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...
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...
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,...
Rounding Up Plant Patents & Other Growing Patent Concerns a Comment on Monsanto v. Schmeiser
Emir A. C. Mohammed On the heels of their ubiquitous and controversial decision in Harvard College v. Canada (Commissioner of Patents) (the so-called ‘Harvard Mouse’ case), the Canadian Courts were soon asked to re-consider the issues surrounding the patentability of biotechnological inventions in Monsanto v. Schmeiser. 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 “Roundup Ready Canola” (a canola seed tolerant of glyphosate herbicides including Monsanto’s own “Roundup”). “The infringement alleged is by the defendants using, reproducing and creating genes,...
Can an Internet Reference Be a “Printed Publication”?
Joanna Toke 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. Therefore, the question of whether an Internet reference is a “printed publication” is critical for today’s inventors, patent attorneys, and judges. It is important for inventors and patent attorneys because they decide whether to pursue a patent based on the existing prior art. It is likewise important for judges because judges may be asked to resolve a dispute where the party challenging a patent’s validity...
Utility Models and Their Comparison with Patents and Implications for the US Intellectual Property Law System
Hans-Peter Brack 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...
Shopping for Expedient, Inexpensive & Predictable Patent Litigation
Kevin A. Meehan Intellectual property has experienced an explosion in recent decades as the value of American corporations has become increasingly reliant on intangible assets. This explosion is reflected in the massive increase in patents issued by the United States Patent and Trademark Office (“USPTO”) and the corresponding spike in patent litigation. Moreover, patent litigation has become a high stakes game that is time consuming and unpredictable. Faced with a system of patent litigation that most people agree is too expensive, too time-consuming, and too unpredictable, plaintiffs frequently attempt to capitalize on their virtually unencumbered choice of venue to shop...
Inequitable Results in Transnational Patent Infringement Liability: Closing the Method Loophole
Alejandro Valencia A set of recent patent infringement cases are primed to have major impacts and, some argue, inequitable effects on the current patent scheme in the United States. A problem has arisen concerning what kind of patent protection, or lack thereof, method and process patents should receive when certain steps of those methods or processes are implemented outside the U.S. Read literally, as the courts have, current law requires a method to have taken place in the U.S. for protection. But what results when a method or process patent is infringed partially in the U.S. and partially abroad? Should...
Was the FDA Exemption to Patent Infringement, 35 U.S.C. § 271(e)(1), Intended to Exempt a Pharmaceutical Manufacturer’s Activities in the Development of New Drugs?
Paul Wiegel Esq. The FDA exemption was not created to assist in the generation of new drug candidates, which are included in the broad interpretation of the “reasonably related” language by the Supreme Court in Merck. Applying the Supreme Court’s interpretation to the facts of Merck means that a pharmaceutical manufacturer may use the patented products and methods of another manufacturer to identify new drug candidates and not infringe. In fact there is almost no limit to what can be considered “reasonably related” to the development of information for submission to the FDA since a great deal of the research...