Millions of women use reproductive health applications (or “apps”) to track menstrual cycles, ovulation, and pregnancy. These apps provide women that use the rhythm method for birth control and women seeking to become pregnant access to more accurate information about their reproductive systems. To accurately track a user’s reproductive cycles, many health apps need the users to share highly sensitive and personal health data. This sensitive data is generally stored and may include dates of ovulation, conception, pregnancy start, and pregnancy end, if applicable. Needless to say, reproductive health app developers manage and maintain a data platform that contains some of the most sensitive and private information about their customers.

The highly sensitive and private customer information contained in reproductive health apps has been thrust to the forefront of the evolving landscape of abortion laws in the United States.  The U.S. Supreme Court (“SCOTUS”) decision to overturn Roe v. Wade authorizes states to limit, restrict, and criminalize abortion. As many as half of all U.S. states have some form of an abortion ban in effect, or one that is expected to take effect in the near future, due to the SCOTUS decision. These abortion ban laws are frequently referred to as “trigger laws.” State laws that criminalize abortion could have an immediate impact on how reproductive health apps implement and enforce personal health data security measures (i.e., privacy policies and procedures).

Read the alert here.

Can human reproductive tissue (“HRT”) held by a fertility clinic serve as collateral for a loan to (or investment in) the fertility clinic? In short, the scope and extent of governmental regulation addressing the sale of or transfer of ownership interests in HRT held by a fertility clinic varies from state to state; however, most state laws would likely prohibit the sale of HRT except in very specified cases. As an extension of this concept, most state laws would also prohibit taking a security interest in the HRT, as would ethical and religious-based concerns triggered by the concept of third-party ownership interests in another person’s HRT. Read the alert here.

On June 29, 2022, the United States Patent & Trademark Office (USPTO) announced that it was temporarily extending its Cancer Immunotherapy Pilot Program (”Patents 4 Patients” or “P4P”) to September 30, 2022, and also issued a request for public input on the P4P.

Under the P4P, Applicants can file a petition for expedited examination of a patent application that recites a method of treating cancer using immunotherapy.  Petitions to enter the P4P are free, i.e., there is  no cost for expediting under this program. This most recently announced extension will allow filing of P4P through September 30, 2022 unless and until the USPTO announces any further extensions.

During the current extension period, the USPTO is also considering whether to further extend and/or modify the P4P.  In support of this effort, the USPTO is seeking input from the public.  The comment period is open until July 29, 2022.

Once the comment period closes, the USPTO will review and decide whether to: (1) extend the current P4P beyond September 30, 2022; and (2) if so, whether or not to make any modifications, such as by expanding its scope in one or more areas.  For example, since the current P4P requires recitation of a method of treatment, one modification could be to allow entry into the P4P based on recitation of compositions of matter, including those which could be used in treating a cancer.  Along similar lines, the P4P could be expanded beyond cancer to include other diseases. The official notice can be accessed at the online federal register (here) and anyone interested in commenting is able to do so here, anytime before midnight July 29, 2022.