Ben Appleton and Mohammed Khimji from patent and trade mark firm, Wilson Gunn, explore the complexities, as well as the possibilities, of obtaining patent protection in Europe for inventions relating to biomarkers.
Key highlights:
- Biomarkers are of crucial importance in the personalised medicine journey. They are measurable indicators of biological states and can indicate regular biological processes and pathogenic processes.
- A biomarker could be a specific molecule, gene, cell, enzyme, or protein and can be used for disease detection, diagnosis, monitoring and potential treatment identification.
- Useful diagnostic techniques may be patented based on methods of detecting biomarkers in tissue or bodily fluid samples taken from a patient (as opposed to being performed directly on the patient, which will generally not be patentable).
- A hurdle to overcome is the methods of treatment of the human are per se excluded from patentability in Europe and most other countries.
The COVID-19 pandemic drove home the importance of healthcare more than ever before, cementing the need to continually develop healthcare products and practices to better equip against new and unknown challenges we may face.
In 2020, innovations in healthcare led the way in Europe, in terms of patent publications. Whilst most fields witnessed a reduction in patenting activity during that year, medical technologies, pharmaceuticals and biotechnology saw growths of 2.6%, 10.2% and 6.3% respectively, placing medical technology in pole position with the latter two becoming the fastest growing patenting fields in Europe.
In particular, published patent application statistics from 2020 to 2021 showed that we are witnessing a huge movement towards more personalised healthcare, in which treatment is tailored to the individual patient rather than the population as a whole (or a sub-population).
Biomarkers are of crucial importance in the personalised medicine journey. They are measurable indicators of biological states and can be used as indicators of regular biological processes, pathogenic processes, or of bodily response to therapeutic intervention. A biomarker may, for example, be a specific molecule, gene, cell, enzyme, or protein; or even a measurable physiological parameter such as body temperature or blood pressure.
Biomarkers are used for disease detection, diagnosis, monitoring, potential treatment identification, and much more. Personalised healthcare involves analysing the presence/amounts of biomarkers in patients to allow them to be categorised into groups and for treatment to be tailored based on each group’s predicted health states.
The immense effort being put into biomarker research today and the consequent advancement of medical and pharmaceutical technologies are creating a massive growth in the number of inventions for which patent protection is particularly valuable in securing revenue and market share.
The patentability of biomarker technologies
Whilst many technologies in the biomarker and personalised medicine fields are generally patentable, the types of technologies for which patent protection can be obtained varies greatly depending on jurisdiction. The position is complicated in the US for instance, where inventions relating to correlations in nature, such as the correlation between a biomarker and a particular disease, are notoriously difficult to protect with patents. Whilst restrictions to patenting of discovered correlations in nature also exist in Europe to a lesser extent, a practical use of such a correlation may very well be the subject of a patentable invention – e.g. the use of a biomarker for diagnosing a disease. That said, the medical patent system in Europe is not without its challenges and careful patent claim drafting is often required to avoid objections and secure valuable protection for inventions in this field.
One of the major hurdles to overcome in obtaining patents relating to personalised medicine and biomarkers is the fact that methods of treatment of the human or animal body by surgery or therapy and diagnostic methods practised on the human or animal body are per se excluded from patentability in Europe and most other countries. Luckily, these exclusions are interpreted narrowly and were merely introduced to avoid a situation in which a medical professional would be prevented from treating a patient due to the existence of a patent right. Claims to diagnostic methods, for instance, are only excluded if they contain method steps relating to all the following four phases:
- The examination phase – involves collection of data,
- The comparison of the data with standard values,
- The finding of any significant deviation during the comparison, and
- The attribution of the deviation to a particular clinical picture.
If any of these steps is missing from a claimed invention, the exclusion will not apply. This doesn’t, however, allow for the deliberate removal of vital steps from the claim, which would necessarily be implied – this may occur if a step of diagnosis is included in the claim, but key steps that allow for the diagnosis are not. However, if the inventive part of the method falls in the collection of data step, it may be possible to claim this step alone as long as it does not directly give rise to a diagnosis. An example could be where a method of measuring body temperature is claimed which does not per se identify a medical condition.
Further, to qualify as an excluded diagnostic method, all steps of technical nature (typically only step (i)) must be performed on a human or animal body. This means that methods performed in vitro and post mortem are not excluded, as the technical step is not performed on a living body. Useful diagnostic techniques may therefore be patented based on methods of detecting biomarkers in tissue or bodily fluid samples taken from a patient (as opposed to being performed directly on the patient, which will generally not be patentable).
More good news comes in that the exclusion of methods of medical treatment and diagnosis in European patent law does not extend to substances or compositions “for use in” these methods. Interestingly, even if the substance or composition is known per se or even if it has been previously used in another medical field, novelty will still be conferred if its use in the specific medical area is new. In other words, even if substance X is known for the treatment of disease Y, if it is subsequently found to be effective for the treatment of disease Z, a patent could be granted for the new use.
Protection in the personalised healthcare sphere is not limited to methods and uses but may also be secured for useful products. If a novel biomarker is used, for example in a diagnostic test kit, this may be patentable per se in Europe without the need to reference its particular use. Similarly, novel devices used in such methods may also be protected.
To provide some insight into the vast range of patentable subject matter in the field, here are a few examples of patents granted in Europe for biomarker/personalised medicine inventions.
Examples of patented biomarker inventions
- Example 1 (Disease diagnosis method) - EP2506016B1 – was a patent granted for a method for the early detection of acute kidney injury, which involved determining the concentration of heat shock protein 72 as a biomarker in a urine sample obtained from a mammal. This avoided the diagnostic method exclusion, as the technical step of determining the concentration of heat shock protein 72 was performed on a urine sample taken from a body but not on the living body itself.
- Example 2 (Biomarker monitoring system) - EP2671180B1 – was granted for a novel biomarker monitoring system which included a communications network and a portable wellness device configured to form a communication link with the communications network. The system was able to generate and render wellness data based upon detection of at least one biomarker in a biologic sample.
- Example 3 (Novel biomarkers) - EP3260866B1 – is a member of a family of patents granted for novel peptide biomarkers for cognitive impairment
Examples 2 and 3 demonstrate that protection for personalised medicine inventions is not limited to methods and can also be obtained for novel devices used in such methods or for novel biomarkers themselves.
- Example 4 (Tailored treatment) - EP2971122B1 – was granted for an invention relating to the use of one or more biomarkers to evaluate the likelihood that a rapamycin analogue would produce an anti-cancer effect in a subject, and based on the results, administering the rapamycin analog to produce the anti-cancer effect. The exclusion of methods of medical treatment was overcome by directing the claims to the rapamycin analog “for use in” the treatment of a cancer, wherein cells of the cancer contain particular biomarkers, rather than claiming a method of cancer treatment per se.
- Example 5 (Test kit) - EP2728018B1 – is a patent granted for a kit for providing a prognosis of a subject having a lung cancer – the kit comprises reagents that bind to specific biomarkers, and also comprises a label for detecting expression levels of the biomarkers in order to provide the prognosis.
- Example 6 (Disease monitoring method) - EP3318881B1 – was granted for a method of determining the course of Gaucher’s disease in a subject, the method involving the step of determining the level of a particular biomarker present in a sample taken from the subject at several points in time, wherein the level of the biomarker is indicative of the severity of the disease in the subject.
Conclusion
The prospects for securing useful patent protection for inventions in the field of personalised healthcare appear brighter in Europe than many other parts of the world. However, the various restrictions relating to medical invention patenting and the nuances of European patent law can make personalised medicine and biomarker patenting a difficult turf to navigate, and careful drafting tailored to the invention at hand is essential to avoid getting caught in inescapable traps during examination of your patent application. It is therefore highly recommended to get in touch with a firm of patent attorneys with experience in this sector before pursuing patent protection alone.