United States Patent 11,123,299: A Detailed Analysis of Scope, Claims, and Patent Landscape
Introduction
United States Patent 11,123,299, hereafter referred to as the '299 patent, is a critical component of the intellectual property portfolio related to the contraceptive drug SLYND®, developed and marketed by Exeltis USA, Inc. This patent is central to ongoing litigation and plays a significant role in the pharmaceutical industry, particularly in the realm of contraceptive medications.
Background of the Patent
The '299 patent is one of several patents listed in the FDA’s Orange Book for SLYND®, a progestin-only birth control pill containing drospirenone. This patent, along with others, is the subject of a patent infringement lawsuit filed by Exeltis USA, Inc. against Lupin Ltd. and its subsidiaries[2].
Claims of the Patent
The '299 patent includes several claims, but the most relevant for this analysis is claim 14. Here is a detailed breakdown of this claim:
- Claim 14:
- A pharmaceutical composition comprising drospirenone in the form of particles with specific size parameters:
- Median particle size ranging from 10 micrometers (µm) to 30 µm.
- d90 particle size of less than 100 µm.
- d10 particle size of more than 3 µm.
- The drospirenone is present in an amount ranging from 3 milligrams (mg) to 4.5 mg.
- The composition includes one or more pharmaceutically acceptable excipients[1].
Claim Construction
The court has provided specific constructions for terms within the claims of the '299 patent:
- Particle Size:
- Construed to mean "particle size as determined by any means," not limited to volume-based techniques[1].
- In Vitro Dissolution Test:
- Construed as "an in vitro dissolution test using the USP XXIII Paddle Method," without requiring specific test conditions[1].
- Particles Comprising Drospirenone:
- Construed as "discrete units of material which include drospirenone"[1].
Patent Scope and Validity
The scope of the '299 patent is defined by its claims and the written description requirement under 35 U.S.C. § 112. Here are key points regarding its scope and validity:
- Written Description Requirement:
- The specification must clearly allow persons of ordinary skill in the art to recognize that the inventor invented what is claimed. This involves an objective inquiry into the four corners of the specification[1].
- Indefiniteness:
- The party raising indefiniteness bears the burden of proving it by clear and convincing evidence. The claims must be clear and definite to avoid indefiniteness[1].
Litigation and Infringement
The '299 patent is at the center of a patent infringement lawsuit under the Hatch-Waxman Act. Here are the key points related to the litigation:
- Defendants and Plaintiffs:
- Exeltis USA, Inc., Leon Farma, Chemo Iberica, and Chemo Research (plaintiffs) are suing Lupin Ltd. and Lupin Pharmaceuticals, Inc. (defendants) for patent infringement[2].
- Abbreviated New Drug Application (ANDA):
- Lupin’s filing of an ANDA for a generic version of SLYND® triggered the lawsuit, as it was filed before the expiration of the '299 patent and other related patents[2].
- Trial and Findings:
- A four-day bench trial was conducted from February 26–29, 2024, focusing on infringement and invalidity arguments, including obviousness, written description, and indefiniteness[2].
Patent Landscape
The '299 patent is part of a broader patent landscape related to SLYND® and contraceptive medications:
- Orange Book Listings:
- The '299 patent is one of fourteen patents listed in the FDA’s Orange Book for SLYND®[2].
- Related Patents:
- Other patents involved in the litigation include U.S. Patent Nos. 11,291,632, 11,351,122, 11,413,249, and 11,478,487, among others[2].
Impact on Innovation and Industry
The scope and claims of the '299 patent have significant implications for innovation and the pharmaceutical industry:
- Patent Scope Metrics:
- Research suggests that narrower claims, such as those in the '299 patent, are associated with a higher probability of grant and a shorter examination process. This can influence the incentives for innovation by reducing licensing and litigation costs[3].
- Competition and Generic Entry:
- The litigation surrounding the '299 patent highlights the challenges generic manufacturers face when seeking to enter the market. The patent's scope and validity directly impact the timing and feasibility of generic competition[2].
Conclusion and Key Takeaways
- Specific Claims: The '299 patent includes detailed claims regarding the particle size and composition of drospirenone, which are crucial for its validity and infringement analysis.
- Litigation: The patent is central to ongoing litigation under the Hatch-Waxman Act, involving Exeltis USA, Inc. and Lupin Ltd.
- Patent Scope: The patent's scope is defined by its claims and the written description requirement, with implications for innovation and industry competition.
- Impact on Industry: The '299 patent affects the entry of generic competitors and the overall landscape of contraceptive medications.
FAQs
Q: What is the main subject matter of U.S. Patent 11,123,299?
A: The main subject matter is a pharmaceutical composition comprising drospirenone in specific particle sizes and amounts, used in the contraceptive drug SLYND®.
Q: What are the key claims of the '299 patent?
A: Claim 14 specifies the particle size parameters and the amount of drospirenone in the composition, along with the inclusion of pharmaceutically acceptable excipients.
Q: Why is the '299 patent involved in litigation?
A: The patent is involved in a lawsuit under the Hatch-Waxman Act due to Lupin’s filing of an ANDA for a generic version of SLYND® before the patent’s expiration.
Q: How does the '299 patent impact the pharmaceutical industry?
A: It affects the timing and feasibility of generic competition, influencing innovation and the costs associated with licensing and litigation.
Q: What is the significance of the Orange Book listing for the '299 patent?
A: The listing in the FDA’s Orange Book indicates that the patent is associated with an approved drug product, SLYND®, and is a key factor in determining patent infringement and validity.
Cited Sources:
- IN THE UNITED STATES DISTRICT COURT FOR THE DISTRICT OF DELAWARE, Exeltis USA, Inc. v. Lupin Ltd., No. 1:22-cv-00434-RGA-MPT.
- IN THE UNITED STATES DISTRICT COURT FOR THE DISTRICT OF DELAWARE, Exeltis USA, Inc. et al v. Lupin Ltd. et al, No. 1:24-cv-00732-UNA.
- Patent Claims and Patent Scope, SSRN, September 29, 2016.
