Protecting intellectual property: IP strategy for life sciences companies

Key takeaways

• In life sciences, intellectual property is rarely just a patent. Commercial value often sits in a package of patents, know-how, data, SOPs, materials, software, brands and trade secrets. 

• Not every valuable asset can or should be registered. Patents, trademarks, designs and utility models generally require filing and registration. Copyright and trade secrets may arise without registration, but still need to be secured in practice. 

• Patent protection does not start with the filing alone. It starts with the right disclosure strategy. Publications, pitch decks, conference materials, data rooms, CDAs and MTAs should be managed so that novelty, confidentiality and negotiating leverage are not damaged. 

• IP protection is only robust if the chain of title is clear. Founder IP, employee inventions, consultant contributions, university or research institute rights, CROs, CDMOs and collaboration partners must be allocated properly by contract. 

• Enforcement matters, but it is not the only purpose of IP. For biotech, pharma, MedTech and digital health companies, IP is most valuable when it can support financing, licensing, collaborations and due diligence. 

This article was co-authored with Tobias Dammer, Research Associate in NEUWERK’s Life Sciences team.

What does it mean to protect intellectual property?

Intellectual property protects intangible value. In life sciences, that does not only mean technical inventions. It often also includes data, know-how, software, materials, technical drawings, regulatory documentation, manufacturing information, brands, designs and confidential development records.

The term “intellectual property” can sound abstract. In practice, it is about very concrete commercial questions: who may use a technology, analyse data, apply a manufacturing process or license a platform? And can the company show investors, licensees or buyers that it actually owns or can validly use the relevant rights?

That matters in life sciences because many companies have no product revenues in the early years. Their value lies in scientific progress, protected technology, data packages, regulatory optionality and the ability to turn these elements into an investable and exploitable asset.

Protecting IP is therefore not just about filing a patent. It means defining the real asset, separating formal IP rights from confidential know-how and securing the rights to all value-relevant components by contract.

What types of intellectual property matter in life sciences?

For life sciences companies, six categories are particularly relevant.

Patents protect technical inventions. These may include new active ingredients, formulations, manufacturing processes, medical uses, diagnostic methods or technical platforms. In general, the invention must be new, involve an inventive step and be industrially applicable.

Utility models may, in some jurisdictions, provide a faster and simpler form of protection for technical inventions. They are sometimes described as “small patents”. That can be misleading because the scope of protection, examination process and strategic usefulness depend heavily on the relevant legal system.

Trademarks protect signs, such as product names, company names, logos or other identifiers that distinguish goods or services. In life sciences, trademarks often become visibly important later in the development cycle. They can nevertheless carry significant value for product launches, platform positioning, diagnostics offerings and digital health products.

Designs protect the external appearance of a product. In classic biotech, they are often less central than patents and know-how. In MedTech, diagnostic devices, wearables, packaging or digital interfaces, they can be relevant.

Copyright arises without registration in most jurisdictions. In life sciences, it may protect the concrete form in which something is expressed, for example scientific texts, graphics, technical drawings, software code, training materials, study documents or certain documentation. It does not usually protect the underlying scientific result, technical concept or raw data as such. Put simply: copyright may stop someone from copying your report, drawing or code, but it does not by itself stop them from using the scientific insight or technical idea behind it.

Special care is needed where content is generated using artificial intelligence. In many jurisdictions, copyright protection requires human creative input. Pure AI outputs may therefore create protection gaps. For life sciences companies, this can matter where AI is used for texts, images, code, data analysis, molecule concepts or documentation. It should be clarified early which elements are protectable, what rights exist in input and output data and whether protection should instead rely on contracts, trade secrets or technical access controls.

Trade secrets protect confidential information with commercial value. In life sciences, this may include manufacturing parameters, assay set-ups, cell line information, protocols, SOPs, negative results, raw data, analytical models, supplier knowledge, regulatory strategies and non-public regulatory or dossier information. Trade secrets are often as important as patents, and sometimes more important.

Which IP rights need to be registered?

Some IP rights arise only through filing and registration. This applies in particular to patents, trademarks, designs and utility models.

For these registered rights, the formal process is part of the protection. The application defines the subject matter. The authority examines formal requirements and, depending on the right, sometimes substantive requirements as well. Once the right is registered or granted, it can be enforced against third parties.

For patents, this process is particularly demanding. The application must disclose the invention so that a skilled person can carry it out. At the same time, the patent claims must define the scope of protection precisely. Those claims later determine whether a competitor’s product or process falls within the patent.

This is one reason why patent protection needs strategy. A claim set that is too narrow may offer too little commercial protection. A claim set that is too broad may become vulnerable. A filing that comes too late may fail because the invention has already been disclosed.

For life sciences companies, another point is essential: patent protection is territorial. A patent application does not automatically protect the invention worldwide. International filing strategies therefore need prioritisation. Relevant questions include:

• Where are the relevant competitors located? 

• Where will products be developed, manufactured or commercialised? 

• Where are potential licensees or buyers located? 

• Which markets matter for reimbursement, clinical development or production? 

• Which territorial strategy is financially realistic for an early-stage company? 

The aim is not to cover as many countries as possible. A good filing strategy should reflect the business model, available budget and intended commercialisation route.

Which IP positions arise without registration?

Not every valuable asset is recorded in a register. In life sciences, a significant part of company value often sits in unregistered IP positions.

Copyright can arise automatically, for example in software code, certain texts, graphics, technical drawings, database structures or scientific materials. This protection is useful, but it does not replace patent protection for technical inventions or contractual protection for know-how, data and materials.

Trade secrets are often even more important. They do not arise through registration, but through actual confidentiality. Information is not a trade secret simply because it is labelled “confidential”. It must be secret, have commercial value and be protected by appropriate, actually implemented confidentiality measures.

For companies, that means trade secret protection requires organisation. Typical measures include access restrictions, role and permission concepts, internal policies, clean documentation, need-to-know principles, confidentiality agreements, controlled data rooms and clear rules for external partners.

Does every life sciences company need a patent?

No. Not every life sciences business model necessarily needs a patent portfolio. But every life sciences company needs an IP strategy.

Patents are particularly important where commercial value lies in a technical invention that competitors could copy once it becomes known. This is often the case for therapeutics, diagnostics, formulations, manufacturing processes or specific medical uses.

There are also business models where other protection mechanisms matter more. In data-driven models, access to data, data quality, software, regulatory positioning or speed may be more important than a single patent. In service or platform models, know-how protection may be central. For certain manufacturing processes, it may be more sensible to protect critical process parameters as trade secrets rather than disclose them in a patent application.

The key question is therefore not: “Do we have a patent?”

The better question is: Which protection strategy supports our business model?

That also requires a deliberate choice between patent protection and confidentiality. A patent application can create a strong exclusive right, but it normally requires disclosure of technical information. Trade secrets avoid that disclosure, but they only protect information for as long as it remains secret and is properly secured.

In practice, both strategies often coexist. A company may patent the core of an invention while keeping certain manufacturing details confidential. What matters is that this decision is made consciously, rather than accidentally through early publications, uncontrolled data rooms or imprecise partner discussions.

Why disclosure can be dangerous

IP protection often fails not because the idea is weak, but because it is disclosed too early or without sufficient control.

This is particularly relevant for patents. An invention must be new. If technical details are made public before filing, novelty may be lost. Scientific publications, posters, conference abstracts, pitch decks, website content, grant applications, data room materials or discussions with potential partners can all become relevant.

Not every disclosure carries the same risk. Confidential discussions under a robust CDA are different from public presentations. Still, life sciences companies should follow a simple rule:

Before any substantive disclosure, it should be clear whether the relevant information is to be patented, kept confidential or deliberately published.

The same applies to MTAs. Sharing materials often means sharing more than physical samples. Materials can reveal information about technology, manufacturing processes, assays or development steps. An MTA should therefore address not only transport and use, but also purpose limitation, onward transfer, reverse engineering, results, IP in improvements, return or destruction and confidentiality.

Who owns the IP?

IP protection is only valuable if the chain of title is clear.

Many companies focus on which rights should be filed. At least as important is the question who actually owns the relevant rights. In life sciences, contributions often arise in complex environments: universities, research institutions, founding teams, employees, external consultants, CROs, CDMOs, software developers, collaboration partners or publicly funded projects.

It is not safe to assume that the person who had the idea owns all rights in a way that benefits the company. Nor is it safe to assume that everything developed for the company automatically belongs to the company.

Typical risk points include:

• founders bring in IP created before incorporation 

• scientific work was created at a university or research institution 

• employees develop inventions or software 

• freelancers, consultants or CROs create new results 

• collaboration partners contribute to data, assays or improvements 

• materials or data originate from third parties 

• funding terms impose conditions on commercialisation 

For investors, licensees and buyers, chain of title is often decisive. In due diligence, the question is not only whether a patent exists. It is whether the company can show that it owns the relevant rights or can validly use them. Employee inventions may also be subject to specific national rules that require clean internal reporting and allocation.

That is why IP assignments, Founder IP Assignment Agreements, employee invention processes, consultant agreements, collaboration agreements, CDAs and MTAs are not secondary paperwork. They are part of the IP architecture.

How can contracts protect IP?

Contracts close the gap between formal IP rights and practical exploitability. Several contract types are particularly important:

Confidential Disclosure Agreements (CDAs). CDAs define which information is confidential, for what purpose it may be used, who may access it and what happens after discussions end. Before partnering discussions, investor processes or due diligence, a robust CDA is often the first protection mechanism.

Material Transfer Agreements (MTAs). MTAs govern the use of biological material, samples, cell lines, plasmids, reagents and other research materials. In life sciences, they are often critical because materials can reveal technology, assays, manufacturing processes or development steps.

Founder IP Assignment Agreements. These agreements ensure that IP created by founders before or around incorporation is transferred properly into the company. For start-ups, this is particularly important because investors and buyers will later review whether the chain of title is complete.

Employment and consultant agreements. These should ensure that new inventions, software, documentation, data and know-how vest in the company or can be used by it to the extent legally possible. This should not be left open where external developers, consultants or scientific advisers are involved.

Research and collaboration agreements. These should clearly address Background IP, Project IP, Improvements, data rights, publications, confidentiality and use rights. In life sciences, this contractual architecture often determines whether later licensing, financing or a transaction can proceed without friction.

License agreements. These govern who may use a technology and to what extent. Field of use, territory, exclusivity, sublicensing, know-how, data access, improvements and commercial terms all matter.

Good IP protection therefore does not depend on a single document. It results from the alignment of IP rights, confidentiality, internal processes and contracts.

As a practical starting point, the BIO.LAW Toolkit provides free templates, including CDAs, MTAs and Founder IP Assignment Agreements, each available in German and English.

How is intellectual property enforced?

IP protection is only credible if the rights can be enforced when needed.

Depending on the right and jurisdiction, several remedies may be available. Typical claims include injunctions, damages, information, accounts, destruction, recall and removal from distribution channels. In some cases, inspection or document production claims may also be relevant, especially where evidence of a technical infringement is needed.

Patent enforcement is often technically demanding. Having a patent is not enough. The rights holder must show that the challenged product or process falls within the scope of protection. For active ingredients, formulations, manufacturing processes or diagnostic methods, that can be complex. Evidence preservation is therefore critical.

In Germany, enforcement often begins out of court, for example with a cease-and-desist letter or a rights enquiry. In urgent cases, preliminary injunctions may be considered. Procedures differ in other jurisdictions. For international life sciences companies, enforcement should therefore not be viewed purely through a national lens, but in light of market relevance, competitors, evidence and commercial objectives.

Criminal law may also become relevant in serious cases, particularly where infringement is deliberate and commercial in scale. In practice, however, civil enforcement and commercial strategy are usually the primary focus.

Practical steps for a robust IP strategy

No company needs a perfect IP system on day one. But several steps should be addressed early.

1. Define the asset. What actually makes the company valuable: patent, data, know-how, material, software, process, platform or a combination? 

2. Separate hard IP and soft IP. What should be registered, what should remain confidential and what must be secured by contract? 

3. Control disclosure. Do not publish or share critical information before the patent strategy, CDA or MTA position is clear. 

4. Review chain of title. Map founders, employees, consultants, universities, CROs, CDMOs and collaboration partners. 

5. Review contracts for IP. Align CDAs, MTAs, employment agreements, consultant agreements, research agreements and license agreements on IP allocation, use rights, improvements and confidentiality. 

6. Build documentation. Keep records of inventions, data packages, materials, versions, access rights and decisions. 

7. Think about enforcement. Rights should be drafted and documented so they are not only attractive on paper, but also enforceable in practice.