Details for Patent: 8,685,980

Which drugs does patent 8,685,980 protect, and when does it expire?

Patent 8,685,980 protects KISQALI and KISQALI FEMARA CO-PACK (COPACKAGED) and is included in two NDAs.

This patent has sixty-two patent family members in forty-eight countries.

Summary for Patent: 8,685,980

Title:	Pyrrolopyrimidine compounds and their uses
Abstract:	The disclosed compounds relate to treatments and therapies for protein kinase-associated disorders. There is also a need for compounds useful in the treatment or prevention or amelioration of one or more symptoms of cancer, transplant rejections, and autoimmune diseases. Furthermore, there is a need for methods for modulating the activity of protein kinases, such as CDK1, CDK2, CDK4, CDK5, CDK6, CDK7, CDK8 and CDK9, using the compounds provided herein. ##STR00001##
Inventor(s):	Besong; Gilbert Ebai (Bad Duerkheim, DE), Brain; Christopher Thomas (North Reading, MA), Brooks; Clinton Alan (Smyrna, GA), Congreve; Miles Stuart (Royston, GB), Dagostin; Claudio (Cambridge, GB), He; Guo (Lexington, MA), Hou; Ying (Belmont, MA), Howard; Steven (Cambridge, GB), Li; Yue (Shanghai, CN), Lu; Yipin (Dublin, CA), Mortenson; Paul Neil (Cambridge, GB), Smith; Troy D. (Nashua, NH), Sung; Moo Je (Belmont, MA), Woodhead; Steven John (San Diego, CA), Wrona; Wojciech (Waltham, MA), Lagu; Bharat (Acton, MA)
Assignee:	Novartis AG (Basel, CH) Astex Therapeutics, Ltd. (Cambridge, GB)
Application Number:	13/060,154
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for patent 8,685,980
Patent Claim Types: see list of patent claims	Composition; Compound;

Detailed Analysis of the Scope and Claims of United States Patent 8,685,980

Introduction

United States Patent 8,685,980, titled "Pyrrolopyrimidine Compounds and Their Uses," is a significant patent in the pharmaceutical sector, particularly related to the drug KISQALI® (ribociclib succinate). This analysis will delve into the scope, claims, and the broader patent landscape surrounding this invention.

Inventors and Assignees

The patent was issued to a group of inventors including Gilbert Ebai Besong, Christopher Thomas Brain, Clinton Alan Brooks, Miles Stuart Congreve, Claudio Dagostin, Guo He, Ying Hou, Steven Howard, Yue Li, Yipin Lu, Paul Neil Mortenson, Troy D. Smith, Moo Je Sung, Steven John Woodhead, Wojciech Wrona, and Bharat Lagu. The patent is owned by Novartis Pharmaceuticals Corporation and Astex Therapeutics Ltd.[2].

Patent Claims

The patent claims cover pyrrolopyrimidine compounds, specifically ribociclib succinate, which is used as an active ingredient in the drug KISQALI®. These claims are crucial as they define the scope of protection for the invention.

Claim Scope

The scope of the patent claims is determined by the language and specificity of the claims themselves. A broader claim scope generally offers more protection against potential infringers because it is harder to design around. In contrast, narrower claims are more specific but may be easier to circumvent. For U.S. Patent 8,685,980, the claims are detailed and specific, focusing on the chemical structure and uses of the pyrrolopyrimidine compounds[1].

Claim Length and Scope

Research suggests that the length of a patent claim can be an indicator of its scope. Longer claims typically imply more conditions that must be met for a patent to be violated, making them narrower. The claims in U.S. Patent 8,685,980 are detailed, indicating a narrower but well-defined scope[3].

Patent Term and Extensions

The original expiration date of U.S. Patent 8,685,980 was May 25, 2030. However, the patent holders applied for and were granted a patent term extension under 35 U.S.C. § 156 due to the regulatory review period for the drug KISQALI®. The extension period was calculated to be 292 days, extending the patent term until March 13, 2031[1].

Regulatory Review Period

The regulatory review period for KISQALI® began on August 26, 2010, and ended on March 13, 2017, with the FDA approval of the New Drug Application (NDA). This period, totaling 2,393 days, was a critical factor in determining the patent term extension[1].

Patent Landscape

Litigation and Infringement

U.S. Patent 8,685,980 has been involved in patent infringement litigation. Novartis Pharmaceuticals Corporation and Astex Therapeutics Ltd. have taken legal action against defendants alleged to have infringed on this patent, along with other related patents (U.S. Patents 8,962,630 and 9,416,136)[2].

Related Patents

The patent landscape surrounding U.S. Patent 8,685,980 includes other patents related to the same drug and its uses. For example, U.S. Patent 8,415,355, also owned by the same inventors, covers related compounds and has a similar expiration date adjusted for patent term extensions[4].

Economic Value

The economic value of a patent like U.S. Patent 8,685,980 can be substantial. The prices for pharmaceutical patents can vary widely, but they often command high values due to their potential for generating significant revenue. For instance, the mean price per document for pharmaceutical patents can be in the hundreds of thousands of dollars, with some transactions reaching millions[5].

Measuring Patent Scope

Traditional measures of patent scope, such as the number of patent classes, citations, and claims, have been found to be less reliable than newer methods. The number of words in the first claim of a patent is a more predictive measure of its scope, with longer claims indicating narrower scope. This method has been validated through studies involving patent attorneys and extensive data analysis[3].

Conclusion

U.S. Patent 8,685,980 is a critical asset for Novartis Pharmaceuticals Corporation and Astex Therapeutics Ltd., providing exclusive rights to the drug KISQALI®. The patent's scope is defined by its detailed claims, and its term has been extended due to regulatory review periods. Understanding the patent landscape, including related patents and litigation, is essential for navigating the complex world of pharmaceutical intellectual property.

Key Takeaways

• Patent Claims: Specific and detailed claims defining the scope of protection for pyrrolopyrimidine compounds.
• Patent Term Extension: Extended by 292 days due to regulatory review periods.
• Regulatory Review: Began on August 26, 2010, and ended on March 13, 2017.
• Litigation: Involved in patent infringement litigation.
• Economic Value: Substantial economic value due to its potential revenue generation.
• Measuring Scope: Longer claims indicate narrower scope, a more reliable measure than traditional methods.

FAQs

Q: What is the main subject of U.S. Patent 8,685,980? A: The main subject is pyrrolopyrimidine compounds, specifically ribociclib succinate, used in the drug KISQALI®.

Q: Who are the inventors and owners of U.S. Patent 8,685,980? A: The inventors include Gilbert Ebai Besong, Christopher Thomas Brain, and others, with ownership by Novartis Pharmaceuticals Corporation and Astex Therapeutics Ltd.

Q: What is the significance of the patent term extension for U.S. Patent 8,685,980? A: The extension adds 292 days to the original expiration date due to the regulatory review period for the drug KISQALI®.

Q: How is the scope of a patent like U.S. Patent 8,685,980 typically measured? A: The scope is often measured by the length and specificity of the claims, with longer claims indicating a narrower scope.

Q: What is the economic significance of pharmaceutical patents like U.S. Patent 8,685,980? A: These patents can command high economic values due to their potential for generating significant revenue from drug sales.

Sources

1. Regulations.gov: AUG 3 0 2017 - Regulations.gov
2. Insight.rpxcorp.com: NOVARTIS PHARMACEUTICALS CORPORATION and ASTEX ...
3. BU.edu: The Ways We've been Measuring Patent Scope are Wrong:
4. Regulations.gov: AUG 3 ·.o 2017 - Regulations.gov
5. Perpetual Motion Patents: The value of a patent - Perpetual Motion Patents

Drugs Protected by US Patent 8,685,980

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Patented / Exclusive Use	Submissiondate
Novartis	KISQALI	ribociclib succinate	TABLET;ORAL	209092-001	Mar 13, 2017		RX	Yes	Yes			Y	Y
Novartis	KISQALI FEMARA CO-PACK (COPACKAGED)	letrozole; ribociclib succinate	TABLET;ORAL	209935-001	May 4, 2017		RX	Yes	Yes			Y	Y

Foreign Priority and PCT Information for Patent: 8,685,980

PCT Information
PCT Filed	August 20, 2009	PCT Application Number:	PCT/EP2009/060793
PCT Publication Date:	February 25, 2010	PCT Publication Number:	WO2010/020675

International Family Members for US Patent 8,685,980

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
European Patent Office	2331547		300909	Netherlands
European Patent Office	2331547		PA2017039	Lithuania
European Patent Office	2331547		CR 2017 00060	Denmark
European Patent Office	2331547		122017000102	Germany
European Patent Office	2331547		LUC00048	Luxembourg