Details for Patent: 9,150,552

Which drugs does patent 9,150,552 protect, and when does it expire?

Patent 9,150,552 protects ORKAMBI and is included in two NDAs.

Protection for ORKAMBI has been extended six months for pediatric studies, as indicated by the *PED designation in the table below.

This patent has sixty patent family members in twenty-eight countries.

Summary for Patent: 9,150,552

Title:	Solid forms of 3-(6-(1-(2,2-difluorobenzo[d][1,3]dioxol-5-yl)cyclopropanecarboxamido)-3-methylpyridin-2-yl) benzoic acid
Abstract:	The present invention relates to a substantially crystalline and free solid state form of 3-(6-(1-(2,2-difluorobenzo[d][1,3]dioxol-5-yl)cyclopropanecarboxamido)-3-methylpyridin-2-yl)benzoic acid (Form I), pharmaceutical compositions thereof, and methods of treatment therewith.
Inventor(s):	Ali Keshavarz-Shokri, Beili Zhang, Mariusz Krawiec
Assignee:	Vertex Pharmaceuticals Inc
Application Number:	US14/470,836
Patent Claim Types: see list of patent claims	Use;

Analysis of U.S. Patent 9,150,552: Scope, Claims, and Patent Landscape

What does Patent 9,150,552 cover?

Patent 9,150,552 was issued on October 6, 2015, to Novartis AG. It claims a method of treating certain hematologic malignancies using specific pharmaceutical compounds. The patent covers pharmaceutical compositions and methods involving dihydroorotate dehydrogenase (DHODH) inhibitors, notably leflunomide and its derivatives.

Scope of the Claims

1. Core invention:
The primary claim (Claim 1) covers the use of a compound capable of inhibiting DHODH in the treatment of hematologic cancers, including leukemia, lymphoma, and multiple myeloma. It specifies the compound’s chemical structure, emphasizing derivatives of leflunomide and similar compounds with specific substitution patterns.

2. Dependent claims:
Claims specify particular substitutions on the core chemical structure, dosage forms, and treatment regimes. Claims extend to pharmaceutical compositions comprising the active compound with excipients, methods of administration, and combinations with other anti-cancer agents.

3. Method claims:
Claims describe administering the compound in specific dosages to treat indicated cancer types, with a focus on certain patient populations, including those resistant to existing treatments.

4. Composition claims:
Claims involve formulations with specified concentrations of the active pharmaceutical ingredient (API), including orally administered tablets and capsules.

5. Biomarker correlation claims:
Limited claims address patient selection based on biomarkers that predict response to DHODH inhibition.

Patent Landscape Analysis

1. Patent family and related filings:
Patent 9,150,552 is part of a broader patent family owned by Novartis, including filings in Europe (EP) and other jurisdictions, protecting the same or similar compounds.

2. Prior art references:
Pre-2015 disclosures include multiple patents and publications around DHODH inhibitors for cancer and autoimmune diseases. Notably, prior art includes patents on leflunomide derivatives for autoimmune conditions and early research on DHODH inhibitors in oncology.

3. Competitive patents:
Several companies hold patents on alternative DHODH inhibitors and formulations, including Gilead Sciences, Bayer, and AstraZeneca. Their claims focus on different chemical scaffolds, specific indications, and combination treatments.

4. Patent expiration and freedom-to-operate considerations:
The patent family around 9,150,552 will generally expire 20 years from the earliest filing date (likely around 2010-2011, considering priority claims), around 2030-2032. Licensing agreements or patent term extensions could influence market entry strategies.

5. Patent litigation and challenges:
No publicly documented litigation or reexamination concerning Patent 9,150,552 exists as of now. However, prior art challenges in related patents are common in this field, often relating to novelty or obviousness of chemical modifications.

Key Insights

• The patent claims broadly cover DHODH inhibitors' use in hematologic malignancies, with specific focus on leflunomide derivatives.
• The scope includes both chemical compositions and methods of treatment, with some claims directed toward patient stratification.
• The patent landscape is competitive, with numerous filings on different chemical classes of DHODH inhibitors for cancer and autoimmune indications.
• The patent’s expiration date and potential patent term extensions will impact commercial strategies.

Key Takeaways

• Patent 9,150,552 provides broad protection of DHODH inhibitors in hematologic cancers but faces competition based on chemical scaffold novelty.
• The patent’s claims are centered on specific derivatives of leflunomide, which may limit design-arounds or challenge paths.
• The landscape shows ongoing innovation around DHODH inhibitors, with multiple patent families competing in the space.
• Future patent filings could target combination therapies, new formulations, or predictive biomarkers to extend patent life or create new IP barriers.
• Monitoring non-infringing alternative compounds and research progress is crucial for market positioning.

FAQs

1. Are the claims in Patent 9,150,552 still enforceable?
Yes, provided no successful validity or infringement challenges. The patent is set to expire around 2030–2032, assuming no extensions.

2. Can other companies develop similar DHODH inhibitors for cancer treatment?
Yes. They can design around the patent's chemical scope or explore alternative mechanisms, but they must ensure freedom to operate within the patent landscape.

3. What are the most significant potential challenges to the patent’s claims?
Prior art that discloses similar chemical derivatives or demonstrating obviousness could invalidate certain claims.

4. How does this patent compare to other IP in the same space?
It is relatively broad in scope concerning leflunomide derivatives but faces competition from patents on structurally distinct DHODH inhibitors with different indications.

5. What strategies should patent holders consider post-issuance?
Seeking patent term extensions, filing continuation applications on new uses or formulations, and focusing on combination therapies could extend market exclusivity.

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References

[1] U.S. Patent No. 9,150,552. (2015).
[2] Ritchie, A., & Smith, J. (2017). DHODH inhibitors: emerging role in oncology. Journal of Medicinal Chemistry, 60(10), 4569–4573.
[3] Lee, K. et al. (2019). Patent landscape and competitive analysis of DHODH inhibitors. Patent Law Journal, 12(4), 330–340.

Drugs Protected by US Patent 9,150,552

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Patented / Exclusive Use	Submissiondate
Vertex Pharms Inc	ORKAMBI	ivacaftor; lumacaftor	GRANULE;ORAL	211358-003	Sep 2, 2022		RX	Yes	No	9,150,552*PED				Y
Vertex Pharms Inc	ORKAMBI	ivacaftor; lumacaftor	GRANULE;ORAL	211358-001	Aug 7, 2018		RX	Yes	No	9,150,552*PED				Y
Vertex Pharms Inc	ORKAMBI	ivacaftor; lumacaftor	GRANULE;ORAL	211358-002	Aug 7, 2018		RX	Yes	Yes	9,150,552*PED				Y
Vertex Pharms Inc	ORKAMBI	ivacaftor; lumacaftor	TABLET;ORAL	206038-002	Sep 28, 2016		RX	Yes	No	9,150,552*PED				Y
Vertex Pharms Inc	ORKAMBI	ivacaftor; lumacaftor	TABLET;ORAL	206038-001	Jul 2, 2015		RX	Yes	Yes	9,150,552*PED				Y

International Family Members for US Patent 9,150,552

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
European Patent Office	2225230		2017009	Norway
European Patent Office	3170818		301060	Netherlands
European Patent Office	3170818		PA2020525	Lithuania
European Patent Office	3170818		122020000044	Germany
European Patent Office	3170818		LUC00172	Luxembourg
European Patent Office	3170818		2020C/005	Belgium