Details for Patent: 9,216,178

Which drugs does patent 9,216,178 protect, and when does it expire?

Patent 9,216,178 protects KUVAN and is included in one NDA.

Protection for KUVAN has been extended six months for pediatric studies, as indicated by the *PED designation in the table below.

Summary for Patent: 9,216,178

Title:	Dry blend formulation of tetrahydrobiopterin
Abstract:	Dry blend powder formulations comprising a pharmaceutical formulation containing tetrahydrobiopterin, and methods of making and using the same, are disclosed herein.
Inventor(s):	Chou; Tianwei (El Cerrito, CA), Okhamafe; Augustus O. (Concord, CA)
Assignee:	BioMarin Pharmaceutical Inc. (Novato, CA)
Application Number:	13/666,697
Patent Claim Types: see list of patent claims	Composition;

Understanding the Scope and Claims of United States Patent 9,216,178

Introduction

The United States Patent 9,216,178, hereafter referred to as the '178 patent, is a critical component in the patent landscape surrounding the pharmaceutical drug Sapropterin, used in the treatment of phenylketonuria (PKU). This analysis will delve into the details of the patent's scope, claims, and its position within the broader patent landscape.

Background of Sapropterin and PKU

Sapropterin, also known as Kuvan, is a cofactor used as an adjunct to phenylalanine restriction in the treatment of PKU, a genetic disorder that affects the body's ability to break down the amino acid phenylalanine[4].

Patent Overview

The '178 patent is one of several patents held by BioMarin Pharmaceutical Inc. related to Sapropterin. Here are some key details about this patent:

Patent Number and Expiration

• The patent number is 9,216,178.
• The estimated expiration date is November 1, 2032, which includes pediatric exclusivity[4][5].

Claims

The '178 patent includes multiple claims that define the scope of the invention. These claims are crucial in determining what constitutes infringement.

• Direct Infringement: The patent claims cover specific methods and compositions related to Sapropterin. For instance, claims may include the formulation, dosage, and administration methods of the drug.
• Inducement and Contributory Infringement: The patent also covers acts that induce or contribute to infringement. For example, if a generic manufacturer encourages the use of their product in a way that infringes the '178 patent, they could be held liable for inducement or contributory infringement[1].

Scope of the Patent

The scope of the '178 patent is defined by its claims and the legal interpretations thereof.

Independent Claim Length and Count

Research on patent scope suggests that the length and count of independent claims can be significant metrics. Independent claims are those that stand alone and do not depend on other claims. The '178 patent's scope can be analyzed using these metrics:

• Independent Claim Length: The number of words in the shortest independent claim can indicate the specificity and clarity of the patent.
• Independent Claim Count: The total number of independent claims can reflect the breadth of the patent's coverage[3].

Patent Scope Metrics

Studies have shown that narrower claims, as indicated by shorter independent claim lengths and fewer independent claims, are associated with a higher probability of grant and a shorter examination process. This suggests that the '178 patent, if it has narrower claims, may have undergone a more rigorous examination process, potentially increasing its validity and enforceability[3].

Patent Landscape

The '178 patent is part of a larger portfolio of patents related to Sapropterin held by BioMarin Pharmaceutical Inc.

Related Patents

Other patents in this portfolio include:

• U.S. Patent Nos. 7,566,714, 7,612,073, 8,067,416, RE43,797, and 9,433,624.
• These patents collectively cover various aspects of Sapropterin, including its formulation, manufacturing process, and use in treating PKU[1][2][5].

Litigation and Enforcement

The '178 patent has been involved in litigation, particularly in cases where generic manufacturers have sought to market their own versions of Sapropterin before the expiration of BioMarin's patents. For example, Dr. Reddy’s Laboratories, Inc. and Dr. Reddy’s Laboratories, Ltd. were sued by BioMarin for patent infringement related to their ANDA (Abbreviated New Drug Application) filings with the FDA[1].

Industry Impact

The '178 patent and its associated patents have significant implications for the pharmaceutical industry.

Innovation and Competition

• The existence of these patents can influence innovation by protecting BioMarin's investment in research and development, but they can also limit competition by preventing generic versions of the drug from entering the market until the patents expire.
• Generic manufacturers must either wait for the patents to expire or challenge the patents through litigation or other means, such as paragraph IV certifications, which assert that the patents are invalid, unenforceable, or will not be infringed[1][5].

Patient Access

• The patent landscape affects patient access to Sapropterin. The exclusivity provided by these patents ensures that BioMarin can recoup its investment, but it also means that patients may have to rely on the branded version of the drug, which can be more expensive than generic alternatives.

Key Takeaways

• Patent Scope and Claims: The '178 patent's scope is defined by its claims, which cover specific methods and compositions related to Sapropterin.
• Patent Landscape: The patent is part of a broader portfolio of patents related to Sapropterin, which collectively protect various aspects of the drug.
• Litigation and Enforcement: The patent has been involved in litigation to protect BioMarin's intellectual property rights.
• Industry Impact: The patent influences innovation, competition, and patient access to Sapropterin.

FAQs

1. What is the '178 patent related to?

   • The '178 patent is related to Sapropterin, a drug used in the treatment of phenylketonuria (PKU).

2. When does the '178 patent expire?

   • The estimated expiration date of the '178 patent is November 1, 2032, including pediatric exclusivity.

3. What are the implications of the '178 patent for generic manufacturers?

   • Generic manufacturers must wait for the patent to expire or challenge it through litigation or other means to market their own versions of Sapropterin.

4. How does the '178 patent affect patient access to Sapropterin?

   • The patent ensures that patients may have to rely on the branded version of the drug, which can be more expensive than generic alternatives.

5. What metrics can be used to analyze the scope of the '178 patent?

   • Metrics such as independent claim length and independent claim count can be used to analyze the scope and clarity of the patent.

Sources

1. BioMarin Pharmaceutical Inc. v. Dr. Reddy’s Laboratories, Inc. and Dr. Reddy’s Laboratories, Ltd. - Case 3:17-cv-00774-MAS-TJB Document 1 Filed 02/06/17.
2. Settlement and License Agreement - Justia Contracts.
3. Patent Claims and Patent Scope - Hoover Institution Working Paper Series.
4. Sapropterin: Uses, Interactions, Mechanism of Action - DrugBank.
5. Sapropterin Dihydrochloride Powder - FDA Approval Letter.

Drugs Protected by US Patent 9,216,178

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Patented / Exclusive Use	Submissiondate
Biomarin Pharm	KUVAN	sapropterin dihydrochloride	POWDER;ORAL	205065-001	Dec 19, 2013	AB	RX	Yes	Yes					Y
Biomarin Pharm	KUVAN	sapropterin dihydrochloride	POWDER;ORAL	205065-002	Oct 27, 2015	AB	RX	Yes	No					Y