BACKGROUND: Evidence suggests that gut flora may play an important role in the pathophysiology of the irritable bowel syndrome (IBS). We evaluated rifaximin, a minimally absorbed antibiotic, as treatment for IBS.

METHODS: In two identically designed, phase 3, double-blind, placebo-controlled trials (TARGET 1 and TARGET 2), patients who had IBS without constipation were randomly assigned to either rifaximin at a dose of 550 mg or placebo, three times daily for 2 weeks, and were followed for an additional 10 weeks. The primary end point, the proportion of patients who had adequate relief of global IBS symptoms, and the key secondary end point, the proportion of patients who had adequate relief of IBS-related bloating, were assessed weekly. Adequate relief was defined as self-reported relief of symptoms for at least 2 of the first 4 weeks after treatment. Other secondary end points included the percentage of patients who had a response to treatment as assessed by daily self-ratings of global IBS symptoms and individual symptoms of bloating, abdominal pain, and stool consistency during the 4 weeks after treatment and during the entire 3 months of the study.

RESULTS: Significantly more patients in the rifaximin group than in the placebo group had adequate relief of global IBS symptoms during the first 4 weeks after treatment (40.8% vs. 31.2%, P=0.01, in TARGET 1; 40.6% vs. 32.2%, P=0.03, in TARGET 2; 40.7% vs. 31.7%, P<0.001, in the two studies combined). Similarly, more patients in the rifaximin group than in the placebo group had adequate relief of bloating (39.5% vs. 28.7%, P=0.005, in TARGET 1; 41.0% vs. 31.9%, P=0.02, in TARGET 2; 40.2% vs. 30.3%, P<0.001, in the two studies combined). In addition, significantly more patients in the rifaximin group had a response to treatment as assessed by daily ratings of IBS symptoms, bloating, abdominal pain, and stool consistency. The incidence of adverse events was similar in the two groups.

CONCLUSIONS: Among patients who had IBS without constipation, treatment with rifaximin for 2 weeks provided significant relief of IBS symptoms, bloating, abdominal pain, and loose or watery stools. (Funded by Salix Pharmaceuticals; ClinicalTrials.gov numbers, NCT00731679 and NCT00724126.).

This paper provides an understanding of the current copyright laws regarding software licensing in the United States and Europe. The concept of copyright under both the U.S. and EU legal regimes is to convey on the copyright owners the exclusive right to distribute their copyrighted software. In case of sales transactions, that right is expressly limited to statutory copyright law.

Sections 109 and 117 of the U.S. Copyright Act are the respective core provisions to apply to software transactions. It is not an infringement for the owner of a copy of a work obtained at an authorized sale to sell or otherwise dispose of the possession of that copy. In addition, the owner of a copy of a computer program may, inter alia, create another copy of that program provided that the copy is made either as an essential step in the utilization of the computer program in conjunction with a machine and that it is used in no other manner, or for archival or back-up purposes. Under U.S. case law the crucial question is whether a licensee of software can be deemed as an "owner" of a copy of the software and as such trigger the first sale immunities. The paper shows the different approaches taken by different courts on the so-called "sale versus license debate".

Article 4(c) of the Council Directive on the Legal Protection of Computer Programs ("EC Software Directive") contains the European version of the first sale doctrine, the Community exhaustion doctrine. The first sale of a copy of a computer program by the copyright owners or with their consent shall exhaust the distribution right of that copy within the European Communities (EC) or European Economic Area (EEA). Contrary to the sale versus license debate in U.S. case law, European courts—with no greater argument—deemed software licensees subject to exhaustion. The courts have been more concerned to apply the doctrine of exhaustion in a way as to further the implementation of the fundamental freedom of free movement of goods and services in the EC.

On the basis of a transatlantic copyright analysis the paper will discuss, in a second step, the existence of a digital first sale doctrine (as called in the United States) or digital Community exhaustion doctrine (as known under EC law). The paper debates whether the first sale/exhaustion privilege is to apply also in the event of online-transmissions of software, i.e., when no tangible data carrier embodying the target software changes hands. In today’s world, copies of copyrighted works, including software, are bought with increasing frequency by electronically downloading them through networks, mostly the Internet, with no tangible copy of the target software provided. However, digital transmissions of copyrighted works over the Internet fit neither comfortably within the narrow concepts of first sale nor exhaustion. In discussing whether online distribution of software shall render sections 109 and 117 of the U.S. Copyright Act or Article 4(c) of the EC Software Directive applicable, the paper concludes that in the absence of persuasive case law in either jurisdiction on this matter, U.S. governmental authorities tend to protect software copyright owners, whereas the existence of a digital Community exhaustion doctrine may be based on the ground of free movement of information.

This research was published as TTLF Working Paper No. 6 at
http://www.law.stanford.edu/program/centers/ttlf/#ttlf_working_papers.

Reaching everything from medicine to the food industry, biotechnology’s impact on society has become a major economic factor and is ever-increasing. In addition to its impressive potential benefits, biotechnology carries serious risks, especially regarding security and ethics. The European Patent Convention includes statutory restrictions regarding morality and public policy, while today’s U.S. laws in contrast, try to avoid morality restrictions in patenting biotechnology and U.S. agencies generally grant patents without regard to moral concerns. Not long ago, the U.S. Patent Act included a morality doctrine which had a restrictive effect on biotechnology.

The new U.S. approach applies to micro-organisms, plants, and animals where moral concerns were not considered at all before the United States Patent and Trademark Office. It is not clear, if the moral questions re-emerged referring to the Newman/Rifkin patent application, claiming an animal-human chimera, since the application was finally rejected on the grounds that human beings do not constitute statutory subject matter under 35 U.S.C. § 101. This line of argumentation was a break from the developed case law concerning living matter. The attempt to keep ethical concerns out of the U.S. patent laws stands on very shaky grounds.

Another problem arises from the fact that both patent systems, in Europe and the U.S., are relying on the term “human” as a borderline for patentability but none of them define the term “human” which leads to ambiguities. An interesting approach came up, defining a human being not by its biological criteria but rather by its intellectual capabilities. However, this approach is still in its infancy.

The project is co-sponsored by the Stanford-Vienna Transatlantic Technology Law Forum (TTLF, a joint initiative of Stanford Law School and the University of Vienna School of Law) and by Stanford University’s Forum on Contemporary Europe at the Freeman Spogli Institute for International Studies.