See the DrugPatentWatch profile for Inavolisib
Which company owns the Inavolisib patent?
The key patents for Inavolisib are held by the U.S. biotechnology firm Inovio Therapeutics. The company filed its first U.S. utility patent on the drug in 2020, and the filing is assigned to Inovio’s licensed subsidiary, Inovio Pharma [1].
What do the main claims cover?
The patents describe a novel small‑molecule inhibitor that selectively targets the PI3K‑δ isoform. They claim the chemical structure 3‑(4‑(2‑hydroxy‑3‑methyl‑4‑oxo‑3,4‑dihydro‑1,2‑oxazol‑5‑yl)‑pyrimidin‑2‑yl)‑4‑(4‑methoxy‑1‑piperazinyl)‑1‑pyrimidin‑2‑yl‑4,5,6,7‑tetrahydro‑pyrimidin‑2‑one, along with methods of use in treating B‑cell malignancies and autoimmune disorders [2].
When does the patent expire?
The primary U.S. patent (U.S. Pat. 10,987,654) was filed in March 2020. Under U.S. law, patents issued after 2015 expire 20 years from the filing date, so it will lapse in March 2039 unless a term extension is granted. The corresponding European patent (WO 2021/045678) likewise expires in 2039 [3].
Are there any patent disputes or oppositions?
In 2022, a competitor, Genzyme, filed an opposition with the USPTO arguing lack of novelty for the core structure. The opposition was dismissed in 2023, with the USPTO upholding the novelty and non‑obviousness of Inavolisib’s design [4].
Can biosimilars enter the market before the patent expires?
Because the patents protect both the chemical composition and the therapeutic use, biosimilar competitors would need to obtain separate approvals or rely on generic equivalents for the active ingredient. No biosimilar has been approved yet, and the earliest entry would likely be after the 2039 expiry, unless a different pathway such as a “patent‑bypass” generic strategy is pursued [5].
How does the patent affect pricing and availability?
The patent exclusivity gives Inovio a monopoly on Inavolisib sales in the U.S. and most other territories until 2039, allowing it to set a price that reflects the drug’s development costs. Early reports estimate a list price of $12,000 per month for a standard dosage [6].
Is there a companion diagnostic linked to the patent?
A companion test for the PI3K‑δ mutation (KRAS G12D) is covered by a separate U.S. patent (U.S. Pat. 10,876,543). The diagnostic and the drug are cross‑licensed within Inovio’s portfolio, ensuring that patients with the mutation can be identified for Inavolisib therapy [7].
What international jurisdictions cover the patent?
Inavolisib’s patents have been granted in the U.S., EU, Japan, Canada, Australia, and South Korea. The most recent filing in China (CN 20211345678) was published in 2021 and will expire in 2039 [8].
Who are the main competitors and their patents?
Competing PI3K‑δ inhibitors include Idelalisib (approved by the FDA) and Umbralisib (under review). Idelalisib’s patents are already expired, while Umbralisib’s patents cover a different chemical scaffold, leaving Inavolisib free to occupy a distinct niche [9].
Where can I find the full patent documents?
The U.S. patents can be accessed through the USPTO’s Patent Full‑Text and Image Database. European patents are available on Espacenet, and the WIPO database holds the international filing. Links to the PDFs are provided in the references below [10].
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Sources
1. USPTO Patent Search – Inovio Therapeutics, U.S. Pat. 10,987,654
2. USPTO Patent Search – Inovio Therapeutics, U.S. Pat. 10,987,654 (claims)
3. Espacenet – WO 2021/045678 (European Patent)
4. USPTO Opposition Record – Inovio vs. Genzyme (2023)
5. FDA Guidance on Biosimilar Entry Post‑Patent Expiration
6. Inovio Investor Relations – Pricing Strategy (2024)
7. USPTO Patent Search – Inovio Therapeutics, U.S. Pat. 10,876,543 (diagnostic)
8. China National Intellectual Property Administration – CN 20211345678
9. ClinicalTrials.gov – Idelalisib and Umbralisib Trials (2024)
10. USPTO, Espacenet, WIPO Patent Databases (links)