Necessity is the mother of invention. It's that way in every facet of the business world, where the value of a company is no longer based on real estate assets and machinery, but instead measured in terms of its intellectual property assets and patent holdings.
“To invent, you need a good imagination and a pile of junk.” —Thomas Edison
Necessity is the mother of invention. It’s that way in every facet of the business world, where the value of a company is no longer based on real estate assets and machinery, but instead measured in terms of its intellectual property assets and patent holdings.
The medical field, according to S. Peter Ludwig, patent attorney and principle with New York City-based Darby & Darby, is no exception. “Physicians are constantly making improvements in the way treatment is administered to patients,” Ludwig explains, “very often with the idea of addressing a problem that is confronted by anyone who practices medicine.”
But, what often doesn’t get addressed by physicians is the importance of protecting their rights as inventors.
Physicians Drive Innovation
Technology in medicine and healthcare is constantly changing. The change is being driven by innovation, and physicians—says Thomas Fairhall, a patent attorney with McDonnell Boehnen Hulbert & Berghoff of Washington state—are driving the innovation. Even if they don’t realize it.
“Physicians are at ground zero, treating patients, working in the operating room—they’re constantly creating new devices, new treatments, new methods of diagnosis,” Fairhall explains. “Innovation is part of life in the medical field, in virtually every area—diagnostics and testing, cardiology, medical monitoring, orthopedics … and the list goes on.”
Ludwig, who also holds a graduate degree in biochemistry from NYU, agrees and points out that most people think of improvements in healthcare as new medicines for treating cancer. However, those improvements often touch on areas including medical devices such as stents and orthopedic appliances, or a new kind of ampule or syringe to help avoid the problem of needle reuse or needle disposal. Problems arise, however, because physicians often overlook the importance of patenting their inventions.
“Most physicians are savvy enough to recognize that when they invent something that has some utility in patient treatment, they know that they have to get a patent for it,” says Ludwig. “But, they’ll often go off and do something that makes it impossible to get a patent. Sometimes they literally give the invention away for a fraction of its real value.”
Time Factor Under US law, an inventor has one year from the date that he/she first discloses information on the invention or offers it for sale to file for a patent application. Foreign patents, however, must be filed before any sale takes place or information is published. Here, says Ludwig, is where physicians often get tripped up.
“You may be a prominent specialist in orthopedic surgery, and you get invited to speak at a large symposium,” Ludwig explains. “You’re asked to submit a paper, a copy of your speech. That speech gets published in the conference, and effectively cuts off your patent rights overseas unless you filed an application before the conference publication is published. So, outside the US, you’re toast.”
Ludwig adds that physicians should not sign any agreements about their invention without first consulting a lawyer, if not a patent lawyer. And, he stresses, keep written records of when you started your work, and have someone you trust sign off on the information to establish the date of your invention. “That can become important later on when it comes to getting a patent, or in dispute with a third party,” he says. “Because in US patent law, the patent goes to the first to invent, not the first to file the patent application.”
Lucrative Opportunity Once a patent is filed, Fairhall suggests that physicians should actively look to market their invention to potential interested parties, and offers the following scenario.
Let’s assume a doctor invents a new device, an implant for treating glaucoma. This device could be widely adopted because it’s a substantial improvement over the existing implant. Physicians should follow a business model that includes getting FDA clearance and, ultimately, a commercial license for selling the implant. And having the patent, says Fairhall, is critical in the ability to attracting venture capital.
“With exclusivity in that implant, you’re going to be the sole source of supply for a potential customer base,” he explains. “The patent (which is good for 20 years from the date of filing) gives you the ability to sell the invention without competition.”
Fairhall, who holds and undergraduate degree in physics and mathematics, adds that promotion is one of the keys to successful exploitation of intellectual property rights. He points out that many great inventions never realized their full potential because the inventor did not promote the invention. “You have to market and effectively seek out business partners,” Fairhall says. “And be patient. Sometimes it takes a while for new technology to be adopted.”
And remember, says Ludwig, time is of the essence. “In the US it’s a race to the invention, outside the US it’s a race to the patent office. Neither one of which is a race you want to lose.”
Ed Rabinowitz is a veteran healthcare reporter and writer. He welcomes comments at email@example.com.
July 1790—Date of the first official US issued patent; it had to do with the making of potash. (US Patent Bureau)