United States Patent 7,473,710: A Detailed Analysis of Scope, Claims, and Patent Landscape
Introduction
The United States Patent 7,473,710, part of the second family of patents owned by Dey, Inc., is a crucial component in the treatment of chronic obstructive pulmonary disease (COPD) using formulations of formoterol. This patent, along with others in the same family, has been at the center of significant legal and technological discussions.
Background of the Patent
Filing and Issuance
The patent 7,473,710 was filed on March 2007 and issued on January 5, 2010. It claims the benefit of a provisional application filed on July 10, 2003, which is a common thread among the patents in Dey's second family[2][4].
Scope of the Patent
Claims and Inventions
The patent 7,473,710 pertains to stable aqueous formulations of formoterol, a long-acting beta-2 adrenergic agonist used in the treatment of COPD. The claims include various aspects of the formulation, such as specific concentration ranges of formoterol, buffer compositions, and ionic strength ranges. These claims are designed to ensure the stability of the formulation during long-term storage, a key differentiator from other similar patents[2][4].
Independent and Dependent Claims
The patent includes independent claims that define the core inventions, as well as dependent claims that add specific limitations to these core claims. For example, dependent claims might specify particular buffer concentrations or ionic strength ranges that enhance the stability of the formoterol formulation[1].
Patent Landscape
Competing Patents
Dey's patents, including 7,473,710, compete with Sunovion's patents, particularly U.S. Patent No. 6,040,344 (the "Gao patent"), which was issued in March 2000. Sunovion's patent covers similar formulations but lacks the specific stability enhancements claimed by Dey's patents[2][4].
Legal Disputes
The validity of Dey's patents, including 7,473,710, has been challenged in court. A significant dispute arose when Sunovion argued that Dey's patents were invalid due to public use of the formulations during clinical trials. However, the Federal Circuit ultimately reversed the district court's decision, ruling that the clinical trials did not constitute public use under 35 U.S.C. § 102(b)[4].
Reexamination and Validation
USPTO Reexamination
In a separate but related context, Dey's first family of patents (6,667,344 and 6,814,953) underwent reexamination by the USPTO. Although this did not directly involve the 7,473,710 patent, it highlights the rigorous scrutiny that pharmaceutical patents often face. The USPTO initially rejected several claims in the first family of patents but later withdrew these rejections after Dey submitted amended claims and arguments[1].
Impact on Pharmaceutical Industry
Innovation and Stability
The 7,473,710 patent and its counterparts in Dey's second family contribute significantly to the development of stable formoterol formulations. This innovation is crucial for ensuring the efficacy and safety of COPD treatments over extended periods[2][4].
Patent Scope and Quality
The debate over patent scope and quality is relevant here. Research suggests that narrower claims, such as those in Dey's patents, are associated with a higher probability of grant and shorter examination processes. This aligns with the findings that the examination process tends to narrow the scope of patent claims, enhancing their clarity and validity[3].
Key Takeaways
- Stability Enhancements: The 7,473,710 patent focuses on stable aqueous formulations of formoterol, differentiating it from other similar patents.
- Competitive Landscape: Dey's patents compete with Sunovion's patents in the COPD treatment market.
- Legal Validity: The patent's validity was challenged but ultimately upheld by the Federal Circuit.
- Reexamination: While not directly involved, the reexamination process for related patents highlights the scrutiny pharmaceutical patents face.
- Industry Impact: The patent contributes to the development of stable and effective COPD treatments.
FAQs
Q: What is the primary focus of the United States Patent 7,473,710?
A: The primary focus is on stable aqueous formulations of formoterol for treating COPD.
Q: How does this patent differ from Sunovion's patents?
A: The key difference lies in the stability of the formulations during long-term storage.
Q: What was the outcome of the legal dispute regarding public use?
A: The Federal Circuit ruled that the clinical trials did not constitute public use under 35 U.S.C. § 102(b).
Q: Did the USPTO reexamine this specific patent?
A: No, the reexamination involved Dey's first family of patents, not the 7,473,710 patent.
Q: How does the patent scope affect the pharmaceutical industry?
A: Narrower claims, like those in this patent, are associated with higher grant probabilities and shorter examination processes, enhancing innovation and patent quality.
Sources
- Dey, Inc. v. Sepracor, Inc., 847 F. Supp. 2d 541 - Casetext
- After District Court Invalidates Pharmaceutical Product Patent Based On Clinical Trials, Federal Circuit Reverses Because Clinical Trial Was Not Public - Vlex
- Patent Claims and Patent Scope - SSRN
- United States Court of Appeals for the Federal Circuit - DEY, L.P. v. SUNOVION PHARMACEUTICALS, INC.
- Drug Patent Watch - Patent 7,473,710
