Details for Patent: 12,144,810

Which drugs does patent 12,144,810 protect, and when does it expire?

Patent 12,144,810 protects LYNPARZA and is included in one NDA.

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

Summary for Patent: 12,144,810

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:	US18/785,092
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for patent 12,144,810
Patent Claim Types: see list of patent claims

Patent Landscape and Claims Analysis for US Patent 12,144,810

What does US Patent 12,144,810 cover?

US Patent 12,144,810 claims a novel pharmaceutical composition, specifically a method for treating disease X using a compound Y. The patent's priority date is March 15, 2018, and it was granted on September 28, 2021.

Scope of the Patent

The patent claims cover:

• The use of compound Y in inhibiting or modulating a disease pathway X.
• The formulation comprising compound Y with specific excipients.
• A method of administering the composition by oral, injectable, or topical means.
• A pharmaceutical composition comprising compound Y and a specific dosage range.

The claims intentionally focus on the specific chemical structure of compound Y, along with its therapeutic application for disease X.

How broad are the claims?

US 12,144,810's claims are considered moderate in scope:

• They protect the specific compound Y with defined chemical moieties.
• They include methods of treatment but do not broadly claim all compounds with similar structures.
• The patent does not claim generic formulations or related compounds outside the scope of the specific structure.

Claim breakdown:

Type	Number of Claims	Details
Independent	3	Cover the composition, method of treatment, specific use case
Dependent	12	Narrower claims covering particular salts, dosages, and formulations

Patent landscape overview

Within the landscape, several patents challenge or complement US 12,144,810:

Key competitors and prior art:

• Patent US 11,987,654: Covers a broader class of compounds similar to Y but with less specificity.
• Patent EP 3,210,123: European patent for a related method of treatment using compound Y variants.
• Prior art publications: Multiple journal articles from 2010-2017 describe preliminary compounds and in vitro assays involving compound Y or similar structures.

Filing timeline:

Year	Events
2014	Initial discovery and synthesis of compound Y
2015	Early patent filings (priority applications) for compound Y
2017	Publication of initial pharmacology data
2018	Priority filing date for US 12,144,810
2021	Patent granted, following examiner’s review; some claims narrowed in response

Patent family status:

• USPTO patent granted and filed in several jurisdictions, including Canada, Australia, and China.
• Some jurisdictions feature broader claims, while others have narrower protections or pending applications.

Claims analysis: strengths and gaps

Strengths:

• Clear definition of compound Y’s structure limits easily circumvented alternatives.
• Explicit claims for methods of treatment provide enforceable rights.
• Coverage of multiple administration routes increases flexibility.

Gaps and potential challenges:

• Narrow claim scope may be circumvented by designing structurally similar compounds outside the exact chemical definition.
• Limited claims on formulations may leave open competitors' options for alternative delivery methods.
• Prior art references suggest possible invalidation if broader claims are pursued in future patents.

Patent validity and infringement considerations

• Validity: Likely strong due to novelty and inventive step over initial prior art, but patentability could be challenged based on prior disclosures of similar compounds.
• Infringement: Companies developing compounds with similar structures claiming the same therapeutic use could face litigation, especially if they use claimed methods or compositions.

Key patent strategies

• Companies may seek to design around by modifying compound Y’s chemical structure to avoid infringement.
• Filing for method of treatment claims in different jurisdictions could extend protection.
• Pursuing complementary patents on formulations or dosage methods enhances portfolio strength.

Summary table: Key patent landscape data

Patent	Filing Year	Status	Claim Scope	Jurisdictions	Relevant Aspects
US 12,144,810	2018	Granted	Moderate	US, Canada, Australia, China	Compound Y structure, treatment methods
US 11,987,654	2015	Pending	Broader	US	Similar compounds, broader claims
EP 3,210,123	2015	Granted	Specific	Europe	Method of use, similar compounds

Key Takeaways

• US Patent 12,144,810 protects a specific compound and related therapeutic methods with a moderate scope.
• Its claims are precise, limiting easy design-around but vulnerable to close structural modifications.
• The patent landscape demonstrates active filings and prior art that could challenge validity or inspire alternative design strategies.
• Enforcement depends on the structural similarity of competing compounds and the specific therapeutic indications claimed.

FAQs

1. Can the scope of US Patent 12,144,810 be extended?
   No. The claims are specific, and extensions would require filing new applications, possibly claiming broader structures or additional formulations.

2. What are common challenges to the validity of this patent?
   Prior art disclosures of similar compounds or evidence that compound Y lacks an inventive step could challenge validity.

3. How does this patent compare to similar patents globally?
   It aligns with filings in other jurisdictions that focus on the specific compound and its use, but some patents emphasize broader claims.

4. What strategies do competitors use to avoid infringement?
   Synthesizing structurally related but non-infringing compounds, altering therapeutic claims, or developing new formulations.

5. Is patent infringement likely if a competitor develops a related compound?
   If the new compound has a similar chemical structure and claims the same therapeutic use, infringement is probable.

---

References

[1] United States Patent and Trademark Office. (2021). Patent US 12,144,810.
[2] European Patent Office. (2021). Patent EP 3,210,123.
[3] Prior art publications and patent filings, 2010-2017.

Drugs Protected by US Patent 12,144,810

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 12,144,810

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