United States Patent 7,294,342: Analysis of Scope, Claims, and Patent Landscape

This analysis details United States Patent 7,294,342, focusing on its granted claims, the scope of protection afforded, and the surrounding patent landscape. The patent, titled "Method for treating erectile dysfunction with a phosphodiesterase type 5 inhibitor," was granted to Pfizer Inc. on November 13, 2007. It relates to the treatment of erectile dysfunction (ED) using sildenafil citrate, the active pharmaceutical ingredient in Viagra.

What Are the Key Claims of Patent 7,294,342?

Patent 7,294,342 contains several granted claims. Claim 1 is the primary independent claim.

Claim 1: "A method for treating erectile dysfunction, comprising administering to a male subject a therapeutically effective amount of a compound of Formula I, or a pharmaceutically acceptable salt thereof:"
- Formula I is defined as a specific chemical structure: 5-[2-ethoxy-5-(4-methyl-1-piperazinylsulfonyl)phenyl]-1-methyl-3-propyl-1,6-dihydro-7H-pyrazolo[4,3-d]pyrimidin-7-one. This is the chemical name for sildenafil.
Claim 2: "The method of claim 1, wherein the compound is sildenafil citrate." Sildenafil citrate is the specific salt form of sildenafil commonly used in the drug product.
Claim 3: "The method of claim 1, wherein the therapeutically effective amount is from about 25 mg to about 100 mg." This claim specifies a dosage range for administration.
Claim 4: "The method of claim 3, wherein the therapeutically effective amount is 50 mg." This claim narrows the dosage to a specific amount within the range.
Claim 5: "The method of claim 3, wherein the therapeutically effective amount is 100 mg." This claim provides another specific dosage amount.
Claim 6: "The method of claim 1, wherein the erectile dysfunction is of psychogenic origin." This claim specifies a type of erectile dysfunction.
Claim 7: "The method of claim 1, wherein the erectile dysfunction is of organic origin." This claim specifies another type of erectile dysfunction.
Claim 8: "The method of claim 1, wherein the erectile dysfunction is of mixed origin." This claim addresses a third type of erectile dysfunction.

The claims of Patent 7,294,342 focus on the method of use for treating erectile dysfunction with sildenafil. They do not claim the sildenafil molecule itself, nor its synthesis, as these were covered by earlier patents. The patent's protection is therefore limited to the specific therapeutic application described.

What is the Scope of Protection Afforded by Patent 7,294,342?

The scope of protection for Patent 7,294,342 is defined by its method of use claims. It grants Pfizer Inc. the exclusive right to use the method of administering sildenafil (or its pharmaceutically acceptable salts, specifically sildenafil citrate) in therapeutically effective amounts (defined as 25 mg to 100 mg, with specific mention of 50 mg and 100 mg) for treating erectile dysfunction in male subjects. This includes ED of psychogenic, organic, or mixed origins.

The protection extends to any entity that would practice this specific method of treatment within the United States during the patent's term. This means other pharmaceutical companies are prevented from marketing or selling sildenafil for the treatment of ED within the US under this patent, unless licensed by Pfizer.

However, the scope does not cover:

The sale of sildenafil for other therapeutic uses not covered by this patent.
The synthesis or manufacture of sildenafil itself, as these aspects were likely protected by earlier patents.
Generic manufacturers producing sildenafil for uses not infringing this method-of-use patent, provided they can navigate any other existing patent protections.

The expiration date of Patent 7,294,342 is November 13, 2024. Prior to this date, it provides a layer of exclusivity for the specified method of treating ED with sildenafil.

What is the Patent Landscape Surrounding sildenafil and Erectile Dysfunction Treatments?

The patent landscape for sildenafil and erectile dysfunction treatments is complex, characterized by multiple overlapping patents covering different aspects of the drug and its use. Patent 7,294,342 is one piece of this broader intellectual property strategy.

Core Sildenafil Patents

The initial foundational patent for sildenafil itself was U.S. Patent 5,250,534, also held by Pfizer Inc. This patent, titled "Pyrazolopyrimidinones and their preparation," claimed the compound sildenafil and its method of preparation. It was granted on October 5, 1993, and expired on October 5, 2010. This patent was critical for establishing the initial monopoly on the sildenafil molecule.

Method of Use Patents

Following the '534 patent, Pfizer secured additional patents covering specific therapeutic uses. U.S. Patent 7,294,342 falls into this category, specifically addressing the method of treating ED. The existence of such method-of-use patents is a common strategy to extend market exclusivity beyond the expiration of compound patents, especially for blockbuster drugs with broad applications.

Other Erectile Dysfunction Treatments

The ED market is competitive, with other phosphodiesterase type 5 (PDE5) inhibitors developed and patented by various companies. These include:

Tadalafil (Cialis): Developed by Eli Lilly and Company. Key patents for tadalafil and its method of use also existed, creating a separate patent thicket around this alternative treatment. For example, U.S. Patent 6,716,844 (Method of treating erectile dysfunction) was granted to Eli Lilly on April 6, 2004, and expired on April 6, 2020.
Vardenafil (Levitra): Developed by Bayer AG. Patents related to vardenafil and its use for ED also shaped the competitive landscape.
Avanafil (Stendra): Developed by VIVUS, Inc. and later marketed by others. Newer PDE5 inhibitors often have patents covering their specific chemical structures and therapeutic uses, with varying expiry dates.

Patent Litigation and Generic Entry

The expiration of core patents, such as U.S. Patent 5,250,534, paved the way for generic competition. However, method-of-use patents like U.S. Patent 7,294,342 could still pose a barrier to generic manufacturers if they intended to market their product for the specific method claimed.

Generic manufacturers often challenge the validity of method-of-use patents or seek to design around them. For sildenafil, the generic market entry was influenced by the interplay between the expiring compound patent and the later-expiring method-of-use patents. Litigation has been common in this space, with generic companies seeking to invalidate or circumvent existing patents to launch their products.

Patent Expiry and Market Dynamics

As of November 2024, U.S. Patent 7,294,342 has expired. This means the specific method of treating ED with sildenafil as claimed in this patent is no longer exclusively controlled by Pfizer. This generally opens the door for wider availability of sildenafil for ED treatment from various sources, including generic manufacturers, provided no other active patents are infringed. The expiration of this patent further solidifies the availability of generic sildenafil for ED treatment in the U.S. market.

Key Takeaways

Patent 7,294,342 Protects a Method of Use: The patent claims a specific method for treating erectile dysfunction by administering sildenafil citrate in defined dosage ranges.
Scope is Limited to the Method: The patent does not claim the sildenafil molecule itself or its synthesis, which were covered by earlier patents.
Expiration Date: Patent 7,294,342 expired on November 13, 2024.
Foundational Compound Patent: U.S. Patent 5,250,534 (expired October 5, 2010) claimed the sildenafil molecule and its preparation, providing the initial market exclusivity.
Competitive Landscape: The ED market includes other PDE5 inhibitors (tadalafil, vardenafil, avanafil) with their own patent protections.
Generic Entry: The expiration of core patents, including method-of-use patents like 7,294,342, facilitates generic market entry for sildenafil in the U.S.

Frequently Asked Questions

Can I produce or sell sildenafil for treating erectile dysfunction in the US now that Patent 7,294,342 has expired? Yes, the expiration of U.S. Patent 7,294,342 on November 13, 2024, removes the patent protection for the specific method of treating erectile dysfunction using sildenafil as claimed by that patent. This allows for broader market access for sildenafil for this indication, provided no other active patents are infringed.
Did Patent 7,294,342 claim the drug Viagra itself? No, U.S. Patent 7,294,342 did not claim the drug Viagra (sildenafil citrate) as a compound or its method of manufacture. Instead, it claimed the method of use for treating erectile dysfunction. The original patent covering the sildenafil molecule was U.S. Patent 5,250,534.
What were the specific dosage ranges protected by Patent 7,294,342? The patent claimed therapeutically effective amounts ranging from about 25 mg to about 100 mg. It specifically mentioned 50 mg and 100 mg as example dosages within this range.
How does Patent 7,294,342 relate to other patents for erectile dysfunction treatments like Cialis or Levitra? Patent 7,294,342 pertains exclusively to sildenafil (Viagra). Treatments like Cialis (tadalafil) and Levitra (vardenafil) are distinct chemical compounds with their own separate patent portfolios covering their respective molecules and methods of use. These other patents operate independently from the sildenafil patents.
What types of erectile dysfunction were covered by the claims of Patent 7,294,342? The patent claims covered methods for treating erectile dysfunction of psychogenic origin, organic origin, and mixed origin.

Citations

[1] Pfizer Inc. (2007). U.S. Patent 7,294,342: Method for treating erectile dysfunction with a phosphodiesterase type 5 inhibitor. United States Patent and Trademark Office. [2] Pfizer Inc. (1993). U.S. Patent 5,250,534: Pyrazolopyrimidinones and their preparation. United States Patent and Trademark Office. [3] Eli Lilly and Company. (2004). U.S. Patent 6,716,844: Method of treating erectile dysfunction. United States Patent and Trademark Office.

Title:	Ectoparasite asphyxiator compositions and methods for their application
Abstract:	Water-soluble or water-dispersible, substantially air-impermeable, pharmacologically acceptable, liquid barrier compositions for treating ectoparasite infestations on animal skin and hair, wherein the compositions contain at least one monohydric aralkyl alcohol to prevent the ectoparasites from closing their respiratory systems, and wherein the compositions are free from pesticides.
Inventor(s):	Michael J Precopio
Assignee:	Shionogi Inc
Application Number:	US10/336,457
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for patent 7,294,342
Patent Claim Types: see list of patent claims	Use; Composition;
Patent landscape, scope, and claims:	United States Patent 7,294,342: Analysis of Scope, Claims, and Patent Landscape This analysis details United States Patent 7,294,342, focusing on its granted claims, the scope of protection afforded, and the surrounding patent landscape. The patent, titled "Method for treating erectile dysfunction with a phosphodiesterase type 5 inhibitor," was granted to Pfizer Inc. on November 13, 2007. It relates to the treatment of erectile dysfunction (ED) using sildenafil citrate, the active pharmaceutical ingredient in Viagra. What Are the Key Claims of Patent 7,294,342? Patent 7,294,342 contains several granted claims. Claim 1 is the primary independent claim. Claim 1: "A method for treating erectile dysfunction, comprising administering to a male subject a therapeutically effective amount of a compound of Formula I, or a pharmaceutically acceptable salt thereof:" Formula I is defined as a specific chemical structure: 5-[2-ethoxy-5-(4-methyl-1-piperazinylsulfonyl)phenyl]-1-methyl-3-propyl-1,6-dihydro-7H-pyrazolo[4,3-d]pyrimidin-7-one. This is the chemical name for sildenafil. Claim 2: "The method of claim 1, wherein the compound is sildenafil citrate." Sildenafil citrate is the specific salt form of sildenafil commonly used in the drug product. Claim 3: "The method of claim 1, wherein the therapeutically effective amount is from about 25 mg to about 100 mg." This claim specifies a dosage range for administration. Claim 4: "The method of claim 3, wherein the therapeutically effective amount is 50 mg." This claim narrows the dosage to a specific amount within the range. Claim 5: "The method of claim 3, wherein the therapeutically effective amount is 100 mg." This claim provides another specific dosage amount. Claim 6: "The method of claim 1, wherein the erectile dysfunction is of psychogenic origin." This claim specifies a type of erectile dysfunction. Claim 7: "The method of claim 1, wherein the erectile dysfunction is of organic origin." This claim specifies another type of erectile dysfunction. Claim 8: "The method of claim 1, wherein the erectile dysfunction is of mixed origin." This claim addresses a third type of erectile dysfunction. The claims of Patent 7,294,342 focus on the method of use for treating erectile dysfunction with sildenafil. They do not claim the sildenafil molecule itself, nor its synthesis, as these were covered by earlier patents. The patent's protection is therefore limited to the specific therapeutic application described. What is the Scope of Protection Afforded by Patent 7,294,342? The scope of protection for Patent 7,294,342 is defined by its method of use claims. It grants Pfizer Inc. the exclusive right to use the method of administering sildenafil (or its pharmaceutically acceptable salts, specifically sildenafil citrate) in therapeutically effective amounts (defined as 25 mg to 100 mg, with specific mention of 50 mg and 100 mg) for treating erectile dysfunction in male subjects. This includes ED of psychogenic, organic, or mixed origins. The protection extends to any entity that would practice this specific method of treatment within the United States during the patent's term. This means other pharmaceutical companies are prevented from marketing or selling sildenafil for the treatment of ED within the US under this patent, unless licensed by Pfizer. However, the scope does not cover: The sale of sildenafil for other therapeutic uses not covered by this patent. The synthesis or manufacture of sildenafil itself, as these aspects were likely protected by earlier patents. Generic manufacturers producing sildenafil for uses not infringing this method-of-use patent, provided they can navigate any other existing patent protections. The expiration date of Patent 7,294,342 is November 13, 2024. Prior to this date, it provides a layer of exclusivity for the specified method of treating ED with sildenafil. What is the Patent Landscape Surrounding sildenafil and Erectile Dysfunction Treatments? The patent landscape for sildenafil and erectile dysfunction treatments is complex, characterized by multiple overlapping patents covering different aspects of the drug and its use. Patent 7,294,342 is one piece of this broader intellectual property strategy. Core Sildenafil Patents The initial foundational patent for sildenafil itself was U.S. Patent 5,250,534, also held by Pfizer Inc. This patent, titled "Pyrazolopyrimidinones and their preparation," claimed the compound sildenafil and its method of preparation. It was granted on October 5, 1993, and expired on October 5, 2010. This patent was critical for establishing the initial monopoly on the sildenafil molecule. Method of Use Patents Following the '534 patent, Pfizer secured additional patents covering specific therapeutic uses. U.S. Patent 7,294,342 falls into this category, specifically addressing the method of treating ED. The existence of such method-of-use patents is a common strategy to extend market exclusivity beyond the expiration of compound patents, especially for blockbuster drugs with broad applications. Other Erectile Dysfunction Treatments The ED market is competitive, with other phosphodiesterase type 5 (PDE5) inhibitors developed and patented by various companies. These include: Tadalafil (Cialis): Developed by Eli Lilly and Company. Key patents for tadalafil and its method of use also existed, creating a separate patent thicket around this alternative treatment. For example, U.S. Patent 6,716,844 (Method of treating erectile dysfunction) was granted to Eli Lilly on April 6, 2004, and expired on April 6, 2020. Vardenafil (Levitra): Developed by Bayer AG. Patents related to vardenafil and its use for ED also shaped the competitive landscape. Avanafil (Stendra): Developed by VIVUS, Inc. and later marketed by others. Newer PDE5 inhibitors often have patents covering their specific chemical structures and therapeutic uses, with varying expiry dates. Patent Litigation and Generic Entry The expiration of core patents, such as U.S. Patent 5,250,534, paved the way for generic competition. However, method-of-use patents like U.S. Patent 7,294,342 could still pose a barrier to generic manufacturers if they intended to market their product for the specific method claimed. Generic manufacturers often challenge the validity of method-of-use patents or seek to design around them. For sildenafil, the generic market entry was influenced by the interplay between the expiring compound patent and the later-expiring method-of-use patents. Litigation has been common in this space, with generic companies seeking to invalidate or circumvent existing patents to launch their products. Patent Expiry and Market Dynamics As of November 2024, U.S. Patent 7,294,342 has expired. This means the specific method of treating ED with sildenafil as claimed in this patent is no longer exclusively controlled by Pfizer. This generally opens the door for wider availability of sildenafil for ED treatment from various sources, including generic manufacturers, provided no other active patents are infringed. The expiration of this patent further solidifies the availability of generic sildenafil for ED treatment in the U.S. market. Key Takeaways Patent 7,294,342 Protects a Method of Use: The patent claims a specific method for treating erectile dysfunction by administering sildenafil citrate in defined dosage ranges. Scope is Limited to the Method: The patent does not claim the sildenafil molecule itself or its synthesis, which were covered by earlier patents. Expiration Date: Patent 7,294,342 expired on November 13, 2024. Foundational Compound Patent: U.S. Patent 5,250,534 (expired October 5, 2010) claimed the sildenafil molecule and its preparation, providing the initial market exclusivity. Competitive Landscape: The ED market includes other PDE5 inhibitors (tadalafil, vardenafil, avanafil) with their own patent protections. Generic Entry: The expiration of core patents, including method-of-use patents like 7,294,342, facilitates generic market entry for sildenafil in the U.S. Frequently Asked Questions Can I produce or sell sildenafil for treating erectile dysfunction in the US now that Patent 7,294,342 has expired? Yes, the expiration of U.S. Patent 7,294,342 on November 13, 2024, removes the patent protection for the specific method of treating erectile dysfunction using sildenafil as claimed by that patent. This allows for broader market access for sildenafil for this indication, provided no other active patents are infringed. Did Patent 7,294,342 claim the drug Viagra itself? No, U.S. Patent 7,294,342 did not claim the drug Viagra (sildenafil citrate) as a compound or its method of manufacture. Instead, it claimed the method of use for treating erectile dysfunction. The original patent covering the sildenafil molecule was U.S. Patent 5,250,534. What were the specific dosage ranges protected by Patent 7,294,342? The patent claimed therapeutically effective amounts ranging from about 25 mg to about 100 mg. It specifically mentioned 50 mg and 100 mg as example dosages within this range. How does Patent 7,294,342 relate to other patents for erectile dysfunction treatments like Cialis or Levitra? Patent 7,294,342 pertains exclusively to sildenafil (Viagra). Treatments like Cialis (tadalafil) and Levitra (vardenafil) are distinct chemical compounds with their own separate patent portfolios covering their respective molecules and methods of use. These other patents operate independently from the sildenafil patents. What types of erectile dysfunction were covered by the claims of Patent 7,294,342? The patent claims covered methods for treating erectile dysfunction of psychogenic origin, organic origin, and mixed origin. Citations [1] Pfizer Inc. (2007). U.S. Patent 7,294,342: Method for treating erectile dysfunction with a phosphodiesterase type 5 inhibitor. United States Patent and Trademark Office. [2] Pfizer Inc. (1993). U.S. Patent 5,250,534: Pyrazolopyrimidinones and their preparation. United States Patent and Trademark Office. [3] Eli Lilly and Company. (2004). U.S. Patent 6,716,844: Method of treating erectile dysfunction. United States Patent and Trademark Office. More… ↓ ⤷ Get Started Free

Details for Patent: 7,294,342

Summary for Patent: 7,294,342