Vitreoretinal surgery is an exciting and rapidly advancing field that is heavy on technology; nearly every instrument and technique that we use was developed as a result of individual innovation. We often hear about the legends of our field and their groundbreaking developments: Jules Gonin and scleral buckling, Charles Schepens and binocular indirect ophthalmoscopy, Robert Machemer and closed vitrectomy, Joan Miller and photodynamic therapy, Carmen Puliafito and optical coherence tomography, Stanley Chang and perfluorocarbon liquid. Each of these technologies began as an idea. For Fellows' Focus, we spoke to 3 leaders in the vitreoretinal subspecialty to gain insights into the process of turning ideas into products. They shared so many insights, in fact, that we are splitting this conversation between this and the following issue of Retina Today. In this issue, we cover some of the mechanics involved in applying for a patent. Next issue, the discussion turns to dealing with companies to take the invention to market.

- Nikolas J.S. London, MD; Andre J. Witkin, MD; and Alok S. Bansal, MD

WHAT IDEAS ARE WORTH PATENTING?

Emmett T. Cunningham Jr., MD, PhD, MPH: Any idea that you believe is good is worth filing as an invention disclosure with a patent counsel. Many fewer are worth advancing all the way through the patent process. The best I can do is to paraphrase United States Supreme Court Justice Potter Stewart and say that it's sort of like pornography: You know it when you see it. Your attorney can help with novelty but will be less helpful judging clinical utility or unmet need.

Paul E. Tornambe, MD: One never knows what idea may become valuable in the future and how much someone else will be willing to offer for the rights to or use of that idea. The patent process can be quite expensive, depending on whether you do it yourself or hire a legal firm to do it for you. A provisional patent may cost $5000 to $10 000, fees that cover patent literature review, patent infringement review, and document creation. A final patent costs an additional $5000 to $10 000.

For example, 25 years ago I was interested in artificial blood for the possible treatment of central retinal artery occlusion (CRAO) or retinopathy of prematurity. I saw a picture of a submerged rabbit with a pink fundus reflex and thought this artificial blood, being developed by a company in San Diego, might be applicable to replace the vitreous with artificial blood and oxygenate it for several days until a CRAO reopened. However, I could not get the company interested in this application. Had I tried the substance in the eye I would have realized it was heavier than water. Incidentally, this artificial blood is perfluorocarbon liquid, and my idea of oxygenating the vitreous would have rapidly changed to using this substance as a tool in retinal detachment surgery. One never knows where an idea will take you.

Eugene de Juan Jr., MD: This is a complex and important question. Different people have different ideas about patenting, so it is important to understand that the purpose of a patent is to protect commercial interests.

It should be noted that the patent laws will be changing soon; in March 2013, the United States will begin following the first-inventor-to-file system, as opposed to the current first-to-invent.1 The rest of the world already follows the first-to-file system. What this means is that, even if you had the idea first and you worked on it, if someone else files for a patent on that idea before you, they have the right to that patent. It does not seem fair, but that is the way the law is going to go. So as soon as you have that idea, you need to get it filed because that's the priority date.

Patents are expensive. The decision to go down the patent road depends on your confidence in the commercial potential of your idea. Perhaps a business can handle filing multiple patents from ideas more easily than a university can, and a university can do it more readily than an individual. You don't necessarily know whether your idea is commercially valuable. Of the patents issued each year in the United States, very few have commercial value.

If you are an individual filing for a patent, the first phase costs about $5000, so it's not an insignificant decision. There are lots of costs related to it, and it takes 5 years or so for a patent to be examined and then granted. The US Patent and Trademark Office (PTO) has said that it wants to get that time down to 1 or 2 years, but currently it takes multiple years.

If you think you have a good idea, there is a problem with discussing it. You need to write it down, and when you disclose it to somebody, if you don't want them to become a co-inventor with you, say, “Do you mind if I tell you my idea, and I don't necessarily want you to invent around my idea.” You can tell them your idea, and they might say, “Well, I think it should be blue.” In a normal conversation you might say, “That's a good idea, I like that, and I'll include it.” And then they become an inventor with you if you include that in your patent. You can do it more officially by having someone sign a confidentiality or disclosure agreement, stating that the other party can receive the information in return for keeping it confidential.

DOES THIS CAUTION INCLUDE MENTORS?

Dr. de Juan:For people whose confidentiality you can really trust, you can explain the situation to them, saying, “I'd like your advice and guidance, but I'm not asking you to participate with me at this point.” People should understand. Now if that person actually contributes to the invention and makes it better, it's OK. You can split the patent costs (chuckle).

There are people you can ask, like a relative or friend, who are not going to claim that they invented something even though they may have helped to stimulate your idea. If someone you are talking to casually makes an important contribution, you probably should include them because in inventorship it is really important to be honest, and different people have different expectations around that.

WHAT DO YOU DO ONCE YOU COME UP WITH AN IDEA?

Dr. Cunningham: Protect it. Draft a dated and signed invention disclosure and file it with an attorney or technology transfer office. Be sure to file before you publish or present your idea; “prior art” is no longer patentable. Unless you have a deep domain expertise that includes what has been patented, what is likely to be patented, and what the market needs are for any given invention, you need to get trusted counsel. This usually comes from a lawyer. If you think the idea is novel, you think the market is big enough, and you are willing to pay the costs to take a US and maybe EU patent all the way through, which can be $20 000 to $30 000 or more, you have to talk with a patent attorney.

I usually suggest that inventors go to a local law firm and ask who in the patent group has expertise in a certain area, surgical tools for example, and make an appointment to meet with that person with drawings and invention disclosure. Many firms will have an invention disclosure form (IDF) for you to fill out. That is very inexpensive to file; you file that with your patent attorney, and that sets the date of invention. The actual date of invention is the date you write on your notes when you came up with the idea. The IDF files it with an attorney, memorializing the date. So if someone comes up with an invention that looks like it was invented or filed after yours, you have proof of your originality. After this, you have to work with your lawyer to covert this into a patent, which includes a review of existing relevant patents and literature, etc.

The patent attorney will tell you broadly if your idea is novel or not. They almost always say they don't know specifically, but for $1000-$3000 they can do a patent search to see if it looks like it's worth pursuing. If it does, then you have to bite the bullet and decide if you're going to pursue it in the US, Europe, or beyond.

To file patents globally is very expensive, hundreds of thousands of dollars from initial filing to final execution. Most people consider the most valuable markets to be the US and Europe. If you are going to pursue just those 2, it's probably a minimum of $20 000 and may easily be double that.

You should also understand what it takes to bring tools, devices, and drugs to market. Three broad categories are tools and instruments, 510(k) (also known as postmarket notification) devices, and premarket approval (PMA) devices and drugs. Respectively, these categories progress from products that take less time and money and a smaller team to those that take more resources to develop. Tools and instruments often take under $500 000 and a year to develop; 510(k) devices, on the other hand, can cost $5 to $50 million to develop and take 3 to 5 years, and PMA devices and drugs may take $50 to $200 million and 5 to 10 years to develop. Tools and instruments can be developed by an individual, whereas sophisticated devices and drugs typically involve larger teams.

WHAT DO YOU DO WITH THE PATENT ONCE IT IS FILED OR GRANTED?

Dr. Cunningham: It depends on the scope, the type of patent, and what it's for. The first question is whether you have a product or a company. Products can be such things as tools, instruments, small market devices, and small market drugs, whereas companies involve multiple products and large markets. Is your product big enough to build a company around it? Most often it's not, in which case you can either license it or try to build it yourself and sell it. I believe one or more of the glaucoma drainage devices are essentially sold by the inventors, not big companies. There are other examples like that.

Once the patent is filed, then you can start telling people about it. I typically do that under a confidential disclosure agreement or nondisclosure agreement. Be sure to choose your advisors carefully. The ideal advisor is discrete, knowledgeable, and experienced. Once it is granted, the patent has a lot more value, so it's typically the granted patents that get traction, particularly with companies or incubators.

At this point you should start thinking about funding sources. Major funding sources today include industry players such as Alcon, venture capital firms, and the National Eye Institute, but there are many other sources. In the very early, pre-seed stage, you will likely invest your own savings as well as ask close friends and family to invest. These investments often total less than $500 000, but this may be enough to get your idea off the ground.

The next step might be to look into research grants and foundations, such as the National Eye Institute, Research to Prevent Blindness, or the Small Business Innovation Research Program, among others. Next, “angel” investors, such as Life Science Angels and Tech Coast Angels, and incubators, such as ForSight Labs and Biogen Idec Innovation Incubator, can provide funding of up to $2 million. Later on, you might look to venture capitalists for larger investments. Industry partnerships can be made at any point but typically are best after some creation. Give yourself enough time to raise funding, 12 months or more, and ask for enough money to get to an important milestone.

In order to sell your idea, you need to start thinking like a businessman. Come to pitch meetings practiced and prepared. Investors must be confident that you are organized, reliable, and trustworthy. Along the same lines, make sure your PowerPoint presentations are polished. Use a lot of graphics and as few words as possible; word slides are sleeping pills. Keep them simple and spartan. Our brains are compartmentalized, and it is difficult to listen and read at the same time. A master of this was Steve Jobs, and you should watch some of his presentations on YouTube.

Dr. Tornambe: If you go through the process and expense of filing a patent, in most cases you should have a business plan to follow through. If you determine that your widget is an instrument that will be widely accepted and used, you will need a company that can manufacture the prototype, engineer the final product, and have people familiar with government regulatory agencies and a marketing unit to promote and distribute the product. Early in the game it might be worth signing a confidentiality agreement with a company already in the business that has done all this before. You can negotiate a royalty, which may be about 6% of the sale price. I have worked with Insight Instruments and Dutch Ophthalmic, both of which have treated me fairly and are excellent companies to partner with. Of course you will not reap the financial reward you would have if you did it yourself, but it may be a good way to get your feet wet.

Dr. de Juan: Once the patent is filed, it's easier to talk to people about the invention. In my experience, I have seen similar ideas appear at similar times, but I have never seen an idea stolen. But they say it does happen, so you need to be careful. You should keep confidentiality if you think you need it. Generally there's an advantage to keeping things confidential. If you tell somebody your idea, they may not use that confidential information, but they may think about the idea and come up with another, potentially better way of doing it.

Once the patent is granted, there is the presumption that it is valid and novel. I have never seen a technology that doesn't have some intellectual property issues around it; there's almost nothing new under the sun. Everything is derivative and combinational to a degree, particularly on the device side.

Commercialization is probably the hardest leap to make—getting a company to make a product, distribute it, and sell it. Everybody has ideas, but few physicians end up benefiting financially from their ideas through patents and business development. You really have to be willing to get into it and stay in it for 10, 15, 20 years.

Nikolas J.S. London, MD; Andre Witkin, MD; and Alok Bansal, MD, are second-year vitreoretinal fellows at Wills Eye Institute, Thomas Jefferson University in Philadelphia and members of the Retina Today Editorial Board. Dr. London can be reached at nik.london@gmail.com; Dr. Bansal can be reached at alok.s.bansal@gmail.com; and Dr. Witkin can be reached at ajwitkin@gmail.com.

Emmett T. Cunningham Jr., MD, PhD, MPH, is a Partner at Clarus Ventures, Director of the Uveitis Service at California Pacific Medical Center, and an Adjunct Clinical Professor of Ophthalmology at Stanford University School of Medicine. He sees patients at West Coast Retina Medical Group in San Francisco. He may be reached at +1 650 238 5014; or via email at emmett_cunningham@yahoo.com.Paul E. Tornambe, MD, FACS, is Founder and President of Retina Consultants San Diego in Poway, CA. He can be reached at +1 858 451 1911; or via email at TornambePE@aol.com.

Eugene de Juan Jr., MD, is the Jean Kelly Stock Distinguished Chair in Ophthalmology at the University of California, San Francisco, and the Founder and Vice Chairman of ForSight Labs, LLC, of Menlo Park, CA. He can be reached at +1 650 326 2656; or via email at edejuan@forsightlabs.com.

  1. America Invents Act: Effective Dates. US Patent and Trademark Office. October 5, 2011. http://www.uspto.gov/aia_implementation/aia-effective-dates.pdf. Accessed January 17, 2012.