The European Union has been a leader in recent years when it comes to regulatory reform intended to protect individuals’ privacy, safety, and health. As Europe leads the way, regulators in the United States often follow suit on the federal or state level. The EU’s passage of the General Data Protection Regulation (GDPR), intended to protect personal data, is a prime example. Several years after GDPR enactment, California adopted a privacy rights statute of its own, the California Consumer Privacy Act (CCPA). Other states have since passed comprehensive consumer privacy laws, with similar proposals under consideration in many state legislatures. This progression should serve as a reminder for those in the United States to keep a watchful eye on European regulatory activity as a potential harbinger of things to come in the U.S.
Colin Cabral is the co-head of Proskauer’s Patent Litigation Group. Colin is an experienced litigator and trial lawyer specializing in complex intellectual property and contract disputes.
Colin represents pharmaceutical, private equity, biotech, and medical device companies in high-stakes commercial litigation in the life sciences industry. He also serves as lead counsel in patent and trade secret matters involving a wide range of technologies, including computer software, electronic devices, and consumer products.
Recently, Colin has tried multiple cases for pharmaceutical companies and investors in contract disputes arising out of unsuccessful drug development programs and the exercise of “commercially reasonable efforts.”
In 2017, Colin was named to Benchmark Litigation’s Under 40 Hotlist, which recognizes attorneys under the age of 40 who “have been deemed the most promising emerging talent in their respective litigation communities . . . by peers and clients.”
Previously, Colin served as in-house litigation counsel for a global life sciences company. He also served as a Special Assistant District Attorney in Dorchester, MA.
Colin volunteers as regular faculty for the National Institute for Trial Advocacy and the firm’s trial advocacy training program. He is Board Chairman of FreeFrom, a charitable organization that helps survivors of domestic violence achieve financial independence. He is also a former board member of the Legal Aid Foundation of Los Angeles (LAFLA).
Pharmaceutical drug development is expensive. One recent study estimates that the median cost to develop a new drug is $985 million, while the average is $1.3 billion. And those figures appear to be on the low end of a broad range. Others have estimated the average cost at approximately $2.5 to $3 billion, with costs increasing annually at a post-inflation rate of approximately 8.5%.
As we mentioned in the early days of the pandemic, COVID-19 has been accompanied by a rise in cyberattacks worldwide. At the same time, the global response to the pandemic has accelerated interest in the collection, analysis, and sharing of data – specifically, patient data – to address urgent issues, such as population management in hospitals, diagnoses and detection of medical conditions, and vaccine development, all through the use of artificial intelligence (AI) and machine learning. Typically, AIML churns through huge amounts of real world data to deliver useful results. This collection and use of that data, however, gives rise to legal and practical challenges. Numerous and increasingly strict regulations protect the personal information needed to feed AI solutions. The response has been to anonymize patient health data in time consuming and expensive processes (HIPAA alone requires the removal of 18 types of identifying information). But anonymization is not foolproof and, after stripping data of personally identifiable information, the remaining data may be of limited utility. This is where synthetic data comes in.
The Ensuring Innovation Act recently became law after passing in the Senate with unanimous, bipartisan support. According to one Senator, the intent of the legislation was to “close loopholes to prevent awarding market exclusivity to products that do not present true innovation and unduly delay cheaper generic from entering the market.” Is this much ado about nothing, or much to be concerned about?