Developers of gene and cell therapy products should tread carefully due to potential exposure to patent infringement suits. The assumption that a legal safe harbor provides broad protection is being proven incorrect by recent case law. Not all preapproval uses of patented technology are necessarily guarded under this protection.
According to Natasha Daughtrey and Joshua Weinger at Goodwin, cell therapy companies must be acutely aware of the limits of patent safe harbors. As of June 2023, more than 3,500 advanced genetic therapies are under active development, each potentially vulnerable to legal scrutiny.
An informed review of patent law and a thorough understanding of the nuances within legal safe harbors is crucial for these companies. It can help in avoiding expensive and time-consuming litigation while ensuring compliance to intellectual property rights. This is a vital component of the pathway to commercialization for gene and cell therapy products.
As the field evolves and the number of advanced genetic therapies increases, the onus will be on companies not just to innovate, but also to navigate the complex terrain of patent law. For this, they should contemplate seeking patent counsel to delineate the scope of protection available and mitigate the risk of infringement suits.
For a detailed understanding of the caveats associated with patent law and how they have affected cell therapy companies, consider reading the expert analysis by Natasha Daughtrey and Joshua Weinger posted on Law360.