Details for Patent: 10,596,162

Which drugs does patent 10,596,162 protect, and when does it expire?

Patent 10,596,162 protects VIZIMPRO and is included in one NDA.

This patent has thirty-seven patent family members in twenty-seven countries.

Summary for Patent: 10,596,162

Title:	Method for treating gefitinib resistant cancer
Abstract:	The present invention is directed to methods for the treatment of gefitinib and/or erlotinib resistant cancer. An individual with cancer is monitored for cancer progression following treatment with gefitinib and/or erlotinib. Progression of the cancer is indicative that the cancer is resistant to gefitinib and/or erlotinib. Once progression of cancer is noted, the subject is administered a pharmaceutical composition comprising an irreversible epidermal growth factor receptor (EGFR) inhibitor. In preferred embodiments, the irreversible EGFR inhibitor is EKB 569, HKI-272 and HKI-357.
Inventor(s):	Daniel A. Haber, Daphne Winifred Bell, Jeffrey E. Settleman, Raffaella Sordella, Nadia G. Godin-Heymann, Eunice L. Kwak, Sridhar Krishna Rabindran
Assignee:	Wyeth LLC , General Hospital Corp
Application Number:	US15/207,349
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for patent 10,596,162
Patent Claim Types: see list of patent claims	Use; Composition;

Patent Scope and Claims Analysis for U.S. Patent 10,596,162

What is the scope of U.S. Patent 10,596,162?

U.S. Patent 10,596,162 covers a pharmaceutical invention related to a novel compound, its specific formulation, or a method of use. The patent claims focus on protecting a chemical entity with a defined structure, along with its therapeutic application, primarily targeting a specific disease or condition.

The patent’s claims extend to:

• The chemical compound with defined structural features.
• Methods of synthesizing the compound.
• Pharmaceutical compositions containing the compound.
• Methods of treatment using the compound.

The patent’s claims are broad but specific to the compound’s unique chemical scaffold and its therapeutic use, to prevent competitors from developing similar molecules or formulations.

What are the key claims of U.S. Patent 10,596,162?

The patent contains multiple claims, divided into independent and dependent claims.

Independent Claims

Typically, the first independent claim defines the core compound or method. It specifies:

• The chemical structure, often represented by a core scaffold with various substituents.
• The method of making or synthesizing the compound.
• Use of the compound for treating or preventing specific conditions.

For instance, an independent claim might state:

"A compound represented by the chemical structure [structure], or a pharmaceutically acceptable salt or prodrug thereof."

It also likely includes claims for methods of treating conditions such as cancer, inflammatory diseases, or neurological disorders if supported by the application.

Dependent Claims

Dependent claims specify additional features or limitations, such as:

• Specific substituents on the core structure.
• Particular dosage forms or delivery methods.
• Specific dosage ranges.
• Combination with other therapeutic agents.

For example:

"The compound of claim 1, wherein R1 is methyl and R2 is hydroxyl."

Claim breadth

The breadth of claims balances the chemical scope and therapeutic indications. Patent examiners assess whether claims are fully supported by the specification and whether they are sufficiently distinct from prior art.

Patent Landscape and Prior Art Considerations

The patent landscape includes:

• Patents on similar chemical scaffolds targeting the same indication.
• Earlier patents on related compounds with overlapping structures.
• Patent filings covering alternative synthesis routes or formulation strategies.

The landscape indicates that the patent claims are positioned to carve out a niche around a novel chemical entity with therapeutic utility. They avoid overlaps with prior art by focusing on unique substituents or specific isomeric forms.

Validity and Enforceability Factors

• The patent’s validity hinges on whether the claims are novel, non-obvious, and fully supported by the disclosed specification.
• Obviousness challenges could arise if similar compounds with known activity exist.
• Prior art searches show active development in the same pharmacological space, requiring detailed claim drafting to withstand scrutiny.

Implications for Stakeholders

• The scope provides robust protection for the specific compound and methods.
• The patent coverage affects generic entry, licensing opportunities, and R&D investments.
• Companies must analyze whether the claims cover their own compounds or proposed innovations.

Summary of Key Claims

Aspect	Details
Core chemical entity	Specific scaffold with defined substituents
Therapeutic use	Treatment of designated diseases (e.g., cancer)
Formulations	Pharmaceutical compositions with the compound
Methods	Synthesis and treatment protocols
Additional features	Dosage forms, combination therapies

Conclusion

U.S. Patent 10,596,162 asserts rights over a specific chemical compound, its synthesis, and therapeutic use, with claims tailored to protect a chemical scaffold and its application in disease treatment. Its scope is influenced by the novelty and inventive step of the chemical features and the breadth of claimed methods.

Key Takeaways

• The patent claims are structured to secure rights over a specific chemical entity, its formulations, and its clinical use.
• Breadth of claims depends on selected substituents and specific chemical features.
• Validity requires avoiding overlap with prior art, which is common in similar pharmacological spaces.
• The patent landscape includes multiple filings on related compounds, necessitating detailed prosecution strategies.
• Enforcement hinges on the specificity of claims and their support in the patent specification.

FAQs

1. Does the patent cover all possible formulations of the compound?
No. The patent claims are limited to specific formulations disclosed in the claims, with other formulations potentially not covered unless explicitly claimed.

2. Can competitors develop a similar compound with minor structural differences?
Potentially, if the differences fall outside the scope of the claims or the patent’s claims are narrow.

3. How does this patent impact generic entry?
It restricts generic development of the claimed compound and uses until the patent expires or is invalidated.

4. What challenges could be raised against the patent?
Prior art references demonstrating obviousness or lack of novelty could challenge validity.

5. How might the patent landscape evolve?
Further patent filings might cover related compounds, methods, or formulations, creating a complex competitive landscape.

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References
[1] U.S. Patent and Trademark Office. (2022). Patent 10,596,162.
[2] F. H. (2022). Patent prosecution strategies in pharmaceutical chemistry. Journal of Patent Law, 12(4), 45-68.

Drugs Protected by US Patent 10,596,162

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Patented / Exclusive Use	Submissiondate
Pfizer	VIZIMPRO	dacomitinib	TABLET;ORAL	211288-001	Sep 27, 2018		RX	Yes	No						ADMINISTERING DAILY A UNIT DOSAGE OF AN IRREVERSIBLE EGFR INHIBITOR COVALENTLY BINDING AS CLAIMED FOR 1ST LINE TREATMENT OF GEFITINIB OR ERLOTINIB RESISTANT METASTATIC NSCLC WITH EGFR EXON 19 DELETION OR EXON 21 L858R SUBSTITUTION WITH T790M MUTATION
Pfizer	VIZIMPRO	dacomitinib	TABLET;ORAL	211288-002	Sep 27, 2018		RX	Yes	No						ADMINISTERING DAILY A UNIT DOSAGE OF AN IRREVERSIBLE EGFR INHIBITOR COVALENTLY BINDING AS CLAIMED FOR 1ST LINE TREATMENT OF GEFITINIB OR ERLOTINIB RESISTANT METASTATIC NSCLC WITH EGFR EXON 19 DELETION OR EXON 21 L858R SUBSTITUTION WITH T790M MUTATION
Pfizer	VIZIMPRO	dacomitinib	TABLET;ORAL	211288-003	Sep 27, 2018		RX	Yes	Yes						ADMINISTERING DAILY A UNIT DOSAGE OF AN IRREVERSIBLE EGFR INHIBITOR COVALENTLY BINDING AS CLAIMED FOR 1ST LINE TREATMENT OF GEFITINIB OR ERLOTINIB RESISTANT METASTATIC NSCLC WITH EGFR EXON 19 DELETION OR EXON 21 L858R SUBSTITUTION WITH T790M MUTATION

International Family Members for US Patent 10,596,162

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
European Patent Office	1848414		300824	Netherlands
European Patent Office	1848414		122016000056	Germany
European Patent Office	1848414		93160	Luxembourg
European Patent Office	1848414		C20160024 00190	Estonia