Tag Archives: safe harbor

September 22 / All Articles, Patent

Proveris v. Innovasystems: Redefining a Patented Invention under § 271(E)(1): An Examination of the Federal Circuit’s Narrowing of the § 271(e)(1) “Safe Harbor” Exemption

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*

February 2 / All Articles, Copyright

Judicial Response: A Safe Harbor In The “Fair Use” Doctrine

Despite the cries of some commentators that copyright law is dead (or at least that they wish it was), [1] copyright law is fully capable of responding to the challenges posed by the new technologies of the digital revolution. Copyright law initially developed in response to the invention of the printing press, [2] and has a long history of addressing changes in technology. [3] Where Congress has not explicitly made provisions for the new technology, the courts have stretched statutory interpretation and common law doctrines to do so. The courts’ express goal in fitting existing copyright law to new technologies has been to strike a balance between stimulating artistic creativity through the limited monopoly provided by copyright and providing “broad public availability of literature, music and the other arts.” [4]


To this end, the common law, [5] and eventually Congress, provided a safe harbor to those who use another’s work for the purposes of “criticism, comment, news reporting, teaching … scholarship, or research”. [6] When someone reproduces a copyrighted work for one of the enumerated purposes, the courts may find that there was no infringement under the fair use doctrine. Congress specified that the courts were to apply a four-factor test in determining whether any specific use is a fair use. [7] The four parts of the test are:


(1) the purpose and character of the use, including whether such use is of a commercial nature of is for nonprofit educational purposes;

(2) the nature of the copyrighted work;

(3) the amount and substantiality of the portion used in relation to the copyrighted work as a whole; and

(4) the effect of the use upon the potential market for or value of the copyrighted work. [8]

The U.S. Supreme Court has said that the fair use doctrine should be applied when a rigid application of the copyright statute would “stifle the very creativity which that law is designed to foster.” [9]


The new technologies of the digital revolution, in particular multimedia development, seem to cry out for the application of the fair use doctrine. As of this time, however, none of the federal appellate courts have considered the application of fair use doctrine to the new technologies of the digital revolution. The Supreme Court considered the application of the fair use doctrine to a predecessor of digital technology, the Betamax Video Cassette Recorder (“VCR”). However, the focus of the Supreme Court’s opinion in Sony Corporation of America v. Universal City Studios, Inc., 464 U.S. 417, 430 (1984) was the issue of contributory copyright infringement of television programs’ copyrights. [10] Although the Court clarified the fair use doctrine, emphasizing that it is an “equitable rule of reason” and that all four statutory factors must be balanced against one another, [11] fair use was a small part of the Court’s analysis. It was the central issue of a subsequent case, Campbell v. Acuff-Rose Music, Inc., 114 S. Ct. 1164 (1994), but this case involved musical parody rather than technology. [12] Notably, however, Acuff-Rose reversed the trend among the lower courts to over-emphasize the commercial nature of the use such that commercial uses were presumptively barred from employing the fair use doctrine as a defense. [13] This reversal clearly has important ramifications for multimedia technology, much of which is purely commercial in nature. [14]


Although neither Sony nor Acuff-Rose directly addressed the application of the fair use doctrine to digital technology, these cases laid important groundwork. The Circuit Courts have built upon this groundwork, and although they have not yet applied fair use to digital technology, either, at least one court has applied the doctrine to the analogous technology of photocopying. [15] In American Geophysical Union v. Texaco, Inc., 37 F.3d 881 (1994), the Second Circuit held that copying of eight articles from the Journal of Catalysis by one of Texaco’s researchers was not fair use. [16] The Texaco opinion is particularly instructive as it builds on the Acuff-Rose opinion and carefully balances the four factors of the fair use doctrine. [17]


In his article on multimedia and fair use, Goldberg argues persuasively that Texaco leads the way for multimedia developers to find a safe harbor in the fair use doctrine. [18] However, Goldberg defines multimedia too tightly to give comfort to many developers or lay users of the new digital technology. Following Michael D. Scott, [19] Goldberg defines multimedia as having five essential characteristics: it 1) involves more than one media, 2) is adaptable for a variety of uses, 3) is delivered through CD-ROM, computer networks, or HDTV, 4) is stored in digital form, and 5) is interactive. [20] This definition excludes multimedia presentations which abound in the corporate world and in daily personal use. For example, presentations made by competing law firms in “beauty-pageant” competitions for a corporation’s business might use graphic images and text (multiple media), might be delivered through digitally projecting a computer screen on which the presentation “played,” and might be stored in digital form (saved on the firm’s computer network). However, under Mr. Goldberg’s definition, this would not be a multimedia production because the presentation had a single use (education of the audience) [21] and was not interactive (the presentation advanced from screen to screen automatically). Similarly, a “Seinfeld” screen saver made by a lay consumer out of sound clips from the popular television program and images of the shows downloaded from the Seinfeld web-page would not be a multimedia presentation because it has a single use (entertainment) and is not interactive. Although a broader definition does risk the “slippery slope of over-inclusion” against which Mr. Goldberg warns, [22] defining multimedia too narrowly risks excluding broad applications of the new digital technologies from this general discussion.


However, such broad considerations might be best left to the legislature. The courts will address the problem of the new technologies, if at all, through discrete facts. Furthermore, the courts are careful to consider applications of the fair use doctrine on a “case-by-case” basis. [23] Therefore, it may be instructive to describe a hypothetical use (which would not qualify as multimedia under Mr. Goldberg’s definition) and then apply the fair use doctrine to this use.


Pamela R. O’Brien*