Technical Minds. Legal Muscle.

Focus on Pharma Panel Discussion

ANDA at 35

Moderator: J.C. Rozendaal

October 25, 2019

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• Timeline and Milestones• Statistics and Trends• Discussion topics

Contents

Timeline and Milestones

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Generic Drugs in the U.S.A Brief Timeline

Pre-Hatch Waxman• 1962 – New FDA

authority (safety and effectiveness)

• 1970 – Abbreviated approvals

• 1974-80 –Substitutions allowed

• 1979-83 – Slow progress (19 generics approved by ‘83)

1984Hatch-WaxmanSimplifies path

for generic approval

2003MMA

Addresses issues identified in FDA review of

P IV cases

2011AIA

Introduces PTAB, new joinder rules

Generic substitution rate grows from 12% in 1984 to

63% by mid-’00s

Dramatic increase in number of law suits, certifications,

and competition

Looking Forward• Intense competition

clustered around many NCE dates

• Falling margins for branded and generic companies

• Consolidation in big pharma

• Growing focus on biologic drugs (BPCIA)

Statistics and Trends

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Rapid Growth of ChallengesPost-MMA and Again Post-Recession

Source: Paragraph Four Reports, 2019

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District Court OutcomesPost-MMA Cases (2003-2018)

Source: Paragraph Four Reports, 2019

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Product by Product: Many Filers, but Not All Products Draw P IV Challenges

Source: Paragraph Four Reports, 2019

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ANDA Cases at the PTABA Spike and a Tailing-off

Source: Paragraph Four Reports, 2019

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IPR Outcomes – 2012-2018

Settled Pre-Institution

14%

Institution Denied32%

Settled Post-Institution

12%

Patent Survives FWD23%

Patent Invalidated at

FWD19%

IPR Outcomes Associated with ANDA CasesOctober 1, 2012-September 30, 2018

Discussion Topics

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• Multiple filers and the potential for hyper-competition on selected drugs (i.e., easy to manufacture, APIs available, large sales volumes, one or few OB patents, etc.)− Innovator perspective on strategic options and implications− Generic perspective on strategic options and implications− Looking forward, should we expect another wave of new competitors out of China?

• District Court or PTAB or both?• Success of patent thicket?• Future of life cycle management?• Political overhang related to the price of drugs?

Strategies and Implications Innovators and Generics