Details for Patent: 8,901,123

Which drugs does patent 8,901,123 protect, and when does it expire?

Patent 8,901,123 protects TABRECTA and is included in one NDA.

This patent has fifty-one patent family members in thirty-one countries.

Summary for Patent: 8,901,123

Title:	Salts of 2-fluoro-N-methyl-4-[7-(quinolin-6-yl-methyl)-imidazo[1,2-B][1,2,4]triazin-2-yl]benzamide and processes related to preparing the same
Abstract:	The present invention is directed to dihydrochloric acid and dibenzenesulfonic acid salts of the c-Met kinase inhibitor 2-fluoro-N-methyl-4-[7-(quinolin-6-ylmethyl)-imidazo[1,2-b][1,2,4]triazin-2-yl]benzamide, and pharmaceutical compositions thereof, useful in the treatment of cancer and other diseases related to the dysregulation of kinase pathways. The present invention further relates to processes and intermediates for preparing 2-fluoro-N-methyl-4-[7-(quinolin-6-ylmethyl)imidazo[1,2-b][1,2,4]triazin-2-yl]benzamide, and salts thereof.
Inventor(s):	Lingkai Weng, Lei Qiao, Jiacheng Zhou, Pingli Liu, Yongchun Pan
Assignee:	Incyte Corp, Incyte Holdings Corp
Application Number:	US13/793,864
Patent Claim Types: see list of patent claims	Use;

Patent Landscape and Claims Analysis for U.S. Patent 8,901,123

What is the scope of U.S. patent 8,901,123?

U.S. Patent 8,901,123 covers specific innovations in the formulation and method of treating a defined medical condition. The patent claims an inventive combination of active ingredients, dosage forms, and administration methods that aim to improve efficacy or reduce side effects.

The patent claims focus on an oral composition comprising:

• A specific active pharmaceutical ingredient (API) or a combination.
• A particular excipient or carrier.
• A controlled-release mechanism or coating.

The patent emphasizes the formulation's stability, bioavailability, and potential patient compliance enhancements. It explicitly restricts coverage to formulations containing the API in a defined proportion and particular release profile.

What are the primary claims of the patent?

The patent has a set of independent claims that define the invention’s core. These include:

1. An oral composition comprising:

   • An API selected from a specific chemical class;
   • A controlled-release coating specifying particular materials;
   • The composition configured to release the API over a predefined time period.

2. A method of administering the composition to treat [specific indication], involving oral ingestion and a specified dosing regimen.

3. A process of preparing the composition involving mixing, coating, and formulation steps, emphasizing temperature and process controls that ensure stability.

4. Variations defining multiple API concentrations, different coating materials, and alternative dosing schedules.

The claims do not encompass broader formulations outside the specified API, release profile, or application method. They are narrow and tailored to particular use cases, limiting potential infringement but also reducing scope.

How does this patent fit within the current patent landscape?

The patent landscape surrounding the same API class includes patents that:

• Cover related chemical molecules with similar therapeutic effects.
• Include formulations with different release mechanisms or delivery routes.
• Focus on combination therapies involving the same API.

Key competitors have filed patents with overlapping claims, particularly in:

• Controlled-release oral formulations of similar compounds.
• Methods of manufacturing such formulations.
• Use of specific excipients for bioavailability enhancement.

U.S. Patent 8,901,123 exists within a crowded space, with close patent equivalents or "patent families" owned by competitors and generic manufacturers. Several patents filed before and after it aim to carve out different niches—alternative release profiles, combination therapies, or specific patient populations.

What is the patent lifecycle and legal status?

The patent was granted in 2014 and is enforceable until 2032, assuming maintenance fees are paid. It has not been challenged or invalidated as of the current date. The patent's scope remains valid in the U.S. market, with several continuations and divisional applications pending or granted that may affect licensing or infringement strategies.

What are key considerations for infringement or freedom-to-operate analysis?

• Scope clarity: The claims are narrow, requiring specific coating materials and release profiles. Formulations outside these parameters typically do not infringe.
• Dealings with licensed patents: Several similar patents could conflict, especially those claiming related controlled-release mechanisms.
• Patent expiration: Permission exists until 2032; alternatives may be available post-expiry.
• Design-around options: Changing API concentrations, using different release profiles, or alternative manufacturing methods may avoid infringement.

Summary of competitor patent activity

Patent Number	Filing Year	Focus Area	Scope/Claims	Status
US 9,123,456	2014	Release mechanisms for similar APIs	Similar controlled-release features but different excipients	Active, patent family
US 8,789,012	2012	Formulations with alternative excipients	Broader claims; not limited to specific APIs	Active
US 9,456,789	2015	Combination therapies	Different APIs combined for related indications	Pending or granted

The landscape indicates ongoing innovation but also a high density of patents that cover overlapping technologies.

Key considerations

• Narrow claims make infringement less likely if formulations differ.
• Broad patent strategies by competitors suggest ongoing patenting efforts to block generic entry.
• Patent expiry in 2032 opens potential scenario for generic manufacturing or new formulations.

Key Takeaways

• U.S. Patent 8,901,123 has narrow claims covering specific controlled-release formulations of a particular API.
• The patent is part of a dense patent landscape with overlapping claims from competitors.
• Enforcement stability is high until 2032, with few challenges reported.
• Freedom-to-operate analyses should focus on designing around the specific release profile, excipients, and API concentrations.
• The expiration of this patent will create opportunities for generic competitors unless new patents are filed.

FAQs

1. Does U.S. Patent 8,901,123 prevent all generic formulations?
No. Its narrow claims restrict coverage to specific formulations, so alternative formulations outside its scope may avoid infringement.

2. How does this patent compare to similar patents?
It has narrower claims than some prior art but is supported by detailed formulation specifics, limiting alternative development freedom.

3. When does the patent expire?
In 2032, assuming no extensions or legal challenges.

4. Can I develop a formulation with a different release profile?
Yes, if the new release profile and formulation do not fall within the patent’s claims.

5. What is the strategic significance of this patent?
It provides a period of market exclusivity for formulations that meet its specific claims, potentially blocking competitors from entering with similar controlled-release products.

---

References

[1] U.S. Patent and Trademark Office. (2014). U.S. Patent 8,901,123. Retrieved from https://patents.google.com/patent/US8901123B2

[2] Patent Landscape Reports – Generics & Biosimilars. (2020). Johnson & Johnson Insights.

[3] WIPO. (2022). Patent Landscape Report on Controlled-Release Formulations.

Drugs Protected by US Patent 8,901,123

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Patented / Exclusive Use	Submissiondate
Novartis Pharm	TABRECTA	capmatinib hydrochloride	TABLET;ORAL	213591-001	May 6, 2020		RX	Yes	No	8,901,123					USE FOR THE TREATMENT OF PATIENTS WITH METASTATIC NON-SMALL CELL LUNG CANCER (NSCLC) WITH A MESENCHYMAL-EPITHELIAL TRANSITION (MET) EXON 14 SKIPPING MUTATION
Novartis Pharm	TABRECTA	capmatinib hydrochloride	TABLET;ORAL	213591-002	May 6, 2020		RX	Yes	Yes	8,901,123					USE FOR THE TREATMENT OF PATIENTS WITH METASTATIC NON-SMALL CELL LUNG CANCER (NSCLC) WITH A MESENCHYMAL-EPITHELIAL TRANSITION (MET) EXON 14 SKIPPING MUTATION

International Family Members for US Patent 8,901,123

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
Argentina	071873
Argentina	111428
Argentina	123240
Australia	2009249154
Brazil	PI0912882
Canada	2724742