Intersection of Patent Law and Food

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Intersection of Patent Law and Food Drug
LawSteven H. Sklar ssklar_at_leydig.com
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The Patent-FDA Highwire Act

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Therapeutic Equivalence

• TE PE BE

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Developing the Picket Fence

• Molecule
• API Physical Properties
• Method of Use
• Drug Product Formulation
• Pharmacokinetic Characteristics

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API Physical Properties

• Polymorphic form
• Hydrates/Solvates
• Particle size
• Purity
• ANDA Exclusionary Specification
• (Bayer v. Elan)

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Method of Use

• Second (or later) approved use
• Dosing regimens
• Other label components food effect, education
  program

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Drug Product Formulation

• Structure
• Dosage Form
• Inactive Ingredients
• Function
• Dissolution Profiles

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Extended-Release Formulations

• Dosage form bi-layer, coat/core, granules,
  coated pellets
• Components polymers, coatings
• Dissolution profile (in vitro/in vivo)
• Pharmacokinetic characteristics (in vivo) AUC,
  Cmax, Tmax

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Bioavailability for Orally Administered Drug
Products IR v. ER
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Follow-On Biologics

• H.R. 1427 (Waxman et al.) biosimilar product
  and reference product contain highly similar
  molecular structural features, notwithstanding
  minor differences in heterogeneity profile,
  impurities, or degradation patterns

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Follow-On Biologics

• H.R. 1548 (Eshoo/Inslee/Barton) no biosimilar
  approved for 12 years from approval of reference
  product (may be extended to 14 years)