Details for Patent: 10,179,140

Which drugs does patent 10,179,140 protect, and when does it expire?

Patent 10,179,140 protects DROSPIRENONE and SLYND and is included in two NDAs.

This patent has sixty-six patent family members in twenty-nine countries.

Summary for Patent: 10,179,140

Title:	Pharmaceutical compositions comprising active drugs, contraceptive kits comprising active drugs, and methods of administering the same
Abstract:	A pharmaceutical composition comprising an active contraceptive drug and one or more pharmaceutically-acceptable excipients. The pharmaceutical composition, when subjected to an in vitro dissolution test according to the USP XXIII Paddle Method, results in no more than 50% of said active drug initially present being dissolved within 30 minutes, and at least 50% of the active drug being dissolved in a time range from about 3 hours to about 4 hours. The pharmaceutical composition is administered daily to a patient having a BMI of about 25 kg/m.sup.2 or more for at least a portion of a treatment cycle. The pharmaceutical composition does not cause a number of days of bleeding events in the patient exceeding an average of 15% per treatment cycle in consecutive treatment cycles of administration after an initial treatment cycle of administration.
Inventor(s):	Perrin; Philippe (Paris, FR), Drouin; Dominique (Verrieres, FR), Boyer-Joubert; Cecile (Fontenay aux Roses, FR)
Assignee:	Laboratorios Leon Farma SA (Leon, ES)
Application Number:	15/433,427
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for patent 10,179,140
Patent Claim Types: see list of patent claims	Use; Composition; Formulation; Dosage form;

Analyzing the Scope and Claims of United States Patent 10,179,140

Introduction

United States Patent 10,179,140, titled "Pharmaceutical compositions comprising active drugs, contraceptive kits comprising active drugs, and methods of administering the same," is a patent that covers specific pharmaceutical compositions and methods related to contraceptive drugs. Here, we will delve into the details of the patent's scope, claims, and the broader patent landscape it operates within.

Overview of the Patent

The patent, US10179140B2, was granted to cover pharmaceutical compositions that include active contraceptive drugs along with pharmaceutically acceptable excipients. It also encompasses contraceptive kits and methods for administering these compositions[4].

Patent Claims

Independent Claims

The patent includes several independent claims that define the scope of the invention. These claims are crucial as they outline what is considered novel and non-obvious about the invention.

• Claim 1: Typically, the first independent claim sets the broadest scope of the invention. For example, it might claim a pharmaceutical composition comprising a specific active contraceptive drug and one or more pharmaceutically acceptable excipients.
• Subsequent Independent Claims: These claims may narrow down the scope by specifying particular excipients, dosage forms, or methods of administration.

Dependent Claims

Dependent claims build upon the independent claims by adding additional limitations. These claims help to further define the invention and can provide additional protection by covering various embodiments.

• Claim 2: This might depend on Claim 1 and specify a particular type of excipient or a specific concentration of the active drug.
• Claim 3: This could depend on Claim 2 and add another limitation, such as a specific method of administration.

Scope of the Patent

The scope of the patent is determined by the language of the claims. Here are some key aspects to consider:

Independent Claim Length and Count

Research has shown that the length and count of independent claims can be metrics for measuring patent scope. Generally, narrower claims (those with fewer words and fewer claims) tend to have a higher probability of grant and a shorter examination process[3].

Claim Language

The clarity and specificity of the claim language are critical. Broader claims may be more susceptible to challenges during the examination process or in litigation. In contrast, narrower claims, while more specific, may offer stronger protection by clearly defining the invention.

Patent Subject Matter Eligibility

Under U.S. patent law, particularly Section 101, the subject matter of the patent must be eligible for patent protection. This involves ensuring that the invention does not fall into non-statutory exceptions such as abstract ideas, natural phenomena, or laws of nature.

• Alice Test: The Alice test, a two-step framework, is used to determine subject matter eligibility. Step one involves determining whether the claim is directed to a judicial exception. Step two evaluates whether the claim includes an "inventive concept" that transforms the claim into something more than just the exception itself[1].

Patent Landscape

Related Patents

The patent landscape includes other patents that may be related to the same technology or field. For example, patents related to other contraceptive drugs or methods of administration could be relevant.

• Continuation and Divisional Patents: Like in the case of Allergan USA, Inc. v. MSN Laboratories Private Ltd., multiple patents can be filed as continuations or divisionals of an original patent. These patents can extend the protection period and cover different aspects of the invention[2].

Expiration Dates and Term Adjustments

The expiration dates of patents are crucial for understanding the patent landscape. Patents typically expire 20 years from the earliest filing date, but adjustments can be made for delays in prosecution (Patent Term Adjustment, PTA) or for regulatory approvals (Patent Term Extension, PTE)[2].

Litigation and Validity

Patent validity can be challenged in various ways, including obviousness-type double patenting (ODP), lack of written description, and subject matter eligibility.

• Obviousness-Type Double Patenting: This doctrine prevents the same inventor from obtaining multiple patents for the same invention. The case of Allergan USA, Inc. v. MSN Laboratories Private Ltd. illustrates how claims can be invalidated under this doctrine if they are not patentably distinct from earlier-filed claims[2].

Industry Impact

The patent in question can have significant implications for the pharmaceutical industry, particularly in the development and marketing of contraceptive drugs.

• Innovation and Licensing: Patents like US10179140B2 can incentivize innovation by providing exclusive rights to the inventor. However, overly broad patents can increase licensing and litigation costs, potentially diminishing innovation[3].

Key Takeaways

• Patent Claims: The scope of the patent is defined by its claims, with independent claims setting the broadest scope and dependent claims adding additional limitations.
• Subject Matter Eligibility: The invention must pass the Alice test to ensure it is eligible for patent protection.
• Patent Landscape: Understanding related patents, expiration dates, and potential litigation issues is crucial for navigating the patent landscape.
• Industry Impact: Patents can drive innovation but also increase costs if they are overly broad or poorly defined.

FAQs

1. What is the primary focus of United States Patent 10,179,140?

   • The primary focus is on pharmaceutical compositions comprising active contraceptive drugs and methods of administering these compositions.

2. How are the claims structured in a patent like US10179140B2?

   • The claims are structured with independent claims defining the broadest scope and dependent claims adding additional limitations.

3. What is the Alice test, and why is it important?

   • The Alice test is a two-step framework used to determine subject matter eligibility under Section 101 of U.S. patent law. It ensures that the invention is not directed to abstract ideas, natural phenomena, or laws of nature without an inventive concept.

4. How do continuation and divisional patents affect the patent landscape?

   • These patents can extend the protection period and cover different aspects of the original invention, potentially affecting the expiration dates and the scope of protection.

5. What are the potential challenges to the validity of a patent like US10179140B2?

   • Challenges can include obviousness-type double patenting, lack of written description, and subject matter eligibility issues.

Sources

1. BitLaw - Patent Law in the United States
2. ALLERGAN USA, INC. v. MSN LABORATORIES PRIVATE LTD.
3. Hoover Institution - Patent Claims and Patent Scope
4. Google Patents - US10179140B2

Drugs Protected by US Patent 10,179,140

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Patented / Exclusive Use	Submissiondate
Exeltis Usa Inc	DROSPIRENONE	drospirenone	TABLET, CHEWABLE;ORAL	216285-001	Jun 29, 2022		DISCN	Yes	No	10,179,140					PREVENTION OF PREGNANCY IN FEMALES OF REPRODUCTIVE AGE
Exeltis Usa Inc	SLYND	drospirenone	TABLET;ORAL	211367-001	May 23, 2019		RX	Yes	Yes	10,179,140					PREVENTION OF PREGNANCY IN FEMALES OF REPRODUCTIVE AGE

International Family Members for US Patent 10,179,140

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
European Patent Office	2588114		CA 2020 00023	Denmark
European Patent Office	2588114		2020C/518	Belgium
European Patent Office	2588114		19/2020	Austria