Giordana Mahn associate at Marshall, Gerstein & Borun in Chicago, examines the IP factors that need to be considered before starting out in the femtech space.
Femtech is becoming the next big thing in healthcare but is held back by a lack of corporate and venture capital investment. Underfunded start-ups often develop cutting-edge ideas on how to use technology to make bold advances in women's health care, and yet they are often ill-prepared to protect and assert their intellectual property (“IP”) rights.
Entrepreneurs may be tempted to avail themselves of do-it-yourself legal advice, using off-the-shelf contracts, for example. While being your own lawyer may save on costs, it's particularly fraught with peril in protecting IP rights. The legal work we do in IP is not intuitive, and one missed deadline or overly narrow claim drafting can ruin your chances to hold on to the rights to a breakthrough invention. If you are an inventor, it is imperative that you seek advice from a patent attorney.
Timing is everything
The most important thing scientists and engineers should know about IP is that there is a limited time in which you can file a patent. In the U.S., you have one year from a public disclosure (which can be as little as discussing your work at with friends at a party or offering your product for sale) to file a patent application with the U.S. Patent and Trademark Office (“USPTO”). Also, patents are awarded to the first to file a patent application on an invention. The first one in the door may receive the patent, not necessarily the first one who invents the technology. In most cases, filing a patent application should always be sooner rather than later.
Trust your collaborators (but get it in writing)
Whether your collaborators are medical research centres, individual scientists, or investors, the lure of fame and fortune can unfortunately fracture relationships. Execute written agreements at the beginning of the research process.
For starters, protect your work with confidential disclosure agreements (“CDA”). A CDA allows you to discuss your work with a third party comfortably, without holding back details that might compromise your ownership. As with other contracts, don't use a generic, downloadable contract available online; you'll want an agreement that is specific to your situation. For example, a CDA might say that each party retains ownership of its pre-existing technology and shares ownership of jointly developed technology. If data is shared, you might have a provision saying it must be returned upon request and remains the property of the original owner. As with any contractual relationship, a balance of power comes into play, and you will sometimes need to weigh the risks and benefits of disclosing your work to someone who can help you but won't sign a CDA.
A patent is your goal
A patent application filed with the USPTO establishes a priority claim to your invention and serves as an objective measure of your contributions to a technology at a given point in time. Being the first to file at the patent office makes it much more difficult for someone to steal your technology. But applications – and this gets back to the lawyering – must be drafted with the utmost care because you will win exclusionary rights over your technology only if the patent office approves your application – meaning, the patent office deems your invention new, not obvious, and of patentable subject matter. If you are not quite ready to file a non-provisional patent application, a provisional application, which is not examined by the USPTO, may buy you at least a year of time to get your data and support in order.
One of the mistakes inventors can make is neglecting to search the prior art – any third-party publication relevant to your application – before filing a patent application or investing in the research. The consequences of not doing a search could be running into a similar patent and finding your investment is for naught or will require negotiating a license to use someone else's technology. Similarly, companies that are anxious to get to market begin investing capital to set up the manufacturing of a product, only to find that it infringes a current patent. A credible search uses proprietary databases and professional researchers are equipped to uncover relevant art in your technological area. After a robust search is conducted, a patent attorney can help with assessing patentability (i.e., whether your invention is unique and non-obvious in view of the prior art) and/or freedom-to-operate (i.e., whether you can avoid infringement while still practicing your invention) opinions.
If your search turns up anything that might impact your originality, you must disclose those publications to the patent office. There is an affirmative duty to disclose, and intentionally concealing material prior art can render a patent unenforceable. Patent examiners almost always will find relevant prior art; it's better to be upfront about it and explain why your work is materially different. Considering that women’s health technology has been historically underfunded and under-researched, the femtech patent landscape undoubtedly has huge areas of white space, or opportunity, in seeking patent protection.
While it might be tempting to file a patent application yourself, a patent attorney is experienced in claim drafting, which is critical to obtaining the broadest coverage over your invention. A patent attorney is trained in claim drafting and using words carefully to avoid unnecessarily limiting your invention and also finding opportunities to protect valuable aspects of your invention that might not have been obvious to even you.
Another tool to protect IP is assignment rights. You may require someone who works with you – perhaps someone you hired for an aspect of a project – to assign their patent rights to you.
Don’t forget about design patents
Design patents can be a very valuable addition to your patent portfolio, especially when the aesthetics of a final design of your invention are very valuable. By comparison to a utility patent, a design patent does not protect the functional aspects of your invention. Rather, a design patent only covers the ornamental appearance of your design. Design patents are cheaper to prepare and prosecute with the patent office, and they are easier to obtain than utility patents. A design patent may be very useful in covering a graphical user interface, for example, of a phone app, where obtaining a utility patent over the application itself could be difficult when proving patentability during prosecution.
Trade secrets seldom remain secret
Patents eventually expire, and since they are public record all the technology then becomes available for others to make, use, sell, and import after expiration. If you choose to keep your technology a closely held secret rather than patent it, your secret should not ever become available to others. The current formula for Coca-Cola, for example, isn’t covered by a patent and the famous "secret formula" is locked in a vault. What works for soft drinks, however, won't necessarily work for all technologies; an IP attorney can help evaluate what type of IP protection is appropriate, and help you take the necessary steps to protect your trade secret.
Anything involving the life sciences will be peer reviewed by the scientific community. "Secret formulas" in health care sound like snake oil. Competitors also are free to reverse engineer a non-patented technology or device. If someone can figure out how a device without patent protection works, they are free to make it, or even file their own patent application. A patent should always be your goal when it comes to medical device technology.
If all this sounds confusing and complex, it is—and we haven't even discussed how IP considerations differ in Europe and other parts of the world. An IP attorney can discuss cost-effective strategies with you to protect your IP, monetise it and, in the case of femtech, use it to help revolutionise healthcare for women.