Patent: 10,624,814

Summary for Patent: 10,624,814

Title:	Container for a solution of human plasma proteins and method for obtaining thereof
Abstract:	A container for a solution of human plasma proteins has a primary inner bag made up of a first multilayer polymer film with two outer layers of polyethylene (PE) and an intermediate layer of ethylene vinyl alcohol (EVOH) copolymer, and a secondary outer bag made up of a second multilayer film with layers of polyethylene terephthalate (PET)-silicon oxides (SiOx), oriented polyamide (OPA), polypropylene (PP)-silicon oxides (SiOx) and polypropylene (PP), referred to as multilayer PP-SiOx.
Inventor(s):	Roura Fernandez; Carlos (San Juan Despi, ES), Garcia Garcia; Jose Antonio (Las Torres Cotillas, ES), Llorens Masas; Estela (Parets del Valles, ES), Marzo Adam; Nuria (Parets del Valles, ES)
Assignee:	GRIFOLS, S.A. (Barcelona, ES)
Application Number:	15/611,582
Patent Claims:	see list of patent claims

Executive summary
United States Patent 10,624,814 centers on a dual-bag container system for solutions of human plasma proteins that reduces weight loss during storage, pairing (i) an inner bag film stack of PE/EVOH/PE with (ii) an outer bag film stack of PET-SiOx/OPA/PP-SiOx/PP. The asserted claims cover the container structure, hermetic inlet cap closure by welding (including ultrasound or heat-contact welding), peelable secondary outer bag form, specific plasma-protein compositions, and a manufacturing method including 0.2 µm sterile filtration, sterile filling, welding-based hermetic closure, secondary bag welding, and an optional 21-day incubation at 25 ± 2°C.

This is a packaging-and-process estate rather than a biologic or clinical-use estate. The defensibility hinges on whether the specific multilayer film architectures (EVOH interlayer on PE for inner bag; SiOx barrier layers on PET and PP plus OPA layer on the outer bag) and the specific welding/closure configurations were already known for plasma-protein storage or for analogous protein formulations, and whether prior art anticipates the 0.2 µm filtration + sterile fill + weld hermetic closure + optional 21-day incubation workflow.

Because no further prosecution history, cited references, or claim-construction record are provided, the analysis below is confined to the claim text you supplied and a critical framework for anticipating key invalidity and design-around risks.

United States Patent 10,624,814: claims, scope, and critical patent landscape for plasma protein container multilayer film packaging

What does US 10,624,814 claim about container multilayer films for plasma-protein solutions?

Direct answer: The patent claims a container with two nested bags: a primary inner bag using a PE/EVOH/PE multilayer polymer film, and a secondary outer bag using a PET-SiOx/OPA/PP-SiOx/PP multilayer polymer film, with “weight loss of the container” reduced. The plasma protein solution is contained in the primary inner bag.

Inner bag film architecture (Claim 1)

Claim 1 requires the primary inner bag comprising sheets of a first multilayer polymer film with:

• two outer layers of polyethylene (PE)
• an intermediate layer of ethylene vinyl alcohol (EVOH) copolymer

This is a specific barrier architecture. EVOH is commonly used as a gas barrier layer in packaging stacks; the claim ties that EVOH interlayer to a PE outer-layer configuration and to a plasma-protein container.

Outer bag film architecture (Claim 1)

Claim 1 requires a secondary outer bag comprising a second multilayer polymer film with layers in the following order:

• PET-SiOx
• oriented polyamide (OPA)
• PP-SiOx
• PP

This is also a specific barrier stack. SiOx is typically a deposited inorganic barrier layer used in oxygen/moisture barrier packaging. The combination of PET-SiOx and PP-SiOx with an OPA middle layer is the technical signature.

Functional limitation: “weight loss … significantly reduced”

Claim 1 uses a performance criterion:

• “wherein a weight loss of the container is significantly reduced.”

That phrase is legally important. It can be used to argue novelty and non-obviousness if the results are shown to be unexpected versus prior art containers. It also creates indefiniteness risk if “significantly” is not supported by objective ranges in the spec, but the text you provided does not include such metrics.

Critical scope implication: A challenger can argue the weight-loss reduction is inherent for many barrier-film stacks and that “significantly reduced” lacks a clear threshold or test method. Conversely, an enforceability position would require a robust experimental basis for the comparison set (not provided here).

What closure and welding limitations narrow the claims of US 10,624,814?

Direct answer: Claims 2–5 add an inlet cap structure that hermetically closes the inner bag either reversibly or irreversibly by welding. Claims 3–4 specify ultrasound welding or heat-contact welding to weld the inlet of the cap to the sheets for irreversible hermetic closure. Claim 5 adds structural “two small wings” on the inlet to facilitate heating and welding.

Hermetic inlet cap closure (Claims 2–4)

• Claim 2: inlet cap structure configured to be hermetically closed “either reversibly or irreversibly by welding.”
• Claim 3: welding produced by ultrasound.
• Claim 4: inlet of the inlet cap structure and sheets of the primary inner bag welded together by heat contact to hermetically close irreversibly.

These limitations can be decisive in infringement because a container with the same film stacks but a different hermetic closure mechanism (e.g., clamp, threaded cap with gasket, crimp only, or adhesive) would avoid the welded inlet cap elements.

Critical design-around opportunity: Replace welding with a non-weld hermetic closure. Even if the outer and inner film stacks are similar, avoiding the claim’s “welding” requirement can reduce infringement risk.

“Two small wings” inlet feature (Claim 5)

Claim 5 requires:

• an inlet comprising two small wings to facilitate heating and welding of the inlet to the sheets.

This is a mechanical/structural narrowing element. If a competitor uses an inlet geometry that lacks wing-like features used for heating/welding, it may avoid Claim 5 even if ultrasound/heat welding is used.

What plasma-protein compositions are covered by US 10,624,814 claims?

Direct answer: Claim 6 recites a broad list of human plasma proteins (albumin, α-1-antitrypsin, von Willebrand factor, coagulation factors such as VII/VIII/IX, immunoglobulins, plasminogen/plasmin, antithrombin III, fibrinogen/fibrin, thrombin or combinations). Claims 7 and 10–11 narrow that list to immunoglobulins.

Composition is framed as “comprises,” not “consists of”

The claim language is open-ended (“comprising … or combinations thereof”). That typically expands coverage to containers holding immunoglobulins plus other plasma proteins, provided the solution is a “solution of human plasma proteins” and the list items are present.

Composition limits can still be a litigation flashpoint

Even if a formulation contains some of the listed proteins, an accused infringer can argue:

• the product is not a “solution of human plasma proteins” as claimed (e.g., if purified recombinants or non-plasma sources are used), or
• the formulation is not contained within the claimed bag stack and closure structure.

Is the secondary outer bag peelable under US 10,624,814?

Direct answer: Yes, Claim 8 adds a peelable form for the secondary outer bag.

Critical scope implication: Peelable outer-bag packaging that uses the same multilayer stack but is not designed for peelability may not meet Claim 8 (though it could still fall under Claim 1 if peelability is not required for all asserted claims).

What manufacturing steps are required by the US 10,624,814 method claims?

Direct answer: Claim 9 requires a specific workflow:

1. sterile filtering of a solution of human plasma proteins through a 0.2 µm membrane to obtain a sterile solution
2. filling the primary inner bag in a sterile environment by lifting the cap and introducing sterile solution
3. inserting an inlet cap into the inlet in sterile environment and hermetically closing by welding
4. inserting the primary bag into the secondary outer bag and welding the secondary bag

Claims 10–11 mirror the composition limitations (same list; immunoglobulins in dependent claims). Claim 12 adds an optional incubation step.

Sterile filtration through 0.2 µm membrane (Claim 9)

This is a specific parameter. It is both common and easy for a challenger to find in prior art. Its value as a differentiator depends on whether the combination with the specific welded multilayer container is novel.

Invalidity angle: A challenger can seek prior art describing sterile filtration at 0.2 µm for plasma protein solutions and packaging in weldable bag systems.

Welded hermetic closure (Claims 9)

The method ties infringement to welding steps consistent with the container claims. A generic process substitute (e.g., filling then using a non-weld closure) can avoid the method claim.

Secondary outer bag welding (Claim 9)

Method coverage extends beyond the inner bag to include welding of the secondary bag after insertion of the primary bag.

When does the optional incubation step in US 10,624,814 matter for validity and infringement?

Direct answer: Claim 12 adds an incubation step for 21 days at 25 ± 2°C.

This step can support:

• experimental demonstration of “weight loss significantly reduced” (if the spec includes before/after weight measurements after incubation), or
• evidence for stability/functional improvement.

Critical enforcement note: If a competitor does not perform the 21-day incubation step as part of its process, it may avoid the specific method claim limitation (though the container product claims may remain relevant).

How can prior art challenge US 10,624,814’s multilayer film combination?

Direct answer: The likely invalidity theories are combination and anticipation around:

• EVOH interlayers on PE films for barrier control
• SiOx barrier coatings on PET and PP films
• OPA interlayers in multilayer packaging
• weldable hermetic bag inlets and ultrasound/heat-welding sealing methods
• stability-driven selection of packaging barriers for protein formulations

Key vulnerabilities to search for in the landscape

1. Same film stacks in other packaging contexts
   If prior art exists showing essentially identical multilayer stacks (PE/EVOH/PE and PET-SiOx/OPA/PP-SiOx/PP) used for solutions of proteins or biologics where weight loss is controlled, Claim 1’s novelty is at risk.

2. Commonly known barrier function but unknown “significantly reduced weight loss”
   If prior art does not mention the specific performance metric, the patent may argue functional novelty. A challenger can counter with inherency: barrier stacks reduce moisture loss and weight change during storage.

3. Hermetic inlet welding with ultrasound or heat contact
   Ultrasound sealing of multilayer polymer film pouches and weldable inlet caps are widely used in medical packaging. If the same sealing technique was already used with similar bag films, dependent claims 2–5 can be weak.

4. Method claims as a predictable combination
   Sterile filtration at 0.2 µm, sterile filling, and welding closure are typically standard in sterile fill operations. If the combination is obvious in view of known packaging systems, Claim 9 can be challenged for obviousness.

What design-around strategies can avoid infringement of US 10,624,814?

Direct answer: The claims have multiple hard structural hooks. Competitors can attempt to avoid one or more.

1) Change the film architecture

• Replace EVOH interlayer with a different barrier polymer (e.g., different copolymer or a different barrier coating) to escape the “PE/EVOH/PE” requirement.
• Replace PET-SiOx/OPA/PP-SiOx/PP with another barrier stack (even if still SiOx-based) that does not match the claimed layering.

2) Keep films but change closure

• Use a non-weld hermetic inlet closure (gasket, clamp, mechanical connector with validated seal) to avoid Claims 2–5 and method steps requiring welding.

3) Modify welding approach

• If ultrasound sealing is used, redesign the inlet cap system so it does not match the claimed structure for the inlet closure.
• For Claim 5, remove or structurally redesign the “two small wings” feature.

4) Avoid peelable secondary outer bag

• If targeting Claim 8, design a non-peelable outer bag format.

5) Avoid the incubation step for method claims

• If a competitor claims only the container, not the process, incubation may be less relevant. For process-only challenges, avoid the 21-day at 25 ± 2°C sequence.

How strong is the patent estate likely to be, claim-by-claim?

Direct answer: Based strictly on the claim text, enforceability strength varies by how “signature” the limitations are versus how commonly known the features are.

Claim 1 (primary container with specific film stacks and weight-loss reduction)

• Strength driver: The precise two-tier multilayer architecture is a specific technical combination.
• Weakness driver: Each film feature may be individually known; the novelty argument must rely on the combination and the functional “significantly reduced” weight loss.

Claims 2–5 (hermetic inlet closure by welding; ultrasound; heat-contact welding; two wings)

• Strength driver: Structural and method-of-sealing details narrow scope.
• Weakness driver: Welding and ultrasound sealing are frequently used in bag and medical packaging; if prior art shows similar welded inlet caps on analogous films, these dependents can fall.

Claims 6–7, 10–11 (protein composition including immunoglobulins)

• Strength driver: Limits to solutions of human plasma proteins and lists of proteins.
• Weakness driver: If the accused product uses immunoglobulins or other listed proteins but is stored in a non-matching container, composition alone does not rescue infringement.

Claims 8 (peelable outer bag)

• Likely narrower and easier to design around.

Claims 9–12 (method with 0.2 µm sterile filtration; sterile fill; welded hermetic closure; secondary bag welding; 21-day incubation)

• Strength driver: The process is specific in steps and parameters.
• Weakness driver: Filtration and sterile fill steps are routine; obviousness risk is higher for method claims unless the specific combination with the claimed packaging produces an unexpected stability outcome.

Key litigation and regulatory linkage points for plasma protein container patents

Direct answer: Packaging and container system patents often affect:

• platform transfers between contract manufacturing organizations (CMOs),
• validation of sterile fill processes and container closure integrity,
• stability protocol acceptance during regulatory submissions,
• and product launch timelines if a competitor’s packaging design triggers a claim.

FDA and regulatory tie-in (high level)

For plasma-derived protein products, container-closure systems can be critical to stability and shelf-life. The claim’s performance element (“weight loss”) likely correlates to moisture/gas transmission effects that can impact concentration and degradation in stability studies. That increases the likelihood that competitors cannot easily switch container designs without revalidation and stability bridging, even if they design around the patent.

What this means for commercialization and generic entry risk

Direct answer: This patent is aimed at manufacturing and packaging of plasma-protein solutions. It can create:

• supply-chain lock-in for particular film stacks and sealing tooling,
• leverage in licensing or freedom-to-operate (FTO) negotiations for CMOs,
• and potential launch delays for any product reformulation or process transfer that would change container design.

Practical risk posture: The strongest risk is for manufacturers that already use PE/EVOH/PE inner bags and PET-SiOx/OPA/PP-SiOx/PP outer bags with welded hermetic inlet caps. Any deviation can reduce both infringement probability and regulatory stability risk.

Key Takeaways

• US 10,624,814 claims a dual-bag system with specific barrier-film stacks: PE/EVOH/PE for the inner bag and PET-SiOx/OPA/PP-SiOx/PP for the outer bag, plus a functional “significantly reduced” weight-loss objective.
• Dependent claims narrow closure mechanics: welded hermetic inlet cap, including ultrasound welding and heat-contact irreversible welding, and an inlet geometry with two small wings for heating/welding.
• The method claims add sterile filtration at 0.2 µm, sterile bag filling, welding-based hermetic closure, secondary outer bag welding, and an optional 21-day incubation at 25 ± 2°C.
• Largest enforceability opportunity is Claim 1 due to its specific multilayer combination, while the largest design-around opportunity is to change either the film architecture or switch away from welded hermetic inlet closure.

FAQs

1. Can a container using PE/EVOH/PE inner film but a different outer barrier stack avoid US 10,624,814?
   If the outer bag does not match the claimed PET-SiOx/OPA/PP-SiOx/PP multilayer requirement, it can avoid Claim 1’s outer bag limitation.

2. Does using a non-weld closure for the inlet cap avoid both container and method claims?
   Claims 2–4 and Claim 9 require welding for hermetic closure, so a non-weld hermetic inlet design can avoid those limitations.

3. If the product contains immunoglobulins, is composition alone sufficient for infringement?
   No. Infringement still requires the claimed container structure (and for method claims, the claimed process steps), not only the presence of listed proteins.

4. How does the “significantly reduced weight loss” limitation affect validity challenges?
   It can help establish functional novelty but can also be attacked if “significantly” lacks a clear metric or is argued to be inherent for known barrier stacks.

5. What is the strongest claim element for a licensing negotiation?
   Claim 1’s specific inner/outer multilayer film combination paired with the weight-loss reduction objective, because it is the broadest and most structural part of the estate.

References (APA)

1. Claims text provided by user for United States Patent 10,624,814.

Details for Patent 10,624,814

Applicant	Tradename	Biologic Ingredient	Dosage Form	BLA	Approval Date	Patent No.	Expiredate
Octapharma Pharmazeutika Produktionsges.m.b.h.	OCTAPLAS	pooled plasma (human), solvent/detergent treated	For Injection	125416	January 17, 2013		2037-06-01