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.