Abstract: The Biologics Price Competition and Innovation Act (BPCIA) was enacted by Congress in 2010 as part of the Affordable Care Act. The BPCIA was intended to help innovators and pharmaceutical drug developers by streamlining the regulation of biologics, much as the Hatch-Waxman Act of 1984 did with respect to small molecule generic drugs. Unlike the Hatch-Waxman Act however, which only covered small molecule generic drugs, the BPCIA regulates large molecule drugs with “no clinically meaningful difference” to the reference product. Biologics, under the BPCIA, are complex molecules such as viruses or therapeutic serums produced for the purpose of preventing, treating, or curing human diseases or conditions. In enacting the BPCIA, Congress sought to facilitate the development and marketing of biosimilars and increase competition amongst drug developers as well as provide a specific process for potential patent infringement claims. Biosimilars are biologics that are “highly similar” to a reference product with no clinically meaningful difference between the biosimilar and the reference product in terms of “safety, purity, and potency of the product.” Recognizing biosimilars as a separate class of products allows drug development companies to produce a drug that is clinically equivalent to a drug already patented and on the market, thus spurring innovation and competition between drug developers and pharmaceutical companies. Because the biosimilar has a reference drug, under the BPCIA, the developer of the biosimilar is able to use clinical data already collected for the reference drug and apply that data for approval from the FDA for their biosimilar. Since the biosimilar developer, referred to as a subsection (k) applicant in 42 USC § 262, does not have to compile its own clinical data regarding the safety, purity, and potency of its drug, the path towards FDA approval is consequently faster, more certain, and less expensive. However, as a result of this streamlined process, the BPCIA also raises issues involving patent infringement and patent litigation, as several cases have been filed primarily concerning the interpretation of the BPCIA and its specific biosimilar approval process requirements.
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Abstract: Social media is now a widely accepted and important medium of evidence in court. Yet Snapchat, a new and popular image messaging app among the youngest generation of smartphone users threatens to upend the field of social media evidence. Snapchat is unique among social media platforms because it functions to avoid permanence. Such is the appeal to today’s teenagers: a normal “snap” (a picture or video captured through the app) can only be viewed for a maximum of ten seconds before it deletes. Users may also choose to upload a snap to their “Story,” which posts the picture or video for all their contacts to view multiple times within a twenty-four hour period. The deleting function unique to Snapchat presents inherent difficulty in saving images taken through the app. In fact, recipients of snaps are left with only one method of saving the images they see: the “screenshot.” A screenshot is a smartphone function not related to Snapchat which captures what the viewer sees on their phone screen at that moment and can be saved. While it has been these screenshots which have allowed Snapchat to enter the world of admissible evidence, it is now use of the app itself as evidence which have signaled courts’ acceptance of Snapchat and its greater value to justice in the near future.
Abstract: As the highest grossing sports league in the world, the National Football League (NFL) operates with expansive and unprecedented reach. Each Super Bowl broadcast from 2010 to 2016 ranks as one of the seven most viewed programs in American television history and Sunday Night Football was the most watched weekly program in four of the past five years. Unsurprisingly, the NFL is intent on protecting their immensely popular product through aggressive intellectual property protections, though few are as pervasive as the telecast warning that accompanies every NFL game: “This telecast is copyrighted by NFL Productions for the private use of our audience. Any other use of this telecast or any pictures, descriptions, or accounts of the game without the NFL’s consent is prohibited.” Does the NFL’s copyright warning truly preclude fans from talking about a game with coworkers or from posting about it on their social media pages? How far does it extend? Given recent coverage by outlets such as ESPN in October 2016, there are indications that the NFL’s aggressive copyright tactics extend to its franchise teams as well. According to sourced league memoranda, the NFL has prohibited its Member Clubs from shooting or streaming video inside the stadium during a game and posting it on any form of social media, punishable by an initial fine of $25,000 and up to $100,000 for additional offenses.6 Further, teams are prohibited from taking video from broadcasts and creating their own highlights or moving images, including Graphics Interchange Format images (popularly known as GIFs). Essentially, the NFL has severely limited a Member Club’s ability to use media content its organization had an essential role in creating and, debatably, authoring.
Abstract: The idiosyncrasy of the Internet often invites colorful analogies in its description: high seas and piracy, Wild West and lawless frontier. This is not undeserved; despite great strides over the course of its development, the Internet remains unexamined and unregulated in many ways, and the regulations that do exist are largely self-governed. Copyright law in particular has proven contentious for lawmakers who are forced to balance digital rights management on a massive scale with the rights of end users. Nowhere is this conflict more apparent than in the practices of the video-sharing juggernaut YouTube.
Abstract: Drug manufacturers often spend millions on research and development for drugs that never make it to market. As a result, manufacturers need to recoup these R&D costs in th
e sale of drugs that do make it to market. They often rely on the patent system, and the exclusivity it provides, to accomplish that recoupment. Drug manufacturers have turned to reverse payment settlements to extend that exclusivity and generate higher profits from a particular drug. Reverse payment settlements arise in the context of generic drugs. A patentee will offer to pay a generic manufacturer, an alleged infringer, to delay the release of the generic drug to the market. The payment is a purchase by the patentee to continue its exclusive right to sell its product; a right it already holds by virtue of the patent. For this reason, the practice is suspect of antitrust violations. In Federal Trade Commission v. Actavis, Inc., the Federal Trade Commission (FTC) filed a complaint alleging that reverse settlement payments were unfair restraints of trade and therefore violated federal antitrust laws. The Supreme Court held that reverse payment settlements in patent infringement litigation are not presumptively unlawful but can sometimes violate antitrust laws, to be determined on a case-by-case basis.The settlements are not immune from antitrust attack even if the agreement’s anticompetitive effects fell within the scope of the exclusionary potential of the patent.
Abstract: Globalization has produced many benefits for United States corporations, but a significant detraction has been the emergence of trade secret theft. As technology advances, trade secret theft has become an even more persistent threat in the general marketplace. There are various ways trade secret theft can occur, but it is increasingly common for the theft to involve cyberspace, especially as these corporations expand into foreign markets. Consequently, Congress has taken a significant interest in curbing trade secret theft, as is evidenced by the various proposals before them today. These proposals offer varying solutions to trade secret theft, which range from creating a private cause of action in federal courts to specifically targeting foreign entities and governments engaged in cyber espionage, such as China. Before analyzing a number of current proposals, it is necessary to define trade secrets and understand their current legal status in the intellectual property landscape.
Abstract: Under 35 U.S.C §101, a patent must be either a new and useful process, machine, manufacture, or composition of matter and, thus, must not lay claim to any idea that isabstract. This abstraction can be increasingly difficult to eliminate when drafting software claims because the implementation of code onto a generic computer is somewhat abstract in nature. Areas of software that are, and are not, abstract have been hotly debated and a thorn in the side of court system. Hence, when Justice Thomas opined that the Supreme Court “need not labor to delimit the precise contours of the ‘abstract ideas’ category” in Alice Corp. Pty. Ltd. v. CLS Bank Intern., he must have realized that abstaining from such a seminal issue would create ripples, if not waves, within the already confusing realm of software patents. Almost two years later, the United States Patent and Trademark Office (“USPTO”) and the Federal Circuit are still failing to distinguish a bright-line rule for such a vague category, and, therefore, the concept of an abstract idea is still an issue. If this is not resolved quickly and clearly through the Federal Circuit or Supreme Court, or even through a legislative action by Congress, software patents will assuredly diminish in number and patent persecutors will continue to draft with uncertainty.
Abstract: The brackets have finally been released for the annual NCAA Men’s Basketball Championship, commonly called March Madness. The term “March Madness” evokes images of massive upsets, busted brackets, and sounds like the buzzer and Bill Raftery’s voice. “March Madness” is just one example of a sports event that truly owns a time of the year and a name that fosters a powerful resonance in American culture. Other examples include Monday Night Football, Sunday Night Football, and Super Bowl Sunday.
The Boston Athletic Association (BAA) thought that “Marathon Monday” was a unique day and term that specifically referred to the Boston Marathon. In late October 2015, however, the U.S. Patent and Trademark Office’s Trial and Appeal Board (TTAB) ruled that “Marathon Monday” does not point “uniquely and unmistakably” to the BAA. The TTAB was correct in denying the trademark, because Marathon Monday is not an event that is specifically associated with the Boston Marathon. Beginning in the 1970’s, marathons have become incredibly popular throughout the United States, and that meant that there was a high probability that the term “Marathon Monday” would be used in many different ways. The BAA should have attempted to trademark the term in the 1970’s, because now the Disney Marathon and New York Marathon both use the term “Marathon Monday.”
Abstract: Spotify launched in 2008 into a new music streaming market that was revolutionizing the way that consumers listened to and purchased music. The primary attraction of streaming services is the access to a vast number of songs, often for a flat fee or even free. While these new streaming platforms have helped contribute to a decline in piracy and rising profits in the music industry , it also may be causing song writers to lose money. Spotify’s compensation model pays out royalties to the record labels, which then compensate the artists and performers. However, Spotify cites the record labels as the reason that artists are not getting paid, but that explanation glosses over whether or not Spotify has infringed upon the copyrights by streaming songs that the company does not have the license to. The streaming service is currently facing the threat of two class action lawsuits that allege that their payment model infringes song writers’ copyrights. The two questions, here, are: Has Spotify infringed upon the copyrights of owners of works that the service streams? Will a class action suit be the remedy for infringement, if infringement can be shown?
Abstract: When new technology arises, lawmakers struggle to keep up: how do I perform the balancing act of managing risk through regulation without stymying innovation. An ongoing struggle is the 3D printer and its copyright liability. 3D printers take a complicated manufacturing process and puts in our homes instead of a factory. The ease in which a person can create an object at home is an incredible feat, but it comes with consequences. Specifically, owners of copyrighted images are weary of their products being reproduced at home and sold in a secondary market. This article briefly describes the source of their concerns and reviews the copyright issues that arise in the world of 3D printing.