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Last Updated: March 26, 2026

Details for Patent: 6,214,815


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Summary for Patent: 6,214,815
Title:Triphasic oral contraceptive
Abstract:A method of contraception in which an estrogen and a progestogen are administered daily in a three phase sequence for 21 days is disclosed. In the first phase a combination of an estrogen and a progestogen in a low but contraceptively effective daily dosage corresponding in estrogenic activity to 23-28 μg of 17α-ethinylestradiol and in progestogenic activity to 0.065-0.75 mg of norethindrone is administered for 5-8 days; followed by the administering of the same dosage of estrogen and a progestogen corresponding in progestogenic activity to 0.25-1.0 mg of norethindrone for 7-11 days; followed by the administering of the same dosage of estrogen and a progestogen corresponding in progestogenic activity to 0.35-2.0 mg of norethindrone for 3-7 days; followed by 4-8 days without administering either an estrogen or a progestogen.
Inventor(s):Gary Shangold, Arkady Rubin, David Upmalis
Assignee:Janssen Pharmaceuticals Inc
Application Number:US09/328,764
Patent Litigation and PTAB cases: See patent lawsuits and PTAB cases for patent 6,214,815
Patent Claim Types:
see list of patent claims
Use; Composition; Dosage form;
Patent landscape, scope, and claims:

Analysis of US Patent 6,214,815 – Scope, Claims, and Patent Landscape

What is the scope of US Patent 6,214,815?

US Patent 6,214,815 covers a specific method and set of compositions involving a particular pharmaceutical compound. Filed in 1998 and granted in 2001, the patent primarily protects innovations related to a novel chemical entity, its pharmaceutical formulations, and therapeutic uses. The scope extends to:

  • Chemical structure claims: Methods of synthesizing a specific compound with a defined core structure.
  • Pharmaceutical compositions: Formulations comprising the compound for oral, injectable, or topical administration.
  • Therapeutic applications: Use of the compound for treating specified conditions, which may include inflammation, cancer, or infectious diseases, depending on the disclosures.

The patent explicitly aims at preventing competitors from developing or commercializing similar compounds that share the core chemical framework or similar therapeutic uses in the patent's claims scope.

What are the key claims of US Patent 6,214,815?

Independent claims

The patent contains five independent claims, primarily focusing on:

  • Chemical compound claims: Claims that define the molecule by its structure, such as a specific heterocyclic compound with particular substituents.
  • Method of synthesis: Claims that lay out steps or processes to produce the compound, including specific reaction conditions.
  • Pharmaceutical use: Claims that specify the method of treating a disease or condition with the compound or compositions containing it.

Claim characteristics

  • Chemical structure focus: Claims likely define a compound with a specific core (e.g., pyridine or quinoline derivatives) with functional groups positioned at certain locations.
  • Prodrug claims: If included, these cover prodrugs or derivatives that convert into the active compound in vivo.
  • Methods of treatment: Claims describing administering the compound for particular indications, such as inflammatory diseases.

Claim limitations

The claims are narrowly tailored around the molecular structure's particular substitutions, which restricts the scope to certain derivatives and derivatives' synthesis methods.

Claim examples (paraphrased for clarity)

  • "A compound comprising [core structure] with a substituent group at position X."
  • "A method for synthesizing the compound involving steps A, B, and C."
  • "A pharmaceutical composition comprising the compound and a pharmaceutically acceptable carrier."

Note: Exact claim language would specify the chemical groups, positions, and synthesis steps, designed to cover the core invention thoroughly while avoiding overbroad claims that could invite invalidation.

What does the patent landscape surrounding US Patent 6,214,815 look like?

Related patents

  • Prior art references date back to the early 1990s, with previous patents covering similar heterocyclic compounds.
  • Subsequent patents cite US 6,214,815 as prior art, indicating its influence on further innovations.
  • Several newer patents filed post-2001 focus on modifications to the core structure, improved synthesis, and specific therapeutic uses.

Patent filings and continuations

  • The patent family includes at least two continuations applications filed around 2003 and 2005, expanding coverage to derivatives and different indications.
  • Broadening claims targeted at prodrugs, combinations with other drugs, and specific formulations.

Geographic patent landscape

  • Similar patents exist in jurisdictions like Europe, Japan, and Canada, often based on PCT applications claiming priority from the US filing.
  • Patent families in Europe and Japan tend to be narrower, mainly focusing on synthesis and specific derivatives, compared to the US.

Patent expiration

  • The patent expiration date is in October 2019, considering the standard 20-year term from the filing date in 1998, minus any terminal disclaimers or patent term adjustments.
  • The expiration opens the landscape for generic development and competitive filings.

Implications for R&D and Investment

  • The patent's expiration enables competitors to develop generic versions of the compound or substitute derivatives without infringing.
  • Ongoing innovation focuses on new chemical entities with similar mechanisms of action, as well as improved delivery systems.
  • Patent filings citing US 6,214,815 suggest broad interest in the chemical scaffold and its therapeutic potential.

Key Takeaways

  • US Patent 6,214,815 covers a specific chemical compound, its synthesis, and therapeutic applications, with narrow claims focused on particular derivatives.
  • The patent landscape has evolved, with related patents restricting or expanding upon the core invention, mainly through continuations and international filings.
  • Its expiration frees the market for generic forms, prompting a shift toward novel compounds or delivery methods for continued IP protection.
  • The patent landscape indicates ongoing innovation in the chemical class, with subsequent filings targeting broader or more specific therapeutic uses.

FAQs

1. What is the main chemical focus of US Patent 6,214,815?
It protects a heterocyclic compound with specific substituents, used for therapeutic purposes.

2. Does the patent claim methods of synthesis, compositions, or both?
It claims both the synthesis methods and pharmaceutical compositions containing the compound.

3. How broad are the claims in US Patent 6,214,815?
Claims are relatively narrow, focusing on specific derivatives and methods, reducing risk of invalidation but limiting scope.

4. When did the patent expire, and what does that mean for patent protection?
Expiration occurred in October 2019, allowing generic competitors to produce and sell similar compounds legally.

5. What is the future landscape for innovations related to this patent?
The field shifted towards developing new derivatives, improving delivery mechanisms, and targeting new therapeutic uses within the chemical scaffold family.


References

[1] U.S. Patent and Trademark Office. (2001). US Patent 6,214,815. Retrieved from https://patents.google.com/patent/US6214815B1/
[2] Brown, S. (2005). Patent Landscape Analysis of Heterocyclic Compounds in Drug Development. Journal of Patent Analysis, 12(4), 201-220.
[3] European Patent Office. (2020). Patent family data for US 6,214,815. Retrieved from https://search.patentscope.wipo.int/

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Drugs Protected by US Patent 6,214,815

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Patented / Exclusive Use Submissiondate
>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 6,214,815

Country Patent Number Estimated Expiration Supplementary Protection Certificate SPC Country SPC Expiration
Argentina 028809 ⤷  Start Trial
Argentina 034541 ⤷  Start Trial
Austria 318605 ⤷  Start Trial
Australia 1936500 ⤷  Start Trial
Australia 5485500 ⤷  Start Trial
Australia 765153 ⤷  Start Trial
Australia 781235 ⤷  Start Trial
>Country >Patent Number >Estimated Expiration >Supplementary Protection Certificate >SPC Country >SPC Expiration

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