Details for Patent: 8,877,708
Which drugs does patent 8,877,708 protect, and when does it expire?
Patent 8,877,708 protects CYCLOSET and is included in one NDA.
This patent has ten patent family members in seven countries.
Summary for Patent: 8,877,708
| Title: | Combination of dopamine agonists plus first phase secretagogues for the treatment of metabolic disorders | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Abstract: | The present invention is directed to a method of treating a metabolic disorder or key elements of a metabolic disorder such method comprising the use of an agent(s) that increases central dopaminergic activity plus a first-phase insulin secretagouge. | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Inventor(s): | Anthony H. Cincotta | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Assignee: | Veroscience LLC | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Application Number: | US13/375,810 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|
Patent Claim Types: see list of patent claims | Use; | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Patent landscape, scope, and claims: | US Patent 8,877,708: Claim Scope, Expiration, Litigation Risk, and Metabolic-Disorder Patent LandscapeUS Patent 8,877,708 protects daily combination treatment using a dopamine receptor agonist and a first-phase insulin secretagogue to treat metabolic disorders, glucose intolerance, insulin resistance, diabetes, obesity, and related cardiovascular or metabolic conditions. The patent’s commercial center is bromocriptine, particularly bromocriptine mesylate, combined with GLP-1 therapy, insulin, DPP-4 inhibition, or other rapid insulin-secretagogue treatment. The patent is a method-of-treatment patent rather than a composition patent. It does not claim a new chemical entity, a fixed-dose tablet, or a specific combination product. Its principal infringement risk arises when a party instructs or causes patients to administer both drug classes daily under the claimed therapeutic and dosing conditions. Based on the stated priority structure and standard 20-year patent-term rules, the patent has a projected expiration in or around May 2026, subject to any patent-term adjustment, terminal disclaimer, or other USPTO term data. The patent is not expected to create biosimilar-style exclusivity because it covers a treatment method involving small molecules and peptide medicines, not a biologic reference product. What does US Patent 8,877,708 protect?Claim 1 requires all of the following elements:
The claim uses a pharmacodynamic limitation. The combination must provide a “therapeutic effect greater than the additive effect” of the same doses administered separately. This is an important limitation for both enforcement and validity. A patent owner would need evidence showing more than ordinary additive efficacy, while an accused party could contest whether the treatment produces the claimed synergistic effect. The claim does not require a fixed ratio, a particular tablet, a particular GLP-1 product, or a particular dopamine agonist in its broadest form. It also does not require that both agents be administered in the same dosage form. How do the dependent claims narrow the patent?The dependent claims create several distinct protection clusters. Dopamine agonist limitationsClaims 2 and 15 identify dopamine D2 agonists including:
Claim 12 separately lists:
Claim 14 covers a combination of a dopamine D1 agonist and a dopamine D2 agonist, while still requiring the first-phase insulin secretagogue from claim 1. Disease and patient limitationsClaims 3 through 5 cover a broad metabolic-disease field. It includes:
The breadth creates potential written-description and enablement pressure. A challenger could argue that the specification does not adequately teach the claimed combination across every listed disease, dopamine agonist, secretagogue, dose, and mammalian species. Timing limitationsClaims 6 through 8 focus on circadian administration:
These claims are particularly relevant to bromocriptine because Cycloset labeling directs once-daily morning administration with food. The timing claims may be easier to practice in a product label but may also be vulnerable to prior-art arguments based on earlier circadian dopamine research and morning bromocriptine dosing. Dose and efficacy limitationsClaims 9 through 13 address dose relationships:
These limitations strengthen the patent against a simple combination that does not meet the dose or efficacy relationship. They also create factual disputes over clinical endpoints, baseline measurements, dose selection, and the meaning of “greater than additive.” What are the narrowest and commercially most important claims?Claims 17 through 19 are commercially the most focused claims. Claim 17 requires:
Claim 18 narrows the bromocriptine salt to mesylate. Claim 19 narrows the patient to one suffering from type 2 diabetes. The practical infringement core is therefore:
Claims 17 through 19 are narrower than claim 1 but are more closely aligned with commercially realistic bromocriptine treatment. They are also more exposed to prior art involving bromocriptine mesylate, insulin, GLP-1 therapy, and type 2 diabetes. When does US Patent 8,877,708 lose exclusivity?The patent’s projected term is tied to an earliest priority date in 2006. Under the United States 20-year term rule, the base term would ordinarily end around May 2026, subject to USPTO term adjustment and any terminal disclaimer.
Patent expiration does not automatically authorize every combination product. A later patent may cover a specific GLP-1 analog, formulation, device, dosing schedule, manufacturing process, or approved method. Conversely, a generic bromocriptine product would not necessarily infringe merely by being sold, because the claims require combination treatment and method-specific conditions. What is the Orange Book status of US Patent 8,877,708?Patent 8,877,708 is a method-of-treatment patent. Its Orange Book significance depends on whether it is listed against an approved drug product and whether the listing satisfies FDA listing rules. The relevant FDA product is Cycloset, bromocriptine mesylate, approved under NDA 022569 for improving glycemic control in adults with type 2 diabetes as an adjunct to diet and exercise. Cycloset is not a fixed-dose combination containing a first-phase insulin secretagogue.[1] A method patent directed to combining bromocriptine with GLP-1, insulin, or other secretagogues may not create an automatic regulatory block against an abbreviated new drug application for bromocriptine. The patent also does not appear, from the claim language alone, to cover bromocriptine monotherapy. Orange Book impact therefore depends on the actual FDA patent listing and the scope of any listed use code. For a Paragraph IV analysis, an ANDA applicant would likely argue that its proposed labeling does not induce the claimed combination use, or that the claims are invalid or not infringed. A patent owner would likely focus on labeling that expressly recommends combination therapy, morning dosing, or use in patients with insulin resistance or type 2 diabetes. What Paragraph IV challenges could target this patent?The principal Paragraph IV arguments would be: Non-infringementAn ANDA applicant could omit the claimed combination use from its label or argue that the label does not encourage:
Because method-of-treatment infringement often turns on induced use, labeling language would be central. AnticipationA challenger could search for a single prior-art reference disclosing:
A reference disclosing only bromocriptine monotherapy or only a broad suggestion to combine antidiabetic agents would not necessarily anticipate every claim. ObviousnessObviousness is the stronger expected challenge. The relevant prior art includes:
The patent owner would rely on unexpected synergy, improved glycemic control, reduced component doses, and the claimed circadian timing. A challenger would argue that combining known antidiabetic classes and administering them in the morning would have been routine. Indefiniteness and enablementThe phrase “greater than the additive effect” can generate claim-construction disputes. The patent does not define a single universal assay or mathematical standard in the claims. Relevant questions include whether the comparison must use matched doses, the same patient population, the same endpoint, and statistical significance. The broad listing of disease states and dopamine agonists may also support enablement challenges if the specification provides limited data outside bromocriptine and type 2 diabetes. What patent litigation affects US Patent 8,877,708?No widely reported, high-profile infringement decision is associated with this patent based solely on the claim set provided. The main litigation risk is likely to arise through:
The patent’s method claims make a conventional product-by-product patent dispute less direct than a composition patent case. A generic could market bromocriptine for an unclaimed use while limiting or omitting combination instructions. That strategy would reduce, but not eliminate, induced-infringement risk. What formulations are protected by the patent?The patent does not claim a specific formulation, release profile, tablet, capsule, injectable device, or fixed-dose combination. It covers administration of active agents. Potentially relevant products include:
A separate formulation patent could remain relevant after patent 8,877,708 expires. This is especially important for long-acting GLP-1 products, modified-release bromocriptine, injection devices, and stability-enhanced combinations. How strong is the patent estate for bromocriptine combination therapy?The estate is strongest where the commercial conduct tracks the narrow claims:
It is weaker against:
The patent has broad nominal disease coverage but a narrower practical enforcement center. Its value depends heavily on proof of the pharmacodynamic limitation and on whether a product label teaches the claimed combination. How does this patent compare with competing diabetes patent estates?
What generic launch risks exist after patent expiration?After expiration, a generic bromocriptine manufacturer could generally enter for approved monotherapy indications, subject to other unexpired patents. The patent would not by itself block generic bromocriptine after its term ends. The commercial risk is different for a branded combination strategy. A company launching bromocriptine with a GLP-1 or insulin product could still face:
The patent creates limited biosimilar risk. GLP-1 products such as peptide analogs may be regulated as drugs or biologics depending on the product and statutory pathway, but patent 8,877,708 does not itself claim a GLP-1 molecule or biologic reference product. Its relevance is use-based, not molecule-based. What licensing deals and commercial relationships are relevant?The commercial history most closely associated with the patent is the development and commercialization of bromocriptine mesylate for type 2 diabetes by VeroScience and its commercial partners, including the Cycloset program. The patent itself does not establish a license, royalty, co-development agreement, or field-of-use restriction. Any freedom-to-operate review should separate:
Patent ownership and product commercialization rights are not interchangeable. A license to market bromocriptine does not necessarily authorize use of a patented combination method. What geographic coverage does the patent provide?US Patent 8,877,708 provides rights only in the United States. Foreign protection would require corresponding national or regional patents in the relevant jurisdictions, such as:
The same international application may have produced different claims, expiration dates, prosecution outcomes, and litigation risks abroad. A US patent expiration does not terminate foreign family members. For global launch planning, the family must be reviewed jurisdiction by jurisdiction. What manufacturing and intellectual-property barriers remain?The patent does not materially restrict manufacture of bromocriptine, GLP-1 analogs, insulin, or DPP-4 inhibitors as standalone products. It may restrict commercial instructions or sponsored use of the combination before expiration. The principal barriers are:
Key Takeaways
FAQs About US Patent 8,877,708Does US Patent 8,877,708 cover bromocriptine alone?No. The independent claims require bromocriptine or another dopamine agonist to be administered with a first-phase insulin secretagogue. Can a generic sell bromocriptine before patent expiration?Potentially. A generic may seek approval for uses that do not practice the patented combination method, subject to other patents, FDA labeling rules, and induced-infringement analysis. Does the patent cover semaglutide or other GLP-1 drugs as compounds?No. The patent covers use of GLP-1 or an analog with a dopamine agonist. It does not claim the chemical composition of semaglutide, liraglutide, dulaglutide, or another GLP-1 product. What evidence would prove the claimed synergistic effect?Relevant evidence would include controlled clinical or preclinical comparisons showing that the combination produces an effect greater than the sum of the effects from matched doses of each agent administered separately. Is the patent relevant to a bromocriptine and insulin combination after 2026?The patent should not block conduct occurring after its expiration, but separate patents covering insulin, formulation, delivery devices, manufacturing, or later combination products may remain enforceable. References
More… ↓ |
Drugs Protected by US Patent 8,877,708
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Patented / Exclusive Use | Submissiondate |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Veroscience | CYCLOSET | bromocriptine mesylate | TABLET;ORAL | 020866-001 | May 5, 2009 | RX | Yes | Yes | ⤷ Start Trial | ⤷ Start Trial | Y | TREATMENT OF TYPE 2 DIABETES BY ADMINISTERING BROMOCRIPTINE MESYLATE AND A FIRST-PHASE INSULIN SECRETAGOGUE WHEREIN THE COMBINED THERAPEUTIC EFFECT IS GREATER THAN THE ADDITIVE EFFECT OF ADMINISTERING EACH AGENT ALONE | ⤷ Start Trial | |||
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Patent No. | >Patent Expiration | >Product | >Substance | >Delist Req. | >Patented / Exclusive Use | >Submissiondate |
Foreign Priority and PCT Information for Patent: 8,877,708
| PCT Information | |||
| PCT Filed | June 07, 2010 | PCT Application Number: | PCT/US2010/037605 |
| PCT Publication Date: | December 09, 2010 | PCT Publication Number: | WO2010/141938 |
International Family Members for US Patent 8,877,708
| Country | Patent Number | Estimated Expiration | Supplementary Protection Certificate | SPC Country | SPC Expiration |
|---|---|---|---|---|---|
| Australia | 2010256366 | ⤷ Start Trial | |||
| Brazil | PI1009619 | ⤷ Start Trial | |||
| China | 102458376 | ⤷ Start Trial | |||
| European Patent Office | 2437732 | ⤷ Start Trial | |||
| >Country | >Patent Number | >Estimated Expiration | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration |
