Details for Patent: 7,173,037

Which drugs does patent 7,173,037 protect, and when does it expire?

Patent 7,173,037 protects ADEMPAS and is included in one NDA.

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

Summary for Patent: 7,173,037

Title:	Carbamate-substituted pyrazolopyridines
Abstract:	The present invention relates to compounds which stimulate soluble guanylate cyclase, to the preparation thereof and to the use thereof as medicaments, in particular as medicaments for the treatment of cardiovascular disorders and/or sexual dysfunction.
Inventor(s):	Alonso-Alija; Cristina (Haan, DE), Bischoff; Erwin (Wuppertal, DE), Munter; Klaus (Wulfrath, DE), Stasch; Johannes-Peter (Solingen, DE), Stahl; Elke (Gladbach, DE), Weigand; Stefan (Wuppertal, DE), Feurer; Achim (Wilhelmsfeld, DE)
Assignee:	Bayer HealthCare AG (Leverkusen, DE)
Application Number:	10/513,869
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for patent 7,173,037
Patent Claim Types: see list of patent claims	Compound; Process; Composition; Use;

Detailed Analysis of the Scope and Claims of United States Patent 7,173,037

Introduction

United States Patent 7,173,037, issued on February 6, 2007, is a significant patent in the pharmaceutical industry, particularly related to the drug Adempas® (riociguat). This patent is held by Bayer AG, Bayer HealthCare Pharmaceuticals Inc., and Adverio Pharma GmbH. Here, we will delve into the scope, claims, and the patent landscape surrounding this invention.

Patent Overview

The patent covers compounds that stimulate soluble guanylate cyclase (sGC), a key enzyme in the nitric oxide signaling pathway. These compounds are used as medicaments, specifically for treating conditions such as pulmonary arterial hypertension (PAH) and chronic thromboembolic pulmonary hypertension (CTEPH)[1].

Claims of the Patent

The '037 Patent includes multiple claims that define the scope of the invention. These claims cover:

• The active ingredient riociguat and its pharmaceutical compositions.
• Methods of preparing these compounds.
• Uses of these compounds as medicaments, particularly for treating PAH and CTEPH[1][4].

Scope of the Patent

The scope of the patent is broad enough to encompass various aspects of the invention:

• Active Ingredient: The patent claims riociguat per se, as well as compositions and formulations containing this active ingredient.
• Pharmaceutical Compositions: It includes various dosage forms such as tablets, which are specified in the FDA-approved product Adempas® (0.5 mg, 1 mg, 1.5 mg, 2 mg, and 2.5 mg)[2][5].
• Therapeutic Uses: The patent covers the use of riociguat for specific therapeutic indications, including PAH and CTEPH.

Patent Landscape and Litigation

The '037 Patent has been at the center of several patent infringement lawsuits:

• Teva Pharmaceuticals: Bayer and its affiliates filed a complaint against Teva Pharmaceuticals USA, Inc. and Teva Pharmaceutical Industries Ltd. for patent infringement related to Teva's Abbreviated New Drug Application (ANDA) for a generic version of Adempas®[2].
• MSN Pharmaceuticals: Similar litigation was initiated against MSN Pharmaceuticals for their ANDA filing for generic Adempas®[5].

These lawsuits highlight the importance of the '037 Patent in protecting Bayer's intellectual property rights and the commercial exclusivity of Adempas®.

Patent Term and Extensions

The original term of the '037 Patent was set to expire on April 25, 2023. However, Bayer sought and was granted an extension of the patent term due to regulatory review periods:

• Regulatory Review Period: The extension was calculated based on the time taken for FDA approval, from the effective date of the Investigational New Drug (IND) application to the date of New Drug Application (NDA) approval, totaling 2392 days. This resulted in an extension of 1317 days, extending the patent term to December 2, 2026[4].

Impact on Generic Competition

The '037 Patent and its extensions have significant implications for generic competition:

• Generic Filings: The patent's listing in the FDA's Orange Book and the ongoing litigation against generic manufacturers like Teva and MSN have delayed the entry of generic versions of Adempas® into the market[2][5].
• Market Exclusivity: The extended patent term ensures that Bayer maintains market exclusivity for Adempas® until December 2, 2026, protecting its revenue stream from this drug.

Metrics for Patent Scope

The scope of the '037 Patent can be analyzed using metrics such as independent claim length and independent claim count:

• Claim Length and Count: Studies suggest that narrower claims, as measured by shorter independent claim lengths and fewer independent claims, are associated with a higher probability of grant and a shorter examination process. However, the '037 Patent's claims are specific and focused on the active ingredient and its therapeutic uses, indicating a well-defined scope[3].

Conclusion

United States Patent 7,173,037 is a critical patent in the pharmaceutical sector, particularly for Bayer's Adempas®. The patent's scope encompasses the active ingredient riociguat, its pharmaceutical compositions, and specific therapeutic uses. The ongoing litigation and patent term extensions highlight the strategic importance of this patent in maintaining market exclusivity and protecting intellectual property.

Key Takeaways

• The '037 Patent covers compounds that stimulate soluble guanylate cyclase, specifically riociguat.
• It includes claims for the active ingredient, pharmaceutical compositions, and therapeutic uses.
• The patent is central to Bayer's market exclusivity for Adempas®.
• Litigation against generic manufacturers has delayed generic competition.
• The patent term has been extended due to regulatory review periods.

FAQs

Q: What is the main subject of United States Patent 7,173,037? A: The main subject is compounds that stimulate soluble guanylate cyclase, specifically riociguat, used in the treatment of PAH and CTEPH.

Q: Which drug is protected by this patent? A: The patent protects Adempas® (riociguat), a drug used for treating PAH and CTEPH.

Q: Why has Bayer filed lawsuits against generic manufacturers? A: Bayer has filed lawsuits to prevent generic manufacturers from infringing on the '037 Patent, thereby protecting its market exclusivity for Adempas®.

Q: How long has the patent term of the '037 Patent been extended? A: The patent term has been extended by 1317 days, resulting in a new expiration date of December 2, 2026.

Q: What metrics can be used to analyze the scope of a patent like the '037 Patent? A: Metrics such as independent claim length and independent claim count can be used to analyze the scope and breadth of a patent.

Sources

1. Drug Patent Watch - Summary for Patent: 7,173,037
2. RPX Insight - Case 1:18-cv-00112-UNA Document 1 Filed 01/19/18
3. SSRN - Patent Claims and Patent Scope
4. Regulations.gov - Attorney Docket Number: 0081565-000048
5. RPX Insight - Case 1:18-cv-00111-UNA Document 1 Filed 01/19/18

Drugs Protected by US Patent 7,173,037

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Patented / Exclusive Use	Submissiondate
Bayer Hlthcare	ADEMPAS	riociguat	TABLET;ORAL	204819-001	Oct 8, 2013	AB	RX	Yes	No			Y	Y
Bayer Hlthcare	ADEMPAS	riociguat	TABLET;ORAL	204819-002	Oct 8, 2013	AB	RX	Yes	No			Y	Y
Bayer Hlthcare	ADEMPAS	riociguat	TABLET;ORAL	204819-003	Oct 8, 2013	AB	RX	Yes	No			Y	Y
Bayer Hlthcare	ADEMPAS	riociguat	TABLET;ORAL	204819-004	Oct 8, 2013	AB	RX	Yes	No			Y	Y
Bayer Hlthcare	ADEMPAS	riociguat	TABLET;ORAL	204819-005	Oct 8, 2013	AB	RX	Yes	Yes			Y	Y

Foreign Priority and PCT Information for Patent: 7,173,037

Foriegn Application Priority Data
Foreign Country	Foreign Patent Number	Foreign Patent Date
Germany	102 20 570	May 8, 2002

PCT Information
PCT Filed	April 25, 2003	PCT Application Number:	PCT/EP03/04304
PCT Publication Date:	November 20, 2003	PCT Publication Number:	WO03/095451

International Family Members for US Patent 7,173,037

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
European Patent Office	1506193		C01506193/01	Switzerland
European Patent Office	1506193		PA2014018,C1506193	Lithuania
European Patent Office	1506193		C300659	Netherlands
European Patent Office	1506193		PA2014018	Lithuania
European Patent Office	1506193		92419	Luxembourg