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Filing for IP: The very basics

In our previous article about filing IP on novel targets and epitopes, we’ve outlined the fundamentals of intellectual property and how to file for it 

Here’s a quick refresh.

There are many ways to protect your intellectual property

For example, patents safeguard technical inventions, trademarks protect brand identity, copyright covers original creative works like written content or code, and trade secrets secure confidential information through contracts such as NDAs.

In biotech, patents are often your most critical form of IP protection because the invention itself is the heart of the business. For biotech startups, a patent is crucial to secure funding.

There are five patentability criteria

Patent offices in the US and the EU both apply five basic criteria to assess whether an invention is patentable:

Question from the audience

Can discovering a therapeutic target be patented?

Only under certain conditions. The application must show that the target is not just scientifically interesting, but has a specific, credible therapeutic application. Simply naming a natural molecule isn’t enough. The claim must typically involve a defined compound, method of use, or demonstrate a technical effect, such as inhibiting the target to treat a disease.

Industrial applicability

When filing with the EPO:
The EPO requires that your invention isn’t just a theoretical idea but has some practical industrial use. This is rarely a hurdle in the life sciences. However, issues can arise when the invention lacks a clearly defined technical effect or real-world use. For example, a biological discovery without a practical application might be deemed insufficiently applicable.

When filing with the USPTO:
The USPTO has a similar requirement, referred to as utility. It must be specific, substantial, and credible. As in Europe, this is generally not a major concern for biotech inventions, but purely speculative or overly broad claims (such as therapeutic use without supporting data) may trigger a utility rejection.

Expert suggestion:
Include a clear description of how the invention can be applied in practice, especially for early-stage discoveries. In fields like diagnostics or drug targets, explaining the functional role or therapeutic potential can help establish industrial applicability and utility in both jurisdictions.

Novelty

When filing with the EPO:
The EPO takes a strict, literal approach to novelty. An invention is not considered new if all elements of a claim are disclosed in a single prior art document. There is no grace period: any public disclosure made before the filing date, including conference presentations, posters, or preprints, can be used as prior art against the application. Novelty must be judged at the time of filing, with no exceptions for inventor-originated disclosures.

When filing with the USPTO:
The USPTO also assesses novelty based on prior art, but offers more flexibility. Most importantly, it provides a 12-month grace period for disclosures made by the inventor or derived from the inventor. This allows researchers to publish or present their work and still file a valid patent application within a year. However, third-party disclosures remain novelty-destroying unless properly disqualified under specific exceptions.

Expert suggestion:
Coordinate publication and filing strategy. For Europe, ensure that no disclosure is made before the filing date. For the US, the grace period can offer useful flexibility, but it shouldn’t be relied on as a substitute for careful IP planning.

Inventive step

When filing with the EPO:
The EPO evaluates inventive step using a structured problem–solution approach. Examiners identify the closest prior art, define the technical problem the invention solves, and assess whether the claimed solution would have been obvious to a person skilled in the art. The invention must show a technical effect beyond what was already known. Without this, the claim may be rejected as obvious, even if it introduces new elements.

When filing with the USPTO:
The USPTO assesses inventive step under the concept of non-obviousness. Unlike the EPO’s structured approach, US examiners may combine multiple prior art references to reject a claim, unless the combination would be considered unreasonable or lacking motivation. While technical effect can help, it’s not a formal requirement like in Europe. The US standard is broader and sometimes less predictable, depending on the examiner’s discretion.

Expert suggestion:
Include clear explanations of the technical problem solved and the advantages over prior art. For the US, anticipate possible combinations of prior art and proactively address why your invention wouldn’t be obvious, even if its components are individually known.

Question from the audience

How can we strengthen a patent so it isn’t seen as obvious under the US approach?

In the US, examiners often combine features from multiple prior art references to argue that a claimed invention is obvious. To counter this, include technical explanations and advantages that clearly differentiate the invention from known approaches. Highlighting unexpected results, functional improvements, or the problem solved can help establish non-obviousness. These same arguments can also strengthen the case for inventive step in Europe!

Enablement

When filing with the EPO:
The EPO requires that the application disclose the invention in a way that allows a person skilled in the art to carry it out without undue burden. The invention must be plausible at the time of filing, meaning that the description and data must sufficiently support the claimed technical effect. Post-filing data is generally not accepted to establish plausibility or enablement. If claims rely on features disclosed only in examples without broader teaching, they may be rejected as insufficiently supported.

When filing with the USPTO:
The USPTO applies enablement alongside a distinct written description requirement. This means the inventor must not only explain how to make and use the invention, but also demonstrate “possession” of the full scope of the claim. The US allows post-filing data to support enablement, but recent rulings have raised the bar. Claims that cover broad functional classes (e.g., antibodies) may be rejected if the specification doesn’t provide enough detail to make substantially all embodiments.

Expert suggestion:
Include a clear technical teaching and representative data that support the claimed invention across its scope, especially in Europe. For the US, Richard suggests being prepared to show that you were in possession of the invention at the time of filing.

Linguistic differences

The EPO requires precise, unambiguous terminology and applies a strict standard for claim amendments. The USPTO generally allows broader interpretation and more flexibility in how language is used. These are some of the most significant differences in the language requirements

Use of terms like “embodiment,” “aspect,” and “invention”

When filing with the EPO:
The EPO takes a strict and literal approach to how terms such as “embodiment,” “aspect,” and “invention” are used in the description. If different features are described as being part of separate embodiments or aspects, examiners may interpret them as distinct disclosures that aren’t meant to be combined.

When filing with the USPTO:
In the US, these terms are treated as stylistic conventions without legal consequence. There is no assumption that features from different “embodiments” or “aspects” are mutually exclusive. Applicants can typically combine elements from across the disclosure without triggering formal objections.

Expert suggestion:
Use these terms sparingly and consistently, or avoid them entirely in applications intended for both jurisdictions. If you use them, the application should make it clear that the described embodiments and aspects can be freely combined, unless stated otherwise.

Literalism in EPO claim interpretation

When filing with the EPO:
The EPO requires that any feature included in a claim be directly and unambiguously disclosed in the application as filed. This means the language used in the description must precisely support the claim wording, without relying on interpretation. Examiners at the EPO interpret terms narrowly, and any inconsistency or ambiguity in wording can result in objections or refusal. This strict approach is particularly relevant when amending claims during prosecution.

When filing with the USPTO:
The USPTO uses a broadest reasonable interpretation (BRI) standard during examination. This allows for more flexibility in how claim language is understood and applied. Applicants are generally allowed to reformulate or recombine disclosed features to adjust claim scope, as long as the overall disclosure supports the invention conceptually.

Expert suggestion:
Draft with the EPO’s stricter standard in mind. Write claim language that is precise, consistent, and fully backed by the description, while avoiding ambiguous or overly general terms.

Question from the audience

Do we really need to list all possible combinations in chemistry?

No, but the way combinations are presented matters. The EPO expects any claim amendment to be based on specific, disclosed combinations, not arbitrary selections from long lists. Instead of listing every possible variant, it’s better to generalize the working examples in the description. Explain why certain features matter, how they interact, and under what conditions they apply. This preserves flexibility without overwhelming the application or violating EPO requirements.

Generalization of working examples

When filing with the EPO:
The EPO treats working examples as specific embodiments of the invention. If a feature appears only within an example (e.g., a specific temperature, assay condition, or compound), it can’t later be used to support a broader claim unless the description also contains a generalized teaching that connects the example to the invention as a whole. Without it, attempts to use such features in amended claims may be considered an impermissible extraction or an arbitrary selection.

When filing with the USPTO:
The USPTO is more flexible in how it uses working examples. Examples can often be cited to support broader claim language, even if the generalization isn’t explicitly spelled out in the description.

Expert suggestion:
Include general statements in the description that explain how the features in the examples relate to the broader invention. This approach preserves flexibility for future amendments and strengthens support for broader claims.

Use of relative terms like “preferably”

When filing with the EPO:
The EPO takes a cautious view of relative or non-limiting language such as “preferably,” “typically,” “generally,” or “may include.” These terms can create ambiguity about what is essential to the invention. If a claim is later amended to include a “preferred” feature, the examiner may argue that it lacks clear support because the original language suggested it was optional, not required. This can result in objections related to clarity, added subject matter, or lack of support.

When filing with the USPTO:
The USPTO generally accepts such terminology without issue. Phrases like “preferably” are treated as standard drafting language and don’t prevent later incorporation of those features into amended claims.

Expert suggestion:
Limit the use of relative terms when drafting for the EPO, or at least clearly define their context. Alternatively, draft multiple formulations that include and exclude the feature explicitly, to preserve amendment options during examination.

Procedural differences

Procedural differences aren’t about whether something is patentable, but rather about how the patent process works.

These are some of the most important procedural differences.

Claim amendments during prosecution

When filing with the EPO:
Claim amendments require that any added feature be directly and unambiguously disclosed in the application as originally filed. This limits applicants’ ability to adjust claim scope during examination. Combining elements from separate parts of the description, especially from different lists, isn’t allowed unless the specific combination is clearly taught in the original text.

When filing with the USPTO:
With the USPTO, applicants can amend claims using language from across the specification, even if the exact combination wasn’t explicitly disclosed. As long as the amended claim reflects the overall concept of the invention and doesn’t introduce new matter, it’s usually accepted.

Expert suggestion:
Draft applications from the outset with potential amendments in mind.

Foreign filing restrictions

When filing with the EPO:
The EPO doesn’t impose restrictions on where an application must be filed first, but individual European countries may have their own rules. For example, France and Spain require first filing in the national office or prior approval to file abroad if the inventors reside there.

When filing with the USPTO:
The USPTO requires that inventions made by US residents or citizens be filed first in the United States, or that a foreign filing license be obtained before filing abroad. Failing to comply can lead to the patent being invalidated or blocked.

Expert suggestion:
Coordinate closely with all inventors and legal counsel when they’re based in different jurisdictions. Before submitting an international application, ensure that all national security and filing requirements are satisfied to avoid procedural complications or legal challenges.

Question from the audience

Can you explain how grace periods work in the US and Europe, especially for academic disclosures?

In the United States, inventors benefit from a 12-month grace period for disclosures made by themselves or derived from them. This allows them to publish or present their work and still file a patent application within a year. In contrast, the European Patent Office doesn’t offer any grace period. In Europe, any public disclosure before the filing date can destroy novelty, even if it originates from the inventor.

Get help early on!

Filing one patent application that satisfies both the EPO’s strict formalism and the USPTO’s broader interpretation standards is challenging. It’s best to get qualified, personalized advice early on.

If you’re a scientist turned entrepreneur, you don’t have to overcome the legal hurdles of building a business alone:

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