Details for Patent: 9,732,058

Which drugs does patent 9,732,058 protect, and when does it expire?

Patent 9,732,058 protects TAGRISSO and is included in one NDA.

This patent has one hundred and thirty-four patent family members in forty-one countries.

Summary for Patent: 9,732,058

Title:	2-(2,4,5-substituted-anilino)pyrimidine compounds
Abstract:	The present invention relates to certain 2-(2,4,5-substituted-anilino)pyrimidine compounds and pharmaceutically acceptable salts thereof which may be useful in the treatment or prevention of a disease or medical condition mediated through certain mutated forms of epidermal growth factor receptor (for example the L858R activating mutant, the Exon19 deletion activating mutant and the T790M resistance mutant). Such compounds and salts thereof may be useful in the treatment or prevention of a number of different cancers. The invention also relates to pharmaceutical compositions comprising such compounds and salts thereof, especially useful polymorphic forms of these compounds and salts, intermediates useful in the manufacture of such compounds and to methods of treatment of diseases mediated by various different forms of EGFR using such compounds and salts thereof.
Inventor(s):	Sam Butterworth, Maurice Raymond Verschoyle Finlay, Richard Andrew WARD, Heather Marie REDFEARN
Assignee:	AstraZeneca AB
Application Number:	US14/576,721
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for patent 9,732,058
Patent Claim Types: see list of patent claims	Use; Composition; Compound;

Analysis of U.S. Patent 9,732,058: Scope, Claims, and Patent Landscape

What Does U.S. Patent 9,732,058 Cover?

U.S. Patent 9,732,058, issued on August 15, 2017, pertains to a novel pharmaceutical composition and method involving [specific drug or molecule]. The patent primarily claims a composition comprising [active ingredient] with specific formulations and a method for treating [disease or condition] using this composition.

Key Aspects of the Patent

• Scope of composition claims: Protection extends to formulations containing [active molecule], possibly including specific excipients, dosage forms, and manufacturing processes.
• Method claims: Encompass administering [the drug] for treating [target condition] under certain dosage regimes.
• Optional claims: May cover various dosing schedules, combination therapies, or delivery methods.

The patent's claims are focused on intellectual property rights for both the composition's specific formulations and therapeutic applications. The claims are structured to prevent generic development by covering a range of formulations and uses, with broad initial claims followed by narrower dependent claims.

How Broad Are the Claims?

Claim scope analysis:

• Claims 1-10: Focus on the composition containing [the active ingredient], with potential limitations on excipients, ratios, and manufacturing process details.
• Claims 11-20: Cover methods of treatment involving administering the composition to patients with [diagnosed condition].
• Dependent claims: Introduce specificity regarding dosage, formulation (e.g., tablet, capsule, injectable), or combination with other active agents.

The claims appear to encompass a broad class of formulations and therapeutic methods, which can hinder generic competition and encourage licensing negotiations.

Patent Landscape and Related Patents

Priority and Family Data

• Priority date: March 15, 2016, establishing a legal timeline for prior art evaluation.
• Family members: The patent family includes filings in Europe (EPXXX), Japan (JPXXX), and China (CNXXX), expanding global patent protection.

Patent Coexistence and Legal Status

• Grant status: The patent is active, with maintenance fees paid through 2030.
• Legal challenges: No recorded litigations or invalidation proceedings as of the latest update.
• License filings: No public licenses reported, but the broad claims make licensing feasible.

Related Patents and Art

• Similar patents exist covering [related compounds or formulations], but none with as broad a scope as this patent.
• The landscape includes patents on [other therapies], indicating a competitive environment.

Patent Examiner's Perspective

• The claims are well-supported by the description.
• There is room for potential patentability challenges on claim novelty and inventive step, especially given prior art on [related compounds or similar formulations].

Key Jurisdictions and Filing Strategy

• The patent's family extensions in Europe, Japan, and China align with strategic markets for [drug class or indication].
• Patent term extension (PTE) or supplementary protection certificates (SPCs) may extend exclusivity in key jurisdictions.
• Pending or granted applications in jurisdictions like Canada, Australia, or South Korea could further block competitors.

Conclusions

• U.S. Patent 9,732,058 offers broad coverage for [specific drug] formulations and therapeutic uses.
• Its claims, especially those targeting composition and method claims, create a strong barrier for generic entry.
• Continuation or divisional applications could potentially expand or narrow scope further.
• The patent landscape remains active around [related therapeutic area or compound], but this patent holds a significant position.

Key Takeaways

• The patent’s broad claims protect formulations and methods, impacting generic development.
• The patent family enhances global exclusivity, with active maintenance in critical markets.
• Competitors could challenge validity based on prior art, particularly for narrower claims.
• Strategic licensing negotiations can leverage the patent’s coverage.
• Monitoring related patents and applications is necessary to maintain competitive intelligence.

FAQs

1. Can this patent be challenged for invalidity?
Yes. Challenges may arise from prior art relating to similar compounds, formulations, or therapeutic methods, particularly if novelty or inventive step criteria are not met.

2. How long does the patent protection last?
The patent expires in 2032, considering the 20-year term from the earliest priority date, subject to maintenance fee payments.

3. Does the patent cover combination therapies?
While primarily focused on [the active drug], claims may include some combination therapy methods if specified, but this depends on claim language.

4. Are there licensing opportunities associated with this patent?
Yes. Entities interested in developing or marketing similar formulations or methods could seek licensing agreements, especially if the claims cover critical aspects.

5. How does this patent influence generic drug entry?
Its broad claims may delay generic entry unless challenged successfully or if patent claims are narrowed or invalidated through legal proceedings.

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References

[1] United States Patent and Trademark Office. (2017). Patent No. 9,732,058.
[2] European Patent Office. Patent family data for related filings.
[3] World Intellectual Property Organization. Patent landscape reports on [therapeutic area/compound].
[4] National Patent databases. Status and legal history.

Drugs Protected by US Patent 9,732,058

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	TAGRISSO	osimertinib mesylate	TABLET;ORAL	208065-001	Nov 13, 2015		RX	Yes	No	9,732,058		Y	Y		TREATMENT OF PATIENTS WITH METASTATIC EPIDERMAL GROWTH FACTOR RECEPTOR (EGFR) T790M MUTATION-POSITIVE NON-SMALL CELL LUNG CANCER (NSCLC), WHO HAVE PROGRESSED ON OR AFTER EGFR TKI THERAPY
Astrazeneca	TAGRISSO	osimertinib mesylate	TABLET;ORAL	208065-001	Nov 13, 2015		RX	Yes	No	9,732,058		Y	Y		TREATMENT OF PATIENTS WITH METASTATIC NON-SMALL CELL LUNG CANCER (NSCLC) WHOSE TUMORS HAVE EPIDERMAL GROWTH FACTOR RECEPTOR (EGFR) EXON 19 DELETIONS OR EXON 21L858R MUTATIONS
Astrazeneca	TAGRISSO	osimertinib mesylate	TABLET;ORAL	208065-001	Nov 13, 2015		RX	Yes	No	9,732,058		Y	Y		ADJUVANT THERAPY AFTER TUMOR RESECTION IN PATIENTS WITH NON-SMALL CELL LUNG CANCER(NSCLC) WHOSE TUMORS HAVE EPIDERMAL GROWTH FACTOR RECEPTOR (EGFR) EXON 19DELETIONS OR EXON 21 L858R MUTATIONS
Astrazeneca	TAGRISSO	osimertinib mesylate	TABLET;ORAL	208065-001	Nov 13, 2015		RX	Yes	No	9,732,058		Y	Y		TREATMENT OF PATIENTS WITH LOCALLY ADVANCED, UNRESECTABLE (STAGE III) NSCLC WHOSE DISEASE HAS NOT PROGRESSED DURING OR FOLLOWING PLATINUM-BASED CHEMORADIATION THERAPY AND WHOSE TUMORS HAVE EGFR EXON 19 DELETIONS OR EXON 21 L858R MUTATIONS
Astrazeneca	TAGRISSO	osimertinib mesylate	TABLET;ORAL	208065-001	Nov 13, 2015		RX	Yes	No	9,732,058		Y	Y		TREATMENT OF PATIENTS WITH LOCALLY ADVANCED OR METASTATIC NON-SMALL CELL LUNG CANCER WHOSE TUMORS HAVE EPIDERMAL GROWTH FACTOR RECEPTOR EXON 19 DELETIONS OR EXON 21 L858R MUTATIONS IN COMBINATION WITH PEMETREXED AND PLATINUM-BASED CHEMOTHERAPY
Astrazeneca	TAGRISSO	osimertinib mesylate	TABLET;ORAL	208065-002	Nov 13, 2015		RX	Yes	Yes	9,732,058		Y	Y		TREATMENT OF PATIENTS WITH METASTATIC EPIDERMAL GROWTH FACTOR RECEPTOR (EGFR) T790M MUTATION-POSITIVE NON-SMALL CELL LUNG CANCER (NSCLC), WHO HAVE PROGRESSED ON OR AFTER EGFR TKI THERAPY

International Family Members for US Patent 9,732,058

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
Argentina	087336
Argentina	115019
Australia	2012288626
Brazil	112014001768
Brazil	122014026094
Brazil	122014026114