All Claims of Pharma America Holding US Patent Application Describing MDMA in Combination with Viagra® Rejected

USPTO directly cites prior art included in Porta Sophia's third-party preissuance submission in establishing application's lack of novelty

MADISON, WI USA (December 14, 2022) Psychedelic drug company Pharma America Holding Inc. has today received a non-final rejection from the USPTO for U.S. Pat. App. Ser. No. 17/525,248 entitled “SEXUAL THERAPY FORMULATION AND METHOD OF TREATMENT”. On July 22, 2022, Porta Sophia filed a third-party preissuance submission that challenged the patentability of the application's claims on the grounds that the claims lack novelty.

Porta Sophia, a non-profit psychedelic prior art library, leverages the experience of legal and interdisciplinary academic scholars to promote an ethical psychedelic patenting landscape that preserves the integrity of the public domain. The organization curates and makes readily available relevant historical documentation for patent examiners and the public alike to explore the scope of psychedelic technologies.

Patent application: MDMA combined with Viagra® for enhanced sexual desire and ability

The '248 application was filed on November 12, 2021 and claims priority to a provisional application filed on November 13, 2020. It describes the drug combination of erectile enhancers with libido stimulators for a synergistic effect that allows a patient to engage in and desire sexual activity - such as the combination of the active ingredient in Viagra®, sildenafil citrate, with MDMA, a very well-documented recreational drug combination commonly known as “sextasy”. In addition to drug combinations, dosage is also claimed.

In the USPTO's notice of non-final rejection, all claims are rejected and the examiner cites prior art included in the third-party reissuance submission as grounds for that action. Specifically mentioned was an Erowid post titled “Foxy Sextasy” detailing both the drug combination and the dosage ranges described within the application. As a result, the examiner concluded that “the synergistic properties are inherent in the formulation” claimed in the application, and therefore the application fails to meet the novelty requirement of patentability. In addition to being published on the Erowid website, this post is also a curated reference in the Porta Sophia psychedelic prior art library.

Given the limited time that examiners have for patentability analysis, relatively unconventional prior art source material, and difficulty associated with navigating online archives, it is “highly unlikely” that the examiner would have found this critical material, according to one of Porta Sophia's founders and legal counsel David Casimir. He continues, “this third-party preissuance submission illustrates the power of collaboration between public interest organizations in protecting the public domain. Erowid collected and published information that is not otherwise easy to find. Porta Sophia identified its relevance to the Pharma America Holding Inc. patent application, recognized that it was not published in a venue that is typically reviewed by the Patent Office, and therefore sent it directly to the Patent Office for consideration. The Patent Office considered the information and rejected all of the claims of the Pharma America Holding Inc. patent application as a result.”

Our third-party preissuance submission's full claims chart and corresponding prior art is available here.

Third-party submissions of prior art

The America Invents Act allows third parties to submit prior art and concise descriptions of their relevance to the USPTO. This ensures that submitted documents will be considered in the examination of associated patent applications. In addition, these submissions have a broad impact because applicants have a duty to disclose the submitted prior art for other relevant patent applications filed by the applicant.

Porta Sophia tracks and analyzes psychedelic patent applications globally. If an application improperly claims innovation of something known in the public domain and meets the standards of Porta Sophia's third party intervention evaluation criteria, the team assembles evidence against these invalid claims and contests them directly to the relevant patent office through third-party interventions.

About Porta Sophia

Porta Sophia, meaning doorway to wisdom, is a non-profit psychedelic prior art library created to support good patents in the field of psychedelics. Based in Madison, Wisconsin USA, Porta Sophia identifies scientific, historical and cultural prior art in common and uncommon spaces and brings it together in one simple search tool for innovators and patent reviewers. The organization's mission is to protect the public domain, stimulate innovation, and support good patents to support the potential for psychedelic therapies to be available at scale to the people who need them.

Porta Sophia works to support equity in the psychedelic field. The organization facilitates community engagement through encouraging submissions of prior art from the public and organizing an interdisciplinary Archival Researcher Network (ARN) to ensure quality psychedelic prior art is readily accessible to patent applicants, examiners, and those interested in psychedelic research.