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Another lost decade for research?

What does the patent landscape look like for antibiotics, vaccines and orphan drugs?

Another lost decade for research?

We are emerging from a decade of intensive research into rare disease treatments. Government incentives have made research into conditions affecting only small proportions of the population commercially viable when otherwise they would have risked neglect.

However, as the problem of antibiotic resistance develops, treatments for widespread conditions are once again grabbing the headlines. In our report, From Rare to Routine, we analysed the patent landscape for antibiotics, vaccines and medicines for rare disorders to establish where research is going in these very different areas of disease treatments.

From rare to routine
The challenges facing rare disease R&D are unique. In contrast to prevalent diseases, there is no clear economic incentive for healthcare companies to invest in new therapies to treat diseases that only affect a small percentage of the population. As a consequence, over the past 15 years or so, different governments, particularly among developed economies, have introduced various incentives ranging from fast-track marketing approval, protocol assistance, fee reductions, tax credits or protection from competing products in the form of market exclusivity periods, with the aim of incentivising healthcare companies to invest in rare disease R&D. While no one jurisdiction particularly stands out in terms of the incentives offered, a key feature of many programmes is a 'pseudo-monopoly' established by the market exclusivity periods that are designed to give the first mover in a particular rare disease field a reasonable period of time to recover its investment. This is in addition to the monopoly conferred by patent protection.

In our report we looked at the patent landscape of rare diseases, which, broadly speaking, are defined as serious or life-threatening disorders that affect only a small percentage of the population.

It is clear that over the past decade there has been a significant amount of research in this field. The annual number of patent families filed in the field of rare diseases is far higher than for vaccines or antibiotics. Although the latter arguably cover smaller research fields, the results nonetheless suggest that there is significant interest in rare diseases R&D.

Turning to the specifics of the patent landscape, although the number of patent families in this field appears to have declined over the past ten years from a peak of 4,436 in 2005, this could be attributed to the global financial crisis. Numbers dipped in 2008 and 2009, but have since been slowly rising as the market has recovered.

In terms of the geographical distribution of patent filings, the US, unsurprisingly, is the clear leader with 87,491 applications filed at its Patent and Trademark Office between 2004 and 2015. Other developed economies follow behind, but with significantly fewer applications: Europe, Japan, Australia and Canada. It is interesting to note that China, despite having the world's largest population, is only sixth on the list, whereas in other sectors we have looked at, China is typically just behind the US and Europe in terms of patent filings. China does not yet have rare disease legislation.

Big pharma dominates the Top Filers in this field, and consistent with our data on geographical distribution, 13 out of the Top 20 Filers are US-based. The only non-private sector organisations that make the list are three US universities: the Universities of California and Texas, and John Hopkins University. Year-on-year analysis of patent filings for the Top Filers shows that many are filing fewer and fewer patents. However, this downward trend is not reflected among the universities, where patent filings have remained consistent. This trend perhaps reflects the effect of harsh market conditions since 2007 on private companies, rather than a waning interest in R&D in this field.

The US is the clear leader with 87,491 applications filed between 2004 and 2015

Antibiotics
Since their discovery in the early 20th century, antibiotics have revolutionised the treatment of microbial diseases. However, through over-use in human health and animal husbandry microorganisms have emerged that are resistant to nearly every class of antibiotics. While legislation and education can go some way to curb the unnecessary use of antibiotics there still remains an urgent need to identify not only effective derivatives of antibiotics already in use but new classes of antibiotics - as well as non-antibiotic approaches such as other anti-infective treatments. This is also a critical time for investment into point-of-care (POC) R&D. Such technologies, which allow doctors to diagnose bacterial from viral infections or distinguish between different bacteria, could lead to personalised treatments and avoid unnecessary prescription of antibiotics.

Over the past 10 years the number of patent families filed in the antibiotics and anti-infectives field has remained stable, with approximately 1,200 families filed every year. This figure is perhaps disappointingly low when compared to application numbers in the rare disease field.

The US again leads the way with over 19,500 filings. Europe is second place but with nearly half the number of filings. In contrast to the rare disease field, China is third, closely behind Europe in terms of patent filings.

This data is consistent with our research into the Top 20 Filers in this field, with just over half of the 20 Top Filers being US-based, and all but two being private companies. Of note, however, the top two Filers are China-based Tianjin Shengji Group and Shandong Xuanzhu Pharmaceutical Technology.

Analysis of patents relating to known classes of antibiotics found that more patent applications are directed to penicillins than to any other class of antibiotic. This demonstrates that even though there is widespread resistance to this important antibiotic, there is still significant interest in developing new effective derivatives and formulations.

In comparison, analysis of patents relating to novel antibiotic classes reveals a volatile landscape, with the numbers of applications filed an order of magnitude lower than for the known antibiotic classes.

In contrast to the antibiotic field, our research, found in our separate report, Microbial infection: Point-of-care diagnostics, into patent filings relating to POC diagnostics over the past five years has shown a general decease in the number of filings. This may be due in part to the global financial crisis, which undoubtedly will have affected R&D in this specialised field.

Once again, the US is the leading jurisdiction in terms of patent filings with a total of 330 applications filed since 2009. This is followed by the usual players: Europe (139 applications), China and India. The top applicants in this field are certainly more varied than in either the rare disease or antibiotic field, and although private companies are responsible for just over half of all filings (of which 70 per cent are SMEs), universities follow closely behind. Interestingly, government agencies also feature suggesting that antimicrobial resistance is an area of concern at government level.

In terms of research focus, the majority of applications in the POC field concern diagnosis of bacterial or viral infections, with antibiotic resistant tuberculosis being a major focus (28 filings in the past five years), along with MRSA (eight filings) and HIV (nine filings).

There still remains an urgent need to identify new classes of antibiotics

Vaccines
While continual research and the strict implementation of global vaccination programmes have led to the successful near-eradication of a number of once serious diseases, there remain a number of diseases that cause significant morbidity and mortality, such as influenza and malaria, but remain difficult to vaccinate against. As such, the field of vaccine R&D remains an important area for investment. Vaccine research is also changing with the advent of 'personalised' vaccines that can be used to target cancers with specific immunological profiles.

Our analysis of the vaccine patent landscape over the last 10 years has found that the number of patent families in this field has remained fairly constant, at around 1,200 each year.

As with every other area of research analysed in our report, the US again dominates as the most popular jurisdiction, with 23,437 applications being filed since 2004. The usual players follow behind: Europe, Japan, Australia, China and Canada.

Consistent with these results, the Top 20 Filers in this field include the US Department of Health, US-based big pharma and US universities, as well as Chinese institutions such as the Harbin Veterinary Institute.

A promising outlook
While the outlook for rare diseases is promising, with numerous government incentives providing applicants the needed stimulus to invest in R&D, the outlook for the antibiotic field is more concerning. Despite an urgent global need to identify new derivatives or classes of antibiotics, the number of patent applications in this field has remained static over the past decade. Given the successes in the rare disease field, it is clear that there is a need for some form of government incentive to galvanise R&D. Fortunately, in the UK at least, efforts in this direction are already underway with projects such as the government's Review on Antimicrobial Resistance investigating how the development of new antimicrobials can be boosted. Together with efforts from other governments around the world, as well as the private sector, the patent landscape will hopefully look very different in 10 years' time.

Andrea Williams is life sciences patent attorney at Marks & Clerk and can be contacted via awilliams@marks-clerk.com or www.marks-clerk.com

15th December 2015

Andrea Williams is life sciences patent attorney at Marks & Clerk and can be contacted via awilliams@marks-clerk.com or www.marks-clerk.com

15th December 2015

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