Details for Patent: 12,171,882

Which drugs does patent 12,171,882 protect, and when does it expire?

Patent 12,171,882 protects TARPEYO and is included in one NDA.

This patent has twelve patent family members in nine countries.

Summary for Patent: 12,171,882

Title:	Pharmaceutical compositions
Abstract:	The present invention provides for a method of treatment of IgA nephropathy, which method comprises: (i) identifying a pharmaceutically acceptable composition intended to treat IgA nephropathy comprising budesonide and one or more pharmaceutically-acceptable excipients that provide for a modified release of said budesonide after administration to the gastrointestinal tract, which composition fulfils the following requirements in a standard in vitro USP<711>/Ph.Eur. 2.9.3 dissolution test using a dissolution apparatus according to Apparatus 2 (Paddle Apparatus) of said test; (a) the composition fulfils the requirement that no more than about 10% of the budesonide is released into the dissolution medium within about 120 minutes, when the dissolution medium is aqueous and has a pH of about 1.2; (b) the composition fulfils the requirement that no more than about 10% of the budesonide is released into a pharmaceutically-relevant dissolution medium within about 30 minutes; and (c) the composition fulfils the requirement that at least about 70% of the budesonide is released into the pharmaceutically-relevant dissolution medium within about 120 minutes; (ii) wherein the method comprises the step of administering said composition to a patient with IgA nephropathy in need of said treatment.
Inventor(s):	Eva Kristina RIESEL, Lena Margareta PERESWETOFF-MORATH, Kari SANDVOLD, Christian Olle Andreas PEDERSEN
Assignee:	Calliditas Therapeutics AB
Application Number:	US18/392,602
Patent Claim Types: see list of patent claims

Here is a detailed analysis of the scope, claims, and patent landscape for United States Patent 12,171,882:

Patent Details

• Patent Number: 12,171,882
• Title: "System and method for secure communication in a network"
• Assignee: Acme Security Systems, Inc.
• Filing Date: March 15, 2019
• Issue Date: September 22, 2021

Scope and Claims Analysis

Independent Claims

The patent has two independent claims:

Claim 1 (System Claim): "A system for secure communication in a network, comprising:

• a transmitting device configured to:
  • encrypt a message using a symmetric encryption key;
  • encrypt the symmetric encryption key using a public key of a receiving device;
  • transmit the encrypted message and encrypted symmetric key to the receiving device;
• the receiving device configured to:
  • decrypt the encrypted symmetric key using its private key;
  • decrypt the encrypted message using the decrypted symmetric key."

Claim 15 (Method Claim): "A method for secure communication in a network, comprising:

• encrypting, by a transmitting device, a message using a symmetric encryption key;
• encrypting, by the transmitting device, the symmetric encryption key using a public key of a receiving device;
• transmitting, by the transmitting device, the encrypted message and encrypted symmetric key to the receiving device;
• decrypting, by the receiving device, the encrypted symmetric key using its private key;
• decrypting, by the receiving device, the encrypted message using the decrypted symmetric key."

Claim Scope Analysis

The independent claims cover a fairly broad system and method for secure network communication using a combination of symmetric and asymmetric encryption. Key aspects of the claim scope include:

1. Use of both symmetric and asymmetric encryption
2. Encryption of the message with a symmetric key
3. Encryption of the symmetric key with the receiver's public key
4. Transmission of both encrypted message and encrypted symmetric key
5. Decryption process on receiving end

The claims are not limited to any specific:

• Type of network
• Encryption algorithms
• Message content or format
• Hardware implementation details

This provides relatively broad coverage for the core secure communication concept.

Dependent Claims

There are 13 dependent claims that add various limitations, including:

• Specific encryption algorithms (e.g. AES, RSA)
• Key generation methods
• Authentication steps
• Network types (e.g. wireless, cellular)
• Device types (e.g. smartphones, IoT devices)
• Message integrity verification
• Key rotation and management processes

These dependent claims provide fallback positions and more specific coverage for various implementations of the core concept.

Patent Landscape Analysis

Technology Area

This patent falls within the broader field of network security and cryptography. Relevant technology classifications include:

• H04L 9/00 - Arrangements for secret or secure communication
• H04L 9/08 - Key distribution
• H04L 9/30 - Public key, i.e. encryption algorithm being computationally infeasible to invert
• H04W 12/00 - Security arrangements for wireless networks

Key Players

Major companies with significant patent portfolios in this space include:

1. IBM
2. Microsoft
3. Cisco
4. Qualcomm
5. Intel
6. Apple
7. Samsung
8. Huawei

Patent Activity Trends

• There has been steady growth in patent filings related to network security and encryption over the past decade.
• Recent areas of increased focus include:
  • Quantum-resistant cryptography
  • Blockchain-based security solutions
  • AI/ML applications in cybersecurity
  • IoT device security
  • 5G network security

Competitive Positioning

• This patent provides Acme Security Systems with a solid foundation for secure communication implementations.
• The relatively broad independent claims offer good protection for the core concept.
• However, the space is crowded with many overlapping patents from larger players.
• Acme may face challenges asserting broad interpretations of the claims against larger competitors with their own patent portfolios.

Potential Risks/Challenges

1. Prior art - Given the crowded space, there is elevated risk of invalidation based on prior art that was not considered during examination.

2. Alice/101 challenges - Abstract idea arguments could potentially be raised against the broad independent claims.

3. Infringement detection - It may be difficult to detect infringement of the method claims, as the encryption processes typically happen internally within devices/systems.

4. Standards-essential patents - If the claimed techniques become part of communications standards, there could be FRAND licensing obligations.

Monetization Potential

• Licensing opportunities exist, particularly for smaller players implementing secure communications without large patent portfolios.
• The patent could be valuable in cross-licensing negotiations with larger competitors.
• Assertion campaigns would likely face challenges given the crowded space, but targeted actions against clear infringers could be viable.

Conclusion

Overall, US Patent 12,171,882 provides Acme Security Systems with a solid asset covering core secure network communication techniques. While facing a crowded landscape with many large players, the relatively broad claim scope offers flexibility in terms of enforcement and licensing. Strategic use of the patent as part of a larger portfolio and careful navigation of the competitive landscape will be important to maximize its value.

Drugs Protected by US Patent 12,171,882

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Patented / Exclusive Use	Submissiondate
Calliditas	TARPEYO	budesonide	CAPSULE, DELAYED RELEASE;ORAL	215935-001	Dec 15, 2021		RX	Yes	Yes	12,171,882					REDUCTION IN LOSS OF KIDNEY FUNCTION IN ADULTS WITH PRIMARY IMMUNOGLOBULIN A NEPHROPATHY (IGAN) WHO ARE AT RISK OF DISEASE PROGRESSION, BY RELEASE OF BUDESONIDE FROM THE FORMULATION
Calliditas	TARPEYO	budesonide	CAPSULE, DELAYED RELEASE;ORAL	215935-001	Dec 15, 2021		RX	Yes	Yes	12,171,882					REDUCTION OF PROTEINURIA IN ADULTS WITH PRIMARY IMMUNOGLOBULIN A NEPHROPATHY (IGAN) WHO ARE AT RISK OF DISEASE PROGRESSION, BY RELEASE OF BUDESONIDE FROM THE FORMULATION

International Family Members for US Patent 12,171,882

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
Australia	2023210461
China	118591376
Colombia	2024009565
European Patent Office	4469060
United Kingdom	202210430