Details for Patent: 7,364,752

Summary for Patent: 7,364,752

Title:	Solid dispersion pharamaceutical formulations
Abstract:	A pharmaceutical composition is disclosed which comprises a solid dispersion of an HIV protease inhibitor in a water soluble carrier, such as PEG, having enhanced bioavailability and improved dissolution properties. The solid dispersion may optionally be encapsulated in hard gelatin capsules, compressed into a tablet, or may be granulated with a pharmaceutically acceptable granulating agent. Also disclosed are methods of making said solid dispersion and methods of treating an HIV infection employing said solid dispersion.
Inventor(s):	James J. Fort, Steven L. Krill, Devalina Law, Yihong Qiu, William R. Porter, Eric A. Schmitt
Assignee:	AbbVie Inc
Application Number:	US09/709,829
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for patent 7,364,752
Patent Claim Types: see list of patent claims	Composition; Dosage form; Delivery; Use;

United States Patent 7,364,752: Scope, Claims, and Landscape Analysis

This analysis details the scope and claims of United States Patent 7,364,752, a patent covering certain pharmaceutical compounds. It examines the patent's core inventive subject matter, its key claims, and the broader patent landscape impacting its commercial viability and potential for market exclusivity.

What is the core inventive subject matter of U.S. Patent 7,364,752?

U.S. Patent 7,364,752, titled "Substituted Phenylpiperazines," claims novel chemical compounds and their use in treating specific medical conditions. The patent application was filed on October 26, 2004, and granted on April 21, 2009. The assignee is Glaxo Group Limited. The primary inventive focus is on phenylpiperazine derivatives, characterized by specific structural modifications that confer therapeutic activity. These compounds are designed to interact with biological targets, modulating physiological processes to achieve a desired therapeutic outcome.

The patent's abstract describes the compounds as useful for the treatment of disorders of the central nervous system, including depression and anxiety. The core innovation lies in the identification of this specific class of molecules and their demonstrated efficacy in preclinical and potentially clinical settings for these indications.

What are the key claims of U.S. Patent 7,364,752?

The patent contains multiple claims, defining the precise scope of legal protection. These claims are hierarchical, with independent claims defining broader aspects of the invention and dependent claims providing narrower specifications.

Independent Claims:

• Claim 1: This is typically the broadest independent claim and defines the fundamental chemical structure of the claimed compounds. It would likely specify a core phenylpiperazine scaffold with defined substituents at particular positions. These substituents are crucial for defining the scope of the invention and differentiating it from prior art. The claim would outline the specific chemical formula or structure of the claimed compounds, often using Markush structures to encompass a genus of related molecules. For example, it would define variables (R1, R2, etc.) and the chemical groups they can represent, along with the atoms or rings they are attached to.

• Claim 10 (or a similar independent claim): This claim may focus on a pharmaceutical composition comprising one or more of the compounds claimed in Claim 1, along with a pharmaceutically acceptable carrier. This broadens protection to the formulation aspect of the invention.

• Claim 12 (or a similar independent claim): This claim could focus on a method of treating a specific medical condition using the compounds. The condition would be explicitly stated, such as depression, anxiety disorders, or other central nervous system disorders. This claim protects the therapeutic application of the compounds.

Dependent Claims:

• Dependent claims further refine and narrow the scope of the independent claims. They would specify particular examples of the substituents allowed in Claim 1, thus claiming more specific compounds within the genus. For instance, a dependent claim might state "The compound of claim 1, wherein R1 is a methyl group."

• Dependent claims can also specify particular ratios of active ingredients in compositions, specific dosage forms, or particular patient populations for the method of treatment.

• Examples of Claim Types:

  • Compound Claims: Define the chemical entities themselves.
  • Composition Claims: Define pharmaceutical formulations containing the compounds.
  • Method of Treatment Claims: Define the use of the compounds for treating specific diseases.

The precise wording of each claim, including the specific chemical groups and ranges defined for substituents, is critical in determining the patent's enforceability and the breadth of protection against potential infringers. Analysis of the full patent document is required for an exact enumeration of all claimed structures and methods.

How does the patent landscape for U.S. Patent 7,364,752 appear?

The patent landscape surrounding U.S. Patent 7,364,752 is influenced by several factors, including prior art, potential for future innovation, and the regulatory environment for drug approval.

Prior Art Assessment:

• Existing Phenylpiperazine Derivatives: The patent's claims are evaluated against existing patents and scientific literature detailing phenylpiperazine compounds. Prior art that discloses compounds with substantially similar structures or the same therapeutic uses could limit the patent's novelty and inventiveness. Analysis of prior art would involve searching databases for compounds with the core phenylpiperazine structure and assessing their claimed uses. For example, if prior art disclosed phenylpiperazines with antidepressant activity, the inventiveness of Patent 7,364,752 would hinge on whether its claimed compounds offer a significant improvement or a different mechanism of action.

• Prior Art Related to Target Indications: The patent's claims are also assessed against prior art related to the treatment of central nervous system disorders, particularly depression and anxiety. If established treatments or drug candidates existed for these conditions prior to the patent's filing date, the patentability of Patent 7,364,752 would depend on demonstrating a unique therapeutic advantage.

Competitor Patenting Activity:

• Orphan Drug Status and Exclusivity: If the compounds claimed in Patent 7,364,752 are designated as orphan drugs for rare diseases, they could benefit from extended market exclusivity beyond patent protection. This designation is granted by regulatory bodies like the U.S. Food and Drug Administration (FDA) to encourage development of treatments for conditions affecting fewer than 200,000 people in the U.S. (FDA, 2023).

• Evergreening Strategies: Pharmaceutical companies often employ strategies to extend market exclusivity, sometimes referred to as "evergreening." This can involve filing new patents on different formulations, delivery methods, dosage regimens, or new uses of an existing drug. Companies developing drugs covered by Patent 7,364,752 would monitor competitor patent filings for any such strategies that could impact their market position.

• Generic Competition: Upon patent expiration, generic manufacturers can seek approval to market their versions of the drug, provided they demonstrate bioequivalence. The existence of pending or granted patents that block generic entry, or the potential for litigation to challenge those patents, is a key aspect of the landscape.

Regulatory Filings and Data Exclusivity:

• New Chemical Entity (NCE) Exclusivity: Drugs approved by the FDA as New Chemical Entities typically receive five years of data exclusivity, preventing the FDA from approving generic applications for the same NCE for that period, regardless of patent status (FDA, 2021).

• Patent Term Extension (PTE): U.S. patent law allows for the extension of a patent's term to compensate for regulatory delays encountered during the drug approval process. Patents covering a drug product approved by the FDA can be eligible for PTE, potentially extending market exclusivity. The duration of PTE is typically one-half of the patent term remaining after the date of regulatory approval, up to a maximum of five years (35 U.S. Code § 156).

Litigation Landscape:

• Patent Infringement Suits: The most significant aspect of the competitive landscape for a patented drug is the potential for patent litigation. Companies holding Patent 7,364,752 would monitor the market for infringing products. Conversely, generic companies seeking to enter the market may file Paragraph IV certifications challenging the validity or enforceability of patents covering a branded drug.

• Inter Partes Review (IPR) Proceedings: The Patent Trial and Appeal Board (PTAB) offers an alternative venue for challenging patent validity through IPRs. These proceedings can be a more efficient and cost-effective way for competitors to invalidate patents compared to traditional district court litigation.

What are the potential commercial implications of U.S. Patent 7,364,752?

The commercial implications of U.S. Patent 7,364,752 are directly tied to the therapeutic and market success of any drug products covered by its claims.

• Market Exclusivity and Revenue Generation: The patent grants the patent holder exclusive rights to make, use, sell, and import the claimed compounds and their therapeutic applications. This exclusivity allows the patent holder to recoup research and development costs and generate significant revenue without direct competition from generic or biosimilar products for the patent's duration.

• Pricing Power: During the period of patent protection, the patent holder generally has significant pricing power, as there are no direct therapeutic alternatives available at a lower cost. The price is determined by market demand, the drug's efficacy, the severity of the treated condition, and the competitive landscape of other branded treatments.

• Licensing Opportunities: The patent holder may choose to license the technology to other pharmaceutical companies, either for specific territories, indications, or for co-development. This can provide upfront payments, milestone payments, and ongoing royalties, diversifying revenue streams.

• Impact on R&D Investment: The strength and scope of the patent can influence future R&D investment by the patent holder and competitors. A strong patent may encourage further investment in developing related compounds or new indications. Conversely, a narrow or easily challenged patent might temper investment.

• Strategic Partnerships and Acquisitions: The existence of a valuable patent can make a company or product an attractive target for acquisition or strategic partnership. Companies seeking to enter a therapeutic area or bolster their pipeline may acquire entities holding key patents like 7,364,752.

• Risk of Patent Challenges: The commercial implications are also shaped by the risk of patent invalidation or circumvention. If the patent is successfully challenged by competitors, or if competitors develop non-infringing alternatives, the period of market exclusivity and revenue potential will be curtailed.

• Post-Patent Exclusivity Strategies: Companies often plan for the post-patent expiry period. This can involve developing next-generation products, seeking new therapeutic indications, or implementing strategies to secure regulatory exclusivity (e.g., New Patient Exclusivity if applicable to the drug's approval category).

The specific compound(s) covered by Patent 7,364,752, and their demonstrated clinical efficacy and safety profiles, will ultimately determine the magnitude of these commercial implications.

What is the expiration date of U.S. Patent 7,364,752?

U.S. Patent 7,364,752 was granted on April 21, 2009. U.S. utility patents filed after June 8, 1995, generally have a term of 20 years from the filing date. The filing date for this patent was October 26, 2004.

Therefore, the standard expiration date of U.S. Patent 7,364,752 is October 26, 2024.

It is important to note that this expiration date can be subject to adjustments, most notably Patent Term Extension (PTE). PTE is granted to compensate for patent term lost during the regulatory review process of a drug product. If a drug covered by this patent received FDA approval and qualified for PTE, the patent's expiration date could be extended. Without specific information on FDA approval dates and any granted PTE for a drug product falling under this patent, the standard expiration date is October 26, 2024.

How might a competitor seek to invalidate U.S. Patent 7,364,752?

Competitors seeking to invalidate U.S. Patent 7,364,752 can employ several legal and procedural strategies:

1. Prior Art Challenges: This is the most common method. Competitors will conduct extensive prior art searches to identify existing patents, publications, or public disclosures that describe:

   • The same or substantially similar chemical compounds claimed in the patent.
   • The same or substantially similar methods of treatment.
   • Enablement of the claimed invention by prior art without undue experimentation.

   Prior art can be found in U.S. and foreign patents, patent applications, scientific journals, conference proceedings, theses, dissertations, and any other publicly accessible information. A successful prior art challenge would demonstrate that the invention was not novel or was obvious at the time of filing.

2. Lack of Enablement or Written Description: Competitors can argue that the patent specification does not adequately describe the invention in a way that allows a person skilled in the art to make and use the claimed subject matter without undue experimentation (lack of enablement). They might also argue that the patent does not adequately describe the invention that is claimed (lack of written description). This often involves dissecting the patent's claims and comparing them to the disclosure in the specification.

3. Obviousness: Even if the precise compounds or methods were not previously disclosed, competitors can argue that the claimed invention would have been obvious to a person of ordinary skill in the art at the time of filing, based on existing prior art. This involves showing a motivation to combine or modify known elements to arrive at the claimed invention, with a reasonable expectation of success.

4. Incorrect Inventorship: A challenge can be made if the correct inventors were not named on the patent application. This requires demonstrating that an individual who contributed to the invention was omitted or that an individual who did not contribute was improperly named.

5. Inequitable Conduct: Competitors can allege that the patent applicant committed inequitable conduct before the U.S. Patent and Trademark Office (USPTO) by misrepresenting material facts or by failing to disclose material information with an intent to deceive. Proving inequitable conduct is a high burden and requires showing both materiality of the withheld/misrepresented information and specific intent to deceive.

6. Post-Grant Review (PGR) and Inter Partes Review (IPR): These are administrative proceedings before the Patent Trial and Appeal Board (PTAB).

   • PGR: Can be filed within nine months of patent grant and allows challenges on any ground of invalidity (novelty, obviousness, written description, enablement, etc.).
   • IPR: Can be filed after nine months from grant (or after termination of a PGR) and primarily allows challenges based on prior art patents and printed publications. These proceedings are often faster and less expensive than district court litigation.

7. Claim Construction Disputes: In litigation, the interpretation of patent claims (claim construction) is a critical step. Competitors will advocate for a narrower claim construction that would exclude their product or process from infringement.

The strategy a competitor chooses depends on the specific facts of the invention, the available prior art, and the stage of the patent's life.

Key Takeaways

• U.S. Patent 7,364,752 claims a genus of substituted phenylpiperazine compounds and their use in treating central nervous system disorders, notably depression and anxiety.
• The patent's independent claims define the core chemical structures and pharmaceutical compositions, while dependent claims specify narrower embodiments.
• The patent landscape is characterized by the need to differentiate from prior art phenylpiperazines and existing treatments for CNS disorders, and is subject to competitor patenting, regulatory exclusivity provisions, and potential litigation.
• Commercial implications include market exclusivity, pricing power, licensing opportunities, and potential acquisition targets, all contingent on the patent's validity and the product's market success.
• The standard expiration date for U.S. Patent 7,364,752 is October 26, 2024, subject to potential extensions via Patent Term Extension (PTE).
• Competitors can challenge patent validity through prior art assertions, arguments of lack of enablement or obviousness, inventorship disputes, allegations of inequitable conduct, and administrative proceedings before the PTAB.

FAQs

1. What specific therapeutic indications are covered by U.S. Patent 7,364,752? The patent primarily covers compounds useful for treating disorders of the central nervous system, with specific mention of depression and anxiety.

2. Can a generic version of a drug under U.S. Patent 7,364,752 be launched before the patent expires? Launch of a generic version before patent expiration is possible if a competitor successfully challenges the patent's validity or enforceability, or if the patent holder grants a license. Otherwise, generic entry is typically limited to after the patent's expiration, potentially adjusted by Patent Term Extension.

3. What is the significance of the filing date and grant date of U.S. Patent 7,364,752? The filing date (October 26, 2004) establishes the priority date for the invention, and the grant date (April 21, 2009) signifies that the USPTO has deemed the invention patentable. The filing date is also used to calculate the standard 20-year patent term.

4. How does Patent Term Extension (PTE) affect the expiration of U.S. Patent 7,364,752? PTE can extend the expiration date of the patent to compensate for delays in obtaining FDA marketing approval for a drug product covered by the patent. If a drug under this patent received approval and qualified for PTE, its expiration date would be later than the standard October 26, 2024.

5. What are the primary legal grounds for challenging the validity of U.S. Patent 7,364,752? The most common grounds for challenging patent validity include lack of novelty, obviousness in light of prior art, insufficient written description, and lack of enablement, meaning the patent does not adequately describe or enable the claimed invention for a person skilled in the art.

Citations

[1] United States Patent 7,364,752. (2009). Substituted Phenylpiperazines. Retrieved from USPTO Patent Full-Text and Image Database. [2] U.S. Food and Drug Administration. (2023). Orphan Drug Designation. Retrieved from [FDA website] (specific URL depends on current FDA site structure). [3] U.S. Food and Drug Administration. (2021). Hatch-Waxman Act Basics. Retrieved from [FDA website] (specific URL depends on current FDA site structure). [4] 35 U.S. Code § 156 - Extension of patent term. (n.d.). Legal Information Institute. Cornell Law School. Retrieved from [LII website] (specific URL depends on current LII site structure).

Drugs Protected by US Patent 7,364,752

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