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Author: Timothy R. Holbrook
Abstract Congress created the United States Court of Appeals for the Federal Circuit in 1982 to bring greater uniformity to the country’s patent laws. Drawing on this purpose, the Federal Circuit has expanded this call for uniformity by also emphasizing the need for predictability and certainty in the law. The court thus has articulated fairly formalistic approaches to a number of issues. The use of bright-line rules, however, is often at the cost of fairness. In the area of property law, Professor Carol Rose highlighted this tension, and noted the historical, pendulum-like shifts between clear, hard-edged, “crystal” rules and uncertain “muddy” rules that afford greater fairness. Professor Chisum identified this same tension in patent law in his important piece, published in this journal in 1998, coining the phrase “the Fair Protection-Certainty Conundrum.”
The Federal Circuit increasingly has articulated rules of law to promote certainty, at the expense of fairness. The root of this bias likely derives from the court’s Congressional mandate to promote uniformity and certainty in patent law. This rules-based approach, however, is not without critics. Professor Jay Thomas recently detailed the evolution of this shift to formal, simplistic rules, noting that this approach may in fact impair innovation, not facilitate it. Professor Arti Rai also has expressed the view that such formalism impairs innovation policy. This Essay posits, however, that not all of the blame should fall on the Federal Circuit’s shoulders. The Supreme Court has expressly encouraged this approach in its recent patent jurisprudence. This Essay will first identify the various ways in which the Federal Circuit has opted for the “certainty” side of the Fair Protection-Certainty Conundrum. Next, the Essay surveys recent Supreme Court cases which show that the Supreme Court has enabled this shift, making the Court complicit in the Federal Circuit’s formalism agenda.
| | certainty circuit claim court doctrine equivalent federal patent rule supreme
Volume 20 Issue 1 Page 1
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Author: Linda R. Judge
Abstract The term “biotechnology” was coined in 1919 by Karl Ereky, a Hungarian engineer. As generally understood, the term “biotechnology” refers to the use of living organisms or their products to modify human health and/or the human environment typically by using the techniques of gene splicing and recombinant DNA technology. As biotechnology has evolved from a basic research endeavor towards practical and commercial applications, protecting inventions by way of patents has become increasingly important. The primary recipients of biotechnology patents are universities, followed by public companies, non-profit institutions and small and large corporations, both U.S. and foreign-based.
Patent law and the ability to patent new inventions has both affected the evolution of the biotechnology industry and has been a significant driving force behind the funding of biotechnology companies and resulting medical innovations. At present, every new biotechnology invention typically has one or more components that are the subject of patent claims to another entity. As a result, the biotechnology industry today is driven by the need to establish collaborations in order to develop a given product. This is increasingly significant as the number of biotechnology-derived approved drugs increases with substantial benefit in treatment of a variety of medical disorders.
Over the past 20 years, patent law relative to biotechnology- based inventions has struggled to strike a balance between reasonable patent protection versus the public interest in terms of access to technology, further complicated by moral and ethical issues. This paper endeavors to provide a historical perspective on the impact of patent law on the evolution of the biotechnology industry in the United States.
| | application biotechnology court description development industry invention patent state technology
Volume 20 Issue 1 Page 79
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Author: Tyler T. Ochoa
Abstract During the past two decades, engineers, authors, publishers, consumers, lawyers and academics have witnessed extraordinary developments in the technological landscape, often leading to equally dramatic developments in the law of copyright. Many of these developments have been chronicled (or foreshadowed) in the pages of the Santa Clara Computer and High Technology Law Journal. To celebrate the Journal’s 20th Anniversary, this essay will place a number of articles which have appeared in the Journal in their historical context by taking a look back on how the law of copyright has changed during the past twenty years.
| | clara computer copyright court first internet protection right software state
Volume 20 Issue 1 Page 167
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Author: Raymond Shih Ray Ku
Abstract I am honored to write this essay on the state of Internet law to commemorate the twentieth anniversary of the Santa Clara Computer and High Technology Law Journal. It is fitting and appropriate that an entire section of this special issue is devoted to addressing the legal and policy challenges posed by a technology that did not exist at the time the journal was founded. Throughout history technological innovation has played and continues to play a major role in the development of law, most often by creating what Justice Cardozo described as the interstices or the space between existing legal rules and decisions. Correspondingly, law’s response influences what technologies are developed and how they are used. The importance of a forum for exploring and discussing these issues cannot be overstated.
When this journal was founded, society was struggling with the then emerging technology of the VCR. A year later, in 1984, the Supreme Court paved the way for a product that is now ubiquitous, one that has provided the public with a valuable means for obtaining and experiencing information and created new markets and generated great wealth for the consumer electronic and entertainment industries. Today, we are struggling with the social, political, and legal implications of a world increasingly interlinked and mediated by computer technology, and lawmakers are constantly struggling with the legal implications of this new technology. In this context, the history of the VCR is more than an example of the integral relationship between law and technology; it is a cautionary tale as well. While it appears in hindsight that the Supreme Court reached the “correct” decision regarding the VCR, at the time, the great weight of scholarly authority was to the contrary. So how does one evaluate Internet law when one recognizes that no one, let alone lawyers, is prescient and capable of accurately predicting the impact of new technologies? In other words, how does one evaluate the state of Internet law while the revolution is still occurring?
To engage in this analysis, this essay draws upon the framework for social revolutions provided by Crane Brinton as a means for making some preliminary judgments about the current state of Internet law and for providing guidance going forward. Doing so does not suggest that one can simply map Brinton’s anatomy of revolution directly onto Internet law. There are limitations to the metaphor and its application to what may be described as a technological and legal rather than socio-political revolution. Rather, recognition of the dynamics of revolution provided by Brinton’s fever metaphor and outline of the evolution of revolution are useful measures for evaluating the state of the law even though if the fit is not perfect or universal. Moreover, unlike Brinton, I do not claim to describe without evaluating. In this context, I do not believe that such detachment is useful let alone possible. The choice of the framework as well as the examples to which it is applied reflects both conscious as well as sub-conscious biases and normative judgments. Nonetheless, this analogy with political revolution is proposed in the hopes of facilitating a dialogue on the state of Internet law including whether such a discussion is both possible and meaningful.
| | brinton internet revolution
Volume 20 Issue 1 Page 205
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Authors: Tait Graves and Alexander Macgillivray
Abstract There is a growing debate between the proponents of the public domain and supporters of private ownership of information. The contentious discussion on these issues has not yet focused on trade secret law, but it is time to subject trade secret law to the same questions of public policy now asked of copyright, patent, and trademark law. One theory of trade secret law that poses a direct threat to the public domain is the so-called combination trade secret, a concept that permits some combinations of publicly available information to be treated as intellectual property. Despite more than a century of case law on this theory, courts and commentators have never developed a set of tests to properly analyze whether an asserted combination trade secret should be recognized as such. We propose that such combination secrets must satisfy standards no less stringent than those applied for individual trade secrets in order to qualify for intellectual property protection. Specifically, combination trade secrets must not be obvious and must have functionally interrelated elements that provide economic value over combinations with publicly known alternatives. Furthermore, in order to have misappropriated a combination trade secret, a defendant must know about and intend to misappropriate the entire combination, and not have independently derived it. If applied, these tests would protect information in the public domain from overbroad or exaggerated combination claims, while ensuring that truly unique combinations receive intellectual property protection.
| | combination court defendant element information known plaintiff public secret trade
Volume 20 Issue 2 Page 261
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Author: Rachel Clark Hughey
Abstract Since the Supreme Court’s decision in Markman, courts have struggled to determine whether one court’s claim interpretation is binding on another court, and the decisions have not been uniform. Some courts have held that claim interpretation has a special finality and collateral estoppel always applies to an earlier claim interpretation, and others have held it does not. As scholars debated the issue, the Federal Circuit appeared content to remain silent. In the case of RF Delaware, Inc. v. Pacific Keystone Technologies, Inc., however, the Federal Circuit finally considered the issue.
In RF Delaware, the Federal Circuit held that collateral estoppel did not apply to the earlier claim constructions because the required standard for finality was not met. The court held that the lower court’s orders granting partial summary judgment and the following settlement were not sufficiently firm to have preclusive effect. With its decision, the Federal Circuit clarified some of the questions that the lower court decisions were unable to answer, although the RF Delaware court never acknowledged either the growing circuit split or its clarification of that split.
Part I of the Article provides an overview of patent law, claim interpretation, collateral estoppel, and examines pre- and post- Markman decisions on collateral estoppel, focusing especially on the “essential to final judgment” element. Part II examines the Federal Circuit’s decision in RF Delaware. Part III analyzes the Federal Circuit’s decision and suggests how the decision affects the law of collateral estoppel of claim interpretation. This Article concludes that collateral estoppel can apply to a court’s claim interpretation, but there is no special finality to a claim interpretation, and the form of the court’s Markman hearing may affect whether collateral estoppel can apply to the claim interpretation.
| | apply claim collateral court estoppel interpretation issue judgment markman patent
Volume 20 Issue 2 Page 293
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Author: Juanda Lowder Daniel
Abstract In May 2003, Article 2 of the Uniform Commercial Code was revised to facilitate electronic contracting for the sale of goods. It now allows a contract to be formed by the interaction of two pre- programmed computers, even though no individual was aware of it. This article will examine apparent anomalies created by combining the new electronic contracting provisions with the surviving provisions of Article 2 and emphasize the need to provide contracting parties with the opportunity for human intervention before the contract is formed. After introducing the new provisions and the potential problems it creates, the article proceeds to analyze whether allowing contracting between computers comports with the long- standing notion of contractual intent. In addition, the new provisions are analyzed under Article 2’s provisions relating to parol evidence, output and requirements contracts, and waivers and modifications. The focus then turns to whether the current common law doctrines of fraud and mistake afford any relief from contracts formed between preprogrammed computers. Lastly, the conclusion offers remedial measures in order to avoid the seemingly unintentional effects predicted by this article.
| | agent agreement contract contracting electronic provision section term transmission u.c.c
Volume 20 Issue 2 Page 319
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Author: Natlie M. Derzko
Abstract Patents are acknowledged to be of central importance in the area of biomedical research and development. At the same time, however, many commentators have expressed concern about there being too much patenting in this area, particularly in the area of biomedical research tools. The concern of these critics is that patents on research tools may block future biomedical research and development. This paper argues that, while patenting of such tools is desirable and thus should not be obliterated, some legal limitations on the ability of patent owners to enforce their biomedical research tool patents should exist. That is, certain users and uses of research tools should be exempted from patent infringement and limits should be imposed on amounts and types of royalties that a patent owner can collect from their research tool patents.
Part I of this paper is devoted to defining the term ‘biomedical research tool” and what it encompasses, as well as exploring how such tools might be used. In Part II, we develop an understanding of the problem associated with the patenting of biomedical research tools. In this context, we trace what essentially is the demise of the common law experimental use exception, and how this development has contributed to the urgency of the research tools problem. Part III considers the link between the statutory experimental use exception pursuant to 35 U.S.C. § 271(e)(1) and biomedical research tools. Section 271(e)(1) originally was intended to benefit generic pharmaceutical companies who manufacture “copycat” drugs based on original, patented drugs. That is, this exception was intended to give these companies a safe harbor from infringing the original drug’s patent while they conducted the necessary experiments to obtain FDA approval on their copycat drug. However, both U.S. courts and the many players in the biomedical research community have interpreted the provision much more broadly. Recently, Judge Rader deviated sharply from this broad interpretive approach in Integra Lifesciences I, Ltd. v. Merck KGaA, when he found that the experimental use exception in § 271(e)(1) cannot be extended to render non-infringing a company’s otherwise infringing use of a patented research tool. Part III explores the effects of this decision on the patent problem relating to biomedical research tool patents. Finally, Part IV proposes a solution for addressing the problem arising from patents on biomedical research tools.
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Volume 20 Issue 2 Page 347
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Author: Katherine C. Hall
Abstract Section 1201(a) of the Digital Millennium Copyright Act governs legal protection for “access control” technologies that safeguard intellectual property in digital and analog form. The provision creates a new tort that is separate from copyright infringement. Illegal conduct may be subject to civil remedies or criminal penalties, depending on a defendant’s intent. This survey article applies § 1201(a) to published facts about a toy hack in order to analyze the statute’s structure and language. The article is written for non-specialists. It provides basic vocabulary and concepts, making the statute widely accessible and offering an early view of potential issues.
| | circumvention computer control copyright furby measure purpose statute technological unauthorized
Volume 20 Issue 2 Page 411
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Author: Jennifer L. Davis
Abstract To secure a patent for an invention, one of the most fundamental requirements is an adequate description of the invention in words. Not only does the description help a patent examiner determine whether the invention meets the requirements for patentability, but more importantly, it tells the world what has been invented as of the filing date of the patent application. It serves one of the main objectives of the patent system: fostering the exchange and sharing of ideas such that others may build and improve upon the creations of others. The written description requirement is codified in the patent statute and has been interpreted by courts in various ways throughout history within the context of specific technological fields.
In the biotechnology arena, the Court of Appeals for the Federal Circuit (CAFC) has interpreted the written description requirement in the context of claims to nucleic acid sequences on several occasions. Each decision seems to bring forth a new pronouncement regarding the sufficiency of a written description for such claims. This has lead to confusion in the legal community, even among members of the court as evidenced by a reversal, three months after the first decision, by the same panel of judges. Thus, it is currently not clear whether an inventor must demonstrate possession of the invention, list the sequence of the claimed nucleic acid, or support the claim by describing functional properties of the sequence correlated with other known attributes.
The conflicting decisions and lack of clear standards has led to debate in the legal community regarding how the written description requirement should be applied to nucleic acid sequence claims. This comment will explore the controversial CAFC decisions as well as the two sides of the debate. Then, noting that both sides of the debate have merit, this paper concludes with a proposal reconciling the sides by providing a novel test for nucleic acid sequence claims, dubbed the primary cloning test. The primary cloning test addresses the dual nature of nucleic acids as molecules amenable to scientific discovery and isolation from their natural sources, and, secondarily, as molecules of laboratory experimentation. This test is then applied to the Enzo patent currently pending before the district court on remand from the CAFC. The primary cloning test creates a new, bright-line criterion to guide consideration of the adequacy of the written description supporting nucleic acid sequence claims.
| | claim cloning description invention nucleic patent primary requirement sequence written
Volume 20 Issue 2 Page 469
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Authors: Jefferson F. Scher and Colby B. Springer
Abstract In Enterprise Rent-A-Car Co. v. Advantage Rent-A-Car, Inc., the United States Court of Appeals for the Federal Circuit rendered its first construction of the Federal Trademark Dilution Act of 1995. On appeal from the Trademark Trial and Appeal Board, the Federal Circuit faced the issue of whether an opposition proceeding based on dilution can be maintained when the applicant for a mark had been used only in a limited geographic area before the opposing party’s mark became famous. The court also considered whether a state dilution statute could serve as the basis for a federal opposition proceeding.
The Federal Circuit rejected the opposer Enterprise’s arguments on both points. As long as the applicant’s use was “in commerce” within the meaning of the Lanham Act, “the owner of a famous mark cannot oppose registration based on dilution where its mark did not achieve fame prior to the applicant’s use in a limited geographic area.” The Federal Circuit found no evidence that Congress intended to add state dilution statutes to the grounds for opposition to a federal trademark application. Because the Federal Circuit’s statutory interpretation applies equally to District Court proceedings, it presents yet another hurdle for trademark holders seeking relief under the Federal Trademark Dilution Act.
| | advantage circuit dilution enterprise famous federal opposition registration state trademark
Volume 20 Issue 2 Page 489
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Authors: Richard D. Chaves Mosier and Steven W. Ritcheson
Abstract The line where the patent laws and antitrust laws meet has been described as an “accommodation,” an “intersection,” an “impact,” a “clash,” and, here, a faultline. This case note reveals that faultline within the context of two recent court decisions that analyze antitrust claims brought against parties to patent settlement agreements involving the Hatch-Waxman Act, 21 U.S.C. §§ 301–99. Specifically, we examine the seemingly contradictory decisions of the Sixth Circuit’s opinion in In re: Cardizem CD Antitrust Litigation and the Eleventh Circuit’s opinion in Valley Drug Co. v. Geneva Pharmaceuticals, Inc.
In re: Cardizem CD Antitrust Litigation pitted Hoescht Marion Roussel, Inc. (“HMR”), the producer of Cardizem CD—a highly profitable brand-name prescription drug used for treating angina and hypertension and preventing heart attacks and strokes—against Andrx Pharmaceuticals, Inc. (“Andrx”), a manufacturer of generic drugs. On June 13, 2003, the United States Court of Appeals for the Sixth Circuit (“Sixth Circuit”) held an agreement entered into between HMR and Andrx as per se illegal under antitrust laws. The agreement provided that Andrx, in exchange for quarterly payments of $10 million, would refrain from marketing any generic version of HMR’s Cardizem CD even after Andrx had received Food and Drug Administration (“FDA”) approval. In finding this agreement was a per se violation, the Sixth Circuit answered in the affirmative, and thereby functionally affirmed, a question that was certified for interlocutory appeal by the United States District Court for the Eastern District of Michigan.
Rejecting the Sixth Circuit’s holding in Cardizem, the United States Court of Appeals for the Eleventh Circuit (“Eleventh Circuit”) reached a seemingly contrary conclusion in Valley Drug Co. v. Geneva Pharmaceuticals, Inc. On September 15, 2003, the Eleventh Circuit held that two separate agreements between Abbott Laboratories, the manufacturer of a name-brand hypertension drug, and generic drug manufacturers Zurich Goldline and Geneva Pharmaceuticals, were not per se illegal even though the agreements involved payments to the generic manufacturers in exchange for their agreements not to enter the market. The Eleventh Circuit found that the district court had failed to consider the fact that, as a patent- owner, Abbott had a lawful right to exclude potential infringers from practicing its patents. On remand, the district court was instructed to analyze whether the agreements unlawfully exceeded this right.
In this casenote, Part II provides a brief background of the Hatch-Waxman Act. In Part III, the facts of the two cases are set out at greater length. Finally, in Part IV, we take a closer look at the faultline between patent and antitrust law and the apparent clash between the Sixth and Eleventh Circuits. We then suggest a framework for analyzing these types of cases in light of our view that both circuit courts may well have reached the correct conclusion, but via the wrong procedure.
| | abbott agreement andrx antitrust cardizem circuit court generic infringement patent
Volume 20 Issue 2 Page 497
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Authors: Carl P. Bretscher and Victor N. Balancia
Abstract In its recent decision in Honeywell Int’l, Inc. v. U.S. Int’l Trade Commission, the U.S. Court of Appeals for the Federal Circuit affirmed a final determination by the U.S. International Trade Commission (“ITC” or “Commission”) that the claims of Honeywell’s U.S. patent (“‘976 patent”) were invalid as indefinite under 35 U.S.C. § 112, second paragraph. Honeywell is unique in that the dispute was not so much over the meaning of the term at issue, “melting point elevation” (“MPE”), as it was over how to determine its value. Finding that where there were multiple methods known in the art for determining the melting point of polyethylene terephthalate (“PET”) yarn, and that different methods yielded significantly different results, the Federal Circuit concluded the claims were indefinite because they failed to reasonably apprise competitors whether their products were within the scope of the claims. This case should serve as a warning to patentees and practitioners to ensure that any quantitative parameters or formulae in their claims have single, well-understood meaning in the art or are clearly defined in the patent or prosecution history, particularly where the patentees have invented that parameter or formula for the purpose of drafting their claims.
| | claim commission determination honeywell melting method patent point preparation sample
Volume 20 Issue 2 Page 517
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Author: Dana Beldiman
Abstract As our society develops, it produces new and different kinds of intangible goods. However, many of the mechanisms available to protect such goods date back hundreds of years and are inadequate and in desperate need of an overhaul in order to adapt to the new realities of our world. Overly rapid doctrinal expansion can result in negative collateral effects, such as lack of precisely defined standards and blurring of boundaries between doctrines. Such side-effects risk disturbing the delicate balance between free competition and protection that underlies the structure of our intellectual property laws. The growth of intellectual property protection must therefore involve a constant rebalancing between the interests of creators and those of the public at large.
One of the areas that has undergone rapid change in recent years is protection of product design. Pressured by systemic demands for stronger protection mechanisms, judicial decisions have dramatically broadened the scope of protection, in particular in the area of trade dress law. Many of these decisions, however, are rendered in an immature doctrinal environment, characterized by the use of imprecisely defined concepts and doctrines that are incongruous with the needs of the intellectual property to be protected. This incongruity between problem and solution can create precedents that threaten the balance between free competition and protection. That balance can be restored, however, by limiting trade dress protection and implementing specialized design protection mechanisms. Legislative models for more closely tailored protection mechanisms exist, and should be considered.
| | copyright court design dress product protection right source trade trademark
Volume 20 Issue 2 Page 529
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Authors: Kenneth J. Dow and Traci Dreher Quigley
Abstract In 1985, Amgen was a fledgling biotechnology company just four years old. Faced with a dilemma common to many start-up biotechnology companies, the company had two promising drugs, Epogen® and Neupogen®, but was cash strapped and did not have nearly enough money to develop the two products. To make its financial situation worse, Amgen was burdened with the prospect of a costly patent battle with Genetics Institute over the commercialization of its Epogen product, a promising new recombinant protein product called erythropoietin alfa (EPO) useful for treating various forms of anemia. As a consequence of these pressures, Amgen did what many biotechnology companies faced with such prospects do: it forged a deal with Ortho Pharmaceutical, a subsidiary of Johnson & Johnson. In return for a much needed cash infusion of $10 million dollars, Amgen granted Ortho exclusive worldwide rights to sell EPO while retaining its own rights to sell EPO for the kidney dialysis market in the United States. Following the deal, Ortho launched its EPO product under the trademark Procrit® in the United States for the larger non-dialysis market and Amgen launched its Epogen product for the dialysis market. At the time, the deal was a lifesaver for Amgen, but it also deprived the company of approximately two-thirds of the market for its Epogen product. | | agreement clause improvement license licensed licensee licensor patent product right
Volume 20 Issue 3 Page 577
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Author: Otilio Gonzalez
Abstract National attempts to control, or at least limit, transmission of objectionable speech in the electronic media might result in failure because the absence of physical frontiers in the new electronic media, coupled with the current patterns of convergence, make regulations aimed at the speaker very difficult to enforce. An option is to shift from the traditional regulatory model based on the speaker to a paradigm based both on electronic media speakers and receivers. The United States might be in the threshold of such a regulatory shift, as more regulations addressing the availability of objectionable programming depend on technology-based blocking mechanisms controlled by the receiver of the information: the end user of the new electronic media.
This paper addresses constitutional and policy implications of such a regulatory transition. First, a definition of objectionable speech is provided, along with a discussion of how traditional content regulations have attempted to provide constitutional solutions to the problems associated with the exposure of minors to that content. Second, the paper takes a brief look at how the elements of convergence and transnationalism of electronic media affect the implementation of traditional regulatory approaches based solely on the speakers. Finally, the paper suggests that a variable approach, which balances responsibility between speakers and receivers for exposure of minors to objectionable content in the electronic media, might assist policy-makers in their interest in protecting minors from harm. It is argued that the United States might be taking the initial steps in that direction, relying on end user-controlled blocking mechanisms that allow parents and other guarding adults to pre- determine content to be accessed by minors under their care. However, gaps in technology might delay full implementation of such an approach.
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Volume 20 Issue 3 Page 609
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Author: John W. Osborne
Abstract Notwithstanding the increased frequency of assertion of the patent exhaustion defense in recent years, there is no clearly perceived standard for its application. The Supreme Court’s 1942 Univis Lens decision, the controlling authority on patent exhaustion, mandated that the authorized disposition of an article embodying the essential features of a patent claim exhausts the patentee’s exclusive right in that claim. Sixty-two years later, Univis Lens is still misinterpreted. However, a coherent reading of the essential features dictate of Univis Lens and subsequent caselaw compels the conclusion that, in the context of patent exhaustion, essential features are patentably distinctive features. This conclusion provides an analytical framework for determining whether the doctrine should apply in a given factual situation and also resolves the apparent conflicts between the patent exhaustion and related doctrines.
| | claim combination component court doctrine essential exhaustion feature patent univi
Volume 20 Issue 3 Page 643
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Author: Richard J. Smith
AbstractNo abstract available | |
Volume 20 Issue 3 Page 695
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Author: Christopher J. Brown
Abstract In Mattel, Inc. v. MCA Records, Inc. (Mattel), the Ninth Circuit recently held that a song based on the Barbie doll was a parody and therefore qualified for a fair use defense against a claim of trademark infringement. A few years ago, however, this same circuit in Dr. Seuss Enterprises, L.P. v. Penguin Books USA, Inc. (Seuss) held that a book using the writing style of Dr. Seuss, as well as a character fashioned after the Cat in The Cat in the Hat, was a satire and therefore did not qualify for a fair use defense against claims of trademark and copyright infringement. A contrast of these two cases reveals the inadequacy of the standard adopted by the Ninth Circuit to determine when parody should be permitted as a defense to copyright or trademark infringement.
This comment will examine the standard utilized by the Ninth Circuit both in relation to other relevant decisions and within the framework of established literary scholarship on parody. Part II examines the statutory basis of the parody defense, the Supreme Court’s decision on the subject, the subsequent Ninth Circuit decisions in Seuss and Mattel, and several other recent federal court decisions. Part III discusses literary scholarship on the definition of parody. Part IV examines the standard currently in use in the Ninth Circuit in relation to all the cases discussed in Part II. Part V concludes by proposing the use of a more expansive definition of parody to allow a broader range of artistic expression to qualify for the parody defense.
| | barbie character circuit copyright court mattel original parody seuss trademark
Volume 20 Issue 3 Page 721
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Author: Jordan M. Blanke
Abstract The Court of Appeals for the Seventh Circuit recently handed down a decision that squarely supports the Supreme Court holding in Feist that noncopyrightable facts contained in a database are not and cannot be protected by copyright. The decision, written by Judge Richard A. Posner, plainly states that such facts cannot be protected by copyright law no matter how far embedded or intertwined they may be with copyrightable portions of code or structure. While the facts in this case are almost as barren of originality as those in Feist, the strong opinion strikes a blow to those who would like to skirt the clear principles enunciated in Feist.
| | assessment copyright court database fact judge municipality posner protection wiredata
Volume 20 Issue 3 Page 755
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Author: Amy L. Landers
Abstract In any given patent dispute, the protections afforded by the attorney-client privilege and work product doctrines are foundational assumptions when documentation is created and client communications take place. The purpose of each doctrine is to encourage “full and frank communication” between lawyer and client, and afford attorneys the opportunity to permit thorough trial preparation without the fear that such material will become available to opposing counsel through discovery. Therefore, memorandum, e- mails and transcribed voicemails often contain sensitive information created based on the parties’ belief that the sensitive information will not become available to opposing counsel. However, when creating such sensitive documentation, attorneys may not always carefully consider the fact that the sensitive material may later be displayed— larger than life—to a jury examining whether their client has engaged in willful patent infringement.
At first blush, it may be difficult to conceive of circumstances under which such protections would be voluntarily waived. However, an accused infringer seeking to rely on an “advice of counsel” defense to a charge of willful infringement may choose to do so as a necessary price to pay to obtain the benefits of an advice of counsel defense Generally, prior to invoking an advice of counsel defense, a client will engage opinion counsel, who is asked to consider the patent claims and the potentially infringing process, method or device, and to provide an independent, informed legal opinion as to whether infringement has occurred or whether the patent will likely be held valid and enforceable. If the client has exercised diligence in obtaining a competent, independent and informed opinion of counsel indicating that there is no infringement and/or that the patent is invalid or unenforceable, the client may then assert good faith reliance on counsel’s opinion when the patent-holder claims that the allegedly infringing activity is willful. According to the courts, a patent holder’s good faith reliance on an opinion of counsel constitutes important evidence that an infringement was not “willful.”
After litigation commences and the alleged infringer decides to rely on an opinion of counsel defense, the alleged infringer must then produce the opinion of counsel to opposing counsel. Established precedent holds that the “deliberate injection of the advice of counsel defense into a case waives the attorney-client privilege.” The issue then becomes the court’s determination of the scope of the waiver. Does the waiver of attorney-client privilege extend solely to counsel’s opinion? Does it include all communications with the client concerning the opinion? Does the waiver extend to trial counsel? Is the protection afforded to work product created in anticipation of litigation, such as trial strategy memoranda, also waived? Answers to these questions can be found in a number of district court decisions, each of which evidence the court’s increasingly fractionalized view on the scope of waiver. In fact, even trial courts within the same district have reached strikingly different results. To make matters worse, the Federal Circuit has yet to provide any definitive ruling on the issue.
Once litigation commences and the advice of counsel defense is invoked, rarely are agreements on the scope of waiver of privilege reached between the parties because patent holders typically have little incentive to agree to anything less than the fullest disclosure permitted by law. The potential to mine the alleged infringer’s files in the hopes of obtaining a glimpse into its trial strategy or of discovering a “smoking gun” admission that would eliminate or substantially impair the alleged infringer’s defenses at trial creates a powerful incentive to hold out for maximum disclosure. On the other hand, alleged infringers will fight to keep the scope of the waived privileged information as narrow as possible. However, where the accused infringer has retained the same counsel for both opinion work and trial, trial strategy memoranda may be particularly at risk for production to the opponent.
Two recent district court decisions, Aspex Eyewear, Inc. v. E’lite Optik, Inc., and BASF Aktiengesellschaft v. Reilly Industries, Inc., demonstrate the courts’ difficulty in arriving at a uniform position on the scope of waiver and uncertainty facing patent holders and their counsel. Aspex Eyewear and BASF both illustrate the courts’ willingness to examine the specific facts and circumstances of each case when determining the scope of the waiver. Because the scope of the waiver question depends on the circumstances present in a particular case, both Aspex Eyewear and BASF demonstrate a troublesome lack of predictability for those involved in drafting opinions of counsel.
Given the uncertainty as to whether information held or obtained by opinion counsel will ultimately become discoverable by opposing counsel and admissible at trial, counsel preparing an opinion must exercise great care. This challenge is especially difficult, given that as a temporal matter, an opinion is typically generated well in advance of a court’s determination of the precise scope of the waiver in any particular case. Because of the possibility that the court might compel a broad scope of disclosure that may contain damaging admissions, additional consideration must be given to whether to proffer the advice of counsel opinion after litigation has commenced.
BASF and Aspex Eyewear illustrate the risks inherent in relying on an opinion of counsel at trial and provide lessons to those accused of patent infringement and their counsel. As both courts found, the scope of the waiver rests to some degree in the hands of the accused infringer and their counsel. Thus, reviewing these decisions is helpful to those involved patent disputes in which the patent holder may become accused of willful patent infringement.
| | attorney client counsel court defendant infringer opinion patent scope waiver
Volume 20 Issue 3 Page 765
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Authors: Robert A. Matthews, Jr. and Louis M. Troilo
Abstract United States patent law precludes obtaining or enforcing patents covering an invention previously in use or described in a printed publication. Where a printed prior-art reference discloses within its four corners all aspects of a subsequently claimed invention, the reference “anticipates” the claimed invention. References that anticipate a claimed invention show that the invention lacks novelty and renders invalid any claim to that described invention.
In a typical anticipation analysis, the challenger (an accused infringer, if in litigation, or the Examiner, if in prosecution) usually tries to show that a single prior-art reference expressly discloses each and every limitation of the asserted claim. Generally, if the prior-art reference does not disclose each and every claim limitation, the reference does not anticipate the claim. Sometimes the reference if combined with another prior-art reference may show each claim limitation in a way that renders the claimed invention obvious, and thereby invalid under 35 U.S.C. § 103(a), but the reference by itself still does not anticipate.
Quite often it is easier to prove that a prior-art reference anticipates a claimed invention than to prove that it renders the claimed invention obvious. Obviousness based on a modification of single prior-art reference or a combination of references requires proving, inter alia, that a person of ordinary skill in the art would have the motivation to make the modification or combination. Patentees may also try to rebut a prima facie case of obviousness by presenting evidence of secondary considerations, such as commercial success, teaching away, unexpected results, or long-felt need, etc. Anticipation, on the other hand, requires only showing that each limitation of the claimed invention is found within the four corners of a prior-art reference. Issues of motivation, commercial success, teaching away, or unexpected results have no relevance in rebutting an assertion of anticipation.
Challengers seeking to invalidate a patent claim for anticipation often find that a prior-art reference, which looks promising at first, falls short of explicitly describing all of the limitations of the claimed invention. Despite the lack of an express disclosure, if the challenger can show that the missing aspect necessarily results from practicing the subject matter explicitly disclosed in the reference, the law will consider the missing aspect inherently present. Thus, the doctrine of inherency allows a de facto implicit disclosure to provide missing express disclosure when considering anticipation. Where the combination of the expressly disclosed subject matter and the inherently disclosed subject matter meets each claim limitation of a later-claimed invention, the reference inherently anticipates the later- claimed invention.
Until recently, no reported Federal Circuit case had considered invalidating a patent claim on the basis that the entire anticipatory disclosure was inherently disclosed in a prior-art reference. That changed with the Federal Circuit’s recent decision in Schering Corp. v. Geneva Pharmaceuticals, Inc.
In Schering, the Federal Circuit held that a prior-art reference, allegedly silent on a later-claimed compound, can nevertheless inherently anticipate claims to that compound if the production of the compound necessarily follows from practicing a process described in the reference. Further, the Federal Circuit held that it does not matter that one of skill in the art may not have recognized that the prior-art process inherently produces the later-claimed compound.
This article reviews the law on the doctrine of inherent anticipation. It further examines the panel’s decision in Schering and the Federal Circuit’s later denial of the patentee’s petition for an en banc hearing. Finally, the article provides some suggestions for drafting claims in view of the decision.
| | anticipation claim claimed disclosure inherent invention patent prior reference schering
Volume 20 Issue 3 Page 779
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Author: Lara J. Hodgson
Abstract It has been well ingrained in all of us that what is fair is generally right, and what is unfair is wrong. We are all familiar with the notion that we cannot have our cake and eat it, too. How far does that sense of fairness extend? Should it take precedence over other public policy concerns which have helped to shape our laws and justice system? These questions have plagued the courts in the context of patent law and assignment agreements. The following hypothetical situations help illustrate the dilemma.
Consider an inventor who acts fraudulently in obtaining a patent, which he then assigns to Company A. Can that inventor assert an inequitable conduct defense to render the patent unenforceable when he is later charged with infringement by Company A?
What about an inventor who assigns her patent to Company A, knowing that a prior art reference exists which will likely invalidate the patent? Can she defeat Company A’s infringement allegations by invalidating the patent with that same prior art reference?
What about the case of an inventor who assigns his patent and subsequently discovers a previously unknown prior art reference which he believes invalidates the patent? Should the inventor be allowed to allege invalidity based on that prior art reference in defense of an infringement action?
Alternatively, what if Company A, who was assigned the patent by Inventor, subsequently assigns the patent to Company B? Should Company A be prohibited from attempting to invalidate the patent by using a prior art reference discovered after it had assigned the patent to Company B?
Finally, issues arise when corporate employees are part of a team of inventors. For example, an employee-inventor assigns his invention to Company A as required by his employment agreement, signs the inventor’s oath to accompany a patent application which he did not prepare, and then leaves Company A while the patent is being prosecuted. Is he prevented from challenging the validity of any patent which ultimately issues from the initial application? What about his subsequent employer, Company B, who thought enough of the employee-inventor to place him in charge of its infringing product line?
It is easy to review the first scenario and determine that the inventor should not be able to avoid infringement by claiming that the patent he assigned is unenforceable as a result of his own conduct. Similarly, it seems reasonable that the employee inventor in the final hypothetical should not be prevented from arguing that a patent prosecuted and obtained by his former employer is invalid, nor should his subsequent employer. But where should the line be drawn in the other scenarios? Should a non-inventor assignor be held to the same standards as an inventor assignor?
The courts have used the doctrine of assignor estoppel to help answer these questions, but its interpretation has not been consistent. The doctrine of assignor estoppel is a reflection of our fundamental sense of fair play, the notion that one cannot undermine the value of that which she conveyed by later challenging its worth. More specifically, assignor estoppel precludes an assignor of a patent from attacking the novelty, utility, or validity of the patent as a defense to a charge of infringement. The doctrine was originally adopted from the British common law, but has not always found favor with the courts. In fact, the United States Supreme Court spent the better part of the twentieth century slowly eroding the doctrine until it was effectively rendered nonviable. The Court of Appeals for the Federal Circuit, on the other hand, took up the gauntlet and has revived the doctrine. However, the broad application of the doctrine advocated by the Federal Circuit raises concerns about, among other things, patent law policies and employer-employee relationships and rights.
| | assignment assignor circuit court doctrine estoppel federal invention inventor patent
Volume 20 Issue 3 Page 797
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Author: Santa Clara Computer & High Technology Law Journal
AbstractNo abstract available. | | copyright technology
Volume 20 Issue 4 Page 933
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Author: Mia Garlick
Abstract The Internet and digital technologies offer the promise of greater dissemination of information and technology globally. However, the same technological developments have been classified by U.S. copyright owners as a “unique digital threat” to their businesses because they also potentially enable mass, anonymous individual copying by users located across the globe.
In response to this perceived threat, copyright owners have apparently adopted a twofold strategy. Firstly, they have promoted the development and deployment of technological protections, such as encryption and password protections, which control the ability of users to access and use digitized content and technology, such as software, otherwise than on their terms. Secondly, copyright owners have pushed for the legal backup of these technological protections in the form of “anti-circumvention measures,” so called because they give proprietors a cause of action against devices or services which circumvent these technological protections.
The anti-circumvention measures first took shape as international standards for copyright protection in the digital age in the WIPO Copyright Treaty 1996 and the WIPO Performances and Phonograms Treaty 1996 (collectively, “WIPO Internet Treaties”). These WIPO Internet Treaties were concluded in 1996 and took effect on March 6, 2002 and May 20, 2002, respectively, three months after thirty countries had ratified or assented to each of the treaties. The U.S. was one of the first ten countries to ratify the WIPO Internet Treaties and adopted a “maximalist” interpretation of its WIPO obligations in the form of § 1201 of the Digital Millennium Copyright Act of 1998 (“DMCA”).
The DMCA’s anti-circumvention measures have been much debated. The debate has focused primarily on the implications of § 1201 on the formulation of U.S. copyright laws. The purpose of this paper is to explore the international ramifications of § 1201, in particular for developing countries. In the international arena, the competing interests of copyright owners and copyright users are similar to those in the domestic U.S. market but the variables are different, particularly for developing countries where the market is less attractive to copyright proprietors and the impact copyrighted goods can have on public well-being is greater.
Section 1201 sets a high level of legal protection for technological measures. As such, it has very real implications for the developing world. The new provisions were designed to encourage U.S. copyright owners to make their works available online. Relying on § 1201, they are increasingly doing so in technically protected formats which circulate beyond U.S. borders. The terms on which access to these items can be gained therefore reflect the commercial and legal interests of these U.S. copyright owners rather than the domestic laws of a user's country—laws that are likely to be tailored to reflect that country's specific developmental and cultural objectives. Technological protections can, as a practical matter, directly interfere with the ability of residents of developing countries to access and use a considerable amount of copyrighted materials, thereby halting the public benefits which can flow from the use of those materials, such as education, research and scholarship, as well as, participation in the digital economy. In other words, by introducing legal protections of technological locks, § 1201, and the technology it protects, has the potential, either by example or direct application, to lock the gate on the bridge spanning the digital divide. As one commentator has observed "[i]t is indeed ironic that that the very technology that has the potential of truly evening out the playing field is the same technology that may widen the gap between the 'haves' and the 'have nots.'"
This paper argues that it should be a matter for each country, particularly developing countries, to decide the level of protection their laws afford to technological locks on copyrighted materials. The background and context of U.S. copyright law recognizes the value of access and use of copyrighted materials to promote economic, cultural and social well-being. Fair use exceptions and other limitations temper copyright law to facilitate these benefits. However, similar limitations have not been translated into the new anti-circumvention measures introduced in the U.S. While the U.S. maximalist interpretation of its obligations to protect technological locks under the WIPO Internet Treaties may be reasonable in the context of U.S. interests, correspondingly high levels of protection may not be appropriate in other countries.
It appears, however, that the U.S. Congress intended that § 1201 serve as a model for other legislatures in formulating their own anti- circumvention measures. Section 1201, therefore, has international implications by serving as an model for legislatures of other countries adopting § 1201-style provisions, in accordance with their obligations under bilateral and multilateral agreements negotiated with the U.S., or failing that, possibly, by the direct application of § 1201 to foreign activity.
Rather than having § 1201 serve as a uniform example of anti- circumvention measures, the model of anti-circumvention measures adopted in other countries, whether maximalist, minimalist or a combination, should be structured sensitive to the domestic situations of those other countries. A review of the status of recent bilateral and multilateral agreements suggests that the interests of developing countries are better addressed through international, multilateral intellectual property negotiations, rather than through bilateral negotiations.
| | circumvention copyright country court digital internet measure protection technological treaty
Volume 20 Issue 4 Page 941
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Author: Tyler T. Ochoa
Abstract The Copyright Act gives a copyright owner the exclusive right “to prepare derivative works based on the copyrighted work.” Does the Copyright Act require that a derivative work be “fixed in a tangible medium of expression” in order to be infringing? Existing case law is contradictory, stating both that a derivative work does not need to be “fixed” but that it does need to be embodied in some “concrete or permanent form.” This contradiction stems from the fact that although the statutory language does not appear to require fixation, reading the statutory language literally would render illegal merely imagining a modified version of a copyrighted work. This contradiction can be eliminated by recognizing that what Congress intended was to prohibit the public performance of an unfixed derivative work, as well as the reproduction, public distribution, public performance or public display of a fixed derivative work. Congress’ intent can be fully implemented by holding that the exclusive right to prepare derivative works is dependent upon, rather than independent of, the other four exclusive rights. The advantage of this interpretation is that it leaves all private performances of a derivative work, whether fixed or unfixed, outside the realm of copyright infringement.
| | copyright copyrighted derivative display fixation fixed original public right version
Volume 20 Issue 4 Page 991
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Author: Nikki D. Pope
Abstract Until the mass-market introduction of digital recording technology, consumers were unable to make near-perfect duplications or seamless alterations of video and audio recordings of artists. That was then; this is now. Today computers allow consumers to burn their own CDs and DVDs. They can create their own music compilations. Usenet groups post copies of newly released movies that members can download . . . sometimes, even before the movie’s first theatrical release! Peer-to-peer file sharing services, like the now defunct Napster and its replacements (KaZaA, Grokster, and others), allow one consumer to browse the hard drives of thousands of other consumers in distant locations to find music, movies, and other types of electronic documents and download them to their own computers.
This consumer behavior is nothing new. When tape recorders were introduced, consumers recorded their vinyl albums for use in their car tape decks and Walkmans.® They made party tapes for their friends. When videotape recorders were introduced, consumers recorded TV shows and movies for their friends and for themselves. With premium cable and pay-per-view programs, commercials were eliminated, allowing for seamless videotaping of commercial-free programming. However, with digital technology, these recordings are virtually indistinguishable from the originals. Analog reproductions (audiotape, videotape, etc.) degrade with each generation. So, if a movie is taped and given to someone who makes a copy from the tape and so on, the copy will eventually become unwatchable. With digital reproduction, the degradation is almost imperceptible from generation to generation, greatly postponing the unwatchable stage.
Digital technology scares the entertainment industry, and rightly so. Not only are they losing control over the distribution of their products, they are also losing control over the actual product. For example, a backlash against the character Jar-Jar Binks in font-variant: small-caps;Star Wars® The Phantom Menacefont-variant: normal; (Lucasfilm, 2001) resulted in an underground version of the movie with Jar-Jar removed from the film. Bootleg copies of movies that have not even opened in theaters yet are showing up on the sidewalks of New York, China, and Russia. The entertainment industry is grappling with how to reclaim control over its products and protect its intellectual property against future infringements.
It is against this backdrop that we consider the Clean Flicks case. Should a third party be allowed to edit a movie to remove content the third party finds objectionable? What if the third party is a co- operative of consumers who have similar concerns about objectionable content? What if the co-operative uses their library of “sanitized” movies to attract new members? What if the members want to own their own sanitized version of the movie? What if the people who created the movie, the directors, writers, cinematographers, and other artists are not the copyright owners? Do they have any rights regarding the alteration and distribution of their creations, and if so, what are those rights? These are just some of the issues that the court will wrestle with in the Clean Flicks case.
Clean Flicks puts forth two alternative fair use defenses for its actions: (1) the company’s actions create no loss of revenue because there is a one-to-one ratio between the originals and sanitized copies, or (2) they are a co-op film club that should be treated like a “lending library” because they lack a commercial motive. While both are novel arguments, the court should reject them as violative of the copyright law and not a valid exercise of the fair use doctrine.
The directors named in the suit have made a trademark infringement and trademark dilution counterclaim under the Lanham Act. They argue that by editing a director’s movie without authorization, Clean Flicks is fraudulently implying a link between the director and the edited movie.
This comment will discuss these defenses and counterclaims and attempts to predict the outcome of this controversy. Although the directors have filed various motions to join other plaintiffs (Movie Mask and ClearPlay for example), this comment will focus on the Clean Flicks copyright claim, the directors’ trademark counterclaim, and a possible motive underlying the way in which Clean Flicks brought this suit.
| | clean copyright court director edited flick movie movy studio version
Volume 20 Issue 4 Page 1045
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Author: Gretchen Stoeltje
Abstract Legal issues surrounding the distribution and licensing of independent documentary films in the digital age are just beginning to emerge. At present, most independent documentaries, which are frequently distributed by small, specialized distributors to educational institutions, are sold on VHS analog tape. As distribution via digital formats becomes increasingly affordable and technologically possible, distributors are beginning to convert parts of their collections to DVD and are considering eventually streamed video or downloaded video-on-demand. At the same time, educational institutions are developing new teaching models such as distance learning programs, which require that teaching materials be available in digital form for student access. With these new formats come new uses—and misuses—of films. All of these developments raise questions of film licensing which both the larger film industry, of which documentary distributors are a small part, and the law are struggling to address. This comment will focus on independent documentary makers and distributors.
After the Introduction, Part II of this comment sets the stage for the discussion, describing the present context for distributing educational documentaries. This section provides technical details about current format and licensing practices, a general description of the economics of documentary filmmaking, and the relationship of documentaries to the Fair Use Doctrine. It concludes with a discussion of the most recent technology shift, which produced the new issues that are the main subject of this comment.
Part III describes the new laws and the short and long term licensing questions brought about by new laws and new technologies Two statutes inform this discussion: the Digital Millennium Copyright Act (DMCA) and the Technology, Education and Copyright Harmonization (TEACH) Act. The most relevant provision of the DMCA is the much-contested anti-circumvention provision (17 U.S.C. § 1201) which both protects and limits rights of documentary film producers. The provision prohibits the unauthorized circumvention of encryption, a kind of copy protection, which producers may build into a digital delivery format on which they are delivering their product. That format might be DVD, streamed video, downloaded video-on-demand, or some other format by which a film (as a digital file) may be distributed. Encryption is designed to prevent access to a digital product, acting as a technological lock one can embed in a digital product to prevent illegal access and, thereafter, reproduction. It is one function of emerging Digital Rights Management Systems that can be used to police licenses using technology. The law protects the interests of a producer against certain types of conduct by prohibiting access to the encrypted product. If unauthorized access is a violation of the law, then copying of an encrypted file would be impossible. It also severely curtails that same producer’s ability to use the copyrighted materials of others in non-infringing ways under the Fair Use Doctrine of the Copyright Act.
Finally, how to best shape and control licenses in the digital age is complicated by the permissions available to educational institutions to reproduce intellectual property under certain circumstances. The Fair Use Doctrine suggests that educational institutions might be allowed to digitize analog materials not yet available in digital form. More recently, however, the TEACH Act addresses this issue directly. The Act has been described as an effort to “strike a balance between protecting copyrighted works, while permitting educators to use those materials in distance education.” The statute sets out stringent conditions under which this use may occur, conditions which would seem to favor the copyright holder and protect its future market. But it provides a back door around those requirements with regard to acquiring copyrighted material not yet available in digital form. This situation raises questions that producers and distributors of social issue documentaries may want to consider as they make new licensing decisions.
The subject of Part IV is a set of specific suggestions for approaching licensing, both in the short term, given the new conditions created by the TEACH Act, and in the long term, for digital content delivery defined primarily by the DMCA. Two recent models for licensing copyrighted material in a digital environment have emerged which reveal a spectrum of licensing choices, from extremely permissive to extremely restrictive possibilities. One model is the Creative Commons project, creator and provider of free, customizable, machine-readable licenses. This non-profit organization advocates retaining little or no copyright control, and claims to embody the original spirit and intent of the Founders of the Constitution. A second model is MovieLink, a conglomerate of five Hollywood studios experimenting with downloading feature films directly to personal computers, using highly restrictive licenses whose terms are enforced automatically by the delivery technology. Somewhere in between is a licensing option appropriate for filmmakers who desire copyright protection, but who dislike restrictions on the flow of ideas from which they have traditionally benefited.
| | copyright digital documentary film filmmaker institution license material protection right
Volume 20 Issue 4 Page 1075
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Author: Shanshan Zhang
Abstract Advances in genetics and molecular biology have changed our views on what life means and what a human being is. They will ultimately reshape the interpretation of terms such as “reproduction, individuality, history, freedom and subjectivity.” For the past several decades, emerging frontiers of biotechnology have grown dramatically and continue to offer innovative methods to detect, diagnose, and treat diseases. Recently, much of the attention of the biotechnology industry has been focused on the Human Genome Project, which has a primary goal of producing a roadmap of the human genome. The potential being delivered by this gene map is immense, as the knowledge on gene sequences can serve as a starting point for scientists to understand the functions of genes and how alterations in gene’ structure and function may affect a disease state. Genomics has not only become a “vast scientific” venture but also a “commercial enterprise.” Both public and private sectors have entered into this arena to search for new and better ways to prepare vaccinations, cure diseases, and relieve the suffering caused by debilitating conditions. In the meantime, researchers have sought for and obtained patents to protect their knowledge of human genes. The World Health Organization has reported that an increasing number of patent applications have been filed to claim inventions related to gene sequences. These patent applications and granted patents have generated considerable discussion and debate on the acceptability of gene patenting.
Generally, in order to obtain a patent, an invention must be a patentable subject matter that is novel, non-obvious, and useful, and must comply with the written disclosure requirements in 35 U.S.C. §112. Under current U.S. patent law, a deoxyribonucleic acid (“DNA”) sequence is a patentable subject matter as a composition of matter or an article of manufacture. However, naturally occurring genes are not eligible for a patent; therefore, to be patentable, a DNA molecule must be “isolated and purified” from its natural state. Similar to all other inventions, inventions directed to DNA sequences also need to fulfill all statutory requirements under U.S. patent law.
The U.S. economy has become increasingly dependent on technological innovations. The patent system has worked well for more than 200 years to foster innovation and its commercial development. As for other areas of inventions, patent protection for DNA sequences will be needed to provide incentives to invent and discover, and to secure new capital for growth.
On the other hand, patenting DNA sequences is not free of problems. Because of the unique nature of DNA sequences, DNA technology has fundamentally changed the way that biological and medical research is conducted. The term, “invention,” has acquired a new meaning, and patents on DNA sequences are intrinsically different from traditional mechanical patents. As discoveries of new genes and knowledge gained from genomic research continue to have substantial impact on development of drugs and therapeutics for humans, people have stronger feelings about DNA sequence patents. Some researchers, physicians, non-profit organizations and religious groups have opposed patenting DNA sequences. They believe that granting patent rights on DNA sequences will lead to “private appropriation of the genetic commons.” Furthermore, patents have been issued to cover short DNA fragments, such as expressed sequence tags (“EST”) and single nucleotide polymorphisms (“SNP”), as well as large fragments that contain genes of medical interest. Sometimes, the patented small fragments turn out to be part of the gene covered by the patent claiming the larger fragment. Under the current system, both patents can co-exist. However, “the second patent holder may have to obtain licenses from . . . the primary patent holder but is not prevented form obtaining the second patent.” While the law allows multiple patents to be granted on the same sequence, certain groups fear that this trend will lead to more litigation. Additionally, others argue allowing DNA patents will result in higher expenses in obtaining licenses to conduct research, more costly products, and heavier burdens on the healthcare system. For example, Myriad Genetics, a U.S. company, holds patents on BRCA1 and BRCA2 genes, which indicates susceptibility to breast cancer. It charges $2,680.00 for each diagnostic test. Healthcare professionals are worried that women at risk for breast cancer will be adversely affected by Myriad’s monopoly. Furthermore, while recognizing that patents protect the intellectual property and efforts of the inventors, many have expressed concerns that exclusive rights granted to the inventors of gene patents may block public access to important information, which in turn will impede genetic research, inhibit technology development, and ultimately produce an adverse effect on public health.
In order to maintain a balance among the competing interests with regard to patenting DNA sequences, changes are needed to avoid the pitfalls in the current system. Modifications to the current system will ensure that gene patents continue to serve their intended purpose of promoting science and exchange of information, while further ensuring that exclusive property rights on sequences do not impede the research and development of new technologies.
This paper argues that some of the concerns posed by patenting DNA sequences can be addressed through changes made by the United States Patent and Trademark Office (“USPTO”). First, the U.S. has recently revised its examination guidelines for the utility requirement and written description requirement. The new heightened guidelines will work to eliminate ineligible claims, improve the quality of DNA sequence patents, and reduce the likelihood that a patent may be challenged by a third party. Also, the inter partes re-examination procedure can serve as an inexpensive alternative to full litigation in challenging a patent. Furthermore, this paper will propose solution-oriented reform structures, which are necessary to improve the current system. A patent pool can be used as a powerful tool to make obtaining a license much easier. Additionally, legislative changes including compulsory licensing schemes and research exemptions will ensure that the granting of DNA patents does not affect scientific research. Ultimately, a fundamental reform of the patent law may serve as the true gatekeeper in guarding against invalid patents.
| | diagnostic examination invention license patent patented research sequence system utility
Volume 20 Issue 4 Page 1139
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