Lawsuits rise with explosion in diabetes care options
Diabetes treatment has evolved since Mary Fortune was diagnosed in 1967 and hospitalized because there was no reliable way to monitor her blood sugar. These days, a glucose skin patch transmits her levels day and night to her iPhone and shares the data with others.
Fortune and other diabetics are benefiting from an explosion in technology and innovation, from under-the-skin sensors that eliminate the need for painful finger pricks, to smartphone alerts when glucose levels rise too high. But the technology, and its integration with mobile devices, has brought the types of lawsuits typically seen by Silicon Valley companies.
For glucose monitors alone, the number of published patent applications has grown steadily for a decade and has accelerated significantly since 2015, according to an analysis by the research firm Patinformatics. More than 880 patent applications related to glucose monitoring have been published so far this year, said Tony Trippe, managing director of the Dublin, Ohio-based company.
“Everybody in the market is realizing there’s an enormous opportunity there,” said Paul Desormeaux, a senior analyst with Toronto-based Decision Resources Group. “Other players are starting to come in, and there’s a lot of competition to make advanced products.”
The boom is driven by a variety of factors, Desormeaux said. The number of people with diabetes in the U.S. is rising – the Centers for Disease Control estimates more than 100 million Americans are now living with diabetes or prediabetes. Insurance coverage for new devices has increased, and there’s a growing number of partnerships between health companies and traditional technology firms such as Alphabet Inc.’s Google, International Business Machines Corp., and Fitbit Inc.
Abbott Laboratories, Roche Holding AG, DexCom Inc. and Medtronic Plc are the top owners of patents, with San Diego-based medical device company DexCom having shown the highest rate of growth since 2015, Trippe said.
Desormeaux is projecting the market for continuous glucose monitors like those used by Fortune to reach $2 billion in 2026, up from $670 million in 2017. That figure doesn’t include devices like insulin pumps, smartphone applications, more traditional products like one-time blood tests, or projections for new products like an artificial pancreas.
“We have so many choices that are more innovative now, than what we had when I was diagnosed,” said Fortune, now executive vice president of the Diabetes Foundation of Mississippi. “With the latest technology, it is much easier to manage and it is only getting better.”
The need for new devices isn’t limited to the U.S., either. China has the most diabetics in the world and is considered a valuable emerging market, according to Bloomberg Intelligence analysts Cinney Zhang and Jamie Maarten.
With the financial stakes rising, so has the number of legal disputes among companies seeking to increase their market share for these new treatments over innovations like signal processing, increased sensitivity of glucose levels, and wireless communications.
DexCom, the market leader in monitors, is embroiled in litigation with AgaMatrix Inc. in federal court, before the U.S. Patent and Trademark Office, and at the U.S. International Trade Commission. DexCom’s also fighting an infringement suit filed by closely held Arbmetrics LLC over an implantable glucose sensor, while DexCom and Abbott resolved several patent suits in 2014.
Roche’s diagnostic unit last year settled a case over patents for sending medical information to smartphones.
A small Texas company called Blue Sky Networks sued Roche over short-range direct communication between wireless devices. Blue Sky has also sued Fitbit Inc., Toyota Motor Corp., and Lenovo. Medtronic two years ago fended off an infringement suit targeted at its CareLink system of diabetes tracking.
And it’s not just glucose monitors or disputes over proposed generic versions of diabetes drugs. Sinocare Inc.’s Polymer Technology Systems has filed patent-infringement complaints against Acon Laboratories Inc. over blood cholesterol systems and test strips that can be used in homes or at health fairs for on-the-spot results. Patents for cholesterol tests are on the rise as well, Trippe said, as part of a trend of innovation to help people who are part of America’s obesity epidemic.
“Any time you see trends with the population, you’re going to see corporate America respond to that,” said Kirsten Thomson, a lawyer with McDonnell Boehnen Hulbert & Berghoff who specializes in medical device patents and trademarks. “The race is on to be the market leader in this space.”
There’s no cure for diabetes, although the condition can be treated and controlled. It affects some 30 million Americans, more than 9 percent of the population, according to the CDC. Rates of those diagnosed with diabetes rises with age, to 25 percent of those 65 and older. The disease, in which the body doesn’t produce or properly use the insulin needed to process sugars, can lead to heart disease, stroke, blindness, kidney failure, and amputations of the feet and legs. It’s the seventh leading cause of death in the U.S. Another 84 million U.S. adults have prediabetes, a condition that often leads to type 2 diabetes within five years if untreated.
Being able to monitor the ups and downs of blood sugar levels can help patients adjust their lifestyles and make informed choices on insulin amounts, said Jake Leach, senior vice president of research and development at DexCom.
“Parents who used to go to their child’s school every day after lunch, now they don’t have to go – they can just watch their children’s glucose on the phone,” Leach said. “It’s changed a lot of people’s lives.”
Most of today’s devices are designed to help people with type 1 diabetes, who need daily doses of insulin, and insulin-dependent type-2 diabetes. As the devices get more sensitive, they can be used by other type-2 patients or those with prediabetes to learn how their bodies react to food so they can control it with diet and exercise, Leach said. Researchers also are looking at using monitors for all patients admitted to hospital, to identify stress-induced hyperglycemia, or an excess of glucose in the bloodstream.
“Innovation in the area of glucose monitoring is clearly stepping into the space of making it less intrusive, discreet and intuitive to handle,” said Ulrike Engels-Lange, a Roche spokeswoman.
Most diabetics manage their conditions on their own, but things like remote coaching and therapy support help them connect with doctors when needed, she said.
“This can contribute to improved therapy outcomes, motivation and adherence, but also can support efficiencies for the health-care systems.” Engels-Lange said.
Brenda Rendelman, director of diabetes education for the Central Ohio Diabetes Association, said the newer devices and improvements in insulin treatments have transformed the lives of all people with diabetes. While it’s never a good time to have diabetes, the fast pace of innovation is exciting, she said.
“People with well-managed diabetes can and do the most amazing things,” Rendelman said. “The fact is, diabetes does not kill. It’s the complications that happen when diabetes is not well-managed, for whatever reason – that’s what kills.”