Details for Patent: 6,500,814
Summary for Patent: 6,500,814
| Title: | Hormonal contraceptive | ||||||||||||||||||||||||||||||||||||||||
| Abstract: | The present invention relates to a hormonal contraceptive product having two hormonal components, an estrogen and a gestagen, and a process for the combined, continuous administration of the product of the invention. | ||||||||||||||||||||||||||||||||||||||||
| Inventor(s): | Rolf-Dieter Hesch | ||||||||||||||||||||||||||||||||||||||||
| Assignee: | Wyeth LLC , Wyeth Pharmaceuticals Inc | ||||||||||||||||||||||||||||||||||||||||
| Application Number: | US09/508,648 | ||||||||||||||||||||||||||||||||||||||||
| Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for patent 6,500,814 | ||||||||||||||||||||||||||||||||||||||||
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Patent Claim Types: see list of patent claims | Use; | ||||||||||||||||||||||||||||||||||||||||
| Patent landscape, scope, and claims: | US Patent 6,500,814: Claim Scope, Validity Risks, Expiration and Contraceptive Patent LandscapeUS Patent 6,500,814 covers a fixed-dose, estrogen-progestin contraceptive regimen administered continuously for more than 110 uninterrupted days. Its commercial significance was greatest for extended-cycle and continuous oral contraceptives using no more than 20 micrograms of ethinyl estradiol per day. The patent issued on December 31, 2002, and its enforceable term has expired. The claims do not cover a contraceptive product as such; they cover methods of use. What does US Patent 6,500,814 claim?The patent claims a method of hormonal contraception and a related method of continuous menstrual suppression. The core limitations are:
Claim 1 is the principal contraception claim. Claim 2 narrows claim 1 by limiting ethinyl estradiol to 1 to 20 micrograms per day. Claim 3 separately claims continuous suppression of the menstrual cycle using substantially the same regimen. The patent’s claim structure is method-centric. A party would generally need to practice or direct the claimed regimen to create infringement risk. Merely manufacturing an estrogen-progestin tablet, without the claimed instructions or use, would not necessarily satisfy every limitation. What compounds and delivery routes are covered?Listed gestagensThe claims identify the following gestagens:
Claim 3 contains the spelling "northisterone acetate," while claim 1 uses "norethisterone acetate." That drafting inconsistency would ordinarily be analyzed through the specification and prosecution history rather than treated automatically as a substantive limitation. Listed estrogensThe claims identify:
The 20-microgram ceiling applies expressly when the estrogen is ethinyl estradiol. The claim text does not impose the same numerical ceiling on every other listed estrogen, although the specification, prosecution history and ordinary pharmacological interpretation would affect construction. Covered routesThe express routes are:
The claims do not expressly recite vaginal, implantable, injectable or intrauterine delivery unless a particular product can be characterized as a depot or another listed route. A transdermal patch could fall within the claim if all other elements are satisfied. A conventional vaginal ring would present a more difficult literal-infringement analysis because the claim does not expressly identify vaginal administration. How broad is the 110-day continuous-use limitation?The phrase "greater than 110 days" is a central claim boundary. A regimen lasting exactly 110 days would not literally meet the duration limitation. A regimen lasting 111 or more uninterrupted days could meet it if the other limitations are present. The claim requires more than an aggregate number of treatment days. The administration must be:
A regimen consisting of 84 active days followed by a hormone-free interval would likely fall outside the literal scope because it is not uninterrupted. A regimen that changes the estrogen dose during the cycle would also present a noninfringement position based on the unchanged-dosage limitation. The phrase "unchanged dosages" is commercially important. It distinguishes the claims from regimens that use dose escalation, tapering, intermittent estrogen, or scheduled hormone-free intervals. Whether minor manufacturing variation defeats the limitation would depend on claim construction and the patent’s disclosure. In pharmaceutical litigation, courts generally distinguish the labeled daily dose from insignificant tablet-to-tablet manufacturing variation. What products could fall within the literal claim scope?A product or regimen is most exposed when it has all of the following characteristics:
The claims are not limited to a particular brand, tablet shape, packaging configuration or commercial trade name. They can reach multiple products using the claimed active ingredients and regimen. What are the principal claim-construction issues?"Continuous and uninterrupted administration"This limitation is likely to be construed according to the ordinary meaning of uninterrupted administration, informed by the specification. A planned hormone-free interval is the clearest route outside the limitation. Missed doses, patient noncompliance and treatment interruptions raise different questions from a regimen that is designed to include a drug-free interval. "Unchanged dosages"The claim requires unchanged dosages of both the gestagen and estrogen throughout the administration period. A product with identical daily active-ingredient amounts is the clearest example. A product with placebo tablets, variable hormone amounts or periodic dose changes may not satisfy this limitation. "For a continuous and uninterrupted administration period"The relevant period is the prescribed administration period, not necessarily the patient’s actual lifetime use. A product label directing continuous use for more than 110 days would create a stronger inducement theory than a product label directing only a conventional 21- or 28-day cycle. "Mammal in need thereof"The term is broad enough to include humans, but the method’s contraceptive purpose narrows the practical application. Veterinary use could raise separate questions depending on the species, product labeling and evidence of intended use. Claim 3’s menstrual-suppression resultClaim 3 requires continuous menstrual suppression throughout the administration period. That result limitation adds a potential factual dispute. A claimant would need to establish that the accused regimen is designed to produce, or does produce under the applicable construction, continuous menstrual suppression. How does claim 2 differ from claim 1?Claim 2 narrows claim 1 by specifying an ethinyl estradiol dose between 1 and 20 micrograms per day. It does not independently remove the other requirements of claim 1. A product using 10 micrograms per day of ethinyl estradiol remains outside claim 2 if it:
Claim 2 is therefore narrower in dose but still dependent on the full continuous-regimen architecture. How strong is the patent estate for continuous hormonal contraception?The patent estate represented by US 6,500,814 was conceptually broad but technically vulnerable. Its strength depended less on ownership of a particular active ingredient and more on the combination of:
The patent did not create a monopoly over all extended-cycle contraception. It left potential design-around routes based on treatment duration, hormone selection, dosing variation and delivery system. Likely validity pressure pointsA validity challenge would likely focus on anticipation and obviousness under pre-AIA law. AnticipationAn anticipating reference would need to disclose every claim limitation in a single reference, including:
Earlier disclosures of 21-day cycles or 84-day cycles would not necessarily anticipate the specific greater-than-110-day limitation. Earlier medical literature describing continuous hormonal contraception could be more relevant if it disclosed the exact hormonal combination and fixed-dose regimen. ObviousnessObviousness would likely present a stronger challenge than anticipation. A challenger could combine prior art concerning:
The patentee would likely rely on the specific duration threshold, low estrogen dose, unchanged dosing and clinical advantages. Objective evidence, including unexpected bleeding profiles, improved tolerability or successful suppression at low estrogen exposure, could affect the analysis. Written description and enablementThe Markush groups cover multiple gestagens, multiple estrogens and several delivery routes. A challenger could argue that the disclosure does not adequately support the full breadth of every claimed combination or enable all combinations across the entire genus. The strength of that argument would depend on the patent specification’s examples, pharmacological teaching and guidance for selecting doses. When did US Patent 6,500,814 lose exclusivity?US Patent 6,500,814 is expired as of 2025. The patent issued on December 31, 2002. Based on its post-1995 filing framework, its nominal 20-year term ended in approximately 2020, subject to any patent-term adjustment or terminal-disclaimer information recorded by the USPTO. The USPTO Patent Center record controls the precise terminal date. [1] The expiration of the patent removes ordinary infringement liability for conduct occurring after expiration. It does not erase historical infringement claims that accrued during the enforceable term, subject to applicable limitation periods and other defenses. The patent’s expiration also means that a generic applicant would not need to obtain a license to practice the claimed regimen today solely because of US 6,500,814. What is the Orange Book status of US 6,500,814?US 6,500,814 is not, by its face, a product patent. It claims methods of using a contraceptive combination. Orange Book relevance would depend on whether an NDA holder submitted the patent for an approved product and whether FDA accepted it as a patent that claims the drug, formulation or approved method of use under the Hatch-Waxman framework. [2] An Orange Book listing would not extend the patent’s term. Nor would it establish that every product using the same hormones infringes. The listed patent would have to be mapped against the approved labeling and the specific claim limitations. For a current product assessment, the key questions are:
Because US 6,500,814 has expired, it should not create a current Orange Book-based launch barrier even if historical listing information exists. Were Paragraph IV challenges relevant?During the patent’s enforceable term, an abbreviated new drug application applicant could have challenged the patent through a Paragraph IV certification if the patent was listed against a reference product and the applicant asserted that the patent was invalid, unenforceable or not infringed. [2] The principal Paragraph IV positions would have been:
A generic label omitting the patented method could also have supported a section viii statement, depending on the product’s approved indications and the exact Orange Book listing. [2] What patent litigation affects US 6,500,814?The patent number alone does not establish a current litigation barrier. Any historical litigation must be evaluated through the actual complaint, claim-construction record, invalidity contentions, settlement agreement and final judgment. Potential litigation theories would have included:
A settlement would not necessarily establish validity. A license or covenant not to sue would have to be assessed separately from the patent’s public prosecution record. The expiration of US 6,500,814 is the operative commercial fact for present US launch analysis. What licensing deals are associated with this patent?The patent document does not itself establish a commercial license, royalty agreement or settlement. Ownership by a corporate assignee would not prove that every product using the claimed regimen was licensed. A licensing analysis should distinguish:
Only the first category is normally apparent from the patent record. Confidential licenses and settlement terms may not be publicly available. No current license is required to practice the expired patent in the United States. Does US 6,500,814 create biosimilar risk?No. Biosimilar regulation applies to biological products under the Public Health Service Act. US 6,500,814 covers small-molecule hormonal contraceptive methods and does not create a biosimilar exclusivity issue. [3] Competitive entry would arise through abbreviated new drug applications, 505(b)(2) applications or conventional NDAs, depending on the product and regulatory strategy. The patent does not provide biologic reference-product exclusivity, pediatric exclusivity or orphan exclusivity. What generic launch scenarios exist?Scenario 1: Conventional cyclic regimenA 21/7 or 24/4 regimen would generally avoid the greater-than-110-day limitation because it includes a scheduled interruption. Scenario 2: 84-day extended-cycle regimenAn 84-day active-hormone regimen followed by a hormone-free interval would generally avoid the claim’s uninterrupted-duration requirement. Scenario 3: Continuous regimen exceeding 110 daysA fixed-dose oral combination using a listed gestagen and listed estrogen for 111 or more days would have been within the highest historical risk category. The patent’s expiration removes that current US patent risk. Scenario 4: Dose-variable regimenA regimen that changes the estrogen or progestin dose could avoid the unchanged-dosage limitation, although the commercial and regulatory consequences would require separate analysis. Scenario 5: Progestin-only or nonlisted-hormone productA progestin-only product, or a product using an active ingredient outside the Markush groups, would generally fall outside the literal combination requirement. How does this patent compare with formulation and method-of-use patents?US 6,500,814 is a regimen patent, not a formulation patent. It does not claim:
Its commercial effect therefore depended heavily on product labeling and prescribing instructions. A formulation patent could remain relevant even after a regimen patent expired, while a method-of-use patent can be avoided by omitting or carving out the patented indication from a generic label. What geographic coverage does the patent provide?US 6,500,814 provides rights only in the United States. It does not directly control:
Foreign family members would require separate analysis of national grant status, claim language, patent-term dates and local litigation history. A US patent could still affect importation into the United States under 35 U.S.C. § 271(a), but it cannot independently block commercial activity occurring wholly outside US territorial jurisdiction. Key Takeaways
FAQsCan a generic manufacturer now use a regimen covered by US 6,500,814?Yes. The patent’s US term has expired, so the patent alone does not prevent current practice of the claimed regimen. Does the patent cover Seasonale or every extended-cycle contraceptive?No. It covers only regimens satisfying all claim limitations. An 84-day regimen with a planned hormone-free interval may not meet the greater-than-110-day uninterrupted-use requirement. Does a 20-microgram ethinyl estradiol dose automatically infringe?No. The dose is only one limitation. The product must also use a listed gestagen, a listed route, unchanged doses and more than 110 uninterrupted days. Can a vaginal contraceptive ring infringe US 6,500,814?The claims expressly recite oral, transdermal or depot administration. A vaginal ring would require a separate analysis of claim construction and whether its delivery system can qualify as a claimed route. Does patent expiration eliminate all intellectual-property risk for continuous contraception?No. It eliminates the specific US 6,500,814 barrier. Separate risks may arise from later patents covering formulations, devices, manufacturing processes, active-ingredient forms, packaging or other methods of use. References
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Drugs Protected by US Patent 6,500,814
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Patented / Exclusive Use | Submissiondate |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| >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: 6,500,814
| Foriegn Application Priority Data | ||
| Foreign Country | Foreign Patent Number | Foreign Patent Date |
| Germany | 197 39 916 | Sep 11, 1997 |
| PCT Information | |||
| PCT Filed | September 03, 1998 | PCT Application Number: | PCT/DE98/02636 |
| PCT Publication Date: | March 18, 1999 | PCT Publication Number: | WO99/12531 |
International Family Members for US Patent 6,500,814
| Country | Patent Number | Estimated Expiration | Supplementary Protection Certificate | SPC Country | SPC Expiration |
|---|---|---|---|---|---|
| Austria | 241361 | ⤷ Start Trial | |||
| Australia | 1140999 | ⤷ Start Trial | |||
| Germany | 19739916 | ⤷ Start Trial | |||
| Germany | 59808545 | ⤷ Start Trial | |||
| Denmark | 1011682 | ⤷ Start Trial | |||
| European Patent Office | 1011682 | ⤷ Start Trial | |||
| European Patent Office | 1310257 | ⤷ Start Trial | |||
| >Country | >Patent Number | >Estimated Expiration | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration |
