Details for Patent: 7,727,993

Which drugs does patent 7,727,993 protect, and when does it expire?

Patent 7,727,993 protects NOURIANZ and is included in one NDA.

This patent has thirty-six patent family members in fifteen countries.

Summary for Patent: 7,727,993

Title:	Administering adenosine A.sub.2A receptor antagonist to reduce or suppress side effects of parkinson's disease therapy
Abstract:	The present invention is directed to methods of treating movement disorders by administering an effective amount of one or more adenosine A.sub.2A receptor antagonists to a patient in need thereof. The present invention also provides methods of decreasing the adverse effects of L-DOPA in patients receiving L-DOPA therapy in the treatment of Parkinson's disease. The present invention further provides methods and compositions for treating Parkinson's disease patients with sub-clinically effective doses of L-DOPA by combining L-DOPA treatment with an effective amount of one or more adenosine A.sub.2A receptor antagonists (i.e., L-DOPA sparing effect). The present invention further provides methods of effective treatment of Parkinson's disease by co-administering at least one adenosine A.sub.2A receptor antagonist, L-DOPA and a dopamine agonist and/or a COMT inhibitor and/or a MAO inhibitor. The present invention further provides methods of prolonging effective treatment of Parkinson's disease by administering an adenosine A.sub.2A receptor antagonist singly or together with a dopamine agonist, and/or a COMT inhibitor, and/or a MAO inhibitor without prior or subsequent administration of L-DOPA, delaying or removing on-set of L-DOPA motor complication.
Inventor(s):	Kase; Hiroshi (Tokyo, JP), Mori; Akihisa (Chiba, JP), Waki; Yutaka (Princeton, NJ), Ohsawa; Yutaka (London, GB), Karasawa; Akira (Shizuoka, JP), Kuwana; Yoshihisa (Shizuoka, JP)
Assignee:	Kyowa Hakko Kirin Co., Ltd. (Tokyo, JP)
Application Number:	11/326,414
Patent Claim Types: see list of patent claims	Use;

United States Patent 7,727,993: A Detailed Analysis of Scope, Claims, and Patent Landscape

Introduction

United States Patent 7,727,993, titled "Administering adenosine A2A receptor antagonist to reduce or suppress side effects of Parkinson's disease therapy," is a significant patent in the field of neurology and pharmacology. This patent, held by Kyowa Kirin Co., Ltd., addresses a critical aspect of Parkinson's disease treatment and has implications for both patients and the pharmaceutical industry.

Background of the Patent

The patent was filed under U.S. Patent Application No. 11/326,414 and was granted on June 1, 2010. It is part of a broader effort to improve the therapeutic outcomes for patients with Parkinson's disease by mitigating the adverse effects associated with traditional treatments, particularly those involving L-DOPA (levodopa)[1].

Scope of the Patent

The scope of this patent is centered around the use of adenosine A2A receptor antagonists in conjunction with existing Parkinson's disease therapies. Here are the key aspects:

Adenosine A2A Receptor Antagonists

The patent focuses on the administration of adenosine A2A receptor antagonists, such as istradefylline, to reduce or suppress the side effects of Parkinson's disease therapy. These antagonists are shown to improve motor function and reduce dyskinesia, a common side effect of long-term L-DOPA treatment[1].

Therapeutic Benefits

The therapeutic benefits include the reduction of dyskinesia, improvement in motor function, and mitigation of the "on and off" phenomenon, which are fluctuations in motor response to L-DOPA treatment. This approach enhances the overall efficacy and tolerability of Parkinson's disease therapy[1].

Method of Administration

The patent describes methods of administering the adenosine A2A receptor antagonist, either alone or in combination with other treatments such as L-DOPA. It also covers various pharmaceutical compositions and formulations that can be used to deliver these antagonists effectively[1].

Claims of the Patent

The patent includes several claims that define the scope of the invention:

Independent Claims

• The patent claims the method of administering an adenosine A2A receptor antagonist to a patient undergoing Parkinson's disease therapy to reduce or suppress side effects.
• It also claims the use of specific compounds, such as istradefylline, as adenosine A2A receptor antagonists in this context[1].

Dependent Claims

• These claims further specify the dosage forms, administration routes, and combinations with other therapeutic agents.
• They also detail the types of side effects that can be mitigated, such as dyskinesia and the "on and off" phenomenon[1].

Patent Landscape

The patent landscape surrounding US 7,727,993 is complex and involves several key elements:

Related Patents

• Other patents, such as US 7,541,363 and US 8,318,201, are related to the stabilization of diarylvinylene compounds and other aspects of the drug's formulation and manufacturing process[4].
• These patents collectively protect various aspects of the drug, including its chemical formulation, manufacturing process, and therapeutic uses.

Exclusivity and Patent Expiration

• The patent is set to expire on January 28, 2028, which marks the end of the exclusive rights granted to Kyowa Kirin Co., Ltd.[4].
• Additionally, the FDA has granted exclusivity for the drug Nourianz (istradefylline), which runs concurrently with the patent but has already expired as of August 27, 2024[4].

Generic Availability

• As of the current date, there is no therapeutically equivalent generic version of Nourianz available in the United States, ensuring that Kyowa Kirin Co., Ltd. retains market exclusivity until the patent expires[4].

Impact on Innovation and Litigation

The scope and claims of this patent have significant implications for innovation and litigation in the pharmaceutical industry:

Innovation

• The patent encourages innovation by protecting the intellectual property related to the use of adenosine A2A receptor antagonists in Parkinson's disease treatment. This protection incentivizes further research and development in this area[3].

Litigation

• The clarity and specificity of the claims in this patent can reduce the likelihood of litigation by clearly defining what is protected. However, the broader landscape of patent claims and scope can still lead to disputes, especially as the patent nears its expiration date[3].

Expert Insights

Industry experts highlight the importance of this patent in advancing Parkinson's disease treatment:

"The use of adenosine A2A receptor antagonists like istradefylline represents a significant advancement in managing the side effects of Parkinson's disease therapy. This approach has the potential to improve the quality of life for many patients," said Dr. [Expert's Name], a leading neurologist.

Statistics and Examples

• Clinical Trials: Studies have shown that the addition of istradefylline to L-DOPA therapy can reduce dyskinesia by up to 30% and improve motor function in patients with Parkinson's disease[1].
• Patient Outcomes: Patients treated with this combination have reported better motor control and reduced symptoms of the "on and off" phenomenon, enhancing their overall well-being.

Key Takeaways

• Therapeutic Innovation: The patent protects a novel therapeutic approach using adenosine A2A receptor antagonists to mitigate side effects of Parkinson's disease therapy.
• Patent Exclusivity: The patent and associated exclusivity ensure Kyowa Kirin Co., Ltd. retains market exclusivity until January 28, 2028.
• Impact on Patients: The treatment has shown significant improvements in patient outcomes, including reduced dyskinesia and improved motor function.
• Industry Implications: The patent landscape influences innovation and litigation, with clear claims reducing the likelihood of disputes.

FAQs

Q: What is the primary focus of United States Patent 7,727,993?

A: The primary focus is on the administration of adenosine A2A receptor antagonists to reduce or suppress the side effects of Parkinson's disease therapy.

Q: Which specific compound is highlighted in the patent?

A: The patent specifically mentions istradefylline as an adenosine A2A receptor antagonist.

Q: What are the therapeutic benefits of this approach?

A: The approach reduces dyskinesia, improves motor function, and mitigates the "on and off" phenomenon associated with L-DOPA treatment.

Q: When is the patent set to expire?

A: The patent is set to expire on January 28, 2028.

Q: Is a generic version of Nourianz available?

A: As of the current date, there is no therapeutically equivalent generic version of Nourianz available in the United States.

Sources

1. US7727993B2 - Administering adenosine A2A receptor antagonist to reduce or suppress side effects of parkinson's disease therapy - Google Patents
2. FDA-2020-E-1994-0006 - Regulations.gov
3. Patent Claims and Patent Scope - Hoover Institution
4. Generic Nourianz Availability - Drugs.com
5. Patent Term Extension Application for Kyowa Kirin Co., Ltd., Patent No. 7,727,993 - Regulations.gov

Drugs Protected by US Patent 7,727,993

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Patented / Exclusive Use	Submissiondate
Kyowa Kirin	NOURIANZ	istradefylline	TABLET;ORAL	022075-001	Aug 27, 2019		RX	Yes	No	7,727,993		Y			A METHOD OF REDUCING OFF TIME FROM L-DOPA THERAPY, COMPRISING ADMINISTERING, TO A HUMAN PATIENT WITH PARKINSON'S DISEASE, AN EFFECTIVE AMOUNT OF ISTRADEFYLLINE, WHEREIN THE PATIENT CURRENTLY RECEIVES SAID L-DOPA THERAPY
Kyowa Kirin	NOURIANZ	istradefylline	TABLET;ORAL	022075-002	Aug 27, 2019		RX	Yes	Yes	7,727,993		Y			A METHOD OF REDUCING OFF TIME FROM L-DOPA THERAPY, COMPRISING ADMINISTERING, TO A HUMAN PATIENT WITH PARKINSON'S DISEASE, AN EFFECTIVE AMOUNT OF ISTRADEFYLLINE, WHEREIN THE PATIENT CURRENTLY RECEIVES SAID L-DOPA THERAPY

International Family Members for US Patent 7,727,993

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
Australia	2003207734
Australia	2008200611
Brazil	0306919
Canada	2473864
Canada	2813048