For this post I want to build upon a great introduction to the world of patents that my colleague Nate Valverde, J.D. provided in his excellent article: Patent 101: Learn the importance of patents…and how to protect your invention.here

Many academic researchers have specific questions as they seek to translate their basic science discoveries into promising therapeutics. In fact, the first time most academics interact with their institution’s technology transfer office (commonly referred to as the TTO, but here at Partners Healthcare we call ourselves the Innovation Office) is when the scientist has created an invention in the lab and the institution’s IP policy requires that the invention is disclosed to the TTO.

Naturally, most scientists making their first disclosure are unsure of what to expect or where the path they’ve started down will lead. Each TTO has its own procedures to determine how best to move forward with technology that is disclosed by their investigators, but that’s a topic for another post. For now, let’s simply assume the TTO has evaluated the technology and determined that an investment in a patent application is warranted. This is a significant step, and in my experience there are quite a few questions that inventors usually ask.

Q: Why do we have to file this thing at all?

A: A number of inventors have asked why we even need to be concerned with filing the patent application at all. They ask, “Why can’t we get our technology into the clinic without a patent?” I understand where they’re coming from. They want to make their science as widely available as possible; a filing could restrict the use of their innovative science. On top of that, in their view, a patent application involves significant effort on their part.

The cold reality for an academic scientist is even if you’ve got a great technology, you must convince potential partners that you have a clear way of providing them with the market exclusivity that will help deliver the return on investment that the risk of developing therapeutics demands. Otherwise, you will be left watching from the sidelines as investors focus their resources on other competing programs, some with potentially less exciting science but with the critical IP protection.

Q: When do will we file?

A: When to file a patent application for a promising technology requires a conversation between the scientist and the TTO. Generally, it’s considered best practice to file the application as near to, but before, the first public disclosure of the invention. That disclosure could be any type of public presentation of the invention – a poster presentation or abstract, a seminar, a grant application, a journal article, a student’s graduate thesis, or even a media blog or interview. Certainly, it is the decision of the inventor as to when they will disclose the invention, after all it is their science, and they may have a strong academic interest in publishing the data. It is paramount, however, that the inventor and TTO have an open line of communication about upcoming disclosures. If the invention is inadvertently disclosed before a patent application is filed, the rights to protect the invention will be forfeited in foreign countries, which can dramatically reduce the chances of finding a licensing and co-development partner down the road.

Q: Who will be listed as inventors?

A: This is one of the most common conversations I have with inventors. Unlike the process of determining authorship on a manuscript, there is a legal basis and associated guidance used in determining inventorship on a patent application. Most often, there are far fewer inventors on a patent application compared to the manuscript associated with the invention.

Critically, to be considered an inventor one must have contributed to the conception of one of the claims in the application and eventually the issued patent. This means that an inventor is one who has participated in the practice of conceiving the invention in its permanent and definite form. There are, of course, many ways to contribute, and what precisely those contributions might be is highly dependent on the research plan and the nature of the invention.

Again, this should be a conversation that the lead inventor has with their TTO representative, and potentially the external legal counsel who will draft the patent application. In this discussion I find it is most helpful to provide guidance to inventors about what activities are not considered to cause an individual to rise to the level of inventor, such as simply performing routine experiments as directed by others or supplying a critical reagent in the absence of an intellectual contribution.

Q: Great, so now that we have a patent (or at least an application), we can form our start-up, we’ll license them the patent, and they’ll go ahead and use our invention. Smooth sailing from here, right?

A: Nate’s article touches on this common misconception, which is one shared by many patent applicants: that a granted patent will enable us to be the only party practicing the invention. This isn’t far from the truth, but there is a key distinction to be made. A patent will simply allow us to exclude people from practicing our invention. However, that doesn’t mean we can practice our invention ourselves. Wait, what? We can keep others from doing it, but we can’t do it ourselves? Nate touches on the regulatory reasons that this might be true, but here I’d like to focus on another reason we might lack what is called “freedom-to-operate”. That is, we will not be able to practice if another party holds a valid patent that allows them to exclude us from practicing our own invention. Let me explain:

This most often occurs when an academic scientist uses a publicly available compound in a new way, i.e. potentially demonstrating a new use for an old medicine. While the scientist and the academic institution may be able to receive a granted patent on the method of using the compound (and perhaps others like it) in a new indication, without a license to the composition of matter patent that is typically held by the pharmaceutical company marketing the drug, that company can exclude us (and our potential commercial partners) from using their drug in a new indication.

This is one of the clearest reasons why scientists interested in translating their biological insight into an investable opportunity are advised to pursue a development path that will result in novel composition of matter, as hard as that may be. The path to composition of matter intellectual property can be a tough one for biology focused academic labs, but it’s a road worth pursuing if you’re truly interested in being involved in the clinical future of your pre-clinical biological findings. I’ll cover some of the approaches I’ve seen to climbing this hurdle, as well as and the pros and cons of each, in a future blog post.

Don’t wait until it’s too late!

In the end, the best advice for inventors who have these questions and anticipate navigating this translational path is to reach out to your institution’s technology transfer office now. There’s never a good reason to wait and it is never too early to start the conversation. Meet with the TTO representative assigned to your lab, tell them about your discovery, your plans, and all your hopes and dreams for where the technology could go. They’ll be thrilled to hear about your exciting science and should be able to provide much more personalized answers than the general ones I’ve provided here.

I’d love to have your feedback on this article and the Found in Translation blog. Let me know where I can add insights and advice, what you want to know more about and what new challenges are out there for us to work through together.

I look forward to hearing from you!