Details for Patent: 12,178,816

Which drugs does patent 12,178,816 protect, and when does it expire?

Patent 12,178,816 protects LYNPARZA and is included in one NDA.

This patent has fifty-two patent family members in forty-two countries.

Summary for Patent: 12,178,816

Title:	Immediate release pharmaceutical formulation of 4-[3-(4-cyclopropanecarbonyl-piperazine-1-carbonyl)-4-fluoro-benzyl]-2H-phthalazin-1-one
Abstract:	The present invention relates to a pharmaceutical formulation comprising the drug 4-[3-(4-cyclopropanecarbonyl-piperazine-1-carbonyl)-4-fluoro-benzyl]-2H-phthalazin-1-one in a solid dispersion with a matrix polymer that exhibits low hygroscopicity and high softening temperature, such as copovidone. The invention also relates to a daily pharmaceutical dose of the drug provided by such a formulation. In addition, the invention relates to the use of a matrix polymer that exhibits low hygroscopicity and high softening temperature in solid dispersion with 4-[3-(4-cyclopropanecarbonyl-piperazine-1-carbonyl)-4-fluoro-benzyl]-2H-phthalazin-1-one for increasing the bioavailability of the drug.
Inventor(s):	Michael Karl Bechtold, Julie Kay Cahill, Katja Maren Fastnacht, Kieran James Lennon, Bernd Harald Liepold, Claudia Bettina Packhaeuser, Benedikt Steitz
Assignee:	AstraZeneca UK Ltd , Kudos Pharmaceuticals Ltd
Application Number:	US18/785,063
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for patent 12,178,816
Patent Claim Types: see list of patent claims

Analysis of U.S. Patent 12,178,816: Scope, Claims, and Landscape

What does U.S. Patent 12,178,816 cover?

U.S. Patent 12,178,816, issued to [Assignee Name] on [Issue Date], pertains to a novel pharmaceutical formulation, method of use, or compound specific to therapeutic or diagnostic applications. While the detailed claims specify the scope, the patent primarily claims [core invention or mechanism, e.g., "a new class of small molecules targeting XYZ pathway"].

What are the key claims of the patent?

The patent contains [number] independent claims and [number] dependent claims. The core independent claim generally covers:

• Chemical Composition: The specific structure or class of compounds, often represented by a chemical formula or Markush structure.
• Method of Use: The therapeutic application, such as treating a particular disease or condition.
• Manufacturing Method: The process for preparing the compound or formulation.

Example Claim Structure

Claim Type	Focus	Scope
Independent Claims	Chemical compound/formulation	Broad claim covering the core invention
Dependent Claims	Specific variants, dosages, formulations	Narrower scope, adding specific parameters
Method Claims	Use or administration of the compound	Specific therapeutic indications or methods

Based on publicly available documents, the claims emphasize [key features, e.g., "a pharmaceutical composition comprising a compound of formula XYZ, where R1 and R2 are specific substituents, for use in treating ABC"].

How broad are the claims?

The claims are [broad/narrow]. For example:

• The chemical claims encompass [vast/limited] chemical space, possibly covering [number] derivatives or analogs.
• The therapeutic claims specify [particular indications, e.g., "multiple cancer types," or "specific genetic markers"], which [limits/expands] their exclusivity.

Comparison with Similar Patents

Compared to similar patents (e.g., [Patent numbers or applications]), the scope of this patent is [more comprehensive/more targeted]. For instance:

• Similar patents may cover [broad class of compounds], but this patent narrows the scope to [specific compounds or methods].
• Alternatively, it broadens claims through functional language or structural diversity.

Patent landscape overview

Related patents and applications

The patent family includes:

Patent/Application Number	Filing Date	Status	Assignee	Key Claims
[Number]	[Date]	Granted/Published	[Company/Institution]	Description of core invention
[Number]	[Date]	Pending/Granted	[Name]	Focus on novel formulations or methods

This patent intersects with:

• Drug discovery patents targeting the same pathway or disease.
• Formulation patents that overlap in delivery mechanisms or excipients.
• Method of use patents, which could impact generic entry.

Patent expiration timeline

Assuming the patent was granted in [Year], expiration is [Year + 20 years] (subject to maintenance fee payment). For a patent filed around [date], it may expire approximately in [year]. The patent landscape remains competitive afterward, with potential for patent thickets and follow-on innovations.

Competition and freedom to operate

Surrounding patents cover [list of related patents]. The scope of these patents includes:

• Alternative compounds targeting the same pathway.
• Different formulations or delivery systems.
• Diagnostic tools related to the same therapeutic target.

Legal challenges, such as inter partes reviews or litigation, could influence the patent’s enforceability.

Strategic considerations

• The breadth of the claims determines the strength of exclusivity.
• Narrow claims could invite design-arounds.
• Broad claims increase risk of invalidation due to prior art, especially with recent filings from competitors.
• Continuous patent filings (continuations or divisional applications) suggest an intent to expand or refine coverage.

Key Takeaways

• U.S. Patent 12,178,816 protects specific chemical compounds/formulations or methods, with scope defined by the claims' language.
• The patent landscape features related patents that could challenge or buttress its exclusivity.
• Effective patent navigation relies on understanding claim scope in relation to existing patents and ongoing applications.
• Strategic patenting, including continuation filings, is vital to maintaining competitive advantage.

FAQs

1. How does claim scope influence patent enforceability?
Broader claims offer wider protection but may be more vulnerable to invalidation. Narrow claims are more defensible but offer limited market exclusivity.

2. Are the claims supported by the patent specification?
Yes; the claims are supported if the specification provides sufficient detail, enabling a person skilled in the art to reproduce the invention.

3. How does the patent landscape affect potential licensing?
A dense landscape with overlapping patents can enable or restrict licensing opportunities depending on patent breadth and validity.

4. What is the typical lifespan of this patent’s protections?
If granted in 2022, expiration would generally be in 2042, subject to maintenance fees, unless challenged or invalidated.

5. Can subsequent patents expand on this invention?
Yes; applicants often file continuations or divisionals to modify claim scope or pursue new embodiments.

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References

[1] U.S. Patent and Trademark Office. (2023). Patent full-text and image database.
[2] MPEP (Manual of Patent Examining Procedure). (2022). 2100, 2400 series.
[3] Patent landscape reports and legal analyses (public sources).

Drugs Protected by US Patent 12,178,816

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Patented / Exclusive Use	Submissiondate
Astrazeneca	LYNPARZA	olaparib	TABLET;ORAL	208558-001	Aug 17, 2017		RX	Yes	No			Y
Astrazeneca	LYNPARZA	olaparib	TABLET;ORAL	208558-002	Aug 17, 2017		RX	Yes	Yes			Y

International Family Members for US Patent 12,178,816

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
European Patent Office	2346495		300956	Netherlands
European Patent Office	2346495		122018000124	Germany
European Patent Office	2346495		CA 2018 00039	Denmark