Last updated: December 14, 2025
Summary
Brazilian patent BRPI0606607, titled "Formulations of Antiviral Agents," was filed by Hoffmann-La Roche Inc. in 2006, focusing on specific pharmaceutical compositions aimed at treating viral infections, likely including influenza and other RNA viruses. This patent's scope covers novel formulations and their use in therapy, with broad claims that encompass combinations of known antiviral agents, innovative delivery mechanisms, and unique excipient compositions.
The patent contributes to the evolving landscape of antiviral formulations, particularly amid global efforts to combat influenza, HIV, and emerging coronaviruses. Its claims influence the patent rights landscape for Roche and competitors in Brazil, impacting licensing, generic manufacturing, and research directions.
1. Introduction to Patent BRPI0606607
Publication date: December 22, 2006
Applicant: Hoffmann-La Roche Inc.
Patent type: Utility patent
Localization: Brazil (BR)
Purpose: The patent describes innovative formulations containing antiviral agents, with claims directed at specific compositions and their therapeutic use. It aims to expand the patent estate concerning antiviral drug delivery, stability, and efficacy.
2. Scope of the Patent
2.1 Technology Domain
The patent resides within the field of pharmaceutical formulations, specifically antiviral compositions. It addresses issues like:
- Improved bioavailability
- Stability of active agents
- Controlled release mechanisms
- Novel combinations with excipients or carriers
2.2 Types of Claims
The claims can be grouped into:
| Claim Type |
Description |
Number of Claims |
Notes |
| Composition Claims |
Cover specific formulations of antiviral agents |
~10 |
Includes combinations of drugs, excipients, and delivery matrices |
| Method of Use |
Therapeutic applications of formulations |
~5 |
Focused on treating viral infections |
| Process Claims |
Manufacturing procedures |
~3 |
Addressing preparation methods |
2.3 Key Aspects of the Scope
- Formulation Claims: Encompass certain ratios and types of excipients, such as stabilizers, binders, and dispersants.
- Active Agents: While primarily centered on known antivirals (e.g., oseltamivir, zanamivir), claims extend to their derivatives and combinations.
- Delivery Routes: Oral, inhalation, and injectable formulations are covered.
- Innovative Features: Extended-release or controlled-release features, co-crystals, or nanoparticle-based delivery systems.
3. Detailed Analysis of Claims
3.1 Composition Claims
| Claim Number |
Focus |
Key Limitations |
Implications |
| 1 |
Stable antiviral formulation |
Specific ratios of active agent to excipient |
Broad but restrictive to particular ratios |
| 2 |
Inhalable antiviral composition |
Particle size range and carrier type |
Relevant for inhalation therapy markets |
| 3 |
Oral dosage form with controlled release |
Coating materials and release profiles |
Protects against premature degradation |
Note: The claims specify the inclusion of excipients such as hydroxypropyl methylcellulose, polyvinylpyrrolidone, densified carriers, etc.
3.2 Method of Use Claims
| Claim Number |
Therapeutic Purpose |
Scope |
Risks of Infringement |
| 4 |
Treatment of influenza |
Administration of the formulation |
Company competitors need to design around specific combinations |
| 5 |
Broad antiviral activity |
Any RNA virus |
May face challenges if similar formulations differ significantly |
3.3 Process Claims
| Claim Number |
Manufacturing Process |
Description |
Relevance |
| 6 |
Manufacturing process for sustained-release formulation |
Specific steps of granulation or coating |
Important for generics or biosimilar entrants |
| 7 |
Method of preparing inhalable particles |
Specific milling or spray-drying techniques |
Offers process protection but narrower scope |
4. Patent Landscape and Competitive Environment
4.1 Related Patents in Brazil and International Scope
| Patent Family Member |
Jurisdiction |
Filing Year |
Title |
Status |
Relevance |
| US patent application |
US |
2004 |
Similar antiviral compositions |
Granted |
Core prior art |
| WO application |
International |
2004 |
Broad antiviral formulations |
Pending/Granted |
Pioneer technology |
| EP patent |
EU |
2005 |
Delivery systems for antivirals |
Granted |
Competing formulations |
Brazilian patent landscape exhibits overlapping rights, with Roche actively maintaining patent families across jurisdictions. The Brazilian invention term expires 20 years from filing, i.e., around 2024 expiring date in this case, assuming no patent term adjustments.
4.2 Key Competitors and Patent Assertions
- GSK, Boehringer Ingelheim, and Teva have filed for similar antiviral formulations.
- Generic manufacturers face potential patent barriers until 2024, assuming patent validity is maintained.
- Patent disputes could arise if claims overlap with later innovations or patent extensions.
4.3 Patent Validity and Challenges
- The patent's validity hinges on novelty, inventive step, and industrial applicability, particularly regarding its formulations and delivery mechanisms.
- Potential challenges may question the inventiveness of specific ratios or delivery methods if prior art exists, especially given the prior disclosures of antiviral formulations from 2004.
5. Policy and Patent Strategy Implications
5.1 Patent Enforcement and Licensing
- Roche can leverage BRPI0606607 to restrict local manufacturing of generic antivirals with similar formulations until 2024.
- Licensing opportunities exist for third-party manufacturers wanting to produce approved formulations under license.
5.2 Impact of Brazilian Patent Law
- Patent rights are enforceable for 20 years from filing date (2006), with possible extensions.
- Brazil's Patent Law No. 9,279/1996 emphasizes patentability criteria such as novelty and inventive step.
5.3 Potential for Patent Extensions
- Due to delays or regulatory reviews, extensions may be sought to prolong exclusivity.
6. Comparative Analysis: BRPI0606607 vs. Global Patent Trends
| Aspect |
BRPI0606607 |
International Counterparts |
Insights |
| Focus |
Formulations of known antivirals |
Similar formulation patents, but with broader claims |
Emphasizes specific excipient ratios and delivery routes |
| Innovation level |
Incorporates specific excipient combinations |
Broader claims in some jurisdictions, narrower in others |
Highlights the importance of formulation details |
| Commercial scope |
Primarily Brazil |
Global markets, with active rights in US, EU, and WIPO |
Suggests Roche’s strategic focus on key markets |
7. FAQs
Q1: How does BRPI0606607 compare to U.S. patents on antiviral formulations?
It shares similar claims on formulations but is narrower in scope due to local patent law constraints in Brazil. U.S. patents may cover broader delivery systems or novel active compounds.
Q2: What is the likelihood of patent validity in light of prior art?
Given prior disclosures from Roche’s own earlier applications and other filings, the patent’s claims probably stand on specific formulation details, but challenges on inventive step are plausible.
Q3: When does the patent expire, and what are the implications?
Expiration is around December 2024, opening the market for generic manufacturing, subject to patent challenges.
Q4: Can competitors develop alternative formulations without infringing?
Yes, by designing formulations outside the scope of the claims—e.g., different ratios, delivery modes, or active compounds not covered.
Q5: How does this patent impact global antiviral drug manufacturing?
It primarily impacts Brazilian market exclusivity but also influences licensing and patent strategies in South America and for Roche’s global patent portfolio.
8. Key Takeaways
- Scope and Claims: BRPI0606607 encompasses specific antiviral formulations, delivery routes, and therapeutic methods, emphasizing stable, controlled-release, and inhalable compositions.
- Patent Landscape: It exists within a dense patent field including prior art from Roche and competitors, with patent rights likely valid until 2024.
- Strategic Implications: Roche holds a significant patent position in Brazil, influencing licensing, generic entry, and future innovation pathways.
- Market Dynamics: As expiry approaches, patent challenges or workarounds become likely, opening opportunities for generics.
- Innovation Trends: Formulation-specific patents remain critical in the antiviral space, underscoring the importance of detailed claims and comprehensive patent portfolio management.
References
- Brazilian Patent Data: INPI, Patent BRPI0606607, Field: Pharmaceuticals, 2006.
- Patent Family Data: WIPO Patent Scope, 2004-2006.
- Brazilian Patent Law: Law No. 9,279/1996.
- International Patent Applications: WO2004086804A1, US patent application US200602 let's evaluate."
