Details for Patent: 10,793,547

Which drugs does patent 10,793,547 protect, and when does it expire?

Patent 10,793,547 protects TRIKAFTA (COPACKAGED) and is included in two NDAs.

This patent has fifty-one patent family members in thirty-four countries.

Summary for Patent: 10,793,547

Title:	Modulator of the cystic fibrosis transmembrane conductance regulator, pharmaceutical compositions, methods of treatment, and process for making the modulator
Abstract:	Compounds of Formula (I): ##STR00001## pharmaceutically acceptable salts thereof, deuterated derivatives of any of the foregoing, and metabolites of any of the foregoing are disclosed. Pharmaceutical compositions comprising the same, methods of treating cystic fibrosis using the same, and methods for making the same are also disclosed. Also disclosed are solid state forms of Compound 1 and salts and solvates thereof.
Inventor(s):	Abela; Alexander Russell (San Diego, CA), Alcacio; Timothy (San Diego, CA), Anderson; Corey (San Diego, CA), Angell; Paul Timothy (Carlsbad, CA), Baek; Minson (San Diego, CA), Clemens; Jeremy J. (San Diego, CA), Cleveland; Thomas (San Marcos, CA), Ferris; Lori Ann (Wilmington, MA), Grootenhuis; Peter Diederik Jan (Del Mar, CA), Gross; Raymond Stanley (Poway, CA), Gulevich; Anton V. (San Diego, CA), Hadida Ruah; Sara Sabina (La Jolla, CA), Hsia; Clara Kuang-Ju (San Diego, CA), Hughes; Robert M. (San Diego, CA), Joshi; Pramod Virupax (San Diego, CA), Kang; Ping (San Diego, CA), Keshavarz-Shokri; Ali (San Diego, CA), Khatuya; Haripada (San Diego, CA), Krenitsky; Paul John (San Diego, CA), McCartney; Jason (Cardiff by the Sea, CA), Miller; Mark Thomas (San Diego, CA), Paraselli; Prasuna (San Diego, CA), Pierre; Fabrice Jean Denis (La Jolla, CA), Shi; Yi (Natick, MA), Shrestha; Muna (Belmont, MA), Siesel; David Andrew (San Diego, CA), Stavropoulos; Kathy (Quincy, MA), Termin; Andreas P. (Encinitas, CA), Van Goor; Fredrick F. (San Diego, CA), Uy; Johnny (San Diego, CA), Young; Timothy John (San Diego, CA), Zhou; Jinglan (San Diego, CA)
Assignee:	Vertex Pharmaceuticals Incorporated (Boston, MA)
Application Number:	15/836,627
Patent Claim Types: see list of patent claims	Use; Composition; Compound;

Understanding the Scope and Claims of United States Patent 10,793,547: A Detailed Analysis

Introduction

United States Patent 10,793,547, assigned to Vertex Pharmaceuticals Incorporated, is a significant patent in the field of cystic fibrosis treatment. This patent protects a combination of drugs known as Trikafta (copackaged), which includes elexacaftor, ivacaftor, and tezacaftor. Here, we will delve into the scope, claims, and the broader patent landscape surrounding this invention.

Patent Overview

Inventors and Assignee

The patent lists multiple inventors, including Alexander Russell Abela, Timothy Alcacio, Corey Anderson, and others, all affiliated with Vertex Pharmaceuticals Incorporated in various locations in California and Massachusetts[4].

Patent Assignment

The patent is assigned to Vertex Pharmaceuticals Incorporated, a company well-known for its innovative treatments in cystic fibrosis[4].

Scope of the Patent

Patented Use

The patent covers the treatment of cystic fibrosis in patients aged 6 years and older who have at least one F508del mutation or a mutation in the CFTR gene that is responsive based on in vitro data. The treatment involves a combination of elexacaftor, ivacaftor, and tezacaftor[1][4].

Pharmaceutical Compositions

The patent describes pharmaceutical compositions comprising these modulators of the cystic fibrosis transmembrane conductance regulator (CFTR). These compositions are designed to improve the function of the CFTR protein, which is defective in patients with cystic fibrosis[4].

Claims of the Patent

Independent Claims

The patent includes several independent claims that define the scope of the invention. These claims are broad and cover various aspects of the treatment, including the specific combination of drugs, their formulations, and methods of treatment. For instance, one independent claim might cover the method of treating cystic fibrosis using a solid composition comprising elexacaftor, tezacaftor, amorphous ivacaftor, and less than 30% crystalline ivacaftor[1][4].

Dependent Claims

In addition to independent claims, the patent includes dependent claims that serve as fallback positions. These claims are narrower than the independent claims and provide additional specificity to the invention. For example, a dependent claim might specify a particular dosage form or a specific patient population[3].

Patent Landscape

Number of Patents and Patent Family Members

The Trikafta (copackaged) drug is protected by 32 US patents and has 504 patent family members in 45 countries. This extensive patent coverage indicates a robust protection strategy by Vertex Pharmaceuticals[1].

Regulatory Exclusivities

Besides patent protection, Trikafta (copackaged) benefits from seven FDA regulatory exclusivities. These exclusivities further delay the entry of generic versions into the market[1].

Patent Expiration and Generic Entry

Estimated Loss of Exclusivity (LOE) Date

The earliest date for generic entry is estimated to be December 8, 2037, based on the analysis of patents and regulatory exclusivities. However, this date can change due to patent challenges, generic licensing, or other factors[1].

Patent Litigation and Challenges

There has been one patent litigation case involving the patents protecting Trikafta (copackaged), indicating strong interest in generic launch. Historical data suggest that 63% of patent challenges are decided in favor of the generic patent challenger, and 54% of successful challengers promptly launch generic drugs[1].

Measuring Patent Scope

Claim Length and Scope

The scope of a patent is often measured by the length of its first independent claim. Longer claims typically imply more conditions that must be met for a patent to be violated, making the patent narrower. In contrast, broader patents have shorter claims and are harder to design around[3].

Traditional Measures of Patent Scope

Traditional measures such as the number of patent classes, citations, and claims have been found to be less predictive of patent scope. The number of claims, for instance, only explains 7% of the variation in patent scope, while the number of citations is statistically insignificantly related to patent scope[3].

Economic and Strategic Implications

Broad Patents and Protection

Broad patents, like those protecting Trikafta, offer more protection against infringers because they are harder to design around. This breadth is crucial for maintaining market exclusivity and preventing competitors from producing readily substitutable variations of the invention[3].

Impact on Generic Entry

The extensive patent and regulatory protection surrounding Trikafta (copackaged) significantly delays generic entry. This delay allows Vertex Pharmaceuticals to maintain a monopoly on the market, which can be economically beneficial but also impacts patient access to affordable treatments.

Conclusion

United States Patent 10,793,547 is a critical component of the intellectual property portfolio protecting Trikafta (copackaged), a groundbreaking treatment for cystic fibrosis. The patent's broad claims and extensive regulatory exclusivities ensure strong protection against generic competition until at least 2037. Understanding the scope and claims of this patent provides insights into the strategic and economic implications for both the innovator company and the broader healthcare market.

Key Takeaways

• Patent Protection: Trikafta (copackaged) is protected by 32 US patents and 504 patent family members globally.
• Regulatory Exclusivities: The drug benefits from seven FDA regulatory exclusivities.
• Generic Entry: The earliest generic entry date is estimated to be December 8, 2037.
• Patent Scope: The patent's scope is defined by its broad independent claims, which are harder to design around.
• Economic Implications: The extensive protection allows Vertex Pharmaceuticals to maintain market exclusivity, impacting both revenue and patient access.

FAQs

Q: What is the primary use of the drugs protected by United States Patent 10,793,547?

A: The primary use is the treatment of cystic fibrosis in patients aged 6 years and older who have at least one F508del mutation or a mutation in the CFTR gene that is responsive based on in vitro data.

Q: How many patents protect Trikafta (copackaged) in the United States?

A: Trikafta (copackaged) is protected by 32 US patents.

Q: What is the estimated date for generic entry of Trikafta (copackaged)?

A: The earliest date for generic entry is estimated to be December 8, 2037.

Q: What factors can influence the actual generic entry date?

A: Factors such as new patent filings, patent extensions, patent invalidation, early generic licensing, and other regulatory considerations can influence the actual generic entry date.

Q: Why are broad patents like those protecting Trikafta (copackaged) significant?

A: Broad patents offer more protection against infringers because they are harder to design around, providing stronger market exclusivity.

Sources

1. DrugPatentWatch, TRIKAFTA (COPACKAGED), [https://www.drugpatentwatch.com/p/tradename/TRIKAFTA+(COPACKAGED)][1]
2. Unified Patents, US-20180162839-A1 - Modulator of the Cystic Fibrosis Transmembrane Conductance Regulator, [https://portal.unifiedpatents.com/patents/patent/US-20180162839-A1][2]
3. Boston University Law, The Ways We've been Measuring Patent Scope are Wrong: How to Measure and Draw Causal Inferences with Patent Scope, [https://www.bu.edu/law/files/2017/10/The-Ways-Weve-Been-Measuring-Patent-Scope-Are-Wrong-How-to-Measure-and-Draw-Causal-Inferences-with-Patent-Scope.pdf][3]
4. Google Patents, United States Patent 10,793,547, [https://patentimages.storage.googleapis.com/1e/f1/57/9f7b89aef3880d/US11453655.pdf][4]

Drugs Protected by US Patent 10,793,547

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Patented / Exclusive Use	Submissiondate
Vertex Pharms Inc	TRIKAFTA (COPACKAGED)	elexacaftor, ivacaftor, tezacaftor; ivacaftor	GRANULES;ORAL	217660-001	Apr 26, 2023		RX	Yes	No	10,793,547		Y	Y		TREATMENT OF CYSTIC FIBROSIS IN PATIENTS AGED 2 TO
Vertex Pharms Inc	TRIKAFTA (COPACKAGED)	elexacaftor, ivacaftor, tezacaftor; ivacaftor	GRANULES;ORAL	217660-002	Apr 26, 2023		RX	Yes	Yes	10,793,547		Y	Y		TREATMENT OF CYSTIC FIBROSIS IN PATIENTS AGED 2 TO
Vertex Pharms Inc	TRIKAFTA (COPACKAGED)	elexacaftor, ivacaftor, tezacaftor; ivacaftor	TABLET;ORAL	212273-002	Jun 8, 2021		RX	Yes	No	10,793,547		Y	Y		TREATMENT OF CYSTIC FIBROSIS IN PATIENTS AGED 6 YEARS AND OLDER WHO HAVE AT LEAST ONE F508DEL MUTATION IN THE CFTR GENE OR A MUTATION IN THE CFTR GENE THAT IS RESPONSIVE BASED ON IN VITRO DATA WITH ELEXACAFTOR, TEZACAFTOR, AND IVACAFTOR

International Family Members for US Patent 10,793,547

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
Argentina	110346
Australia	2017371200
Australia	2021211993