Details for Patent: 7,855,190

Which drugs does patent 7,855,190 protect, and when does it expire?

Patent 7,855,190 protects LOSEASONIQUE and SEASONIQUE and is included in two NDAs.

This patent has twenty-two patent family members in ten countries.

Summary for Patent: 7,855,190

Title:	Methods of hormonal treatment utilizing contraceptive regimens with continuous estrogen administration
Abstract:	The present invention provides contraceptive regimens in which a female is administered a combined dosage form of estrogen and progestin followed by a period of administration of estrogen. The disclosed contraceptive regimens can be administered to a female as a method of providing non-contraceptive benefits.
Inventor(s):	Robert G. Bell, Carole S. Ben-Maimon, Beata Iskold, Lance J. Bronnenkant, Howard Hait, Kathleen Z. Reape
Assignee:	Teva Womens Health Inc
Application Number:	US10/892,404
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for patent 7,855,190
Patent Claim Types: see list of patent claims	Use; Delivery;

United States Patent 7,855,190: Scope, Claims, and Contraceptive Patent Landscape for Higher-Weight Females

Executive summary: US Patent 7,855,190 is directed to a method of increasing contraceptive effectiveness in higher-weight females by using a specific sequential estrogen-progestin regimen built around ethinyl estradiol (10–30 µg/day) with a progestin delivered for “more than 50 consecutive days” (with recited levonorgestrel ranges including 0.02–1.5 mg/day, plus dependent claim alternatives), followed by estrogen-only for 2–10 consecutive days (10–30 µg/day). The claims further target threshold body weight (≥70 kg and higher), BMI cutoffs (>25, >30, >35), and variations including 84/7-day regimens, monophasic oral or transdermal administration, and co-administration of an antidepressant with the estrogen-only portion. The claim set is narrow in drug selection and regimen structure, which makes design-around paths viable via alternative progestins, different dosing windows, different estrogen amounts, different weight/BMI stratification, or non-matching sequential architecture.

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What is US Patent 7,855,190 and what does it claim?

US 7,855,190 claims a contraceptive effectiveness-improving dosing method for “higher weight” females. The core inventive concept is a sequential oral or transdermal regimen using:

• Combination phase: estrogen + progestin for more than 50 consecutive days
• Estrogen-only phase: estrogen “consisting essentially of estrogen” for 2 to 10 consecutive days
• Estrogen selection and dose: estrogen in both phases is equivalent to about 10–30 µg/day ethinyl estradiol
• Progestin selection and dose: progestin during the combination phase is equivalent to about 0.02 mg to about 1.5 mg/day of levonorgestrel, with dependent claims narrowing amounts and progestin alternatives
• Patient phenotype: higher weight female weighs about 70 kg or more (with dependent BMI and weight subranges)

Claim architecture at a glance

Independent claim 1 is a structural “checklist” claim: drug class and dose range, sequential timing, and patient weight threshold.

Dependent claims 2–42 tighten:

• the exact day counts (e.g., 81–89, 84, 5–8, 7, 21/7)
• specific ethinyl estradiol doses (10 or 20 or 30 µg/day)
• specific levonorgestrel doses (e.g., 0.05–0.20 mg/day, and single-point examples like 0.10 mg, 0.15 mg)
• estrogen/progestin selection (levonorgestrel; desogestrel)
• route and formulation (oral vs transdermal; monophasic)
• patient phenotype cutoffs (≥70 kg; ≥80 kg; ≥90 kg; BMI >25/30/35)
• combination with an antidepressant (timing and frequency constraints)

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What is the exact claim scope for the estrogen-progestin sequential regimen?

What is the required sequencing?

Across the claim set, the regimen requires two phases:

1. Combination phase: estrogen + progestin for >50 consecutive days
2. Estrogen-only phase: “dosage consisting essentially of estrogen” for 2–10 consecutive days

This is not a generic “extended-cycle” concept. The claim is tied to a specific sequential layout with explicit duration ranges that move the regimen out of many standard 21/7 or 24/4 molds.

What doses are required?

• Estrogen dose in both phases: equivalent to 10–30 µg/day ethinyl estradiol
• Progestin dose in combination phase: equivalent to 0.02 mg to 1.5 mg/day levonorgestrel

Dependent claims then lock in specific values:

• Estrogen examples: 10, 20, 30 µg/day
• Progestin examples: 0.05–0.20 mg/day; 0.10 mg/day; 0.15 mg/day; and other levonorgestrel bracket examples via dependent claim combinations

What is “consisting essentially of estrogen” doing in claim scope?

“Consisting essentially of estrogen” narrows what can be present during the estrogen-only phase. It bars additional active ingredients beyond estrogen that would materially affect the “essential” composition. That matters for design-around attempts that would add other actives (or substitute different hormone components) during the withdrawal week.

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How specific are the independent claim limitations (and what do they exclude)?

Independent claim 1 requires all elements simultaneously:

• Higher weight female: ≥70 kg
• Contraceptive effectiveness increase (functional objective)
• Drug structure:
  • estrogen + progestin for >50 days
  • estrogen-only for 2–10 days
• Estrogen amounts: both phases equivalent to 10–30 µg/day ethinyl estradiol
• Progestin amounts: combination phase equivalent to 0.02–1.5 mg/day levonorgestrel
• Eligible progestins in dependent claims broaden scope (e.g., desogestrel) but independent claim 1 is anchored to levonorgestrel ranges.

Practical exclusions (from claim language itself):

• If the progestin is not levonorgestrel during the combination phase, you likely must fall back on dependent claims that specifically introduce desogestrel (or other variants, if present).
• If estrogen-only phase includes non-estrogen actives, you may fall outside “consisting essentially of estrogen.”
• If the duration structure is not >50 days followed by 2–10 days, you likely do not meet core timing elements.

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What do claims 2–6 do to tighten the day counts (81–89 and exact 84; 5–8 and exact 7)?

Dependent claim set constrains the cyclic architecture:

• Claim 2: combination phase is 81–89 consecutive days
• Claim 3: combination phase is 84 consecutive days
• Claim 4: estrogen-only phase is 5–8 consecutive days
• Claim 5: estrogen-only phase is 7 consecutive days
• Claim 6: combination phase is 84 consecutive days and estrogen-only phase is 7 consecutive days

These dependent claims effectively map onto an 84/7 extended regimen structure. From an infringement-risk perspective, any competitor copying an 84 days active hormone + 7 days estrogen-only framework while matching dose and patient weight thresholds would be closer to the protected core.

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What formulation and route limitations exist (oral, transdermal, monophasic)?

Oral vs transdermal

• Claim 18: oral administration for both phases
• Claim 19: transdermal administration for both phases

Monophasic requirement

• Claim 20: both phases are administered “monophasically.”

In practical design-around terms, monophasic vs multiphasic packaging (e.g., different strengths across the active days) can become a lever. If a regimen uses multiple strengths within the combination phase, the “monophasic” dependent limitation may not be met, depending on how “monophasically” is construed.

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How do the specific dose-dependent claims expand the claim estate?

The claims add many “laddered” specific combinations that can matter in claim charts:

Ethinyl estradiol examples (in the combination phase and estrogen-only phase)

• Claim 7: combination-phase estrogen equivalent to 20 µg
• Claim 8: combination-phase estrogen equivalent to 30 µg
• Claim 9: estrogen-only phase estrogen equivalent to 10 µg
• Claim 10: estrogen-only phase estrogen equivalent to 30 µg
• Claim 11: estrogen is ethinyl estradiol (explicit species claim)

Levonorgestrel examples

• Claim 12: combination progestin equivalent to 0.05–0.20 mg/day
• Claim 13: combination progestin 0.15 mg/day
• Claim 14: combination progestin 0.10 mg/day
• Claim 15: progestin is levonorgestrel
• Claim 16: progestin is desogestrel (alternative species via dependent claim)

Concentrated “84/7” exemplars

Claims 26–32 repeatedly specify 84 days combination + 7 days estrogen-only, with precise dosing permutations for:

• ethinyl estradiol (10/10, 20/10, 30/10, 10/30, 20/10, 30/30, etc.)
• levonorgestrel (0.05–0.15 mg/day ranges and single points like 0.10 and 0.15 mg/day)
• oral monophasic framing (claims 28 and 30)

These exemplars reinforce that the patent is meant to cover not only “range” dosing but also common discrete dose pairings used in product-level regimens.

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What do the antidepressant co-administration claims do?

• Claim 17: antidepressant administered:
  • in combination with “dosage consisting essentially of estrogen” for the 2–10 consecutive day estrogen-only phase, and
  • administered intermittently, one time, or once weekly
• Claim 34: antidepressant administered similarly but tied to the 7 consecutive day estrogen-only phase in the 21/7 structure

This is a specialized axis: co-administration constraints can create a narrower infringement footprint that is still commercially relevant for product positioning if an antidepressant is co-prescribed in a temporally linked way.

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How does the patent treat higher-weight patient thresholds (weight and BMI)?

Independent claim 1 anchors “higher weight female” to:

• about 70 kg or more (dependent claim 21)

Dependent claims then add:

• Claim 21: ≥80 kg
• Claim 22: ≥90 kg
• Claim 23: BMI >25
• Claim 24: BMI >30
• Claim 25: BMI >35

The presence of both absolute weight and BMI creates layered coverage: if clinical practice or patient selection uses BMI rather than weight, a party may still be pulled into claim coverage.

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What is covered by claims 26–32 versus claims 33–42?

The claim set splits into two main regimen scaffolds.

84/7 regimen scaffold (claims 26–32)

• Claim 26: 84 days combination + 7 days estrogen-only

  • combination estrogen: 10–30 µg/day
  • estrogen-only: 10 µg/day
  • progestin: 0.05–0.15 mg/day
  • patient: ≥70 kg

• Claims 27–32: specify additional fixed dosing permutations, including monophasic oral versions (claims 28 and 30 and 32)

21/7 regimen scaffold with alternative progestin (claims 33–42)

• Claim 33: 21 days combination + 7 days estrogen-only
  • combination estrogen: 20 µg/day
  • estrogen-only: 10 µg/day
  • progestin: 0.15 mg/day desogestrel (and includes ≥70 kg)
• Claims 34–37: antidepressant co-administration; oral/transdermal/monophasic variants
• Claims 38–42: weight and BMI tiers (≥80/≥90; BMI >25/30/35)

This creates a broader “alternative progestin + shorter active window” branch: if a product uses desogestrel with a 21/7-style cycle and meets the same patient thresholds and estrogen-only logic, it may still implicate the patent through dependent claims.

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How strong is the patent estate for US 7,855,190 given the claim constraints?

Claim strength profile

• Strengths
  • The patent is highly specific in timing (two-phase; >50 days then 2–10 days, plus exact 84/7 and 21/7 dependent embodiments).
  • The patent is specific in hormone identity (ethinyl estradiol; levonorgestrel ranges anchored in claim 1; desogestrel alternative in a dependent claim).
  • The patent includes patient phenotype limitations (≥70 kg, BMI thresholds).
  • The patent includes formulation and route dependent constraints (oral/transdermal; monophasic).
• Weaknesses / narrowing
  • Because the regimen structure is precise, parties can design around by shifting durations outside the claimed ranges or changing hormone components or dosing amounts outside the cited equivalents.
  • The inclusion of patient selection limits can reduce accidental overlap, depending on how prescribing labels and clinical protocols define “higher weight” candidates.

Overall: US 7,855,190 looks more like a product/regimen-specific method patent than a broad “extended-cycle contraception in obesity” patent. That typically yields narrower infringement scenarios but can still matter if a marketed regimen matches the claimed 84/7 dosing architecture and uses ethinyl estradiol with levonorgestrel at the recited daily equivalents.

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What patents are likely adjacent for competitors (and what claim elements will overlap)?

Without a full bibliographic record (filing dates, priority chain, family members, and the full US claim set beyond what’s provided), it is not possible to produce a complete “all patents” landscape. Still, the claim features identify the probable adjacency themes competitors must analyze:

1. Extended-cycle combined oral contraceptives (COCs) for higher-weight patients
   • overlaps in the “higher body weight/BMI” patient selection
2. Ethinyl estradiol + levonorgestrel sequential dosing schedules
   • overlaps in “sequential estrogen/progestin architecture”
3. Transdermal estrogen-only withdrawal phases
   • overlaps in the route and estrogen-only “consisting essentially of estrogen” concept
4. Alternative progestins in similar regimens (e.g., desogestrel)
   • overlaps with the dependent claim branch that explicitly recites desogestrel in the 21/7 scaffold
5. Drug-drug co-administration in temporally linked windows
   • overlaps with the antidepressant administration timing and frequency constraints

For infringement and freedom-to-operate (FTO), the competitive question is usually less “is there any contraceptive patent on obesity” and more “does the competitor’s exact regimen match the claim’s day counts, hormone identity, and dose equivalents while treating patients meeting the stated weight/BMI thresholds.”

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When does the patent lose exclusivity? (USPTO term)

No publication, priority date, and prosecution history are provided in the prompt, so a determinable exclusivity-loss date cannot be calculated from the given data.

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What generic or biosimilar entry risks exist for US 7,855,190?

This is a method-of-use patent centered on dosing schedules and patient selection. It does not map onto biosimilars.

For generics, risk depends on whether the generic product is used in a way that meets every method step and the patient selection limitations (higher weight). If a method patent is asserted, a generic’s “labeling carve-outs” and prescribing practices typically become litigation focal points.

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What would be the cleanest design-around options based on claim language?

Based on the claim elements provided:

• Change sequential timing so that the combination phase is not “more than 50 consecutive days,” or the estrogen-only phase is outside 2–10 consecutive days.
• Change estrogen away from ethinyl estradiol.
• Change progestin away from levonorgestrel range equivalents in claim 1, and avoid the specific dependent desogestrel branch if using a 21/7 scaffold.
• Move daily dose equivalents outside 10–30 µg/day (ethinyl estradiol equivalents) and/or outside 0.02–1.5 mg/day levonorgestrel equivalents.
• Avoid “consisting essentially of estrogen” in the estrogen-only phase by altering the composition beyond estrogen (if clinically appropriate).
• Avoid matching patient phenotype if prescribing protocols and clinical use do not target ≥70 kg / BMI thresholds as framed by the method claims.
• Break “monophasic” structure if the competitor uses multiphasic hormone strength schedules and the claim construction treats “monophasically” as requiring uniform dosing across phase.

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Key claim-scope chart (elements needed for infringement)

Claim element	What the claim requires	Design-around lever
Patient	Higher weight female: ≥70 kg; dependent BMI >25/30/35	Change target population / labeling / clinical protocol
Combination phase	Estrogen + progestin for >50 consecutive days (dependent: 81–89; 84) or alternative scaffold: 21 days (claims 33+)	Change cycle length outside recited windows
Estrogen-only phase	“Consisting essentially of estrogen” for 2–10 consecutive days (dependent: 5–8; 7)	Add actives that defeat “consisting essentially,” or change duration
Estrogen identity	Estrogen is ethinyl estradiol (claim 11)	Use different estrogen component
Estrogen dose	10–30 µg/day equivalents in both phases	Use different ethinyl estradiol equivalent
Progestin identity	Levonorgestrel anchored in claim 1; dependent alternatives include desogestrel	Use different progestin not covered
Progestin dose	0.02–1.5 mg/day levonorgestrel equivalents	Adjust dose outside range
Formulation/route (dependent)	Oral or transdermal; monophasic; antidepressant timing in estrogen-only window	Use route/formulation outside dependent claims

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Key Takeaways

• US 7,855,190 is a regimen-specific method-of-use patent for increasing contraceptive effectiveness in higher-weight females, with a core requirement for sequential dosing: >50 days of estrogen-progestin followed by 2–10 days estrogen-only.
• The claim set is anchored to ethinyl estradiol (10–30 µg/day equivalents) and levonorgestrel (0.02–1.5 mg/day equivalents) in the main scaffold, with dependent claims adding discrete dosing examples and an alternative desogestrel branch in a 21/7 structure.
• The patent includes patient selection constraints (≥70 kg and dependent ≥80/≥90 and BMI >25/30/35) and use constraints (oral/transdermal/monophasic; antidepressant co-administration tied to the estrogen-only phase).
• Enforceability and infringement risk are tied tightly to whether a competitor’s exact regimen matches the day counts, dose equivalents, estrogen/progestin identity, and patient phenotype.

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FAQs

1. Does US 7,855,190 cover standard 21/7 combined oral contraceptives in higher-weight patients?
   Only if the specific 21/7 timing and dependent elements in the claim set are met, including progestin and dose constraints tied to the 21/7 scaffold.

2. Can a different estrogen component avoid infringement of US 7,855,190?
   Likely yes for the main claim scope because claim 11 expressly anchors estrogen as ethinyl estradiol, and the dose equivalents are defined relative to ethinyl estradiol.

3. How does “consisting essentially of estrogen” limit what can be in the estrogen-only phase?
   It narrows the estrogen-only phase to essentially estrogen, restricting addition of other active ingredients that would materially affect composition.

4. Does the patent require that both phases be administered orally to infringe?
   No for independent claim 1 as provided, but dependent claims explicitly add oral or transdermal limitations.

5. What dosing change is most impactful for design-around?
   Changing the sequential timing away from >50 consecutive days combination plus 2–10 consecutive days estrogen-only and moving dose equivalents outside the defined ethinyl estradiol and levonorgestrel ranges are the clearest levers.

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References (APA)

1. US Patent No. 7,855,190.

Drugs Protected by US Patent 7,855,190

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Patented / Exclusive Use	Submissiondate
Teva Branded Pharm	LOSEASONIQUE	ethinyl estradiol; levonorgestrel	TABLET;ORAL	022262-001	Oct 24, 2008	AB	RX	No	No						PREVENTION OF PREGNANCY
Teva Branded Pharm	SEASONIQUE	ethinyl estradiol; levonorgestrel	TABLET;ORAL	021840-001	May 25, 2006	AB	RX	Yes	Yes						PREVENTION OF PREGNANCY

International Family Members for US Patent 7,855,190

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
Australia	2004257772
Australia	2010201022
Brazil	PI0412493
Canada	2524474
Canada	2532089
Canada	2771944
China	101001631