Trends in Patent Litigation in India

Transcription

1 Trends in Patent Litigation in India Archana Shanker Anand and Anand 4 th 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 1

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 2

3 Writs Infringement suits and counter claim IP Courts and Tribunals Writ Special Leave Petition High Court Writ petition Supreme Court Special Leave Petition TM & Patent office Appeal Intellectual Property Appellate Board Patents: Pre grant/ Post grant TM: Show cause hearing/ opposition/ rectification Revocation/ Rectification Appeal 3

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 4

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 5

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 6

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. 7

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 8

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 9

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 10

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 11

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 timenot 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 12

13 Admission of suit Stages of Litigation Completion of pleadings Disposal of applications Admission/ denial Framing of Issues Evidence by affidavit Recordal of evidence before Commissioner or Joint Registrar (including cross) Arguments by Plaintiff Reply arguments by Defendant Rebuttal (rejoinder) arguments by Plaintiff Stages Timeline Stages Timeline Stages Timeline PRE TRIAL TRIAL FINAL ARGUMENTS Judge Judge Judge Expedited 2 3 months Normal 6 months 1 year Expedited 3 4 months Normal 1 2 years Expedited Upto 6 months Normal 1 2 years Trial over video conference Cross examination of foreign witness over video conference (Mattel Inc. and Anr. v Jayant Agarwalla and Ors.) Lawyers in India Witness in U.K. The Local Commissioner Officer of the Indian High Commission 13

14 Number of 9/16/2013 Statistics and Trends Opposition trends Opposition Trend Pre Grant Post Grant Pre Grant 2 Post Grant

15 Opposition Jurisdiction Delhi Mumbai Chennai Kolkata Pre Grant Post Grant Opposition Trend: Win Rate Total Decisions Patent Revoked Win % 40.5% Post Grant, 42 Pre Grant, 88 Total Decisions Patent Rejected Win % 48.9% 15

16 Technology Wise Trend Pharmaceuticals Mechanical 9 29 Biotechnology 0 6 Post Grant Pre Grant Software 1 2 Chemical 6 10 FMGC 0 9 Others Number of Decisions TRENDS IN PATENT COURT CASES 16

17 COURT WISE DECISIONS ON PATENT CASES UTTARAKHAND, HC 3% SUPREME COURT 6% OTHERS 6% GUJARAT, HC 8% DELHI, HC 39% MUMBAI, HC 8% KOLKATA, HC 14% CHENNAI, HC 16% SUBJECT WISE COURT DECISIONS SOFTWARE / HARDWARE 1% MEDICAL DDEVICE 4% BIO-TECH 1% OTHERS 17% PHARMA 24% FMGC 4% SEMICONDUCTOR 4% ELECTRICAL / ELECTRONICS 7% MECHANICAL 25% CHEMICAL / MATERIAL ENGINEERING 13% 17

18 YEAR WISE TRENDS ON PATENT CASES (COURT, IPAB, PO) COURT TRENDS IN SUCCESS RATE (COURT, IPAB, PATENT OFFICE) MEDICAL SEMICONDUC PHARMA MECHANICAL CHEMICAL ELECTRONICS DEVICE TOR COURT SOFTWARE FMGC 18

19 SUCCESS RATE IN INFRINGEMENT CASES (COURT DECISIONS) TOTAL NUMBER OF CASES NUMBER OF WINS SUCCESS RATE (%) PRELIMINARY INJUNCTION % PERMANENT INJUNCTION % TRENDS IN IPAB CASES 19

20 NUMBER OF DECISIONS CUMULATIVE COUNT 9/16/2013 TRENDS: PATENT CASES IN IPAB NUMBER OF DECISIONS IS INCREASED OVER LAST THREE YEARS WITH 30% INCREASE IN THE YEAR 2012 AND 43% INCREASE IN THE YEAR DECISIONS IN PATENT IN THE YEAR 2012 AS COMPARED TO 310 DECISIONS IN THE TRADEMARK DECISION DISTRIBUTION BY JUDGES Z.S.NEGI AND S. CHANDRASHEKHARA N, 17 S. USHA AND S. CHANDRASHEKHARA N, 28 S.USHA AND D.P.S PARMAR, 12 PRABHA SRIDEVAN AND D.P.S. PARMAR, 79 PRABHA SRIDEVAN AND D.P.S. PARMAR CASES 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 20

21 NUMBER OF DECISIONS (CUMULATIVE COUNT) 9/16/2013 ISSUE WISE DECISION TRENDS OTHERS (20) APPEAL (30) PCT APPLICATION (11) CONDONATION OF DELAY (17) OPPOSITION/PATENTABILITY /REVOCATION (50) MISCELLANEOUS PETITION (11) 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 TRENDS IN INVENTIVE STEP: FOREIGN PATENTEE CASES FOREIGN WIN WIN RATE OF FOREIGN ENTITY IN REVOCATION PROCEEDING IS 11% (2 OUT OF 18 CASES) YEARS CASES FOREIGN WINS

22 NUMBER OF DECISIONS (CUMULATIVE COUNT) 9/16/2013 TRENDS IN INVENTIVE STEP: INDIAN PATENTEE 50 CASES INDIAN WIN WIN RATE OF FOREIGN ENTITY IN REVOCATION PROCEEDING IS 33% (9 OUT OF 27 CASES) YEARS CASES INDIAN WINS 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 22

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? [email protected] 23