The Food and Drug Administration’s (“FDA”) regulation of drugs and medical devices impacts the everyday lives of Americans in both noticeable and inconspicuous ways. [1] For example, a recall of contaminated food or adulterated pharmaceuticals illustrates how the FDA noticeably affects impacts our everyday lives. [2] Additionally, unobservable consequences springing from the overlap between FDA regulations and patent law also affects the lives of Americans by stimulating market competition and providing incentives for medical research and development. [3]


Attempting to promote continued innovation in medical science, while at the same time provide the public with “more low cost generic drugs,” the U.S. Government amended both FDA regulations and patent laws through the Price-Competition and Patent Term Restoration Act (“the Act”). [4] The Act, commonly known as the Hatch-Waxman Act, consists of two sections, Title I and Title II, which function in tandem “affect[ing the] introduction procedures and patent requirements for certain kinds of generic new drugs.” [5] Title I of the Act provides for a new route of FDA regulatory approval for generic drugs (also known as “generics”), the Abbreviated New Drug Application (“ANDA”). [6] Congress’s intent behind the ANDA process was to allow generic drug manufacturers to get generics on the market sooner and at lower costs. [7] Title II of the Act made several amendments to the U.S. patent laws regarding how they apply to federally regulated products. [8]


The “safe harbor” provision of 35 U.S.C. § 271(e)(1) is a patent law amendment created by Title II of the Act. [9] Utilized in conjunction with the ANDA provision in Title I, Congress believed § 271(e)(1) would aid generics in obtaining market approval “between 18 months and 2 years earlier.” [10] Under § 271(e)(1), the otherwise infringing use of a “patented invention” is immunized from liability if the infringing use is “reasonably related” to the development of data for FDA approval. [11] Although § 271(e)(1) appears to lend itself to a fairly straightforward interpretation, its scope has been the source of much judicial and commentator debate over the last two decades. [12]       Since the enactment of § 27(e)(1), the Supreme Court has weighed in on its scope only twice. [13] In both cases the Court held the plain language and legislative intent behind the Act indicated that § 271(e)(1) was supposed to immunize a broad scope of inventions and actions, related to FDA approval, from patent infringement. [14] Despite the Court’s broad holdings in both cases, the United States Court of Appeals for the Federal Circuit (the “Federal Circuit”) recently narrowed the scope of § 271(e)(1) with its holding in Proveris Scientific Corp. v. Innovasystems, Incorporated. [15] The Federal Circuit employed a narrow test, termed the “perfect product fit” analysis, for determining what constitutes a “patented invention” under § 271(e)(1). [16] Under Proveris’ perfect product fit analysis, in order for infringement of a patented invention to be immunized by § 271(e)(1), the “patented invention” must be eligible for a 35 U.S.C. § 156(e)(1) patent term extension. [17]


While Proveris may appear to comport with sound patent policy, the reasoning of the Federal Circuit fails to properly consider Congress’s overall purpose for the Act. Additionally, Proveris’ new interpretation of “patented invention” flatly contradicts the meaning previously assigned to the statutory phrase by the Supreme Court in Eli Lilly & Company v. Medtronic, Incorporated. [18] Further, the Federal Circuit misinterprets Lilly’s discussion of statutory symmetry (between § 271(e)(1) and § 156), through which the Court intended to broaden the § 271(e)(1) term “drugs,” not narrow the phrase “patented invention.” [19]


By reducing the scope of “patented inventions” within § 271(e)(1) to only inventions comporting with the “perfect product fit” analysis, Proveris has drastically altered the function of § 271(e)(1) and potentially impairs the ability of generic manufactures to fully utilize the ANDA process created in Title I of the Act. [20] Adherence to Proveris’ “perfect product fit” rule risks establishing loopholes that potentially allows patent holders of pioneer drugs and medical devices to delay generic manufacturers from bringing less expensive generics to the market. [21]


This Note critiques the Federal Circuit’s recent narrowing of § 271(e)(1) in Proveris. Part I provides a historical overview of FDA regulations on drugs and medical devices, the promulgation of the Act, and judicial interpretations of § 271(e)(1). Part II furnishes an in-depth review of the Federal Circuit’s holding in Proveris, and discusses the reasons cited as supporting the court’s narrowing of § 271(e)(1). Part III analyzes the Federal Circuit’s “perfect product fit” test, found to control the scope of § 271(e)(1), and discusses how the “perfect product fit” test contradicts the judicial precedent cited by the court as supporting its holding. Part IV illustrates how Proveris operates contrary to Congress’s intention for the Act, and suggests a “sliding scale” analysis for Federal courts when faced with a § 271(e)(1) defense….


Duane C. Marks*