During his career as a patent attorney specialising in the life sciences – and with over two decades of experience at Katzarov – Gilles Pfend has worked with many SMEs, start-ups and universities in Switzerland and abroad to help protect their innovation. In this article, Gilles explains some of the key areas every innovator in the life sciences needs to know about when it comes to intellectual property and regulation.

IP (intellectual property) is fundamental for any scientist developing an innovation or discovery. There are various ways, including patents, designs and copyright, to obtain legal protection for IP, thus ensuring people can benefit from their inventions. A patent will protect an invention for a maximum of 20 years (or 25 years for a drug), during which time the patent owners are granted the exclusive right to their product or process.

Having IP in place is also essential to raise funds. It can take many years to benefit from any return on investment in a life science innovation, so a large amount of funding is usually needed to keep a project moving forward. With IP in place, you’re in a much better position to convince a potential investor to allocate a large sum to your start-up. So when should scientists start to think about IP?

Clarity and contracts are key

From the very start, researchers need to be very clear about who will own the IP for their invention. There is a clear distinction between the role of ‘author’ and ‘inventor’ on a patent. Unless a person helps to generate the ideas and concepts behind the invention, they aren’t an inventor. This means that not all the authors who will later be named as such in scientific journals will be included in the IP. It’s good practice to define roles clearly from the start and have agreements in place – that include an IP clause – with contractors, subcontractors and researchers.

Can you keep a secret?

When you’re working on an innovation, it can be tempting to shout it from the rooftops. It’s crucial, however, not to disclose information relating to your invention before filing the patent application.

Often, disclosing information too early stems from a misunderstanding of how protection works. In the US, there is what is called a novelty grace period, during which you can disclose your invention without destroying its novelty. This means you can still file a patent despite your invention being public knowledge. In Europe, however, if you disclose this information – be it on a poster, in an article or at a conference – it will no longer be considered novel. When developing a drug, for example, I strongly advise that you do not disclose its structure and stick to generic naming that doesn’t give anything away.

When to file a patent

One of the biggest challenges around IP in the life sciences is when to file a patent application. You can’t do this too early, as you’ll need a minimum amount of data to file your application. It can’t be too late, either, because then the risk of disclosing some of the information is greater.

Most IP authorities now request some data about the feasibility of the invention. For most of the patent applications that we file, the invention has been proven on cells or in vitro but not yet in clinical trials. Each project will have different requirements when it comes to timings, but in all cases inventors should carefully think about the right time to file – and do so before there is any disclosure.

Is your invention patentable?

There are also challenges when it comes to understanding what can and can’t be protected. Exceptions to patentability mostly apply to inventions in the life sciences, such as stem cells that derive from human embryonic cells. In Europe, treatment methods cannot be protected either. Finally, computer-implemented inventions, mathematical methods or algorithms are hard to protect too. In these fields, you need to show evidence that your invention solves a technical problem.

Investing in IP

If you’ve filed your patent application, you probably can’t wait to launch your start-up. Before you do, don’t forget to check whether you have what’s called ‘freedom to operate’. A university spin-off launched by the inventor of an innovation still needs go through licensing before they can use the technology without infringement regarding the university’s IP. It’s also crucial to leverage the help needed to carry out a background check on any similar IP that could exist. Although the final product might not yet be on the market, a competitor may have protected the discovery or invention already. A company that has IP relating to a drug, for instance, can be prevented from marketing it because someone already has IP rights to a different element of that same drug. This should be checked at an early stage to ensure you’re not pouring money into a product that cannot be marketed or sold.

IP and regulation in the life sciences is a vast and complex field. Whereas patent applications in other fields are sometimes just a few pages, those in the life sciences can be the length of a short novel. Given this complexity, inventors should consider seeking professional advice from patent attorneys when putting together a patent application. This is the best way to avoid costly mistakes and ensure you’ll benefit from your inventions for decades to come.