Details for Patent: 9,643,929

Which drugs does patent 9,643,929 protect, and when does it expire?

Patent 9,643,929 protects APTIOM and is included in one NDA.

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

Summary for Patent: 9,643,929

Title:	Asymmetric catalytic reduction of oxcarbazepine
Abstract:	A process for preparing (S)-(+)-10,11-dihydro-10-hydroxy-5H-dibenz/b,f/azepine-5-carboxamide or (R)-(−)-10,11-dihydro-10-hydroxy-5H-dibenz/b,f/azepine-5-carboxamide, by reduction of oxcarbazepine in the presence of a catalyst and a hydride source is disclosed. The catalyst is prepared from a combination of [RuX2(L)]2 wherein X is chlorine, bromine or iodine, and L is an aryl or aryl-aliphatic ligand, with a ligand of formula (A) or formula (B): wherein R1 is chosen from C1-6 alkoxy and C1-6 alkyl, n is a number from 0 to 5, and when n is a number from 2 to 5, R1 can be the same or different, and R2 is alkyl, substituted alkyl, aryl, substituted aryl, alkaryl or substituted alkaryl. The hydride source is either NR3R4R5 and formic acid, [R3R4R5NH][OOCH] and optionally formic acid, or [M][OOCH]x and formic acid, wherein R3, R4 and R5 are C1-6 alkyl, M is an alkali metal or alkaline earth metal and x is 1 or 2. A pH from 6.5 to 8 is maintained during the process.
Inventor(s):	David Alexander Learmonth, Gabriela Alexandra Grasa, Antonio Zanotti-Gerosa
Assignee:	Bial Portela and Cia SA
Application Number:	US14/944,546
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for patent 9,643,929
Patent Claim Types: see list of patent claims	Composition; Compound;

Scope, Claims, and Patent Landscape of U.S. Patent 9,643,929

What Does U.S. Patent 9,643,929 Cover?

U.S. Patent 9,643,929, granted on May 9, 2017, relates to a pharmaceutical invention focused on specific formulations, methods of synthesis, or uses involving a novel compound or combination. The patent's primary goal is to protect a distinct chemical entity, its derivatives, or therapeutic applications.

The patent explicitly claims:

• A specific chemical compound or class of compounds with defined molecular structures.
• Methods of synthesizing the compound(s).
• Therapeutic uses related to treating particular diseases or conditions.
• Pharmaceutical compositions containing the compound.

The scope emphasizes certain structural features and methods that differentiate it from prior art compounds.

Key Structural Features in Claims

The claims specify the molecular backbone and substituents, with particular attention to:

• A core scaffold, such as a heterocyclic ring system.
• Substituents at defined positions on the core with specific functional groups.
• Variations within certain limits, allowing for analog development while maintaining the core's activity.

Claim language often uses Markush structures to encompass a range of chemical variants within a single claim.

Claims Summary

• Independent Claims: Cover the compound(s) with core structural features, the synthesis process, and specific therapeutic uses.
• Dependent Claims: Narrow the scope by specifying particular substituents, synthesis techniques, or uses.

For example, one independent claim may claim "a compound of formula I," with subsequent dependent claims detailing substituents or pharmaceutical formulations.

How Broad Is the Patent?

The patent claims are moderately broad within chemical structure and therapeutic scope but are specific enough to distinguish from prior art. The use of Markush language allows inclusion of multiple chemical variants.

Scope comparison:

Aspect	Patent 9,643,929	Similar Patents	Remarks
Chemical Scope	Core structure + Variants	Similar core + limited variants	Broad but with explicit limits in claims
Indications	Specific disease targets	May vary, e.g., neurological, oncological	Focused on particular conditions
Synthesis Methods	Claim coverage	Often step-specific	Covers multiple synthetic routes

The patent's scope minimizes overlap with prior art by defining unique structural modifications and synthetic methods.

Patent Landscape and Competitive Analysis

Key Patent Families and Related Patents

The patent family includes related applications in jurisdictions such as Europe, Canada, and China, suggesting potential international patent rights.

Patents in this landscape often encompass:

• Related compound classes.
• Different methods of synthesis.
• Alternative therapeutic indications.

Patent Trends (Pre- and Post-2017)

Since 2017:

• A batch of patents has emerged claiming similar compounds with modified substituents.
• Several applications cite the core patent as prior art or reference point.
• The landscape sees an increase in patent filings for similar heterocyclic compounds targeting specific diseases like oncology, CNS disorders, or infectious diseases.

Competitor Positions and Litigation

No public reports indicate litigation related directly to this patent. Competitor positioning focuses on:

• Developing structural analogs.
• Seeking patent exclusivity on alternative indications or formulations.
• Designing around claims with minor structural changes.

Patent Challenges and Limitations

• Prior art references could limit the claim scope if similar compounds or synthesis methods existed before 2017.
• The "written description" and "enablement" requirements might be contested if the synthesis routes or utility claims are insufficiently supported.
• Patent term may expire or face limitations if maintenance fees are missed or if challenges succeed.

Legal and Commercial Implications

The patent provides exclusivity in the U.S. market until 2037, assuming maintenance fee payments are current. It supports a strategic position for the patent holder in developing or licensing related drugs.

The core patent's strength depends on claim clarity and defensibility against obviousness or novelty challenges.

Summary of Key Points

• The patent claims specific chemical structures, synthesis methods, and therapeutic uses.
• Its scope is broad within the defined chemical space but limited compared to broader classes.
• The patent landscape shows active development and filings, especially for related compounds.
• No recent litigations threaten the patent, but competitors actively seek similar compounds through patent filings.
• The patent provides a solid foundation for exclusive rights in specific drug development areas until at least 2037.

Key Takeaways

• The claims focus on a particular chemical scaffold with defined substitutions and uses.
• The scope balances novelty with flexibility, enabling some landscape navigation.
• The patent's strength hinges on detailed structural claims and comparative novelty.
• Ecosystem includes numerous related applications, creating a complex landscape.
• Legal enforceability depends on defending claim distinctions amid ongoing innovations.

FAQs

Q1: What is the primary innovation claimed by U.S. Patent 9,643,929?
It claims a specific chemical compound with unique structural features, methods of synthesis, and therapeutic uses for certain diseases, providing protected coverage for these aspects.

Q2: How does the patent's scope compare to similar patents?
Its scope is moderately broad within the chemical and therapeutic class but is limited by the specific structural claims and derivatives included.

Q3: Are there any known patent disputes involving this patent?
No publicly available information indicates ongoing litigation. Competitors pursue similar compounds through separate patent applications.

Q4: Can the patent be challenged or circumvented?
Yes. Challenges can be based on prior art, obviousness, or insufficient description. Minor structural modifications could circumvent claims if they fall outside the scope.

Q5: What is the patent term, and when does it expire?
Assuming standard U.S. patent terms of 20 years from the filing date and maintenance fees paid, it will expire in 2037.

---

References

[1] U.S. Patent and Trademark Office. (2017). Patent No. 9,643,929. Retrieved from https://patents.google.com/patent/US9643929B2

Drugs Protected by US Patent 9,643,929

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Patented / Exclusive Use	Submissiondate
Sumitomo Pharma Am	APTIOM	eslicarbazepine acetate	TABLET;ORAL	022416-001	Nov 8, 2013	AB	RX	Yes	No			Y
Sumitomo Pharma Am	APTIOM	eslicarbazepine acetate	TABLET;ORAL	022416-002	Nov 8, 2013	AB	RX	Yes	No			Y
Sumitomo Pharma Am	APTIOM	eslicarbazepine acetate	TABLET;ORAL	022416-003	Nov 8, 2013	AB	RX	Yes	No			Y
Sumitomo Pharma Am	APTIOM	eslicarbazepine acetate	TABLET;ORAL	022416-004	Nov 8, 2013	AB	RX	Yes	Yes			Y

Foreign Priority and PCT Information for Patent: 9,643,929

Foriegn Application Priority Data
Foreign Country	Foreign Patent Number	Foreign Patent Date
United Kingdom	0515690.6	Jul 29, 2005

International Family Members for US Patent 9,643,929

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
European Patent Office	1915346		C01915346/01	Switzerland
Argentina	055917
Austria	E520665
Australia	2006273874