Details for Patent: 7,468,390

Which drugs does patent 7,468,390 protect, and when does it expire?

Patent 7,468,390 protects ENTRESTO and is included in one NDA.

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

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

Summary for Patent: 7,468,390

Title:	Methods of treatment and pharmaceutical composition
Abstract:	The invention relates a pharmaceutical composition comprising a combination of: (i) the AT 1-antagonist valsartan or a pharmaceutically acceptable salt thereof; and (ii) a NEP inhibitor or a pharmaceutically acceptable salt thereof and optionally a pharmaceutically acceptable carrier and to a method for the treatment or prevention of a condition or disease selected from the group consisting of hypertension, heart failure, such as (acute and chronic) congestive heart failure, left ventricular dysfunction and hypertrophic cardiomyopathy, diabetic cardiac myopathy, supraventricular and ventricular arrhythmias, atrial fibrillation, atrial flutter, detrimental vascular remodeling, myocardial infarction and its sequelae, atherosclerosis, angina (whether unstable or stable), renal insufficiency (diabetic and non-diabetic), heart failure, angina pectoris, diabetes, secondary aldosteronism, primary and secondary pulmonary hypertension, renal failure conditions, such as diabetic nephropathy, glomerulonephritis, scleroderma, glomerular sclerosis, proteinuria of primary renal disease, and also renal vascular hypertension, diabetic retinopathy, the management of other vascular disorders, such as migraine, peripheral vascular disease, Raynaud's disease, luminal hyperplasia, cognitive dysfunction, such as Alzheimer's, glaucoma and stroke, comprising administering a therapeutically effective amount of the pharmaceutical composition to a mammal in need thereof.
Inventor(s):	Ksander; Gary Michael (Amherst, NH), Webb; Randy Lee (Flemington, NJ)
Assignee:	Novartis AG (Basel, CH)
Application Number:	10/341,868
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for patent 7,468,390
Patent Claim Types: see list of patent claims	Composition; Compound; Device;

Detailed Analysis of the Scope and Claims of United States Patent 7,468,390

Introduction

United States Patent 7,468,390 is a significant patent in the pharmaceutical industry, and understanding its scope, claims, and the surrounding patent landscape is crucial for stakeholders. This analysis will delve into the key aspects of this patent, including its ownership, claims, regulatory context, and the broader implications within the patent landscape.

Ownership and Assignment

The patent 7,468,390 is owned by Novartis Pharmaceuticals Corporation, following a series of assignments. Initially, the patent was assigned from the inventors, Gary Michael Ksander and Randy Lee Webb, to Novartis AG, and subsequently from Novartis AG to Novartis Pharmaceuticals Corporation. These assignments are recorded in the U.S. Patent and Trademark Office (USPTO)[1].

Patent Claims and Scope

The patent claims a method of using a product, which is defined under 37 C.F.R. § 1.710(b)(1). This involves specific methods of use related to the drug product that is the subject of the patent. For each pending method of use claimed by the patent, the applicant must identify the precise claim numbers and the words of the approved labeling that describe the patented method of use[4].

Regulatory Context

The patent is listed in the FDA's Orange Book, which is a critical registry for drug patents. The FDA requires detailed information for each patent submitted, including the United States Patent Number, issue date, expiration date, and the specific claims related to the pending method of use of the drug product[4].

Expiration Date and Extension

The original expiration date of the patent was November 27, 2023. However, the applicant sought a patent term extension under 35 U.S.C. § 156 and 37 C.F.R. § 1.720. The regulatory review period, which includes both the testing and application periods, was calculated to determine the extension. The extension period was determined to be 270 days, resulting in a new expiration date of October 11, 2023, although the extension is limited to a maximum of five years from the original expiration date, making the final expiration date January 14, 2028[1].

Patent Landscape and Evergreening Practices

The patent landscape surrounding 7,468,390 is complex and influenced by practices known as "evergreening." Evergreening involves patenting trivial or obvious modifications of existing medications to extend monopoly protections. This practice is particularly prevalent in the pharmaceutical industry and can significantly delay the entry of generic and biosimilar competitors, leading to higher costs for patients and healthcare systems[2].

Impact on Generic and Biosimilar Competition

The extension of patent protection through evergreening practices can prevent generic and biosimilar drugs from entering the market, resulting in significant financial losses for healthcare systems like Medicare. For instance, patent abuses on drugs subject to Medicare price negotiation have been estimated to cost taxpayers between $4.9 and $5.4 billion by January 1, 2026, due to the delayed entry of lower-cost alternatives[2].

Patent Analytics and Claim Coverage

To manage and analyze the complex landscape of patents like 7,468,390, companies use patent analytics tools. These tools help in categorizing patents by claims and scope concepts, making it easier to identify gaps in coverage and potential future design opportunities. Claim charts generated by software like ClaimScape® can be reviewed by technical experts to determine the applicability of scope concepts to target products or methods[3].

Administrative Challenges and Legislative Proposals

Patents like 7,468,390 can be challenged through administrative forums such as the Patent Trial and Appeal Board (PTAB). However, legislative proposals like the PREVAIL Act could make it harder to invalidate patents through these forums by raising the evidentiary standard, potentially further delaying access to lower-cost treatments[2].

Key Takeaways

• Ownership and Assignment: The patent is owned by Novartis Pharmaceuticals Corporation following assignments from the inventors and Novartis AG.
• Claims and Scope: The patent claims specific methods of use related to the drug product.
• Regulatory Context: Listed in the FDA's Orange Book with detailed requirements for submission.
• Expiration and Extension: Original expiration date extended due to regulatory review periods.
• Evergreening Practices: The patent is part of a broader landscape where evergreening practices extend monopoly protections.
• Impact on Competition: Delays entry of generic and biosimilar drugs, leading to significant financial losses.
• Patent Analytics: Tools like ClaimScape® help in managing and analyzing patent claims.

FAQs

Q: What is the current ownership of United States Patent 7,468,390? A: The patent is currently owned by Novartis Pharmaceuticals Corporation.

Q: What is the significance of the FDA's Orange Book in relation to this patent? A: The FDA's Orange Book is a registry where drug patents are listed, and it requires detailed information for each patent, including claim numbers and approved labeling.

Q: How does the practice of evergreening affect the patent landscape? A: Evergreening involves patenting minor modifications to extend monopoly protections, delaying the entry of generic and biosimilar competitors and increasing costs for patients and healthcare systems.

Q: What is the role of the Patent Trial and Appeal Board (PTAB) in challenging patents? A: The PTAB provides a forum for challenging problematic patents, but legislative proposals like the PREVAIL Act could make it harder to invalidate these patents.

Q: How do patent analytics tools help in managing patents like 7,468,390? A: Patent analytics tools categorize patents by claims and scope concepts, helping to identify gaps in coverage and potential future design opportunities.

Sources

1. Regulations.gov - SEP 1 2015 - Regulations.gov
2. Citizen.org - Using the Inflation Reduction Act to Rein in Patenting ...
3. SLWIP - Patent Analytics | Intellectual Property Law
4. FDA - 207620Orig1s000 - accessdata.fda.gov

Drugs Protected by US Patent 7,468,390

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Patented / Exclusive Use	Submissiondate
Novartis Pharms Corp	ENTRESTO	sacubitril; valsartan	TABLET;ORAL	207620-001	Jul 7, 2015	AB	RX	Yes	No	7,468,390*PED
Novartis Pharms Corp	ENTRESTO	sacubitril; valsartan	TABLET;ORAL	207620-002	Jul 7, 2015	AB	RX	Yes	No	7,468,390*PED
Novartis Pharms Corp	ENTRESTO	sacubitril; valsartan	TABLET;ORAL	207620-003	Jul 7, 2015	AB	RX	Yes	Yes	7,468,390*PED

International Family Members for US Patent 7,468,390

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
European Patent Office	1467728		16C0019	France
European Patent Office	1467728		19/2016	Austria
European Patent Office	1467728		300811	Netherlands
European Patent Office	1467728		93074	Luxembourg
European Patent Office	1467728		CA 2016 00022	Denmark