By: Eddy Atallah
Since the inception of the Hatch-Waxman Amendments, the Food and Drug Administration’s (FDA) determination for three-year clinical investigations exclusivity was generally unquestioned. However, Braeburn v. FDA brought about significant interpretive challenges to the provision and questions about agency deference. This Blog considers the “double-edged sword” in trying to mitigate ambiguity within the Hatch-Waxman act. This Blog proposes a legal and scientific standard that should suffice the Court’s new requirement over the exclusivity determination process, a standard already firmly rooted in intellectual property law. Finally, this Blog also proposes changes to the FDA’s drug approval process which will help the agency fend off interpretive challenges.
Hopefully, with these suggestions, litigation surrounding this inherently ambiguous statute will diminish. But importantly, these suggestions hope to maintain the overall purpose of the three-year clinical investigation’s exclusivity provision; incentivize the development of new drugs, albeit in forms such as a new indication, a new route of administration, or new dosage forms, while still enabling the approval of lower-cost generic copies or competitive therapies.

By: Sam Hayes
The Supreme Court left the government edicts doctrine untouched for nearly 130 years until last year, when the Court revisited the doctrine in Georgia v. Public.Resource.Org, Inc. The central issue in Georgia v PRO concerned the copyrightability of the Official Code of Georgia Annotated, which included the text of every Georgia statute, as well as various non-binding annotations. The Court concluded that the Code’s annotations were not copyrightable because they were authored by legislators who have the authority to make the law. Particularly, although the annotations were drafted by a private company in a work-for-hire agreement with the Code Revision Commission, the Court nevertheless found that the Commission functioned as an arm of the Georgia Legislature. Despite the favorable judgment for the public, the standard developed by the Court, one in which the government edicts doctrine bars copyright protection based on authorship, remains too narrow to protect the public. It is unclear how the newly explained doctrine would apply in situations where works are authored by private parties, and then referenced or incorporated after the fact by lawmaking officials. Lower court decisions present two possible solutions for the Supreme Court to take in order to protect the public from this problem: (1) treating lawmaking officials as the authors of works that were produced by private parties when those lawmaking officials publicly incorporate them in their own works, or (2) adopt a case-by-case framework for when to consider lawmaking officials as authors of privately authored works on a case-by-case basis.

By: Raj Shah, Senior Regulatory Attorney & Policyholder Advisor, MagMutual Insurance Company & Nicholas Forsyth, Risk Intern, MagMutual Insurance Company

This blog involves data protection and privacy law and addresses the difference in outcomes of the Georgia Supreme Court case of Collins and the 11th Circuit case of Captiva. The work discusses whether Georgia law and the 11th Circuit have different pleading standards in a class action regarding negligence in a data breach. The work lays out the probable future implications these two court cases will have on healthcare organizations located within Georgia. The work offers our thoughts and opinions and related advice to healthcare organizations and their counsel on reducing the likelihood of a class action suit regarding negligence in a data breach.

By: Taylor Bussey

Internet memes are a unique derivative use of otherwise copyrightable content. In this blog post I will discuss whether or not protection matters. Given the nature of the internet—very fleeting content—and of intellectual property litigation—traditionally, painfully slow—does copyright of a meme even matter? I will include a law and economics analysis, using the Cosean placement-of-entitlement matrix, regarding whether the placement of the entitlement will ultimately affect bargaining amongst the parties. I conclude that the placement of the entitlement does not matter because of the weakness of the enforcement mechanisms against copyright infringement of this scale.

By: Tyler Dysart

The sports apparel market is plagued by counterfeit products that reproduce athletic teams’ trademarks at a fraction of the cost. This problem is catalyzed by exclusive licensing deals granted to manufacturers by sports teams, which drive up costs of these officially licensed goods and in turn forcing many consumers to go to black market websites to purchase apparel. This dichotomy is due to the unique nature of sports trademarks, whose purpose is not to inform consumers about the source of the good, but merely used to inform others about the consumers themselves – that they support a specific team. This is out of line with the modern policies behind trademark law, which is to protect consumers, not the manufacturers. Therefore, I propose a federal system that would regulate sports trademark licensing, making it available to all manufacturers at specified rates, thus lowering the costs of goods for consumers and squashing out the black market.

By: Marcus McGinnis

Within the twelve months prior to publication of this blog, changes to the Digital Millennium Copyright Act (the “DMCA”) enforcement protocols on Twitch have created an unsustainable environment for creators on the platform who are subject to a set of draconian pre-Web 2.0 laws that stifle content creation efforts through unfair copyright enforcement mechanisms. The issue lies mostly in how the DMCA incentivizes online service providers to “expeditiously” handle licensing issues. This approach has led to creator’s having to delete entire backlogs based on claims that would likely be considered fair use if actually looked into because it is the most efficient solution for the platform. This sort of deadweight loss is detrimental to platforms, creators, and audiences because the risk of demonetization or deletion after the fact may dissuade some creators and audiences from even investing in content creation efforts at all. In this blog post, I will explain how Twitch found itself in its current DMCA predicament, why its current proposed solution of mass backlog deletion is unsustainable, and why the platform should follow the approach of rival platforms and proactively utilize its vast resources to negotiate a more equitable, private contract solution with music license holders. Given the disparity in negotiating power between a platform the size of Twitch and individual creators, Twitch is better situated to take on the burdens of negotiating a music licensing solution on behalf of all of the creators who drive traffic to their site.

By: Baylee Carter

From “Narcos” to “Stranger Things”, Netflix has produced binge-worthy content. With the many shows, movies, and documentaries that Netflix brings to viewers, there have been increased allegations of copyright infringement. This blog post looks at several noteworthy copyright infringement cases Netflix has defended in the last few years in the United States. Content examined includes whether or not Netflix settled and what defenses were asserted if Netflix went to trial. Using the last few cases as a guide, I will examine what Netflix has learned from these past cases and then predict how Netflix content and defense strategies may change based on the outcomes of these requisite cases.

By: Mickey Tomlinson

This blog post addresses how important consumer surveys will be for “generic.com” owners because of the United States Supreme Court’s recent Booking.com BV v. USPTO decision. The Supreme Court held there is not a per se rule that automatically bars a “generic.com” from being trademarked, rather the consumer perception of the mark determines its eligibility for trademark registration. Booking.com presented evidence consumer surveys illustrating the fact that consumers associate “Booking.com” as a specific company that offers online hotel booking and accommodation services rather than as a class of goods or services. While the Supreme Court found Booking.com’s evidence persuasive, the dissent did not; Justice Breyer argued “generic.com” cannot receive trademark registration because (1) it violates traditional trademark law and (2) consumer surveys are not reliable. Ultimately, the Booking.com BV v. USPTO decision indicates consumer surveys are invaluable and will likely be offered early as evidence in the trademark registration process for similar “generic.com” marks.

By: Jake Shapiro

Artists have recently discussed the consequences of not owning their masters, which results in a lack of control of the music they created. This is the result of certain provisions in a recording agreement, and it is unlikely that these provisions go away despite efforts by artists to negotiate more favorable deals. This type of provision played a large role in a lawsuit where 50 Cent sued Rick Ross for Rick Ross’s sampling of a portion of 50 Cent’s “In Da Club” hit. Because 50 Cent’s recording agreement with Shady/Aftermath records left him without any copyright ownership in his masters, 50 Cent had to sue based on a state right-of-publicity theory since the record label had the exclusive right to enforce or not enforce the copyright ownership. The U.S. Court of Appeals for the Second Circuit affirmed the district court’s grant of summary judgment for Rick Ross under the doctrine of implied and express preemption as federal copyright law preempted 50 Cent’s state right-of-publicity claim in this case. I use this result to show provisions in a recording agreement can impact litigation. I then explain how artists should negotiate more favorable provisions to give them the right to sue when their record label decided to tolerate infringement and not take legal action.

By: Audrey Harris

Illegal streaming currently causes an estimated $29.2 billion annual loss to the United States’ economy. This economic loss to the economy prompted the passage of the Protecting Lawful Streaming Act (PLSA) on December 27, 2020. Prior to the passage of this law, the public performance of copyrighted material resulted in only misdemeanor liability, while the reproduction of copyrighted material resulted in felony liability, leading to what was known as the “streaming loophole.” The Protecting Lawful Streaming Act aims to close this streaming loophole by mandating that the public performance of copyrighted material will result in felony liability. This blog posting explores the economic implications that gave rise to the new law and the prior failed attempts to close the streaming loophole, while assessing potential repercussions of PLSA on the growing industry of DJs providing virtual concerts.