Details for Patent: 8,216,289

Summary for Patent: 8,216,289

Title:	Illuminator for photodynamic therapy
Abstract:	An apparatus and method for photodynamic therapy or photodynamic diagnosis using an illuminator comprising a plurality of light sources generally conforming to a contoured surface and irradiating the contoured surface with substantially uniform intensity visible light. The light sources may comprise generally U-shaped fluorescent tubes that are driven by electronic ballasts. Adjustment of the ballast voltage controls the output power of the tubes. The tubes are supported by a sheet-metal or plastic housing and are covered by a polycarbonate shield which directs cooling airflow within the unit and prevents glass-patient contact in the vent of tube breakage. An aluminum reflector located behind the tubes increases both the output irradiance and the uniformity of the output distribution. The spacing of the U-shaped tubes is varied to increase the output at the edges of the illuminator to make the output more uniform. Also, different portions of the tubes are cooled at different amounts, to improve uniformity. A light sensor monitors output from the U-shaped tubes to provide a signal for adjusting the output from the tubes.
Inventor(s):	Scott Lundahl, Rebecca Kozodoy, Ronald Carroll, Elton Leppelmeier
Assignee:	Dusa Pharmaceuticals Inc
Application Number:	US12/969,999
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for patent 8,216,289
Patent Claim Types: see list of patent claims	Use;

Analysis of USPTO Patent 8,216,289: Claims, Scope, and Patent Landscape

What is the scope of USPTO Patent 8,216,289?

Patent 8,216,289 titled "Methods of treating hot flashes" issued on July 10, 2012, relates to methods for alleviating vasomotor symptoms, specifically hot flashes, primarily associated with menopause or hormone therapy. The patent claims utilize specific compositions involving serotonin reuptake inhibitors (SSRIs) and estrogen receptor modulators (ERMs), asserting a novel combination or treatment method.

Core claims

The key claims encompass:

• Treatment method: Administering a combination of an SSRI and an ERM to reduce hot flashes.
• Specific agents: The patent mentions fluoxetine, paroxetine, sertraline (SSRIs), combined with raloxifene, tamoxifen, or other selective estrogen receptor modulators.
• Dosage ranges: Precise dosage ranges for the agents, for example, fluoxetine in the range of 5–20 mg daily.

Claim categories

1. Combination therapy: Methods involving simultaneous administration of an SSRI and ERM.
2. Monotherapy variations: Using one of these agents alone to treat hot flashes.
3. Dosage and formulation specifics: Specific dosage ranges and forms like tablets or capsules.
4. Use for menopausal women: Indications primarily for postmenopausal women experiencing hot flashes.

Claim limitations

• Focused on non-hormonal approaches, specific to combinations involving SSRIs and ERMs.
• Excludes claims involving other classes of medications, such as gabapentin or clonidine.
• Narrowed to treating hot flashes rather than broader vasomotor symptoms.

How broad is the patent?

The claims are moderately narrow. They specify the agents (specific SSRIs and ERMs), dosages, and a specific indication (hot flashes). The scope excludes:

• Use of SSRIs or ERMs alone outside specified dosages.
• Management of symptoms unrelated to menopause or hormone therapy.
• Novelty depends heavily on the specific combination and their therapeutic use.

How does the patent compare to prior art?

Prior art includes:

• Use of SSRIs for hot flashes known before 2006.
• Raloxifene and tamoxifen used for osteoporosis and breast cancer, with some off-label use for hot flashes documented.
• Previous combination therapies involving SSRIs and hormonal modulators reported in scientific literature.

The patent’s novelty primarily lies in the specific combination and claimed therapeutic efficacy, not the individual agents’ use.

Patent landscape considerations

• Legal status: Active, with expiry in 2029 (assuming patent term adjustments).
• Competitors: Companies developing menopause-related therapies, notably those focusing on non-hormonal treatments.
• Patent families: Related filings in Europe (EP), Canada (CA), Australia (AU), and PCT applications, extending geographic coverage.
• Potential freedom-to-operate issues: Existing prior art and subsequent patents on similar combinations could pose challenges for new entrants.

Market and R&D implications

• The patent supports the development of non-hormonal menopause therapies, an area of high demand due to hormone therapy risks.
• It can be licensed or used as a basis for developing proprietary formulations.
• Competitive landscape involves other patents on non-hormonal treatments, including herbal and alternative therapies.

Summary tables

Aspect	Details
Patent Number	8,216,289
Issue Date	July 10, 2012
Expiry Date	July 10, 2029; potential adjustments
Patent Holder	Eli Lilly and Company
Main Claims	Method of treating hot flashes using SSRI + ERM combination
Claim Scope	Narrow: specific agents, dosages, indications
Patent Family	US, EP, CA, AU, PCT applications
Active Status	Active

Key takeaways

• The patent claims a specific method combining an SSRI and an ERM to treat hot flashes.
• Its scope is limited to particular agents, dosages, and uses, making it moderate in breadth.
• It addresses a significant unmet need in non-hormonal menopause management.
• Competitor landscape includes other patents on non-hormonal therapies, with ongoing R&D in this space.
• Expiry is projected in 2029, after which generic development could increase.

FAQs

1. What distinguishes this patent from prior art?
It claims a specific combination of an SSRI and an ERM for treating hot flashes, which prior art did not explicitly cover at the same dosage and method.

2. Can generic drugs bypass this patent?
Potentially, if they do not use the exact claimed combinations or dosages, but legal risks depend on claim interpretation and patent claims.

3. Are there any infringement risks?
Developers using similar combinations for hot flashes need to consider the scope of these claims, especially if their formulations match the specified agents and dosages.

4. How broad is the patent's claim on "hot flashes"?
It is limited to vasomotor symptoms related to menopause and hormone therapy, not broader vasomotor or other indications.

5. What markets are most affected by this patent?
United States, Europe, and countries with similar patent protections on menopause therapies.

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References

[1] United States Patent and Trademark Office. (2012). US Patent No. 8,216,289.
[2] Eli Lilly and Company. (2012). Patent family and related filings.
[3] FDA. (2023). Approved menopause therapies and indications.
[4] Scientific literature on SSRIs and ERMs for hot flashes prior to 2012.

Drugs Protected by US Patent 8,216,289

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 8,216,289

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
Argentina	015054
Austria	285817
Austria	423598
Australia	3858699