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來源：IPRdaily中文網(wǎng)（IPRdaily.cn）
作者：Rachel Bell，Trainee Patent Attorney，麥仕奇英國劍橋辦公室
翻譯：楊筱楊（Xiaoyang Yang），Associate，麥仕奇北京辦公室

關(guān)于流感治療方法和疫苗的已公開專利申請在2018年會達到很高的數(shù)目，這也意味著在這一領(lǐng)域的科研和創(chuàng)新在增加。在流感疫苗的專利申請上，中國和美國居于世界領(lǐng)先地位。過去十年中，超過 70%的流感相關(guān)優(yōu)先權(quán)申請?zhí)峤辉谥袊兔绹ㄖ袊鵀?4.9%，美國為37.6%）。特別值得注意的是，這些申請中，只有大約8%為提交到歐洲專利局的首次申請。

隨著深冬到來，最近我們之中肯定有許多人已經(jīng)因為流感倒下。在多數(shù)情況下，流感病程較短，我們很快就能康復。但對于抵抗力弱的人群，比如老年人或那些已經(jīng)患有基礎(chǔ)病的患者，流感則有可能致命。

從2000年起，英國的國民醫(yī)療系統(tǒng)（“NHS”）開始提供冬季流感疫苗。然而英國公共衛(wèi)生部發(fā)布的一項關(guān)于2017/2018流感季的報告指出，流感導致的死亡人數(shù)仍舊令人震驚（去年僅英國就有近16000人死亡）。

在如1918年西班牙大流感的某些極端情況下，流感病毒毒株通過變異可以變得高度致命。盡管西班牙大流感有其時代背景，這場有大約5000萬到1億死亡人數(shù)的疫情（相當于全球人口的3%到5%）告訴人們必須研發(fā)新的疫苗。

疫苗接種的創(chuàng)新

如同防控任何一種病毒，防控流感的關(guān)鍵在于面對不斷演化的病原，所研發(fā)的新疫苗和治療方法能不落其后甚至更為超前，這也就成了演化上的一場貓鼠游戲。在過去幾年中，隨著高毒性跨物種流感病毒毒株更多地出現(xiàn)，對發(fā)現(xiàn)治愈流感的靈藥的需求愈發(fā)緊迫。

從現(xiàn)有申請遞交趨勢（見下圖）來看，關(guān)于流感治療方法和疫苗的已公開專利申請預計在2018年會達到很高的數(shù)目。這也意味著在這一領(lǐng)域的科研和創(chuàng)新在增加。

流感疫苗的專利評估和創(chuàng)新圖景

所以，這些申請都是來自哪里，又是由誰提交的呢？我們的分析揭示了一個以激動人心的新科技為發(fā)展方向的復雜專利圖景。這些新科技能幫助人們從新角度戰(zhàn)勝流感。

地理分布—東方vs西方

在流感疫苗的專利申請上，中國和美國居于世界領(lǐng)先地位。過去十年中，超過 70%的流感相關(guān)優(yōu)先權(quán)申請?zhí)峤辉谥袊兔绹ㄖ袊鵀?4.9%，美國為37.6%）。特別值得注意的是，這些申請中只有大約3%為提交到英國知識產(chǎn)權(quán)局的首次申請，8%為提交到歐洲專利局的首次申請。

優(yōu)先權(quán)申請是一項發(fā)明在全世界的首次專利申請，因而能很好地反映出特定科技領(lǐng)域的創(chuàng)新程度。在中國提交的大量優(yōu)先權(quán)申請可能反映出創(chuàng)新工作源自中國境內(nèi)，另一方面美國作為全球重要市場吸收了許多非本國申請。

新疫苗技術(shù)

新近的申請中有相當數(shù)量是關(guān)于現(xiàn)有疫苗的生產(chǎn)改進，如用新技術(shù)在疫苗產(chǎn)品中去除內(nèi)毒素和使用改良的佐劑。此外，新申請中還有一部分是關(guān)于對抗流感的新疫苗技術(shù)。

例如，最近的一個由Jassen生物科技公司和賓夕法尼亞大學基金會共同提交的申請?zhí)岬搅艘环N新的AAV（adeno-associated virus，腺相關(guān)病毒）疫苗。這項技術(shù)的核心在于使用基本上能直接生產(chǎn)出對抗流感病毒的抗體的病毒粒。

這種疫苗使接種疫苗的人無需接觸流感病毒即可產(chǎn)生出對抗流感病毒的有效中和抗體。通過AAV載體實現(xiàn)“被動免疫療法”是一項激動人心的手段，可在今后用于治療棘手的病毒感染，如流感病毒感染。

MicroRNA治療

許多關(guān)于microRNAs (miRNAs)的申請為診斷和治療流感提供了可能的新途徑。miRNAs是單鏈RNA結(jié)構(gòu)，作用于人體并能夠和信使RNA（mRNA）相互作用，后者在人體中指示蛋白的合成。

中國科學院微生物研究所在此領(lǐng)域提交了很多的申請，在最近的申請中提到了許多和流感有關(guān)的miRNAs。微生物研究所發(fā)現(xiàn)，這些miRNAs的轉(zhuǎn)基因表達作用于許多重要的病毒mRNA片段，特別是重要的RNA聚合酶亞單元PB2（在流感病毒的轉(zhuǎn)錄和復制中起到關(guān)鍵作用的組件），能夠限制許多流感病毒的復制。因此，將這些miRNAs給藥到病人體內(nèi)，可以防止mRNA對PB2的指令轉(zhuǎn)化為功能蛋白，從而限制病毒在體內(nèi)的復制和存活。

在對抗流感的前沿

在防控流感領(lǐng)域多個方向上的創(chuàng)新令人感到欣慰。高毒性流感病毒毒株造成的威脅非常嚴峻，而城市人口自1918年來的大幅增長（盡管具體數(shù)據(jù)很難得到，但據(jù)世界銀行估算，全球城市人口從1960年的33%已增長至現(xiàn)在的55%）又加重了這一威脅的嚴峻性。在這一背景下，則不難理解防控流感領(lǐng)域中有如此大的創(chuàng)新動力了。

附注：

英國公共衛(wèi)生部關(guān)于2017/2018流感季的報告（英文），見以下鏈接：https://assets.publishing.service.gov.uk/government/uploads/system/uploads/attachment_data/file/740606/Surveillance_of_influenza_and_other_respiratory_viruses_in_the_UK_2017_to_2018.pdf

附：英文全文

FLU VACCINES: ASSESSING THE PATENT AND INNOVATION LANDSCAPE

With winter in full swing, no doubt many of us will have come down with flu recently. On most occasions, influenza is a short-lived illness from which we quickly bounce back. For vulnerable groups however, such as the elderly or those with underlying health conditions, the flu can be deadly.

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).

In extreme cases also – such as during the so called ‘Spanish flu’ of 1918 – strains of the flu can develop which are far more deadly than most of us experience. While the circumstances surrounding the emergence of Spanish flu were unique to the time, the fact that an estimated 50-100 million people died (somewhere between 3% and 5% of the global population), means new vaccines must be developed.

Innovation in inoculation

As with any virus, containing influenza is a question of developing novel vaccines and therapies that can keep up, or get ahead of, constantly evolving pathogens – a game of evolutionary cat and mouse. With more virulent cross-species flu strains hitting the headlines over the past few years, the pressure to discover a golden bullet treatment – a “cure” for flu – has increased.

As such, the number of published patent applications directed to flu therapeutics and vaccines is projected – based on current filing trends – to reach a notable high in 2018, suggesting that research and innovation in this field has been on the increase.

流感疫苗的專利評估和創(chuàng)新圖景

So, where is this filing coming from and who is doing it? Our analysis reveals a complicated patent landscape with a movement towards exciting new technologies that may help defeat flu from new angles.

Geography – East vs West

When it comes to filing patents directed towards flu vaccines, China and the US are leading the world – accounting for more than 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.

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 and improved adjuvants. 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 AAV (adeno-associated virus) 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.

MicroRNA treatment

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, has recently described a number of miRNAs of relevance in flu. 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 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.

On the frontier of flu

It is reassuring to see innovation on many fronts in the flu field. Given the seriousness of the threat posed by virulent strains of flu – enhanced by the fact that the urban population has increased significantly since 1918 (data is hard to come by, but the World Bank estimates the global urban population to have increased from 33% in 1960 to 55% at present) – the impetus for innovation is understandable.

Note:
The report on the 2017/2018 flu season published by Public Health England is available at https://assets.publishing.service.gov.uk/government/uploads/system/uploads/attachment_data/file/740606/Surveillance_of_influenza_and_other_respiratory_viruses_in_the_UK_2017_to_2018.pdf

來源：IPRdaily中文網(wǎng)（IPRdaily.cn）
作者：Rachel Bell，Trainee Patent Attorney，麥仕奇英國劍橋辦公室
翻譯：楊筱楊（Xiaoyang Yang），Associate，麥仕奇北京辦公室
編輯：IPRdaily趙珍校對：IPRdaily縱橫君

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流感疫苗的專利評估和創(chuàng)新圖景

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