Awareness of available IP options is key to building a robust and investable patent portfolio, which can drive R&D, thereby allowing for better drugs and diagnostics
At the core of any new pharmaceutical company - or the start of a new project for a more established pharma company - is an innovative piece of science that is believed to lead to new and beneficial healthcare products. It will take the combined efforts of a wide range of scientists, researchers, and clinical and regulatory experts to push these new healthcare products towards the market. Often, the innovation provides one or more new drug candidates, which the pharma company moves along the stages of R&D towards having a new blockbuster drug on the market or is aimed at earlier or better detection of disease and the research focuses on validating and refining the sensitivity and selectivity of the diagnostic tests.
To make spending time and money worthwhile when developing a new healthcare product, an exclusive market is needed, at least for a few years, during which the product can be sold at a price that enables re-couping the investment and making a profit. Therefore, aside from the underlying science and the company's key individuals, intellectual property (IP) - usually patents - protecting the innovation is needed.
An awareness of the importance of IP, the patenting process, its restrictions, and options - by those concerned at all stages of the product development and validation process - can help to ensure a stronger and more robust patent portfolio protecting that drug or diagnostic test.
Considering when one may be ready to file a new patent application is a balancing act between, on the one hand, making sure one files before any competitors working in the same space to get the earliest priority date, and, on the other hand, waiting until such a time when enough evidence is available to put into the new patent specification to show that the new healthcare product really works as claimed. Waiting too long means a competitor can get in before and take the lead or exclude the company from that technology space. However, filing too soon could mean not enough evidence exists to confirm that the new healthcare product actually works or does so for all of the applications claimed, which could be a problem.
Clearly, a patent application for a new drug is filed years before the clinical trials are performed, which is the true test of whether a drug works. Therefore, a key...