Details for Patent: 8,604,064

Which drugs does patent 8,604,064 protect, and when does it expire?

Patent 8,604,064 protects DALIRESP and is included in one NDA.

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

Summary for Patent: 8,604,064

Title:	Process for the preparation of roflumilast
Abstract:	A method for the treatment of chronic obstructive pulmonary disease (COPD), including administering to a patient suffering from COPD, a therapeutically effective amount of roflumilast having a purity of greater than or equal to 99% by weight, and N-(3,5-dichloropyrid-4-yl)-3-cyclopropylmethoxy-4-hydroxybenzamide present (relative to roflumilast) in an amount greater than zero and less than 0.1% by weight.
Inventor(s):	Kohl; Bernhard (Constance, DE), Mueller; Bernd (Constance, DE), Palosch; Walter (Rielasingen, DE)
Assignee:	Takeda GmbH (Constance, DE)
Application Number:	13/860,248
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for patent 8,604,064
Patent Claim Types: see list of patent claims	Use; Composition; Dosage form; Formulation;

Understanding the Scope and Claims of United States Patent 8,604,064

Introduction

United States Patent 8,604,064, hereafter referred to as the '064 Patent, is part of a family of patents owned by AstraZeneca AB, which are crucial in the protection of the drug roflumilast. This patent is significant in the pharmaceutical industry, particularly in the treatment of chronic obstructive pulmonary disease (COPD) and other airway disorders.

Patent Background

The '064 Patent, along with U.S. Patent Nos. 8,536,206 and 8,618,142, forms a group of patents known as the Patents-at-Issue. These patents are related to U.S. Patent No. 7,470,791, which describes novel processes for the production of highly pure roflumilast[1][2].

Claim Construction

Claim construction is a critical aspect of patent law, as it defines the scope of the inventor's right to exclude others from making, using, or selling the invention. The Federal Circuit has established that claim construction is a matter of law for the court to determine, and it must be based on the plain and ordinary meaning of the claim terms as understood by one of ordinary skill in the art[1].

Key Claims of the '064 Patent

The '064 Patent includes claims related to methods for treating acute or chronic airway disorders using highly pure roflumilast. Here are some key aspects:

Methods of Treatment

• The patent claims methods for treating COPD and other airway disorders in patients using roflumilast. These methods are detailed in the claims of the '064 Patent, which specify the use of highly pure roflumilast for therapeutic purposes[1][5].

Pharmaceutical Compositions

• The patent also covers pharmaceutical compositions, dosage forms, and tablets containing roflumilast. These compositions are designed to deliver the drug in an effective and stable form[1].

Scope of Protection

The scope of protection for the '064 Patent is defined by its claims and the specifications provided in the patent document.

Definition of Roflumilast

• The term "roflumilast" is clearly defined in the patent specifications as "N-(3,5-dichloropyrid-4-yl)-3-cyclopropylmethoxy-4-difluoromethoxybenzamide (INN: roflumilast)"[1].

Process Patents

• The '064 Patent, along with the '206 Patent, is a process patent that claims methods for the treatment of airway disorders. This distinguishes it from product patents, which would claim the drug itself[1].

Patent Landscape

The patent landscape surrounding the '064 Patent is complex and involves several key players and legal considerations.

Litigation and Infringement

• The '064 Patent has been involved in several patent infringement cases, notably against generic drug manufacturers like Apotex and Aurobindo Pharma. These cases often revolve around Abbreviated New Drug Applications (ANDAs) filed with the FDA, which seek approval to market generic versions of the drug before the patent expires[2][5].

Jurisdiction and Personal Jurisdiction

• Courts have jurisdiction over these cases under 28 U.S.C. §§ 1331 and 1338. Personal jurisdiction is often established based on the defendants' systematic contacts with the state where the lawsuit is filed, such as New Jersey in the case of Aurobindo Pharma USA Inc.[2].

Economic and Technological Trends

The '064 Patent is part of a broader trend in patent activity, particularly in the pharmaceutical and biotechnology sectors.

USPTO Patent Activity

• In 2018, the USPTO granted 309,000 utility patents, with a significant portion going to businesses. The pharmaceutical sector, while not the largest, is a significant recipient of these patents, reflecting ongoing innovation in drug development and treatment methods[4].

Technological Fields

• Patents in the pharmaceutical field are classified under various technological fields, including chemistry and instruments. The increase in electrical engineering patents, driven by information and communication technologies (ICT), also has implications for the development of new drugs and treatments[4].

Industry Impact

The '064 Patent and its associated patents have a substantial impact on the pharmaceutical industry.

Market Protection

• These patents protect AstraZeneca's market position for Daliresp®, the brand name for roflumilast, by preventing generic manufacturers from entering the market until the patents expire[5].

Innovation

• The protection afforded by these patents incentivizes further innovation in drug development and treatment methods. Companies are more likely to invest in research and development when they can expect a period of exclusivity for their inventions[4].

Legal Considerations

Several legal principles are crucial in understanding the scope and claims of the '064 Patent.

Clear Disavowal

• The Federal Circuit emphasizes the importance of clear disavowal or contrary definition in claim construction. Statements made during prosecution must clearly disavow or redefine claim terms to limit the claim scope[1].

Prosecution History

• The prosecution history of the patent, including statements made during the application process, can influence claim construction. However, absent a clear disavowal, the plain and ordinary meaning of the claim terms prevails[1].

Conclusion

The '064 Patent is a significant component of the intellectual property landscape for roflumilast, a drug used in treating COPD and other airway disorders. Understanding its claims, scope, and the broader patent landscape is essential for both pharmaceutical companies and generic manufacturers.

Key Takeaways

• Claim Construction: The '064 Patent's claims are interpreted based on their plain and ordinary meaning.
• Scope of Protection: The patent protects methods for treating airway disorders using highly pure roflumilast and related pharmaceutical compositions.
• Litigation: The patent has been involved in several infringement cases against generic drug manufacturers.
• Economic Impact: The patent protects AstraZeneca's market position and incentivizes innovation in drug development.
• Legal Considerations: Clear disavowal and prosecution history are critical in claim construction.

FAQs

What is the main subject of the '064 Patent?

The '064 Patent primarily covers methods for treating acute or chronic airway disorders using highly pure roflumilast.

Who is the current owner of the '064 Patent?

The '064 Patent is owned by AstraZeneca AB.

What are the key claims of the '064 Patent?

The key claims include methods for treating COPD and other airway disorders, as well as pharmaceutical compositions and dosage forms containing roflumilast.

Why is the '064 Patent important in the pharmaceutical industry?

The '064 Patent protects AstraZeneca's market position for Daliresp® and incentivizes innovation in drug development.

What legal principles are important in interpreting the '064 Patent?

Clear disavowal and the plain and ordinary meaning of claim terms are crucial in claim construction.

Sources

1. In re Certain Consol. Roflumilast Cases, Civ. Action No. - Casetext.
2. John E. Flaherty Ravin P. Patel MCCARTER & ENGLISH LLP Four ... - Insight.RPXCorp.
3. Patent Claims Research Dataset - USPTO.
4. Invention: U.S. and Comparative Global Trends - NCSES.NSF.
5. John E. Flaherty Ravin R. Patel McCARTER & ENGLISH LLP Four ... - Insight.RPXCorp.

Drugs Protected by US Patent 8,604,064

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Patented / Exclusive Use	Submissiondate
Astrazeneca	DALIRESP	roflumilast	TABLET;ORAL	022522-002	Jan 23, 2018	AB	RX	Yes	No	8,604,064					TREATMENT TO REDUCE THE RISK OF COPD EXACERBATIONS IN PATIENTS WITH SEVERE COPD ASSOCIATED WITH CHRONIC BRONCHITIS AND A HISTORY OF EXACERBATIONS
Astrazeneca	DALIRESP	roflumilast	TABLET;ORAL	022522-001	Feb 28, 2011	AB	RX	Yes	Yes	8,604,064					TREATMENT TO REDUCE THE RISK OF COPD EXACERBATIONS IN PATIENTS WITH SEVERE COPD ASSOCIATED WITH CHRONIC BRONCHITIS AND A HISTORY OF EXACERBATIONS

Foreign Priority and PCT Information for Patent: 8,604,064

Foriegn Application Priority Data
Foreign Country	Foreign Patent Number	Foreign Patent Date
	03005245	Mar 10, 2003

International Family Members for US Patent 8,604,064

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
European Patent Office	1606261		PA2010010	Lithuania
European Patent Office	1606261		C20100008 00033	Estonia
European Patent Office	1606261		PA2010010,C1606261	Lithuania
European Patent Office	1606261		C 2010 014	Romania
Argentina	043531
Austria	447555