Caught in the Middle: Reducing the Uncertainty Created by the FDA and the Patent System for Genetic Diagnostic Test Makers

Caught in the Middle: Reducing the Uncertainty Created by the FDA and the Patent System for Genetic Diagnostic Test Makers
The scientific complexity of genetic diagnostic testing produces test results which are often flawed or difficult to interpret. Therefore, increased regulation of these tests is necessary to protect consumers and encourage patient reliance. However, increased regulation is accompanied by increased costs for genetic diagnostic test makers. If such costs are increased with no opportunity for test makers to recoup their investments, the proposed regulations will reduce public access to these genetic tests, and will reduce future innovation in this field. In similar industries, manufacturers can recoup regulatory costs through intellectual property protection—using a patent to prevent competitors from bringing identical products to market. Unfortunately, the law is unclear as to whether genetic diagnostic tests fall within patentable subject matter. Here I suggest five changes that would alleviate consumer concerns while spurring further innovation in the genetic diagnostic test industry: (1) Increase labeling and genetic counseling requirements for direct-to-consumer tests; (2) Provide for statutory data exclusivity (rather than patent protection) for tests that require clinical studies for FDA approval; (3) Create mandatory maximum approval times for certain classes of genetic diagnostic tests to reduce the regulatory burden on manufacturers; (4) Require that manufacturers and regulatory agencies solicit complaints directly from consumers; and (5) Require minimal new regulation for purely software-based genetic diagnostic tests.

Ideas and the Public Domain: Revisiting INS v. AP in the Internet Age

Ideas and the Public Domain: Revisiting INS v. AP in the Internet Age
The integration of the Internet into all aspects of society has led to the quick and widespread distribution of information in digital form. This digital information can be easily aggregated and redistributed by third parties. Such information aggregators can free ride on the work of others. For example, Google News collects links to news stories from other news outlets. Blogs, Facebook, Twitter and other social media also enable redistribution of news stories and other information. Newspapers, wire services and other news creators and providers have voiced concern that such free riding allows aggregators to benefit from the work of enterprises that create news media without having to pay any of the costs to obtain such news stories. It has been asserted that free riding is unfair and that it can economically injure or destroy such enterprises. These concerns are reminiscent of the 1918 Supreme Court decision in International News Service v. Associated Press, in which a news organization successfully enjoined a competitor from free riding on its efforts to obtain news stories. The underlying basis for the Court’s decision was a federal common law action for misappropriation. Although a subsequent Supreme Court decision negated federal common law some states adopted the misappropriation doctrine from International News Service under state unfair competition law. This doctrine has been asserted with limited success but courts continue to hold that the doctrine is viable under appropriate facts. This Article will critically examine the International News Service decision and subsequent judicial decisions relying on the misappropriation doctrine. It will argue that International News Service has been misunderstood and misapplied; and, that courts should unequivocally repudiate the doctrine as inconsistent with property law. Additionally, the commonly asserted rationales for the doctrine—preventing free riding and ruinous competition—are not legitimate. Instead, any common law action to protect ideas or information should only succeed, if at all, under existing contract and tort causes of action.

Not Your Father’s Domain Name: How gTLD Expansion Is Poised to Change the Way We Navigate the Internet

International domain-name overseer, ICANN, has been developing plans for the dramatic expansion of available g-TLDs, the .com’s and .gov’s currently so limited in variety that we have them all committed to muscle memory. Proposed regulations allowing for the creation of new dot.possibilities present intuitive marketing opportunities for companies interested in adding sophistication to their online presence. Andy Mcneil explores this potential and the legal challenges that ICANN’s costly and untested regulatory framework present in trademark protection and other strategic marketing competition.

“Term”inal Illness: Curing the Patent Term Using Empirical Analysis of Patent Globalization

As patent protection afforded outside the United States becomes increasingly lucrative, the time is ripe to consider recalibrating the duration of patent protection afforded within the United States. Wesley D. Markham takes an empirical approach to this policy-based issue. Specifically, he develops a new metric, the “global patent term” (GPT), and uses it to analyze the patenting strategies of three firms in three very different industries. Based on the results of these three case studies, he concludes that patent globalization is more lucrative in some industries than others. Accordingly, the United States should seriously consider technology-specific patent terms to ensure all firms receive appropriate incentives to innovate. This Article presents the key findings of Wesley D. Markham’s empirical study and is a condensed version of a longer paper reporting his research. The full paper is available at http://ssrn.com/abstract=1796030.

Is Facebook Killing Privacy Softly? The Impact of Facebook’s Default Privacy Settings on Online Privacy

Facebook has rapidly become one of the most dominant websites on the planet and now boasts over 600 million active user accounts. The site provides users with a platform through which they can share large amounts of personal information, but this functionality, by its very nature, involves an erosion of personal privacy. Facebook has significantly revised its privacy policy over its six-year existence, establishing more intrusive default settings and reducing user control. In light of these changes, Michael J. Kasdan argues that users and regulators alike must continue to monitor the conduct of social networking companies and carefully weigh the benefits of increased interconnectivity against the costs of reduced privacy.

“Adapting to the Realities of 21st Century Journalism”: Keith Olbermann and an Examination of Legal and Political Constraints in an Era of Partisan News Outlets

When NBC News suspended Keith Olbermann for donating to political campaigns and thus violating company policies, the news reporters became the news. The punditry tried to assess whether or not NBC’s decision to suspend their controversial commentator made sense from both journalistic and legal perspectives. Benjamin Kabak argues (i) that newsroom standards and practices codes do not graph accurately onto the demands of the partisan nature of television news commentary and (ii) that Keith Olbermann’s suspension, while likely a legal exercise of NBC’s powers, is highly problematic in the context of a news commentary program with a clear political bend.

You May Not “Like” This Title: Everything Stored on Facebook Is Discoverable

Facebook has revolutionized the way that people communicate and do business by providing an open and connected environment for individuals and businesses alike. This openness has largely contributed to both its popularity and success. However, enjoying the openness of this revolutionary platform may come at an unexpected cost, especially for those who do not understand how the website’s content may be used as evidence in a lawsuit. Darren Heitner demonstrates how content published on a person’s Facebook account may be discoverable for the purposes of litigation, even when the information sought is unavailable through Facebook’s privacy settings.

Patent Eligibility of Molecules: “Product of Nature” Doctrine After Myriad

In March 2010, the U.S. District Court in the Southern District of New York held in the Myriad case that patent claims directed to isolated DNA molecules were invalid under 35 U.S.C. § 101 for failing to claim patent-eligible subject matter, relying heavily on the so-called “product of nature” doctrine. Instead of a chronological order, this Note reviews the legal history of the “product of nature” doctrine in a brand new analytical framework, analyzing the application of the “product of nature” doctrine to relevant cases based on whether the claimed subject matter is an element, a molecule, or a microorganism. This Note then proposes an appropriate test for applying the doctrine to patent claims directed to molecules. Retroactive application of the proposed test to moleculeclaim case law would have yielded results consistent with the vast majority of relevant cases. Application of the proposed test to the DNA-molecule claims-insuit in Myriad leads to a legal conclusion that the claimed DNA molecules are patent-eligible, contrary to the conclusion of the Myriad court. This Note also makes an effort to address certain issues in the court’s opinion, and to provide some practical tips to patent practitioners in drafting DNA molecule claims.

What Are the Constitutional Limits on Awards of Statutory Damages?

Music piracy is a major problem in this country, robbing the economy of billions each year. Andrew Berger argues that, if piracy is to end, large verdicts of the kind awarded in Sony BMG Music Entertainment et al. v. Tenenbaum may be necessary. In Tenenbaum, the first file sharing case ever to reach an appellate court following trial, the court held that the jury’s statutory damages award violated the Due Process Clause, even though the award was within the statutory range set by Congress. Berger discusses the ways in which this decision could negatively impact copyright enforcement for years to come.

Substantial Disparity: Copyright Chaos in the Second Circuit

The test for substantial similarity is a doctrinal mess.  In response, recent commentators have called for the inclusion of expert testimony at this stage of an infringement analysis.  Graham Ballou, however, argues that judicial latitude in the framing of the inquiry is more responsible for jury confusion than a lack of expert witnesses.  After surveying three years of summary judgment opinions on substantial similarity from district courts in the Second Circuit, Ballou concludes that copyright law should discourage summary judgment on and de novo review of substantial similarity, therefore re-empowering the jury on the inherently subjective question of improper appropriation.