Dosage Patenting in Personalized Medicine
Jerry I-H Hsiao, PhD; Wei-Lin Wang, JSD Inventions for dosage regimens often arise after the pharmaceutical product has been dosed in patients and more information is known about the in vivo and pharmacokinetic properties of the medical agent. However, securing patent protection for this type of invention has been difficult because dosage inventions are considered to be simple medical methods whose protection is believed to limit doctors’ choices in clinical practice. Moreover, novel dosage inventions are also considered to involve a process that does not enjoy the same scope of patent protection as new chemical entities despite their superior therapeutic...
Digital Copyright, “Fair Access” and the Problem of DRM Misuse
Nicolo Zingales The advent of the digital age and the wide diffusion of copyrighted works over the Internet have brought about a drastic challenge to the pre-existing rules and legal standards governing the exchange of information. This article points out one of the ways the development of these new technologies has altered the boundaries of copyright, specifically by enabling copyright holders to strategically expand the scope of protection through the strategic use of Digital Rights Management (hereinafter, DRM). After a brief overview of these technologies and their contribution to the development of online markets for copyrighted works, the article discusses...
Geographical Indications: Which Way Should ASEAN Go?
Malobika Banerji “Geographical Indications‟ (hereafter GIs) under the Trade-Related Aspects of Intellectual Property Rights (hereafter TRIPS) has been the subject of vigorous scholarly debate across the world in the last decade. The TRIPS is the first multilateral text providing for a comprehensive protection of GIs. It provides for (a) a base-level protection for geographic indications related to all products; (b) an additional protection for wines and spirits; and (c) an extra-additional protection only for wines. The “extra-additional‟ protection accorded to wines has generated significant controversy and discussion. The TRIPS mandates the need to accord protection for each GI for wines...
Do Business Method Patents Encourage Innovation?
Rajnish Kumar Rai; Srinath Jagannathan Although the United States Patent and Trademark Office (“PTO”) had issued business method patents (“BMPs”) prior to 1999, the decisions of the United States Court of Appeals for the Federal Circuit (“Federal Circuit”) in State Street Bank & Trust Co. v. Signature Financial Group, Inc. in 1998 and AT&T Corp. v. Excel Communications, Inc. in 1999 led to a significant increase in the number of BMP applications filed with and granted by the PTO. Although grants of such patents have considerably stabilized in recent years, many policy issues raised by financial, electronic commerce and software...
Avoid the Rainy Day: Survey of U.S. Cloud Computing Caselaw
Fernando M. Pinguelo; Bradford W. Muller Cloud computing, a computer networking model that gives users on-demand access to shared software applications and data storage, is becoming increasingly popular among businesses and individuals. For example, if you use Google’s Gmail for your email and calendaring, or Snapfish for your online photo sharing and storage; or if your business remotely stores data with a third-party server provider like Salesforce, or uses Windows Azure to create and host web applications and services, you are already “floating in a cloud.” To provide guidance to those companies working within a cloud – or those considering...
Digital Sampling of Music and Copyrights: Is It Infringement, Fair Use, or Should We Just Flip a Coin?
Christopher C. Collie; Eric D. Gorman D.J. Girl Talk is one of the budding artists in the music industry today, and his instrument is a laptop. D.J. Girl Talk (hereinafter also referred to as “Girl Talk”), whose real name is Gregg Gillis, “samples,” or uses short clips, from other artists’ songs to create popular dance music. Girl Talk’s songs combine old, contemporary, and downright odd genres of music. Within these different genres, he samples from artists such as Clipse, Kelly Clarkson, and Hot Chip. At his live concerts, D.J. Girl Talk leads massive crowds who dance non-stop to his songs....
A Safe Bet? State Control of Internet Gambling
Scott L. Jones Gambling has been a part of American life longer than the Constitution. The first recorded instance of gambling in the English colonies occurred in 1620 with horse races in Virginia. Shortly thereafter came the first instance of government in America addressing the issue of gambling when in 1621 the Plymouth Colony placed restrictions on gambling in that colony. Ever since that time, gambling has been regulated at both the federal and state levels. With the advent of the Internet, gambling regulations that do not anticipate the use of online gambling are quickly becoming outdated. As individual citizens...
On Federal Preemption of Contractual First Sale Waivers
Gary Miller Congress is working with a very sensitive scale and it would be tough enough to keep things steady without copyright holders sneaking over and sticking a big toe on the edge every time they feel threatened. It is true that Congress (or at least some member or members of Congress) might have expected parties to contract around the first sale requirement, and of course, the copyright holders assert that, with the world changing too fast for the statute to keep up, therefore the big toe has been absolutely necessary for protection from looting, piracy and/or insolvency–in other words,...
Proveris v. Innovasystems: Redefining a Patented Invention Under § 271(E)(1): An Examination of the Federal Circuit’s Narrowing of the § 271(e)(1) “Safe Harbor” Exemption
Duane C. Marks By reducing the scope of “patented inventions” within § 271(e)(1) to only inventions comporting with the “perfect product fit” analysis, Proveris has drastically altered the function of § 271(e)(1) and potentially impairs the ability of generic manufactures to fully utilize the ANDA process created in Title I of the Act. Adherence to Proveris’ “perfect product fit” rule risks establishing loopholes that potentially allows patent holders of pioneer drugs and medical devices to delay generic manufacturers from bringing less expensive generics to the market. This Note critiques the Federal Circuit’s recent narrowing of § 271(e)(1) in Proveris. Part...
Patent Litigation: What About Qualification Standards for Court Appointed Experts?
Dolly Wu “The descriptions in patents are not addressed to the public generally, to lawyers or to judges, but, as [35 U.S.C.] section 112 states, to those skilled in the art to which the invention pertains.” This leads to a tenet of patent law, that the meaning of patents and claim terms must be construed by a person of ordinary skill in the relevant art (“POSA”). However, federal district court docket statistics show that for tasks such as claim construction, the “experts” hired by courts to aid the courts themselves may, in fact, not meet the POSA standard In contrast,...