Details for Patent: 5,270,305

Summary for Patent: 5,270,305

Title:	Medicaments
Abstract:	Pharmaceutical compositions comprising effective amounts of salmeterol (and/or a physiologically acceptable salt thereof) and fluticasone propionate as a combined preparation for simultaneous, sequential or separate administration by inhalation in the treatment of respiratory disorders.
Inventor(s):	James B. D. Palmer
Assignee:	Glaxo Group Ltd
Application Number:	US07/753,907
Patent Claim Types: see list of patent claims	Use; Composition;

United States Patent 5,270,305 Scope and Claim Map: Salmeterol (1-hydroxy-2-naphthalenecarboxylate) Plus Fluticasone Propionate Inhalation Combinations

US Patent 5,270,305 protects inhaled fixed-dose combinations of salmeterol (including its 1-hydroxy-2-naphthalenecarboxylate salt) and fluticasone propionate, with coverage extending across composition form factors (MDI and dry powder) and defined unit-dose ranges, plus method-of-treatment and manufacturing-use claims tied to twice-daily administration.

---

What does US Patent 5,270,305 claim protect (salmeterol + fluticasone propionate) and who is covered?

Core protected subject matter (claims 1, 8, 9):
A pharmaceutical composition and corresponding use/method claims directed to a combined inhalation preparation of:

• Salmeterol or a physiologically acceptable salt, and
• Fluticasone propionate,
  for simultaneous, sequential or separate administration in the treatment of respiratory disorders.

This is a combination-therapy patent focused on the pairing of the two actives in an inhaled regimen, not on device mechanics alone.

Key claim-elements that define infringement risk

• Active ingredient pairing: salmeterol + fluticasone propionate.
• Salt specificity (depends on claim): generic “salmeterol or salt” in independent claim 1; narrower salt-specific coverage in claims 2, 5, 6.
• Delivery mode: administration by inhalation (composition and method claims).
• Regimen flexibility: “simultaneous, sequential or separate” administration (captures multiple dosing architectures).
• Respiratory indication breadth: “respiratory disorders” is not limited in the provided claim set to COPD or asthma.

---

How broad are the claims in US 5,270,305 for combinations, salts, and dosing?

Broadest coverage (Claim 1):
A composition comprising effective amounts of salmeterol (or any physiologically acceptable salt) and fluticasone propionate, as a combined inhalation preparation, for treatment of respiratory disorders.

Salt-limited coverage (Claims 2, 5, 6):
Where salmeterol is specifically the 1-hydroxy-2-naphthalenecarboxylate salt (a defined counterion salt form). This narrows the scope to a particular salt identity and any composition that falls within those formulations.

Dose range limitation (Claims 4, 6, 11):
Claims 4 and 6 require unit-dose ranges:

• salmeterol (or specified salt) 25–100 μg per dosage unit
• fluticasone propionate 25–500 μg per dosage unit

Claim 11 further requires daily totals for a twice-daily regimen:

• salmeterol 50–200 μg/day
• fluticasone propionate 50–1000 μg/day

Delivery format limitation (Claims 3, 5, 7):
Coverage includes compositions “presented in the form of a metered dose inhaler or a metered dry powder composition.”

Regimen limitation (Claims 10–11):
Twice daily basis is specified for method claims when those dependent claims are asserted.

---

What is the claim-by-claim scope and how does each dependent claim narrow coverage?

Claim 1 (composition, broad actives + combined inhalation preparation)

• Salmeterol or physiologically acceptable salt
• Fluticasone propionate
• Combined preparation for inhalation
• Simultaneous, sequential or separate administration
• Treatment of respiratory disorders

Interpretive impact: This is the primary “pairing” claim and likely the main infringement hook for any inhaled salmeterol/fluticasone combination product, assuming “combined preparation” is construed broadly enough to include separate inhalers used together in a coordinated regimen.

Claim 2 (salt-specific formulation)

• Same as claim 1 but salmeterol = 1-hydroxy-2-naphthalenecarboxylate salt.

Impact: Any accused product using a different salmeterol salt (or no salt form consistent with this) would avoid claims 2/5/6 while still potentially implicating claim 1.

Claim 3 (device/delivery form for claim 1)

• Claim 1 in form of:
  • metered dose inhaler (MDI) or
  • metered dry powder composition.

Impact: If an accused product is inhalation-delivered but not metered (or not categorized within these terms), the claim might not read; if it is an MDI or a metered DPI, it likely does.

Claim 4 (defined unit-dose ranges for claim 1)

• MDI or DPI is not required here (that’s claim 3).
• Requires dose unit ranges:
  • 25–100 μg salmeterol (or salt)
  • 25–500 μg fluticasone propionate

Impact: Dose strengths outside the ranges create potential non-infringement for this dependent claim even if claim 1 might still be met.

Claim 5 (salt-specific + device/form for claim 2)

• Claim 2 in form of MDI or metered dry powder.

Claim 6 (salt-specific + defined unit-dose ranges)

• Requires:
  • salmeterol 1-hydroxy-2-naphthalenecarboxylate
  • 25–100 μg per dosage unit
  • 25–500 μg fluticasone propionate per dosage unit
  • with MDI or metered dry powder (per “presented in the form” wording)

Claim 7 (salt-specific + delivery format redundancy)

• Claim 6 presented as MDI or metered dry powder. (As written, claim 7 is a reiteration/stacking of format limitation already in claim 6.)

Claim 8 (manufacturing-use claim)

• “Use of salmeterol and fluticasone propionate in manufacture” as a combined preparation for inhalation treatment.

Impact: This claim supports infringement theories even where the composition might be made for downstream administration. It aligns with typical US “use in manufacture” claim strategies.

Claim 9 (method of treating respiratory disorders)

• Method claim: inhalation administration of effective amounts of salmeterol and fluticasone propionate, simultaneous/sequential/separate.

Claim 10 (twice daily method limitation)

• Adds twice daily basis.

Claim 11 (daily dose range for the twice-daily method)

• Twice daily method with:
  • salmeterol 50–200 μg/day
  • fluticasone propionate 50–1000 μg/day

Impact: If an accused regimen uses different total daily amounts, claim 11 may not be implicated even if claim 9 is.

---

How does “simultaneous, sequential or separate administration” affect design-around and multiple-inhaler products?

The phrase expands coverage beyond a single inhaler architecture to include coordinated regimens where salmeterol and fluticasone are not necessarily delivered in the same device at the same time.

Practical coverage interpretation:

• Simultaneous: single inhaler or synchronized dosing.
• Sequential: dose one active then the other shortly after, within the same treatment visit.
• Separate: different inhalers used in the same overall regimen.

Design-around implication:
A competitor seeking to avoid this claim would need to change more than timing mechanics. It would typically have to avoid one of:

• the active pair (salmeterol and fluticasone propionate together),
• inhalation administration,
• the effective-amount combination as claimed,
• or (for dependent claims) the salt form or dose-strength ranges.

---

What formulations are protected: MDI vs dry powder and where are the strength boundaries?

Device category coverage:

• MDI and metered dry powder are explicitly included (claims 3, 5, 7).

Strength boundaries for dependent protection:

• Per dosage unit:
  • salmeterol 25–100 μg (claims 4, 6)
  • fluticasone propionate 25–500 μg (claims 4, 6)
• Per day (twice daily method):
  • salmeterol 50–200 μg/day (claim 11)
  • fluticasone propionate 50–1000 μg/day (claim 11)

Actionable inference:
If a product uses salmeterol/fluticasone strengths that fall outside these windows, it may still fall within the broad independent claims (claim 1/9) depending on how “effective amounts” and “combined preparation” are construed. Strength-limited dependent claims tighten the infringement analysis.

---

What patents surround US 5,270,305 in the salmeterol–fluticasone combination landscape?

A complete “adjacent patent landscape” requires the full patent family data, cited references, and the Orange Book listing history for the specific combination product(s) associated with this claim set. That mapping cannot be produced from the claim text alone with enough precision to identify:

• which continuation/divisional patents were filed,
• which specific device-formulation patents exist in the same families,
• which method-of-use patents overlap in jurisdictional scope, and
• which US patents list the same actives and dose forms.

Only defensible scope from the provided record: US 5,270,305 is an early foundational combination patent tying salmeterol + fluticasone propionate to inhaled therapy with broad administration-timing flexibility and dependent constraints on salt form and dosage strength.

---

When does US 5,270,305 lose exclusivity (and do dependent claims extend protection)?

A reliable exclusivity timeline and expiration date for US 5,270,305 depends on:

• the application filing date,
• whether it issued from a continuation with different filing dates,
• any terminal disclaimers,
• PTA (patent term adjustment),
• and any listed Orange Book or regulatory exclusivities tied to a specific NDA/505(b)(2).

Those values are not present in the prompt, so an accurate expiration/exclusivity timeline cannot be generated.

---

How strong is the patent estate for combination salmeterol/fluticasone claims like this?

Strength factors inherent to the claim language provided:

• Broad independent claims target the combination itself and inhalation administration with synchronized treatment flexibility.
• The claims include both composition claims and method/use claims, which supports multiple infringement pathways: manufacturing, selling/using, and administering.

Potential weakening factors (based on claim structure only):

• Dependent claims add constraints (salt identity; dose ranges; twice daily regimen). Products outside those constraints may avoid dependent claim coverage.
• “Respiratory disorders” could be construed broadly but still requires the accused product to be used for relevant respiratory treatment.

A quantitative strength rating versus competitor patents requires the full estate and prosecution history, including validity challenges and prior art. That information is not provided.

---

What generic entry risks exist for salmeterol/fluticasone inhalation combinations given these claim types?

Risk drivers:

• If a generic/similar product includes both actives in an inhalation regimen and the dosage strengths fall within dependent ranges, it faces meaningful claim coverage.
• If a product uses different dose strengths or a different salmeterol salt form, dependent claims (2/4/6/11) may be avoided while still triggering coverage under the broad independent claims.

Stated differently:
The existence of claim 1 and claim 9 means entry risk is not limited to a single strength or salt identity.

---

Does this patent cover separate vs fixed-dose combination products?

The language “simultaneous, sequential or separate administration” is written to cover treatment regimens that administer the two drugs together while allowing multiple administration architectures.

Implication for competitors:
A competitor can still face infringement exposure if it supplies two separately administered inhaled components that are used as a coordinated regimen to treat respiratory disorders with salmeterol and fluticasone propionate.

---

Key Takeaways

• US 5,270,305 protects inhaled salmeterol + fluticasone propionate combination therapy for respiratory disorders with simultaneous, sequential, or separate administration.
• Independent claims (1, 8, 9) are broad on actives and administration timing.
• Dependent claims narrow protection by:
  • salmeterol salt form (1-hydroxy-2-naphthalenecarboxylate) in claims 2/5/6,
  • unit-dose ranges (25–100 μg salmeterol and 25–500 μg fluticasone per dosage unit) in claims 4/6,
  • device form (MDI or metered dry powder) in claims 3/5/7,
  • twice-daily regimen and daily dose totals in claims 10–11.
• The claim set supports infringement theories tied to composition, manufacturing use, and method of treatment, not only device-specific marketing forms.
• A full US patent landscape view (family members, Orange Book status, litigation, and expiration dates) cannot be constructed from the provided claim text alone.

---

FAQs

1) Does US 5,270,305 require a single inhaler containing both drugs?
No. The claim language covers simultaneous, sequential or separate administration, which can encompass coordinated multi-inhaler regimens.

2) If a product uses salmeterol in a different salt form, does it still infringe?
It can still implicate claim 1/9 (salmeterol “or physiologically acceptable salt”), while potentially avoiding salt-specific dependent claims 2/5/6.

3) What dose characteristics matter most for dependent-claim infringement?
Dependent claims 4/6 and 11 require defined unit-dose and daily dose ranges. Strength deviations can reduce or eliminate exposure to those dependents.

4) Does the patent cover both MDIs and dry powder inhalers?
Yes. Claims 3/5/7 cover compositions presented as metered dose inhalers or metered dry powder compositions.

5) Are manufacturing and treatment uses covered, or only compositions?
Both. Claim 8 covers use in manufacture, and claim 9 covers a method of treating respiratory disorders.

---

References (APA)

1. U.S. Patent No. 5,270,305.

Drugs Protected by US Patent 5,270,305

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: 5,270,305

Foriegn Application Priority Data
Foreign Country	Foreign Patent Number	Foreign Patent Date
United Kingdom	8920392.1	Sep 08, 1989
United Kingdom	8923644.2	Oct 20, 1989

International Family Members for US Patent 5,270,305

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
European Patent Office	0416951		C990012	Netherlands
European Patent Office	0416951		12/1999	Austria
Austria	99941
Australia	6226290
Australia	640682
Belgium	1003053
Canada	2024916