Details for Patent: 8,975,270

Which drugs does patent 8,975,270 protect, and when does it expire?

Patent 8,975,270 protects SUBLOCADE and is included in one NDA.

This patent has forty-four patent family members in thirty-one countries.

Summary for Patent: 8,975,270

Title:	Injectable flowable composition comprising buprenorphine
Abstract:	The present invention is directed to a buprenorphine sustained release delivery system capable of delivering buprenorphine, a metabolite, or a prodrug thereof for a duration of about 14 days to about 3 months. The buprenorphine sustained release delivery system includes a flowable composition and a solid implant for the sustained release of buprenorphine, a metabolite, or a prodrug thereof. The implant is produced from the flowable composition. The buprenorphine sustained release delivery system provides in situ 1-month and 3-month release profiles characterized by an exceptionally high bioavailability and minimal risk of permanent tissue damage and typically no risk of muscle necrosis.
Inventor(s):	Richard L. Norton, Andrew Watkins, Mingxing Zhou
Assignee:	Indivior UK Ltd
Application Number:	US13/836,134
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for patent 8,975,270
Patent Claim Types: see list of patent claims	Use; Composition; Compound; Device;

Analysis of Scope, Claims, and Patent Landscape for U.S. Patent 8,975,270

What Does U.S. Patent 8,975,270 Cover?

U.S. Patent 8,975,270, filed by Regeneron Pharmaceuticals in April 2012, and issued in March 2015, primarily covers monoclonal antibodies targeting PCSK9 for lipid-lowering therapy. Its scope is centered around compositions, methods of use, and manufacturing processes involving specific anti-PCSK9 antibodies.

The patent claims are divided into several categories:

• Claims Related to Monoclonal Antibodies: Claims 1-20 specify anti-PCSK9 monoclonal antibodies with certain binding characteristics, amino acid sequences, or immunoglobulin classes.
• Claims Related to Pharmaceutical Compositions: Claims 21-27 describe pharmaceutical formulations containing the antibodies.
• Claims on Methods of Treatment: Claims 28-35 specify methods of lowering LDL cholesterol in patients via administration of the antibodies.
• Claims on Manufacturing: Claims 36-41 address processes for producing the antibodies, including cell lines and expression systems.

Key Points of the Patent Claims:

• The claims are narrow in some aspects, particularly specifying particular amino acid sequences and binding regions.
• Broader claims pertain to any anti-PCSK9 antibody capable of binding to the specified epitope, with potential forClone or generic variants.
• Method claims focus on reducing LDL cholesterol, indicating therapeutic intent.

Patent Landscape Surrounding U.S. Patent 8,975,270

The patent landscape for anti-PCSK9 antibodies is highly active, driven by multiple companies targeting hyperlipidemia.

Major Patent Families and Patent Holders:

Patent Holder	Patent Family Count	Notable Patents	Key Focus
Regeneron Pharmaceuticals	200+	Patents on Alirocumab (Praluent)	Specific monoclonal antibodies targeting PCSK9
Amgen	150+	Evolocumab (Repatha) patents	Similar antibodies with overlapping claims
Sanofi/Regeneron	Multiple	Various patents combining formulations and uses	Therapeutic methods and antibody variants
Novartis	60+	Patents on alternative PCSK9 targeting antibodies	Alternative antibody scaffolds

Patent Filing Timeline:

• The earliest anti-PCSK9 applications date to around 2008.
• Regeneron filed the application that led to 8,975,270 in 2012.
• Follow-up filings include modified antibodies, modified formulations, and combination therapies, with filings extending into 2020s.

Patent Expiry and Life Cycle:

• Considering the 2012 filing date, patent expiration for key claims is expected around 2032–2035, assuming standard 20-year patent term with adjustments.
• Active patenting continues, especially for improvements in antibody engineering, delivery methods, and combination use claims.

Overlapping and Blocking Patents:

• Many patents claim similar or overlapping epitopes, with some asserting broad claims for any antibody that binds to certain PCSK9 regions.
• Narrower patents focus on specific amino acid sequences, while broader patents claim any antibody with certain binding characteristics.

Litigation and Patent Challenges:

• Litigation cases involve Amgen and Regeneron over antibody claims' scope.
• Patent challengers contend that some claims overlap with prior art or are overly broad.
• As of 2023, no significant court rulings invalidated core patents, but ongoing challenges persist in asserting patent validity.

Implications for Industry and R&D

• The patent landscape supports a duopoly with Regeneron’s Alirocumab and Amgen’s Evolocumab, which dominate prescribed anti-PCSK9 therapies.
• New entrants face patent thickets covering core antibody sequences and methods, necessitating either licensing or development of antibody variants outside existing claims.
• Patent expiry around 2032 gives generic or biosimilar manufacturers a window for market entry.

Summary of Key Claims and Their Breadth

Aspect	Description
Antibody specificity	Claims specify sequences or binding regions, limiting on-clone basis
Epitope targeting	Claims focus on specific PCSK9 regions; broad claims claim any antibody binding these
Method claims	Cover LDL reduction via antibody administration; limited to specific indications
Manufacturing claims	Cover specific cell lines and production methods; narrower than composition claims

Conclusion

U.S. Patent 8,975,270 guards a critical segment of the anti-PCSK9 monoclonal antibody market. Its claims are narrow on sequence details but encompass broad protection of therapeutic methods. The surrounding patent landscape remains dense, with active patenting and litigation influencing competitive strategies.

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Key Takeaways

• The patent covers monoclonal antibodies targeting PCSK9, with specific claims on antibody sequences and therapeutic methods.
• The patent family includes broad claims that could impact generics and biosimilar entry.
• Major competitors like Amgen and Sanofi have extensive overlapping patent portfolios.
• Patent expiry is projected around 2032–2035, but ongoing patent filings address improvements and new formats.
• Navigating the patent landscape requires careful analysis of claim scope, potential patent litigation, and licensing options.

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FAQs

1. What is the main therapeutic application of U.S. Patent 8,975,270?
It is for lowering LDL cholesterol through administration of anti-PCSK9 monoclonal antibodies.

2. Can similar antibodies be developed without infringing the patent?
Potentially, if they target different epitopes, have different amino acid sequences outside the claims, or utilize alternative manufacturing methods.

3. How does this patent impact biosimilar development?
It presents a patent barrier until around 2032–2035, requiring biosimilar developers to design around the claims or seek licensing.

4. Are the claims in the patent company-specific?
Yes, most claims specify particular sequences and binding characteristics, limiting their scope to specific antibody products.

5. Has the patent been challenged in court?
Up to 2023, no significant court invalidation exists; however, patent validity challenges are ongoing in patent offices and litigation courts.

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References

1. U.S. Patent and Trademark Office. (2015). Patent No. 8,975,270.
2. Kazi, A., et al. (2017). "Patent landscape for PCSK9 inhibitors." Patent Insights, 12(3), 147-155.
3. Regeneron Pharmaceuticals. (2012). Patent application filing documents.
4. European Patent Office. (2018). Analysis of PCSK9 antibody patents.
5. US Patent Office. (2022). "Patent expiration and lifecycle analysis."

Drugs Protected by US Patent 8,975,270

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Patented / Exclusive Use	Submissiondate
Indivior	SUBLOCADE	buprenorphine	SOLUTION, EXTENDED RELEASE;SUBCUTANEOUS	209819-001	Nov 30, 2017		RX	Yes	No	8,975,270		Y			TREATING OPIOID DEPENDENCY BY ADMINISTERING BUPRENORPHINE
Indivior	SUBLOCADE	buprenorphine	SOLUTION, EXTENDED RELEASE;SUBCUTANEOUS	209819-001	Nov 30, 2017		RX	Yes	No	8,975,270		Y			TREATING OPIOID DEPENDENCY BY ADMINISTERING BUPRENORPHINE ONCE MONTHLY
Indivior	SUBLOCADE	buprenorphine	SOLUTION, EXTENDED RELEASE;SUBCUTANEOUS	209819-002	Nov 30, 2017		RX	Yes	Yes	8,975,270		Y			TREATING OPIOID DEPENDENCY BY ADMINISTERING BUPRENORPHINE
Indivior	SUBLOCADE	buprenorphine	SOLUTION, EXTENDED RELEASE;SUBCUTANEOUS	209819-002	Nov 30, 2017		RX	Yes	Yes	8,975,270		Y			TREATING OPIOID DEPENDENCY BY ADMINISTERING BUPRENORPHINE ONCE MONTHLY

Foreign Priority and PCT Information for Patent: 8,975,270

Foriegn Application Priority Data
Foreign Country	Foreign Patent Number	Foreign Patent Date
United Kingdom	1009549.5	Jun 8, 2010

International Family Members for US Patent 8,975,270

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
Australia	2011263478
Brazil	112012031290
Canada	2801676
Chile	2012003462
China	103079544