Understanding the Scope and Claims of United States Patent 11,052,126: A Detailed Analysis
Introduction
The United States Patent 11,052,126, titled "Method of Treating Diseases," is a significant patent in the pharmaceutical and biotechnology sector, particularly in the treatment of conditions such as acromegaly and other related diseases. This patent, assigned to Amryt Endo, Inc., is part of a broader landscape of intellectual property protections for somatostatin analogs like octreotide.
Background on Octreotide
Octreotide is a peptide drug that mimics the action of somatostatin, a natural hormone that inhibits the release of various other hormones. It is used to treat conditions such as acromegaly, a disorder caused by excessive growth hormone production, and diarrhea associated with metastatic carcinoid tumors[1].
Patent Overview
Issuance and Assignee
The patent 11,052,126 was issued on August 17, 2021, and is assigned to Amryt Endo, Inc. The inventors listed are Roni Mamluk and Sam Teichman, who have been involved in several other related patents[5].
Claims and Scope
The patent covers methods of treating diseases, specifically acromegaly, using oral administration of octreotide. Here are some key aspects of the claims:
Method of Administration
The patent describes methods of orally administering octreotide to patients, with specific dosages and timing relative to meals. For example, the method involves administering at least one dosage form of octreotide, typically 20 mg, at least 1 hour before a meal or at least 2 hours after a meal[5].
Therapeutic Indications
The primary therapeutic indication is the treatment of acromegaly, but the patent also mentions other diseases and conditions that can be treated using this method. This includes idiopathic intracranial hypertension and other conditions where somatostatin analogs are beneficial[4].
Dosage Forms
The patent specifies various dosage forms of octreotide, including oral capsules and other formulations designed to enhance bioavailability and patient compliance.
Patent Landscape and Related Patents
Related Patents
Several other patents are related to the treatment methods and formulations described in 11,052,126. These include:
Patent 10,238,709
Issued on March 26, 2019, this patent also covers methods of treating acromegaly using oral octreotide, with similar dosage and administration guidelines[5].
Patent 10,695,397
Issued on June 30, 2020, this patent further elaborates on the methods of treating diseases using oral octreotide, with a focus on maintaining therapeutic efficacy and patient compliance[5].
Patent 11,141,457
Issued on October 12, 2021, this patent addresses the administration of oral octreotide in female subjects, particularly in relation to contraception methods[5].
Patent Expiration Dates
The patent 11,052,126, along with related patents such as 10,238,709 and 10,695,397, is set to expire on February 3, 2036. This expiration date is crucial for understanding the timeline of exclusive rights and potential generic competition[5].
Intellectual Property Protection
Drug Patents and Exclusivity
Drug patents, including 11,052,126, provide exclusive legal rights to the patent holder to protect the proprietary chemical formulation, dosage form, and manufacturing process. These patents typically expire 20 years from the date of filing but can be extended or modified due to various factors such as new formulations or patent infringement litigation[5].
Generic Competition
As of now, there is no therapeutically equivalent generic version of Mycapssa (the brand name for oral octreotide) available in the United States. This lack of generic competition is partly due to the robust patent protection and exclusivity rights held by Amryt Endo, Inc.[5].
Challenges in Patent Scope and Claims
Genus Claims and Enablement
The pharmaceutical and biotechnology industries face significant challenges in drafting patent claims that balance breadth with specificity. The Federal Circuit's rigid stance on genus claims and the requirement for detailed written descriptions and enablement can make it difficult to secure meaningful patent protection. This can lead to a situation where innovators are unable to claim the full scope of their invention without violating patent disclosure laws[3].
Impact on Innovation
The stringent requirements for patent claims can hinder innovation in these industries. Innovators must navigate the complex landscape of patent law to ensure their claims are neither too broad nor too narrow, avoiding both invalidation and easy circumvention by competitors[3].
Conclusion
The United States Patent 11,052,126 is a critical component of the intellectual property strategy for Amryt Endo, Inc., particularly in the treatment of acromegaly and related conditions using oral octreotide. Understanding the scope and claims of this patent, along with the broader patent landscape, is essential for both innovators and competitors in the pharmaceutical and biotechnology sectors.
Key Takeaways
- Patent Scope: The patent covers specific methods of orally administering octreotide for treating acromegaly and other diseases.
- Related Patents: Several related patents exist, covering similar methods and formulations.
- Expiration Dates: The patent is set to expire on February 3, 2036.
- Intellectual Property Protection: Robust patent protection and exclusivity rights are in place, currently preventing generic competition.
- Challenges in Patent Law: The pharmaceutical and biotechnology industries face challenges in drafting patent claims that meet the stringent requirements of genus claims and enablement.
FAQs
Q: What is the primary therapeutic indication for the methods described in Patent 11,052,126?
A: The primary therapeutic indication is the treatment of acromegaly.
Q: How is octreotide administered according to the patent?
A: Octreotide is administered orally, typically 20 mg, at least 1 hour before a meal or at least 2 hours after a meal.
Q: What is the expiration date for Patent 11,052,126?
A: The patent is set to expire on February 3, 2036.
Q: Are there any generic versions of Mycapssa available in the United States?
A: No, there are currently no therapeutically equivalent generic versions of Mycapssa available in the United States.
Q: What challenges do pharmaceutical and biotechnology companies face in drafting patent claims?
A: These companies face challenges in balancing the breadth and specificity of patent claims to avoid invalidation and easy circumvention by competitors, given the stringent requirements for genus claims and enablement.
References
- DrugBank Online - Octreotide: Uses, Interactions, Mechanism of Action.
- RPX Insight - in the united states district court.
- DigitalCommons@NYLS - Eviscerating Patent Scope.
- Google Patents - Method of treating diseases - US11052126B2.
- Drugs.com - Generic Mycapssa Availability.
