Rare Disease Patent Filings Up, Report Says, But Antibiotics May Lose Another Decade

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By John T. Aquino

June 16 — Global patent filings for rare diseases continue to be strong, while those for new classes of antibiotics lag far behind, according to a report a London law firm released June 16 at the 2015 BIO International Convention in Philadelphia.

Gareth Williams of Marks & Clerk told Bloomberg BNA in a pre-session interview that the key message of the report is that government incentives work.

“The top five for patent filings for drugs to treat rare diseases are the U.S., Europe, Japan, Canada and Australia, all of which have instituted incentives to treat rare diseases, although in the U.S. they are called ‘orphan drugs,' ” Williams said. “And there are fewer filings for vaccines and antibiotics, where there are fewer government incentives.”

Williams said, “And so it is logical to conclude that there is a need for other incentives for vaccines and antibiotics beyond patent filings.”

The report, titled “From Rare to Routine,” looks at patent filing trends around the world in the rare diseases, vaccines and antibiotics markets over the last decade and finds striking differences.

Change Needed for Antibiotics

According to the report, antibiotic research levels are extremely low, particularly for new classes of antibiotics, and the approaching crisis in antibiotic resistance has the potential to be catastrophic for human health care.

Williams told Bloomberg BNA that, “Research into new antibiotics classes averages less than 5 per cent of total antibiotic research patents filed over the last 10 years, which means that something has to change in order for antibiotic-resistant research to avoid losing another decade.”

Seven times more patents are being filed for prophylactic vaccines, which are designed to prevent the occurrence or lessen the effects of a disease, than for therapeutic vaccines, which are created to treat diseases such as cancer and HIV/AIDS, the report said.

“Big pharma” dominates rare diseases research, but Chinese companies are significant antibiotics innovators and public organizations are filing large volumes of patents for vaccines research, the report said.

Other highlights of the report were:

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

• universities are also playing a key role in antibiotic research, with the universities of California and Texas the third- and the eighth-highest filers;

• big pharmas 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 active in this area;

• public organizations are significant filers of vaccines-related patents, with the U.S. Department of Health and Human Services filing more than double the amount of any other filer; and

• Chinese organizations recently have begun or increased filing programs for vaccines—Lanzhou Veterinary Research Institute, Pulai Ke Biological Engineering and Jiangsu Academy of Agricultural Sciences.


Antibiotics, Patent Eligibility

Williams told Bloomberg BNA that an additional problem in obtaining patent claims for antibiotics is the impact of Ass’n for Molecular Pathology v. Myriad Genetics, Inc., in which the Supreme Court held that isolated DNA isn't patent eligible because it is naturally occurring. A recently discovered new class of the antibiotic teixobactin, which was found in a pile of dirt, was held by the U.S. Patent and Trademark Office to be patent ineligible under Myriad. The patent owners are asking the PTO for a reconsideration.

If there were attempts to patent penicillin today it would be difficult to see how they would succeed in the U.S., given recent court decisions, Williams said.

“It would not be the same problem with patent eligibility in Europe and almost every other country to patent a new class of antibiotics. It is primarily a U.S. problem. But patent filings for new classes of antibiotics is still a problem throughout the world because of the issue of low profitability of antibiotics that has caused life sciences companies to put their research efforts elsewhere. It’s also difficult to find new classes of antibiotics. The largest patent filings for antibiotics are modifications of existing classes and the largest of these are related to penicillin. And finally, until recently, there have been few government incentives to find new classes of antibiotics.”

Williams said, “The issue of the possible ineligibility of patent claims for new classes of antibiotics shows that this is an area where there is the need for more government incentives that offer some exclusivity regardless of the status of the patent filing.”

A Catalyst?

Williams said, “We hope the results of these reviews for new classes of antibiotics, together with increasing public pressure and media attention, will result in an increase in research into antibiotics, particularly from big pharma.”

He 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 health-care companies. Research in this area shows little sign of abating, with patent filing numbers gradually regaining their pre-financial crisis level.”

To contact the reporter on this story: John T. Aquino in Washington at jaquino@bna.com

To contact the editor responsible for this story: Lee Barnes at lbarnes@bna.com

The report is at http://www.marks-clerk.com/MarksClerk/media/MCMediaLib/PDF's/Reports/Life-Sciences-Report-2015-From-rare-to-routine.pdf.

An infographic showing the numbers of patents filed by the world’s top 10 pharmaceutical companies over the last decade in medicines for rare diseases, antibiotics and vaccines is available at http://www.marks-clerk.com/MarksClerk/media/MCMediaLib/PDF's/Reports/Life-Sciences-Report-2015-From-rare-to-routine-Infographic.pdf

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