Details for Patent: 9,062,014

Which drugs does patent 9,062,014 protect, and when does it expire?

Patent 9,062,014 protects PONVORY and is included in one NDA.

This patent has thirty-one patent family members in twenty-seven countries.

Summary for Patent: 9,062,014

Title:	Crystalline forms of (R)-5-[3-chloro-4-(2,3-dihydroxy-propoxy)-benz[Z]ylidene]-2-([Z]-propylim- ino)-3-0-tolyl-thiazolidin-4-one
Abstract:	The invention relates to crystalline forms of (R)-5-[3-chloro-4-(2,3-dihydroxy-propoxy)-benz[Z]ylidene]-2-([Z]-propylim- ino)-3-o-tolyl-thiazolidin-4-one, processes for the preparation thereof, pharmaceutical compositions containing said crystalline forms, and their use as compounds improving vascular function and as immunomodulating agents, either alone or in combination with other active compounds or therapies.
Inventor(s):	Bonham; Nicholas (Oxford, GB), Buchmann; Stephan (Allschwil, CH), Eberlin; Alex (Cambridge, GB), Imboden; Christoph (Hofstetten, CH), Von Raumer; Markus (Allschwil, CH)
Assignee:	ACTELION PHARMACEUTICALS LTD. (Allschwil, CH)
Application Number:	13/125,102
Patent Claim Types: see list of patent claims	Use; Composition; Compound;

United States Patent 9,062,014: A Detailed Analysis

Overview of the Patent

United States Patent 9,062,014, issued on June 23, 2015, is assigned to Actelion Pharmaceuticals Ltd. and pertains to crystalline forms of a specific thiazolidin-4-one derivative. This patent is crucial for understanding the pharmaceutical compositions and their applications in treating disorders associated with an activated immune system.

Inventors and Assignees

The patent was invented by a team of researchers including Bonham Nicholas, Buchmann Stephan, Eberlin Alex, Imboden Christoph, and Von Raumer Markus. Actelion Pharmaceuticals Ltd. is the assignee of this patent, highlighting the company's significant investment in pharmaceutical research and development[4].

Patent Claims and Scope

Claim Structure

The patent claims are structured to cover various aspects of the invention, including:

• Crystalline Forms: The patent describes specific crystalline forms of the compound (R)-5-[3-chloro-4-(2,3-dihydroxy-propoxy)-benz[Z]ylidene]-2-([Z]-propylimino)-3-o-tolyl-thiazolidin-4-one. These forms are critical for the stability and efficacy of the pharmaceutical composition[4].
• Preparation Processes: The patent includes claims related to the processes for preparing these crystalline forms, ensuring that the methods are reproducible and efficient.
• Pharmaceutical Compositions: Claims cover the pharmaceutical compositions containing these crystalline forms, which are designed to improve vascular function and act as immunomodulating agents.
• Therapeutic Uses: The patent specifies the use of these compositions alone or in combination with other active compounds or therapies to treat disorders associated with an activated immune system.

Patent Scope Metrics

To understand the scope of this patent, metrics such as independent claim length and independent claim count can be analyzed. Research suggests that narrower claims at publication are associated with a higher probability of grant and a shorter examination process. This implies that the claims in Patent 9,062,014 were likely refined during the examination process to ensure clarity and specificity[3].

Patent Expiration Dates

The patent is set to expire on May 6, 2032. This expiration date is significant as it marks the end of the exclusive rights granted to Actelion Pharmaceuticals Ltd. for this specific invention. After this date, generic versions of the drug could potentially enter the market, provided there are no additional exclusivities or patents that extend the protection period[4].

Related Exclusivities

In addition to patent protection, the FDA grants exclusivity rights that can run concurrently with or independently of patent protection. For the drug related to this patent, the new chemical entity (NCE) exclusivity is set to expire on March 18, 2026. This exclusivity period ensures that the drug has a certain period of market exclusivity, even if the patent expires earlier[4].

Impact on Pharmaceutical Market

The expiration of this patent and related exclusivities will have significant implications for the pharmaceutical market. Generic manufacturers will be able to develop and market their own versions of the drug, potentially reducing costs and increasing accessibility for patients. This could also lead to increased competition, driving innovation and better pricing in the market.

Competitive Landscape

The pharmaceutical landscape is highly competitive, especially in the area of immunomodulating agents. The expiration of patents like 9,062,014 opens up opportunities for other companies to enter the market with generic or biosimilar products. This competition can drive down prices and improve patient outcomes by providing more treatment options.

Regulatory Considerations

Regulatory bodies like the FDA play a crucial role in ensuring that generic versions of drugs meet the same safety and efficacy standards as the original branded drug. The approval process for generics involves demonstrating bioequivalence to the branded drug, which helps maintain the quality and safety of the medications available in the market.

Economic Implications

The economic implications of patent expiration are substantial. The entry of generic drugs can significantly reduce healthcare costs by providing cheaper alternatives. For example, a study by the Generic Pharmaceutical Association found that generic drugs saved the U.S. healthcare system over $1.7 trillion from 2007 to 2016[3].

Innovation and R&D

While patent expiration can lead to increased competition and lower prices, it also underscores the need for continuous innovation in pharmaceutical research and development. Companies like Actelion Pharmaceuticals Ltd. must invest in new research to develop novel compounds and secure new patents to maintain their market position.

Conclusion

United States Patent 9,062,014 is a critical piece of intellectual property for Actelion Pharmaceuticals Ltd., covering specific crystalline forms of a thiazolidin-4-one derivative. Understanding the claims, scope, and expiration dates of this patent is essential for navigating the pharmaceutical market. As the patent approaches its expiration date, it is crucial for stakeholders to consider the regulatory, economic, and competitive implications.

Key Takeaways

• Patent Claims: The patent covers crystalline forms, preparation processes, pharmaceutical compositions, and therapeutic uses.
• Expiration Date: The patent expires on May 6, 2032.
• Exclusivities: NCE exclusivity expires on March 18, 2026.
• Market Impact: Patent expiration will open the market to generic competition.
• Regulatory Considerations: Generic drugs must demonstrate bioequivalence to the branded drug.
• Economic Implications: Generic entry can significantly reduce healthcare costs.
• Innovation: Continuous R&D is necessary to maintain market position.

FAQs

What is the main subject of United States Patent 9,062,014?

The main subject of this patent is the crystalline forms of the compound (R)-5-[3-chloro-4-(2,3-dihydroxy-propoxy)-benz[Z]ylidene]-2-([Z]-propylimino)-3-o-tolyl-thiazolidin-4-one, used in pharmaceutical compositions to treat disorders associated with an activated immune system.

Who are the inventors of this patent?

The inventors are Bonham Nicholas, Buchmann Stephan, Eberlin Alex, Imboden Christoph, and Von Raumer Markus.

What is the expiration date of this patent?

The patent is set to expire on May 6, 2032.

What are the implications of patent expiration for the pharmaceutical market?

Patent expiration will allow generic manufacturers to enter the market, potentially reducing costs and increasing accessibility for patients, while also driving competition and innovation.

How do regulatory bodies ensure the quality of generic drugs?

Regulatory bodies like the FDA ensure that generic drugs meet the same safety and efficacy standards as the original branded drug by requiring bioequivalence testing.

Cited Sources

1. Generic Ponvory Availability - Drugs.com
2. Patent Claims and Patent Scope - Hoover Institution
3. The Lens - Patent Lens
4. Generic Pharmaceutical Association (not directly cited but referenced for economic implications)

Drugs Protected by US Patent 9,062,014

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Patented / Exclusive Use	Submissiondate
Vanda Pharms Inc	PONVORY	ponesimod	TABLET;ORAL	213498-001	Mar 18, 2021		RX	Yes	Yes			Y	Y		TREATMENT OF RELAPSING FORMS OF MULTIPLE SCLEROSIS (MS), TO INCLUDE CLINICALLY ISOLATED SYNDROME, RELAPSING-REMITTING DISEASE, AND ACTIVE SECONDARY PROGRESSIVE DISEASE, IN ADULTS
Vanda Pharms Inc	PONVORY	ponesimod	TABLET;ORAL	213498-002	Mar 18, 2021		RX	Yes	No			Y	Y		TREATMENT OF RELAPSING FORMS OF MULTIPLE SCLEROSIS (MS), TO INCLUDE CLINICALLY ISOLATED SYNDROME, RELAPSING-REMITTING DISEASE, AND ACTIVE SECONDARY PROGRESSIVE DISEASE, IN ADULTS
Vanda Pharms Inc	PONVORY	ponesimod	TABLET;ORAL	213498-003	Mar 18, 2021		RX	Yes	No			Y	Y		TREATMENT OF RELAPSING FORMS OF MULTIPLE SCLEROSIS (MS), TO INCLUDE CLINICALLY ISOLATED SYNDROME, RELAPSING-REMITTING DISEASE, AND ACTIVE SECONDARY PROGRESSIVE DISEASE, IN ADULTS
Vanda Pharms Inc	PONVORY	ponesimod	TABLET;ORAL	213498-004	Mar 18, 2021		RX	Yes	No			Y	Y		TREATMENT OF RELAPSING FORMS OF MULTIPLE SCLEROSIS (MS), TO INCLUDE CLINICALLY ISOLATED SYNDROME, RELAPSING-REMITTING DISEASE, AND ACTIVE SECONDARY PROGRESSIVE DISEASE, IN ADULTS
Vanda Pharms Inc	PONVORY	ponesimod	TABLET;ORAL	213498-005	Mar 18, 2021		RX	Yes	No			Y	Y		TREATMENT OF RELAPSING FORMS OF MULTIPLE SCLEROSIS (MS), TO INCLUDE CLINICALLY ISOLATED SYNDROME, RELAPSING-REMITTING DISEASE, AND ACTIVE SECONDARY PROGRESSIVE DISEASE, IN ADULTS
Vanda Pharms Inc	PONVORY	ponesimod	TABLET;ORAL	213498-006	Mar 18, 2021		RX	Yes	No			Y	Y		TREATMENT OF RELAPSING FORMS OF MULTIPLE SCLEROSIS (MS), TO INCLUDE CLINICALLY ISOLATED SYNDROME, RELAPSING-REMITTING DISEASE, AND ACTIVE SECONDARY PROGRESSIVE DISEASE, IN ADULTS

Foreign Priority and PCT Information for Patent: 9,062,014

Foriegn Application Priority Data
Foreign Country	Foreign Patent Number	Foreign Patent Date
United Kingdom	0819182.7	Oct 20, 2008

PCT Information
PCT Filed	October 19, 2009	PCT Application Number:	PCT/IB2009/054592
PCT Publication Date:	April 29, 2010	PCT Publication Number:	WO2010/046835

International Family Members for US Patent 9,062,014

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
Argentina	073904
Australia	2009305980
Brazil	PI0919673
Canada	2740313
Chile	2011000867
China	102177144