economic aspects & enforcement of ip_dr mandar kodgule_19th dec 2013_wk

05/01/2023 Copyright(C) - Global IP, Wockhardt Ltd

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Economic Aspects & Enforcement of IPDr Mandar M KodguleVice President, Global IP & Strategic PlanningWockhardt Ltd

DisclaimerThe purpose of this presentation is to raise issues for discussion in a developing area of law. The views expressed herein are solely the author's and should not be attributed to his employer or clients. The author makes no claims, promises or guarantees about the accuracy, completeness, or adequacy of the information contained herein.

IPR Conclave 2013 Mumbai, 19th & 20th December,

2013


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AgendaInnovation trends in Pharma Economic Aspects on IPRole of Acquisitions on IPChange of Business modelIP Licensing trends in PharmaLegal challenges in enforcement

◦US◦EU

Indian Pharma Patents scenario


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Innovation Trends - Pharma

Huge reductio

ns in mortality from critical

diseases

Increased Life

expectancy

Fewer side

effects and/or

improved

tolerability

Faster recovery

Significant

progress in

quality of life


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IP in the Pharma Sector• Product Patent – Generic / Specific /

Prodrug / Salt / Ester• Methods of Manufacture – API /

Formulation• Methods of Use / Administration• Chemical intermediates / Polymorphs /

Co-crystals / Impurities• Modified Release Compositions /

Targeted Delivery• Mechanisms of action, • Packaging – Device / Blisters /

Trademarks• Blood Levels / Metabolites• Screening methods• Biological targets

Patents


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IP in the Pharma Sector

•Size / Shape•Color•Break-lines•Specific Packs•Specific kits

Trademarks


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Innovation – Driving Competition


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Economic Aspects on IP

Shrinking pipelines (NCEs)

Govt / payer pressure on price control

Emergence of new Quality

standards

Issues in managing

clinical trials


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Economic Aspects on IP

Changing regulatory and legal scenario

Higher operating & developmen

t costs

Emergence of Biotech / Bio-similar


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Role of Acquisitions on IPInnovators

acquiring innovato

rs

Pfizer’s acquisiti

on of WyethInnovato

rs acquiring generics

Daiichi acquiring Ranbaxy

Generics acquiring generics

Teva, Mylan, Watson

Generics acquiring innovato

rs

Teva acquiring Cephalon


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Change of Business Model

Generics becoming “Super-generics”

Generic becomin

g innovator

s

Innovators selling generics of their

own brand

Innovators

partnering with

generics on supply

The rise of

“Authorized

Generic”


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IP Licensing Trends in PharmaEmergence of

small to medium CROs / CMOs

Outsourcing of key, value added

servicesDevelopme

nt of platform

technologies

Building of libraries for

licensing

Patient compliance - devices, packs etc


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Legal Challenges in IP Enforcement

Ever increasing cost

Lengthy procedures

and timelines

Jurisdiction and available

remedial measures

Role of in-house team v/s outside counsel

Support of management and business

teams

Aggressive strategies

adopted by accused

infringers


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US Litigation: P-IV Lawsuits


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Emerging Trends: FTFs


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US: District Court Cases

339 Cases

Brand wins by Judgment

84 Cases (25.0%)

Brand wins by

Procedure15 Cases (4.4%)

Generics wins by Judgment

66 Cases (19.5%)

Generics wins by

Procedure6 Cases (1.8%)

Case Settled

168 Cases(49.6%)


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District Court: Time Span


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Federal Circuit Outcomes

Average of 15 months required by CAFC to take decisions on cases appealed


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Patent Settlement - Pharma


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Litigation Facts US- Pharma

Overall success rate for

generics:

48% (Cases till full trial).

Success rates jumps

to 76% (settlement

s)

Best Litigation Success Rate:

Perrigo

Wockhardt

Top three courts by volume :

New Jersey,

Delaware,

Southern District of NewYork

All three accounts for 69% of all

decisions with generic

success rate of 36%.


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Litigation Facts US- PharmaFour courts never ruled against a generic:

California,

New York,

Minnesota and

Missouri

Most at risk launches: Teva

12 of the 28 at-risk

launches since 2002.

Max. Number of settlements:

54 in 2009.

Top AG players:

Watson/Par

Prasco


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EU Litigation – How different than US

Nature of court

systems

Claim construction before

trial

Attacking patent validity

Discovery

Witnesses,

particularly experts

Damages and Costs


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Indian ScenarioIntroduction of Article 3(d)Availability & affordability are of prime importanceCompulsory licensingEnforcement of remedial measures


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Indian Scenario – Patent decisions


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Thank You www.wockhardt.c

omResearch is in our

genes

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