By: Dr. Hadassa Waterman, Head of the Biotech Department, Ehrlich & Fenster of Ehrlich Group
Drug repurposing has been around for centuries. However, a recent report shows that in the last few years, Drug Repurposing, Repositioning and Rescue (DRPx) products are about 30% of the annual revenues of the entire pharma industry. This is a very interesting phenomenon. Pharma companies slowly realize that there is a market for what is referred to as “failed drugs”. The long and costly process of obtaining Food and Drug Administration (FDA) approval is not always a successful one. In the past, a lot of failed drugs ended up ultimately abandoned by pharmaceutical companies. Since the early 1990’s, the pharma industry discovered a cost effective way to find new therapies without going through the whole process of research, development and clinical trials. For example, repurposing a failed drug that has already established relative safety in phase 1 of the clinical trials can save a lot of time and money to pharma companies. DRPx products are not limited to failed patents. Drug repurposing can be done on live patents and drugs sold on the market, as well as on generic drugs.
So while Drug repurposing and DRPx products offer solutions to many industry’s problems, there are major issues with IP protection and regulations. Drug repurposing will always rely on a previously known drug. This makes obtaining a patent registration very challenging. According to 35 U.S.C. § 101, a repurposed drug may indeed be considered patentable subject matter provided its new use has not been published before. However, the eligibility of “use” patents varies between jurisdictions. While use patents are patentable in the US and Australia, for instance as “methods of treating”, and in other jurisdictions as well, e.g., Europe and China, such claims are excluded from patentability in other jurisdictions, e.g., India and Brazil. In the latter case, one can consider patenting novel formulations. Indeed, it is also quite a challenge for repurposed drugs which were known beforehand. With that said, there are still ways to overcome these obstacles in order to obtain protection for repurposed drugs and DRPx products. A mindful pre-planned approach to the prosecution of repurposed drugs and DRPx patents can really go a long way in order to provide a basis for a novel, non-obvious claim. Professional thoughtful preparation of the application done by experts with the specific knowledge and know-how in obtaining protection for repurposed drugs and DRPx products will lead to better, stronger protection.