12 December 2023

Patent in life science – how do you protect your invention?

Patents in life science are a necessity to raise capital. In this interview with Helle Friis Svenstrup, AWA Denmark A/S, gain insight into everything from application to patent issuance.
Patent protection-i-life-science

Patents are essential and play a significant role in all innovative industries – especially within life science, where the development of new products takes place over a long period and in a competitive market. As a company, you need to address patents, not only considering your patent opportunities but also the existing patent rights of other companies.

Together with Helle Friis Svenstrup, we will make you more knowledgeable about what a patent is, what it takes to obtain a patent, and the steps you must go through in the application process.

She is the Life Science team leader, a partner at AWA, and has been a patent advisor for over a decade.

Awa - Patent i life science
Helle Friis Svenstrup, AWA Denmark

If you have made an invention, you can apply for a patent

Definition: A patent is a legal document where you disclose your invention to others. In this document, you also specify what others are not allowed to do. For instance, if you have invented a new medicine and obtained a patent, others are prohibited from producing, selling, or marketing the product without your permission. A patent typically lasts for 20 years from the date of filing.

As a general rule, anyone who has made an invention can apply for and obtain a patent provided that it:

  • is new
  • possesses inventive step
  • is industrially applicable

An invention is considered new if it has not been described or produced anywhere else. An invention possesses inventive steps if not apparent to someone skilled in the field.

“It can mean that your invention has a surprising effect. For example, it might be surprising that a known medicine can treat a different disease than the one the substance was initially known for. The requirement is that your invention must be significantly different from what is already known,” says Helle Friis Svenstrup, further explaining:

“Our clients are often surprised that the requirements for inventive steps are not higher than they are, as many inventions can seem obvious once invented.”

Helle Friis Svenstrup
Patent Advisor and Partner at AWA Denmark

That’s why it’s a good idea to seek help from an objective expert to identify what you should try to patent. You can obtain patents for both products and processes and their applications.

Strategic considerations in patenting

Within life science, patents are crucial for a company’s survival. If a company has yet to protect its innovation with patents, raising capital isn’t possible. That applies to both the initial seed funding and subsequent rounds. One can rightly say that patents constitute the very foundation of a life science company.

Some essential considerations you should address about patenting are best discussed with a patent advisor. According to Helle Friis Svenstrup, these considerations may include:

  • How, where, and when does the innovation fit into the company’s business plan, and what value does it hold for the company?
  • What does the market landscape look like in the relevant countries?
  • What is the ‘go-to-market’ strategy (timing is crucial)?
  • When do you expect to obtain marketing authorization for the product or other regulatory approvals?

A patent advisor can assist you with these and other important IP strategic considerations.

A patent is not a right to use, but a right to prohibit

A patent doesn’t grant the right to exploit an invention but the right to prevent others from using it. Hence, it’s crucial to be aware of patents held by other companies.

“It’s crucial to understand the distinction that obtaining a patent doesn’t grant exclusivity; it grants prohibition to others.”

Helle Friis Svenstrup
Patent Advisor and Partner at AWA Denmark

You can easily obtain patents that overlap with something you already have patented yourself; as Helle Friis Svenstrup explains, you can get different patents for your product.

An analysis that uncovers patents held by other companies is called a Freedom To Operate (FTO) analysis and is typically conducted in collaboration with a patent advisor.

A patent is a significant investment – is it worth the price?

“Consider the value of what you’ve invented. It’s expensive to file a patent application, and you pay annual fees in each country where the patent is granted,” explains Helle Friis Svenstrup.

She mentions that the patent process can quickly cost around 50,000 Danish kroner in the application process, plus much human resources. Additionally, there are fees for correspondence with authorities, and it’s wise to hire an advisor who can assist throughout the process.

However, cutting costs on patent work might be more expensive in the long run.

“The patent process is costly and complex, but as it constitutes the very foundation for most life science companies, there’s no way around it,” states Helle Friis Svenstrup, further elaborating:

If you do your homework correctly and build a high-quality patent portfolio, the company’s value will significantly increase during fundraising or capital-raising efforts.

Helle Friis Svenstrup
Patent Advisor and Partner at AWA Denmark

Patent Application: Step by Step

Are you about to apply for a patent in life science —or are you considering if it’s a good idea?

Here are the steps of the application process.

1. Specify the invention and describe how it stands out

If you have an invention you want to patent, you need to prepare an application.

“In the application, you describe what already exists within the technical field you’re working in, often requiring documentation of the invention with laboratory and clinical data,” explains Helle Friis Svenstrup. She continues, “Afterward, you detail your invention, specifically highlighting how it differs from the closest prior innovation.”

Following this, you apply to the relevant patent authority in the country and pay the associated fees for the authorities to conduct a search for the invention.

2. Your application gets approved—or the authorities request more information

Once the authorities have processed your application, it will either be approved if it meets the criteria, or they may raise several objections.

“The authorities might have found existing rights relevant to the invention and would like clarification on how your invention stands out. They might also request documentation. Sometimes, additional data is necessary to demonstrate the effect of the invention to get a patent approved,” explains Helle Friis Svenstrup.

There’s no definitive answer to how long it takes to approve a patent application. Depending on the authorities’ requirements and the application’s content, it can be quick or prolonged.

3. Which countries do you want to patent in?

When your patent application gets approved, it doesn’t mean you’re automatically covered in all European countries. A patent is a national right.

Hence, you need to apply for a patent in all the countries where you seek protection.

4. You now have a patent

Once you’ve completed the formalities in the European countries where you want the patent to be effective, you have a valid patent.

A patent lasts up to 20 years, requiring yearly renewal throughout those two decades. There’s a fee associated with renewing the patent annually. Additionally, an extension for up to five years is possible for patents covering pharmaceuticals or plant protection products.

Important aspects of patent protection in life science

There are many considerations when seeking a patent in the life science industry. Therefore, we’ve listed several key points when applying for a patent.

  • A patent lasts up to 20 years and requires annual renewal with fees.
  • Anyone can apply for a patent — having one is often a life science requirement.
  • Generally, you must choose the countries where you want to obtain a patent.
  • Starting June 1, 2023, you can apply for a unitary patent valid in 17 European countries.
  • If you want global patent protection, you can file a PCT application covering 170 countries for 30 or 31 months. However, the application must be pursued separately in each country after that period.

If you want to know more about patents and the application process, you can learn more on the Danish Patent and Trademark Office website.

You can also contact AWA Denmark to learn more about the options.