Tag: Austin Shaffer

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Copyright

Artist Roundtable Presented by the Mason Sports & Entertainment Law Association and the Arts & Entertainment Advocacy Clinic

The following post comes from Austin Shaffer, a 2L at Scalia Law and a Research Assistant at CPIP.

the word "copyright" typed on a typewriterBy Austin Shaffer

On April 6th, the Mason Sports & Entertainment Law Association, in conjunction with the Arts & Entertainment Advocacy Clinic, hosted its Artist Roundtable event. Moderated by Professor Sandra Aistars of Scalia Law, the panel featured musician and producer David Lowery, filmmaker and photographer Stacey Marbrey, and author and director David Newhoff. To kick off the event, Prof. Aistars invited each of the panelists to introduce themselves and highlight any ongoing projects.

About the Panelists

Stacey Marbrey is an award-winning film director, producer, and internationally recognized editorial photographer and has programmed numerous film festivals. Previously, she acted as Program Director for an international film exchange under the auspices of the U.S. Department of State in concert with both the President’s Committee on the Arts and Humanities and the American Film Institute.

David Lowery is an American guitarist, vocalist, songwriter, mathematician, and activist. He is the founder of alternative rock band Camper Van Beethoven and co-founder of the traditional rock band Cracker. Throughout his career in the music industry, Mr. Lowery has worked in nearly every role imaginable, from both the business and music perspectives. Recently, he worked on a small project with limited online CD sales to experiment with a new revenue stream and business model. Mr. Lowery frequently posts at the popular blog “The Trichordist.”

David Newhoff is a writer and copyright advocate. He recently finished his first book, Who Invented Oscar Wilde? The Photograph at the Center of Modern American Copyright. He lives in New York’s Hudson River Valley, where he is currently working on his next book. Mr. Newhoff also writes the popular copyright blog “The Illusion of More.”

How do creative roles intersect with legal issues? What can lawyers do a better job of understanding when engaging with creators?

Mr. Lowery highlighted the importance of the intersection between the arts and legal roles. Unfortunately, he noted, there is a stigma in the artistic community regarding the use of legal action. He commented that, while you should generally attempt to resolve disputes internally, you cannot be afraid to use the legal system to enforce your rights. Even the legally savvy artists can misjudge the scope of the rights to which they are entitled. Mr. Lowery emphasized the need to provide artists with an “intervention”: register your works with the Copyright Office, guarantee your revenue streams with the Mechanical Licensing Collective, and enforce your rights.

On a similar note, Mr. Newhoff echoed the notion that some artists do not fully appreciate the scope of their rights and––perhaps more importantly—their obligations. It is not uncommon, he explained, for creators to assume that their publisher will handle all the legal responsibilities that go into creating a work (i.e., clearing photographs, obtaining permission to publish interviews, etc.). That assumption, however, leaves the author subject to potential liability for copyright infringement. Rather than taking that risk, Mr. Newhoff argued, creators should be proactive in fulfilling their legal obligations. 

Commenting on Mr. Newhoff’s observations, Ms. Marbrey remarked that, in many cases, creators wear many different hats and serve in various roles throughout the course of creating a work. Particularly in the film industry, it can be difficult for creators to keep their various duties and obligations separated and organized. Ms. Marbrey argued that this is one problem that lawyers can help to solve. By taking the time to understand the numerous roles in which a single creator may serve, lawyers can help to ensure that creators are getting maximum value out of their efforts.

The Stigma Against Contracts

The panelists each made unique observations on the use of contracts and how their respective industries tend to perceive them. Prof. Aistars pointed out a concerning trend: creators tend to have a negative view towards contracts and consequently refrain from using them. She commented that, in general, no one wants to be the person to involve lawyers in otherwise “friendly deals.”

The panelists shared stories from their careers that demonstrated this stigma. Ms. Marbrey, for example, worked on a collaborative project involving multiple SAG actors. The parties declined to set up a contractual framework to properly address various SAG-AFTRA requirements for actors. Consequently, the production was later paused to renegotiate deals with the actors after the film was already completed. Due to this misstep, the release of the project was delayed.

The panelists concluded that, while it may force some uncomfortable conversations at the onset of a project, creators should become more liberal with their use of contracts. Doing so allows for a mutual understanding between all parties before any time is invested into the creative process.

Current Trends to Watch in Copyright Law

This portion of the discussion offered a unique insight into the development of copyright law from creators’ perspectives. While the conversation was wide-ranging, there were several common topics that the panelists found especially significant.

The panelists came to a consensus that the general agenda of weakening copyright law could cause devastating effects to the creative community. Mr. Newhoff pointed specifically to the ongoing work being done by the American Law Institute (ALI) on a potential Restatement of Copyright. He argued that broadly speaking, the academic world tends to take an anti-copyright law stance. The panelists agreed that this should generate concern from the creative community and that individual creators should strive to have their voices heard as this project continues.

In general, creators tend to have difficulties understanding the scope of fair use. Especially given the recent Supreme Court decision in Google v. Oracle, there is an element of amorphousness to the fair use doctrine. The panelists concurred that, without legal assistance, creators will likely continue to struggle in determining what constitutes fair use and what requires a license to use.

The event concluded with a discussion on how creators can adapt to and update with the digital age. As a threshold matter, Mr. Newhoff argued that it is hard to fit 20th-century copyright doctrine into the 21st-century landscape. Moving forward, some of the copyright laws may need to be updated (or at least monitored) to better facilitate the production of creative works. Optimistically, Ms. Marbrey noted that the “streaming takeover” is exciting for filmmakers. Although streaming can pose tricky and previously unconsidered issues surrounding copyright law, it offers a new way for creators to showcase their works and opens the door to innovative revenue streams.

Categories
Patent Law Patents Pharma

Professors Erika Lietzan and Kristina Acri on “Distorted Drug Patents”

The following post comes from Austin Shaffer, a 2L at Scalia Law and a Research Assistant at CPIP.

pharmaceuticalsBy Austin Shaffer

In their new paper, Distorted Drug Patents, CPIP Senior Scholar Erika Lietzan of Mizzou Law and Kristina Acri of Colorado College explore a paradox in our patent system: Innovators are less motivated to work on drugs that take more time to develop as drug research incentives are being skewed away from the harder problems (e.g., Alzheimer’s disease and interventions at the early stages of cancer). The paper, which was published in the Washington Law Review in late 2020, was supported in part by a CPIP Leonardo da Vinci Fellowship Research Grant.

Although many condemn later-issued drug patents as “insidious,” Profs. Lietzan and Acri argue that those conceptions should be recalibrated, since the use of such patents is fully consistent with the intent of Congress when the Patent Act was amended in 1984 to restore some of the patent term lost to premarket R&D and FDA review. While a few scholars have considered the implications of patent term restoration from an empirical perspective, none have done so to the same extent as Profs. Lietzan and Acri. By using an expansive dataset and including a temporal dimension in the analysis, the scholars offer a fresh assessment of patent restoration and its implications.

How Can Drug Patents be “Distorted”?

Drug research is notoriously risky—investors allocate massive amounts of time and money to a project without knowing whether the drug will succeed in trials or how long the trials could last. Even if trials are successful, the Public Health Service Act and the Federal Food, Drug, and Cosmetic Act require premarket approval of new drugs before they can be commercialized. Starting in the 1960s, federal regulatory requirements grew more demanding, and the FDA’s expectations became more rigorous to obtain premarket approval. Given that the FDA approves only finished products, not mere active moieties, drug research is not only expensive but also uncertain. While this process drags out, the clock on the patent continues to run. By the time all is said and done, the effective life of the patent is distorted, an unfortunate reality that further disincentivizes complex drug research. By the 1980s, Congress had addressed this problem by amending the Patent Act to allow entities to apply for patent term restoration.

35 U.S.C. § 156 authorizes the PTO to restore the life of a patent lost to clinical trials and FDA review. However, the PTO has restricted the practicality of these restorations, making them subject to stringent limitations. It restores only half of the testing period after patent issuance and caps restoration at five years, and the effective patent life post-restoration cannot exceed fourteen years. Additionally, the PTO must deny restoration if the FDA has already approved the active ingredient. Only one patent can be extended per regulatory review period, and patents can only be extended under Section 156 once. After a certain point, premarket R&D simply and unavoidably equates to lost patent life. But despite the limitations and restraints on this process, it is widely agreed that the 1984 amendment was a step in the right direction.

The value of patent restoration was complicated, however, by the Uruguay Round Agreements Act (URAA), which revised Section 154 of the Patent Act and altered the length of patent terms. To say the least, the relationship between the URAA extension and patent term restoration was initially muddled, particularly in the context of parent/child applications. Ultimately, it played out that drugs approved since the enactment of Section 156 have been protected by patents subject to three different regimes: (1) the pre-URAA regime, in which patents lasted for seventeen years from issuance; (2) the post-URAA regime, in which patents lasted for twenty years from application or parent application; and (3) the transition regime, in which patents lasted for twenty years post-application or seventeen years post-issuance, whichever came first.

Profs. Lietzan and Acri were motivated to delve deeper into the data behind patent restorations, operating under the hypotheses that longer R&D programs should distort drug patents (even after term restoration), and that restoring a child patent should be associated with longer final effective life if the patent is subject to the seventeen-year term (pre-URAA regime).

Testing the Hypotheses

Profs. Lietzan and Acri generated an unprecedented dataset containing information on 642 approved drugs for which part of the patent life was restored—every instance between the enactment of Section 156 and April 1, 2017. Regulatory information—such as the start of clinical trials, FDA approval date, the length of testing, and the length of the FDA review period—was collected for each drug. On the patent side, the dataset included, among other data points, the following information: (1) the date on which the inventor filed the patent application that led to issuance of the patent; (2) the date that would control calculation of a twenty-year patent term under current law; (3) the date on which the patent issued (or the date on which the original patent issued, in the case of a reissued patent); (4) the type of term the patent enjoyed (seventeen-year, twenty-year, or transitional); (5) the number of days restored by the PTO; and (6) the final patent expiry date after restoration.

The data analysis produced some interesting findings. The average effective patent life without restoration—meaning the time from FDA approval to the original expiration date of the patent—was 8.71 years (median 9.49 years). And while the average clinical development program was 6.04 years, the average amount of patent life restored was only 2.87 years. Seeking to dig deeper into the findings, Profs. Lietzan and Acri performed various regression analyses to assess which variables explain effective patent life before the award of patent term restoration. Thought-provoking graphs and tables are included in the Appendix of the paper for those interested in the data science aspect of the research.

Policy Implications

As expected, Profs. Lietzan and Acri found that our legal system not only distorts drug patents but also provides less effective patent life for drugs that take longer to develop. The current scheme further disincentivizes investors and inventors from undertaking critical drug research because of the associated costs and risks of doing so. By the time our government allows the patent owner to commercialize, much of the patent term has already lapsed. And while the 1984 amendment made positive progress to combat this issue by authorizing patent restoration, that power has not been used to its fullest extent. This means that cures and treatments for a wide range of diseases and illnesses are largely under-researched and under-developed.

To add to the quandary, the changes made in 1994 by the URAA mean that a drug company may need to select a later-issued original patent to achieve fourteen full years of effective patent life. These patents are arguably less valuable to the drug’s inventor because it may be possible for generic and biosimilar applicants to develop versions that satisfy regulatory requirements and yet do not infringe the patent. Policymakers have essentially nullified the original purpose of the 1984 amendment to the Patent Act without meaningful discussion of the implications for drug innovation.

In a society begging for more involved research into complex diseases that affect millions of people, such as Alzheimer’s and various cancers, the current setup of our patent system operates as a hindrance and a deterrent against innovation. The argument can be made that drugs requiring more premarket research and investment should receive longer effective patent lives, but at the very least, they should not receive less because of a burdensome regulatory scheme.

Patent life is essential to innovation in the pharmaceutical industry, perhaps more so than any other industry, and Congress recognized that notion by adopting Section 156 to the Patent Act. The fact that the PTO uses its promulgated authority so selectively, combined with further complications stemming from Congress’s changes to the way patent terms are calculated in 1994, leaves drug companies in a predicament. While some policymakers and scholars complain when those companies secure later-expiring patents, the extensive research and analysis by Profs. Lietzan and Acri suggest that those patents may be necessary to accomplish the intentions of the Congress with the 1984 amendment.