Patent Law in India Recent Trends Pravin Anand May 9, 2013 - - PowerPoint PPT Presentation

Patent Law in India Recent Trends

Pravin Anand May 9, 2013

Introduction

• Recent litigation before Courts
• IPAB trends
• Blogs
• Fast – track and remedies
• Conclusion

Recent litigation before Courts

Novartis GLEEVEC Litigation

• Section 3(d) acts as a second tier for pharmaceutical patents

(First tier – Novelty, Utility & Non – obviousnes)

• Efficacy means “therapeutic efficacy” for pharmaceutical substances

(“therapeutic” not defined)

• Inherent properties of new form – cannot be considered for 3(d)

– Eg. Higher solubility of a salt

• Coverage equivalent to disclosure in Indian patent law
• Proceedings and statements made in other jurisdictions in a different

context – can be treated as admissions in Indian proceedings

• Represented by the Additional Solicitor General of India
• India was politically coerced to sign the TRIPS Agreement
• India introduced pharmaceutical patenting only to avoid sanction

under TRIPS

• Section 3(d) is specifically intended to increase threshold for

patentability

• Government interpreted US drug regulatory law and patent law to

argue against patentability of GLEEVEC under Indian law

• Government of India supports the stand taken by generics,

especially CIPLA (“Pharmacy of the world”)

• Lauded by the media

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

• Chief Justice of India and Attorney General praise Alam J.
• n Novartis (and Kasab decision)
• Generics riding the wave - fuelling public opinion against

patents

• Innovators have become more active in the press

regarding need for patents

Pfizer SUNITINIB Litigation

Overview

• Patent claims SUNITINIB and its salt
• Corresponding patent granted in 91 countries
• Highly litigated patent

– Post – grant opposition by CIPLA (2 rounds) – Infringement suit against NATCO – Infringement suit against BDR Pharma

• Litigation story largely successful

Highlights of the litigation

• Post grant opposition proceedings

– First order where Delhi High Court in writ jurisdiction granted interim relief in a patent matter

• Restrained CIPLA from launching its drug

– First order where Supreme Court recognized breach of natural justice principles in an IP case

• Supreme Court set aside order of revocation

– First order where IPAB recognized injury caused by flooding of infringing products by generics

• Stayed order of revocation

• 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

Take home points

• Be on the look – out for procedural flaws

committed by opposite party or Patent Office

• Explore writ remedy against Patent Office

decisions

• Take quick action

Roche Tarceva Litigation

For infringement of patent IN ’774. Claim 1 of IN‘774 is :

• First case post-TRIPS in India relating to pharmaceutical patent;
• First case where patent held valid after final arguments despite adverse finding by

Division Bench of Delhi High Court at interim stage.

• Appeal coming up before Division Bench on May 15 – 18, 2013

Obviousness Not obvious as no lead compound identified by Cipla. Mere Structural Similarity not enough . Absence motivation, mere possibility of substitution not render patent obvious. Section 8 Solely on ground of non-compliance of S. 8 of Act, patent cannot be revoked and said discretion emanates from ‘may’ under S. 64 of the Act. Examination and Investigation Examination and investigation matter between examiner and applicant till third party opposition received. Would be unjust to examine said examination process from perspective of third party coming into picture only at later stage.

Non-infringement Held non-infringement, despite admissions of Cipla that:-

• Erlotinib HCL produced anywhere has same name/chemical formula.
• API in infringing product (Erlocip) is Erlotinib Hydrochloride.
• It is Erlotinib Hydrochloride which acts on body.
• IN’774 comprises all possible polymorphs of main compound.
• Drug approvals were for Erlotinib Hydrochloride tablets.
• Defendant unaware of polymorph B form at the time of approval.
• No mention of polymorph in packaging or package insert of Erlocip.

MSD Sitagliptin Litigation

• MSD sued Glenmark Pharma for patent infringement for SITAGLIPTIN
• MSD had conducted a pre – launch market survey to address pricing
• MSD is selling the drug in India through a local company: Sun Pharma
• A suit was filed within a week of Glenmark launching the product
• Single Judge dismissed the interim injunction application at ad interim

stage

• An appeal is pending before the Division Bench – to be heard on May 22,

2013

• Plaintiff must anticipate defences and plead

them in plaint

• Disposed of application for injunction on Day

1 even without written statement or reply to application

• Merits to be gone into in appeal

Bayer v. NATCO

• 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

IPAB Trends

1 4 14 28 36 47 9 20 40 60 80 100 120 140 160 2007 2008 2009 2010 2011 2012 2013 Number of Decisions 1 5 19 47 83 130 139 160 140 120 100 80 60 40 20 Cumulative Count Number of decisions is increased

• ver 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

Appeal (30) Condonation of Delay (17) Miscellaneous Petition (11) Opposition/Patentabilit y/Revocation (50) PCT Application (11) Others (20)

Issue wise Decision Trends

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

Pharmaceuticals/Chem ical/Biotechnology, 55 Electricals/Electronics, 25 Mechanical, 19 Telecommunication, 9 Software, 4 FMGC, 8 Others, 19

40% of decisions are in the field of pharmaceutical, biotechnology and chemistry field

Industry wise Decision Tends

1 7 28 47 75 83 1 4 12 19 36 55 56 10 20 30 40 50 60 70 80 90 2007 2008 2009 2010 2011 2012 2013 Number of Decisions (Cumulative Count) Foreign Indian

Trends: Indian vs. Foreign Patentee (All Issues)

Exponential growth (28 to 75) in number of cases filed by the foreign entity between the year 2010 to 2012.

Years 2007 2008 2009 2010 2011 2012 2013 Foreign Decisions 1 6 21 19 28 8 Indian Decisions 1 3 8 7 17 19 1

2 4 19 30 42 45 2 3 5 6 10 11 5 10 15 20 25 30 35 40 45 50 2008 2009 2010 2011 2012 2013 Number of Decisions (Cumulative Count) Cases Win

Wins in Inventive Step

Win Rate in Revocation Proceeding is 24%

Years 2008 2009 2010 2011 2012 2013 Cases 2 2 15 11 12 3 Wins 2 1 2 1 4 1

2 4 19 30 42 45 12 13 15 18 1 1 1 2 5 10 15 20 25 30 35 40 45 50 2008 2009 2010 2011 2012 2013 Number of Decisions (Cumulative Count) Cases Foreign Win

Trends in Inventive Step: Foreign Patentee

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 12 1 2 3 Wins 1 1

2 4 19 30 42 45 2 4 7 17 27 27 2 3 4 5 9 9 5 10 15 20 25 30 35 40 45 50 2008 2009 2010 2011 2012 2013 Number of Decisions (Cumulative Count) Cases Indian Win

Trends in Inventive Step: Indian Patentee

Win rate of Foreign Entity in revocation proceeding is 33% (9

• ut of 27 cases)

Years 2008 2009 2010 2011 2012 2013 Cases 2 2 15 11 12 3 Indian 2 2 3 10 10 Wins 2 1 2 1 4 1

Pro - Innovator Pro - Generic Neutral 10 20 30 40 50 60 70 2010 2011 2012 2013 Pro - Innovator Pro - Generic Neutral

What do the blogs say?

Fast Track and Remedies

Legal System

• Unitary (only federal)
• Common law jurisdiction

Supreme Court 23 High Courts Over 500 District Courts

The High Courts

23 High Courts in India

Original jurisdiction vests with 6 High Courts

• ut of which Delhi,

Bombay, Madras and Calcutta are most important Delhi High Court handles 70% of the IP work

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

Trial over video conference

The typed deposition can be viewed simultaneously

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

Pre - Trial Trial Final arguments

Suit in ONE year!

Remedies

• Pre – 2009

– Franz Xavier case – no ex parte injunction

• BMS v. Hetero Labs (2009)

– First ex – parte injunction in a patent matter

• 2009 – 2013

– 9 – 10 cases where ex – parte injunction have been granted when suit filed at the pre – launch stage

Conclusion

• Uphill task for innovators – must understand

the terrain

• Do not ignore pricing
• Transparent PAP
• Local partners
• Do not delay entry in India
• Admissions anywhere in the world relevant
• Appeal adverse orders

Conclusion

• Concentrate on Section 8 and Form 27
• Explore quia timet actions
• Explore fast – track
• Don’t outright reject voluntary license request