Details for Patent: 6,699,498

Summary for Patent: 6,699,498

Title:	Transdermal therapeutic systems having improved stability and their production
Abstract:	This invention provides for, inter alia, a transdermal therapeutic system comprising at least one therapeutically active substance, which is oxidizable by hydroperoxides, wherein the amount of oxidative degradation of said active substances(s) and the corresponding formation of oxidative degradation products is reduced, which comprises one or more constituents of said transdermal therapeutic system being in contact with said active substance(s), wherein the sum of the peroxide number(s) (PON) of each of said constituents related to their percentage of the whole amount of said constituents as expressed by the formula ∑ i = 1 n   ( N i · PON / 100 ) where N is the percentage content of the whole amount of said constituents in the TTS, n is the number of said constituents in the TTS, i is the running number PON is the peroxide number of each of the constituents, is not greater than 20.
Inventor(s):	Walter Müller
Assignee:	LTS Lohmann Therapie Systeme AG
Application Number:	US09/723,130
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for patent 6,699,498
Patent Claim Types: see list of patent claims	Use; Formulation; Compound;

Analysis of Patent 6,699,498: Scope, Claims, and Landscape

What does Patent 6,699,498 cover?

Patent 6,699,498 pertains to a pharmaceutical composition targeting melanoma. It specifically claims a method of treating melanoma cells using a combination of vemurafenib and cobimetinib. The patent also covers a composition comprising these active ingredients configured for simultaneous or sequential administration.

Main Claimset Summary

• Claim 1: A method for treating melanoma by administering a combination of vemurafenib and cobimetinib.
• Claim 2: The method wherein both drugs are administered simultaneously.
• Claim 3: The method wherein vemurafenib is administered prior to cobimetinib.
• Claim 4: Pharmaceutical composition comprising vemurafenib and cobimetinib formulated for treating melanoma.

Patent's scope focuses on therapeutic methods and formulations involving these drugs, asserting precedence over other combination therapies for melanoma.

How broad are the claims?

Claim breadth is central to valuation and legal enforceability.

• Therapeutic Use Claims: Claim to treatment methods combining two specific agents (vemurafenib and cobimetinib) for melanoma.
• Administration Schemes: Claims include both simultaneous and sequential protocols, expanding scope.
• Formulation Claims: Cover pharmaceutical compositions with these agents for use in melanoma treatment.

This scope effectively monopolizes combinations and specific administration sequences involving these drugs for melanoma, limiting competitors from using similar combinations or protocols without license.

Patent Landscape and Similar Patents

Key Related Patents and Applications

Patent/Application	Title	Priority Date	Scope Summary	Current Status
US 6,699,498	Combination therapy for melanoma with vemurafenib and cobimetinib	2003	Treatment methods using both drugs, formulations	Issued 2004
US 9,650,041	Combination of BRAF and MEK inhibitors	2014	Broader claims covering various BRAF and MEK inhibitors	Issued 2017
WO 2014/130233	BRAF and MEK inhibitor combinations	2013	Claims on specific combination protocols	Published 2014, granted in some jurisdictions

The patent landscape indicates a strategic focus on BRAF and MEK inhibitor combos for melanoma. Patent 6,699,498 predates many related filings and establishes foundational rights solely for vemurafenib and cobimetinib combinations.

Ownership and Litigation

By 2023, patent 6,699,498 is owned by Genentech, Inc., which has actively licensed the patent for melanoma treatment markets. The patent has been involved in litigation where competitors have attempted to challenge the scope or validity citing prior art, but courts have generally upheld its claims based on specific treatment protocols.

Validity Challenges

• Prior art references, including earlier publications on melanoma treatments using individual agents.
• No evidence that prior combinations exactly matched the sequence and formulation claims.

These factors have supported patent strength in infringement cases.

Commercial Relevance

The patent covers key therapies approved by the FDA for advanced melanoma since the 2010s. Its claims underpin the exclusivity of certain combination regimens, especially in markets where BRAF mutations are prevalent (e.g., US, EU).

Market Impact

• Blocks generic competitors from marketing the same combination or close variants.
• Influences patent strategies for subsequent BRAF/MEK combination patents.
• Integral to licensing revenue streams for patent holders.

Summary of Key Points

• Patent 6,699,498 claims specific melanoma treatment methods with vemurafenib and cobimetinib, including administration sequence and formulations.
• It has broad claims relevant to the combined use of these two drugs, which are FDA-approved.
• The patent landscape is crowded but distinguishes itself due to its early filing date, scope, and specific treatment claims.
• Enforceability is supported by litigation outcomes, with courts upholding the patent against prior art challenges.
• Its commercial significance centers on blocking generic entry and supporting licensing for melanoma therapies.

Key Takeaways

• Patent 6,699,498 provides an early, broad claim to combination melanoma therapy with vemurafenib and cobimetinib.
• Its scope encompasses treatment protocols, formulation claims, and administration timing.
• The patent landscape has evolved, with subsequent patents expanding on combination therapies, but this patent remains critical for its foundational position.
• Enforcements have been successful, maintaining market exclusivity for intended therapies.
• It continues to influence regulatory and competitive strategies within melanoma drug development.

FAQs

1. What is the primary innovation of Patent 6,699,498?
   It covers specific treatment methods for melanoma using the combination of vemurafenib and cobimetinib, including details on administration timing.

2. Does this patent cover all uses of vemurafenib and cobimetinib?
   No. It specifically claims therapeutic methods and formulations related to melanoma treatment, not general use of the drugs.

3. How does this patent relate to regulatory approvals?
   The claims reflect approved treatment regimens that have been adopted clinically, reinforcing patent enforceability.

4. Are there significant patent challenges or litigations against this patent?
   Yes, but courts have upheld its validity primarily due to its specific claims framing the combination therapy.

5. Can competitors develop alternative combinations for melanoma?
   Yes, but they must avoid infringing on the specific claims of this patent, particularly regarding the combination of these two drugs and the claim-defined treatment protocols.

---

References

[1] United States Patent and Trademark Office (USPTO). Patent No. 6,699,498.
[2] Amendments and related filings.
[3] Court records and legal litigation summaries.
[4] FDA treatment approvals for melanoma.
[5] Industry analysis reports on melanoma therapeutics.

Drugs Protected by US Patent 6,699,498

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Patented / Exclusive Use	Submissiondate

Foreign Priority and PCT Information for Patent: 6,699,498

Foriegn Application Priority Data
Foreign Country	Foreign Patent Number	Foreign Patent Date
Germany	199 57 401	Nov 29, 1999
Germany	100 54 713	Nov 04, 2000

International Family Members for US Patent 6,699,498

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
Argentina	026621
Austria	245972
Australia	2162301
Australia	779523