Details for Patent: 7,858,605

Summary for Patent: 7,858,605

Title:	Oral contraceptives to prevent pregnancy and diminish premenstrual symptomatology
Abstract:	This invention relates to a method of preventing pregnancy and treating PMS including PMDD. More particularly, the invention relates to a method, which involves administering one of several combination oral contraceptive regimens in combination with an antidepressant and a kit containing the same.
Inventor(s):	Robert G. Bell, Carole Ben-Maimon, Beata Iskold
Assignee:	Teva Womens Health Inc
Application Number:	US11/951,492
Patent Claim Types: see list of patent claims	Composition; Compound; Device; Dosage form;

US Patent 7,858,605 Landscape: Claim Scope and US Patent Estate Covering Multi-Strength Ethinyl Estradiol and Levonorgestrel “Dosage-Form Count” Regimens

US Drug Patent 7,858,605 is a regimen-composition patent built around a multi-tablet (or multi-unit) contraceptive/therapy “preparation” defined by (i) the count of dosage forms containing estrogen+levonorgestrel versus (ii) the count of dosage forms containing estrogen alone (no progestin), with (iii) tightly defined per-dose equivaIent ethinyl estradiol ranges and per-dose levonorgestrel ranges, plus (iv) sequence/administration and optional add-on antidepressant embodiments.

The claim set is structured to cover:

• Core preparation (claims 1, 20, 22) with specific unit counts (e.g., 81–89 estrogen+progestin units and 2–8 estrogen-only units).
• Narrow concentration fallbacks (claims 2–5, 19, 21, 24, 28, 26–29).
• Dosage form type (tablet vs transdermal) and monophasic administration (claims 17–19).
• Combination with fluoxetine hydrochloride (claims 11–16).
• Kit with fixed sequence aligned to daily dosing (claim 30).

What matters commercially and for generic risk: The patent is not just “a pill with EE + LNG.” It is an EE/LNG regimen defined by unit counts, per-unit dose equivalencies, and an optional antidepressant-combination kit. That structure raises infringement leverage in litigation because it ties the claim boundary to the pack architecture and daily dosing calendar rather than only pharmacologic ingredient identity.

---

What is US Patent 7,858,605 claim scope for a multi-unit ethinyl estradiol and levonorgestrel regimen?

Core claim architecture: count-based, dose-range constrained “preparations”

Claim 1 is the independent claim and defines the preparation as:

• (a) 81 to 89 dosage forms comprising combination of estrogen and progestin
• (b) 2 to 8 dosage forms consisting essentially of estrogen (no progestin)

with per-dose constraints:

• Estrogen in each (a) unit: ~10 to ~50 μg ethinyl estradiol equivalent
• Estrogen in each (b) unit: ~5 to ~10 μg ethinyl estradiol equivalent
• Progestin in each (a) unit: ~50 to ~150 μg levonorgestrel

This creates a three-dimensional claim boundary:

1. Unit count split (81–89 vs 2–8)
2. Two estrogen strength bands (10–50 μg vs 5–10 μg EE equivalents)
3. Progestin band (50–150 μg LNG only in the “combo” units)

Fallback and narrowing claims built for right-to-left literal infringement

Claims 2–9 lock down narrower sub-ranges or fixed embodiments:

• Claim 2: (a) estrogen per unit: ~10–~30 μg EE
• Claim 3: (a) estrogen per unit: ~30 μg EE
• Claim 4: (b) estrogen per unit: ~10 μg EE
• Claim 5: (a) progestin per unit: ~150 μg LNG
• Claims 6–8: specific unit counts (e.g., 84 units in (a), 5–8 units in (b), 7 units in (b))
• Claim 9: fixed combo counts (84 in (a) and 7 in (b))

These fallback claims matter because they reduce design-around flexibility. A challenger cannot evade simply by selecting a different estrogen strength or a slightly different LNG strength if the alternate target still lands inside one of the specific numeric fallbacks.

Ingredient identity is explicit in the independent claim

• Claim 10: estrogen is ethinyl estradiol.

Given claim 1’s quantification in EE-equivalents, claim 10 functions as an identity confirmation that the claim set targets EE rather than any “any estrogen” universe.

Dosage form type and administration pattern

• Claim 17: dosage forms are tablets for oral administration
• Claim 18: dosage forms are transdermal dosage forms
• Claim 19: dosage forms are for monophasic administration

These are not trivial. They expand potential infringement into non-oral delivery designs and constrain claimed regimens to a monophasic dosing scheme (at least as the claim requires for dependent embodiments).

---

How do claims 20–29 modify the scope (tablets, fixed numeric points, and estrogen-only unit definition)?

Claims 20–29 repeat and sharpen the core regimen concept with explicit numeric point selections and a clearer “estrogen-only unit” definition.

Claim 20: fully specified 84/7 and tablet architecture

Claim 20 requires:

• (a) 84 dosage forms with EE+LNG
• (b) 7 dosage forms consisting essentially of estrogen
• EE per (a) unit: ~10–~30 μg
• EE per (b) unit: ~10 μg
• LNG per (a) unit: ~50–~150 μg
• dosage forms in (a) and (b) are tablets for oral administration

This is a “pack-level” embodiment that maps directly to a calendar design like a 21-active + 7-low-estrogen style architecture, except here the counts are 84/7 rather than 28-day cycles, implying multiple cycles or longer pack sequences.

Claims 21 and 24 and 28: fixed per-unit numeric embodiments

These claims select specific fixed strengths:

• Claim 21: (a) EE ~10–30? No. It sets:
  • (a) EE per unit: ~30 μg
  • (b) EE per unit: ~10 μg
  • (a) LNG per unit: ~150 μg
  • tablets
  • counts: 84 (a) and 7 (b)
• Claim 24: counts remain 84/7, but:
  • (a) EE per unit: ~30 μg
  • (b) EE per unit: ~10 μg
  • (a) LNG per unit: ~150 μg
  • also requires estrogen-only (b) consists of estrogen + excipients (not “pure estrogen”)
• Claim 28: again 84/7, but phrased as:
  • (a) EE: ~30 μg
  • (b) EE: ~10 μg
  • (a) LNG: ~150 μg
  • (b) defined as estrogen + excipients

Claims 22–23: broader unit count split with estrogen-only/no-progestin definition

• Claim 22:
  • (a) 81–89 combo units
  • (b) 2–8 estrogen-only units without progestin
  • EE per (a): ~10–~30 μg
  • EE per (b): ~5–~10 μg
  • LNG per (a): ~50–~150 μg
• Claim 23: (b) dosage consists of estrogen + pharmaceutically acceptable excipients

This “consisting essentially of / consisting” language is key for infringement because it narrows allowable components in the estrogen-only units.

Claims 26–27 and 29: alternative estrogen-only band with 84/7

• Claim 26:
  • (a) EE: ~10–~30 μg
  • (b) EE: ~5–~10 μg
  • LNG: ~50–~150 μg
  • counts: 84/7
• Claim 27: estrogen-only (b) defined as estrogen + excipients
• Claim 29: mirrors 26/27 constraints with fixed estrogen points:
  • (b) estrogen-only: ~10 μg EE (as used in 29’s dependent structure)

---

Does US 7,858,605 cover antidepressant combination products (fluoxetine)?

Yes, the claim set explicitly covers an antidepressant combination embodiment layered onto the estrogen-only or estrogen+progestin unit structure.

Fluoxetine hydrochloride combination scope

• Claim 11: preparation further comprises an antidepressant.
• Claim 12–13: antidepressant is present in combination with the 2–8 estrogen-only units (claim 12) or 5–8 estrogen-only units (claim 13).
• Claim 14: antidepressant amount is equivalent to ~5 mg to ~120 mg fluoxetine hydrochloride.
• Claim 15: antidepressant is present in combination with one dosage form of the estrogen-only units.
• Claim 16: antidepressant is fluoxetine hydrochloride.

Practical infringement angle: A product using a co-pack, synchronized administration, or a kit where fluoxetine appears alongside a specific subset of estrogen-only tablets/units would be mapped to these dependent claims. The count constraints are a second gating factor: even if EE/LNG matches, the antidepressant pairing must land inside the claimed “combination-with” windows for the estrogen-only units.

---

What does claim 30 mean for kits with fixed sequence aligned to daily administration?

Claim 30 is a kit claim:

• “A kit comprising the preparation of claim 1,” where
• dosage forms are arranged in a fixed sequence corresponding to stages of daily administration.

That language typically gives enforcement traction against:

• blister packs with printed week/day calendars,
• cartons with unit dose organizers,
• any packaging scheme where ordering is part of how the regimen is delivered.

If an accused product uses the same unit counts and dose strengths but uses a different sequencing/arrangement strategy, claim 30 can become the pivot.

---

What design-around options exist against US 7,858,605’s numeric regimen constraints?

Because this patent is defined by explicit numeric bands and counts, typical design-around levers are constrained. The claim set still leaves multiple possible evasion routes:

1) Shift unit counts outside 81–89 vs 2–8

• Move combo units to 80 or 90+ (depending on literal claim coverage).
• Move estrogen-only units to 1 or 9+.

2) Shift estrogen strength in each unit band

• Combo units (a) EE-equivalent: move outside 10–50 μg (or outside the narrower 10–30 μg depending on which claim you target).
• Estrogen-only units (b) EE-equivalent: move outside 5–10 μg or specifically outside ~10 μg if targeting fixed-strength claims.

3) Shift LNG band in combo units

• LNG outside 50–150 μg.

4) Change what is in “estrogen-only” units

Dependent claims specify (b) as “consisting essentially of estrogen” or “consisting of estrogen and excipients.” If a competitor adds other pharmaceutically active ingredients into the estrogen-only units, it can fall outside those limitations.

5) Avoid tablet/oral vs transdermal dependent embodiments

A competitor could attempt to avoid dependent embodiments by using non-tablet/non-transdermal configurations. But note: claim 1 itself is not limited to tablets in the text you provided, while dependent claims 17–18 narrow the dosage form category. So avoiding a dependent claim does not necessarily avoid the independent claim.

6) Avoid kit fixed sequence (claim 30)

Packaging and regimen arrangement can be a strategic point in litigation. But again, claim 30 is dependent on claim 1.

---

How strong is the patent estate for US 7,858,605 around regimen “pack architecture” rather than formulation alone?

Based on the claim set you provided, the strength is derived from:

• High specificity (unit counts, per-unit EE and LNG ranges, fixed numeric embodiments).
• Regimen structure enforcement (kit sequencing aligned to daily administration).
• Optional co-therapy expansion (fluoxetine hydrochloride combination with count-bound estrogen-only units).

What this claim family is likely designed to prevent is “near-miss” generics that replicate ingredient identity but shift dosing calendar, per-unit strength, or pack counts. The numeric structure reduces “ingredient-only” arguments.

---

Key timing and regulatory linkage points (what the claims imply for generic entry risk)

The claim scope, as written, implies that entry risk is highest where a generic attempts to match:

• the same EE/LNG dual-unit schedule with the same count split and
• similar (or identical) per-unit strengths and
• same packaging sequence.

If an FDA-listed generic or 505(b)(2) product can show a different regimen architecture (different counts or different per-unit EE/LNG), it may have stronger noninfringement arguments against these regimen-count claims.

---

What patents would typically co-exist in the same US estate for this type of product architecture?

While you provided only the asserted claims of US 7,858,605, this kind of regimen-count and kit sequencing claim often co-exists with neighboring patent themes in the same family or continuation set:

• composition/potency claims (EE and LNG in a unit dose),
• specific dosage form manufacturing claims (e.g., tablet blend layers),
• method-of-use claims tied to contraceptive dosing schedules,
• packaging claims (blister/calendar strip and sequence),
• co-pack/combination therapy claims (here, fluoxetine combination).

A litigation strategy often attacks either:

• the regimen architecture (counts and strength bands) for noninfringement,
• or the validity of numeric ranges and “consisting essentially of” limitations.

---

Key Takeaways

• US 7,858,605 claim scope is governed by pack-level regimen architecture: 81–89 estrogen+levonorgestrel units and 2–8 estrogen-only units.
• In the estrogen+progestin units, EE-equivalent must be ~10–~50 μg (and narrower dependent alternatives exist like ~10–~30 μg) with LNG ~50–~150 μg per unit.
• In estrogen-only units, EE-equivalent must be ~5–~10 μg (with fixed-dependent embodiments at ~10 μg), and those units are limited to estrogen (plus excipients in some claims).
• Dependent claims expand coverage to tablet oral and transdermal embodiments and include monophasic administration.
• The estate includes a defined fluoxetine hydrochloride combination pathway tied to the estrogen-only unit subset counts and a fluoxetine dose equivalence range of ~5–~120 mg.
• A kit with fixed daily sequencing is an explicit claim anchor (claim 30), strengthening enforcement against calendar-blister presentation.

---

FAQs

1. How does “consisting essentially of estrogen” in the estrogen-only units affect infringement risk for combination generics?
2. Which numeric parameters in US 7,858,605 are most likely to be used to argue noninfringement (unit counts vs EE band vs LNG band)?
3. Can a product that matches EE and LNG ingredients avoid claims 20–29 by changing only the number of estrogen-only tablets?
4. How does the fluoxetine hydrochloride dependent claim structure limit which co-pack strategies are covered?
5. What packaging and sequencing facts matter most for assessing exposure under claim 30’s fixed-sequence kit limitation?

---

References

1. US Patent 7,858,605.

Drugs Protected by US Patent 7,858,605

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Patented / Exclusive Use	Submissiondate

International Family Members for US Patent 7,858,605

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
European Patent Office	1453521		122015000093	Germany
European Patent Office	1453521		CA 2016 00016	Denmark
European Patent Office	1453521		93156	Luxembourg
European Patent Office	1453521		300814	Netherlands
European Patent Office	1453521		C20160011 00192	Estonia
European Patent Office	1453521		39/2015	Austria