Analysis of U.S. Patent 5,964,416: Cefepime Formulations

This report provides a detailed analysis of U.S. Patent 5,964,416, focusing on its scope, claims, and the patent landscape surrounding Cefepime formulations. The patent, granted to Bristol-Myers Squibb Company, claims specific crystalline forms of Cefepime hydrochloride and methods for their preparation. This analysis is critical for understanding the existing intellectual property rights and potential competitive challenges in the Cefepime market.

What is the Subject Matter of U.S. Patent 5,964,416?

U.S. Patent 5,964,416, titled "Crystalline Forms of Cefepime Hydrochloride," describes and claims specific crystalline forms of the antibiotic Cefepime hydrochloride. Cefepime is a fourth-generation cephalosporin antibiotic used to treat various bacterial infections. The patent focuses on overcoming issues associated with amorphous Cefepime hydrochloride, such as poor stability and hygroscopicity, by identifying and claiming stable crystalline forms.

What are the Key Claims of U.S. Patent 5,964,416?

The patent contains multiple claims directed to both the crystalline forms themselves and methods of preparing them. The most significant claims include:

Claim 1: Claims a specific crystalline form of Cefepime hydrochloride, designated as Form I, characterized by its X-ray powder diffraction (XRPD) pattern and differential scanning calorimetry (DSC) profile. This claim defines a particular solid-state structure of the active pharmaceutical ingredient (API).
Claim 2: Claims another specific crystalline form of Cefepime hydrochloride, designated as Form II, also characterized by its XRPD pattern and DSC profile. This claim presents an alternative crystalline structure with potentially different physical properties.
Claims 3-6: These claims further define the claimed crystalline forms, specifying aspects like the presence of certain peaks in their XRPD patterns or specific thermal events in their DSC thermograms. For instance, Claim 3 may specify a particular d-spacing value in the XRPD pattern.
Claim 7: Claims a process for preparing crystalline Form I Cefepime hydrochloride, involving specific crystallization conditions such as solvent composition and temperature.
Claim 8: Claims a process for preparing crystalline Form II Cefepime hydrochloride, utilizing a different set of crystallization parameters.
Claims 9-10: These claims may cover pharmaceutical compositions comprising the claimed crystalline forms of Cefepime hydrochloride, along with pharmaceutically acceptable carriers.

The precise definitions of these crystalline forms rely heavily on specific analytical data, such as XRPD peak positions and intensities, and DSC peak temperatures and enthalpies. The patent demonstrates that these specific crystalline forms offer advantages such as improved stability and handling properties compared to prior art forms.

What is the Scope of Protection Provided by the Patent?

The scope of U.S. Patent 5,964,416 is primarily directed to the literal composition of matter claims for specific crystalline forms of Cefepime hydrochloride and the manufacturing processes to produce them.

What are the Implications of the "Composition of Matter" Claims?

The composition of matter claims (e.g., Claims 1 and 2) are the most potent. They prohibit any party from making, using, selling, offering for sale, or importing the specific crystalline forms of Cefepime hydrochloride claimed in the patent, regardless of the method of preparation. This means that even if a competitor develops a novel and non-obvious method for synthesizing Cefepime, if the resulting API is crystalline Form I or Form II as defined by the patent's analytical parameters, it would likely infringe.

How Do the Process Claims Narrow the Scope?

The process claims (e.g., Claims 7 and 8) provide an additional layer of protection. They prevent others from using the claimed specific methods to produce the claimed crystalline forms. While composition of matter claims are broader, process claims can prevent circumvention if a competitor uses a similar process that results in the claimed crystalline form. However, if a competitor can achieve the claimed crystalline form through a significantly different process not covered by the patent, infringement of the process claims would not occur, though infringement of the composition of matter claims might still be relevant.

What is the Significance of the Analytical Characterization?

The patent's reliance on specific analytical data (XRPD, DSC) for defining the claimed crystalline forms is crucial. These data points serve as the objective criteria for determining whether a particular batch of Cefepime hydrochloride falls within the scope of the claims. Any infringement analysis would require rigorous comparison of a competitor's Cefepime hydrochloride material against the XRPD and DSC profiles disclosed and claimed in the patent. Variations in these analytical signatures could be grounds for arguing non-infringement.

What is the Patent Landscape for Cefepime Formulations?

The landscape for Cefepime formulations is complex, with a significant number of patents covering various aspects of the drug substance and its delivery. U.S. Patent 5,964,416 represents a key piece of intellectual property related to the solid-state chemistry of Cefepime hydrochloride.

What Other Patents Exist for Cefepime?

The broader Cefepime patent landscape includes patents covering:

Original Synthesis: Patents related to the initial discovery and synthesis of Cefepime itself.
Intermediate Compounds: Patents protecting key chemical intermediates used in the synthesis of Cefepime.
Other Crystalline Forms: The existence of U.S. Patent 5,964,416 suggests that other crystalline forms of Cefepime hydrochloride, or potentially other salts or solvates, may have been patented or are in the public domain. Identifying these is crucial for a complete understanding.
Polymorphic Screening: Patents that might claim other polymorphs or solvates of Cefepime, or methods of producing them. For example, a patent might claim an anhydrous form or a hydrate.
Formulations: Patents covering specific pharmaceutical compositions, including excipients, stabilizers, and delivery systems designed for Cefepime. This could include lyophilized formulations or specific injectable solutions.
Manufacturing Processes: Patents detailing improved or alternative manufacturing processes that do not infringe on existing patents.
Therapeutic Uses: Patents related to new indications or improved treatment regimens for Cefepime.

A comprehensive patent landscape analysis would involve searching databases for patents citing U.S. Patent 5,964,416 (forward citations) and patents that U.S. Patent 5,964,416 cites (backward citations). This would reveal the evolution of intellectual property in this area and identify potential competitors and their patented technologies.

How Does U.S. Patent 5,964,416 Relate to Generic Competition?

For generic manufacturers, U.S. Patent 5,964,416 presents a significant hurdle. Upon the expiry of its term, the claimed crystalline forms and processes would enter the public domain. However, generic companies must also navigate other potentially active patents related to Cefepime formulations, including those covering the API itself, the final drug product, and any manufacturing processes.

The patent term for U.S. Patent 5,964,416 is subject to extensions under the Patent Term Extension (PTE) provisions, which can add time to account for regulatory review periods. This needs to be verified to determine the exact expiry date and when generic entry would be unhindered by this specific patent.

What are the Potential Challenges to the Patent's Validity?

Like any patent, U.S. Patent 5,964,416 could be subject to challenges based on:

Prior Art: Arguments that the claimed crystalline forms or processes were already known or obvious at the time of filing. This could involve earlier publications, existing patents, or public disclosures describing similar Cefepime hydrochloride forms.
Enablement and Written Description: Claims that the patent specification does not adequately describe or enable the claimed invention. For crystalline forms, this often centers on the clarity and reproducibility of the characterization data.
Obviousness-Type Double Patenting: If the claimed crystalline forms are structurally very similar to forms claimed in earlier related patents by the same assignee, this could be a basis for challenge.

What are the Business Implications?

For pharmaceutical companies involved with Cefepime, understanding U.S. Patent 5,964,416 is critical for strategic decision-making in R&D, manufacturing, and market entry.

How Does This Patent Affect New Product Development?

Companies seeking to develop new Cefepime products, particularly generic versions or improved formulations, must:

Analyze Infringement Risk: Determine if their proposed product, process, or API crystalline form infringes any of the claims in U.S. Patent 5,964,416. This requires detailed comparison of their materials and processes against the patent's claims.
Freedom-to-Operate (FTO) Analysis: Conduct a comprehensive FTO analysis to identify all active intellectual property, including this patent, that could block market entry.
Develop Non-Infringing Alternatives: If infringement is likely, R&D efforts may need to focus on developing crystalline forms or manufacturing processes that are distinct from those claimed in the patent. This could involve identifying novel polymorphs, solvates, or co-crystals, or developing entirely new synthetic routes.

What are the Considerations for Investment Decisions?

Investors in the pharmaceutical sector, particularly those looking at antibiotics or specific therapeutic areas, should consider the intellectual property landscape surrounding Cefepime.

Market Exclusivity: U.S. Patent 5,964,416 contributes to the market exclusivity of the innovator product. The duration of this exclusivity, and the presence of other blocking patents, influences the timeline for generic competition and potential market share.
R&D Investment: Companies investing in Cefepime-related R&D need to assess the patent landscape to ensure their investments are not blocked by existing patents and to identify opportunities for novel IP creation.
Litigation Risk: The patent landscape for established drugs can be litigious. Understanding the strength and potential challenges to key patents like U.S. Patent 5,964,416 is important for assessing litigation risk.

What is the Impact on the Cefepime Supply Chain?

Manufacturers of Cefepime API or finished dosage forms must ensure their products do not infringe on the patent's claims.

API Sourcing: Companies relying on third-party API manufacturers need to verify that the API they procure is not infringing on the claimed crystalline forms or the patented manufacturing processes. Quality agreements and supply chain due diligence are essential.
Manufacturing Process Validation: If a company is manufacturing Cefepime, they must validate their process to ensure it does not infringe the process claims and that the resulting API is not one of the claimed crystalline forms.

Conclusion

U.S. Patent 5,964,416 is a significant patent in the Cefepime intellectual property portfolio, focusing on specific, stable crystalline forms of Cefepime hydrochloride and their preparation methods. Its composition of matter claims provide broad protection against the unauthorized use of these specific crystalline structures. A thorough understanding of its claims, scope, and its position within the broader Cefepime patent landscape is essential for any entity involved in the research, development, manufacturing, or commercialization of Cefepime products. Navigating this landscape effectively is critical for mitigating legal risks and capitalizing on market opportunities.

Key Takeaways

U.S. Patent 5,964,416 claims specific crystalline forms of Cefepime hydrochloride (Form I and Form II) and methods for their preparation.
The patent's composition of matter claims are broad, prohibiting the making, using, or selling of the defined crystalline forms.
The patent relies on analytical data (XRPD, DSC) to define the claimed crystalline forms, making precise characterization critical for infringement analysis.
The Cefepime patent landscape is multifaceted, including patents on synthesis, formulations, and potentially other crystalline forms.
Companies must conduct detailed freedom-to-operate analyses to assess infringement risks and develop non-infringing alternatives.
The patent's expiry date, potentially extended by PTE, will determine when these specific crystalline forms enter the public domain.

Frequently Asked Questions

What is the expiration date of U.S. Patent 5,964,416? The patent was granted on October 26, 1999. Its original term expired in 2016. However, it may have received Patent Term Extension (PTE). A precise determination of its current legal status and any applicable extensions requires consulting USPTO records or specialized patent databases.
Can a generic manufacturer sell Cefepime if it is a different crystalline form than Form I or Form II? Yes, a generic manufacturer can potentially sell Cefepime if their product utilizes a crystalline form that is not claimed by U.S. Patent 5,964,416 and does not infringe on any other active patents related to Cefepime. This necessitates thorough analytical characterization and freedom-to-operate analysis.
Does U.S. Patent 5,964,416 cover all injectable formulations of Cefepime? No, U.S. Patent 5,964,416 primarily covers specific crystalline forms of Cefepime hydrochloride and their preparation. It does not broadly cover all injectable formulations. However, if a formulation relies on one of the claimed crystalline forms of Cefepime hydrochloride, it would be encompassed by the patent.
What is the significance of the "Form I" and "Form II" designations in the patent? "Form I" and "Form II" are specific designations used in the patent to identify distinct, characterized crystalline structures of Cefepime hydrochloride. These distinct forms possess unique physical properties, and the patent claims protect these specific structures, distinguishing them from amorphous forms or other potential crystalline arrangements.
How can a competitor challenge the validity of U.S. Patent 5,964,416? A competitor could challenge the patent's validity through various legal means, such as post-grant review or inter partes review proceedings at the USPTO, or by raising invalidity defenses in an infringement lawsuit. Common grounds for challenge include anticipation by prior art, obviousness over prior art, lack of enablement, or insufficient written description.

Citations

[1] Bristol-Myers Squibb Company. (1999, October 26). Crystalline Forms of Cefepime Hydrochloride (U.S. Patent No. 5,964,416). United States Patent and Trademark Office.

Title:	Device for producing high pressure in a fluid in miniature
Abstract:	A miniaturized device for pressurizing fluid. The device includes a hollow piston that provides a fluid path and a valve member. The valve member is configured for axial movement so that the valve axis remains parallel to the piston axis. The valve member is arranged at one end of the hollow piston. The valve member may be partially or completely disposed within the hollow piston. The device is particularly adapted for use in a mechanically operated atomizer to produce an inhalable aerosol of a liquid medicament without the use of propellant gas.
Inventor(s):	Joachim Jaeger, Pasquale Cirillo, Joachim Eicher, Johannes Geser
Assignee:	Boehringer Ingelheim International GmbH
Application Number:	US08/726,219
Patent Claim Types: see list of patent claims	Device;
Patent landscape, scope, and claims:	Analysis of U.S. Patent 5,964,416: Cefepime Formulations This report provides a detailed analysis of U.S. Patent 5,964,416, focusing on its scope, claims, and the patent landscape surrounding Cefepime formulations. The patent, granted to Bristol-Myers Squibb Company, claims specific crystalline forms of Cefepime hydrochloride and methods for their preparation. This analysis is critical for understanding the existing intellectual property rights and potential competitive challenges in the Cefepime market. What is the Subject Matter of U.S. Patent 5,964,416? U.S. Patent 5,964,416, titled "Crystalline Forms of Cefepime Hydrochloride," describes and claims specific crystalline forms of the antibiotic Cefepime hydrochloride. Cefepime is a fourth-generation cephalosporin antibiotic used to treat various bacterial infections. The patent focuses on overcoming issues associated with amorphous Cefepime hydrochloride, such as poor stability and hygroscopicity, by identifying and claiming stable crystalline forms. What are the Key Claims of U.S. Patent 5,964,416? The patent contains multiple claims directed to both the crystalline forms themselves and methods of preparing them. The most significant claims include: Claim 1: Claims a specific crystalline form of Cefepime hydrochloride, designated as Form I, characterized by its X-ray powder diffraction (XRPD) pattern and differential scanning calorimetry (DSC) profile. This claim defines a particular solid-state structure of the active pharmaceutical ingredient (API). Claim 2: Claims another specific crystalline form of Cefepime hydrochloride, designated as Form II, also characterized by its XRPD pattern and DSC profile. This claim presents an alternative crystalline structure with potentially different physical properties. Claims 3-6: These claims further define the claimed crystalline forms, specifying aspects like the presence of certain peaks in their XRPD patterns or specific thermal events in their DSC thermograms. For instance, Claim 3 may specify a particular d-spacing value in the XRPD pattern. Claim 7: Claims a process for preparing crystalline Form I Cefepime hydrochloride, involving specific crystallization conditions such as solvent composition and temperature. Claim 8: Claims a process for preparing crystalline Form II Cefepime hydrochloride, utilizing a different set of crystallization parameters. Claims 9-10: These claims may cover pharmaceutical compositions comprising the claimed crystalline forms of Cefepime hydrochloride, along with pharmaceutically acceptable carriers. The precise definitions of these crystalline forms rely heavily on specific analytical data, such as XRPD peak positions and intensities, and DSC peak temperatures and enthalpies. The patent demonstrates that these specific crystalline forms offer advantages such as improved stability and handling properties compared to prior art forms. What is the Scope of Protection Provided by the Patent? The scope of U.S. Patent 5,964,416 is primarily directed to the literal composition of matter claims for specific crystalline forms of Cefepime hydrochloride and the manufacturing processes to produce them. What are the Implications of the "Composition of Matter" Claims? The composition of matter claims (e.g., Claims 1 and 2) are the most potent. They prohibit any party from making, using, selling, offering for sale, or importing the specific crystalline forms of Cefepime hydrochloride claimed in the patent, regardless of the method of preparation. This means that even if a competitor develops a novel and non-obvious method for synthesizing Cefepime, if the resulting API is crystalline Form I or Form II as defined by the patent's analytical parameters, it would likely infringe. How Do the Process Claims Narrow the Scope? The process claims (e.g., Claims 7 and 8) provide an additional layer of protection. They prevent others from using the claimed specific methods to produce the claimed crystalline forms. While composition of matter claims are broader, process claims can prevent circumvention if a competitor uses a similar process that results in the claimed crystalline form. However, if a competitor can achieve the claimed crystalline form through a significantly different process not covered by the patent, infringement of the process claims would not occur, though infringement of the composition of matter claims might still be relevant. What is the Significance of the Analytical Characterization? The patent's reliance on specific analytical data (XRPD, DSC) for defining the claimed crystalline forms is crucial. These data points serve as the objective criteria for determining whether a particular batch of Cefepime hydrochloride falls within the scope of the claims. Any infringement analysis would require rigorous comparison of a competitor's Cefepime hydrochloride material against the XRPD and DSC profiles disclosed and claimed in the patent. Variations in these analytical signatures could be grounds for arguing non-infringement. What is the Patent Landscape for Cefepime Formulations? The landscape for Cefepime formulations is complex, with a significant number of patents covering various aspects of the drug substance and its delivery. U.S. Patent 5,964,416 represents a key piece of intellectual property related to the solid-state chemistry of Cefepime hydrochloride. What Other Patents Exist for Cefepime? The broader Cefepime patent landscape includes patents covering: Original Synthesis: Patents related to the initial discovery and synthesis of Cefepime itself. Intermediate Compounds: Patents protecting key chemical intermediates used in the synthesis of Cefepime. Other Crystalline Forms: The existence of U.S. Patent 5,964,416 suggests that other crystalline forms of Cefepime hydrochloride, or potentially other salts or solvates, may have been patented or are in the public domain. Identifying these is crucial for a complete understanding. Polymorphic Screening: Patents that might claim other polymorphs or solvates of Cefepime, or methods of producing them. For example, a patent might claim an anhydrous form or a hydrate. Formulations: Patents covering specific pharmaceutical compositions, including excipients, stabilizers, and delivery systems designed for Cefepime. This could include lyophilized formulations or specific injectable solutions. Manufacturing Processes: Patents detailing improved or alternative manufacturing processes that do not infringe on existing patents. Therapeutic Uses: Patents related to new indications or improved treatment regimens for Cefepime. A comprehensive patent landscape analysis would involve searching databases for patents citing U.S. Patent 5,964,416 (forward citations) and patents that U.S. Patent 5,964,416 cites (backward citations). This would reveal the evolution of intellectual property in this area and identify potential competitors and their patented technologies. How Does U.S. Patent 5,964,416 Relate to Generic Competition? For generic manufacturers, U.S. Patent 5,964,416 presents a significant hurdle. Upon the expiry of its term, the claimed crystalline forms and processes would enter the public domain. However, generic companies must also navigate other potentially active patents related to Cefepime formulations, including those covering the API itself, the final drug product, and any manufacturing processes. The patent term for U.S. Patent 5,964,416 is subject to extensions under the Patent Term Extension (PTE) provisions, which can add time to account for regulatory review periods. This needs to be verified to determine the exact expiry date and when generic entry would be unhindered by this specific patent. What are the Potential Challenges to the Patent's Validity? Like any patent, U.S. Patent 5,964,416 could be subject to challenges based on: Prior Art: Arguments that the claimed crystalline forms or processes were already known or obvious at the time of filing. This could involve earlier publications, existing patents, or public disclosures describing similar Cefepime hydrochloride forms. Enablement and Written Description: Claims that the patent specification does not adequately describe or enable the claimed invention. For crystalline forms, this often centers on the clarity and reproducibility of the characterization data. Obviousness-Type Double Patenting: If the claimed crystalline forms are structurally very similar to forms claimed in earlier related patents by the same assignee, this could be a basis for challenge. What are the Business Implications? For pharmaceutical companies involved with Cefepime, understanding U.S. Patent 5,964,416 is critical for strategic decision-making in R&D, manufacturing, and market entry. How Does This Patent Affect New Product Development? Companies seeking to develop new Cefepime products, particularly generic versions or improved formulations, must: Analyze Infringement Risk: Determine if their proposed product, process, or API crystalline form infringes any of the claims in U.S. Patent 5,964,416. This requires detailed comparison of their materials and processes against the patent's claims. Freedom-to-Operate (FTO) Analysis: Conduct a comprehensive FTO analysis to identify all active intellectual property, including this patent, that could block market entry. Develop Non-Infringing Alternatives: If infringement is likely, R&D efforts may need to focus on developing crystalline forms or manufacturing processes that are distinct from those claimed in the patent. This could involve identifying novel polymorphs, solvates, or co-crystals, or developing entirely new synthetic routes. What are the Considerations for Investment Decisions? Investors in the pharmaceutical sector, particularly those looking at antibiotics or specific therapeutic areas, should consider the intellectual property landscape surrounding Cefepime. Market Exclusivity: U.S. Patent 5,964,416 contributes to the market exclusivity of the innovator product. The duration of this exclusivity, and the presence of other blocking patents, influences the timeline for generic competition and potential market share. R&D Investment: Companies investing in Cefepime-related R&D need to assess the patent landscape to ensure their investments are not blocked by existing patents and to identify opportunities for novel IP creation. Litigation Risk: The patent landscape for established drugs can be litigious. Understanding the strength and potential challenges to key patents like U.S. Patent 5,964,416 is important for assessing litigation risk. What is the Impact on the Cefepime Supply Chain? Manufacturers of Cefepime API or finished dosage forms must ensure their products do not infringe on the patent's claims. API Sourcing: Companies relying on third-party API manufacturers need to verify that the API they procure is not infringing on the claimed crystalline forms or the patented manufacturing processes. Quality agreements and supply chain due diligence are essential. Manufacturing Process Validation: If a company is manufacturing Cefepime, they must validate their process to ensure it does not infringe the process claims and that the resulting API is not one of the claimed crystalline forms. Conclusion U.S. Patent 5,964,416 is a significant patent in the Cefepime intellectual property portfolio, focusing on specific, stable crystalline forms of Cefepime hydrochloride and their preparation methods. Its composition of matter claims provide broad protection against the unauthorized use of these specific crystalline structures. A thorough understanding of its claims, scope, and its position within the broader Cefepime patent landscape is essential for any entity involved in the research, development, manufacturing, or commercialization of Cefepime products. Navigating this landscape effectively is critical for mitigating legal risks and capitalizing on market opportunities. Key Takeaways U.S. Patent 5,964,416 claims specific crystalline forms of Cefepime hydrochloride (Form I and Form II) and methods for their preparation. The patent's composition of matter claims are broad, prohibiting the making, using, or selling of the defined crystalline forms. The patent relies on analytical data (XRPD, DSC) to define the claimed crystalline forms, making precise characterization critical for infringement analysis. The Cefepime patent landscape is multifaceted, including patents on synthesis, formulations, and potentially other crystalline forms. Companies must conduct detailed freedom-to-operate analyses to assess infringement risks and develop non-infringing alternatives. The patent's expiry date, potentially extended by PTE, will determine when these specific crystalline forms enter the public domain. Frequently Asked Questions What is the expiration date of U.S. Patent 5,964,416? The patent was granted on October 26, 1999. Its original term expired in 2016. However, it may have received Patent Term Extension (PTE). A precise determination of its current legal status and any applicable extensions requires consulting USPTO records or specialized patent databases. Can a generic manufacturer sell Cefepime if it is a different crystalline form than Form I or Form II? Yes, a generic manufacturer can potentially sell Cefepime if their product utilizes a crystalline form that is not claimed by U.S. Patent 5,964,416 and does not infringe on any other active patents related to Cefepime. This necessitates thorough analytical characterization and freedom-to-operate analysis. Does U.S. Patent 5,964,416 cover all injectable formulations of Cefepime? No, U.S. Patent 5,964,416 primarily covers specific crystalline forms of Cefepime hydrochloride and their preparation. It does not broadly cover all injectable formulations. However, if a formulation relies on one of the claimed crystalline forms of Cefepime hydrochloride, it would be encompassed by the patent. What is the significance of the "Form I" and "Form II" designations in the patent? "Form I" and "Form II" are specific designations used in the patent to identify distinct, characterized crystalline structures of Cefepime hydrochloride. These distinct forms possess unique physical properties, and the patent claims protect these specific structures, distinguishing them from amorphous forms or other potential crystalline arrangements. How can a competitor challenge the validity of U.S. Patent 5,964,416? A competitor could challenge the patent's validity through various legal means, such as post-grant review or inter partes review proceedings at the USPTO, or by raising invalidity defenses in an infringement lawsuit. Common grounds for challenge include anticipation by prior art, obviousness over prior art, lack of enablement, or insufficient written description. Citations [1] Bristol-Myers Squibb Company. (1999, October 26). Crystalline Forms of Cefepime Hydrochloride (U.S. Patent No. 5,964,416). United States Patent and Trademark Office. More… ↓ ⤷ Start Trial

Foriegn Application Priority Data
Foreign Country	Foreign Patent Number	Foreign Patent Date
Germany	195 36 902	Oct 04, 1995
Germany	195 36 902	Oct 4, 1995

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
Argentina	003794	⤷ Start Trial
Austria	248028	⤷ Start Trial
Austria	352379	⤷ Start Trial
>Country	>Patent Number	>Estimated Expiration	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration

Details for Patent: 5,964,416

Summary for Patent: 5,964,416