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CRISPR Technology and Patent Ownership

May 02, 2023

The expert panel convened at the 2023 Master in Law Annual Lecture explored patent disputes over CRISPR technology.

By Leanna Tilitei C’23

The 2023 Master in Law Annual Lecture featured a panel discussion around the legal disputes arising from patent ownership of CRISPR technology. Three leading experts in science and law joined the University of Pennsylvania Carey Law School community to discuss the groundbreaking tool that utilizes gene editing to correct genetic defects and prevent disease.

The panel, luminaries in their respective fields, included Dr. Kiran Musunuru ML’19, a geneticist and cardiologist at Penn’s Perelman School of Medicine; the Honorable Leonard P. Stark, a judge on the U.S. Court of Appeals for the Federal Circuit, which has national jurisdiction to hear appeals in patent cases, as well as an Adjunct Professor of Law at Penn Carey Law; and R. Polk Wagner, the Michael A. Fitts Professor of Law at Penn Carey Law and renowned intellectual property expert.

Each year, the Master in Law (ML) program invites distinguished scholars, jurists, or practitioners from law and other disciplines, usually with a connection to the ML program as faculty, students or alumni, to discuss an issue of global significance, showcasing the law’s intersectionality and impact across fields and in everyday life. The Annual Lecture is an opportunity for ML students and the broader Penn community to engage with leading figures across disciplines.

As a 2019 ML graduate, Musunuru shared that he was particularly excited to have been invited to speak during the annual lecture.

“You see a lot of initials after my name. I like going to school a little too much,” he said. “But I am extremely proud of the last two initials: ‘ML.’”

Before receiving his ML degree, Musunuru received his BSc from Harvard College in 1997, his PhD in Biomedical Sciences from Rockefeller University in 2003, his MD from Weill-Cornell Medicine in 2004, and his MPH from Johns Hopkins in 2009.

Musunuru began the lecture by providing an overview of CRISPR technology and his research. CRISPR is a gene editing technology that allows scientists to directly modify DNA sequences in cells. It has the potential to revolutionize medicine and agriculture by enabling scientists to cure genetic diseases and create genetically modified crops.

As a trained cardiologist, Musunuru specifically focused CRISPR’s potential to combat the effects of heart disease, the leading cause of death in America. While traditional treatments for heart disease can effectively manage symptoms, medications and surgeries often do not address the underlying genetic cause of the disease.

“The problem is that people don’t like to take medication, or they can’t afford it. If you track patients who have been hospitalized for certain heart conditions, a year after they leave the hospital, half of them are no longer taking their statins. Imagine that, instead of getting that prescription for a statin, patients get this one-time treatment before they leave the hospital that permanently reduces their cholesterol levels and protects them for the rest of their lives,” Musunuru said. “Then they never have to worry about their cholesterol again. That’s what I’d really like to see at hospitals like the hospital of the University of Pennsylvania.”

Musunuru’s research aims to do just that. He and his team use CRISPR to target and correct the specific genetic traits that cause heart disease, potentially curing the disease altogether. He described how Verve Therapeutics, a company for which he serves as Co-Founder and Senior Scientific Advisor, has already achieved success in animal models and has dosed its first human in its clinical trials in New Zealand. After Musunuru spoke, Wagner detailed the ongoing legal disputes surrounding the patent ownership of CRISPR technology. Wagner has written over 20 articles and has authored the book Patent Law: Concepts and Insights. He holds degrees from Stanford Law School, the University of Michigan, and the College of Charleston. Before joining Penn Carey Law faculty in 2000, he clerked for Judge Raymond C. Clevenger III of the U.S. Court of Appeals for the Federal Circuit.

Wagner shared that many in the scientific community credit the discovery of CRISPR to Jennifer Doudna of the University of California, Berkeley, and Emmanuelle Charpentier of the Max Planck Institute for Infection Biology in Berlin. Both won a Nobel Peace Prize for their research on CRISPR.

While Doudna and Charpentier filed a patent application for the technology in May 2012, a team led by Feng Zhang of the Broad Institute of MIT and Harvard filed another patent application for CRISPR seven months later. The Broad Institute was the first to receive the patent in 2014, leading to a legal battle over who should own the rights to the technology. The principal issue concerns whether Doudna and Charpentier’s group, known as the CVC group, was the first to invent CRISPR or whether Zhang’s team had made significant enough technological modifications to warrant a separate patent.

The changes to patent laws over time have complicated this legal battle even further. Until 2013, the United States followed a “first to invent” system, where the first party to invent the technology or product received priority in obtaining the patent. After 2013, the United States changed to a first-to-file system, where the first party to file for a patent gets priority in receiving the patent.

Since both patents were filed before 2013, the courts can choose which system they will follow in the CRISPR patent litigation. The decision may drastically change the outcome of the proceedings.

As of now, the Broad Institute appears victorious. The courts have widely upheld their initial patent and have determined that the Broad Institute has priority. Meanwhile, several of the CVC group’s patent applications remain pending. Dr. Musunuru’s Verve Therapeutics research team is licensed to utilize CRISPR technology from the Broad Institute.

Judge Stark has handled over 2,000 intellectual property cases, which comprise about half of his docket, and currently works on several patent dispute cases. Though unable to share the specifics of each case, Judge Stark described the pathways through which patent cases can reach the federal circuit.

“We get our patent cases in two ways: from the district courts or from the patent office. As we heard from the summary of the CRISPR litigation, it has principally been an interference proceeding, which is a proceeding within the patent office,” Judge Stark explained. “Ultimately, if a party is unhappy with the patent office’s handling of an interference, they can take an appeal which goes to the federal circuit.”

President Joe Biden nominated Judge Stark to serve in his current role as a judge on the Court of Appeals for the Federal Circuit in March 2022. He first became a U.S. District Court Judge in August 2010 after being nominated by President Barack Obama and confirmed by the U.S. Senate. Judge Stark then served as Chief Judge of the District of Delaware from July 2014 through June 2021 before joining the Federal Circuit bench. He also created and teaches courses on complex litigation and pharmaceutical patent litigation at Penn Carey Law and the George Washington University Law School.

Judge Stark holds a PhD in British Politics from the University of Oxford (Magdalen College) and a JD from Yale Law School. He also received his bachelor’s and master’s degrees from the University of Delaware.

Following the panel discussion, audience members engaged with the panelists in a lively and insightful Q&A session. Audience members who asked questions included law students as well as members of the bar and judiciary and the medical, scientific, and technology communities from Penn and beyond.

The topic of the Master in Law Annual Lecture varies from year to year focusing on cutting-edge issues at the intersection of law and another discipline, with significant societal implications. Past events have covered the Opioid Crisis, Regulation and Regulatory Authority During a Public Health Emergency, and the Presidential Impeachment Hearings.

Learn more about Penn Carey Law’s unique and unrivaled Master in Law program.