Five tips for patenting inventions in personalised and stratified medicine

As medical treatments become increasingly bespoke, we reveal some best practices to ensure that you secure the highest quality patents possible.

The idea of customising treatments to patients is not new, but the degree to which therapies can now be tailored to specific sub-groups – defined by particular genetic or other molecular characteristics – or even individuals is the most significant breakthrough in medical science to emerge in our times. As might be expected from such a high-investment, high-yield field of research, those working in the space are keen to protect their innovations using the patent system.

However, patenting personalised and stratified medicine inventions is a complex and diverse area of domestic and international law, with different countries holding distinct perspectives on the protection of such technologies. This article analyses five key considerations when building a portfolio in this sector.

1) Data, data, data

For inventions in the precision medicine space, you can expect examiners to get into the detail of the invention and pay particular attention to the data included with the application. As many IP offices do not allow for evidence to be supplemented later in the patent procedure, it is critical to consider what you include at the filing stage, to ensure that it matches your ambitions for the scope of the claims.

The amount of detail required to obtain a granted patent varies from case to case, but as a rough guide the data should render the invention of the claims plausible. The required level is incomparable to the data obtained from a clinical trial and is likely to be less than required for manuscript publication. However, applications are more likely to succeed if they include evidence for the diagnostic correlation, patient sub-group or other effect in more than a single patient or sample class. For example, if the data in the application demonstrates the upregulation of a particular biomarker in only a few samples of serum obtained from patients who share particular characteristics (eg, they are all male), it is not unreasonable to predict that some patent offices will be reluctant to grant claims that encompass the detection of that biomarker in any type of sample, in any patient, regardless of sex.

Of course, balancing the need to file a patent application with the time required to obtain a broader or deeper data set is a recurring problem for patenting in the life sciences. However, holding off on disclosures in order to include additional data in the application can reap benefits in the personalised medicine space. The extra information may prove essential for overcoming allegations of lack of novelty or obviousness, with patent offices frequently identifying high volumes of prior art against personalised and stratified medicine claims.

Given the intensive scrutiny that such cases often experience, and the high volume of prior art that often emerges, it is particularly important to pay close attention to further claim features and fallback positions. Features such as sample type, sample processing steps, threshold values or analysis tools may at first glance appear unduly limiting and consequently undesirable. However, they may prove to be a lifeline for the patent application. Moreover, such features can turn out to be less restrictive than first thought, particularly when coupled with a first-to-market position and the regulatory hurdles faced by late comers. Consulting with product development teams during the prosecution process can therefore help to ensure that the commercial product and the patent portfolio develop in tandem.

2) Predict the future

Patenting strategies for inventions for personalised and stratified medicine technologies can be a particular challenge, as key biomarkers or combinations may change as the project matures. Therefore, it is crucial to draft initial and follow-up applications with the flexibility to claim new aspects of the technology as it evolves.

Initial patent application filings in this space are often born from large-scale biomarker discovery programmes. While it may be tempting to include the full set of identified biomarkers in the patent filing, this can lead to problems later if the general description focuses on only those few biomarkers that were predicted to be important at the date of filing. If subsequent analysis finds that the clinically relevant biomarker is not one of these predicted few but rather another mentioned in the full set, it can be challenging to refocus the claims due to the absence of general disclosure pointing specifically to that biomarker. On the other hand, the mere presence of this biomarker in the specific examples can create problematic prior art, which makes it harder to file a new patent application later on.

Consequently, while it is important that patent applications relating to personalised medicine be data-heavy, this must be done with an eye to the development of the technology and its significance as prior art against later filings in the portfolio. Future applications may provide valuable additional patent term and can arise from the identification of biomarker combinations with high predictive value, refinements of the protocol or bioinformatic methods developed to analyse the data.

3) Be aware of international differences

The specific requirements of different patent offices around the world should be factored in from an early stage. In addition to the normal approaches to issues such as new matter, enablement, novelty and obviousness, patent applications for personalised and stratified medicine face unique challenges.

The patent laws of many countries explicitly exclude inventions relating to diagnostic methods from protection. In jurisdictions such as Europe and Japan, this restriction applies only insofar as the method is practised directly on the human or animal body. Diagnostic methods practised on samples that have been obtained from a patient are eligible; therefore, patents can be procured for such inventions, provided that the claims do not explicitly recite steps relating to the collection of the sample from the patient. However, some countries (notably, China) take this further and will not grant patents to any method of diagnosis.

The USPTO is a challenging office for innovators in this arena. The US Supreme Court’s 2012 Mayo decision and 2013 Myriad ruling resulted in a dramatic shift in the USPTO’s approach, prohibiting protection for innovations in this field that were previously patentable. Despite this, there are some practical measures that applicants can take to obtain patent protection in the United States, including steps in the method claim that lead to the active transformation of a naturally occurring element (eg, washing, removing or sequencing), actively treating the patient (eg, administering a medicament) or by claiming new combinations of biomarkers or particular detection levels that are indicative of the condition.

Conversely, the EPO is one of the more applicant-friendly for this field, as creative attorneys and the Boards of Appeal have already developed the legal tools needed to protect inventions in the personalised medicine space. For example, the principle that a newly appreciated patient sub-group could give rise to a patentable invention has been in place since 1987 (Decision T 19/86); more recently, in 2007, it was successfully argued (in T 1642/06) that a new technical effect arising from a treatment can lead to “a new clinical situation” that is protectable using medical use claims at the EPO. Combined, this case law provides a sound basis for claims to personalised medicine inventions in the European Union.

The complex international picture means that claims of various formats and relating to different features of a personalised or stratified medicine invention may need to be pursued in separate countries around the world. The specific requirements of each patent office should be factored in from an early stage, to ensure that the application allows for the formulation of claims that meet these.

4) Think about infringement

A key reason for obtaining a patent is the option to enforce it against a copycat. Early consideration of infringement scenarios has particular significance in the personalised and stratified medicine space.

Composition of matter claims are rarely appropriate for such inventions, and method claims and medical use claims dominate the landscape. However, this raises interesting questions about infringement, which should always be considered at an early stage in order to ensure that the protection obtained is a useful deterrent against copying.

During infringement proceedings, the burden of demonstrating that each and every step in the claimed method is being performed by the infringer falls on the patent owner. Consequently, as in other fields of invention, method claims with as few steps as possible are preferable. Attempting to match the language of the claim to the anticipated wording of any marketing authorisation (eg, for a companion diagnostic) is also a helpful, if challenging, approach.

A particular difficulty with patents in the personalised and stratified medicine space is identifying likely infringers and the parties you may wish to enforce a patent against. The process of obtaining a diagnosis or determining whether a patient is suitable for a particular treatment often involves a large number of different actors. For example, a patient may provide a biological sample to a physician, who passes this to a third party for analysis. The third party may constitute multiple separate parties, each carrying out individual parts of the analysis (eg, so-called ‘wet lab’ analytical techniques on the sample, data analysis and data processing), before returning data to the physician for further analysis and ultimately diagnosis of the patient. Indeed, the physician receiving the data may not be the same individual who initiated the sample collection or requested the analysis. In this situation, no single person has undertaken every step of the diagnosis and it may be challenging to demonstrate coordination between all parties, making the enforcement of a multi-step method or use claim problematic.

A further problem for personalised and stratified medicine claims arises from the increasingly international nature of medical science. Centralised diagnostic facilities in one country may receive samples or data from others, meaning that different phases of the methodology can occur in different countries. Tis contrasts with the jurisdictional nature of patent law, where the effects of a patent often stop at the border. We can expect further complications as data processing, storage and analysis migrates to the Cloud, as it may not be tied to computer hardware in a particular location.

There is no single strategy available to mitigate these problems. However, claims with fewer steps or which target only a part of the diagnostic process, rather than the method from patient to patient, may be more enforceable.

Patent law provisions that extend the protection of process claims to the products obtained directly from those processes can offer an alternative route to enforcing patents in this area. Such provisions can be found in the national laws of many European countries, as well as other major jurisdictions such as the United States and Japan, and patentees should consider whether the diagnosis itself (eg, whether the patient has a particular disease or is suitable for treatment with a certain medicament) could be understood to be the direct product of a patented process and thus an act such as importing that diagnosis could be considered infringing. For this reason, dependent claims to seemingly routine steps (eg, delivering the diagnosis to the patient) may be useful.

However, success with this approach is not guaranteed. In Decision X ZR 124/15, the German Supreme Court found that the import of test results did not constitute an infringement, in part because “information” was not something that was protectable under German patent law. Tis approach is likely to be tried again in the future and it will be interesting to see whether other jurisdictions follow the German example or adopt a more patentee-friendly approach.

5) Be prepared for the legal landscape to shift

A final tip for the owners of personalised and stratified medicine inventions is to be aware that the law in this area is in flux and is likely to remain so in the coming years as companies and governments continue to invest heavily in these technologies. It is difficult to predict or prepare for significant changes in approach, such as those triggered by Myriad and Mayo in the United States. However, by taking account of the various methods already adopted by offices around the world, and by incorporating claim language and general descriptions that reflect experimental data included in the application, patent filings can incorporate a degree of future proofing.

This blog was originally published on iam. View the original article here.