Michael E. Byczek
Attorney at Law


Pharmaceutical Intellectual Property

Intellectual property can be used to research and better understand pharmaceutical drugs in the United States.

Consider prostate cancer as an example.

On December 18, 2020, the Food and Drug Administration approved the first oral gonadotropin-releasing hormone (GnRH) receptor antagonist, relugolix, (ORGOVYX, Myovant Sciences, Inc.) for adult patients with advanced prostate cancer.

Patents

The Orange Book, maintained by the FDA, is a freely accessible list that describes all pharmaceutical drugs that have been proven both safe and effective.

One resource available through the Orange Book is a list of patents for a particular medication. Patents listed in the Orange Book pertain to the active pharmaceutical ingredient (API) or the drug formulation itself.

Searching for Orgovyx in the Orange Book reveals eight patents:

7,300,935 (11/27/2007) - THIENOPYRIMIDINE COMPOUNDS AND USE THEREOF [Assignee: Takeda Pharmaceutical Company, Osaka (JP)]

8,058,280 (11/15/2011) - SUBSTITUTED THIENO|2,3-D|PYRIMIDIN-2,4-DIONE COMPOUNDS AND USES THEREOF [Assignee: Takeda Pharmaceutical Company Limited, Fujisawa-Shi (JP)]

8,735,401 (5/27/2014) - THIENOPYRIMIDINE COMPOUNDS AND USE THEREOF [Assignee: Takeda Pharmaceutical Company Limited, Osaka-shi (JP)]

10,350,170 (7/16/2019) - SOLID PREPARATION [Assignee: Takeda Pharmaceutical Company Limited, Osaka (JP)]

10,449,191 (10/22/2019) - TREATMENT OF PROSTATE CANCER [Assignees: Myovant Sciences GmbH, Basel (CH); Takeda Pharmaceutical Company Limited, Osaka (JP)]

10,786,501 (9/29/2020) - TREATMENT OF PROSTATE CANCER [Assignees: Myovant Sciences GmbH, Basil (CH); Takeda Pharmaceutical Company Limited, Osaka (JP)]

11,583,526 (2/21/2023) - TREATMENT OF PROSTATE CANCER [Assignees: Myovant Sciences GmbH, Basel (CH); Takeda Pharmaceutical Company Limited, Osaka (JP)]

11,795,178 (10/24/2023) - COMPOSITIONS OF THIENOPYRIMIDINE DERIVATIVES [Assignee: Takeda Pharmaceutical Company Limited, Osaka (JP)]

The links above open the PDF of that patent downloaded from the USPTO Patent Public Search tool (https://ppubs.uspto.gov/pubwebapp/static/pages/ppubsbasic.html)

The FDA Label Search and Drugs@FDA: FDA-Approved Drugs (links below) can be used to learn more about Orgovyx from official FDA resources.

Trademarks

A search of USPTO registered trademarks (https://tmsearch.uspto.gov/search/search-information) reveals four trademarks for Orgovyx:

US Registration Number: 6646082 (2/15/2022) [Owner: SUMITOMO PHARMA SWITZERLAND GMBH] - Pharmaceutical preparations for human use for the treatment of oncological diseases, disorders and conditions, and prostate cancer; biologic preparations for medical and therapeutic purposes for the treatment of oncological diseases, disorders and conditions, and prostate cancer

US Registration Number: 6338910 (5/4/2021) [Owner: SUMITOMO PHARMA SWITZERLAND GMBH] - Pharmaceutical preparations for human use for the treatment of oncological diseases, disorders and conditions, and prostate cancer; biologic preparations for medical and therapeutic purposes for the treatment of oncological diseases, disorders and conditions, and prostate cancer

US Registration Number: 6824104 (8/23/2022) [Owner: SUMITOMO PHARMA SWITZERLAND GMBH] - (1) Patient consumer support featuring consumer product information in the field of pharmaceuticals via a website or telecommunications networks; patient support services, namely, business administration of patient reimbursement programs via a website or telecommunications networks; (2) Patient support services, namely, financial administration of patient reimbursement programs via a website or telecommunications networks; and (3) Providing health and medical information; providing information relating to the diagnostic, prophylactic and therapeutic properties of pharmaceutical preparations and biologic preparations for the prevention and treatment of diseases, disorders and conditions; patient consumer support featuring information in the field of healthcare and pharmaceuticals for medical purposes via a website; patient support services, namely, providing health and medical information, pharmaceutical advice, medical treatment and disease management; patient assistance programs in the nature of providing information about the provision of drugs free of charge to low-income patients without prescription drug coverage via a website or telecommunications network.

US Registration Number: 6824105 (8/23/2022) [Owner: SUMITOMO PHARMA SWITZERLAND GMBH] - (1) Patient consumer support featuring consumer product information in the field of pharmaceuticals via a website or telecommunications networks; patient support services, namely, business administration of patient reimbursement programs via a website or telecommunications networks; (2) Patient support services, namely, financial administration of patient reimbursement programs via a website or telecommunications networks; and (3)Providing health and medical information; providing information relating to the diagnostic, prophylactic and therapeutic properties of pharmaceutical preparations and biologic preparations for the prevention and treatment of diseases, disorders and conditions; patient consumer support featuring information in the field of healthcare and pharmaceuticals for medical purposes via a website; patient support services, namely, providing health and medical information, pharmaceutical advice, medical treatment and disease management; patient assistance programs in the nature of providing information about the provision of drugs free of charge to low-income patients without prescription drug coverage via a website or telecommunications network.

The links above open the PDF of that trademark application downloaded from the USPTO.

Sources:

Orange Book: Approved Drug Products with Therapeutic Equivalence (U.S. Food and Drug Administration) https://www.accessdata.fda.gov/scripts/cder/ob/index.cfm [Accessed 4/6/2024]

FDA approves relugolix for advanced prostate cancer (U.S. Food and Drug Administration) https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-relugolix-advanced-prostate-cancer [Accessed 4/6/2024]

FDA Label Search (U.S. Food and Drug Administration) https://labels.fda.gov [Accessed 4/6/2024]

Drugs@FDA: FDA-Approved Drugs (U.S. Food and Drug Administration) https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm [Accessed 4/6/2024]

Orgovyx (Sumitomo Pharma and Pfizer Oncology) https://www.orgovyx.com [Accessed 4/6/2024]


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