The antibiotics market is at risk of losing another decade to inadequate levels of research and innovation, according to international intellectual property firm Marks & Clerk’s new report From rare to routine—medicines for rare diseases, vaccines and antibiotics. Research highlights the striking difference between research levels into rare diseases, vaccines and antibiotics across the globe.

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

In antibiotics:

• Less than 5% of patents filed for antibiotic research since 2004 are directed toward new classes of antibiotics. Amgen is the leading filer of patents related to new antibiotics.
• 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 top two filers of antibiotics patents (including both known and new classes) are Chinese companies Tianjin Shengji Group and Shandong Xuanzhu Pharmaceutical Technology.
• Universities also are playing a key role in antibiotic research with Universities of California and Texas third and eighth highest filers.

• Big pharma companies dominate top filers. Pfizer, Merck, Novartis and Johnson & Johnson are strongest (when subsidiaries’ filings are taken into account).
• European companies are strong in this area, with Novartis, GlaxoSmithKline, Roche, Boehringer Ingelheim, Janssen Pharmaceuticals and Sanofi all among top 10 filers.
• Filing numbers are consistently high and now are gradually increasing following a dip during the financial crisis, but are yet to recover to pre-2008 levels.

• Public organizations are significant filers of vaccines-related patents, with the U.S. Department of Health filing more than double the amount of any other filer. Harbin Veterinary Institute, Universities of California, Pennsylvania and Texas and Institut Pasteur are among the Top 10 Filers.
• Veterinary research organizations and companies also are present.
• Chinese organizations have recently begun or increased filing programs (Lanzhou Veterinary Research Institute, Pulai Ke Biological Engineering and Jiangsu Academy of Agricultural Sciences).
• Seven times more patents are being filed for prophylactic vaccines than for therapeutic vaccines.

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,” said Williams. “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 U.S. 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 said, “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.”