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
Legal System
The High Courts
23 High Courts in India
Original jurisdictionvests with 6 High Courts out of which Delhi, Bombay, Madras and Calcutta are most important
Delhi High Court handles 70% of the IP work
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
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)
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,
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
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.
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 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
• 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
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
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)
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
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 TrendPre Grant Post Grant
N
um
be
r o
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%
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
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%
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
TOTAL NUMBEROF CASES NUMBEROF WINS SUCCESS RATE (%)
PRELIMINARY INJUNCTION 42 16 38%
PERMANENT INJUNCTION 4 2 50%
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
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
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
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)