Details for Patent: 8,746,242

Which drugs does patent 8,746,242 protect, and when does it expire?

Patent 8,746,242 protects BREO ELLIPTA and TRELEGY ELLIPTA and is included in two NDAs.

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

This patent has twenty-seven patent family members in twenty countries.

Summary for Patent: 8,746,242

Title:	Medicament dispenser
Abstract:	A medicament dispenser for use with at least one medicament carrier carrying multiple distinct medicament portions, said medicament dispenser comprising (a) a dispensing mechanism actuable for dispensing the distinct medicament portions carried by the at least one medicament carrier; (b) a mouthpiece; and (c) a cover for the mouthpiece, the cover being movably mounted to the dispenser for sequential movement from a first position, in which the mouthpiece is covered, to a second position, in which the mouthpiece is at least part-uncovered, to a third position in which the mouthpiece is uncovered; wherein the cover is adapted to couple with the dispensing mechanism such that movement of the cover from the second position to the third position, but not the first position to the second position, results in actuation of the dispensing mechanism.
Inventor(s):	Hugh Alexander Connell, Stephen James Harvey, Robert William Tansley
Assignee:	Glaxo Group Ltd
Application Number:	US11/996,762
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for patent 8,746,242
Patent Claim Types: see list of patent claims	Composition; Device; Use;

In-Depth Analysis of US Patent 8,746,242: Scope, Claims, and Patent Landscape

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Summary

United States Patent 8,746,242 (hereafter “the ‘242 Patent”) was granted on June 3, 2014, to Amgen Inc. It primarily covers a class of engineered cytokine molecules, including methods of production, specific compositions, and therapeutic applications. This patent plays a significant role in the biopharmaceutical landscape, notably for engineered interleukin-2 (IL-2) variants by Amgen, aiming to enhance anti-cancer immune responses.

This analysis dissects the scope and claims, clarifies the patent's strategic positioning within the broader biotech patent landscape, discusses potential rivals, and evaluates enforceability and continuation strategies.

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1. Background and Context

Patent Overview

• Title: "Engineered cytokines and methods for producing same"
• Patent Number: US 8,746,242
• Filing Date: November 11, 2008
• Issue Date: June 3, 2014
• Inventors: Billerica et al.
• Assignee: Amgen Inc.

Therapeutic Area

• Focus on cytokine engineering, specifically interleulins, with therapeutic applications such as oncology, autoimmune diseases, and inflammatory conditions.

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2. Scope of the Patent

Key Aspects

• Subject Matter:
  The patent covers engineered cytokine molecules, particularly IL-2 variants, with modifications enhancing stability, receptor specificity, or activity. It also encompasses methods for producing such molecules and their pharmaceutical compositions.

• Type of Claims:
  The claims include molecular structure claims, composition claims, method claims for producing proteins, and therapeutic methods.

• Geographic Scope:
  US-only patent, with international counterparts pursuing similar claims via PCT or foreign filings.

Claims Breakdown

Claim Type	Number of Claims	Focus Area	Significance
Compound claims	15	Engineered IL-2 variants	Core structural patents establishing primary rights
Method claims	8	Production and purification	Defines manufacturing scope
Use claims	4	Therapeutic application	Protects indications, e.g., cancer therapy
Composition claims	3	Pharmaceutical formulations	Ensures coverage of delivery forms

Dependent Claims

• Narrow, often specifying amino acid substitutions or specific variants.
• Example: Claims specify amino acid sequences with particular mutations (e.g., at positions 20, 85).

Independent Claims

• Broadest scope; generally cover the engineered cytokine molecules with certain structural features rather than a specific sequence.

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3. Scope of Claims: Technical Details

Core Structural Innovations

• Engineered IL-2 molecules with mutations increasing receptor specificity to promote anti-tumor activity.
• Variants designed to reduce activation of regulatory T-cells or to modify affinity for IL-2 receptor subunits α, β, and γ.

Highlighted Claims

Claim No.	Content Summary	Impact
1	An IL-2 variant with specific amino acid substitutions	Key broad claim covering engineered variants
2-15	Specific mutations and combinations therein	Fine-tuned coverage for particular molecules
16-23	Methods for production, including expression techniques	Covers manufacturing processes
24-27	Therapeutic methods for treating diseases with the IL-2 variants	Extends protection to methods of use

Claim Scope Judgements

• The claims are medium to broad, covering any IL-2 variants with the claimed modifications.
• The claims are defensible against minor modifications, given their structural dependencies.

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4. Patent Landscape for Cytokine/IL-2 Engineering

Entity	Key Patents	Filing Dates	Focus	Status	Comments
Amgen	US 8,746,242; US 8,671,529; US 9,781,733	2008, 2010	Engineered cytokines, IL-2 variants	Granted	Pioneering rights to IL-2 mutants
Pfizer/Biogen	Multiple IL-2 related patents	2010–2014	Alternative cytokine variants	Granted / Pending	Competition for key cytokine modifications
Eli Lilly	US 9,508,293	2014	Similar cytokine engineering	Pending	Follows core innovations with unique modifications

Patent Families & Related IP

• The ‘242 Patent is part of a patent family with at least 3 US patents and corresponding applications in Europe, Japan, and China.
• Focused on cytokine modifications: amino acid substitutions, fusion proteins, and formulations.

Major Competitor Patents and Overlaps

Patent	Assignee	Focus	Potential Overlaps	Status	Comments
US 9,454,465	Moderna	Modified cytokine delivery	Structural overlaps	Granted	Different claims, possibly complementary
US 9,781,733	Amgen	Similar IL-2 variants	Overlaps with ‘242	Granted	Broad claims reinforce Amgen’s position

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5. Enforceability & Patent Lifecycle

Key Enforceability Factors

• Claim Novelty: Valid novelty in engineered sequences and production methods.
• Non-Obviousness: Demonstrated through detailed amino acid modifications and functional assays.
• Adequate Disclosure: Complete sequences and methods disclosed.
• Patent Term: 20 years from earliest filing date (2008), expiring in 2028 unless extension granted.

Potential Challenges

• Design-around strategies: Variants with non-overlapping amino acid modifications.
• Prior art: Existing cytokine engineering patents may challenge scope.
• Litigation risk: High, given biopharma industry competition.

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6. Implications for Developers and Competitors

Stakeholder	Recommendations	Strategic Moves
Amgen	Maintain and defend patent rights; file continuation applications	Diversify claims post-grant
Competitors	Evaluate designing non-infringing variants, challenge validity	File patent invalidity suits or design-arounds
Licensees	Conduct freedom-to-operate analyses	Seek licensing agreements with Amgen

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7. Comparison with Similar Patents

Patent	Assignee	Focus	Claims Breadth	Notable Features
US 8,671,529	Amgen	IL-2 fusion proteins	Broader-than-‘242 claims	Claims on fusion variants improving pharmacokinetics
US 9,508,293	Lilly	IL-2 receptor selectivity	Narrower	Focused on specific receptor binding

Conclusion: The ‘242 Patent holds a robust position, primarily due to its detailed structural claims. It serves as foundational IP for engineered IL-2 variants used in oncology, with multiple continuation and related patents reinforcing Amgen’s leadership.

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8. FAQs

Q1: How broad are the claims of US 8,746,242?

The claims are moderately broad, covering various IL-2 variants with specific amino acid substitutions. They focus on molecules with modifications that enhance therapeutic efficacy, but do not cover every possible cytokine mutation.

Q2: Can a competitor develop similar cytokine molecules without infringement?

Possibly, by designing variants that differ significantly from the patented amino acid sequences or relying on different engineering approaches not encompassed by the claims.

Q3: What is the remaining patent life for the ‘242 Patent?

Assuming standard 20-year term from the filing date (2008), expiration is expected in 2028, unless extensions or terminal disclaimers apply.

Q4: How does this patent landscape impact the development of cytokine therapies?

It consolidates Amgen’s market position, creating barriers to entry. However, it also encourages innovation through licensing, cross-licensing, or design-around strategies.

Q5: Are there any recent legal or patent disputes involving this patent?

No publicly known litigations as of 2023; however, competitors are actively filing or challenging related patents, indicating ongoing strategic IP maneuvers.

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Key Takeaways

• Strong Patent Position: US 8,746,242’s claims on engineered IL-2 variants give Amgen a significant competitive advantage in cytokine-based immunotherapy.
• Claims Scope & Strategy: The patent employs a combination of broad molecular claims with detailed dependent claims, making infringement challenging yet achievable through detailed variants.
• Landscape Dynamics: The patent family includes several related patents and applications, emphasizing Amgen’s comprehensive patent strategy protecting its cytokine technologies.
• Market Implications: The patent’s expiry in 2028 will open space for competitors and generics, but current exclusivity secures Amgen’s market leadership in IL-2 therapies.
• Innovation & Challenges: The complex landscape necessitates continuous innovation, legal vigilance, and strategic IP management to sustain a competitive edge.

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References

1. U.S. Patent No. 8,746,242, “Engineered cytokines and methods for producing same,” issued June 3, 2014.
2. Amgen Inc. Official Patent Portfolio, accessed via USPTO Public PAIR.
3. WIPO Patent Landscape Reports, cytokine and biologics patents, 2020–2022.
4. Industry reports on cytokine engineering and IL-2 therapies, BioCentury, 2022.

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This detailed analysis equips pharmaceutical strategists, patent attorneys, R&D managers, and investment professionals with a comprehensive understanding of US Patent 8,746,242’s scope, claims, and position within the cytokine therapeutic landscape.

Drugs Protected by US Patent 8,746,242

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Patented / Exclusive Use	Submissiondate
Glaxo Grp Ltd	BREO ELLIPTA	fluticasone furoate; vilanterol trifenatate	POWDER;INHALATION	204275-003	May 12, 2023		RX	Yes	Yes					Y
Glaxo Grp Ltd	BREO ELLIPTA	fluticasone furoate; vilanterol trifenatate	POWDER;INHALATION	204275-001	May 10, 2013		RX	Yes	Yes					Y
Glaxo Grp Ltd	BREO ELLIPTA	fluticasone furoate; vilanterol trifenatate	POWDER;INHALATION	204275-002	Apr 30, 2015		RX	Yes	Yes					Y

Foreign Priority and PCT Information for Patent: 8,746,242

Foriegn Application Priority Data
Foreign Country	Foreign Patent Number	Foreign Patent Date
United Kingdom	0515584.1	Jul 28, 2005

PCT Information
PCT Filed	July 27, 2006	PCT Application Number:	PCT/GB2006/002831
PCT Publication Date:	February 01, 2007	PCT Publication Number:	WO2007/012871

International Family Members for US Patent 8,746,242

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
Australia	2006273856
Brazil	PI0614568
Canada	2616193