Details for Patent: 8,361,972

Which drugs does patent 8,361,972 protect, and when does it expire?

Patent 8,361,972 protects QTERN, BYDUREON, BYDUREON PEN, BYDUREON BCISE, and FARXIGA, and is included in four NDAs.

Protection for BYDUREON has been extended six months for pediatric studies, as indicated by the *PED designation in the table below.

This patent has sixty patent family members in twenty-seven countries.

Summary for Patent: 8,361,972

Title:	Pharmaceutical formulations containing an SGLT2 inhibitor
Abstract:	Pharmaceutical formulations are provided which are in the form of capsules or tablets for oral use and which include a medicament dapagliflozin or its propylene glycol hydrate ##STR00001## and a pharmaceutical acceptable carrier therefor, which formulation is designed for immediate release.
Inventor(s):	Bindra; Dilbir S. (New Brunswick, NJ), Dali; Mandar V. (New Brunswick, NJ), Parab; Prakash V. (New Brunswick, NJ), Patel; Jatin M. (New Brunswick, NJ), Tao; Li (New Brunswick, NJ), Tejwani; Ravindra W. (New Brunswick, NJ), Vatsaraj; Nipa (New Brunswick, NJ), Wu; Yongmei (New Brunswick, NJ)
Assignee:	Bristol Myers-Squibb Company (Princeton, NJ)
Application Number:	13/529,463
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for patent 8,361,972
Patent Claim Types: see list of patent claims	Use; Composition; Formulation; Dosage form;

Understanding the Scope and Claims of U.S. Patent 8,361,972: A Detailed Analysis

Introduction

U.S. Patent 8,361,972, like many pharmaceutical patents, is a complex document that outlines the intellectual property rights for a specific drug formulation. This analysis will delve into the patent's scope, claims, and the broader patent landscape, particularly in the context of pharmaceuticals.

Patent Overview

Patent Number and Title

The patent in question is U.S. Patent 8,361,972. While the specific title is not provided in the sources, it is associated with pharmaceutical formulations, as indicated by its inclusion in litigation documents related to generic versions of drugs[5].

Patent Claims

Types of Claims

Patent claims are the heart of any patent, defining the scope of protection. For U.S. Patent 8,361,972, the claims would typically include:

• Independent Claims: These are the broadest claims that define the invention.
• Dependent Claims: These are narrower claims that depend on the independent claims and further specify the invention[3].

Claim Language and Scope

The scope of patent claims is crucial for determining the breadth of protection. Metrics such as independent claim length (ICL) and independent claim count (ICC) can be used to measure patent scope. Generally, narrower claims at publication are associated with a higher probability of grant and a shorter examination process[3].

Patent Scope and Examination Process

Metrics for Measuring Scope

• Independent Claim Length (ICL): The number of words in the shortest independent claim. Shorter claims often indicate clearer and more focused inventions.
• Independent Claim Count (ICC): The total number of independent claims. Fewer independent claims can suggest a more focused invention[3].

Examination Process

The examination process at the U.S. Patent and Trademark Office (USPTO) tends to narrow the scope of patent claims. This is reflected in the reduction of claim length and count during the examination period. Longer examination durations often result in more significant scope reductions[3].

Patent Landscape in Pharmaceuticals

Evergreening and Patent Thickets

In the pharmaceutical sector, practices like evergreening and creating patent thickets are common. Evergreening involves patenting minor modifications to extend exclusivity, while patent thickets refer to the accumulation of multiple patents around a single product to delay generic competition[2].

Example: IMBRUVICA

For instance, IMBRUVICA, a drug manufactured by Johnson & Johnson, has 41 patents listed in the Orange Book, with 75% of the remaining patents being duplicative after terminal disclaimers. This highlights the complexity and potential for abuse in the patent system[1].

Litigation and Enforcement

PTAB and District Court Cases

Patents like U.S. Patent 8,361,972 are often subject to litigation, including inter partes reviews (IPRs) at the Patent Trial and Appeal Board (PTAB) and district court cases. The number of PTAB cases has risen significantly, indicating increased challenges to pharmaceutical patents[4].

Case Example: AstraZeneca’s FARXIGA

In the case of AstraZeneca’s FARXIGA, generic manufacturers have challenged the patents, including U.S. Patent 8,361,972, to gain approval for generic versions. This underscores the ongoing battle between branded and generic drug manufacturers over patent validity and enforcement[5].

Economic Impact

Cost to Medicare and Taxpayers

Patent abuses, including evergreening, can result in significant economic losses. For example, Medicare is estimated to lose between $4.9 and $5.4 billion by 2026 due to delayed access to generic and biosimilar alternatives caused by such practices[2].

Regulatory and Legislative Context

USPTO Rules and Legislative Proposals

The USPTO has proposed rules to address issues like terminal disclaimers and obviousness-type double patenting rejections. However, legislative proposals such as the PREVAIL Act could make it harder to challenge problematic patents, potentially exacerbating the issue of evergreening[1][2].

Key Takeaways

• Patent Scope and Claims: The scope of a patent is defined by its claims, with metrics like ICL and ICC providing insights into the breadth of protection.
• Evergreening and Patent Thickets: These practices are prevalent in the pharmaceutical industry and can significantly delay generic competition.
• Litigation and Enforcement: Patents are frequently challenged through PTAB and district court cases.
• Economic Impact: Patent abuses can lead to substantial economic losses for Medicare and taxpayers.
• Regulatory and Legislative Context: Ongoing regulatory and legislative changes can impact how patents are challenged and enforced.

FAQs

What is the purpose of independent claim length (ICL) and independent claim count (ICC) in patent analysis?

These metrics help measure the scope of a patent by assessing the clarity and focus of the invention. Shorter ICL and fewer ICC often indicate a more defined and narrower invention.

How do evergreening and patent thickets affect generic competition in pharmaceuticals?

Evergreening and patent thickets delay generic competition by extending exclusivity through minor modifications and accumulating multiple patents around a single product.

What is the role of the PTAB in challenging pharmaceutical patents?

The PTAB provides a forum for inter partes reviews, allowing for faster resolution of challenges to problematic patents and helping to expedite access to generic and biosimilar alternatives.

How do patent abuses impact Medicare and taxpayers?

Patent abuses, such as evergreening, can result in significant economic losses for Medicare and taxpayers by delaying access to lower-cost treatments.

What are the implications of the PREVAIL Act on patent challenges?

The PREVAIL Act could make it harder to invalidate problematic patents by raising the evidentiary standard in PTAB proceedings, potentially reducing leverage for obtaining settlements that expedite access to lower-cost alternatives.

Sources

1. Letterhead DC Office - Regulations.gov: "Our patents reflect important innovative and inventive steps..."
2. Using the Inflation Reduction Act to Rein in Patenting ...: "Using the Inflation Reduction Act to Rein in Patenting Abuses"
3. Patent Claims and Patent Scope - Hoover Institution: "Patent Claims and Patent Scope"
4. The BioLoquitur Bulletin - Seyfarth Shaw LLP: "The BioLoquitur Bulletin"
5. in the united states district court - RPX Insight: "in the united states district court"

Drugs Protected by US Patent 8,361,972

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 Ab	QTERN	dapagliflozin; saxagliptin hydrochloride	TABLET;ORAL	209091-002	May 2, 2019		RX	Yes	No	8,361,972					TREATMENT OF TYPE 2 DIABETES MELLITUS
Astrazeneca Ab	QTERN	dapagliflozin; saxagliptin hydrochloride	TABLET;ORAL	209091-001	Feb 27, 2017		RX	Yes	Yes	8,361,972					METHOD FOR TREATING TYPE 2 DIABETES MELLITUS (T2DM) IN PATIENTS WHO ARE ALREADY TREATED WITH DAPAGLIFLOZIN AND SAXAGLIPTIN
Astrazeneca Ab	QTERN	dapagliflozin; saxagliptin hydrochloride	TABLET;ORAL	209091-001	Feb 27, 2017		RX	Yes	Yes	8,361,972					METHOD FOR TREATING TYPE 2 DIABETES MELLITUS (T2DM) IN PATIENTS WHO HAVE INADEQUATE CONTROL WITH DAPAGLIFLOZIN
Astrazeneca Ab	QTERN	dapagliflozin; saxagliptin hydrochloride	TABLET;ORAL	209091-001	Feb 27, 2017		RX	Yes	Yes	8,361,972					TREATMENT OF TYPE 2 DIABETES MELLITUS
Astrazeneca Ab	BYDUREON	exenatide synthetic	FOR SUSPENSION, EXTENDED RELEASE;SUBCUTANEOUS	022200-001	Jan 27, 2012		DISCN	Yes	No	8,361,972*PED				Y

International Family Members for US Patent 8,361,972

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
European Patent Office	2139494		PA2020522	Lithuania
European Patent Office	2139494		CA 2020 00035	Denmark
European Patent Office	2139494		301054	Netherlands
European Patent Office	2139494		122020000043	Germany
European Patent Office	2139494		LUC00176	Luxembourg