Research tools, cell lines, and other techniques, many of which are patented and useful for products or therapies under development, are different. When a third-party patent issue is raised with respect to such patented technology, many partners develop products or treatments to support the FDA’s application for biopharmaceutical approval (BLA). I dismiss the concern because it is being patented. Therefore, it is not affected by infringement proceedings under the Development Safe Harbor.
In fact, in the United States, 35 USC § 271 (e) (1) expressly expresses certain infringements as long as they are carried out solely for the purpose of use reasonably relevant to the development and submission of information under federal law. Exempted. Those that regulate the manufacture, use, or sale of pharmaceutical or biological products.
Similar exemptions exist under the laws of many other jurisdictions. Historically, this safe port, also known as the “Bolar exemption,” has been widely interpreted in the United States. However, as recent procedural law shows, there are patented research tools such as cultured host cells that help manufacture gene therapy. Products or fluorescent proteins – by themselves are not subject to FDA premarket approval, so safe harbors may not apply.
With the availability of additional patented research tools, it becomes wise for CTGT product developers to include potential development techniques as part of their analysis of future operational freedoms. Development collaboration arrangements also require companies to ensure that the partners engaged in development work have the appropriate licenses to carry out such development activities.
This article is the fifth in the 2022 series “Trends in Cell, Tissue, and Gene Therapy” and is constantly informed about the various legal and regulatory issues that affect companies doing business in the field of regenerative medicine. The purpose is to do. From clinical research to patenting to manufacturing scale-up, our global team discusses new issues that arise in all parts of the world, including CTGT companies’ unique transactions, litigation, and testing concerns.