It takes a tremendous amount of time and money to develop a new therapeutic product. Without the right protection, your hard work can be gone in a moment if a competitor uses your methods or products to advance their businesses. If you want to ensure the long-term success of your biotechnology startup, you need to know what it takes to protect your innovation. The key is to craft an intellectual property (IP) strategy to safeguard your assets. In this guide, developed in collaboration with Philipp Marchand of Vossius & Partner, we’ll break down the best practices in developing a successful IP strategy you can use in your biotech startup to protect your inventions.
In 2023, the biotech industry in Europe and the U.S. raised $81.1 billion in capital.
While the potential for a multimillion-dollar business exists, you have to meet high standards to be eligible for investors. Your IP is the most important asset you have — even more reason to get IP protection right.
Protecting IP in the biotech industry is mostly done with patents. Ideally, you should consider protecting your IP before your idea becomes a business.
Let’s start with a few basic facts about patents: A patent doesn’t grant you the right to do something. But it prevents others from doing what you have protected, giving you a 20-year-long monopoly on it. You can use the protected innovation yourself or license it to another company to benefit passively.
A patent also facilitates trading. It makes an idea tangible and lets you put a monetary value on it, like an asset for your company. Some grants and accelerator or incubator programs consider it a prerequisite that you have your IP protected by a patent too (or a very good plan how to get there, in place). Investors consider a secured patent often as a critical factor.
The main disadvantage is that the innovation becomes publicly available.
With your innovation no longer secret, competitors might start to replicate it. Once your patent application is published (and in the public), it still takes about 4-5 years to gain protection from the patent, so you are exposing your secrets to the competition without protection for some time.
The other disadvantage is the costs.
Filing a biotech patent can range anywhere from $10,000 to $20,000 on average.
For a young company, this can be a major price to pay to protect your IP. It’s important to carefully balance costs and benefits to find the ideal time to file a patent application.
First biotech patents in a new area of discovery can be granted with generic claims covering fundamental innovations. As the technology advances, more specific patent applications need to be filed to cover selected areas such as active ingredients or processes within the generic claims of the basic patent. The further research advances in a field, the more carefully you need to check if more general patents already cover the area generically.
For example, your patent may be granted for an antibody described by its amino acid sequence that aims at a specific target. While a patent application relating to this specific antibody may be granted, there could be patents held by another party that generically cover antibodies that aim at that target. While your specific sequences are new and innovative, they could still fall within the scope of an existing patent.
This overlap can lead to a patent conflict, where you might infringe upon the broader patent, potentially requiring you to negotiate a license or face legal challenges to be allowed to commercialize your antibody.
Here are five common requirements to follow when you file for a patent:
To patent your biotech invention, clearly define and describe its unique biological or chemical components, processes or technologies, ensuring they are new and innovative (non-obvious).
There are certain subject matters that can’t be patented, which include:
Experts in your field must be able to reproduce or make use of your invention with their general knowledge.
To be considered “novel”, your invention needs to differ from the state of the art in at least one characteristic.
“State of the art” in the context of IP refers to any publicly available information or existing knowledge related to an invention before a patent application is filed. It includes earlier patents, publications, products, or demonstrations. Oral statements, for example as part of a technical presentation at a scientific conference, also belong to the state of the art.
To avoid a novelty objection when trying to patent an invention, it’s crucial to conduct thorough research, including patent databases and technical literature, to ensure no identical invention exists.
A useful mantra to live by: a patent application must always be filed for the invention before you can publish it!
To prove the inventive step in a patent claim, you must demonstrate that a qualified person wouldn’t be able to arrive at your invention in an obvious manner from the currently available state of the art.
For instance, if a claim presents five unique features and the current state of the art includes four of them, the inventive step hinges on showing that the final feature isn’t an obvious addition.
This often requires a nuanced argument that combining such features from disparate documents wouldn’t have been an obvious step for experts at the time of the invention.
The claims are also assessed for enablement. This means you will be assessed whether a qualified person can actually put the claimed invention into practice without requiring an inventive scale.
If all these requirements are fulfilled, the responsible patent office will grant a patent.
In Switzerland, an invention is transferred to the employer if made within the duties of an employment contract.
For most employees, an invention they make on the job would be transferred to their employer.
If there are multiple employers for the group of inventors, then all the parties that have rights are assigned to become co-owners of the patent application.
You should talk about this with all your co-inventors or the different employers before filing a patent application (i.e. how to handle all the formalities and how to distribute the rights).
It’s imperative for academic inventors to consult their university’s technology transfer office to start the patent process and understand their rights and obligations regarding their inventions.
For emerging companies, filing a biotech patent can be challenging, and many doubts about patentability, timelines, required data, geographical distribution or filing process arise.
If you want to ensure you and your startup are set up for success, adequate consultation from experts in the biotech startup field can prevent future roadblocks and pitfalls to ensure you have the right protection for your invention.
To deepen your understanding of IP strategy for biotech startups or for any legal help, you can reach out to Philipp Marchand at reach out to Vossius & Partner, one of BaseLaunch’s domain partners and an internationally renowned intellectual property firm.
Interested in learning more about this topic? Then check out our podcast episode with Philipp “Never underestimate the true value of IP”.
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