Tag Archives: 2009

July 19 / All Articles, Patent

The Biologics Price Competition and Innovation Act: Innovation Must Come Before Price Competition

Unlike traditional pharmaceutical drugs, which are small molecule compounds synthesized by chemists, biologics are typically large molecules that are produced in living things. [1] [2] Breakthroughs in the life sciences over the last two decades have led to new biologically derived treatments for debilitating diseases including autoimmune diseases, metabolic disorders, degenerative diseases, blood disorders, and cancer. [3] Several new biological treatments for diseases presently untreatable by other means are currently under development. [4] Despite these advances, new biologics come at a substantial cost for developers, consumers, and health care payers and providers. For developers, internal research, development, and production costs often exceeds a billion dollars per product brought to market. [5] For consumers, the purchase price of any given biologic treatment can be up to several thousand dollars per year. [6] For example, the cost per year per patient for Avastin®, a biologic used to treat colon cancer, is $100,000, and the cost for Cerezyme®, which is used to treat the metabolic disorder Gaucher Disease, is over $300,000. [7] On average, across treatments, the cost of medicinal biologics per patient is over $16,000 per year. [8]


For health care payers, the cost of biotech products is rising dramatically. According to IMS Health Inc., a provider of business intelligence for biotech and pharmaceutical companies, expenditures on biologics in the United States was over $40.3 billion dollars in 2006, which marks an increase of 20% from 2005. [9] Public and private insurance companies have declared that a continued increase is not sustainable without cuts to health care coverage. [10] Biologic medicines are of little benefit if they are too expensive for patients to afford.


Although Congress has made efforts to make biologics more affordable for the consumer market, such legislation must be carefully balanced to maintain incentives for innovators as they develop new therapeutic regimens. [11] [12] Without adequate incentives for biotechnology companies to discover new market-viable biologic medicine, there would be a dearth of breakthrough products available to patients. The majority of new biologics are discovered by small to medium-sized innovative biotechnology companies. [13] Research and development of biologics is an extraordinarily high risk endeavor requiring a great deal of up-front capital investment, [14] and returns are often not realized for several years due to the length of time required for the product to be developed and go through the stringent regulatory approval process of the Food and Drug Administration (“FDA”). [15]


In an effort to reduce the costs of medicine for patients, Congress must be especially careful not to impair the ability of the biotechnology industry to thrive by substantially diminishing profitability. Currently, the biotechnology industry is “still relatively nascent” and is largely fueled by venture capital investment. [16] Of the approximately 1400 biotechnology companies operating in the United States today, only twenty are profitable. [17] Many of these companies are small, with revenues of under a million dollars per year, and do not even have a product on the market yet. [18] Leaders in the biotechnology industry have expressed concern over the ability to secure investments in the wake of new biologics legislation:


Biotechnology researchers must have some certainty that they can protect their investment in the development of new breakthrough therapies for a sufficient period of time in order to secure necessary financial resources. If … legislation were to fail to provide adequate protections, it could jeopardize the ability of biotechnology researchers to continue to innovate. [19]

In June 2007, a bipartisan bill sponsored by Edward Kennedy (D- Mass.), and co-sponsored by Hillary Clinton (D- N.Y.), Orrin Hatch (R- Utah), Mike Enzi (R-Wyo.), and Charles Schumer (D- N.Y.), titled the Biologics Price Competition and Innovation Act of 2007 (“BPCIA”), was introduced to and unanimously passed by the Senate Committee on Health, Education, Labor, and Pensions. [20] The BPCIA seeks to balance patients’ needs for affordable biologic medicine with the needs for innovation in the biotechnology industry to continue to develop new therapeutics. [21]


This Note will discuss key provisions of the BPCIA and will analyze the likely impact of its passage on innovation in the biotechnology industry and patient access to lower cost biologic medicine. Part I will provide a brief background on biologics and the complexity of their manufacture. Part II will describe the regulation of small molecule drugs under the Food Drug and Cosmetic Act (“FDCA”) [22] and the regulation of biologics under the Public Health Services Act (“PHSA”). In addition, the Hatch-Waxman amendments to the FDCA that allow for abbreviated new drug applications (e.g., generics) will be discussed. [23] Part III will explain why legislative action is necessary for a viable path forward to abbreviated FDA approval of biologics. Part IV will describe key provisions of the BPCIA that lay the framework for regulation of follow-on biologics. Finally, in Part V, this Note will analyze the impact that enactment of the BPCIA might have on innovation in the biotechnology industry and patient access to lower cost biologic medicine….


Robert N. Sahr*

July 19 / All Articles, Computing

“Indecent” Deception: The Role of Communications Decency Act § 230 In Balancing Consumer and Marketer Interests Online

“[T]he Internet represents a brave new world of free speech … [it] is fundamentally different from traditional forms of mass communication in at least three important respects. First, the Internet is capable of maintaining an unlimited number of information sources …, Second, the Internet has no “gatekeepers”–no publishers or editors controlling the distribution of information …. Finally, the users of the Internet are also its producers. But every person who taps into the Internet is his [or her] own journalist. In other words, the Internet has shifted the focus of mass communication to the individual …” [1]


I. Introduction


In 1992, the Hard Rock Café Licensing Corporation appealed to the Seventh Circuit to find Concession Services Inc. (CSI), the operator of Chicago-area flea markets, liable for contributory trademark infringement. [2] Private investigators hired by Hard Rock to search for counterfeit merchandise had discovered Mr. Iqbal Parvez selling counterfeit Hard Rock t-shirts from stalls in CSI’s Tri-State Swap-O-Rama and Melrose Park Swap-O-Rama. [3] The court applied tort law principles to find liability only in cases where the operator knew or had reason to know that the infringing activity was taking place. [4] Although CSI would have been liable if it had known or should have known that Parvez was selling Hard Rock t-shirts, it had no affirmative duty to ferret out or prevent such illegal activity. [5]


Nine years later, in 2001, Gucci America, Inc., the high-end fashion apparel and accessory house, sued Mindspring Enterprises for contributory trademark infringement and unfair competition, because the web hosting service hosted a website advertising jewelry sold under the Gucci trademark. [6] Mindspring had not responded to Gucci’s two emails notifying Mindspring of the infringement. [7] Similarly, in 2008, eBay Inc. was sued for claims that “live bidding” at its “carefully screened” third party auction houses was safe. [8] The plaintiff claimed that eBay’s own marketing representations were false, and that vendors employed shill bidders to increase product costs. [9]


Should web hosts like Mindspring and online auction houses like eBay be held to the same standard as CSI, a brick-and-mortar flea market operator? Or does the Internet require special treatment due to its higher value as a vast source of information, communication, and social networking? On one hand, the Internet is a developing resource that the free market could shape without governmental regulation. [10] Additionally, it is likely technologically infeasible for Mindspring or eBay to screen every vendor and product that passes through its virtual universe. [11] On the other hand, consumers deserve protection from false and deceptive marketing practices of those who take advantage of the Internet’s lack of accountability. [12]


Congress provided a partial (and vague) answer to this question when it enacted § 230 of the Communications Decency Act (CDA). [13] § 230 provides a safe harbor for Internet service providers (ISPs) from liability for third party actions. [14] The intent of § 230 was to encourage the growth of the Internet [15] and to provide protection for those “Good Samaritans” who take measures to screen or filter indecent or otherwise offensive content. [16] § 230 has been applied to immunize ISPs from an array of civil actions, including false representations, fraud, and unfair business practices. [17] The exact scope of § 230’s reach is yet unclear, however, as courts have found that it does not provide blanket immunity for false or deceptive marketing practices. [18]


An investigation into the legislative history of the statute, and the case law that followed its enactment, sheds light on the future of § 230’s protection against marketing liabilities. The legislative history and case law suggest litigation strategies that are likely to be effective for plaintiff consumers and defendant website hosts and auction houses. Because recent cases show that courts may shield ISPs and forum websites for some actions but not others under the CDA, [19] the CDA succeeds to some extent in balancing consumer’s and ISP’s needs on the Internet. However, Internet commerce needs additional solutions to protect consumers while at the same time fostering the growth of the virtual market. This paper discusses some strategies for balancing consumer and ISP interests, through both governmental and private regulation….


Amy J. Tindell

July 19 / All Articles, Computing, Copyright

The Unlitigated Case: A Study of The Legality of Guitar Tablatures

Abstract–Guitar tablature Web sites have been the subject of recent cease-and-desist letters, forcing most to shut down. Litigation has been side-stepped with the arrival of new creative means to continue operation. The case that may have gone to court is discussed here, ranging from the appropriate legal claims of copyright infringement to the fair-use-defense arguments that would have been made. Policy solutions are considered to resolve the tension between the public’s desire to use such tablatures and the copyright owners of the original artists.


“An attack on this website is really an attack on every one of you who have told someone (in person, or via the written word, telephone, or e-mail) how you play a song on guitar. And who, especially among small websites, has the deep pockets to fight the NMPA/MPA?” [1]


I. Introduction


Rob Balch may consider himself to be a facilitator of online music education, but others consider him to be a copyright infringer. [2] Balch ran Guitar Tab Universe, an online repository of guitar tablature, an annotation system that reduces to simple text how to play songs. The text represents the fingerings a guitarist may use to play a song. Figure 1 below is an example of such a tablature, or “tabs” as they are also known as.


The text is easily written and displayed using typewritten characters and can be posted online, downloaded and printed with ease. These tabs most often only have one part of the song–for instance, the guitar solo, the bass part, or the chorus. The user commonly looks for the tabs of a song that he already has heard or has a recording of; and using the tabs as a guide, he is able to reconstruct the playing of the song in an approximate form.


Balch started the site in 1999 while he was in college and learning how to play guitar. Eventually the site averaged 360,000 unique visitors per month. The advertising revenue he generated was enough to cover the costs of running the site. [4] In early 2006, the Music Publishers’ Association and the National Music Publishers’ Association sent cease-and-desist letters to several large sites, including OLGA.net and MxTabs as well as Guitar Tab Universe. Many acquiesced and closed down. [5] Site owners cited problems with finding legal resources to fight the court action as well as difficulties their internet service providers faced themselves from threatened action. [6] Meanwhile, in March of 2007, MusicNotes, an online music publisher, and the Harry Fox Agency, which represents 31,000 music publishers, reached an agreement to create a new online repository that had the blessing of the music industry. [7] The new site is the reincarnation of a formerly popular tab site, MxTabs, [8] which is owned by MusicNotes. [9] Using advertising revenue generated by the site, money is split between MusicNotes and the Harry Fox Agency as well as the copyright holders of the songs on the Web site. [10] Thus, litigation was, at least temporarily, avoided. However, the threat still looms. The age-old tension between rewarding artists while recognizing fair uses of their works by musicians and tabbers [11] continues to simmer beneath the surface.


This Note considers the case that may have been litigated. What would have happened if sites such as Balch’s or MxTabs decided not to give in? Would there have been viable claims of copyright infringement? Would the guitar tablature Web sites have been able to fend off the suits? This hypothetical lawsuit would address the novel question of copyright interests and guitar tablatures. In some ways tabs have analogs to existing and established creative works, but in other ways they represent a new idea in the burgeoning digital age. The next section looks at the first step in any copyright litigation, asking whether there is a viable claim of copyright infringement followed up with a section on the defense to such a claim, known as the fair use doctrine. Concluding that there is sufficient gray area that suggests that either or both interests may prevail, suggestions to resolve the conflict are proposed….


James T. Tsai [1]

July 5 / All Articles, Patent

Rounding Up Plant Patents & Other Growing Patent Concerns a Comment on Monsanto v. Schmeiser

On the heels of their ubiquitous and controversial decision in Harvard College v. Canada (Commissioner of Patents) (the so-called ‘Harvard Mouse’ case), [1] the Canadian Courts were soon asked to re-consider the issues surrounding the patentability of biotechnological inventions in Monsanto v. Schmeiser. [2] Unlike Harvard Mouse, this matter was an infringement action. At the Trial Division, the crux of the action lay with Schmeiser’s alleged failure to obtain a license Monsanto’s patented [3] “Roundup Ready Canola” (a canola seed tolerant of glyphosate herbicides including Monsanto’s own “Roundup”). [4]


“The infringement alleged is by the defendants using, reproducing and creating genes, cells and canola seeds and plants containing genes and cells claimed in the plaintiffs’ patent, and by selling the canola seed they harvested, all without the consent or licence of the plaintiffs.” [5]…



Emir A. C. Mohammed

January 21 / All Articles, Computing, Patent

Can An Internet Reference Be A “Printed Publication”?

Much of the information to the public is provided by the Internet today. The Internet has also become increasingly popular among researchers who now turn to it for articles, journals, and online databases. [2] Therefore, the question of whether an Internet reference is a “printed publication” is critical for today’s inventors, patent attorneys, and judges. [3] It is important for inventors and patent attorneys because they decide whether to pursue a patent based on the existing prior art. [4] It is likewise important for judges because judges may be asked to resolve a dispute where the party challenging a patent’s validity offers an Internet reference as the potentially invalidating prior art. [5]

This Article argues that an Internet reference is a “printed publication” within the terms of Section 102 if it is accessible to the public and credible. This Article begins with a brief review of the “printed publication” requirement of Section 102. Next, it discusses two different theories that emerged interpreting the “printed publication” bar to patentability, focusing, in particular, on the impact of technological advancement on judicial interpretations of § 102. The Article then explores existing commentary on the matter and argues that while the commentaries address many crucial aspects of the statutory bar, they may nevertheless be insufficient in defining whether an Internet reference is a “printed publication.” The article continues by recommending that a “printed publication” requires both public accessibility and credibility. Accessibility should be dependent on the author’s or inventor’s intent to share his work with the public. Moreover, the Federal Rules of Evidence may be used to ensure the integrity of a reference. Lastly, the article analyzes the unanswered question in MercExchange v. eBay of whether a newsgroup posting is a “printed publication” within the terms of §102. [6] The article concludes that the newsgroup posting in MercExchange was not a “printed publication” because it was not publicly accessible; however, newsgroup postings could be “printed publications” if certain other requirements are met. [7]…


Joanna Toke [1]

January 1 / All Articles, Patent

Utility Models and Their Comparison with Patents and Implications For The US Intellectual Property Law System

Abstract–European Patent Office (EPO) practice, guided by the European Patent Convention (EPC) is in many aspects very similar to Europe’s national patent practice, such as the German patent law. In this article, the US practitioner is briefly reminded of some of the considerable differences between US Patent and Trademark Office (USPTO) patent prosecution practice and its European counterparts, primarily the EPO. The utility model is highlighted and discussed using the patent laws of Germany as a case study for comparison. Additionally, this paper examines the potential benefits of utility model protection in the US, as well as what changes would be required in order to minimize any negative impact of the introduction of such a new intellectual property (IP) right to the existing US legal system.




USPTO and EPO patent prosecution practices differ in several respects. For example, a patent application to the EPO goes through a centralized application and prosecution phase, and, if granted by the EPO, this patent has the same effect as a national patent granted by all contracting states. Therefore a European patent (EP) is subject not only to the national law of the individual member states but also to the provisions of the EPC. During centralized prosecution at the EPO, patent claims are generally amended more easily than in the US, and without significant negative consequence. Finally, one of the more notable differences is that an EP application may be subject also to a centralized inter-parties opposition process at the EPO in which it may be granted in either its original or amended form or revoked.


Another important difference is that the USPTO has a “first to invent” system whereas the EPO is a “first to file” system. Thus, the earliest applicant may obtain an EP even if the invention was first invented or conceived of by another party. Also, an inventor has the right to be named on an EP application, but–in contrast to the US–the inventor on an EP application has the right to decline being named as an inventor on the patent application. In addition, and most importantly, incorrect naming of the inventor will not jeopardize the validity of the EP.


Also in contrast to US patent law, EP applications are required to have “absolute novelty.” For the purposes of the EP application, if the invention was known, described in a printed publication, or publicly used anywhere prior to the priority date of the EP application, novelty of the invention is destroyed. Thus the concept of a grace period is not known in Europe, generally, with the exception of a six-month grace period in extremely rare cases related to certain exhibitions or instances of evident abuse. Novelty of an EP application is destroyed also if the invention has been described in another EP application with an earlier priority date–even if it was not published before the priority date of the application under examination. However, even where such “special” prior art does carry an earlier priority date, it cannot be used for evaluating non-obviousness (inventive step) in the prosecution of an EP application.


The hurdle to demonstrate inventive step is often higher in EP practice. EPO examiners have never been under an obligation to demonstrate a prima facie case, for example, and they are able to base their arguments on what is generally known to one skilled in the art more than their US counterparts. Another key difference is that it is expected that inventive step in EPO practice will be argued on the basis of the “problem solution approach”, which consists of determining (1) the closest prior art, (2) the technical problem which the claimed invention addresses and solves in light of the closest prior art (the objective technical problem), and (3) examining whether the claimed solution to the objective technical problem is obvious to the skilled person in view of the state of the art in general. [i]


Furthermore, there is no requirement to specifically disclose a “best mode” in an EP application; an enabling mode is sufficient. Also, applicants for an EP are not under any requirement to disclose known prior art or evidence relevant to the patentability of an application to the EPO together with the application or later during its prosecution.


It is worth noting, finally, that European prosecution history estoppel has been a matter for national law rather than one for the EPO. With fairly limited exceptions, prosecution history estoppel does not exist in the member states of the EPO.


Dr. Hans-Peter Brack [a1]

January 1 / All Articles, Computing

The Edge of Ethics in Iparadigms

Abstract–In an attempt to stem a perceived rise in student plagiarism, educational institutions are increasingly turning to anti-plagiarism technologies. The use of these technological means to police student writings has been controversial, socially, politically, and legally. This article discusses the outcome of A.V. et al. v. iParadigms, to date the most important opinion on the legality of such technology’s use. The author examines the case in detail and presents arguments against the technology’s use, on the grounds that such use undermines educational policy by allowing the ethics of teachers to become a by-product of available technological means and by contributing to a detrimental framing of students as criminals.


Some especially tony colleges, such as Harvard, do not subscribe to Turnitin or other plagiarism-detection software services but prefer to preach to their students about the evils of plagiarism. These schools are naïve. [2]


Let’s be serious. [3]


One can hardly spend a nanosecond within the walls of academia without hearing tell of the epidemic of student plagiarism. [4] While empirical evidence of an epidemic may remain wanting, it is clear that a collective perception of crisis has taken hold in educational circles. [5] A noteworthy reaction to this perception of escalating plagiarism has been the academic embrace of commercial anti-plagiarism systems. This article is an examination of a recent ruling, A.V. et al. v. iParadigms, [6] stemming from this embrace. In section I, I sketch the context for that legal controversy that foregrounds its entangled technological and social aspects. [7] Sections II-V comprise a discussion of the case’s facts, and the case’s rulings in the area of contract law and copyright law. A speculative exploration of the possible pitfalls of too quickly embracing the plagiarism epidemic mood along with the technological fixes subsequently touted as its solution constitute sections VI and VII….


Michael G Bennett [1]