Detailed Analysis of the Scope and Claims of United States Patent 10,780,055
Introduction
United States Patent 10,780,055, titled "Delayed release deferiprone tablets and methods of using the same," is a significant patent in the pharmaceutical industry, particularly for the treatment of transfusional iron overload caused by thalassemia syndromes. Here, we will delve into the scope, claims, and the broader patent landscape surrounding this invention.
Overview of Deferiprone
Deferiprone, marketed under the brand name Ferriprox, is an iron chelator used to treat patients with transfusional iron overload. This condition is common in patients with thalassemia syndromes who require frequent blood transfusions, leading to excessive iron accumulation in the body[1].
Patent Details
Patent Number and Issue Date
The patent number is US10,780,055, and it was issued on September 22, 2020[2].
Assignee
The patent is assigned to Chiesi Farmaceutici S.P.A., an Italian pharmaceutical company known for its innovative treatments in various therapeutic areas[5].
Inventors
The inventors listed on the patent are Sherman Bernard Charles and Spino Michael, who have contributed to the development of the delayed release formulation of deferiprone[5].
Scope of the Patent
Pharmaceutical Compositions
The patent is directed to pharmaceutical compositions, specifically tablets that exhibit delayed release properties. These tablets are designed for oral administration and are bioequivalent to immediate release tablets administered thrice daily, but with a twice-daily dosing regimen. This formulation enhances patient compliance and convenience[5].
Delayed Release Mechanism
The delayed release mechanism is a critical aspect of this patent. The tablets are formulated to release deferiprone in a controlled manner, ensuring that the drug is absorbed at a consistent rate over a longer period. This can help maintain therapeutic levels of the drug in the body with fewer doses, improving patient adherence[5].
Claims of the Patent
The patent includes several claims that define the scope of the invention:
Claim 1: Pharmaceutical Composition
The first claim describes the pharmaceutical composition comprising deferiprone in a delayed release formulation. This includes the specific excipients and the method of preparing the tablets[5].
Claim 2: Method of Administration
This claim outlines the method of administering the delayed release tablets, emphasizing the bioequivalence to immediate release formulations administered more frequently[5].
Claim 3: Manufacturing Process
The patent also claims the methods of making the delayed release tablets, including the steps involved in preparing the formulation and the manufacturing process[5].
Patent Landscape
Exclusivities and Patent Protection
The patent is part of a broader portfolio of patents protecting Ferriprox. These patents, including US10,780,055, are set to expire on October 25, 2038. Additionally, the FDA has granted exclusivities to Ferriprox, which prevent the marketing of generic or bioequivalent versions until these exclusivities expire, further extending the exclusive marketing rights beyond the patent expiration dates[2][5].
Litigations and Challenges
Ferriprox has been subject to various legal proceedings, including patent litigations. For example, Taro challenged the validity of an earlier patent (US7049328) in 2017, which was later settled. These litigations highlight the competitive and legal complexities surrounding pharmaceutical patents[2].
Impact on the Pharmaceutical Industry
Patient Compliance
The delayed release formulation of deferiprone enhances patient compliance by reducing the frequency of dosing. This can lead to better therapeutic outcomes and improved quality of life for patients with thalassemia syndromes[5].
Market Dominance
The exclusive rights granted by the patent and FDA exclusivities ensure that Chiesi Farmaceutici S.P.A. maintains market dominance for Ferriprox until the expiration of these protections. This allows the company to recoup its investment in research and development and to continue innovating in the field of iron chelation therapy[2][5].
Conclusion
United States Patent 10,780,055 is a pivotal patent in the treatment of transfusional iron overload. The delayed release formulation of deferiprone it describes enhances patient compliance and convenience, while the patent and exclusivity landscape ensures that Chiesi Farmaceutici S.P.A. retains exclusive marketing rights until 2038.
Key Takeaways
- Delayed Release Formulation: The patent describes a delayed release formulation of deferiprone, which is bioequivalent to immediate release formulations but with a reduced dosing frequency.
- Patent Expiration: The patent is set to expire on October 25, 2038.
- FDA Exclusivities: Additional FDA exclusivities extend the exclusive marketing rights beyond the patent expiration dates.
- Litigations: Ferriprox has been subject to patent litigations, highlighting the competitive nature of pharmaceutical patents.
- Impact on Patient Compliance: The delayed release formulation improves patient compliance and therapeutic outcomes.
FAQs
Q: What is the primary use of deferiprone?
A: Deferiprone is used to treat patients with transfusional iron overload caused by thalassemia syndromes.
Q: What is the significance of the delayed release formulation of deferiprone?
A: The delayed release formulation reduces the dosing frequency, improving patient compliance and convenience.
Q: Who is the assignee of US Patent 10,780,055?
A: The assignee is Chiesi Farmaceutici S.P.A.
Q: When is the patent set to expire?
A: The patent is set to expire on October 25, 2038.
Q: Are there any FDA exclusivities associated with Ferriprox?
A: Yes, the FDA has granted exclusivities that prevent the marketing of generic or bioequivalent versions until these exclusivities expire.
Sources
- DrugBank: Deferiprone: Uses, Interactions, Mechanism of Action.
- Pharsight: Ferriprox patent expiration.
- Hoover Institution: Patent Claims and Patent Scope.
- Canadian Patents Database: Patent 2620082 Summary.
- Drugs.com: Generic Ferriprox Availability.
