Have you had your flu jab this year? Despite the controversy surrounding the efficacy of the flu vaccine, almost 12 million people were given the vaccine in the UK during the 2017/2018 flu season. In light of the news that this flu season brings a brand new ‘adjuvanted’ vaccine for those aged 65 and over, Rachel Bell takes a look at the patent landscape surrounding innovation in flu therapeutics and vaccines.
A winter flu vaccine has been offered on the NHS since 2000. However, a report on the 2017/2018 flu season published by Public Health England indicates that flu still causes a shocking number of deaths (almost 16,000 deaths in the UK alone last year), mainly among the elderly. With more virulent cross-species flu strains hitting the headlines over the past few years, this has only fuelled the search for a golden bullet treatment – a ‘cure’ for flu.
2018 sees a peak in flu patent publications
The number of published patent applications directed to flu therapeutics and vaccines is projected to reach a notable high in 2018 based on current filing trends, suggesting that research and innovation in this field has been on the increase. Top filers over the last few years include a number of key players in the pharmaceutical industry such as Janssen Sciences, MedImmune and Novartis, but of note, a number of universities and research institutes also came out on top.
Our analysis indicates that China and the US are leading the way, producing over 70% (34.9% and 37.6% respectively) of flu-related priority applications filed in the last decade. Notably, only around 3% were first filed at the UK Intellectual Property Office, and 8% at the European Patent Office. A priority application is a first patent filing of an invention anywhere in the world, and hence tends to be a good indicator of innovation in a particular technology area. Whilst the large volume of priority applications filed in China is likely to reflect innovation coming from China itself, as a major market the US also attracts many non-US applicants.
An insight into flu innovation
Traditional Chinese medicines
Intriguingly, the vast majority of new Chinese priority applications over the past few years have been directed to traditional Chinese medicines, involving a range of plant extracts such as peppermint, honeysuckle and chrysanthemum. It is interesting to consider the patentability of such medicines, given that many have been used for several thousand years and so the use of these extracts to treat particular ailments may well have been ‘disclosed’ to the public previously. One particular pending application (CN201810793200) describes toothpaste with a number of additives including Angelica dahurica, ginger, rhubarb and menthol – which is claimed to offer influenza killing properties, as well preventing tooth cavities.
Whilst the jury is still out on the efficacy of such medicines, as China hopes to modernise and develop the exportation of their traditional medicines, these products may well be an area of growth outside of China in the future. We will watch this space to see if the flu-killing toothpaste application, as well as other traditional Chinese medicines, is successfully granted.
New vaccine technologies
There have been a significant number of recent applications directed at improving the production of existing vaccines such as new techniques for removing endotoxins in vaccine products (CN107893058A) and improved adjuvants (CN108452300A). However, in addition, new vaccine technologies against flu have also been demonstrated in recent filings.
For example, a recent filing by joint applicants Janssen Biotech, Inc. and The Trustees of the University of Pennsylvania (US20180243416A1) describes a new adeno-associated virus (AAV) vaccine. The core of this technology is a viral particle which produces, essentially, ready-made antibodies against the flu virus. One effect of this type of vaccine is that a vaccinated individual is able to produce effective neutralising antibodies against the influenza virus, without the need for exposure to the flu virus. Using AAV vectors for what is known as ‘passive immunotherapy’ is an exciting option for treating challenging viral infections, including influenza, in the future.
A number of filings directed to microRNAs (miRNAs) offer a new potential avenue for both diagnosis and treatment of flu. miRNAs are single-stranded RNA structures which are processed by the body and capable of interacting with messenger RNA (mRNA) which serve as the instructions for the production of proteins.
For instance, a particularly prolific filer in this area, The Institute of Microbiology, Chinese Academy of Sciences, have recently described a number of miRNAs of relevance in flu – mir-487-5p (CN108374011A), mir-486-5p (CN108079007A), mir-127-3p (CN108342388A) and mir-593-5p (CN108359725A). The applicant in this case has found that the transgenic expression of these miRNAs can limit replication of a number of flu viruses by targeting of a number of key viral mRNA fragments, in particular PB2 which is an important RNA polymerase subunit – an essential part of flu viral machinery which drives transcription and hence replication of the virus. Delivery of these miRNAs to a patient prevents the conversion of the mRNA instructions for PB2 to a functional protein, therefore limiting the viruses’ ability to replicate and survive in the body.
All in all, there appears to be growing innovation in the flu field, which is probably unsurprising given the challenges of a constantly mutating viral opponent, and the media storm whenever a new flu pandemic threatens.