Patents: Indispensable tool for innovation
You don’t need to convince Sontra Medical that patents are important. The Franklin company, which is developing devices based on MIT ultrasound research, is already fending off a possible infringer just months after its first product reached the market.
On February 1, Sontra sent a letter to Dermisonics, a Pennsylvania startup, claiming that one of that firm’s products — U-Strip — may be infringing on Sontra patents involving transdermal delivery of drugs. "Sontra takes this matter very seriously and will take all necessary actions to protect our intellectual property," warned CEO Thomas Davison in a statement.Sontra’s SonoPrep system uses a titanium handpiece, pressed against the skin, to deliver ultrasound energy. The procedure makes the skin permeable enough either to deliver medication or to draw fluids from the body, as in glucose monitoring for diabetics.
In June 2004, the FDA approved SonoPrep, used with an anesthetic cream, to numb the skin prior to inserting a hypodermic needle or intravenous line. Some 300 medical facilities have adopted the system, says Marketing VP Barry Marston, primarily in pediatric settings. The application represents a $100 million annual market, according to Sontra.
Far more enticing is the potential use of ultrasound technology in the $5 billion annual worldwide market for glucose monitoring. Instead of the annoying finger prick tests that most diabetics must endure to monitor blood sugar levels, SonoPrep employs ultrasound and a biosensor to perform the test noninvasively. This year Sontra is beginning clinical trials on this application of the technology.
Filling the IP arsenal
Sontra Chief Engineer Scott Kellogg says that obtaining and defending patents is essential to getting these new devices to market. Besides licensing MIT patents, Sontra has received four U.S. patents of its own, and 6 more are pending. And to tap global markets, the firm has obtained 2 foreign patents, with 15 pending.
Kellogg estimates that Sontra spends about $150,000 a year on intellectual property, and he devotes about 10 percent of his time to IP strategies. "You must constantly evaluate your technology to decide where patents are needed moving forward," explains Kellogg.
Area patent attorneys agree that it is particularly important for medical companies to begin the patent process as early as possible, due to the high volume of applications and the complexity of the technology. "I have one client in the dental field who will be waiting three years by the time examiners begin evaluating the application," says Jody McLane, a patent attorney at Bowditch & Dewey in Worcester. That’s double the waiting time for a typical mechanical device.
Because of such delays at the U.S. Patent and Trademark Office — patent filings are now at an all-time high of 350,000 annually – some devices in fast-changing fields could be obsolete even before a patent is issued, adds Worcester patent attorney Brian Dingman of Mirick O’Connell DeMallie & Lougee.
Dingman stresses that protecting intellectual property goes hand in hand with business strategy. He urges companies to ask their patent attorneys to perform an "intellectual property audit" to help determine where patents make sense. And while patent applications for electromechanical devices like SonoPrep account for a large portion of patent volume, attorneys point to a surge in "business method" patents. This area covers everything from software to investment strategies.
Whatever their focus, patents aren’t cheap. Total fees to steer an application through the patent maze can easily reach $12,000, says McLane of Bowditch & Dewey. Still, attorneys note that those costs pale in comparison to the market losses that can occur if competitors hijack your idea.
Larry Maloney can be reached at lmaloney@wbjournal.com
WBJ Web Partners
Most Recent
Most Recent
0 Comments