Patent Litigation in India Pravin Anand Anand And Anand MIP International Patent Forum 2011 April 5, 2011, London

The Challenges… First, a weak Patent Law Pre and post grant oppositions (Span case) Rigid deadlines (4) Section 3(d) - Novartis Section 8 - Chemtura Working requirements , Compulsory licence Section 39

The Challenges… Second, Generics, Copyleft, open-source aggressive: Parliamentary Forums Judge training Press/Blogs No counter measures by innovators

The Challenges… Third, top ten filers are chemistry patents World trend: top filers are IT companies Being an IT Power, ironic that Chemistry leads Generics – very patent savvy..

The Changes… 2005 Patent Amendments CPC – Streamlining Processes Supreme Court – 4 month orders (20 in 2010) Delhi High Court – 70% IP cases Docket Management Old order – 5 to 10 years Today – possibly 6 months to one year

e Court

Remedies Revolution Ex parte injunctions – before launch “status quo” Expedited trial preferred Anton Piller, Mareva Injunctions John Doe Orders Damages : Punitive / Exemplary (65 orders)

Time Inc vs. Lokesh Srivastava Red Border contributed to finding of dishonesty Punitive/ exemplary damages granted for the first time

Strategies Design action before launch Emphasis on original documents Issues : Document : Witness analysis – cannot miss the document window in fast track Expert evidence of great value ( average – 2 witnesses per side, 6 hours cross, 150 ques) Emphasis on original documents Section 65 – Secondary evidence Section 65 B – Internet downloads

Strategies Invalidation before IPAB or counter claim before High Court IPAB slow High Court Fast May avoid cease & desist notice Amendments allowed - infringement action or after invalidation

Strategies Judges Rely on foreign case law – favorable decisions elsewhere help – gestalt perception judges often, a third force Generics look at prosecution histories all over – EPO highly respected Suppression –big cause for failure - overstate

Strategies Demystify the science Use the defendants patent applications for estoppel arguments Highlight Public Interest, pricing, patient access, investment in drug development Avoid Interim – move to Fast track

Cases Novartis Gleevec Supreme Court (19th April) Roche vs Cipla – final Arguments (April) GSK vs Union of India – writ quashed publication United Phosphorus – pesticide formulation – suit decreed 34 days 20 other suits of BMS, Sanofi Aventis, Scherring Plough etc likely to conclude in 2011

Conclusions Despite the weak legislation, major positive changes Bulk decisions in 2011 will show the long lasting trends Other high courts may be positively impacted – time will tell..