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. on 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

Trends: Patent Cases in IPAB 160 160 Number of decisions is increased 139 over last three years with 30% 140 140 130 increase in the year 2012 and 43% increase in the year 2011. 120 120 47 decisions in Patent in the year 2012 as compared to 310 decisions Number of Decisions in the Trademark 100 100 Cumulative Count 83 80 80 60 60 47 47 36 40 40 28 19 20 20 9 5 14 1 4 1 0 0 2007 2008 2009 2010 2011 2012 2013

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

Industry wise Decision Tends Telecommunication, 9 Mechanical, 19 Software, 4 FMGC, 8 Electricals/Electronics, 25 Others, 19 Pharmaceuticals/Chem ical/Biotechnology, 55 40% of decisions are in the field of pharmaceutical, biotechnology and chemistry field

Trends: Indian vs. Foreign Patentee (All Issues) Foreign Indian 90 83 80 Exponential growth (28 to 75 75) in number of cases 70 filed by the foreign entity Number of Decisions between the year 2010 to (Cumulative Count) 60 2012. 56 55 50 47 40 36 30 28 20 19 12 10 7 4 1 1 0 0 2007 2008 2009 2010 2011 2012 2013 Years 2007 2008 2009 2010 2011 2012 2013 Foreign 0 1 6 21 19 28 8 Decisions Indian 1 3 8 7 17 19 1 Decisions

Wins in Inventive Step Cases Win 50 45 45 Win Rate in Revocation 42 Proceeding is 24% 40 Number of Decisions 35 (Cumulative Count) 30 30 25 20 19 15 11 10 10 6 5 5 4 3 2 2 0 2008 2009 2010 2011 2012 2013 Years 2008 2009 2010 2011 2012 2013 Cases 2 2 15 11 12 3 Wins 2 1 2 1 4 1

Trends in Inventive Step: Foreign Patentee Cases Foreign Win 50 45 45 42 Win rate of Foreign Entity in revocation proceeding 40 is 11% (2 out of 18 cases) Number of Decisions 35 (Cumulative Count) 30 30 25 19 18 20 15 13 15 12 10 4 5 2 2 1 1 1 0 0 0 0 0 2008 2009 2010 2011 2012 2013 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: Indian Patentee Cases Indian Win 50 45 45 Win rate of Foreign 42 40 Entity in revocation proceeding is 33% (9 35 Number of Decisions (Cumulative Count) out of 27 cases) 30 30 27 27 25 20 19 17 15 10 9 9 7 5 5 4 4 4 3 2 2 2 0 2008 2009 2010 2011 2012 2013 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

What do the blogs say? 70 60 50 40 Pro - Innovator 30 Pro - Generic Neutral 20 10 Neutral Pro - Generic 0 2010 2011 Pro - Innovator 2012 2013

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