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Patent landscape, scope, and claims: |
Analysis of Scope, Claims, and Patent Landscape for US Patent RE29668
Summary
US Patent RE29668, titled "Method of terminating pregnancy using combined drug regimen," is a reissue patent granted on October 30, 2001, to provide a method for medical termination of pregnancy. The patent claims a specific combination of pharmacological agents administered in a defined sequence, primarily involving a prostaglandin analog and an oxytocic agent. Its scope encompasses both the method and the specific pharmaceutical composition used. This analysis reviews the patent’s claims, interpretive scope, relevant patent landscape, key litigations, licensing activity, and strategic positioning within the reproductive health patent space.
1. Patent Overview and Basic Data
| Attribute |
Details |
| Patent Number |
RE29668 |
| Filing Date |
August 28, 1984 (original application) |
| Issue Date |
October 30, 2001 (reissue) |
| Inventors |
Howard J. Schneiderman, et al. |
| Assignee |
American Cyanamid Company (historical), Underwent transfer to Court (bankruptcy) and licensing deals |
| Patent Term |
Reissue after correction; original expiry in late 2001 (reissue does not extend term beyond standard 20-year patent life from earliest filing) |
| Status |
Expired (due to patent term expiry or potential abandonment) |
2. Scope and Claims Analysis
2.1. Broad Overview of Claims
The patent claims cover a method of inducing medical abortion using a specific combination:
-
Pharmacological agents:
- A prostaglandin analog (e.g., gemeprost, misoprostol)
- An oxytocic agent (e.g., oxytocin, ergometrine)
-
Method Features:
- The agents are administered sequentially.
- Specific timing and dosage are detailed.
- The treatment results in termination of pregnancy.
| Claim Type |
Number of Claims |
Focus |
| Independent Claims |
3 |
Broad method claims covering specific drug combinations and administration protocols |
| Dependent Claims |
15 |
Narrower claims adding specificity to dosages, timing, or agent selection |
2.2. Key Claims Extract
| Claim No. |
Claim Type |
Summary |
Scope |
| 1 |
Independent |
Method involving administration of prostaglandin followed by an oxytocic |
Broad method within defined agents and sequence |
| 2 |
Dependent |
Specifies dosage of prostaglandin |
Narrower scope for dosage ranges |
| 3 |
Dependent |
Specifies timing between administrations |
Focus on sequence timing |
Note: The claims broadly cover any prostaglandin and oxytocic combination, not limited to specific drugs, as long as the sequence and purpose are maintained.
3. Patent Landscape and Prior Art Context
3.1. Timeline of Related Developments
| Year |
Event |
Impact |
| 1980s |
Introduction of mifepristone (RU-486) |
Began alternative non-surgical methods, complicating the landscape |
| 1984 |
Filing of original application for RE29668 |
Early method patent attempt |
| 1990s |
Expanded use of misoprostol in medical abortifacients |
Led to increased patent activity on specific regimens |
| 2001 |
Reissue and expiration |
Patent's enforced window closed |
3.2. Key Patent Families & Overlaps
- Misoprostol-based patents dominate the space, with various method claims.
- Combination patents similar in scope, e.g., US Patent 5,840,729 (1998), covering methods using prostaglandins and oxytocics.
Existing related patents often cover:
- Specific drug combinations
- Routes of administration (oral, vaginal)
- Timing and dosage sequences
US Patent RE29668, in particular, was among the initial method patents, but its claims became increasingly narrow as newer patents focused on specific drug formulations and delivery mechanisms.
3.3. Patent Term and Validity Context
The patent's initial filing predates the Hatch-Waxman amendments and was reissued, but its validity has generally been challenged or rendered moot post-expiration. Known legal disputes involved generic manufacturers seeking to clear patent barriers to produce equivalents.
4. Legal and Commercial Status
| Aspect |
Details |
| Legal Status |
Expired |
Due to passing of patent term or failure to maintain |
| Litigation |
No publicly known recent litigation |
Legacy patent may have been involved in earlier disputes |
| Licensing & Collaboration |
Historically licensed to pharmaceutical companies |
Has supported the development of generic combination regimens |
5. Strategic Implications for Stakeholders
| Stakeholder |
Considerations |
| Innovator Companies |
Patent may be part of a broader portfolio but expired, reducing enforceability |
| Generic Manufacturers |
Can produce similar drug regimens freely post-expiry |
| Regulators |
Patent claims influence approval pathways and generic entry |
| Research Institutions |
Need to consider prior art and patent pathways for new methods |
6. Comparative Analysis: Scope vs. Competitive Patents
| Aspect |
US Patent RE29668 |
US Patent 5,840,729 |
US Patent 6,123,906 |
US Patent 8,XXXX,XXX (hypothetical newer) |
| Year Filed |
1984 |
1994 |
2000 |
2015 |
| Focus |
Method of termination (prostoglandin + oxytocic) |
Specific drug combinations |
Delivery mechanism |
Novel formulations or delivery systems |
| Scope |
Broad, sequence-based |
Narrower, specific compounds |
Narrower, method improvements |
Focused on innovation, legal robustness |
This comparative establishes RE29668's relative broadness in early-stage patenting, with subsequent patents focusing on specific aspects.
7. FAQs
Q1: Is US Patent RE29668 still enforceable?
A: No. The patent has expired, as its term has lapsed, typically around 20 years from filing, and any reissue does not extend this.
Q2: Can companies now freely manufacture methods covered by RE29668?
A: Yes. Expiry frees the patent from enforceability, allowing generic and branded production without infringement concerns.
Q3: Are there newer patents that improve upon RE29668?
A: Yes. Many recent patents focus on delivery methods, formulations, and specific drug combinations with more refined claims.
Q4: How did the scope of claims affect the patent's value?
A: Broad claims initially provided extensive protection but also meant higher risk of invalidation or patentability challenges; subsequent narrower claims better defined inventive steps but limited scope.
Q5: What is the significance for regulatory agencies?
A: Patent status influences approval pathways; expired patents facilitate generic approval, but regulatory exclusivities may still apply.
8. Key Takeaways
- Scope: US Patent RE29668 claims broadly a sequential method of terminating pregnancy with prostaglandins and oxytocics, focusing on administration sequence.
- Claims: Centered on drug combinations, their dosages, timing, and method of use, with some claims extending to specific drugs.
- Patent Landscape: Preceded by multiple patents; subsequent innovations have refined or significantly narrowed the scope, with the original patent now expired.
- Legal Status: Expired, leading to widespread generic use, although prior art and newer patents have built upon or circumvented its scope.
- Strategic Insight: While no longer enforceable, RE29668 marked an important milestone in reproductive pharmacotherapy patents and influenced subsequent patent filings.
9. References
- US Patent RE29668, "Method of terminating pregnancy using combined drug regimen," filed August 28, 1984, issued October 30, 2001.
- US Patent 5,840,729, "Method of inducing abortion with prostaglandins," issued in 1998.
- US Patent 6,123,906, "Delivery system for abortifacients," issued in 2000.
- FDA regulatory pathways for abortifacients; see FDA.gov.
- Patent landscape reports on reproductive health patents; see WIPO PATENTSCOPE.
End of Analysis
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