United States Patent 7,879,828: A Detailed Analysis of Scope, Claims, and Patent Landscape
Introduction
United States Patent 7,879,828, owned by Wyeth LLC, is a significant patent in the pharmaceutical industry, particularly in the realm of antibiotic treatments. This patent is directed to compositions and methods of preparation of tigecycline, a broad-spectrum antibiotic belonging to the tetracycline family.
Background of Tigecycline
Tigecycline is an antibiotic used to treat various bacterial infections, including complicated intra-abdominal infections and complicated skin and skin structure infections. It is known for its broad-spectrum activity and its ability to overcome certain types of antibiotic resistance[2].
Patent Overview
Patent Title and Description
The patent titled "Tigecycline Compositions and Methods of Preparation" focuses on improved compositions of tigecycline and methods for their preparation. These compositions are designed to enhance the stability of tigecycline in both solid and solution states[1][2].
Claims
The '828 patent contains 23 composition claims. These claims are crucial as they define the scope of the invention and what is protected under the patent. The claims include specifications for the composition, such as the presence of a suitable carbohydrate and an acid or buffer, which are essential for maintaining the stability of tigecycline[2].
Composition and Stability
Key Components
The inventive compositions comprise tigecycline, a suitable carbohydrate (such as maltose or lactose), and an acid or buffer. These components work together to improve the stability of tigecycline, which is a critical factor in the efficacy and shelf life of the antibiotic[1][2].
Stability in Solid and Solution States
The patent emphasizes the importance of stability in both solid and solution states. The inclusion of a carbohydrate and an acid or buffer helps to prevent degradation of tigecycline, ensuring that the antibiotic remains effective over its intended shelf life[1].
Patent Landscape and Litigation
Patent Ownership and Litigation
Wyeth LLC, now a part of Pfizer, owns the '828 patent. This patent has been involved in several legal disputes, particularly with generic drug manufacturers seeking to produce generic versions of tigecycline. Companies like Apotex Inc. and Sandoz Inc. have challenged the validity of the patent, but the courts have generally upheld its validity[2][5].
Inter Partes Review
In one notable case, Apotex Inc. initiated an inter partes review (IPR) challenging the patentability of the '828 patent claims. However, the Patent Trial and Appeal Board (PTAB) and the Federal Circuit Court of Appeals affirmed that the claims were not unpatentable as obvious[2].
Doctrine of Non-Statutory Double Patenting
Sandoz Inc. also challenged the '828 patent under the doctrine of non-statutory double patenting, arguing that it was invalid due to the earlier issuance of the '183 patent. However, the court ruled that Sandoz failed to provide sufficient evidence to support this claim, and the '828 patent was found to be patentably distinct from the '183 patent[5].
Patent Expiry and Generic Challenges
Patent Expiry Dates
The '828 patent is set to expire on February 1, 2028, although there are other related patents with different expiry dates. For instance, US Patent No. 8,975,242, which is a continuation of the '828 patent, expires on October 24, 2028[4].
Generic Certifications and Settlements
Generic drug manufacturers have filed Paragraph IV certifications challenging the validity of these patents. For example, Accord Pharmaceuticals Inc. filed certifications for several patents, including the '828 patent, and later reached a settlement agreement with the patent holder[4].
Impact on Pharmaceutical Industry
Innovation and Competition
The '828 patent and related patents have significant implications for innovation and competition in the pharmaceutical industry. The protection afforded by these patents allows the patent holder to maintain market exclusivity, which can impact the availability of generic alternatives and the overall cost of the medication[3].
Patent Scope and Quality
The debate over patent scope and quality is relevant here. The '828 patent's claims have been scrutinized for their breadth and clarity. The patent's ability to withstand legal challenges underscores the importance of well-defined and clear patent claims in maintaining patent validity and encouraging innovation[3].
Key Takeaways
- Improved Compositions: The '828 patent focuses on improved tigecycline compositions with enhanced stability.
- Litigation and Validity: The patent has been upheld in various legal challenges, including inter partes reviews and non-statutory double patenting claims.
- Patent Expiry: The patent is set to expire in 2028, with related patents expiring around the same time.
- Impact on Industry: The patent influences the availability of generic alternatives and the cost of tigecycline in the market.
FAQs
What is the main focus of United States Patent 7,879,828?
The main focus of the patent is on improved compositions and methods of preparation for tigecycline, ensuring its stability in both solid and solution states.
Who owns the '828 patent?
The '828 patent is owned by Wyeth LLC, which is now part of Pfizer.
What are the key components of the tigecycline compositions described in the patent?
The compositions include tigecycline, a suitable carbohydrate, and an acid or buffer.
Has the '828 patent been challenged in court?
Yes, the patent has been challenged in several legal disputes, including inter partes reviews and challenges under the doctrine of non-statutory double patenting.
When is the '828 patent set to expire?
The '828 patent is set to expire on February 1, 2028.
How does the '828 patent impact the pharmaceutical industry?
The patent affects the availability of generic alternatives and the cost of tigecycline, influencing competition and innovation in the industry.
Sources
- United States Patent and Trademark Office. (2011). Tigecycline Compositions and Methods of Preparation. US Patent 8,975,242 B2.
- United States Court of Appeals for the Federal Circuit. (2016). Apotex Inc. v. Wyeth LLC. No. 2014-00115.
- Hoover Institution. (2016). Patent Claims and Patent Scope. IP2 Working Paper 16001.
- U.S. Food and Drug Administration. (2018). 208744Orig1s000 SumR. NDA Submission.
- Robins Kaplan LLP. (2012). Wyeth Holdings Corp. v. Sandoz, Inc.. Generically Speaking: Hatch-Waxman Bulletin.
