As opportunities for innovation and investment in women’s healthcare accelerate, Femtech is helping to match capital and talent to unmet needs[1], enabling better outcomes for female patients and consumers, stakeholders, and society at large.[2] Broadly defined, Femtech provides a wide range of solutions to improve healthcare for women across a number of female-specific conditions, including maternal health, menstrual health, pelvic and sexual health, fertility, menopause, and contraception, and a number of general health conditions that affect women disproportionately or differently (such as osteoporosis or cardiovascular disease).[3]

Depending on scope, estimates for Femtech’s current market size range from $500 million to $1 billion.[4] Forecasts suggest opportunities for double-digit revenue growth, and the global Femtech industry is estimated to be worth $79.4 billion by 2025.[5] With a significant market for opportunity, this article discusses how innovators in the Femtech space can protect their innovations and defend market share with patents.

Protecting Innovations With a U.S. Utility Patent and/or a U.S. Design Patent

Because innovation continues and is expected to grow in the Femtech space, you should consider protecting your innovation with a U.S. utility patent. A U.S. utility patent is “a grant to the patentee … of the right to exclude others from making, using, offering for sale, or selling throughout the United States, or importing the invention into the United States.” [6] This right to exclude is for a period of 20 years from the date the application for patent was filed, provided maintenance fees are paid. [7]

To obtain a U.S. utility patent, each patent claim[8] in a U.S. utility application must include patent eligible subject matter, which includes a process, machine, manufacture, or a composition of matter.[9] For innovations in Femtech, representative subject matter includes consumer products, wearables and clinical devices, diagnostic appliances, healthcare software, therapeutic drugs, medical devices, clothing, apps, and services.[10]

In addition, each patent claim must also be useful, new, and not obvious. For example, if someone else already described the same improved medical device, then the idea is not new or novel.[11] Also, the differences between the claimed invention and one or more prior art patents, for example, must not be obvious to a person that works in the related technology.[12]

It is often helpful to conduct a patentability search to understand what may already exist, such as earlier patents and publications related to the proposed invention before filing a patent application. The patentability search results may help you understand the potential scope of the patent protection available and help the patent drafter craft a claim strategy. It is also important to protect your idea by not sharing it with anyone else unless they agree to keep it confidential. Such a disclosure may forfeit potential patent rights in certain countries.

Examples of U.S. utility patents recently issued in the Femtech space include patents directed to: a method for assessing preeclampsia (the second most common cause of maternal mortality); at-home testing for identifying the fertile window; MobileODT relating to an AI-powered mobile technology for screening for cervical cancer (the fourth most common cancer in women); and using blockchain technology to track and trace the transfer of biospecimens, which provides information to women and families going through IVF or egg freezing.[13]

Additionally and/or alternatively, you may also wish to consider protecting your innovation with a U.S. design patent. While a U.S. utility patent protects the way an article is used and works, a U.S. design patent protects the way an article or product looks.[14] The protectable appearance for an article includes its shape/configuration or surface ornamentation applied to the article, or both.[15]

Both U.S. design and utility patents may be obtained on an article if invention resides both in its utility and ornamental appearance.[16] The term of a design patent is 15 years measured from the date of grant, if the design application was filed on or after May 13, 2015.[17] This is shorter than the 20-year term of a U.S. utility patent. However, there are no maintenance fees for a U.S. design patent.[18]  In any case, both U.S. utility and design patents can be critical tools to the success of a new Femtech venture.[19]

As a resource for women innovators, the U.S. Patent and Trademark Office (USPTO) recently launched a Women’s Entrepreneurship Program (WE).[20] The WE program is a community focused, collaborative, and creative initiative to encourage and empower more women founders across America.[21] The program features advice and resources to help women protect their IP, fund their ideas, and expand their network of mentors and advisors, [22] which could be particularly helpful to women inventors in the Femtech space. The World Intellectual Property Organization (WIPO) is also active in working to help support women inventors and entrepreneurs through its Gender Equality and IP program, offering webinars and papers addressing some obstacles faced by women seeking to protect and monetize their inventions.[23]

How to Leverage Patent Protection Once Obtained

Getting patent protection is valuable both as an asset for your company and as the first step in preventing competitors from using your invention, i.e., infringing your patent. But competitors won’t always know that your patent exists and, sometimes, they may not agree that what they are doing is prevented by the patent. You will need to take steps to leverage your patent against competitors.

It is important to familiarize yourself with the market and know your competitors and their products. And, as you see new products encroaching on your patented invention, you will need to affirmatively enforce your patent. This may start with an initial outreach (often called a cease-and-desist letter), advising the competitor of the existence of your patent(s) and letting them know that you think they are infringing the patent.

It is important to consult with a patent attorney before making this outreach, as it can have unexpected consequences. For example, even after a patent has been issued by the USPTO, someone can challenge whether that issuance was proper either in the federal courts or before the USPTO itself.[24]

If the letter does not resolve your issue, you may ultimately choose to file a federal lawsuit or, for products that are being imported into the U.S., initiate an investigation before the U.S. International Trade Commission (ITC). This is an expensive undertaking, and you should again be sure that you understand the potential outcomes before you start the process.

Once you understand your options, though, enforcing your patent can provide a strong defense to infringement, with potential remedies including monetary damages and injunctions that prevent the competitor from making, using, selling, importing, or offering for sale the patented invention.

References:

[1] https://www.mckinsey.com/industries/healthcare/our-insights/the-dawn-of-the-femtech-revolution

[2] https://www.mckinsey.com/industries/healthcare/our-insights/the-dawn-of-the-femtech-revolution

[3] https://www.thenationalnews.com/lifestyle/wellbeing/2022/02/01/what-is-femtech-and-why-is-it-so-important-for-womens-health/

[4] https://www.thenationalnews.com/lifestyle/wellbeing/2022/02/01/what-is-femtech-and-why-is-it-so-important-for-womens-health/

[5] https://www.thenationalnews.com/lifestyle/wellbeing/2022/02/01/what-is-femtech-and-why-is-it-so-important-for-womens-health/

[6] 35 U.S.C. § 154 (2021); see also 35 U.S.C. § 100(c) (“(t)he word ‘patentee’ includes not only the patentee to whom the patent was issued but also the successors in title to the patentee”).

[7] See 35 U.S.C. § 154 (2021)

[8] The claims of a patent define the scope of protection conferred by the patent.  In other words, the claims define the limits of what is and what is not covered by the patent.  A patent owner generally has the right to exclude others from making, selling, using, or importing into the U.S. things which fall within the scope of the claims.

[9] See 35 U.S.C. § 101 (2021)

[10] See https://patentlawyermagazine.com/wp-content/uploads/2022/02/TPL_Issue-58_interactive.pdf

[11] See 35 U.S.C. § 102 (2021).

[12] See 35 U.S.C. § 103 (2021).

[13] https://patentlawyermagazine.com/wp-content/uploads/2022/02/TPL_Issue-58_interactive.pdf

[14] See 35 U.S.C. § 171  (2021)

[15] https://www.uspto.gov/web/offices/pac/mpep/s1502.html

[16] https://www.uspto.gov/web/offices/pac/mpep/s1502.html

[17] See 35 U.S.C. § 171  (2021)

[18] https://www.uspto.gov/web/offices/pac/mpep/s1502.html

[19] https://patentlawyermagazine.com/wp-content/uploads/2022/02/TPL_Issue-58_interactive.pdf

[20] https://www.uspto.gov/initiatives/we/learn-about-we

[21] https://www.uspto.gov/initiatives/we/learn-about-we

[22] https://www.uspto.gov/initiatives/we/learn-about-we

[23] https://www.wipo.int/women-and-ip/en/

[24] These post-grant proceedings before the USPTO include Inter Partes Review, Post Grant Review, and Ex Parte Reexaminations. See, e.g., 37 CFR Part 42.