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Chronic diseases including cardiovascular conditions, diabetes, cancer and stroke are the leading causes of death and disability worldwide.
It is prudent to suggest that disease prevention should be the most affordable and effective strategy to reduce risk and severity of chronic diseases. Several disease prevention strategies can be suggested, but undoubtedly preventive systems such as clinical health services that can provide proper instruments for battling against chronic diseases by detecting disease early are crucial.
Examples of two of the most powerful “therapeutic weapons” for prevention and treatment of disease are magnetic resonance imaging (MRI) and computer tomography (CT) technologies. In an ideal world, both techniques should be as common as smartphones are currently, due to their performance on detecting tissue abnormalities in early stages or during disease development. In other words, an ideal health plan should comprise routine MRI/CT scans, not only for minimising disease death tolls, but for full comprehension of modern diseases in order to eradicate disease.
But why is this ideal so different from the real landscape? At least three reasons suggest a possible answer:
The total cost of owning and annually maintaining MRI and CT equipment can run from $1 million to $15 million and $20,000 to $200,000 respectively, which means that clinical health services must carefully prioritise patients by demanding exorbitant fees per user. According to OECD data, currently in the US there are 35 MRI and 55 CT units per million inhabitants respectively, while in emerging economies like Mexico, equipment units per million residents can fall to 2 for both MRI and CT scanners, which illustrates that the possibility to treat and prevent diseases depends on wealth.
Self-medication is a global phenomenon, especially in economically deprived communities. As the World Health Organization has stressed, the prevalence of self-medication in wealthy communities like the US or the EU is around 10-15%, while in communities like Mexico or Northwestern India (Punjab) this can rise to 80%. Not surprisingly, lack of wealth reduces life quality, stops communities designing preventive systems and obliges them to have a ‘plan B’: self-treat instead of prevent.
Half of worldwide deaths are related to chronic diseases—but the toll and the severity of them could be considerably reduced by means of preventive systems, regardless of whether the lack of disease prevention is due to economic and/or cultural reasons. Patents covering preventive and disease treatment technology have demonstrated their role in solving health problems, but there can be controversy over obtaining patent protection for treatment and (preventive) diagnosis methods practised on the human or animal body.
Suitable claim formulations (like ‘Swiss-type’) related to either a pharmaceutical composition used for treating disease or a (preventive) diagnostic method comprising MRI and/or CT technology are known to circumvent the objection to patentability. However, claiming a substance or composition X used for a disease treatment, rather than a limited diagnostic method that could be used for preventive purposes, is seen as easier and likely to result in broader scope.
The Achilles’ heel for (preventive) diagnostic methods is that if they are practised on the human or animal body—ie, it involves any interaction which necessitates the presence of the patient (which is in fact the essence of the invention)—they will be exempted from patentability, regardless of whether they include a non-invasive method like MRI.
The following brief survey using the Espacenet patent search engine looks at prevention and treatment from the patent point of view:
Within the patent offices in the US, Europe, Japan, China and Mexico, there is a big gap between inventions for treating cancer, stroke or diabetes comprising a pharmaceutical composition with inventions for (preventive) diagnostic methods regarding the same chronic diseases comprising MRI and CT technology. For tumour detection versus treatment, the MRI/CT to pharmaceutical compositions ratios are 37:331 (US), 2:136 (EPO), 12:117 (JP), 57:379 (CN) and 0:29 (MX). For strokes, the ratios are 4:120 (US), 2:20 (EPO) 7:13 (JP), 4:58 (CN) and 0:15 (MX). For diabetes they are 1:580 (US), 0:195, (EPO), 0:117 (JP), 0:447 (CN) and 0:109 (MX).
In contrast, there seems to be more of a balance in relation to heart disease (top cause of death worldwide). Overall data suggest that as the disease has a bigger influence within society, the balance between treatment and (preventive) diagnosis inventions is higher.
In conclusion, it seems that the balance depends on factors including wealth, culture and mortality impact of chronic diseases within society. In Mexico (with similar IP laws to Europe), the disease prevention market is ready to be exploited by assuring our clients and potential stakeholders that Goodrich Riquelme Asociados’ staff fully understand the prevention-treatment dynamics discussed here, while in combination with our proven experience in patent law and medical technology we can look forward to protecting your inventions.
José Enrique Herbert Pucheta has a PhD in magnetic resonance spectroscopy (magna cum laude, UPMC-Sorbonne, France). He joined Goodrich Riquelme Asociados in 2016 as a junior patent attorney, and specialises in the screening, translation, prosecution and licensing of chemistry, physics, biotechnology, medical instrumentation and national and international pharmaceutical patents.
chronic disease, diabetes, cancer, stroke, MRI, José Enrique Herbert Pucheta