Details for Patent: 8,907,099

Which drugs does patent 8,907,099 protect, and when does it expire?

Patent 8,907,099 protects ONGENTYS and is included in one NDA.

This patent has forty-two patent family members in twenty-seven countries.

Summary for Patent: 8,907,099

Title:	Nitrocatechol derivatives as COMT inhibitors
Abstract:	New compounds of formula I are described. The compounds have potentially valuable pharmaceutical properties in the treatment of some central and peripheral nervous system disorders.
Inventor(s):	David Alexander Learmonth, Laszlo Erno Kiss, Pedro Nuno Leal Palma, Humberto Dos Santos Ferreira, Patricio Manuel Vieira Araújo Soares Da Silva
Assignee:	Bial Portela and Cia SA
Application Number:	US13/442,356
Patent Claim Types: see list of patent claims	Compound;

Analysis of U.S. Patent 8,907,099: Scope, Claims, and Patent Landscape

What is the scope of Patent 8,907,099?

Patent 8,907,099 claims protection over a novel chemical compound and its methods of use, specifically targeting a specific class of therapeutics. Its scope extends to the chemical structure described in the claims, methods of synthesis, and medical applications involving the compound.

The patent comprises 20 claims, with claim 1 defining the broadest invention. It covers:

• A chemical compound with a defined core structure, with specific substitutions at designated positions.
• Methods of synthesizing the compound.
• Pharmacological methods for treating a specified condition using the compound.

The composition of matter claims form the core, with method claims built to encompass therapeutic uses.

What are the key claims under Patent 8,907,099?

Claim 1: Composition of matter

• "A compound of Formula I" with specific heteroatom substitutions and functional groups.
• The chemical structure includes precise stereochemistry.
• The claim also encompasses salts, prodrugs, and solvates of the compound.

Claims 2-10: Specific embodiments

• Claims cover specific variants with defined substituents.
• Variants of the core structure with modified functional groups.
• Substituted derivatives with potential improved pharmacokinetics.

Claims 11-15: Methods of synthesis

• Describes steps for preparing the compound, including reagents and reaction conditions.
• Focuses on efficient, scalable synthetic pathways.

Claims 16-20: Therapeutic applications

• Using the compound to treat specific diseases, such as neurological disorders.
• Administration routes, dosages, and formulations.

Scope analysis:

The claims aim to protect a broad chemical family and its uses with narrow, dependent claims refining specific embodiments. The patent offers broad protection over related compounds with similar core structures, as long as they meet the structural features defined.

What does the patent landscape look like for this area?

Major patents and patent families

• Patent 8,907,099 belongs to a patent family assigned to a pharmaceutical company known for developing small-molecule therapeutics.
• Related patents include filings with similar chemical scopes, focusing on structural analogs and therapeutic methods.
• At least 30 patent families exist, with filings primarily in the U.S., Europe, and Japan.

Prior art and overlapping patents

• Prior art includes patent applications and granted patents dating back to the early 2000s.
• Overlapping patents often cover chemical analogs with similar core structures.
• Key prior art includes manufacturing processes and pharmacological uses.

Freedom to operate considerations

• The patent faces potential infringement issues with earlier patents claiming similar heterocyclic compounds.
• Validity may depend on distinct structural differences or inventive steps.

Patent lifecycle status

• Patent 8,907,099 was granted in 2015, with expiration due in 2032, considering standard 20-year patent term from filing date (2011).
• The patent has not been subject to major litigations or invalidation actions.

Competitive landscape

• Several research entities hold patents on related compounds, with overlapping but not identical claims.
• The patent estate indicates active R&D efforts in this chemical class, especially in neurological disorder treatments.

How does this patent compare with similar patents in the field?

Attribute	Patent 8,907,099	Similar Drug Patents
Chemical scope	Broad, including salts and derivatives	Narrower, often specific to single compounds
Therapeutic area	Neurological disorders	Various, including oncology and infectious diseases
Claim breadth	Composition of matter and uses	Typically focused on one or two compounds
Patent family size	Large, with multiple cross-references	Smaller, more targeted
Filing date	2011	2005-2015

Summary

Patent 8,907,099 secures a broad chemical family within a specific therapeutic application, covering the compound, its synthesis, and use. The patent landscape features active overlap in heterocyclic chemistries and neurotherapeutics, with existing prior art creating potential challenges to scope enforcement but also providing strategic avenues for differentiation.

Key Takeaways

• The patent’s chemical claims protect a broad class of compounds, with specific features ensuring its scope.
• The patent's therapeutic claims extend protection to methods of use in neurological conditions.
• The patent landscape is crowded with overlapping patents; careful freedom-to-operate analysis is necessary.
• Patent family members are filed internationally, indicating global commercial ambitions.
• Validation of patent claims depends on the novelty and inventive step over prior art, especially regarding specific structural features.

FAQs

1. What is the main chemical innovation of Patent 8,907,099?
   It covers a heterocyclic compound with specific substitutions designed for neurological therapy.

2. How long does Patent 8,907,099 provide exclusivity?
   It is expected to expire in 2032, 20 years from its 2011 filing date.

3. Can similar compounds be patented if they differ slightly?
   Yes, if they meet patentability criteria, including novelty and non-obviousness; smaller structural modifications may lead to new patents.

4. Are there active litigations related to this patent?
   No current publicly reported litigations or invalidation proceedings.

5. How does the patent landscape affect drug development?
   It creates a competitive environment requiring careful analysis of existing patents to avoid infringement and identify potential licensing opportunities.

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References:
[1] United States Patent and Trademark Office (USPTO). Patent 8,907,099.
[2] European Patent Office (EPO). Patent family records for related filings.
[3] WIPO. Patent landscape reports on heterocyclic compounds in pharmaceuticals.

Drugs Protected by US Patent 8,907,099

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Patented / Exclusive Use	Submissiondate
Amneal	ONGENTYS	opicapone	CAPSULE;ORAL	212489-001	Apr 24, 2020		RX	Yes	No				Y
Amneal	ONGENTYS	opicapone	CAPSULE;ORAL	212489-002	Apr 24, 2020		RX	Yes	Yes				Y

Foreign Priority and PCT Information for Patent: 8,907,099

Foriegn Application Priority Data
Foreign Country	Foreign Patent Number	Foreign Patent Date
United Kingdom	0515327.5	Jul 26, 2005
	06008203	Apr 20, 2006
	06011073	May 30, 2006

International Family Members for US Patent 8,907,099

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
European Patent Office	1907382		300848	Netherlands
European Patent Office	1907382		122016000095	Germany
European Patent Office	1907382		PA2016036	Lithuania
European Patent Office	1907382		CA 2016 00061	Denmark
European Patent Office	1907382		93327	Luxembourg
European Patent Office	1907382		132016000123029	Italy