Chapter 18 Outline

• Jurisdiction: United States

Chapter 18

Specialized Categories of Infringement

Introduction

§18.01 Drug Marketing Application Filings Under 35 U.S.C. §271(e)

[A] Introduction

[B] Technical Infringement Under §271(e)(2)

[1] Paragraph IV Certifications

[2] Automatic Stay

[C] Safe Harbor Under §271(e)(1)

[1] Merck KgaA v. Integra Lifesciences (U.S. 2005)

[2] Federal Circuit Decisions Post- Merck

[D] Settlements of Hatch-Waxman Litigation

§18.02 Component Exports Under 35 U.S.C. §271(f)

[A] Deepsouth Packing v. Laitram (U.S. 1972) and Legislative Response

[B] "Supplying or Causing to Be Supplied"

[C] "Components"

[1] Microsoft v. AT&T (U.S. 2007)

[2] Federal Circuit Decisions Post- AT&T

[D] "Actively Induce the Combination" Under §271(f)(1)

[1] Facts of Promega v. Life Techs.

[2] "Self-Inducement" Can Create Liability

[E] "Substantial Portion of the Components" Under §271(f)(1)

[1] Federal Circuit View: Evaluate Qualitatively

[2] Supreme Court Reverses: "Substantial Portion" Must Be Evaluated Quantitatively

[F] Territoriality Issues in §271(f) Damage Awards

§18.03 Importation Under 35 U.S.C. §271(g)

[A] Process Patent Amendments Act of 1988

[B] Product Made by a Patented Process

[C] "Materially Changed" Product

Introduction

Earlier chapters of this treatise examined direct infringement under 35 U.S.C. §271(a)¹ and indirect infringement under 35 U.S.C. §§271(b)-(c).² This chapter separately analyzes the remaining three categories of infringement enumerated in §271 under subparagraphs (e), (f), and (g). Each is a specialized form of infringement, less typically encountered than infringement under §§271(a)-(c) but important nonetheless.

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Notes:

^[1] See supra Chapter 14 ("Analytical Framework for Patent Infringement"); Chapter 16 ("Comparing...