Suppose that you've come up with an idea for a new instrument, or an improvement to an existing one, that could help solve a problem you see repeatedly in your practice. Maybe it's a new phaco tip design, an improved blade for incisions or a new eye shield. You're positive it's a great idea, and you've never seen anything like it in the industry. Maybe you should patent the invention; the microsurgical-intensive nature of ophthalmology drives many of its creative practitioners to invent their own instruments or devices. No matter how business-savvy they may be, however, ophthalmologist-inventors may find the road from invention to manufacture a confusing one. Here's how to get started in the patent process.
How to Begin
It's likely you have done a few mechanical sketches of your invention and written out some notes. To make sure that you get credit (and compensation) for this invention, securing a pat-ent from the government confers upon you the right to exclude others from making, using, selling, offering to sell, or importing that invention for a set period of time. Acquiring a patent will protect the integrity of your invention and keep others from using it without your consent or manufacturing versions of lesser quality.
 |
Write down everything about your invention, being as detailed as possible, covering its structure, operation and even manufacture. Collect any drawings or sketches needed to fully understand your invention. Record the dates when you came up with your invention and started developing it.
You will want to be a bit secretive at the beginning. Don't take your invention into the office and show it to your partner, patients or the sales reps who visit you. Displaying a potentially patentable invention to anyone who hasn't signed a confidentiality agreement puts you in the risky position of potentially losing valuable patent rights.
To make sure that all of your rights aren't lost, you must file a patent application. A U.S. patent application will cover your patent rights in the United States. A Patent Cooperation Treaty (PCT) patent application will protect your patent rights in most foreign countries, as well. A U.S. patent application must be filed within one year of the first public disclosure of the invention. What's more, for most foreign countries, you must file a patent application at least somewhere in the world prior to public display anywhere, or risk losing foreign rights. You may decide not to go to the expense of filing in foreign countries if you don't desire to market your invention outside the U.S. and are not concerned with foreign competition.
For assistance with filing your patent application, locate a reputable patent attorney. To find one, you can get recommendations from your practice's at-torney; maybe someone in his law firm specializes in patent work. Use your connections. Ask patients whom you may know to be lawyers, or other physicians.
Don't take your idea to one of the late-night TV invention promoters. While some of these people may be legitimate, others may be scams that can cost you. One known invention scam guaranteed a patent in exchange for a $10,000 payment, and then filed a patent application with false information in order to obtain a virtually worthless patent. To combat these frauds, Congress incorporated revisions to the U.S. Patent Laws in 1999 to help protect unwary inventors.
Prior Art
Give your attorney copies of all notes and drawings. If you know of other ideas that have come before your in-vention that are close to your invention, but have failed to solve the problem that you have solved, bring them to the attorney's attention as well. These could be other patents, technical journal articles, advertisements, actual products or anything else that's in the public domain. For example, if your invention is an improvement to a particular surgical instrument, show your attorney what the original instrument looks like and why it can't perform the actions of yours. These references are known as "prior art" and enable the patent attorney to demonstrate what is so great about your invention and distinguish it from what has come before.
Filing the Application
There are several routes you may take to patenting your invention. In the first, you file a "provisional" patent application. This application obtains a filing date and allows you to publicly disclose your invention without risking the loss of any patent rights. A provisional application may be a good choice if you are planning to show off your in-vention at a medical conference in the very near future, for example, but don't have the time for your attorney to re-search and draft a full patent application. Be aware, however, that a provisional application won't initiate examination of your invention by the U.S. Patent and Trademark Office, and it won't mature into a patent. To get to the next step, you must file a "non-provisional" patent application or a PCT patent application within one year of filing the provisional application.
If you skip the provisional application and directly file the non-provisional or the PCT application, your application starts its way through the patent examination process more quickly and could mean more rapid issuance of a patent.
| Why Be an Ophthalmologist-Inventor? |
| Ophthalmologists are prolific inventors because "by nature, we're tinkerers," says David J. McIntyre, MD, of Bellevue, Wash. "We like to take things apart and work things out." Norristown, Pa.'s Richard Fugo, MD, agrees about the creative nature of the people in ophthalmology: "Take a new technology and put it in the hands of ophthalmologists — they're going to come up with myriad new applications." Creativity and a willingness to share their ideas have led many surgeons like Drs. McIntyre and Fugo through the patent application process. Dr. McIntyre believes that a serious ophthalmologist-inventor is willing to invest in two relationships: the patent attorney and the manufacturer. "It takes a very long time and a lot of money to do the investigation necessary to apply for a patent. You have to be willing to take the time and explain to the attorney exactly what your invention is and what it will do," he says. Working closely and patiently with the craftsman is also important, says Dr. McIntyre. "You are constantly sending prototypes back and forth for review. You have to help the craftsman understand how the invention will be used in the surgeon's hand." He also says that the inventor must be firm about what he thinks is the best design. "The manufacturer will try to make 'improvements,'" he warns. "You don't have to accept their 'improvements'; stick to your design." Dr. Fugo chose to start his own company, MediSURG Research & Management Corporation, to manufacture and sell his novel plasma blade. He lists two reasons: "First, I knew we could manufacture the plasma blade to my certain specifications. And second, I have a very specific vision of how this technology should be applied. I have a tremendous commitment to the Third World, and I believe that the plasma blade offers an opportunity to raise the bar in health care there." By acquiring the patent to the plasma blade, Dr. Fugo says, "I can make sure that this device ends up in applications that aren't going to just help Europe and the United States, but offer a worldwide benefit." By holding the patent, he says, you can control how it is made and who uses it and when. For example, all surgeons who wish to use the plasma blade must take a certification course. "By maintaining our rights to the device, we can maintain the quality of the surgeon. If the surgeon misuses this in anyway, we can withdraw his certification. To the best of our ability, we can maintain high standards of use." —H. Wunder |
Expect a lot of questions from your attorney as he drafts the application; he needs to fully understand all of the features of your invention. Once you and your attorney are satisfied that the patent application covers your invention, he will file it with the USPTO.
Manufacture
There are plenty of medical device and equipment manufacturers who are tooled up to produce the type of product you have envisioned. You can begin talking to manufacturers before a patent is issued by the USPTO, but understand that if your patent application is denied, you have no recognized rights in the invention. Use your connections with physicians and vendors to find a reputable company.
Expect to be asked to sign a confidentiality or non-disclosure agreement (NDA); it's a routine business practice. Sometimes a non-disclosure agreement will include a "no forum-shopping" clause that will keep you from shopping around your invention for a specified period of time. Run the NDA by your attorney, and don't be afraid to suggest changes related to the duration of the agreement, the scope or type of the information being exchanged by the parties. Most companies are willing to negotiate changes, but some, refuse to change their standard NDA. After the NDA has been signed, both you and the company are free to discuss your invention in detail and how you can work together to bring it to market.
Retaining Rights and Payment
Before you sign an agreement with a manufacturer, ask yourself a few questions:
• What is your vision of your relationship with the company?
• Do you want to sell the patent rights to the company for a flat fee or a percentage of the revenue derived from the product? By selling the rights, you give up ownership of the patent.
• Do you want to retain the patent rights but allow the company to manufacture and sell the product for a percentage of the revenue? You'll still own the patent rights, but the manufacturer will have a license to make and sell the patented product. With such a licensing arrangement you may be able to oversee the quality control of the manufactured product.
• Do you want to devise a combination of these options?
Talk to your attorney about the benefits and drawbacks of each option. Keep in mind, if your invention requires Food and Drug Administration approval, you may want to let the manufacturer deal with the FDA and give up something on your end—a percentage point on a license or several thousand dollars on the sale of the patent.
Issuance of a Patent
While you're talking to potential business partners, your patent application is working its way through the USPTO. Be patient; it can take two to three years before a decision is made. The patent examiner may find some prior art that renders the invention un-patentable—the prior art either discloses the invention, or it would be ob-vious to modify the prior art to come up with the invention. Bad patent ap-plication paperwork can be an issue, usually leading to an attorney malpractice situation that is outside the scope of this article.
During this processing period, your patent attorney will likely have argued your position and/or amended you ap-plication at least once to persuade the patent examiner that your invention is indeed worthy of a patent. The payoff will be recognition of your invention, a potential business opportunity, an increase in revenue for you and/or your practice and a ribboned patent certificate with your name, patent number and the seal of U.S. Patent and Trademark Office.
Joseph E. Maenner, Esq., is a registered patent attorney with Monte & McGraw, P.C. Contact him at (610) 584-9400 or jmaenner@montemcgraw.com. W. John Bentley, Esq., is an attorney specializing in business law for physicians and their practices with Health Care Law Associates, P.C. Contact him at (610) 828-0360 or jbentley@healthcaregroup.com.
