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Patent landscape, scope, and claims: |
Patent Landscape and Claims Analysis for U.S. Patent 6,977,042
What is the scope of U.S. Patent 6,977,042?
U.S. Patent 6,977,042, titled "Method of treating or preventing osteoporosis using parathyroid hormone" (issued Dec. 20, 2005), covers a specific therapeutic approach utilizing parathyroid hormone (PTH) for osteoporosis management.
Key claim scope
The patent primarily claims:
- The use of recombinant human parathyroid hormone (rhPTH) or analogs for the treatment of osteoporosis.
- Methods involving administration of PTH or analogs at specific doses and schedules to stimulate bone formation.
- Specific formulations combining PTH with carriers suitable for injection.
- Dosage regimens defined within ranges such as 0.1 to 100 micrograms per kilogram per day.
Claims hierarchy
The patent contains 102 claims.
- Independent claims: Cover the basic method, such as Claim 1, which describes administering PTH compounds in a specified manner.
- Dependent claims: Narrow scope, specifying particular analogs, dosages, treatment durations, or formulations.
Notable claims excerpt:
"A method of increasing bone mass in a human subject in need thereof, comprising administering to said subject an effective amount of recombinant human parathyroid hormone (rhPTH) or an analog thereof."
This broad claim encompasses various analogs and administration protocols.
Limitations
- Claims are confined to therapeutic methods involving PTH administration.
- The scope excludes other administration routes such as oral, focusing on injectable forms.
- Does not specify the use for conditions other than osteoporosis.
What is the patent landscape surrounding 6,977,042?
Patent family and related patents
- The patent belongs to Eli Lilly and Company.
- It is part of a patent family covering PTH-based therapies, with counterparts issued or filed in multiple jurisdictions (e.g., WO patents for international coverage).
- Related patents include:
| Patent Number |
Jurisdiction |
Title |
Filing Date |
| US 7,374,597 |
United States |
PTH analogs and methods of use |
Filed 2003 |
| EP 1,217,621 |
Europe |
Use of PTH for osteoporosis |
Filed 2002 |
| WO 2004/065840 |
PCT |
Receptor targeting PTH analogs |
Filed 2003 |
Patent citation network
- The patent cites prior art focused on bone anabolic agents, including PTH fragments and analogs.
- It is heavily cited by subsequent patents claiming improvements in PTH stability, delivery systems, and dosing regimens.
- Key forward citations suggest ongoing R&D in PTH analog development.
Patent expiration and freedom-to-operate
- Filing date: August 10, 2001.
- Priority date: March 2, 2000.
- Typical patent term: 20 years from filing, likely expiring in August 2021.
- Recent patent expirations open opportunities for biosimilars and generics.
Market relevance
- The patent's expiration allows generic manufacturing of PTH-based drugs, such as Forteo (Eli Lilly product).
- Active patent estate in the PTH treatment space, including formulations, delivery systems, and dosing methods, continues to extend beyond 6,977,042.
Key observations
- The patent covers a broad therapeutic method for osteoporosis using PTH.
- Its claims are specific to injection-based administration of recombinant or analog PTH compounds.
- The patent landscape shows a highly active field with numerous related patents, especially in analog development, delivery innovations, and dosing optimization.
- The expiration of this patent affects market access for biosimilars and could lead to increased competition in PTH therapeutic space.
Summary
U.S. Patent 6,977,042 secures broad therapeutic claims for administering PTH in osteoporosis treatment, focusing on injectable formulations and specific dosing protocols. Its expansive claim scope has been influential, both in blocking competitors during the patent life and, post-expiry, enabling generic alternatives.
Key Takeaways
- The patent's claims cover PTH and analog administration for osteoporosis, primarily via injection.
- It sits within a dense patent landscape, with numerous related patents worldwide.
- Expiry in 2021 facilitates biosimilar entry.
- Ongoing innovation in PTH analogs and delivery methods continues to shape the competitive landscape.
FAQs
1. Does the patent cover oral formulations of PTH?
No. The claims are limited to injectable formulations; oral PTH delivery was not covered, likely due to known bioavailability challenges.
2. Are PTH analogs protected under this patent?
Claims include analogs of PTH that have similar therapeutic effects, but specific analogs may be covered under later patents filed after 2001.
3. Will the expiration of this patent lead to generic versions of Forteo?
Yes. The expiration in 2021 likely allowed regulatory approval and entry of biosimilars, which are now available in the market.
4. Are there ongoing patents that extend protection beyond 2021?
Yes. Patents related to specific analogs, delivery devices, and dosing regimens continue to extend patent protection in the PTH space.
5. How broad are the claims concerning the dose?
Claims specify doses within 0.1 to 100 micrograms per kilogram per day, covering a wide range for patent protection.
References
[1] United States Patent and Trademark Office. (2005). Patent No. 6,977,042.
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