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Quarterly Journal 44-3

All documents are in PDF format* 

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Individual Articles (click the title to view the article):

How to Win Your Case When You Win It and When You Lose It: Strategies to Avoid the Impact of ITC Exclusion Orders
Members Only  
Mark Abate, Alexandra Valenti, & Marcia Sundeen
Facing an exclusion order from the International Trade Commission can seem an insurmountable obstacle. The prospect of a company’s product being excluded from importation into the U.S. is a severe remedy. But if your client is subjected to an exclusion order and comes to you with the question “what now?,” your answer need not be “nothing.” In reality, there are many avenues to explore in the face of this draconian penalty. This article will examine efficient and cost-effective strategies that can be employed to avoid the harsh impact of an exclusion order.

Addressing Dual-Use Technology in an Age of Bioterrorism: Patent Extensions to Inspire Companies Making Dual Use Technology to Create Accompanying Countermeasures  Members Only 
H. Rachael Million-Perez
This Article explores the intersection of national security and patent law, specifically incentives for countermeasure development. It narrowly focuses on the term “dual-use technology” – technology that, once created, can be simultaneously used for societal advancement or detriment, and thus requires countermeasures. Although the U.S. government has implemented countermeasure development incentives in the past, each fails to specifically stimulate dual-use technology countermeasure development. As a potential solution, this Article proposes a three-year patent-term extension in exchange for dual-use technology countermeasure development. This incentive is not offered to supplant current legislation; rather, it seeks to supplement legislation by addressing a specific, yet highly important, issue with a simple and practical solution.

Further Erosion of Patent Protection for Diagnostics: The Federal Circuit Denies En Banc Rehearing in Ariosa Diagnostics, Inc. v. Sequenom IncMembers Only 
Dr. Alice Martin, Ph.D., J.D., Dr. Kimberly Vines, Ph.D., J.D.
Both the district court held and the Federal Circuit affirmed that the patent claims at issue in Ariosa v. Sequenom were directed to patent ineligible subject matter under 35 U.S.C. § 101. Method claims directed to judicial exceptions (laws of nature, natural phenomena, and abstract ideas) are analyzed using a rigid framework as defined by the Supreme Court in Mayo v. Prometheus. The denials of Sequenom’s petition for an en banc rehearing by the Federal Circuit followed by the recent denial of Sequenom’s petition for a writ of certiorari by the Supreme Court insure that the current rigid Mayo framework will remain in force. This is despite the urgings from members of the Federal Circuit for the Supreme Court to clarify the Mayo test. This article discusses § 101 jurisprudence following the Myriad, Mayo, and Ariosa decisions and the detrimental effect it has had on the prosecution of patent applications directed to diagnostic inventions.

A Reasonable Approach to Reasonableness: A Proposal to Improve RAND Application in Patent Arbitration Proceedings  Members Only 
Matt Rosenberg & Jake Berdine
There has been a substantial amount of recent debate regarding the best approach for determining what is reasonable and non-discriminatory for the royalty rate of a patent that has been subjected to arbitration. One approach that courts have recently implemented in litigation is a modified version of the Georgia-Pacific factors. Another approach that scholars have suggested is to transfer the burden for establishing fee shifting to the losing party, such that the losing party must pay all fees unless its position was “reasonably justified in law and fact or that special circumstances make an award unjust.” This Article advocates for a hybrid of these two approaches that would increase the efficiency and effectiveness of arbitrators in resolving patent disputes by encouraging parties to agree that their arbitrators will apply a modified Georgia-Pacific analysis and incorporate reciprocal fee-shifting terms into their arbitration provisions. These changes will furnish a clear framework for determining an appropriate royalty and incentivize parties to settle their disputes. The proposed framework will also streamline arbitration resulting from prior dispute resolution agreements between the parties and aid compliance with Standard Setting Organization (SSO) requirements.

Student Notes

Using Patent Protection to Help the Least-Developed Countries Members Only 
Brenda G. Crabtree
When discussing patent protection at the international level, it is frequently assumed that people in Least Developed Countries (LDCs) are, and will continue to be, victims of these systems, especially with regards to issues such as affordable access to medicines. LDCs generally do not have the resources needed to establish robust patent systems of their own, but people are not limited to using the patent systems in their home countries. This article examines potential means by which people in LDCs may benefit from the international patent system and the systems of wealthy nations by analyzing three questions in the context of pharmaceutical patent protection: (1) whether patent protection can allow for affordable access to medicines; (2) whether it can promote economic growth; and (3) whether it can encourage domestic innovation in LDCs. The article concludes that people in LDCs can be empowered through use of the patent systems of developed nations to stimulate growth and innovation in their home countries.

Vaccines . . . Patent Eligible Now or No? An Assessment of the Patent Eligibility of an Ebola Vaccine in Light of Recent Supreme Court Decisions Members Only 
Nicole DeAbrantes
The sudden outbreak of the Ebola virus in several West African countries caused great concern for individuals around the world. Although several vaccines are in development, no vaccine has proved to be both effective and safe. This outbreak has raised concerns regarding the speed of vaccine development. The U.S. Center for Disease Control and Prevention (“CDC”) made a vaccine years ago and applied for a patent with the hope of making the vaccine available to the public. Patent protection for vaccines would incentivize private companies to invest more money in vaccine research. The USPTO’s recent Interim Guidance in the wake of Alice aims to clear up the confusion introduced by the Myriad guidelines for the patentability of nature-based products. Most importantly, the Interim Guidance establishes a “markedly different” characteristic – nature-based products are patent eligible if the product contains a markedly different characteristic from the naturally occurring counterpart. This note compares the Myriad guidelines to the Interim Guidance following Alice, arguing that Alice may establish an easier path to patentability for vaccines. This note also contains a case study focusing on the recent Ebola outbreak to illustrate how certain claims may be treated differently depending on the analysis being applied.