Strategies for increasing the quality of patent applications in the life sciences sector

Whether methods for the targeted modification of genes (e.g. CRISPR technology) or mRNA-based vaccines - the scientific disciplines that deal with the structures and processes of living organisms are summarised under the term ‘life sciences’. The most important fields include biotechnology, chemistry, biology and medicine.

In our knowledge-based economy, the protection of intellectual property plays a central role: on the one hand, it motivates innovation through economic incentives; on the other hand, it ensures the dissemination of new technologies, which in turn enable further progress. Over the last ten years, the perceived economic value of patents has changed dramatically. Technology companies, and more recently the financial markets, have begun to view patents not just as a bundle of legal rights, but as assets in their own right, comparable to real estate. A high-quality patent can give start-ups and founders a decisive competitive advantage - whether by securing investment, creating a solid basis for co-operation or protecting against imitators.

The value of a patent on the market depends on its quality. The decisive factor is the advantage of the underlying invention over the state of the art, the scope of protection of the patent claims and the potential benefit in current and future markets.

The quality of a patent application is crucial to effectively enforce IP rights and maximise the economic value of your invention.

In the field of chemistry and biotechnology, the specific strategies listed below can significantly improve the quality of patent applications:

1. Proof of effectiveness over the entire scope of the claims

The application should show that the invention functions over the entire scope of the claims. This requires a precise description of technical effects, preferably supported by experimental data.

Example: If a new conjugate is developed for the treatment of sepsis, the efficacy should not only be demonstrated on one organ, but also on the lung, liver and kidney. This means that experiments should be carried out to demonstrate the technical effects of the invention in different applications or under different conditions.

Author

Clarissa Regler is a patent attorney at Winter Brandl. She specialises in patent prosecution, opposition and nullity proceedings in the fields of biotechnology and chemistry as well as advising start-ups on the protection of their innovations.

2 Functional features

Functional features in patent claims usually offer a broader scope of protection than structural features and can help to distinguish the subject matter of the application from the prior art.

Example: A patent claim could read as follows:
‘A monoclonal antibody comprising a heavy chain having the amino acid sequence SEQ ID NO: 1 and a light chain having the amino acid sequence SEQ ID NO: 2.’

Here the antibody is specifically defined by the exact amino acid sequence of its heavy and light chain. These are structural features.

The same claim could be formulated functionally:
‘A monoclonal antibody that specifically binds to antigen XYZ.’

Here the antibody is not defined by its exact sequence, but by its function, namely the specific binding to a target antigen (XYZ).

The functional definition thus enables a broader scope of protection, as it also covers antibodies with varying sequences as long as they fulfil the same function.

However, at least in the description, structural features should be defined as examples of functional features in order to serve as a fallback position if required.

We will introduce you to other strategies, such as the so-called ‘two-list principle’, in part 2 of the article in January. 

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