Home Insights Are you patent ready? IP guidance for life sciences researchers

Are you patent ready? IP guidance for life sciences researchers

Read time
5  minute read
Date published
09 November 2022

So, you have an idea with commercial potential, some early data that suggests it might actually work, and you want to protect its value while you work towards the final product, and regulatory approvals. Whether you are an academic or industry-based researcher, the question is the same: when is the ‘right’ time to file a patent application?

There are a lot of moving parts that will influence when to file, including: competitor landscape, available experimental data, research programme schedule and commercial goals. Dr Karen Holden, Dr Malcolm Lyons and Dr Toby Thompson highlight key factors that help you identify the optimal time to file.

Patent basics

A patent is one type of intellectual property (IP). For a patent to grant, the invention claimed in the application must be novel (new, undisclosed), inventive (not obvious), supported (based on experimental data) and useful (works as promised). Although there are other requirements, these are the fundamentals. These requirements are judged against what was in the public domain, or the “prior art” at the priority date (the date the first patent application in the family is filed).

What patent types are there?

Provisional patent applications

A provisional patent applications sets the priority date that could see you stay a step ahead of your competitors. It gives you 12 months to generate further data to support your claims and develop the invention, before a final full patent application must be filed. Enforceable rights are not granted on a provisional patent application.

Standard patent applications

A standard patent application is what most researchers think of when they hear the word ‘patent’. This is a full patent application which provides long term protection (20 years from its filing date, and up to 25 years for some pharmaceutical products). If a standard patent application “claims priority” to a provisional patent application, it is judged against the prior art at the filing date of the provisional patent application. The process to grant enforceable rights on a standard patent application usually takes several years, but can be expedited under certain circumstances, e.g. for commercial reasons.

International patent applications

An international patent application (also known as a PCT application), provides a route to obtain patent protection in many countries, including the US, Europe, Australia, China, India and Japan.  A PCT application does not lead to a single granted international patent covering all countries, but has the benefit of providing additional time (typically 18 months) to evaluate the value of your technology before incurring costs in different countries.

Divisional patent applications

A divisional patent application is used to claim a second invention disclosed in a patent application, because a single patent application can only claim one invention – this is referred to as unity. The advantage is that the divisional patent retains the priority date of the parent patent application, so no later prior art can be cited against it. Divisional applications must be filed when its “parent” application is alive, and depending on the jurisdiction, this could be before acceptance or sometime after acceptance, but before grant.

How does IP dovetail with your product development programme?

Factors to consider with respect to your IP include:

  • does your technology/ invention address an unmet need?
  • have you identified your market and/or potential licensees?
  • have you engaged end-users to ensure the product or service is practical in the relevant field?
  • can your product be manufactured, or service delivered at commercial scale?
  • are you already developing your lead candidates?
  • are you working through the regulatory pathway?

The infographic below links each stage of product development with potential key IP steps, but this is only one possibility. The key point shown by the infographic is that IP requires constant attention to identify newly created IP, maximise its value and its promotion of commercial value for your technology/invention.

Where does IP fit in the therapeutic product development pipeline?

For example, alongside core IP protecting a platform technology or key product of interest such as a therapeutic agent, IP could be generated in and captured from supporting technologies that may include:

  • Analytical tools developed to meet regulatory requirements that evaluate product potency, purity and/or identity.
  • Manufacturing protocols developed to allow commercial scale production and/or optimal shelf life.
  • New applications or uses of the products.

IP is not just patents. In the product or service development pathway, there will be trade secrets and know-how generated that may not be amenable to patent coverage, yet which are worthy of protection. Documenting and controlling access to such information is critical. And of course, don’t forget to seek trademark protection when developing a brand strategy (including words, phrases and logos) important to your company.

Many companies commercialising technology in the life sciences are seeking to develop the technology to a certain degree, and then to look for an investor or acquirer to take the technology to market.  A strong portfolio of assets, including registered IP such as patents and trademarks, together with well-defined trade secrets and other information relating to your technology, will assist in securing a licensing deal or sale.

The right time to file?

Identifying the right time to file a patent application to protect your invention is a key part of the process.  On the one hand, you should file before a public disclosure of the invention takes place, either by your own research group, or by a competitor (although there are limited remedies after premature disclosure as discussed here). However, if there is only limited experimental support for the invention, you may not be able to obtain broad protection for the invention. Also, if the invention is not fully formed and is likely to change significantly, this can also create problems if the patent is filed too early.  In a worst-case scenario, key technology may end up being disclosed in a patent without being supported, leading to a situation where it becomes very difficult to obtain protection.  As a result, a key part of the patenting process involves balancing these factors and developing the right patent filing strategy for your technology.

What other IP issues should be considered?

A common misunderstanding is that obtaining a granted patent is sufficient to allow your technology to be worked without interference from a third party. But that is not true. There is always a possibility that, even if your technology is found to be novel and inventive, there is an earlier patent with broader claims within which your technology and commercial activities fall. Thus, it is important to know what other patents are out there and whether you have “freedom to operate” (FTO), before committing substantial resources to a project.

Given that FTO costs can themselves be significant, a staged and proportionate approach is often the right way to go. This may involve carrying out a high level FTO analysis to check whether there are obvious barriers in key markets for your core technology, and conducting a more comprehensive FTO analysis later on as you near market and have greater certainty about what your final product or service is and what is involved to produce or deliver it. Maintaining an awareness of the patent landscape in your field may allow you to adjust and adapt to meet your commercial goals and timeline.

Key takeaways:

  • Filing a provisional patent application is a common first step for securing patent coverage. There is always potentially a trade-off between securing an earlier filing date and having less data to support your claims, and vice versa. A provisional patent application will provide you 12 months to build on your data, but experiments don’t always go to plan!
  • IP can take many forms and requires constant attention to identify it, protect it and use it to drive commercial value.

Contact us

If you need advice or have any questions about the IP solutions available to you, please contact Malcolm, Toby or Karen directly, or submit an enquiry here.