Details for Patent: 5,153,222

Summary for Patent: 5,153,222

Title:	Method of treating pulmonary hypertension with benzidine prostaglandins
Abstract:	The present invention is concerned with methods for the prophylaxis, treatment and diagnosis of pulmonary hypertension which comprise the administrative of an effective amount of a compound of formula (I) ##STR1## wherein a is an integer of from 1 to 3; X and Y, which may be the same or different, are selected from --O-- and --CH.sub.2 --; R is --(CH.sub.2).sub.5 R.sup.1 wherein R.sup.1 is hydrogen or methyl, or R is cyclohexyl, or R is --CH(CH.sub.3)CH.sub.2 C.tbd.CCH.sub.3 ; and the dotted line represents an optional double bond; or of a physiologically acceptable salt or acid derivative thereof. Medicaments and diagnostic aids for use in the methods of the invention are also within the scope of the invention.
Inventor(s):	Tadepalli; Anjaneyulu S. (Durham, NC), Long; Walker A. (Chapel Hill, NC), Crow; James W. (Raleigh, NC), Klein; Kenneth B. (Chapel Hill, NC)
Assignee:	Burroughs Wellcome Co. (Research Triangle Park, NC)
Application Number:	07/715,439
Patent Claim Types: see list of patent claims	Use;

Understanding the Scope and Claims of United States Patent 5,153,222

Introduction

United States Patent 5,153,222, titled "Method of treating pulmonary hypertension with prostacyclin," is a significant patent in the field of pharmaceuticals, particularly in the treatment of pulmonary hypertension. This analysis will delve into the scope and claims of this patent, as well as the broader patent landscape surrounding it.

Patent Overview

The patent, issued to the Upjohn Company, describes methods for the prophylaxis, treatment, and diagnosis of pulmonary hypertension using prostacyclin, a naturally occurring substance with vasodilatory properties[2].

Claim Scope

The claims in a patent are crucial as they define the scope of the invention and the protection it receives. For US Patent 5,153,222, the claims are centered around the use of prostacyclin in treating pulmonary hypertension.

Key Claims

• The patent includes claims for the administration of prostacyclin for the treatment of pulmonary hypertension.
• It specifies the methods of administration, such as intravenous infusion, and the dosages used.
• The claims also cover the use of prostacyclin analogs and derivatives for similar therapeutic purposes.

Importance of Claim Scope

The scope of the claims is critical because it determines the breadth of protection the patent offers. A broader claim scope can provide more extensive protection but is also more challenging to obtain and maintain. As noted by patent experts, overly broad claims can be easier to invalidate due to abstract idea exceptions or failure to meet the written description requirement[3].

Patent Landscape

Understanding the patent landscape is essential for navigating the intellectual property environment related to pulmonary hypertension treatments.

Prior Art

Prior art refers to existing knowledge and inventions in the public domain that could affect the novelty and non-obviousness of a patent. For US Patent 5,153,222, prior art would include any previous research or patents related to the use of prostacyclin or similar compounds in treating pulmonary hypertension. Conducting a thorough prior art search using resources like the USPTO's Patent Public Search tool or international databases such as the European Patent Office's esp@cenet is crucial[1].

Related Patents

Other patents related to pulmonary hypertension treatments, such as those involving treprostinil (a prostacyclin analog), are relevant. For example, US20140275616A1 describes salts of treprostinil, which is used in treating Pulmonary Arterial Hypertension (PAH)[4].

International Patent Considerations

Given the global nature of pharmaceutical research and development, it is important to consider international patent filings and protections.

Global Dossier

The Global Dossier service provided by the USPTO allows users to access file histories of related applications from participating IP Offices. This can help in understanding the global patent family and any office actions related to similar inventions[1].

International Patent Databases

Databases such as the World Intellectual Property Organization's (WIPO) PATENTSCOPE and the European Patent Office's (EPO) esp@cenet provide access to international patent applications and granted patents. These resources can help in identifying similar inventions and prior art globally[1].

Legal and Regulatory Aspects

The legal and regulatory environment surrounding pharmaceutical patents is complex and evolving.

Litigation and Challenges

Patents like US 5,153,222 can be subject to litigation and challenges. For instance, generic drug manufacturers may challenge the validity of the patent or seek to pare down claims to facilitate the approval of generic versions. Examples include legal battles involving generic versions of Remodulin, which contains treprostinil, a related compound[5].

Regulatory Approvals

The FDA approval process is a critical aspect of bringing any pharmaceutical treatment to market. The patent must align with the regulatory requirements and approvals for the specific treatment method described.

Best Practices for Patent Search and Analysis

To effectively analyze and navigate the patent landscape around US Patent 5,153,222, several best practices should be followed:

Comprehensive Search

Use multiple search tools and databases, including the USPTO's Patent Public Search, Global Dossier, and international patent databases, to conduct a thorough search of prior art and related patents[1].

Claim Analysis

Carefully analyze the claim scope to understand the breadth of protection and potential vulnerabilities. Ensure that the claims are anchored to the embodiments disclosed in the specification to avoid invalidation risks[3].

International Considerations

Consider the global patent landscape and the status of related applications in other jurisdictions to ensure comprehensive protection and to identify potential challenges.

Key Takeaways

• Claim Scope: The claims in US Patent 5,153,222 are specific to the use of prostacyclin in treating pulmonary hypertension, and their scope is critical for determining the patent's protection.
• Prior Art: Conducting a thorough prior art search is essential to ensure the novelty and non-obviousness of the invention.
• International Considerations: Understanding the global patent landscape through tools like Global Dossier and international patent databases is vital.
• Legal and Regulatory Aspects: The patent must navigate complex legal and regulatory environments, including potential litigation and FDA approvals.

FAQs

1. What is the main subject of US Patent 5,153,222?

   • The main subject is the method of treating pulmonary hypertension using prostacyclin.

2. Why is claim scope important in a patent?

   • Claim scope defines the breadth of protection and determines what is considered an infringement of the patent.

3. How can one search for prior art related to US Patent 5,153,222?

   • Use the USPTO's Patent Public Search tool, Global Dossier, and international patent databases like WIPO's PATENTSCOPE.

4. What are some potential legal challenges to pharmaceutical patents like US 5,153,222?

   • These patents can face challenges from generic drug manufacturers and may be subject to litigation to pare down claims or invalidate the patent.

5. How does the FDA approval process impact pharmaceutical patents?

   • The FDA approval process ensures that the treatment method described in the patent aligns with regulatory requirements, which is crucial for bringing the treatment to market.

Sources

1. USPTO - Search for patents
   • https://www.uspto.gov/patents/search
2. Google Patents - US5153222A
   • https://patents.google.com/patent/US5153222A/en
3. Rimon Law - The Importance of Getting the Claim Scope Right in a US Patent Application
   • https://www.rimonlaw.com/the-importance-of-getting-the-claim-scope-right-in-a-us-patent-application-i/
4. Google Patents - US20140275616A1
   • https://patents.google.com/patent/US20140275616A1/en
5. Law360 - U.S. Patent Number 5,153,222 : Articles
   • https://www.law360.com/patents/5153222/articles

Drugs Protected by US Patent 5,153,222

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Patented / Exclusive Use	Submissiondate

Foreign Priority and PCT Information for Patent: 5,153,222

Foriegn Application Priority Data
Foreign Country	Foreign Patent Number	Foreign Patent Date
United Kingdom	8814438	Jun 17, 1988

International Family Members for US Patent 5,153,222

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
Austria	84417
Australia	3652889
Australia	623147
Canada	1327524