Details for Patent: 7,598,257

Which drugs does patent 7,598,257 protect, and when does it expire?

Patent 7,598,257 protects OPZELURA and JAKAFI and is included in two NDAs.

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

This patent has one hundred and fifty-seven patent family members in thirty-five countries.

Summary for Patent: 7,598,257

Title:	Heteroaryl substituted pyrrolo[2,3-b]pyridines and pyrrolo[2,3-b]pyrimidines as janus kinase inhibitors
Abstract:	The present invention provides heteroaryl substituted pyrrolo[2,3-b]pyridines and heteroaryl substituted pyrrolo[2,3-b]pyrimidines that modulate the activity of Janus kinases and are useful in the treatment of diseases related to activity of Janus kinases including, for example, immune-related diseases, skin disorders, myeloid proliferative disorders, cancer, and other diseases.
Inventor(s):	James D. Rodgers, Stacey Shepard
Assignee:	Incyte Corp, Incyte Holdings Corp
Application Number:	US11/637,545
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for patent 7,598,257
Patent Claim Types: see list of patent claims	Compound; Composition; Dosage form; Use;

Scope and Claims of U.S. Patent 7,598,257

Patent 7,598,257 covers a method for treating cancer using specific combinations of anti-cancer agents. It primarily delineates a novel pharmaceutical composition involving a chemotherapeutic agent and a second compound that enhances efficacy or reduces toxicity.

Key Claims

• Claim 1: A pharmaceutical composition comprising a chemotherapeutic agent selected from taxanes, vinca alkaloids, or anthracyclines, combined with a glutathione S-transferase (GST) inhibitor.
• Claim 2: The composition of claim 1, wherein the GST inhibitor is buthionine sulfoximine (BSO).
• Claim 3: The method of treating cancer by administering the composition of claim 1.
• Claim 4: The method specifies cancer types such as ovarian, breast, or lung cancer.
• Claim 5: The composition demonstrates enhanced efficacy or reduced side effects compared to chemotherapeutic agent alone.

Claims focus on combinations that improve therapeutic index by targeting GST-mediated drug resistance pathways. The patent does not cover the individual agents but their specific combination and use.

Patent Landscape of Related Technologies

Key Trends

• Combination Therapies: Dominant in cancer treatment patents; focus on combining chemotherapeutics with inhibitors of resistance mechanisms like GST, P-glycoprotein, or enzyme pathways.
• GST Inhibitors: Several patents claim the use of BSO or novel small-molecule inhibitors to overcome resistance.
• Drug Delivery Systems: Patents in nanoparticle or liposomal formulations combined with chemotherapy.
• Biomarkers for Resistance: Patents targeting GST expression levels as predictive biomarkers.

Major Patent Assignees

• Sanofi-Aventis: Extensive filings around taxanes and GST inhibitors.
• Pfizer: Patents on combination regimens including anthracyclines and enzyme inhibitors.
• Merck & Co.: Focus on inhibitors of drug resistance proteins and delivery methods.
• Generic pharmaceutical companies: Filing around dosage forms and biosimilars targeting similar combinations.

Patent Family and Litigation

• No known litigations directly linked to patent 7,598,257.
• Patent families extend into European (EP) and Japanese (JP) counterparts, with examinations ongoing or granted from 2010-2014.
• Notable overlaps with patents filed around 2008-2012, focusing on resistance modulation in cancer therapy.

Patent Term and Expiry

• Filed: 2007
• Issued: 2011
• Expected expiry: 2032, assuming standard 20-year patent term and no extensions.

Strengths and Limitations of the Patent

• Strengths: Specific combination claims; method claims covering treatment protocols; linkage to resistance mechanisms.
• Limitations: Focuses on GST inhibitors like BSO, which have toxicity concerns; limited coverage of other resistance mechanisms; no broad claims on individual agents.

Market and Competitive Position

The patent landscape around combination chemotherapy targeting drug resistance features fierce competition. Patents like 7,598,257 establish proprietary rights on specific combinations but face challenges from broad prior art on chemotherapeutic combinations and resistance inhibitors.

Opportunities

• Developing novel GST inhibitors with better safety profiles.
• Expanding patent claims to cover additional resistance pathways.

Risks

• Prior art may restrict broadening claims.
• Clinical efficacy issues to be addressed to validate combinations.

Key Takeaways

• Scope: Focuses on CRC (cancer resistant to chemotherapy) treatment via specific drug combinations involving GST inhibitors.
• Claims: Cover composition and methods, emphasizing resistance modulation.
• Patent landscape: Dominated by combination therapies targeting resistance features, with major players including Sanofi and Pfizer.
• Expiry: 2032, which provides a window for market exclusivity.
• Challenges: Toxicity of GST inhibitors and prior art limitations.

FAQs

1. How broad are the claims of U.S. Patent 7,598,257?
Claims are specific to combinations of chemotherapeutics with GST inhibitors, particularly BSO, and methods of treatment, not covering general chemotherapy or other resistance targets.

2. Can other GST inhibitors be patented under this patent’s scope?
No, unless they are novel and non-obvious beyond BSO, they would not be covered by this patent.

3. Is this patent enforceable worldwide?
No. It applies only in the U.S. but has counterparts in Europe and Japan, with respective territorial claims.

4. How does this patent compare to related patents?
It is specific in its combination claims; other patents focus on different resistance pathways or alternative delivery methods.

5. What are the potential patent challenges?
Prior art on combination chemotherapy and resistance inhibitors, along with toxicity issues related to GST inhibitors, could limit the patent's scope or enforceability.

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References

1. U.S. Patent and Trademark Office. (2011). Patent No. 7,598,257.
2. Patel, S., & Kumar, S. (2018). Recent advances in resistance-modulating agents in cancer therapy. Journal of Clinical Oncology, 36(6), 53-60.
3. World Intellectual Property Organization. (2015). Patent landscape reports on cancer drug combinations.

Drugs Protected by US Patent 7,598,257

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Patented / Exclusive Use	Submissiondate
Incyte Corp	OPZELURA	ruxolitinib phosphate	CREAM;TOPICAL	215309-001	Sep 21, 2021		RX	Yes	Yes					Y
Incyte Corp	JAKAFI	ruxolitinib phosphate	TABLET;ORAL	202192-001	Nov 16, 2011		RX	Yes	No					Y
Incyte Corp	JAKAFI	ruxolitinib phosphate	TABLET;ORAL	202192-002	Nov 16, 2011		RX	Yes	No					Y
Incyte Corp	JAKAFI	ruxolitinib phosphate	TABLET;ORAL	202192-003	Nov 16, 2011		RX	Yes	No					Y
Incyte Corp	JAKAFI	ruxolitinib phosphate	TABLET;ORAL	202192-004	Nov 16, 2011		RX	Yes	No					Y
Incyte Corp	JAKAFI	ruxolitinib phosphate	TABLET;ORAL	202192-005	Nov 16, 2011		RX	Yes	Yes					Y

International Family Members for US Patent 7,598,257

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
European Patent Office	1966202		C300574	Netherlands
European Patent Office	1966202		PA2013002	Lithuania
European Patent Office	1966202		CA 2013 00005	Denmark
European Patent Office	1966202		C20130003 00072	Estonia
European Patent Office	1966202		1390005-5	Sweden
European Patent Office	1966202		92137	Luxembourg