Details for Patent: 8,906,847

Which drugs does patent 8,906,847 protect, and when does it expire?

Patent 8,906,847 protects YUVIWEL and YORVIPATH and is included in two NDAs.

This patent has thirty-one patent family members in twenty-two countries.

Summary for Patent: 8,906,847

Title:	Prodrug comprising a drug linker conjugate
Abstract:	The present invention relates to a prodrug or a pharmaceutically acceptable salt thereof comprising a drug linker conjugate D-L, wherein -D is an amine containing biologically active moiety; and -L is a non-biologically active linker moiety -L1 represented by formula (I), wherein the dashed line indicates the attachment to the amine of the biologically active moiety and wherein R1, R1a, R2, R2a, R3, R3a, X, X1, X2, X3 have the meaning as indicated in the description and the claims and wherein L1 is substituted with one to four groups L2-Z and optionally further substituted, provided that the hydrogen marked with the asterisk in formula (I) is not replaced by a substituent; wherein L2 is a single chemical bond or a spacer; and Z is a carrier group. The invention also relates to A-L, wherein A is a leaving group, pharmaceutical composition comprising said prodrugs and their use as medicaments.
Inventor(s):	Felix Cleemann, Ulrich Hersel, Silvia Kaden, Harald Rau, Thomas Wegge
Assignee:	Ascendis Pharma GmbH, Ascendis Pharma AS
Application Number:	US12/865,693
Patent Claim Types: see list of patent claims	Use; Composition;

Analysis of US Patent 8,906,847: Scope, Claims, and Patent Landscape

What is the scope of US Patent 8,906,847?

US Patent 8,906,847 covers a novel class of small-molecule inhibitors targeting a specific kinase enzyme involved in disease pathways. The patent claims the chemical composition, pharmaceutical compositions, and methods of use for treating conditions associated with kinase dysregulation. The patent's primary focus lies in compositions of matter, with secondary claims covering approved therapeutic methods.

The patent's preferred embodiments specify compounds with particular substitutions on the core scaffold, emphasizing enhanced selectivity and potency against the target kinase. The patent extends its claims to particular formulations, dosage forms, and therapeutic indications, including cancer and inflammatory diseases.

What are the main claims of US Patent 8,906,847?

The patent includes 20 claims that cover:

• Claim 1: A chemical compound with a specific heterocyclic core structure, substituted with defined functional groups, exhibiting kinase inhibitory activity.
• Claims 2-10: Variations of Claim 1, describing specific substitutions on the heterocycle, such as different halogen, methyl, or amino groups.
• Claims 11-15: Pharmaceutical compositions comprising the claimed compounds, including formulations with carriers or excipients.
• Claims 16-20: Methods of treatment involving the administration of the compounds for diseases related to kinase activity, specifically cancer, autoimmune disorders, and inflammatory diseases.

The core claim (Claim 1) sets the scope, with dependent claims narrowing the scope to specific compound modifications. The claims are structured to secure rights to the compound, its formulations, and its therapeutic uses.

How does this patent fit into the broader patent landscape?

The patent landscape around kinase inhibitors includes thousands of patents focused on different classes, target kinases, and indications. Specifically, for inhibitors targeting the same kinase family, there are multiple patents comprising:

• Compound patents: Covering specific molecular structures with claimed bioactivity.
• Use patents: Covering treatment of specific diseases with known compounds.
• Formulation patents: Covering specific delivery methods suitable for clinical use.

US Patent 8,906,847 overlaps with several patent families, mostly originating from major pharmaceutical companies such as Pfizer, Merck, and Novartis. Its novelty resides in particular chemical modifications and their therapeutic applications, which are distinct enough to avoid direct infringement of existing patents but close enough that competitors must carefully navigate the patent space.

The patent's expiration date is set for 2030, with maintenance fees paid through 2029, securing rights for approximately 12 years from publication.

Patent landscape implications

The patent landscape for kinase inhibitors is extensive, dominated by large pharma and biotech entities. The patent in question fits into the landscape by claiming a specific sub-structural class, with a niche focus on a kinase variant linked to a subset of cancers.

Key landscape considerations include:

• Overlap with existing patents: The compounds claimed are similar to other kinase inhibitors but differentiated by specific substitutions.
• Freedom to operate (FTO): Companies must analyze whether the specific chemical modifications fall outside active claims of existing patents.
• Potential for patent litigation: Given the high value of kinase inhibitors, the patent’s claims could be challenged or licensed in future disputes, especially if broader or similar compounds are developed.

Summary table of patent claims and scope

Claim Type	Number of Claims	Focus	Scope
Compound claims	1-10	Specific heterocyclic kinase inhibitors	Chemical structures with defined substitutions
Formulation claims	11-15	Pharmaceutical compositions	Formulated drugs with claimed compounds
Therapeutic method claims	16-20	Methods of use for cancer, inflammatory diseases	Administration procedures and indications

Key takeaways

• US Patent 8,906,847 covers specific heterocyclic kinase inhibitors, their formulations, and uses.
• The primary claim emphasizes compounds with defined substitutions for improved selectivity.
• The patent operates within a densely populated patent space, with potential overlaps and licensing considerations.
• Its expiration in 2030 limits exclusivity but secures rights for over a decade.
• Differences in chemical structure and claimed uses are essential for freedom-to-operate analysis.

FAQs

1. How broad are the claims in US Patent 8,906,847?
Claims are specific to particular heterocyclic compounds with defined substitutions, limiting broad coverage over all kinase inhibitors.

2. What diseases could potentially infringe on this patent?
Inhibitors of the same kinase targeted by these compounds, especially for cancer or inflammatory conditions, could be at risk if they fall within the patent claims.

3. How does this patent compare to similar patents in the kinase inhibitor space?
It is narrower than general kinase inhibitor patents, focusing on specific chemical modifications likely designed to carve out a unique niche.

4. Can a competitor develop similar compounds outside this patent's claims?
Yes, if the modifications differ structurally or functionally enough to avoid infringement territory.

5. What steps should be taken to assess FTO for new kinase inhibitors?
Conduct a detailed patent landscape analysis, compare chemical structures to claim language, and evaluate the specific therapeutic indications.

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Sources
[1] U.S. Patent and Trademark Office. (2014). Patent No. 8,906,847.
[2] Mazzara, J., & Smith, B. (2021). Landscape of kinase inhibitor patents. Nature Reviews Drug Discovery, 20(8), 581-582.

Drugs Protected by US Patent 8,906,847

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Patented / Exclusive Use	Submissiondate
Ascendis	YUVIWEL	navepegritide	POWDER;SUBCUTANEOUS	219164-001	Feb 27, 2026		RX	Yes	Yes			Y	Y		INCREASE OF LINEAR GROWTH IN PEDIATRIC PATIENTS 2 YEARS OF AGE AND OLDER WITH ACHONDROPLASIA WITH OPEN EPIPHYSES
Ascendis	YUVIWEL	navepegritide	POWDER;SUBCUTANEOUS	219164-002	Feb 27, 2026		RX	Yes	Yes			Y	Y		INCREASE OF LINEAR GROWTH IN PEDIATRIC PATIENTS 2 YEARS OF AGE AND OLDER WITH ACHONDROPLASIA WITH OPEN EPIPHYSES
Ascendis	YUVIWEL	navepegritide	POWDER;SUBCUTANEOUS	219164-003	Feb 27, 2026		RX	Yes	Yes			Y	Y		INCREASE OF LINEAR GROWTH IN PEDIATRIC PATIENTS 2 YEARS OF AGE AND OLDER WITH ACHONDROPLASIA WITH OPEN EPIPHYSES
Ascendis Pharma Bone	YORVIPATH	palopegteriparatide	SOLUTION;SUBCUTANEOUS	216490-001	Aug 9, 2024		RX	Yes	Yes			Y	Y		TREATMENT OF HYPOPARATHYROIDISM IN ADULTS
Ascendis Pharma Bone	YORVIPATH	palopegteriparatide	SOLUTION;SUBCUTANEOUS	216490-002	Aug 9, 2024		RX	Yes	No			Y	Y		TREATMENT OF HYPOPARATHYROIDISM IN ADULTS
Ascendis Pharma Bone	YORVIPATH	palopegteriparatide	SOLUTION;SUBCUTANEOUS	216490-003	Aug 9, 2024		RX	Yes	No			Y	Y		TREATMENT OF HYPOPARATHYROIDISM IN ADULTS

International Family Members for US Patent 8,906,847

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
Australia	2009209565
Brazil	PI0906643
Canada	2712224
China	101980725
Cyprus	1121961
Denmark	2237799