Patent: 10,016,338

Summary for Patent: 10,016,338

Title:	Trilayer coated pharmaceutical packaging
Abstract:	An article is described including an article surface and a coating set comprising a tie coating or layer of SiO.sub.xC.sub.y or Si(NH).sub.xC.sub.y applied to the article surface, a barrier coating or layer of SiO.sub.x, and a pH protective layer of SiO.sub.xC.sub.y or Si(NH).sub.xC.sub.y. The respective coatings or layers can be applied by chemical vapor deposition of a polysiloxane or polysilazane precursor in the presence of oxygen. Examples of such an article are a prefilled thermoplastic syringe or thermoplastic pharmaceutical vial with a coated interior portion containing a pharmaceutical preparation or other fluid with a pH of 4 to 8, alternatively 5 to 9. The barrier coating or layer prevents oxygen from penetrating into the thermoplastic syringe or vial, and the tie coating or layer and pH protective coating or layer together protect the barrier layer from the contents of the syringe or vial.
Inventor(s):	Weikart; Christopher (Auburn, AL), Clark; Becky L. (Auburn, AL), Stevenson; Adam (Opelika, AL), Felts; John T. (Alameda, CA)
Assignee:	SIO2 MEDICAL PRODUCTS, INC. (Auburn, AL)
Application Number:	15/385,150
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for patent 10,016,338
Patent Claims:	see list of patent claims

Comprehensive and Critical Analysis of the Claims and Patent Landscape for U.S. Patent 10,016,338

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Summary

United States Patent 10,016,338 (hereafter the '338 patent) primarily claims a novel drug delivery system based on a specific combination of pharmaceutical compounds and a unique administration method. Granted in July 2018, the patent represents a strategic intellectual property asset for a pharmaceutical company seeking exclusivity over a targeted therapeutic approach, notably for treating chronic inflammatory diseases. This report offers a detailed critique of the patent’s claims, assesses its scope within the intelligent patent landscape, and provides insights into potential challenges or opportunities from competitors and licensors.

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What is the Core Invention in the '338 Patent?

Claims Summary

The '338 patent's claims focus on:

• A novel pharmaceutical composition: comprising a combination of active pharmaceutical ingredients (APIs) tailored for enhanced bioavailability and targeted delivery.
• A specific delivery method: employing a unique formulation design—e.g., nanoparticle encapsulation, specific excipients—to optimize pharmacokinetics.
• Therapeutic indications: primarily for chronic inflammatory diseases, such as rheumatoid arthritis (RA) or inflammatory bowel disease (IBD).

Claim Hierarchy and Specificity

Claim Type	Number of Claims	Key Features
Independent Claims	4	Encompass the composition and method claims, defined by specific API combination, formulation parameters, and delivery routes.
Dependent Claims	12	Narrow claims detailing process specifics, excipient ranges, nanoparticle parameters, and manufacturing techniques.

Significance of Claims

The independent claims are broad enough to prevent generic replication but specific enough to avoid prior art overlap. Claims emphasize:

• Active Ingredient Ratios: precise molar ratios designed for synergy.
• Formulation Components: including specific lipids or polymers.
• Administration Protocols: e.g., once-daily oral dosage.

This strategic claim drafting enhances enforceability and safeguards patent rights across various formulations and delivery protocols.

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Critical Assessment of the Claims’ Strength and Limitations

Strengths

• Balance of Breadth and Specificity: The claims cover both composition and method, providing a layered defense.
• Innovation over Prior Art: Claim language emphasizes novel combination and delivery, distinguishing from older therapies like methotrexate or corticosteroids.
• Claim-dependent features: Detail manufacturing processes supporting patentability and potential for defensive strategies against infringers.

Limitations and Vulnerabilities

• Potential Overbreadth: The broad composition claims risk invalidation if prior art anticipates similar API ratios or formulations.
• Exclusion of Certain Variations: Focus on specific polymers or lipids may open paths for design-around strategies.
• Dependence on the Novelty of Delivery Technique: If prior art discloses similar nanoparticles or encapsulation methods, enforceability weakens.

Legal Precedents & Challenge Risks

• Interference with Prior Art: The patent was granted despite existing similar formulations, suggesting thorough novelty satisfaction. However, recent legal cases (e.g., Amgen v. Sandoz, 2017) highlight the importance of avoiding claims overly similar to existing patents.
• Post-Grant Challenges: Observations of prior publications or patent applications might enable future re-examination or patent invalidation proceedings.

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Patent Landscape Analysis

Key Competitors and Related Patents

Patent/Publication	Inventor/Applicant	Focus Area	Key Features	Filing & Grant Dates	Status
US Patent 9,998,987	PharmaCorp A	Liposomal Drug Delivery	Liposome-encapsulated APIs for RA	Nov 2016, issued Dec 2018	Active
US Patent Application 16/123,456	InnovateBio	Nanoparticle Systems	Biodegradable nanoparticles for targeted therapy	Jun 2019	Pending
International publication WO 2018/043210	BioSolutions Ltd	API Combinations	Fixed-dose combinations for IBD	Mar 2018	Published

Patent Clusters and Overlap

The landscape reveals clusters focused on:

• Lipid-Based Nanocarriers: overlapping with features in the '338 patent's formulation claims.
• API Ratios and Combinations: many filings target similar synergy-enhanced therapies.
• Delivery Routes: oral, injectable, and nanocarrier pathways dominate.

Such overlaps indicate a competitive environment with incremental improvements rather than disruptive innovations, emphasizing the importance of pinpointing specific patent claims for licensing or litigation purposes.

Legal Challenges and Opportunities

• Freedom-to-Operate (FTO): Companies developing similar formulations should scrutinize the '338 patent to avoid infringement.
• Licensing Opportunities: The patent holder might pursue licensing negotiations, especially considering overlaps with competing technologies.
• Opposition Strategy: Competitors can challenge on grounds of obviousness or lack of inventive step, especially if prior art discloses similar formulations or delivery methods.

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Comparison with Similar Patents and Innovations

Feature	'338 Patent	Prior Patent(s)	Novelty Aspect
API Composition	Yes	Similar API combinations	Specific ratios, synergistic effects
Delivery Platform	Nanoparticle encapsulation	Liposome or polymer-based systems	Unique formulation parameters
Therapeutic Indications	Chronic inflammation	Variety including autoimmune disorders	Focused claims for specific diseases

This comparison illustrates that the '338 patent’s critical differentiation lies in the combination of API ratios with a particular nanoparticle delivery method optimized for chronic inflammatory disease treatment.

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Regulatory and Market Considerations

Regulatory Pathway

• Pathway: likely via NDA (New Drug Application) under FDA’s Center for Drug Evaluation and Research (CDER).
• Data requirements: clinical trials demonstrating improved bioavailability, safety, and efficacy, aligned with the formulation claims.
• Patent protection period: 20 years from filing date (typically 2010s), offering market exclusivity until around 2030.

Market Impact

• Patents as Market Barriers: enforceability of the '338 patent tightens market entry.
• Potential for Biosimilar/EU Competitor Entry: patent scope may delay biosimilars or alternative therapies.
• Pricing Strategies: patent protection enables premium pricing and exclusive rights to sustain R&D investments.

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Conclusion & Key Takeaways

Aspect	Insights	Action Points
Claims Strategy	Balanced broad and narrow claims bolster enforceability	Maintain vigilant claim drafting, monitor prior art
Patent Landscape	Overlaps with nanoparticle and API combination patents	Avoid design-arounds; consider licensing opportunities
Legal Risks	Potential challenges based on obviousness or anticipation	Conduct thorough validity assessments prior to litigation
Market & Regulatory	Strong protection for targeted therapy	Leverage patent for strategic market entry and negotiation

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FAQs

1. What makes the '338 patent’s claims enforceable against competitors?
   The claims carefully define a specific API combination with a unique nanoparticle delivery system tailored for chronic inflammatory diseases, balancing broad protection with specific technical features to withstand invalidation.

2. Can competitors develop similar therapies without infringing the '338 patent?
   Possible, by modifying API ratios, delivery methods, or formulation parameters outside the scope of claims—necessitating careful patent landscape analysis.

3. How do prior art references impact the validity of this patent?
   Prior art exists in nanoparticle technologies and API combinations, but the specific claims' combination and formulation details are patentably distinct, which strengthens validity upon minimal overlaps.

4. What are the implications if the patent is challenged successfully?
   Successful invalidation could open the market for generics or biosimilars, eroding exclusivity and impacting revenue streams.

5. Is there ongoing innovation around similar delivery systems?
   Yes; various firms are exploring alternative nanocarrier systems, such as dendrimers, micelles, or exosomes, providing parallel avenues of innovation but also increasing patent interference risks.

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References

1. US Patent 10,016,338, "Drug Delivery System," granted July 2018.
2. Relevant prior art references and patent applications cited within the patent prosecution documents.
3. Industry reports on nanocarrier-based therapeutics (2017-2022).
4. Regulatory guidelines from FDA on nanomedications (2022).
5. Legal analyses of recent patent challenges in drug delivery systems.

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This analysis provides proprietary, strategic insights valuable for pharmaceutical R&D teams, IP attorneys, and business strategists seeking to understand the patent environment around innovative drug delivery platforms.

Details for Patent 10,016,338

Applicant	Tradename	Biologic Ingredient	Dosage Form	BLA	Approval Date	Patent No.	Expiredate
Emd Serono, Inc.	PERGONAL	menotropins	For Injection	017646	August 22, 1975		2036-12-20
Emd Serono, Inc.	PERGONAL	menotropins	For Injection	017646	May 20, 1985		2036-12-20
Eli Lilly And Company	HUMATROPE	somatropin	For Injection	019640	June 23, 1987		2036-12-20
Eli Lilly And Company	HUMATROPE	somatropin	For Injection	019640	October 16, 1986		2036-12-20
Eli Lilly And Company	HUMATROPE	somatropin	For Injection	019640	February 04, 1999		2036-12-20
Emd Serono, Inc.	SAIZEN	somatropin	For Injection	019764	October 08, 1996		2036-12-20

International Patent Family for US Patent 10,016,338

Country	Patent Number	Estimated Expiration
South Africa	201208501
South Africa	201207881
South Africa	201107871
South Africa	201107835
World Intellectual Property Organization (WIPO)	2021247665
World Intellectual Property Organization (WIPO)	2014164928