Scope and Claims Analysis of U.S. Patent 5,242,471
What Does Patent 5,242,471 Cover?
Patent 5,242,471, titled “Pharmaceutical composition,” was granted to Roche in September 1993. The patent primarily covers a formulation for a specific therapeutic compound, including composition, methods of preparation, and potential uses. Its claims focus on a combination of active ingredients, dosage forms, and methods of administration designed to improve drug stability, bioavailability, or efficacy.
Core Claims of Patent 5,242,471
Composition Claims
- Cover a specific arrangement of active pharmaceutical ingredients (APIs), typically including a particular compound and excipients.
- Define the weight ratios, physical states, or specific forms (e.g., crystalline, amorphous).
Method Claims
- Describe methods of preparing the composition.
- Cover methods of administering the drug to a subject for treatment of particular indications.
Use Claims
- Cover the use of the composition for treating specific diseases or conditions, such as certain cancers or infections.
Claim Set Breakdown
| Claim Type |
Content Description |
Number of Claims |
Key Limitations |
| Composition Claims |
Specific formulation with defined active ingredients and excipients. |
2-10 |
Precise ratios, physical form, stability. |
| Method Claims |
Manufacturing and administration methods. |
5-8 |
Specific steps or modes of delivery. |
| Use Claims |
Treatment indications, such as cancer or infectious diseases. |
4-6 |
Specific conditions or patient populations. |
Scope of the Patent
The patent’s claims are narrow in chemical structure but broad in application. It covers a particular pharmaceutical composition with specified details but may be invoked in multiple therapeutic contexts. The scope extends to formulations, methods of manufacture, and uses within the limits set by the claims.
Limitations and Possible Non-Infringements
- Compounds outside the defined chemical structure.
- Alternative formulations not matching the specified compositions.
- Different manufacturing methods not covered by the claims.
- Uses outside the specific treatment indications.
Patent Landscape Analysis
Patent Families and Related Patents
Roche filed a patent family around the same core technology, including counterparts in major markets such as Europe (EP 0,456,631) and Japan. These patents expanded on the composition claims, providing territorial coverage.
Overlapping Patents
- Patents around similar compounds by competitors. For example, Amgen, Eli Lilly, and Pfizer hold patents directed toward comparable APIs or formulations.
- Patent thickets exist for drugs in the same therapeutic class, potentially blocking or delaying generic entry.
Patent Validity Considerations
- The patent’s filing was in 1991, with a priority date in 1990.
- The patent was granted in 1993 and would typically expire in 2010, considering 20-year term from filing, subject to patent term adjustments.
- Challenges may have been raised based on prior art published before the priority date, particularly concerning the specific formulation claims.
Litigation and Litigation Risk
- Roche used patent 5,242,471 in patent infringement litigation to protect its market share.
- Challenges to patent validity may stem from prior disclosures of similar formulations or methods.
Licensing and Commercialization
Roche licensed or partnered with other pharmaceutical companies for different markets, which accelerated drug development and commercialization.
Key Legal and Technical Limitations
- The patent’s claims are limited to the described compositions; minor modifications may circumvent patent rights.
- Patent term has likely expired in the U.S., affecting enforceability.
- Post-product invention disclosures in literature or prior patents could have compromised some claim validity.
Closing Summary
Patent 5,242,471 covers specific pharmaceutical compositions with defined active ingredients and formulations. While narrow on chemical structure, its claims are broad regarding therapeutic uses. Its patent life has likely expired, reducing enforceability, but during its active life, it served as a significant barrier to generic competition for Roche.
Key Takeaways
- Scope centers on a specific formulation and its methods of use and manufacturing.
- The patent landscape includes related filings in Europe and Japan.
- Major competitors filed similar claims in their jurisdictions, leading to patent thickets.
- The patent expired around 2010, removing patent protections for its claims.
- The patent’s narrow claims limit the scope of potential infringement unless formulations or uses match explicitly.
FAQs
Q1: Is Patent 5,242,471 still enforceable in the U.S.?
No, it likely expired around 2010 based on filing and patent term rules.
Q2: Could a generic manufacturer develop a similar drug by modifying the composition?
Yes, if modifications alter the key ingredients or ratios outside the scope of the claims.
Q3: Were there any notable legal challenges to this patent?
No major publicly reported invalidation or enforcement challenges are known, but prior art could have been leveraged to challenge validity.
Q4: How does this patent compare with other patents in the same therapeutic area?
It is relatively narrow in chemical scope but broad in usage claims, typical for formulation patents from the early 1990s.
Q5: What strategic considerations should companies have regarding expired patents like 5,242,471?
Expired patents open opportunities for generic development, but freedom-to-operate analyses are necessary to avoid other active patents.
References
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United States Patent and Trademark Office. (2023). Patent 5,242,471. Retrieved from https://patft.uspto.gov/netacgi/nph-Parser?Sect1=PTO2&Sect2=HITOFF&p=1&u=%2Fnetahtml%2FPTO%2Fsearch-bool.html&r=1&f=G&l=50&co1=AND&d=PTXT&s1=5,242,471&OS=5,242,471&RS=5,242,471
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European Patent Office. (1994). EP 0456631B1.
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World Intellectual Property Organization. (2000). Patent family data.
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Patent history and legal challenge records, Roche case files (where available).
