA
TIV
E C
OU
NT)
CASES FOREIGN WIN
WIN RATE OF FOREIGN ENTITY IN REVOCATION PROCEEDING IS 11% (2 OUT OF 18 CASES)
YEARS 2008 2009 2010 2011 2012 2013
CASES 2 2 15 11 12 3
FOREIGN 0 0 12 1 2 3
WINS 0 0 1 0 0 1
TRENDS IN INVENTIVE STEP: FOREIGN PATENTEE
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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
NU
MB
ER O
F D
ECIS
ION
S (C
UM
ULA
TIV
E C
OU
NT)
CASES INDIAN WIN
WIN RATE OF FOREIGN ENTITY IN REVOCATION PROCEEDING IS 33% (9 OUT OF 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
TRENDS IN INVENTIVE STEP: INDIAN PATENTEE
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
9/16/2013
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?