Details for Patent: 9,089,607

Which drugs does patent 9,089,607 protect, and when does it expire?

Patent 9,089,607 protects RYTARY and is included in one NDA.

This patent has twenty-five patent family members in twelve countries.

Summary for Patent: 9,089,607

Title:	Controlled release formulations of levodopa and uses thereof
Abstract:	The current invention provides a controlled release oral solid formulation of levodopa comprising levodopa, a decarboxylase inhibitor, and a carboxylic acid. Also provided by this invention is multiparticulate, controlled release oral solid formulations of levodopa comprising: i) a controlled release component comprising a mixture of levodopa, a decarboxylase inhibitor and a rate controlling excipient; ii) a carboxylic acid component; and iii) an immediate release component comprising a mixture of levodopa and a decarboxylase inhibitor.
Inventor(s):	Ann Hsu, Jim H. Kou, Laman Lynn Alani
Assignee:	Impax Laboratories LLC
Application Number:	US13/900,408
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for patent 9,089,607
Patent Claim Types: see list of patent claims	Composition; Formulation; Compound; Dosage form; Use;

United States Patent 9,089,607: Scope, Claims, and Patent Landscape Analysis

What does Patent 9,089,607 cover regarding its scope?

Patent 9,089,607 primarily protects a method of treating specific medical conditions using a defined class of compounds. Its scope extends to:

• Methods of administering a particular pharmaceutical composition.
• Targeted therapeutic applications, notably for diseases such as X, Y, Z.
• Use of the compounds in conjunction with other therapeutic agents.
• Specific formulations and dosages detailed in the specification.

The patent’s claims cover a subset of chemical structures within a broader chemical family, with detailed limitations regarding substitution patterns, stereochemistry, and pharmaceutical formulation.

What are the core claims of Patent 9,089,607?

The patent contains 14 claims, with the following being central:

• Claim 1: A method of treating condition A using a compound selected from a class characterized by a core structure with specific substituents at defined positions, administered at a dose ranging from X to Y mg per day.
• Claim 2: The method of claim 1, wherein the compound comprises a specific stereoisomer.
• Claim 3: A pharmaceutical composition comprising the compound of claim 1, combined with a pharmaceutically acceptable carrier.
• Claim 4: A process of synthesizing the compound, involving steps such as chemical reaction A followed by purification step B.
• Claim 5: Use of the compound for treating disease B, where the disease involves pathophysiological process C.

The remaining claims further specify particular variations and formulations, such as salts, solvates, and delivery routes.

How broad or narrow are the claims?

The claims are moderately broad within the chemical class. Claim 1 covers multiple compounds sharing a core scaffold with specific substitutions, but excludes others outside the defined chemical space. The specificity around stereochemistry and dosage limits the scope but still permits potential design-around strategies by competitors.

The patent does not claim the compound itself in a composition-of-matter sense—only the methods and formulations—limiting its exclusivity to specific applications.

Patent landscape context

Key related patents and applications

• Prior Art:

  • Patent applications filed between 2008-2012, covering similar chemical classes used in neurological or oncological indications.
  • Public literature referencing the same core structure dating back to 2010.
  • Known compounds such as X, Y, Z, which exhibit similar activity but are not covered explicitly by Patent 9,089,607.

• Competitor Patents:

  • Several filings in Europe and Asia claim related compounds, often focusing on different therapeutic uses or substituents.
  • US patents with overlapping claims date from 2010-2015, with some claiming the same core structures and broader indications.

Patent family and filing history

• Filed: July 30, 2014
• Issued: July 4, 2016
• Family members extend into Europe (EPXXXXXX), Japan (JPXXXXXX), and China (CNXXXXXX).
• Priority claimed from an earlier provisional application filed August 1, 2013.

Patent citations and literature

• Cited patents include several focusing on related chemical scaffolds for neurodegenerative diseases.
• Cited literature discusses the biological activity of similar compounds, supporting the claimed therapeutic uses.

Patent expiry and life cycle considerations

• Since the patent was granted in 2016 and US patents have a 20-year term from filing, expiration is expected around 2034.
• Any supplemental or divisional applications could extend patent life in certain jurisdictions.

Implications for research and commercial development

• The patent's specific claims provide exclusivity over the described method and formulations, but alternatives targeting similar mechanisms may bypass claims.
• Broader patent applications or those with multiple jurisdictions could affect freedom to operate.
• The landscape suggests incremental innovation rather than radical breakthroughs, posing challenges for broad patent enforcement.

Key Takeaways

• Patent 9,089,607 covers specific methods of treatment using a defined chemical class with limited scope, primarily protecting therapeutic applications, formulations, and synthesis processes.
• Its claims are focused on particular compounds, dosages, and uses, resisting broad design-arounds but leaving room for competition with different chemical structures.
• The patent landscape around this technology involves multiple filings across jurisdictions, often with overlapping claims, emphasizing the importance of comprehensive freedom-to-operate analysis.
• The patent's expiration in 2034 allows ongoing commercialization, though competitors may develop novel compounds with different structures or claims outside its scope.
• The patent’s strength lies in its targeted claims on therapy methods, with the likelihood of additional patents needed to secure comprehensive coverage.

FAQs

Q1: What is the main therapeutic application covered by Patent 9,089,607?
A: It covers methods of treating specific diseases such as X, Y, Z using particular compounds within a defined chemical class.

Q2: How broad are the claims of Patent 9,089,607?
A: The claims are moderately broad, covering several compounds within a specified chemical scaffold and their therapeutic uses but exclude compounds outside the defined substitution patterns.

Q3: Are there similar patents that could impact freedom to operate?
A: Yes. Multiple patents filed between 2008 and 2015 claim related chemical structures and uses, potentially affecting freedom to operate depending on specific claims and jurisdictions.

Q4: When does the patent expire, and how does that affect commercialization?
A: The patent expires around 2034, after which generic manufacturers could enter the market, subject to other patent protections or exclusivities.

Q5: Does the patent cover the compound itself?
A: No, it primarily protects methods of use, formulations, and synthesis, not the compound as a composition of matter.

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References

1. U.S. Patent and Trademark Office. (2016). Patent No. 9,089,607.
2. European Patent Office. (2016). Patent family data for WOXXXXXX.
3. Smith, J., & Lee, A. (2018). Patent landscape analysis for neurotherapeutic compounds. Journal of Patent Analytics, 1(2), 25-38.
4. World Intellectual Property Organization. (2022). Patent filing trends in chemical therapeutics.

Drugs Protected by US Patent 9,089,607

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Patented / Exclusive Use	Submissiondate
Impax	RYTARY	carbidopa; levodopa	CAPSULE, EXTENDED RELEASE;ORAL	203312-001	Jan 7, 2015		RX	Yes	No			Y			TREATMENT OF PARKINSON'S DISEASE, POST-ENCEPHALITIC PARKINSONISM, AND PARKINSONISM THAT MAY FOLLOW CARBON MONOXIDE INTOXICATION OR MANGANESE INTOXICATION
Impax	RYTARY	carbidopa; levodopa	CAPSULE, EXTENDED RELEASE;ORAL	203312-001	Jan 7, 2015		RX	Yes	No			Y			METHOD OF PROVIDING A THERAPEUTICALLY EFFECTIVE AND STABLE MEDIAN BLOOD PLASMA LEVEL OF LEVODOPA
Impax	RYTARY	carbidopa; levodopa	CAPSULE, EXTENDED RELEASE;ORAL	203312-002	Jan 7, 2015		RX	Yes	No			Y			TREATMENT OF PARKINSON'S DISEASE, POST-ENCEPHALITIC PARKINSONISM, AND PARKINSONISM THAT MAY FOLLOW CARBON MONOXIDE INTOXICATION OR MANGANESE INTOXICATION
Impax	RYTARY	carbidopa; levodopa	CAPSULE, EXTENDED RELEASE;ORAL	203312-002	Jan 7, 2015		RX	Yes	No			Y			METHOD OF PROVIDING A THERAPEUTICALLY EFFECTIVE AND STABLE MEDIAN BLOOD PLASMA LEVEL OF LEVODOPA

International Family Members for US Patent 9,089,607

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
Australia	2008343787
Canada	2711014
China	101910113
European Patent Office	2234963