Last Updated: July 28, 2026

Patent: 11,638,754


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Summary for Patent: 11,638,754
Title:HPV vaccine
Abstract:The present disclosure provides, among other things, a pharmaceutical composition that includes a lipid nanoparticle adjuvant and an anti-human papillomavirus (HPV) comprising HPV virus-like particles (VLPs) of at least one type of human papillomavirus (HPV) selected from the group consisting of HPV types: 6, 11, 16, 18, 26, 31, 33, 35, 39, 45, 51, 52, 53, 55, 56, 58, 59, 66, 68, 73, and 82.
Inventor(s):Andrew J. Bett, John P. Bilello, Amy S. Espeseth, Tong-Ming Fu, Marian E. Gindy
Assignee: Merck Sharp and Dohme LLC
Application Number:US17/170,948
Patent Claims:see list of patent claims
Patent landscape, scope, and claims summary:

United States Patent 11,638,754 claims and US patent landscape: what is protected, who owns it, and what risks exist

Executive summary: US Patent 11,638,754 covers a specific US technology set tied to its independently claimed subject matter and its dependent claim fallbacks. The actionable landscape is determined by (i) the patent’s claim scope (independent claim construction drives infringement exposure), (ii) prosecution history limits created by claim narrowing, (iii) the breadth of complementary continuations/divisionals in the same family, and (iv) whether later patents in the same assignee cluster claim adjacent embodiments that can re-create blocking positions even after expiration. Without the patent text, claim set, inventors/assignee, priority data, and the prosecution and family records, a complete and accurate claim-by-claim and portfolio-level analysis cannot be produced.

What patents cover the technology of US 11,638,754?

No complete and accurate mapping is possible without the actual claims, title/abstract, assignee, priority dates, and the family members for US 11,638,754.

Which assignee and inventors control US 11,638,754?

No complete and accurate identification is possible without the publication record (USPTO bibliographic data) for US 11,638,754.

What claim types exist (composition, formulation, method-of-use, device, process)?

No claim-structure analysis can be performed without the full claim set.


What exactly do the claims of US 11,638,754 protect and how broad are they?

Featured snippet answer: Claim scope is defined by the independent claims and constrained by claim dependencies and any prosecution-history narrowing. Without the claim language, breadth cannot be assessed.

Independent claims: which limitations drive scope?

No limitation-by-limitation breakdown can be produced without the independent claim text.

Dependent claims: what fallback embodiments expand or narrow coverage?

No fallback analysis can be performed without dependent claim text.

Claim construction risk points (means-plus-function, numeric ranges, optional features)

No construction risk assessment can be performed without seeing claim formatting and limitation wording.


When does US 11,638,754 lose exclusivity in the US?

No exclusivity/expiration timeline can be calculated without filing date, priority date, patent term adjustments, and any terminal disclaimers shown in the USPTO record for US 11,638,754.

Patent term basics for US utility patents

A utility patent’s maximum term is generally anchored to the earliest US non-provisional filing date (plus adjustments), subject to terminal disclaimers and any regulatory patent term extensions. Exact dates require the actual bibliographic and adjustment data for this patent.

Does PTA or a terminal disclaimer change expiration?

No PTA/terminal disclaimer effect can be determined without the USPTO patent maintenance/term adjustment data for US 11,638,754.


What Orange Book status affects generics for US 11,638,754?

No Orange Book status can be evaluated without the drug product(s) associated with the patent, which requires knowing whether the patent is listed in the Orange Book and for which NDC/RLD it is tied.


How many continuation or related family patents exist around US 11,638,754?

No family expansion analysis can be produced without the patent family map for US 11,638,754.

Continuation, divisional, or continuation-in-part risk

No assessment of whether the family contains claim-reinforcing continuations can be performed without the related application list.


What formulation and method-of-use patents overlap with US 11,638,754?

No overlap analysis can be produced without knowing the claimed subject matter type (composition vs method-of-use vs process vs device) and the jurisdictional claim equivalents.

Are there device or process claims that block manufacturing?

No manufacturing/IP barrier analysis can be performed without claim recitation covering steps, apparatus, or process parameters.


What patent litigation affects US 11,638,754?

No litigation impact can be analyzed without knowing whether the patent is asserted, who asserted it, in which case, and the current status (dismissal, settlement, claim construction, injunction, or invalidity rulings).


Which companies are challenging or designing around patents related to US 11,638,754?

No competitive design-around map can be produced without identifying asserted parties, commonly cited patents in the same technical niche, and the patent family’s citation network.


How strong is the patent estate around US 11,638,754?

No strength scoring can be produced without analyzing (i) claim breadth, (ii) prior-art citations in prosecution, (iii) prosecution history outcomes, and (iv) whether the family has multiple independently enabling claims.

Weakness vectors to evaluate (only if claim text and file history are known)

Potential vectors include anticipation by earlier publications, obviousness combining cited documents, lack of written description/support for narrower dependent limitations, and indefiniteness risk from functional language.


What generic entry risks exist for products implicated by US 11,638,754?

No generic entry risk can be quantified without (i) the active ingredient/product association and (ii) whether US 11,638,754 is listed in the Orange Book as covering an approved use or formulation, and (iii) whether any Paragraph IV filings cite it.


How does US 11,638,754 compare with adjacent patents in the same technological field?

No comparative analysis can be produced without the claims and without knowing the closest cited/competing patents.


Key Takeaways

  • A complete claim-by-claim and landscape analysis of US Patent 11,638,754 requires the patent text (claims and specification), bibliographic data (assignee, priority, filing, PTA/terminal disclaimer), and family records.
  • Without those inputs, no accurate conclusions can be made about infringement coverage, expiration timing, overlap with formulation/method patents, or litigation and generic-entry risks tied to this specific patent.

FAQs

  1. What are the independent claim limitations in US 11,638,754 and what do they require for infringement?
  2. What is the earliest priority date and the expected US expiration date for US 11,638,754?
  3. Is US 11,638,754 listed in the Orange Book for any FDA-approved drug product?
  4. What continuation or divisional family members extend or narrow the scope of US 11,638,754?
  5. Has US 11,638,754 been asserted in US patent litigation and what were the outcomes?

References (APA)

  1. United States Patent and Trademark Office. (n.d.). US Patent 11,638,754 (bibliographic and claims record). USPTO Patent Center.

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Details for Patent 11,638,754

Applicant Tradename Biologic Ingredient Dosage Form BLA Approval Date Patent No. Expiredate
Merck Sharp & Dohme Llc GARDASIL 9 human papillomavirus 9-valent vaccine, recombinant Injection 125508 December 10, 2014 11,638,754 2041-02-09
>Applicant >Tradename >Biologic Ingredient >Dosage Form >BLA >Approval Date >Patent No. >Expiredate

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