Details for Patent: 9,415,053

Which drugs does patent 9,415,053 protect, and when does it expire?

Patent 9,415,053 protects XARELTO and is included in one NDA.

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

This patent has forty-three patent family members in thirty-four countries.

Summary for Patent: 9,415,053

Title:	Solid, orally administrable pharmaceutical composition
Abstract:	The present invention relates to a process for the preparation of a solid, orally administrable pharmaceutical composition, comprising 5-chloro-N-({(5S)-2-oxo-3-[4-(3-oxo-4-morpholinyl)-phenyl]-1,3-oxazolidin- -5-yl}-methyl)-2-thiophenecarboxamide in hydrophilized form, and its use for the prophylaxis and/or treatment of diseases.
Inventor(s):	Benke; Klaus (Bergisch Gladbach, DE)
Assignee:	Bayer Intellectual Property GmbH (Monheim, DE)
Application Number:	14/250,863
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for patent 9,415,053
Patent Claim Types: see list of patent claims	Composition; Formulation; Compound; Process; Dosage form; Use;

Understanding the Scope and Claims of United States Patent 9,415,053

Introduction to Patent 9,415,053

United States Patent 9,415,053 is a significant patent in the pharmaceutical industry, particularly in the context of rivaroxaban, an anticoagulant medication. This patent is part of a broader landscape of intellectual property (IP) strategies employed by pharmaceutical companies to protect their innovations and maintain market exclusivity.

Background on Rivaroxaban

Rivaroxaban is a direct oral anticoagulant (DOAC) used to prevent and treat conditions such as deep vein thrombosis and pulmonary embolism. The development and marketing of rivaroxaban have been subject to extensive patent protection, including Patent 9,415,053.

Scope of Patent 9,415,053

The scope of Patent 9,415,053 is defined by its claims, which outline the specific aspects of the invention that are protected by the patent. This includes the chemical structure of rivaroxaban, methods for its synthesis, and uses in medical treatments.

Claims Analysis

The patent's claims are crucial for understanding its scope. For example, Claim 1 of Patent 9,415,053 might describe the chemical structure of rivaroxaban, while subsequent claims could detail various methods for synthesizing the compound or its applications in medical treatments.

Independent Claims

Independent claims are those that stand alone without reference to other claims. These are typically the most critical claims as they define the core invention. For instance, an independent claim might specify that the invention includes a compound with a specific molecular structure, such as rivaroxaban.

Dependent Claims

Dependent claims build upon independent claims by adding additional features or limitations. These claims refine the scope of the invention by specifying how the compound can be used or synthesized under specific conditions.

Patent Landscape

The patent landscape for rivaroxaban includes multiple patents filed by various entities over the years. This landscape is dynamic, with new patents being granted and existing ones expiring.

Patent Families

Patent families refer to a group of patents that share a common priority date and are related through common ownership or assignment. For rivaroxaban, there are several patent families that cover different aspects of its development and use.

Exclusivity Periods

Exclusivity periods refer to the time during which a generic version of a drug cannot be marketed without infringing on the original patent holder's rights. For rivaroxaban, these exclusivity periods are critical for maintaining market dominance.

Impact on Pharmaceutical Industry

Patent 9,415,053 has significant implications for the pharmaceutical industry:

Market Exclusivity

The patent provides market exclusivity for Janssen Pharmaceuticals (the original patent holder), allowing them to control the market for rivaroxaban during its validity period.

Generic Competition

The expiration of this patent will trigger generic competition, which can significantly reduce the drug's price and increase accessibility. However, generic manufacturers must navigate complex regulatory hurdles and potential litigation to enter the market.

Litigation Examples

There have been instances where generic manufacturers have challenged the validity of rivaroxaban patents in court. For example, Mylan Pharmaceuticals has faced litigation over its attempts to market a generic version of rivaroxaban (see [5]).

Regulatory Framework

The regulatory framework governing pharmaceutical patents involves both the U.S. Patent and Trademark Office (USPTO) and the Food and Drug Administration (FDA).

USPTO Involvement

The USPTO is responsible for granting patents and ensuring that they meet legal requirements. In the case of rivaroxaban, the USPTO has issued multiple patents that cover various aspects of its development and use.

FDA Involvement

The FDA plays a crucial role in approving new drugs and ensuring their safety and efficacy. For rivaroxaban, the FDA has approved several new drug applications (NDAs) that include patent information and exclusivity data.

Conclusion

Patent 9,415,053 is a critical component of the intellectual property strategy for rivaroxaban. Understanding its scope and claims is essential for navigating the complex landscape of pharmaceutical patents and regulatory frameworks.

Key Takeaways

1. Patent Scope: The scope of Patent 9,415,053 is defined by its claims, which outline the specific aspects of the invention protected by the patent.
2. Claims Analysis: Independent claims define the core invention, while dependent claims refine the scope by adding additional features or limitations.
3. Patent Landscape: The patent landscape includes multiple patents filed by various entities over the years, with several patent families covering different aspects of rivaroxaban's development and use.
4. Exclusivity Periods: Exclusivity periods are critical for maintaining market dominance and controlling generic competition.
5. Regulatory Framework: Both the USPTO and FDA play crucial roles in granting patents and approving new drugs, respectively.

FAQs

1. What is the significance of Patent 9,415,053?

   • This patent protects the intellectual property rights of Janssen Pharmaceuticals for rivaroxaban, an anticoagulant medication.

2. How does the patent landscape impact generic competition?

   • The expiration of this patent will trigger generic competition, which can significantly reduce the drug's price and increase accessibility.

3. What role does the USPTO play in granting pharmaceutical patents?

   • The USPTO is responsible for granting patents and ensuring they meet legal requirements, including reviewing terminal disclaimers filed in listed patents.

4. How does the FDA involvement affect pharmaceutical patents?

   • The FDA approves new drug applications (NDAs) that include patent information and exclusivity data, ensuring safety and efficacy while managing intellectual property rights.

5. What happens when a generic manufacturer challenges a pharmaceutical patent in court?

   • Generic manufacturers may face litigation over their attempts to market generic versions of patented drugs, as seen in cases involving Mylan Pharmaceuticals and rivaroxaban (see [5]).

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Cited Information

1. [1] Procopio, LLC. (2024, December 10). Threat to Many Patent Portfolios Fades as USPTO Withdraws Controversial Proposed Rule. Retrieved from https://www.procopio.com/double-patenting-withdrawn/
2. [2] ALLERGAN USA, INC. v. MSN LABORATORIES PRIVATE LTD. (2024, August 13). Case No. 24-1061 Document: 37 Page: 5 Filed:... Retrieved from https://cafc.uscourts.gov/opinions-orders/24-1061.OPINION.8-13-2024_2366074.pdf
3. [3] Hoover Institution. (2016, August). Patent Claims and Patent Scope - Hoover Institution. Retrieved from https://www.hoover.org/sites/default/files/ip2-wp16001-paper.pdf
4. [4] U.S. Patent and Trademark Office (USPTO). (2018, December). USPTO-FDA_Report_on_Drug_Patent_and_Exclusivity. Retrieved from https://www.uspto.gov/sites/default/files/documents/USPTO-FDA_Report_on_Drug_Patent_and_Exclusivity.pdf
5. [5] Mylan-Rivaroxaban DJ Complaint (10798690.2). (n.d.). Retrieved from https://insight.rpxcorp.com/litigation_documents/15225697

Drugs Protected by US Patent 9,415,053

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Patented / Exclusive Use	Submissiondate
Janssen Pharms	XARELTO	rivaroxaban	TABLET;ORAL	022406-004	Oct 11, 2018		RX	Yes	No					Y
Janssen Pharms	XARELTO	rivaroxaban	TABLET;ORAL	022406-001	Jul 1, 2011		RX	Yes	No					Y
Janssen Pharms	XARELTO	rivaroxaban	TABLET;ORAL	022406-002	Nov 4, 2011		RX	Yes	No					Y

Foreign Priority and PCT Information for Patent: 9,415,053

Foriegn Application Priority Data
Foreign Country	Foreign Patent Number	Foreign Patent Date
Germany	103 55 461	Nov 27, 2003

International Family Members for US Patent 9,415,053

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
Argentina	047844
Argentina	104840
Austria	385782