Details for Patent: 8,513,255

Which drugs does patent 8,513,255 protect, and when does it expire?

Patent 8,513,255 protects PREVYMIS and is included in two NDAs.

This patent has forty-five patent family members in thirty-six countries.

Summary for Patent: 8,513,255

Title:	Substituted dihydroquinazolines
Abstract:	The invention relates to substituted dihydroquinazolines and to processes for their preparation and also to their use for preparing medicaments for the treatment and/or prophylaxis of diseases, in particular for use as antiviral agents, in particular against cytomegalo viruses.
Inventor(s):	Wunberg; Tobias (Hinterbruehl, AT), Baumeister; Judith (Mechelen, BE), Betz; Ulrich (Reinheim, DE), Jeske; Mario (Solingen, DE), Lampe; Thomas (Duesseldorf, DE), Nikolic; Susanne (Monheim, DE), Reefschlaeger; Juergen (Oldenburg, DE), Schohe-Loop; Rudolf (Wuppertal, DE), Suessmeier; Frank (Wuppertal, DE), Zimmermann; Holger (Wuppertal, DE), Grosser; Rolf (Leverkusen, DE), Henninger; Kerstin (Wuppertal, DE), Hewlett; Guy (Haan, DE), Keldenich; Joerg (Wuppertal, DE), Lang; Dieter (Velbert, DE), Nell; Peter (Wuppertal, DE)
Assignee:	AiCuris GmbH + Co. KG. (Wuppertal, DE)
Application Number:	11/728,896
Patent Claim Types: see list of patent claims	Use; Composition; Compound; Process;

United States Patent 8,513,255: A Detailed Analysis of Scope, Claims, and Patent Landscape

Introduction

United States Patent 8,513,255, titled "Substituted dihydroquinazolines," is a significant patent in the pharmaceutical industry, particularly in the development of antiviral medications. This patent, issued to Merck Sharp & Dohme Corp, has been a crucial component in the protection of their drug Prevymis.

Patent Overview

Patent Number and Issue Date

The patent number is US8513255B2, and it was issued on August 20, 2013[2][5].

Inventors and Assignees

The patent is assigned to Merck Sharp & Dohme Corp, with the inventors not specified in the provided sources but typically listed in the patent document itself[2][5].

Scope of the Patent

Subject Matter

The patent relates to substituted dihydroquinazolines, which are compounds used in the preparation of medicaments, particularly antiviral drugs. The invention includes processes for the preparation of these compounds and their use in treating various illnesses, such as cytomegalovirus infections[1][5].

Claims

The patent claims cover the specific chemical structures of the substituted dihydroquinazolines, methods for their synthesis, and their pharmaceutical compositions. These claims are critical as they define the boundaries of the patent owner's rights and protect the proprietary chemical formulations[1][3].

Patent Claims and Their Significance

Active Ingredient Protection

The patent protects the active ingredient (API) of the drug, ensuring that only the patent owner can launch products using this specific API until the patent expires. This protection is essential for maintaining market exclusivity and preventing generic competition[2][5].

Breadth of Claims

The scope of the patent claims is a delicate balance. If the claims are too narrow, competitors can easily design around them by making minor modifications. Conversely, if the claims are too broad and not supported by the patent application, they may be invalidated during litigation or examination. The Federal Circuit's rigid position on genus claims, as outlined in Section 112(a) of the U.S. patent laws, has made it challenging to obtain broad and meaningful patent protection for pharmaceuticals and biologics[3].

Patent Expiration and Status

Expiration Date

The patent US8513255B2 has expired as of May 2024. This expiration marks the end of the exclusive rights granted to Merck Sharp & Dohme Corp for this specific patent[2][5].

Impact of Expiration

With the expiration of this patent, the door is open for generic versions of the drug to be developed and marketed. However, other patents related to the drug, such as US10603384, which protects the pharmaceutical composition containing the antivirally active dihydroquinazoline derivative, remain active until February 28, 2033. This means that while some aspects of the drug are no longer protected, others still enjoy patent protection[2][5].

Recent Legal Activities

Maintenance Fees and Notifications

Recent activities on this patent include the withdrawal of an application for a patent term extension and various notifications related to the patent's maintenance fees and certificate of correction. These activities are part of the ongoing management of the patent's lifecycle[2].

Industry Impact

Pharmaceutical and Biotechnology Industries

The patent landscape for pharmaceuticals and biologics is complex and highly regulated. Patents like US8513255B2 are crucial for innovators to protect their investments in research and development. The expiration of such patents can significantly impact the market, allowing for the entry of generic drugs and potentially altering market dynamics[3].

Market and Financial Implications

The expiration of key patents can lead to a loss of market exclusivity, resulting in reduced revenue for the original patent holder. However, it also opens up opportunities for generic manufacturers to enter the market, potentially increasing competition and reducing drug prices[4].

Challenges in Patent Protection

Genus Claims and Section 112(a)

The Federal Circuit's stance on genus claims under Section 112(a) has created challenges for pharmaceutical and biotechnology companies. The requirement for a written description and enablement of all species within a genus has made it difficult to obtain broad patent protection, forcing innovators to balance the scope of their claims carefully[3].

Designing Around Patents

The narrow scope of some patent claims can allow competitors to design around them by making minor changes, thereby avoiding infringement. This highlights the need for precise and well-crafted patent claims that balance breadth with specificity[3].

Conclusion

United States Patent 8,513,255 has played a significant role in protecting Merck Sharp & Dohme Corp's interests in the antiviral drug Prevymis. The expiration of this patent, while marking the end of exclusive rights for this specific compound, does not immediately open the market to generics due to other active patents. The complex landscape of pharmaceutical patents underscores the importance of careful claim drafting and the ongoing challenges posed by legal and regulatory requirements.

Key Takeaways

• Patent Expiration: US8513255B2 has expired as of May 2024.
• Active Patents: Other patents related to Prevymis, such as US10603384, remain active until February 28, 2033.
• Industry Impact: Patent expirations can lead to generic competition and altered market dynamics.
• Challenges in Protection: The Federal Circuit's stance on genus claims under Section 112(a) complicates broad patent protection.
• Balancing Claims: Patent claims must be carefully crafted to balance breadth with specificity.

FAQs

What is the significance of United States Patent 8,513,255?

This patent protects the substituted dihydroquinazolines used in the antiviral drug Prevymis, ensuring exclusive rights for Merck Sharp & Dohme Corp until its expiration.

When did the patent expire?

The patent US8513255B2 expired in May 2024.

What other patents protect Prevymis?

Other active patents, such as US10603384, protect the pharmaceutical composition containing the antivirally active dihydroquinazoline derivative until February 28, 2033.

How does the expiration of this patent affect the market?

The expiration opens the door for generic versions of the drug, potentially increasing competition and reducing prices, but other active patents delay full generic entry.

What challenges do pharmaceutical companies face in patent protection?

Pharmaceutical companies face challenges due to the Federal Circuit's rigid stance on genus claims under Section 112(a), making it difficult to obtain broad and meaningful patent protection.

Cited Sources:

1. US8513255B2 - Substituted dihydroquinazolines - Google Patents
2. Prevymis patent expiration - Pharsight
3. Eviscerating Patent Scope - DigitalCommons@NYLS
4. List - 54 Drug Patents Expiring in 2024 - GreyB
5. Generic Prevymis Availability - Drugs.com

Drugs Protected by US Patent 8,513,255

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Patented / Exclusive Use	Submissiondate
Merck Sharp Dohme	PREVYMIS	letermovir	SOLUTION;INTRAVENOUS	209940-001	Nov 8, 2017		RX	Yes	Yes			Y	Y
Merck Sharp Dohme	PREVYMIS	letermovir	SOLUTION;INTRAVENOUS	209940-002	Nov 8, 2017		RX	Yes	Yes			Y	Y
Merck Sharp Dohme	PREVYMIS	letermovir	TABLET;ORAL	209939-001	Nov 8, 2017		RX	Yes	No			Y	Y
Merck Sharp Dohme	PREVYMIS	letermovir	TABLET;ORAL	209939-002	Nov 8, 2017		RX	Yes	Yes			Y	Y

Foreign Priority and PCT Information for Patent: 8,513,255

Foriegn Application Priority Data
Foreign Country	Foreign Patent Number	Foreign Patent Date
Germany	103 19 612	May 2, 2003

International Family Members for US Patent 8,513,255

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
European Patent Office	1622880		300933	Netherlands
European Patent Office	1622880		LUC00070	Luxembourg
European Patent Office	1622880		2018C/015	Belgium
European Patent Office	1622880		122018000080	Germany
European Patent Office	1622880		LUC00080	Luxembourg
European Patent Office	1622880		2018C/025	Belgium