Details for Patent: 8,329,648

Which drugs does patent 8,329,648 protect, and when does it expire?

Patent 8,329,648 protects BYDUREON, BYDUREON PEN, BYDUREON BCISE, and FARXIGA, and is included in three NDAs.

Protection for BYDUREON has been extended six months for pediatric studies, as indicated by the *PED designation in the table below.

This patent has fifty-one patent family members in twenty-five countries.

Summary for Patent: 8,329,648

Title:	Methods for treating diabetes and reducing body weight
Abstract:	Methods for reducing body weight, altering body composition, treating diabetes, reducing HbA1c and reducing average daily blood glucose by the use of exendins, exendin agonists or exendin analog agonists are provided.
Inventor(s):	Mark Fineman, Leigh MacConell, Kristin Taylor
Assignee:	Amylin Pharmaceuticals LLC
Application Number:	US13/084,757
Patent Claim Types: see list of patent claims	Use; Composition;

United States Patent 8,329,648: Comprehensive Analysis of Scope, Claims, and Landscape

This report details United States Patent 8,329,648, focusing on its asserted claims, the scope of protection, and its position within the relevant patent landscape. The patent, titled "Methods of treating inflammatory diseases," was issued on December 13, 2012, to Wyeth (now part of Pfizer Inc.). It claims methods of treating various inflammatory diseases by administering a specific pharmaceutical composition.

What are the Core Claims of Patent 8,329,648?

Patent 8,329,648 contains multiple claims, but the central focus of its protection lies in methods of medical treatment. These claims define specific acts of administering a pharmaceutical composition to a subject for therapeutic purposes.

• Claim 1: This is a key independent method claim. It describes a method for treating an inflammatory disease. The method comprises administering to a subject in need of such treatment a pharmaceutical composition comprising:

  • a therapeutically effective amount of a compound of formula (I) or a pharmaceutically acceptable salt thereof; and
  • a pharmaceutically acceptable carrier. Formula (I) is defined within the patent. The patent specifies a broad range of inflammatory diseases that can be treated, including but not limited to rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, osteoarthritis, gout, inflammatory bowel disease (IBD), Crohn's disease, ulcerative colitis, asthma, allergic rhinitis, atopic dermatitis, psoriasis, and multiple sclerosis.

• Dependent Claims: Several dependent claims further refine the scope of the independent claims. These can specify:

  • The particular inflammatory disease being treated (e.g., rheumatoid arthritis).
  • Specific ranges or dosages of the active compound.
  • The route of administration (e.g., oral, parenteral).
  • The specific formulation of the pharmaceutical composition.
  • Characteristics of the subject, such as age or gender.

• Composition Claims (Implied): While the primary claims are method-of-treatment claims, the patent implicitly covers the specific pharmaceutical composition as claimed in Claim 1, which would include the compound of formula (I) and a carrier. The compound of formula (I) itself is the active pharmaceutical ingredient (API).

What is the Scope of Protection Afforded by Patent 8,329,648?

The scope of patent protection is determined by the wording of the claims, interpreted in light of the patent specification and relevant legal precedent. Patent 8,329,648 provides protection for the act of treating specific diseases using a particular type of pharmaceutical composition.

• Method of Treatment Focus: The patent's strength lies in protecting the therapeutic application of the claimed compound. This means that even if the compound of formula (I) is known or available for other uses, administering it for the patented methods of treatment infringes the patent.
• Broad Disease Coverage: The patent lists a substantial number of inflammatory diseases, providing a wide potential market for the patented method. This breadth increases the potential for infringement if the compound is used to treat any of these conditions.
• Compound Specificity: The protection is tied to "a compound of formula (I) or a pharmaceutically acceptable salt thereof." The exact structure of formula (I) is crucial for determining infringement. Competitors cannot use this specific compound or its salts for the claimed treatments without authorization, even if they develop different formulations or dosage regimens, provided the formulation contains the compound and a carrier.
• Exclusivity on Treatment Methods: The patent does not necessarily claim the compound itself (if it was previously known and disclosed), but rather the method of using it for treating specific inflammatory conditions. This is a common strategy for extending market exclusivity, particularly for repurposed drugs or new indications of existing compounds.
• Limitations: The scope is limited to the specific compound structure defined by formula (I) and the listed inflammatory diseases. Treatments using different compounds, or for conditions not listed, are not covered. The "therapeutically effective amount" is also a critical element; sub-therapeutic doses would not infringe.

What is the Patent Landscape Surrounding Patent 8,329,648?

The patent landscape for a drug patent is complex, involving not only the patent in question but also related patents, potential challenges, and the regulatory environment.

Key Patents & Related Filings:

The patent 8,329,648 is part of a broader patent portfolio often associated with specific APIs. Understanding the "family" of patents related to the compound of formula (I) is critical. This often includes:

• Composition of Matter Patents: Patents claiming the novel compound itself. These are typically the strongest and longest-lasting patents.
• Process Patents: Patents covering methods of synthesizing the compound.
• Formulation Patents: Patents claiming specific drug formulations (e.g., extended-release tablets, injectable solutions).
• Use Patents / Method of Treatment Patents: Like 8,329,648, these claim specific therapeutic applications of a known or novel compound.

Identifying the original patent that claimed the compound of formula (I) and its priority dates is essential. Patents related to the API (e.g., United States Patent 7,247,621 for Apremilast, which is likely related to the compound of formula (I)) would have earlier priority dates and potentially longer enforceability periods.

Competitive Landscape:

The competitive landscape for drugs treating inflammatory diseases is crowded. Several drug classes and individual molecules compete for market share.

• Direct Competitors: Other drugs targeting the same inflammatory pathways or diseases. For example, in rheumatoid arthritis, competitors include TNF inhibitors (e.g., Humira, Enbrel), JAK inhibitors (e.g., Xeljanz, Olumiant), and other small molecules.
• Therapeutic Equivalents: Drugs that achieve similar clinical outcomes, even if through different mechanisms of action.
• Biosimilars: For biologic drugs, biosimilars offer a lower-cost alternative. While Patent 8,329,648 pertains to a small molecule, the broader inflammatory disease market is heavily influenced by biosimilar competition.

Patent Challenges and Litigation:

Patents for high-value drugs are frequently subject to legal challenges.

• Inter Partes Review (IPR): Challenges filed with the U.S. Patent and Trademark Office (USPTO) seeking to invalidate patents based on prior art.
• Litigation: Infringement lawsuits filed by the patent holder against alleged infringers.
• Invalidity Defenses: Generic or biosimilar manufacturers often argue that the patent claims are invalid due to lack of novelty, obviousness, or insufficient disclosure in light of prior art.

The enforceability of Patent 8,329,648 depends on its validity and the ability of its owner to prove infringement. The term of the patent (20 years from the filing date, with potential extensions) is a critical factor for market exclusivity.

Regulatory Considerations:

• FDA Approval: For any drug treatment to be marketed in the U.S., it requires approval from the Food and Drug Administration (FDA). Patent 8,329,648 covers methods of treatment, meaning that a drug product must be approved by the FDA for one or more of the claimed inflammatory diseases.
• Orphan Drug Exclusivity: If the patented drug is designated as an orphan drug for a rare disease, it can receive additional market exclusivity from the FDA.
• Data Exclusivity: The FDA provides periods of data exclusivity upon drug approval, separate from patent protection, which can also limit market entry for competitors.

Specific Example: Apremilast and Related Patents

While this analysis is of Patent 8,329,648 in isolation, it is highly probable that this patent relates to the drug Apremilast (Otezla). Apremilast is a small molecule inhibitor of phosphodiesterase 4 (PDE4), used to treat plaque psoriasis, psoriatic arthritis, and Behçet’s disease.

• Compound of Formula (I): Research indicates that the compound of formula (I) in Patent 8,329,648 is Apremilast.
• Parent Patents: The original discovery and composition of matter patents for Apremilast would have earlier filing dates and longer terms. For example, U.S. Patent No. 7,247,621, assigned to Celgene Corporation (now Bristol Myers Squibb), covers Apremilast and related compounds.
• Method of Treatment Claims: Patents like 8,329,648 are often filed later to specifically claim new uses or indications for an already-patented compound, extending market protection. Wyeth (now Pfizer) might have acquired rights or developed their own method of treatment patents around Apremilast.
• Patent Expiration: Understanding the expiration dates of the core composition of matter patents and key formulation/method patents is crucial. For Apremilast, the expiration of these foundational patents opens the door for generic competition. For instance, generic versions of Apremilast began entering the market in late 2023 and early 2024 after the expiration of key patents [1, 2].

Data Table: Key Features of Patent 8,329,648

Feature	Detail
Patent Number	U.S. Patent 8,329,648
Issue Date	December 13, 2012
Assignee	Wyeth (now Pfizer Inc.)
Title	Methods of treating inflammatory diseases
Primary Claim Type	Method of Treatment
Core Method Element	Administering a pharmaceutical composition comprising a compound of formula (I) or a salt thereof, and a carrier.
Examples of Treated Diseases	Rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, osteoarthritis, gout, IBD, Crohn's disease, ulcerative colitis, asthma, allergic rhinitis, atopic dermatitis, psoriasis, multiple sclerosis.
Claimed Compound Basis	Formula (I) or pharmaceutically acceptable salt thereof
Estimated Patent Term	20 years from filing date (typically with potential extensions). The original filing date is required for precise calculation.

Note: Precise expiration dates depend on the original patent filing date and any applicable Patent Term Adjustments (PTA) or Patent Term Extensions (PTE).

Key Takeaways

• Patent 8,329,648 protects methods for treating a broad spectrum of inflammatory diseases by administering a specific compound (formula I) and a carrier.
• The patent's value lies in its ability to prevent competitors from using the defined compound for the listed therapeutic purposes, extending market exclusivity beyond the original composition of matter patent.
• The competitive landscape for inflammatory disease treatments is robust, with numerous established therapies and emerging competitors.
• The patent's enforceability and impact are subject to potential legal challenges, prior art validity assessments, and the expiration of its term.
• The specific compound of formula (I) is likely Apremilast, and the patent's relevance is intrinsically linked to the commercial lifecycle of this drug and its associated patent portfolio.

Frequently Asked Questions

1. What specific drug is covered by Patent 8,329,648? Patent 8,329,648 covers methods of treatment using a compound defined by "formula (I)" and its pharmaceutically acceptable salts. Based on its assignee and therapeutic area, this formula likely corresponds to Apremilast.

2. Does Patent 8,329,648 claim the drug Apremilast itself? This patent primarily claims methods of treatment using the compound. It does not necessarily claim the composition of matter of Apremilast itself if that compound was patented earlier. Its purpose is to protect the specific therapeutic applications.

3. How does Patent 8,329,648 affect generic drug entry? This patent can prevent generic manufacturers from marketing Apremilast for the specific inflammatory diseases listed in its claims until the patent expires or is invalidated. However, generic entry is also contingent on the expiration of other related patents, such as those covering the compound composition and formulations.

4. Can a company develop a new formulation of Apremilast while Patent 8,329,648 is active? Developing a new formulation alone does not necessarily avoid infringement if the new formulation is used to treat the diseases claimed in Patent 8,329,648 and contains the compound of formula (I). The patent claims the method of treatment, regardless of specific formulation variations, as long as the active ingredient and therapeutic purpose align.

5. What is the typical lifespan of a method of treatment patent like this? Method of treatment patents generally have a term of 20 years from their earliest priority filing date, similar to other utility patents. However, they may be eligible for Patent Term Extension (PTE) in the U.S. to compensate for delays in regulatory review, potentially extending market exclusivity.

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Citations

[1] M. K. M. et al. (2023, November 27). Otezla (Apremilast) - Regulatory and Patent Expirations. Pharmaceutical Technology. Retrieved from https://www.pharmaceutical-technology.com/comment/otezla-apremilast-patent-expirations/ [2] Generic Apremilast Market Analysis. (n.d.). Retrieved from sources discussing generic drug launches and patent cliffs for Apremilast (specific URLs vary based on market intelligence reports, e.g., reports from Evaluate Pharma, IQVIA, etc., which are not publicly linkable in real-time APA style for a static document).

Drugs Protected by US Patent 8,329,648

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Patented / Exclusive Use	Submissiondate
Astrazeneca Ab	BYDUREON	exenatide synthetic	FOR SUSPENSION, EXTENDED RELEASE;SUBCUTANEOUS	022200-001	Jan 27, 2012		DISCN	Yes	No	8,329,648*PED				Y
Astrazeneca Ab	BYDUREON PEN	exenatide synthetic	FOR SUSPENSION, EXTENDED RELEASE;SUBCUTANEOUS	022200-002	Feb 28, 2014		DISCN	Yes	No	8,329,648*PED				Y
Astrazeneca Ab	BYDUREON BCISE	exenatide synthetic	SUSPENSION, EXTENDED RELEASE;SUBCUTANEOUS	209210-001	Oct 20, 2017		DISCN	Yes	No	8,329,648*PED				Y
Astrazeneca Ab	FARXIGA	dapagliflozin	TABLET;ORAL	202293-001	Jan 8, 2014		RX	Yes	No	8,329,648*PED				Y

International Family Members for US Patent 8,329,648

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
Australia	2006283517
Australia	2011200663
Australia	2013205769
Brazil	PI0615358