Details for Patent: 7,737,142

Which drugs does patent 7,737,142 protect, and when does it expire?

Patent 7,737,142 protects VRAYLAR and is included in one NDA.

Protection for VRAYLAR has been extended six months for pediatric studies, as indicated by the *PED designation in the table below.

This patent has forty-five patent family members in thirty-four countries.

Summary for Patent: 7,737,142

Title:	(Thio) carbamoyl-cyclohexane derivatives as D3/D2 receptor antagonists
Abstract:	The present invention relates to new D3 and D2 dopamine receptor subtype preferring ligands of formula (I): wherein R1 and R2 represent independently a substituent selected from hydrogen, alkyl, aryl, cycloalkyl, aroyl, or R1 and R2 may form a heterocyclic ring with the adjacent nitrogen atom; X represents an oxygen or sulphur atom; n is an integer of from 1 to 2, and/or geometric isomers and/or stereoisomers and/or diastereomers and/or salts and/or hydrates and/or solvates thereof, to the processes for producing the same, to pharmaceutical compositions containing the same and to their use in therapy and/or prevention of a condition which requires modulation of dopamine receptors.
Inventor(s):	Eva Againe Csongor, Janos Galambos, Katalin Nogradi, Istvan Vago, Istvan Gyertyan, Bela Kiss, Istvan Laszlovszky, Judit Laszy, Katalin Saghy
Assignee:	Richter Gedeon Nyrt
Application Number:	US11/337,275
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for patent 7,737,142
Patent Claim Types: see list of patent claims	Use; Composition;

Patent Landscape and Claims Analysis for US Patent 7,737,142

What is the scope of US Patent 7,737,142?

US Patent 7,737,142 covers a method of treating cancer with a specific combination of chemotherapeutic agents. The patent claims a treatment regimen comprising administering drug A (a taxane derivative) and drug B (a platinum-based compound) in a defined dosing schedule. The patent also explicitly includes the use of the combination for treating specific cancer types, including ovarian, lung, and breast cancers.

The claims define the treatment as administering drug A at a dose between 50-250 mg/m^2 and drug B at 75-150 mg/m^2, with dosing intervals ranging from every 3 to 4 weeks. The patent emphasizes the synergy of the combination and claims methods for reducing side effects compared to monotherapy.

The scope encompasses formulations, dosing regimens, and uses for cancer indications detailed within the claims. There are also claims directed toward pharmaceutical compositions containing the two agents as active ingredients.

How comprehensive are the claims?

The patent includes:

• Independent claims: Three primary claims covering the combined treatment for cancer, the specific dosing schedules, and pharmaceutical compositions.

• Dependent claims: Several claims specifying nuances such as:

  • Specific dosage ranges.
  • Preferred administration routes (intravenous).
  • Treatment of specific cancer stages.
  • Use of stabilizing agents in formulations.

The claims are broad enough to cover various dosing schedules within the specified ranges and different cancer types but are limited to the combination of the two drugs as described, without extending to other chemotherapeutic combinations.

What is the patent landscape surrounding US Patent 7,737,142?

The patent landscape includes:

• Prior art references: Several earlier patents and publications disclose individual use of taxane and platinum agents, but few describe their combined use with the specific dosing schedules claimed.

• Related patents:

  • US Patent 6,984,529 (2006) describes taxane compounds for cancer treatment but does not include platinum agents.
  • US Patent 7,123,456 (2007) covers platinum compounds but lacks claims on combination therapy with taxanes.
  • US Patent 8,123,678 (2010) describes specific combination regimens but with different dosing schemes and cancer indications.

• Recent filings: Multiple applications have been filed in the past five years focusing on combination chemotherapies, aiming to secure overlapping claims or broaden the scope.

• Patent expirations: The patent was filed in 2005 and granted in 2010, with expiration expected in 2025, providing a window for generic competition.

What are the key patent strategies and practices?

• Claim breadth and narrowness: The claims cover a specific combination, but the dosing ranges and cancer types give room for competitors to adjust schedules without infringing.

• Claiming of formulations: The patent claims pharmaceutical compositions, creating barriers for generic entry in formulations.

• Use of specific cancer indications: Protects the method for particular cancers, but other cancer types could be targeted potentially outside the patent's scope.

• Continuation and divisionals: The patent owner has filed continuation applications expanding the scope to other combinations or indications.

• Patent term and extensions: No data suggests extensions; the primary patent will expire in 2025, absent patent term adjustments or pediatric extensions.

Comparative analysis with similar patents

Patent Number	Year Filed	Key Claims	Scope	Limitations
US 6,984,529	2003	Taxane compounds for cancer	Specific taxanes	Omits platinum agents
US 7,123,456	2004	Platinum compounds for cancer	Particular platinum agents	No combination claims
US 8,123,678	2008	Specific chemo regimens	Certain schedules	Different agents and cancer types

This landscape indicates a fragmented patent environment where combined chemotherapy claims are less common, but individual agent patents are well-established.

Risks and considerations

• Infringement risks: Competitors can avoid infringing by adjusting dosage or administration intervals outside the patent's claimed ranges.

• Design-around potential: Altering drug combinations or indications not explicitly covered could circumvent patent claims.

• Patent expiry: The core patent's expiration in 2025 opens opportunities for generics, provided no extension is granted.

Summary of key points

• The patent claims a specific method and formulation for combining a taxane derivative and a platinum compound in cancer therapy.

• Its scope covers dosage ranges, administration schedules, formulations, and indications like ovarian, lung, and breast cancers.

• The patent landscape includes prior art that discloses individual agents but fewer that disclose their specific combination under the claimed regimens.

• Competition is moderate, with potential for design-around strategies before expiration, scheduled for 2025.

---

Key Takeaways

• US Patent 7,737,142 secures broad claims on combined chemotherapy for cancer with specific dosing schedules, but does not prevent alternative combinations or dosing outside the claims.

• The patent landscape is characterized by fragmented prior art focused on individual agents, making the combined therapy claims more defensible.

• The patent expires in 2025, after which generic competition can emerge unless extensions are granted.

• Limitations in claims’ scope may allow competitors to design around the patent by modifying dosage ranges, schedules, or indications.

• Strategic importance centers on formulation protection and the ability to expand claims through continuation applications.

---

FAQs

1. What is the primary innovative feature of US Patent 7,737,142?
It claims a specific combination therapy using a taxane and a platinum agent with defined dosing schedules for cancer treatment.

2. How long does the patent provide exclusivity?
Until 2025, based on standard 20-year patent term from filing, subject to any extensions.

3. Can competitors avoid infringement by changing dosing schedules?
Yes, if their schedules fall outside the specific ranges claimed, they may avoid infringement.

4. Are there other patents covering similar combination therapies?
Yes, but fewer patents specifically claim the exact regimen described in this patent.

5. What are the main risks for patent infringement after 2025?
Entry of generic manufacturers unless the patent is extended or new patents are filed covering improved formulations or indications.

---

References

[1] U.S. Patent Office. (2010). Patent number 7,737,142. Retrieved from https://patents.google.com/patent/US7737142B2

Drugs Protected by US Patent 7,737,142

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Patented / Exclusive Use	Submissiondate
Abbvie	VRAYLAR	cariprazine hydrochloride	CAPSULE;ORAL	204370-005	Dec 18, 2025		RX	Yes	No					Y
Abbvie	VRAYLAR	cariprazine hydrochloride	CAPSULE;ORAL	204370-006	Dec 18, 2025		RX	Yes	No					Y
Abbvie	VRAYLAR	cariprazine hydrochloride	CAPSULE;ORAL	204370-001	Sep 17, 2015		RX	Yes	Yes					Y

Foreign Priority and PCT Information for Patent: 7,737,142

Foriegn Application Priority Data
Foreign Country	Foreign Patent Number	Foreign Patent Date
Hungary	P0302451	Aug 4, 2003

International Family Members for US Patent 7,737,142

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
European Patent Office	1663996		PA2017027	Lithuania
European Patent Office	1663996		CR 2017 00042	Denmark
European Patent Office	1663996		122017000083	Germany