Details for Patent: 8,071,577

Which drugs does patent 8,071,577 protect, and when does it expire?

Patent 8,071,577 protects NATAZIA and is included in one NDA.

This patent has forty-three patent family members in thirty-seven countries.

Summary for Patent: 8,071,577

Title:	Multi-phase contraceptive preparation based on a natural estrogen
Abstract:	The multiphase preparation having higher contraceptive safety and reduced side effects is based on a combination of a natural oestrogen with dienogest or drospirenone. The multiphase preparation is characterized by a first phase consisting of 2 daily dose units of 3 mg of oestradiol valerate, a second phase consisting of 2 groups of daily dose units, wherein a first group is formed by 5 daily dose units each containing a combination of 2 mg of oestradiol valerate and at least two or three times an ovulation-inhibitory dose of dienogest or drospirenone and a second group is formed by 17 daily dose units each containing a combination of 2 mg of oestradiol valerate and at least three or four times the ovulation-inhibitory dose of dienogest or drospirenone, a third phase consisting of 2 daily dose units of 1 mg of oestradiol valerate, and a further phase consisting of 2 daily dose units of pharmaceutically acceptable placebo.
Inventor(s):	Endrikat; Jan (Kirkland, CA), Duesterberg; Bernd (Oberkraemer, DE)
Assignee:	Bayer Pharma Aktiengesellschaft (Berlin, DE)
Application Number:	11/578,771
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for patent 8,071,577
Patent Claim Types: see list of patent claims	Use;

United States Patent 8,071,577: A Detailed Analysis of Scope, Claims, and Patent Landscape

Introduction

United States Patent 8,071,577, titled "Multi-phase contraceptive preparation based on a natural estrogen," is a significant patent held by Bayer Pharma AG. This patent pertains to a multiphase oral contraceptive that combines natural estrogens with synthetic progestogens, offering improved contraceptive reliability and reduced side effects.

Background of the Patent

The patent was filed on April 20, 2004, and granted on December 6, 2011. It is part of a series of patents related to Bayer's oral contraceptive drug, Natazia[2].

Scope of the Patent

Multiphase Contraceptive Preparation

The patent describes a multiphase product for contraception that utilizes a combination of natural estrogens and synthetic progestogens. This multiphase approach is designed to enhance contraceptive reliability throughout the menstrual cycle and improve cyclic bleeding behavior[1].

Phases of the Contraceptive

The multiphase product is divided into several phases:

• First Phase: Consists of 2 to 4 daily dose units, each containing exclusively natural estrogens.
• Second Phase: Divided into two groups of daily dose units. The first group includes 5 to 3 daily dose units, and the second group includes 17 to 13 daily dose units. Both groups contain a combination of at least one natural estrogen and at least one synthetic or natural progestogen[1].

Claims of the Patent

The patent includes several claims that define the scope of the invention:

• Claim 1: Describes the multiphase product with specific daily dose units containing natural estrogens and synthetic progestogens.
• Subsequent Claims: Detail the composition, dosage, and administration of the multiphase product, including the types and amounts of active ingredients in each phase[1].

Benefits of the Invention

The multiphase contraceptive preparation offers several benefits:

• Improved Contraceptive Reliability: Enhanced effectiveness in preventing pregnancy throughout the menstrual cycle.
• Better Cyclic Bleeding Behavior: More predictable and manageable menstrual bleeding.
• Reduced Side Effects: Minimization or elimination of side effects such as breast tenderness, headaches, depressive moods, and libido changes[1].

Patent Landscape

Related Patents and Applications

The patent is part of a broader family of patents and applications filed by Bayer Pharma AG. These include:

• US11/578,771: The original application filed on April 20, 2004.
• US12/726,799 and US13/020,913: Subsequent applications that were eventually abandoned but are part of the same patent family[1].

International Patent Filings

The patent has been filed in multiple countries, including Europe, Japan, Korea, China, and others, indicating a global strategy for intellectual property protection. This includes filings such as EP 1740163B2 in Europe and JP4908399B2 in Japan[1].

Litigation and Enforcement

Bayer Pharma AG has been involved in litigation to enforce this patent, notably in the case of Bayer Pharma AG v. Watson Labs., Inc., where Bayer alleged infringement of U.S. Patent No. 8,071,577 by Watson Laboratories[2][5].

Impact on the Pharmaceutical Industry

The patent has significant implications for the pharmaceutical industry, particularly in the development and marketing of oral contraceptives:

• Innovation in Contraceptives: The use of natural estrogens combined with synthetic progestogens represents an innovative approach to contraceptive formulation.
• Market Competition: The patent provides Bayer with a competitive edge in the market for oral contraceptives, allowing the company to differentiate its product based on its unique formulation and benefits[1].

Conclusion

United States Patent 8,071,577 is a critical patent in the field of oral contraceptives, offering a multiphase product that enhances contraceptive reliability and reduces side effects. The patent's scope, claims, and global filings highlight its significance in the pharmaceutical industry.

Key Takeaways

• The patent describes a multiphase oral contraceptive using natural estrogens and synthetic progestogens.
• It improves contraceptive reliability and cyclic bleeding behavior while minimizing side effects.
• The patent is part of a broader family of patents and has been filed internationally.
• Bayer has enforced this patent through litigation.
• The patent has significant implications for innovation and competition in the pharmaceutical industry.

FAQs

What is the main innovation of U.S. Patent 8,071,577?

The main innovation is the use of a multiphase approach combining natural estrogens with synthetic progestogens to enhance contraceptive reliability and reduce side effects.

Which company holds U.S. Patent 8,071,577?

Bayer Pharma AG holds this patent.

What are the benefits of the multiphase contraceptive preparation described in the patent?

The benefits include improved contraceptive reliability, better cyclic bleeding behavior, and reduced side effects such as breast tenderness, headaches, and depressive moods.

Has Bayer been involved in any litigation related to this patent?

Yes, Bayer has been involved in litigation, notably in the case of Bayer Pharma AG v. Watson Labs., Inc.

Where else has this patent been filed besides the United States?

The patent has been filed in multiple countries including Europe, Japan, Korea, China, and others.

Sources

1. Google Patents: US8071577B2 - Multi-phase contraceptive preparation based on a natural estrogen.
2. Casetext: Bayer Pharma AG v. Watson Labs., Inc.
3. USPTO: Patent Claims Research Dataset.
4. USPTO: Search for patents.
5. Vlex: Bayer Pharma AG v. Watson Labs., Inc. - Federal Cases - Case Law.

Drugs Protected by US Patent 8,071,577

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Patented / Exclusive Use	Submissiondate
Bayer Hlthcare	NATAZIA	dienogest; estradiol valerate	TABLET;ORAL	022252-001	May 6, 2010		RX	Yes	Yes			Y			PREVENTION OF PREGNANCY

Foreign Priority and PCT Information for Patent: 8,071,577

Foriegn Application Priority Data
Foreign Country	Foreign Patent Number	Foreign Patent Date
Germany	10 2004 019 743	Apr 20, 2004

PCT Information
PCT Filed	April 15, 2005	PCT Application Number:	PCT/EP2005/004022
PCT Publication Date:	November 03, 2005	PCT Publication Number:	WO2005/102247

International Family Members for US Patent 8,071,577

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
Argentina	048830
Argentina	084229
Australia	2005235418
Austria	E473734