Rare disease patent filings on the rise, finds report, but antibiotics may lose another decade

Research into new antibiotic classes represents less than 5% of antibiotics-related patent filings

The antibiotics market is at risk of losing another decade to inadequate levels of research and innovation, according to a new report from London law firm Marks & Clerk.

According to the intellectual property specialist’s new report, From rare to routine – medicines for rare diseases, vaccines and antibiotics, released at the BIO International Convention 2015 in Philadelphia, US, there is a striking difference between research levels into rare diseases, vaccines and antibiotics across the globe.

The report looks at patent filing trends in the antibiotics, rare diseases and vaccines and markets over the last 10 years.

Key findings in the antibiotics area reveal that less than 5% of patents filed for antibiotic research since 2004 are directed towards new classes of antibiotics.

Amgen is the leading filer of patents related to new antibiotics, according to the report, while the top two filers of patents for both known and new classes of antibiotics are the Chinese companies Tianjin Shengji Group and Shandong Xuanzhu Pharmaceutical Technology.

Filing numbers are consistently high for rare diseases and are now gradually increasing following a dip during the financial crisis

Patent filing levels are much lower than for rare diseases, although there has been a gradual year-on-year increase in numbers since 2009, the report finds.

Universities are also playing a key role in antibiotic research, with the Universities of California and Texas third and eighth highest filers.

Big Pharma companies such as Pfizer, Merck, Novartis and Johnson & Johnson are the strongest filers of patents for treating rare diseases, while European companies such as Novartis, GlaxoSmithKline, Roche, Boehringer Ingelheim, Janssen Pharmaceuticals and Sanofi are also strong in this area.

Filing numbers are consistently high for rare diseases and are now gradually increasing following a dip during the financial crisis, but are yet to recover to pre-2008 levels.

Public organisations are significant filers of vaccines-related patents, with the US Department of Health filing more than double the amount of any other filer, the report finds.

Harbin Veterinary Institute, Universities of California, Pennsylvania and Texas, and Institut Pasteur are among the top 10 filers. Veterinary research organisations and companies are also present.

Chinese organisations have recently begun or increased their filing programmes (Lanzhou Veterinary Research Institute, Pulai Ke Biological Engineering and Jiangsu Academy of Agricultural Sciences), the report finds.

Seven times more patents are being filed for prophylactic vaccines than for therapeutic vaccines.

Medicines for rare diseases tell a wholly different story

Dr Gareth Williams, European Patent Attorney and Partner at Marks & Clerk, said: 'With research into new antibiotics classes averaging fewer than 5% of total antibiotic research patents filed over the last 10 years, something has to shift in order to avoid losing another decade to the growing threat of antibiotic-resistance. What is more, in terms of patent filings, antibiotics research as a whole is clearly lagging behind research areas like rare diseases, where a huge number of patents are consistently being filed each year.

'The list of top filers in antibiotics research, which is topped by Chinese companies, shows that this has not been a priority area for Big Pharma over the last decade. Governments around the world are implementing strategy reviews as they look to confront the problem of antibiotic-resistance. We hope the results of these reviews, together with increasing public pressure and media attention, will result in an increase in research into antibiotics, particularly from Big Pharma. The US is a clear leader in this area, but the statistics suggest it is less dominant than in rare diseases and vaccines, with China in particular innovating more and more.'

Williams added: 'Medicines for rare diseases tell a wholly different story. No doubt in large part thanks to the government incentives put in place to encourage orphan drug research, the field is dominated by the world’s largest healthcare companies. Research in this area shows little sign of abating, with patent filing numbers gradually regaining their pre-financial crisis level.'