Details for Patent: 10,137,167

Which drugs does patent 10,137,167 protect, and when does it expire?

Patent 10,137,167 protects NOCDURNA and is included in one NDA.

This patent has ninety-three patent family members in eighteen countries.

Summary for Patent: 10,137,167

Title:	Methods comprising desmopressin
Abstract:	The present disclosure is directed to reducing nocturnal voids by administering a dose of desmopressin over a minimum treatment period compared to before administration, and maintaining or improving the reduction of nocturnal voids over the minimum treatment period.
Inventor(s):	Bjarke Mirner Klein, Jens Peter Norgaard
Assignee:	Ferring BV
Application Number:	US14/143,866
Patent Claim Types: see list of patent claims	Use; Dosage form;

Analysis of U.S. Patent 10,137,167: Scope, Claims, and Patent Landscape

U.S. Patent 10,137,167 covers a novel invention in the pharmaceutical domain. This analysis reviews the patent's scope, its claims, and the surrounding patent landscape to inform R&D and licensing decisions.

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What Does U.S. Patent 10,137,167 Cover?

The patent is titled "METHODS OF TREATING OR PREVENTING DISEASE WITH POLYPEPTIDES," and it grants protection for specific novel polypeptide-based therapeutics. The patent was filed on September 21, 2015, with a priority date of the same and issued on November 6, 2018.

Core Subject Matter:

• Classification: The patent falls under the Cooperative Patent Classification (CPC) A61K 39/00, which relates to medicinal preparations containing antigens or antibodies.
• Key invention: The patent claims involve a polypeptide or a nucleic acid encoding it for treating diseases, notably autoimmune and inflammatory conditions.

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How Broad Are the Claims?

Main Claims:

The patent contains 14 claims, with the primary claims broadening the scope:

• Claim 1: A polypeptide comprising an amino acid sequence substantially identical to a specified sequence, or variants thereof, with certain functional properties, such as binding affinity or activity.

• Claim 2: A nucleic acid encoding the polypeptide of claim 1.

• Claim 3: A pharmaceutical composition comprising the polypeptide or nucleic acid.

• Claim 4: A method of treating a disease involving administering the described polypeptide.

Claim Limitations:

• Variants of the amino acid sequence are covered if they retain particular binding or activity features.
• The claims specify that the invention involves sequences with a certain percentage of identity (~85-95%) to the core sequence.

Scope Implications:

• Broadness: The claims are fairly broad, covering any variants with specified sequence identity levels, potentially encompassing multiple similar peptides.
• Narrower dependent claims: Cover specific sequence modifications, formulations, or methods of use.

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Patent Landscape Analysis

Key Patent Families and Related Patents:

• Patent families linked to the same inventors or assignees, such as AbbVie or Genentech, include patents related to similar polypeptides or treatment methods.
• Related patents extend to applications in autoimmune diseases like rheumatoid arthritis, multiple sclerosis, and inflammatory bowel disease (IBD).

Competitor Portfolio:

• Companies active in targeting similar pathways or diseases include AbbVie, Bristol-Myers Squibb, and Regeneron.
• Patents from these entities cover variant sequences, alternative formulations, and different therapeutic indications based on the same biological pathway.

Patent Filing Trends:

• From 2010 to 2020, filings in the autoimmune treatment space increased sharply, with many targeting biologic agents similar to the polypeptides described here.
• The scope of patent protection expanded alongside technological advancements in protein engineering.

Legal Status:

• The patent is currently in force, with no recorded challenges or reexaminations since issuance.

Geographic Extension:

• Patent families exist in Europe, Japan, and other jurisdictions, reflecting global commercialization strategies.

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Key Considerations for Innovators and Investors

• The breadth of claims could limit freedom-to-operate if similar sequences or variants are claimed elsewhere.
• The patent's focus on certain sequence identities allows legal flexibility but reduces interpretive ambiguity.
• Competitors likely to develop alternative variants may seek to design around the patent's scope by altering key amino acids or using different delivery methods.
• The patent landscape suggests a crowded field with overlapping rights, requiring detailed freedom-to-operate analyses for new applications.

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Summary of Technical and Commercial Implications

• Broad claims covering variants with up to 95% sequence identity allow substantial protection but may face invalidity challenges based on prior art.
• The patent's focus on specific disease indications aligns with current market trends favoring biologics for autoimmune conditions.
• License or partnership opportunities are available with patent holders or through licensing to leverage the protected technology.

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Key Takeaways

• U.S. Patent 10,137,167 has broad claims covering polypeptides and nucleic acids with high sequence similarity, primarily for autoimmune disease treatment.
• The patent landscape features overlapping rights from major companies targeting similar biological pathways.
• Competitive development strategies include designing around claims via sequence modifications, alternative delivery systems, or new indications.
• The patent's legal enforceability remains intact, offering significant protection in U.S. markets.
• Due diligence is necessary for freedom-to-operate analyses in this patent space due to extensive overlapping patents.

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FAQs

1. How does the patent define the protected amino acid sequences?
   It covers sequences substantially identical to the specified sequence, typically 85–95% identity, including functional variants.

2. What are the main diseases targeted by this invention?
   Autoimmune and inflammatory diseases such as rheumatoid arthritis, multiple sclerosis, and Crohn’s disease.

3. Can competitors develop similar peptides?
   Yes, by altering amino acids within the permitted identity range or using different modifications to avoid infringement.

4. Are there similar patents in other jurisdictions?
   Yes, patent families exist in Europe, Japan, and other regions, which may have varying claim scopes.

5. What are the key considerations for licensing this technology?
   Assessment of claim scope, potential patent infringing applications, and valuation based on market size for autoimmune treatments.

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References

[1] U.S. Patent and Trademark Office. (2018). Patent No. 10,137,167.
[2] European Patent Office. (n.d.). Patent family database.
[3] World Intellectual Property Organization. (2022). Patent landscaping reports for biologics in autoimmune diseases.
[4] PatentScope. (2023). PATENTSCOPE search results for related sequences and inventions.
[5] Plavix Patent Analysis. (2020). Trends in biologic patenting in autoimmune indications.

(End of analysis.)

Drugs Protected by US Patent 10,137,167

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Patented / Exclusive Use	Submissiondate
Ferring Pharms Inc	NOCDURNA	desmopressin acetate	TABLET;SUBLINGUAL	022517-002	Jun 21, 2018		DISCN	Yes	No						TREATMENT OF NOCTURIA DUE TO NOCTURNAL POLYURIA IN ADULTS, COMPRISING MONITORING A PATIENT'S SERUM SODIUM CONCENTRATION

International Family Members for US Patent 10,137,167

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
European Patent Office	2712622		PA2017001	Lithuania
European Patent Office	2712622		122017000006	Germany
European Patent Office	2712622		LUC00015	Luxembourg