I have a lot of meetings with people who are starting biotech companies. Most have very little experience with the U.S. patent system. They have many questions. Here are the most frequent, with my answers.
1. I have an invention. Should I file a patent application on it?
Intellectual property is a foundational element of your business strategy. If you're going to be investing millions of dollars to commercialize your invention, then, yes, you need to protect your IP with a patent or otherwise.
In any financing event, investors will want to know that you have filed patent applications so that, when you succeed, their investment will be worth something.
2. Is my invention patentable?
Answer: Most likely.
First, your patent attorney will want to confirm that no one else has already done the same thing or something very close that could cause a problem.
After that, while certain classes of inventions are not patentable (ask about "Mayo," "Myriad" and "Alice"), any creative patent attorney should be able to find something about your invention worth patenting.
3. What if I haven’t actually carried out the invention yet?
Answer: You can still file a “prophetic” patent.
If you haven’t actually carried out your invention, but you can describe it in enough detail so that someone else in your field could carry it out and make it work, you are ready to file a patent application.
4. How soon should I file my patent application?
There are many reasons why you should file your patent application sooner rather than later. Here are three:
The first inventor to file a patent application on an invention gets the patent. You don't want to be scooped.
If you or someone else discloses the invention publicly or without confidentiality before you file a patent application, you risk losing rights.
If you are about to embark on a collaboration, you should file a patent application to prove what you've already invented and, therefore, is yours alone.
5. How much will it cost to file my biotech patent application?
Answer: Between $7500 and $25,000.
A patent application is about as complex to prepare as a grant proposal, and takes the same amount of time – about 30 to 50 hours. Patent attorneys and agents will charge between $250/hr and $500/hr. Do the math.
6. Ouch! That's expensive. Can't I write it myself?
Even though it contains a lot of technical material, a patent application is, first, a legal document. Your invention is worth millions of dollars. Let the professional do it.
7. Isn't there some way I can control costs?
Ask for a flat rate. That way you don't bear the risk of overruns.
Ask your attorney to accept payment in the form of equity in your company. Some attorneys will defer payment for equity. Others will take a mix of cash and equity. But, if you are going to ask your patent attorney to double as a venture capitalist, you better have a persuasive pitch deck ready.
8. What is a provisional patent application?
Answer: A provisional patent application is a patent application that is not examined by the Patent Office and that expires after one year.
At that point you have to convert it to a regular application and/or file it abroad.
9. Can I file a cheap provisional as an alternative to a regular patent application?
Answer: Yes, but don’t fool yourself.
Ideally, a provisional patent application should have the same content as a regular patent application, written to protect you throughout the entire scope of your invention.
However, if circumstances require, you may file a short, focused provisional patent application. You have to do this with your eyes wide open. Such applications can give you a false sense of security. If you do this, update the provisional application to a more complete application as soon as possible. Hopefully, the provisional will be good enough that you can count on the early filing date.
10. How do I write an invention disclosure?
Answer: I'm glad you asked!
Think of a patent like an inverted pyramid. The broadest and most powerful ideas are at the top; the narrowest and most specific ideas are at the bottom. In between are all the variations and sub-variations of your invention. This middle level may be the most important, as very broad patents are hard to get, and very narrow patents don't provide much protection. A good invention disclosure describes the invention at all three levels.
Explain the general concept in about 250 words. Describe your specific implementation with the same detail as a "materials and methods" and "results" section of a paper for publication. The middle part is the hardest -- You have to imagine variations on the theme in a hierarchical way.
So, suppose you’ve invented the wheel and axle. The big idea is using the mechanical advantage of turning the wheel to gain leverage on the axle. The specific implementation is a hand crank designed to lift a bucket. In between these two is the rich middle ground. What shapes can the wheel take besides round? How big can it be? What can you use to turn the wheel? How can you use a turning axle? What materials can they be made of?
Provide your attorney with these materials, and enough explanation so that anyone else in your field could re-produce the invention, and you can have a great patent application at a reasonable cost.
Disclaimer: This is general information. Depending on the facts, it may not apply to your specific situation. Consult an attorney.