Welcome. In the dynamic world of life sciences, we’re witnessing a seismic shift. The traditional lines separating pharmaceuticals, biologics, and medical devices are not just blurring; they are dissolving. This convergence has given rise to a new frontier of medicine: the drug/device combination product. From a simple prefilled syringe to a sophisticated AI-powered wearable injector, these products are no longer a niche category. They are rapidly becoming the standard of care, the engine of therapeutic innovation, and the bedrock of next-generation patient treatment.
But with great innovation comes great complexity. For every company venturing into this space, the path to market is a dual-track challenge. On one side, you have the labyrinth of global regulatory agencies, each with its own philosophy, its own rules, and its own hurdles. On the other, you have the high-stakes world of patent law, where protecting your multifaceted invention is a far more intricate dance than for a simple pill. How do you navigate this? How do you transform these twin challenges from a source of risk and delay into a powerful competitive advantage?
That is the core question we will answer in this report. My goal is not simply to recite regulations or patent statutes. It is to provide you, the business leader, the IP counsel, the regulatory strategist, with a comprehensive playbook for mastering this domain. We will dissect the entire lifecycle of combination product patents, from the foundational act of defining your product for regulators to building an impenetrable patent fortress and learning from the billion-dollar legal battles that have shaped this industry.
The commercial stakes have never been higher. The U.S. market for drug-device combination products alone was valued at over $46 billion in 2023 and is projected to surge to more than $78 billion by 2030. This explosive growth is not just a market trend; it’s a reflection of a fundamental evolution in healthcare toward more targeted, patient-centric therapies that require sophisticated delivery and monitoring systems.2 In this new landscape, the companies that thrive will be those that understand that patent strategy and regulatory strategy are not separate functions, but two sides of the same strategic coin. Let’s begin.
Section 1: The New Frontier of Medicine: Defining the Combination Product Landscape
Before we can strategize, we must first define the battlefield. What exactly is a combination product? The answer, perhaps unsurprisingly, depends on who you ask and where you are in the world. This initial definitional stage is not a mere formality; it is the first and most critical strategic decision point. The classification of your product dictates the regulatory pathway, the evidence you must generate, the timeline to market, and ultimately, the very nature of the patent protection you can secure.
What is a Combination Product? A Tale of Two Regulatory Philosophies
At the highest level, a combination product is a therapeutic that brings together components that would normally be regulated separately—a drug, a device, and/or a biologic. But the two largest and most influential regulatory bodies in the world, the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA), approach this concept from fundamentally different philosophical standpoints. Understanding this divergence is the first step to building a robust global strategy.
The U.S. FDA’s Categorical Approach
In the United States, the definition is codified and clear. Under the Code of Federal Regulations (21 CFR 3.2(e)), the FDA formally recognizes a “combination product” and sorts it into one of three primary categories.5 This approach is categorical; the agency wants to know what your product
is so it can place it into the correct regulatory bucket.
Single-Entity Combination Products: These are products where two or more regulated components (e.g., drug/device, biologic/device) are “physically, chemically, or otherwise combined or mixed and produced as a single entity”. Think of this as the most integrated form. The classic examples are a drug-eluting stent, where the drug is coated directly onto the device, or a prefilled syringe, where the drug and the delivery device are presented as one inseparable unit.6 Other common examples include transdermal patches, antimicrobial wound dressings, and even drug pills embedded with tiny sensors.6
Co-Packaged Combination Products: Here, two or more separate products are packaged together in a single package or as a unit. These are often called “convenience kits.” The components are not physically integrated, but they are sold together for a unified purpose. Common examples include a first-aid kit containing both bandages (devices) and antibiotic ointment (a drug), or a vial containing a lyophilized drug packaged with a syringe of sterile water for reconstitution.6
Cross-Labeled Combination Products: This is the most conceptually distinct category. It involves a drug, device, or biologic that is packaged and sold separately but is intended for use only with another specific, approved product. Both components are required to achieve the intended therapeutic effect, and this relationship is explicitly stated in the product labeling.7 The archetypal example is a photosensitizing drug that is activated by a specific, separately sold laser or light source device.
This rigid, categorical framework forces innovators to fit their product into a predefined box. This decision, as we will see in Section 2, is the key that unlocks the door to a specific regulatory center and pathway at the FDA.
The EU EMA’s Functional Approach
The European Union takes a different tack. The legal framework, primarily the Medical Device Regulation (MDR) (EU) 2017/745, does not provide a single, overarching definition for “combination product”.9 Instead, the EU system is functional; it seeks to understand what your product
does to determine how it should be regulated. The terminology reflects this focus on action and purpose.
Integral Products: This is the closest EU equivalent to the FDA’s “single-entity” category. The MDR describes two main types. The first is a device that incorporates a medicinal substance as an “integral part,” such as a drug-eluting stent or an antibiotic-coated catheter. The second is a device intended to administer a medicinal product where the two form a “single integral product” that is for one-time use, such as a prefilled syringe or a single-use autoinjector.10The crucial distinction in the EU is the determination of the product’s principal versus ancillary action.
If the action of the medicinal substance is principal to that of the device, the entire product is regulated as a medicinal product under Directive 2001/83/EC.9 The device component must still meet the relevant safety and performance requirements of the MDR, but the overall regulatory pathway is that of a drug.
If the action of the medicinal substance is merely ancillary to that of the device (meaning it supports the device’s main function), the product is regulated as a medical device and must be CE marked. A drug-eluting stent, for example, is typically considered a device with an ancillary drug action in the EU, as its principal mode of action is the mechanical scaffolding of the artery.
Non-Integral Products: This category covers products where the device and drug are not physically combined but are intended for use together. This includes devices that are co-packaged with a medicinal product or are referenced in the drug’s product information but obtained separately.11 In these cases, the device must be CE marked as a standalone medical device, and the medicinal product is authorized separately.
This functional approach requires a company to build a scientific argument about its product’s core therapeutic contribution. This fundamental divergence between the U.S. and EU regulatory philosophies is the primary source of global strategic complexity. A global development program cannot be monolithic; the strategic narrative and evidence package must be tailored to answer two different questions. For the FDA, the question is, “What is it?” For the EMA, it’s, “What does it do?” This initial fork in the road has massive downstream consequences for everything from clinical trial design to patent claim drafting.
The Modern Arsenal: A Spectrum of Innovative Combination Products
The strategic importance of these definitional nuances becomes clear when we look at the sheer diversity and growing sophistication of modern combination products. They have evolved far beyond simple convenience kits into complex, technology-driven therapeutic systems.
Traditional Drug Delivery Systems: These are the workhorses of the combination product world and remain a massive market segment. They include prefilled syringes, injector pens for insulin or biologics, insulin pumps, and a wide variety of metered-dose and dry powder inhalers for respiratory diseases.2
Advanced Implantable and Topical Systems: This category includes products where the drug and device are intimately integrated to provide a localized or sustained therapeutic effect. Drug-eluting stents, which release anti-proliferative drugs to prevent restenosis, are a prime example. Others include steroid-coated pacemaker leads, antibiotic-impregnated bone cements, and transdermal patches that deliver medication steadily through the skin.2 The development of microneedle patches, which can deliver biologics through tiny needles that painlessly pierce the top layer of skin, represents the cutting edge of this category.
Biologic-Device Integrations: The rise of biologics—large, complex molecules like monoclonal antibodies—has been a major catalyst for combination product innovation. Many biologics cannot be taken orally and require injection. This has fueled the development of user-friendly devices like autoinjectors and wearable “on-body” injectors that can deliver large volumes of viscous drugs over time. Other examples include vaccines delivered via prefilled nasal sprays or antibody-drug conjugates (ADCs), where a potent chemotherapy drug is attached to an antibody, delivered in a prefilled syringe.7
The Rise of “Smart” Products and Digital Health: The newest frontier is the integration of software, sensors, and connectivity. These products don’t just deliver a drug; they participate in the therapeutic process by collecting data and providing feedback to patients and clinicians.
Connected Inhalers: A prime example is the collaboration between Propeller Health and GlaxoSmithKline on a sensor for the Ellipta inhaler. The sensor attaches to the inhaler, records when the medication is used, and transmits this data via Bluetooth to a smartphone app. This provides real-time adherence data that can help patients and doctors better manage asthma or COPD.
Wearable Injectors and Smart Pumps: AbbVie’s Duopa, a treatment for advanced Parkinson’s disease, uses a portable infusion pump to deliver carbidopa and levodopa directly into the small intestine for 16 continuous hours. This is a clear example of a device enabling a therapeutic approach that would otherwise be impossible.
Ingestible Sensors: The concept of drug pills embedded with sensors, though still emerging, represents the ultimate integration, allowing for direct confirmation that a patient has taken their medication.
This technological progression reveals a crucial strategic theme. Combination products have evolved from being about convenience (bundling a drug and syringe) to being enabling (an autoinjector making self-administration of a biologic possible) to now becoming an integral part of the therapeutic feedback loop (a connected device tracking adherence). This evolution fundamentally elevates the strategic importance of the device component. It is no longer a commodity container but a piece of sophisticated, patentable technology that is as critical to the product’s value proposition and commercial success as the drug molecule itself.
Section 2: Charting the Course: Navigating the Global Regulatory Maze
Having defined the landscape, we now turn to the practical challenge of navigating it. The journey of a combination product from the lab to the market is governed by a complex set of rules that differ significantly across jurisdictions. Successfully charting this course requires a deep understanding of the key decision points and regulatory bodies that will shape your product’s destiny. For innovators, this isn’t just a matter of compliance; it’s a strategic exercise where early decisions can create either a streamlined path to approval or a quagmire of delays and redundant effort.
The U.S. FDA Pathway: The Centrality of the Primary Mode of Action (PMOA)
The U.S. regulatory framework for combination products was born out of a need for clarity. Before the Safe Medical Devices Act of 1990, innovators faced uncertainty about which of the FDA’s distinct centers—each with its own culture and statutory scheme—would review their product. The modern system is designed to provide a clear, predictable “front door” to the agency.
The Gatekeeper: The Office of Combination Products (OCP)
At the heart of this system is the FDA’s Office of Combination Products (OCP), established in 2002.3 The OCP does not review marketing applications itself. Instead, it acts as a crucial gatekeeper and traffic cop. Its two primary responsibilities are:
Product Classification: Determining whether a product is a drug, a device, a biologic, or a combination product.
Jurisdictional Assignment: Assigning a combination product to a “lead center” that will have primary jurisdiction over its premarket review and post-market regulation.15
This assignment process is the single most important step in the U.S. regulatory journey.
Determining the Lead Center via PMOA
The assignment of a lead center is based on a determination of the product’s Primary Mode of Action (PMOA). The FDA defines PMOA as “the single mode of action of a combination product that is expected to make the greatest contribution to the overall intended therapeutic effects of the combination product”.6 In simpler terms, the FDA asks: what is the main thing this product does to help the patient?
If the PMOA is achieved through chemical action or metabolism (a drug), the Center for Drug Evaluation and Research (CDER) will be the lead center. The product will generally follow a drug approval pathway, such as a New Drug Application (NDA) or Abbreviated New Drug Application (ANDA). A metered-dose inhaler is a classic example of a drug-led combination product, as its primary therapeutic effect comes from the inhaled medication, not the canister that delivers it.
If the PMOA is achieved through physical means (a device), the Center for Devices and Radiological Health (CDRH) will take the lead. The product will follow a device pathway, such as a Premarket Approval (PMA) application, a De Novo classification request, or a 510(k) premarket notification. A drug-eluting stent is the canonical example of a device-led product. While the drug is critical for preventing restenosis, the FDA has determined that the stent’s primary therapeutic action is the mechanical scaffolding that holds the artery open.13
If the PMOA is attributable to a biologic, the Center for Biologics Evaluation and Research (CBER) will lead the review. The product will typically require a Biologics License Application (BLA). A vaccine delivered in a prefilled nasal spray would be a biologic-led combination product.
What happens if the PMOA is unclear? For some innovative products, there may be two independent modes of action, neither of which is subordinate to the other. In these cases, the FDA’s regulations provide an algorithm for assignment. The product will be assigned to the center that regulates other combination products raising similar questions of safety and effectiveness or, failing that, the center with the most expertise to evaluate the most significant safety and effectiveness questions raised by the product as a whole.6
The Strategic Importance of the RFD and Pre-RFD
Given the profound impact of the PMOA determination, the FDA provides formal and informal mechanisms for sponsors to gain clarity early in the development process.
Request for Designation (RFD): This is a formal submission to the OCP through which a sponsor can request a binding determination on the classification of their product and/or the lead center assignment.13 Filing an RFD provides certainty, which is invaluable for planning long-term development, clinical, and financial strategies.
Pre-Request for Designation (Pre-RFD): This is an informal process that allows sponsors to get non-binding feedback from the OCP on their product’s classification and potential assignment.13 The Pre-RFD is a powerful strategic tool, enabling a dialogue with the agency before committing to a specific development path. It allows a company to test its PMOA argument and understand the agency’s thinking without the formality and finality of an RFD.
The Single Application Model and Intercenter Review
A key feature of the U.S. system, and one that stands in contrast to the EU, is its commitment to a streamlined review process. The FDA strongly encourages sponsors to submit a single marketing application for a combination product, even though multiple centers are involved in its evaluation.18
The designated lead center serves as the sponsor’s primary point of contact throughout the entire premarket process. This center is responsible for coordinating what is known as an intercenter consultative review. For a drug-led combination product reviewed by CDER, for example, CDER will send a formal consult request to CDRH to review the device-specific data within the application, such as engineering specifications, biocompatibility, and human factors studies. This “one front door” approach, while organizationally complex behind the scenes at the FDA, simplifies the process for the sponsor, creating a unified channel for communication and submission.
The EU EMA Pathway: The Dual Hurdles of MDR and Medicinal Product Directives
The European pathway presents a different set of strategic challenges. As we discussed, the system is bifurcated, governed by both the Medical Device Regulation (MDR) for the device aspects and the relevant medicinal product directives for the drug or biologic components.10 This structure often requires sponsors to manage two parallel and interdependent regulatory processes.
The Critical Role of the Notified Body Opinion (NBOp)
For integral drug-device combination products that are regulated as medicinal products (where the drug action is principal), Article 117 of the MDR introduces a critical new requirement that has significantly changed the approval landscape.9 The Marketing Authorisation Application (MAA) submitted to the EMA or a national competent authority is not considered complete unless it includes a
Notified Body Opinion (NBOp).
A Notified Body is a private, third-party organization designated by an EU competent authority to assess the conformity of medical devices before they are placed on the market. For these combination products, the sponsor must engage a Notified Body to review the device constituent part and issue an opinion on its conformity with the relevant General Safety and Performance Requirements (GSPRs) laid out in Annex I of the MDR.21
This is not a trivial undertaking. Obtaining an NBOp requires the sponsor to compile a substantial technical file for the device component, including a full GSPR checklist that provides justification and supporting documentation for each applicable requirement.21 This documentation must cover everything from design and risk management to biocompatibility and human factors. This process is, in effect, a mini-regulatory submission to a separate entity that must be completed
before the main regulatory submission for the medicinal product can be finalized.
This dual-track system creates a significant operational burden that must be carefully managed. A company must simultaneously engage with a private Notified Body, which has its own timelines and submission requirements, and the public medicinal products authority (e.g., EMA). A delay in securing the NBOp from the Notified Body will inevitably cause a delay in the acceptance and review of the entire MAA. This contrasts sharply with the FDA’s “lead center” model, which, despite involving multiple internal centers, presents a more integrated and unified interface to the sponsor. Global companies must account for this fundamental procedural difference in their project timelines, resource allocation, and vendor management strategies.
Comparative Regulatory Overview: U.S. FDA vs. EU EMA for Drug-Device Combination Products
To crystallize these complex differences, the following table provides a side-by-side comparison of the key features of the U.S. and EU regulatory frameworks. This serves as a quick-reference guide for strategic planning, highlighting the distinct paths a single product must travel to gain approval in these two critical markets.
Feature
United States (FDA)
European Union (EMA/National Authorities)
Key Regulation
21 CFR Part 3 & 4; Section 503(g) of FD&C Act 6
Medical Device Regulation (EU) 2017/745 (MDR); Directive 2001/83/EC
Core Definition
Formal legal definition of “combination product”
No single legal definition; uses terms like “integral product” or “drug-device combination” 9
Categorization
Single-entity, Co-packaged, Cross-labeled
Integral vs. Non-integral; Device with ancillary drug vs. Drug with principal action 11
Primary Factor
Primary Mode of Action (PMOA): The single action providing the most important therapeutic effect
Principal vs. Ancillary Action: Determines whether the product is regulated as a medical device or a medicinal product
Lead Authority
A single lead center (CDER, CDRH, or CBER) assigned by the OCP
Varies: A Notified Body for the device part, and a Competent Authority/EMA for the medicinal product part
Key Document
Request for Designation (RFD) for a binding assignment
Notified Body Opinion (NBOp) on GSPR conformity for the device part
Review Model
Integrated review under a single lead center with intercenter consults
Bifurcated review requiring separate engagement with a Notified Body and a medicines authority
Section 3: The Patent Gauntlet: Overcoming Core Challenges to Protect Your Innovation
Once you have a grasp of the regulatory landscape, the next great challenge emerges: securing robust, defensible, and commercially valuable patent protection. Combination products, by their very nature, exist at the complex intersection of multiple technological fields. This hybrid identity creates unique and formidable hurdles in patent law that can trip up even experienced innovators. Successfully running this patent gauntlet requires a sophisticated understanding of three core challenges: obviousness, disclosure, and enforcement.
The Obviousness Hurdle in a Post-KSR World
Perhaps the most significant patentability challenge for any combination invention is the requirement of non-obviousness, codified in the U.S. under 35 U.S.C. §103. An invention cannot be patented if the differences between it and the prior art are such that the invention as a whole would have been obvious to a “person having ordinary skill in the art” (PHOSITA) at the time the invention was made.25 For combination products, which by definition involve bringing together known elements (a drug, a device), this is a particularly high bar.
The KSR v. Teleflex Revolution
For many years, U.S. patent law operated under a relatively permissive standard known as the “teaching, suggestion, motivation” (TSM) test. To prove an invention was obvious, a patent examiner or challenger had to find some explicit teaching, suggestion, or motivation in the prior art to combine the known elements. This low standard led to an “avalanche of new patents” for what were often straightforward combinations.
That all changed in 2007 with the landmark Supreme Court decision in KSR International Co. v. Teleflex Inc..27 The Court unanimously rejected the rigid TSM test, replacing it with a more flexible, expansive, and common-sense approach to obviousness.28 The key principles from
KSR that now govern the patenting of combination products are:
Predictable Results: The Court stated that the “combination of familiar elements according to known methods is likely to be obvious when it does no more than yield predictable results”. Simply putting a known drug into a known syringe to achieve the predictable result of delivering the drug is likely obvious.
The Creative PHOSITA: The Court redefined the PHOSITA not as an “automaton” but as a person of “ordinary creativity” who works within a known framework of design needs and market pressures. This creative PHOSITA would see the benefit of combining known elements to solve a known problem.
Common Sense and “Obvious to Try”: The decision emphasized that common sense can be a valid reason to combine elements. If there is a known problem and a finite number of identified, predictable solutions, pursuing one of those options can be deemed “obvious to try” and therefore unpatentable.
The KSR decision fundamentally shifted the patentability of combination products from a question of structural novelty to one of functional invention. The focus is no longer on whether a prior art document explicitly suggested the combination. Instead, the focus is on the outcome of the combination. This places a much heavier burden on innovators to prove that their combination is truly inventive. It has direct and profound consequences for how research and development must be conducted. R&D must now be geared not just toward creating a functional product, but toward identifying and quantifying the very inventive spark that will satisfy a patent examiner.
Proving Non-Obviousness for Combination Products
In this post-KSR world, a successful patent application for a combination product cannot simply describe the act of combining. It must tell a compelling story of invention, backed by data, that demonstrates the combination achieves something unexpected and valuable. To overcome an obviousness rejection, inventors must be prepared to show:
Unexpected Synergistic Effects: This is the gold standard for proving non-obviousness. The inventor must demonstrate that the combination of the drug and the device produces a result that is greater than the sum of their individual parts.31 This synergy can manifest in many ways: the device material might unexpectedly improve the long-term stability of the drug; the unique delivery mechanism might enhance the drug’s bioavailability; or the combination might significantly reduce side effects compared to administering the drug with a standard device.
Solving a Long-Felt but Unresolved Need: The invention may be non-obvious if it successfully solves a problem that has persisted in the industry, especially if others have tried and failed. For example, if patients have long struggled with dosing errors using existing devices, a new combination product with a novel human-factors design that demonstrably reduces those errors could be considered non-obvious.
Teaching Away: The invention may be non-obvious if the prior art actually discourages or “teaches away” from the path the inventor took. If experts in the field believed that a certain type of plastic was unsuitable for storing a particular biologic, and an inventor discovers a way to make it work, that would be strong evidence of non-obviousness.
The Twin Pillars of Disclosure: Written Description and Enablement
Even if an invention is novel and non-obvious, it can only be patented if the inventor adequately discloses it to the public. This is the quid pro quo of the patent system: in exchange for a limited monopoly, the inventor must teach the public how to make and use the invention. In the U.S., this is governed by 35 U.S.C. § 112, which contains two distinct but related requirements: written description and enablement.
Written Description: This requirement ensures that the inventor was in “possession” of the claimed invention at the time the patent application was filed. The specification (the text and drawings of the patent) must describe the invention in sufficient detail to demonstrate to a PHOSITA that the inventor actually invented what is being claimed. It answers the question, “What is the invention?”
Enablement: This requirement ensures that the specification teaches a PHOSITA how to make and use the full scope of the claimed invention without requiring “undue experimentation”. It’s not enough to say what the invention is; you must explain how to practice it. It answers the question, “How does it work?”
For combination products, these disclosure requirements are particularly treacherous. The patent application must describe and enable not just the individual components in isolation, but their complex interplay. For example, if you claim a prefilled syringe for delivering a biologic, your disclosure must address:
The full scope of the claims: If your claim covers the syringe for use with an entire “class” of biologics (e.g., monoclonal antibodies), your specification must provide enough detail and examples to make it credible that it would work for the whole class, not just the one antibody you tested. Claiming more than you can enable is a fatal flaw.
The critical interactions: The disclosure must describe the functional and structural relationship between the components. How does the silicone oil used to lubricate the syringe plunger interact with the biologic? Does the tungsten from the needle insertion process leach into the drug solution and cause aggregation? Does the drug’s high viscosity require a specific spring force in the autoinjector to ensure a full dose is delivered? Failure to describe and enable these crucial interaction points can render a patent invalid.
There is a powerful and often overlooked connection between these disclosure requirements and the non-obviousness standard. The very data and scientific understanding you develop to prove an “unexpected synergistic effect” for non-obviousness must be adequately disclosed in the patent to satisfy the written description and enablement requirements. If your argument for patentability rests on the claim that your device’s novel coating prevents drug degradation, your patent must sufficiently describe that coating and teach a PHOSITA how to make and use it to achieve that result. A failure to disclose how the synergy works can lead to a court finding that you failed to enable the very inventive concept that justified the patent in the first place.
The Enforcement Nightmare: Divided Infringement
The final and perhaps most commercially devastating challenge is the doctrine of divided infringement. In the U.S., direct patent infringement under 35 U.S.C. § 271(a) occurs only when a single entity performs every step of a patented method or makes, uses, or sells a patented system. This “single-entity rule” creates a massive enforcement loophole for modern combination products, especially those involving digital health and patient interaction, where the infringing acts are often split among multiple parties.
This problem arises most often with two types of patent claims:
Method Claims: These claims, which protect a series of steps, are extremely vulnerable. Consider a patent claim for a method of managing diabetes with a smart insulin pen:
Receiving blood glucose data from a sensor (performed by the pen’s software).
Calculating a recommended insulin dose (performed by the pen’s software).
Displaying the recommended dose to a user (performed by the pen’s screen).
Administering the dose by the user (performed by the patient).
Who infringes this claim? The manufacturer makes the pen that performs steps 1-3, but not step 4. The patient performs step 4, but not steps 1-3. Under the single-entity rule, no single party performs all the steps, and thus, there is no direct infringer. The patent claim, while technologically innovative, may be commercially worthless because it is unenforceable.37
System Claims: The primary strategic defense against divided infringement is to draft claims directed to a system or apparatus, rather than a method. Instead of claiming the method of managing diabetes, one could claim:
“A system for managing diabetes, comprising: a processor configured to receive blood glucose data and calculate a recommended insulin dose; a display configured to present the recommended dose; and an injection mechanism for administering the dose.”
The entity that manufactures and sells this complete, integrated system can be held liable for direct infringement, as they have made and sold the entire claimed invention.
While courts have developed a narrow exception to the single-entity rule where one party “directs or controls” the actions of another (the Akamai v. Limelight standard), this is a very high legal bar to clear and typically requires a contractual or principal-agent relationship that rarely exists between a manufacturer and a patient.38
The threat of divided infringement is not merely a technical legal issue for litigators; it is a fundamental driver of patent drafting strategy for all modern, interactive medical technologies. It forces innovators and their patent counsel to re-engineer their inventions from a legal perspective. The focus must shift away from claiming the novel way a patient uses a product and toward claiming the product itself that enables that novel use. This strategic pivot from user-centric method claims to manufacturer-centric system claims is absolutely essential for creating an enforceable patent asset in the combination product space.
Section 4: From Legal Shield to Commercial Sword: Building a Dominant Patent Strategy
Understanding the legal and regulatory challenges is only half the battle. The true mark of a successful company in the combination product space is the ability to transform intellectual property from a defensive legal shield into a proactive commercial sword. This requires building a patent portfolio that is not just technically sound and legally defensible, but is also deeply integrated with the company’s long-term business goals, product lifecycle plans, and competitive strategy. A dominant patent strategy creates a fortress around your innovation, extends your market exclusivity, and provides a powerful source of competitive intelligence.
The “Picket Fence” Strategy: Creating a Fortress Around Your Product
In the high-stakes world of pharmaceuticals and medical devices, relying on a single patent to protect a blockbuster product is a recipe for disaster. Competitors will relentlessly probe that single patent for weaknesses, and if they find one, your entire monopoly could crumble. The most effective strategy for protecting a complex combination product is to build a “picket fence” or “patent thicket” around it. This involves filing a multitude of patents that cover every conceivable aspect of the product, creating multiple, overlapping layers of protection that are incredibly difficult for a competitor to design around.
A comprehensive picket fence strategy for a combination product, such as a next-generation autoinjector for a biologic drug, should include patents covering:
The Drug: The core patent will likely cover the active pharmaceutical ingredient (API) itself. But the fence should also include patents on specific formulations, crystalline forms (polymorphs), methods of synthesis, and even metabolites of the drug.41
The Device: This is where the strategy becomes particularly crucial for combination products. Utility patents should be filed on every novel mechanical aspect of the device: the unique spring mechanism that reduces injection pain, the novel safety shield that prevents needlestick injuries, the specific ergonomics of the casing that improve grip for arthritic patients. In addition, design patents should be used to protect the unique, non-functional ornamental appearance of the device, creating yet another barrier to copycats.
The Combination Itself: Claims should be drafted that are directed specifically to the synergistic interaction between the drug and the device. For example, a claim to “an autoinjector containing a formulation of drug X, wherein the autoinjector is constructed from polymer Y, and wherein polymer Y reduces aggregation of drug X by at least 50% over 24 months” protects the unique, non-obvious benefit of the combination.
Methods of Use: These patents claim the method of using the combination product to treat a specific disease or a particular patient population. A new patent can often be obtained if a new therapeutic use for the product is discovered.
Manufacturing Processes: Novel techniques used to manufacture the device, aseptically fill it with the sensitive biologic, or assemble the final product can and should be patented. These patents can be particularly difficult for competitors to circumvent, as they may not be able to determine the exact manufacturing process from the final product alone.
Software and Data: For the growing number of “smart” devices, this layer is essential. Patents can cover the software algorithms that calculate dosage, the user interface on the companion app, the methods of encrypting and transmitting data to the cloud, and the AI-driven analytics that provide insights to patients and doctors.
By building this multi-layered fortress, you ensure that even if a competitor successfully challenges one “picket” in your fence (e.g., by invalidating a single device patent), they still face a formidable wall of other patents that block their entry to the market.
Aligning IP with Lifecycle Management and Regulatory Exclusivity
A truly sophisticated patent strategy does not exist in a vacuum. It is dynamically managed over time and is strategically aligned with the product’s entire commercial lifecycle and the parallel track of regulatory exclusivity. Market protection for a new therapeutic is derived from two distinct sources that run on different clocks:
Patent Term: This is granted by the patent office and typically lasts for 20 years from the earliest non-provisional filing date. It can sometimes be extended to compensate for regulatory delays.32
Regulatory Exclusivity: This is granted by the FDA upon approval and prevents the agency from approving a generic or biosimilar competitor for a set period, regardless of the patent status. Key types include New Chemical Entity (NCE) exclusivity (5 years), Biologic exclusivity (12 years), Orphan Drug Exclusivity (ODE) (7 years), and Clinical Investigation Exclusivity (CIE) (3 years for products requiring new clinical studies for approval).
The art of lifecycle management lies in strategically sequencing these two forms of protection. The picket fence strategy is the primary tool for achieving this, a practice sometimes referred to as “evergreening”.45 The goal is to create a continuous wall of market protection where, as one form of protection expires, another takes its place.
Consider this strategic sequence for a new biologic in an autoinjector:
Years 0-12: The product is protected by its 12-year biologic exclusivity. No biosimilar can be approved during this period. The company also has a core patent on the biologic molecule that might expire in year 15.
Year 8: The company, anticipating the end of its exclusivity period, launches a “next-generation” version of the product. This version features an improved autoinjector with a new, patented safety mechanism and a more patient-friendly design. The patents on this new device expire in year 28.
Year 12: The biologic exclusivity expires.
Year 15: The original patent on the biologic molecule expires. At this point, a competitor is free to manufacture a biosimilar version of the drug.
The Commercial Hurdle: However, that competitor faces a major commercial challenge. They cannot launch their biosimilar in an autoinjector that infringes the device patents expiring in year 28. They are forced to either invest significant time and money to design a non-infringing device (a difficult task if the picket fence is well-constructed) or wait for the device patents to expire.
This strategy effectively uses the device patents to extend the de facto monopoly on the combination product, preserving the brand’s revenue stream for years beyond the life of the core drug patent. This is a central and highly effective business strategy for many of the world’s most successful combination products.
“The global market for combination products is expected to reach $177.7 billion by 2026, growing at a CAGR of 9.2% from 2021 to 2026.”
*Source: MarketsandMarkets Report, as cited by DrugPatentWatch *
Leveraging Patent Data for Competitive Intelligence with DrugPatentWatch
Patents are far more than just legal documents; they are a treasure trove of technical and strategic information about your competitors. Proactively monitoring and analyzing the patent landscape is a critical component of any modern business strategy. Specialized databases and business intelligence platforms are invaluable tools in this endeavor.
For instance, a platform like DrugPatentWatch provides the kind of detailed data that can be transformed into actionable competitive intelligence for combination products. By leveraging such a resource, a company can:
Map Competitor Portfolios: Systematically analyze a competitor’s patent filings to deconstruct their “picket fence” strategy. Which aspects of their technology are they protecting most heavily? Where are the potential gaps or “white space” in their portfolio that could represent an opportunity for your own innovation? This analysis can reveal their long-term lifecycle management plans and strategic priorities.
Predict Generic and Biosimilar Entry: The timing of generic competition is one of the most critical variables in pharmaceutical forecasting. By tracking patent expiration dates, patent term extensions, and the status of Paragraph IV patent challenges (where a generic company challenges the validity of a brand’s patents), you can build more accurate models to predict when a blockbuster combination product will lose its exclusivity.32
Inform R&D and Business Development: Monitoring patent filing trends can provide early signals about emerging technologies and shifts in the competitive landscape. Are competitors suddenly filing numerous patents related to connected devices or microneedle technology? This information can help guide your own R&D investments. Furthermore, analyzing the patent landscape can help identify smaller companies with innovative technologies that may be attractive targets for licensing or acquisition.
In essence, turning patent data into competitive advantage means treating the global patent database not as a static legal library, but as a dynamic, real-time map of your industry’s technological and strategic movements.
Section 5: Lessons from the Battlefield: High-Stakes Litigation and Strategic Insights
The abstract principles of patent and regulatory law are best understood through the lens of real-world conflict. The combination product space has been shaped by a series of high-stakes legal battles that offer powerful, and often costly, lessons for innovators. By dissecting these landmark cases, we can extract critical strategic insights on how to build a defensible patent portfolio and how to avoid the pitfalls of anticompetitive behavior.
The Drug-Eluting Stent Wars: Boston Scientific v. TissueGen
The market for drug-eluting stents (DES) has been a hotbed of innovation and intense patent litigation for decades. The case of Boston Scientific v. TissueGen provides a masterclass in how a smaller innovator can successfully defend its patent against an industry giant by focusing on a truly inventive concept.
Case Background and Patented Technology
The dispute centered on Boston Scientific’s Synergy line of drug-eluting stents. TissueGen, along with the University of Texas, filed a lawsuit alleging that the Synergy stents infringed on their patent for a “drug-releasing biodegradable fiber implant”.48 The research, conducted in the late 1990s, was visionary. At a time when the industry was focused on simply coating metal stents with drugs to prevent arterial reclogging (restenosis), TissueGen’s founder, Dr. Kevin Nelson, conceived of a more elegant solution. His invention involved using biodegradable polymer fibers that could not only deliver a therapeutic agent in a controlled manner but were also designed to be absorbed by the body over time. The goal was not just to prop the artery open and prevent scarring, but to actively
heal the arterial wall without leaving a permanent polymer behind.
The Verdict and Its Strategic Implications
In February 2023, a federal jury agreed with TissueGen, finding that Boston Scientific had infringed the patent and awarding $42 million in unpaid royalties. While Boston Scientific planned to appeal, the verdict itself is a powerful lesson in navigating the post-KSR obviousness landscape.
The strength of TissueGen’s patent lay in its specific, inventive narrative. The “obvious” idea, which many companies were pursuing, was simply to combine a stent with an anti-restenosis drug. TissueGen’s patent, however, claimed something far more specific and functionally superior: a novel mechanism (the biodegradable fibers) that produced an unexpected and advantageous result (promoting healing and avoiding long-term polymer exposure).
This is precisely the kind of story required to demonstrate an inventive step for a combination product. The patent successfully distinguished itself from the general, “obvious to try” concept of a drug-coated stent by focusing on the true inventive concept at its core. It highlights the critical importance of identifying, patenting, and being able to articulate the unique technical solution that your combination product provides, rather than just the combination itself.
The EpiPen Saga: Patents, Profits, and Antitrust Allegations
If the TissueGen case is a lesson in how to succeed, the long-running litigation surrounding Mylan’s EpiPen autoinjector is a cautionary tale of how market dominance, when combined with an aggressive and multifaceted intellectual property strategy, can cross the line into anticompetitive conduct and attract massive legal and financial repercussions.
Building a Monopoly Through a Multi-Pronged Strategy
The EpiPen, an autoinjector used to treat life-threatening allergic reactions, became the subject of intense public outrage and numerous lawsuits after its price skyrocketed by over 600% between 2007 and 2016, from around $100 to over $600 for a two-pack.50 A series of class-action and antitrust lawsuits alleged that Mylan, the distributor, and Pfizer, its manufacturer, engaged in a broad, unlawful scheme to maintain their monopoly in the epinephrine autoinjector market.50
The plaintiffs’ allegations paint a picture of a company using every available tool—patent law, regulatory processes, and commercial contracting—to foreclose competition. The key elements of the alleged anticompetitive scheme included:
Patent Thickets and Sham Litigation: Mylan and Pfizer allegedly secured multiple, overlapping patents on what plaintiffs described as minor changes to the EpiPen device. They then used this “patent thicket” to file infringement lawsuits against any generic competitor that attempted to enter the market, such as Teva and Sandoz. The lawsuits were often followed by settlements in which the generic manufacturer agreed to delay its market entry, which plaintiffs characterized as unlawful “reverse payments” or “pay-for-delay” deals.51
Product Hopping and Tying: In 2011, Mylan stopped selling single EpiPens in the U.S. and switched to a mandatory “2-Pak”. Plaintiffs alleged this was an unlawful tying arrangement, forcing consumers to buy a second, often unneeded, device and effectively doubling the price without any compelling medical justification.
Exclusive Dealing Arrangements: Mylan allegedly used its market power to lock competitors out of key distribution channels. This included offering substantial rebates to Pharmacy Benefit Managers (PBMs) and insurers conditioned on them giving EpiPen exclusive or preferred status on their formularies, effectively blocking coverage for rival products like Sanofi’s Auvi-Q. Mylan also used its “EpiPen4Schools” program to sign schools to exclusive contracts, a practice that drew an antitrust investigation from the New York Attorney General.
Regulatory Process Abuse: Plaintiffs alleged that Mylan filed a “sham” Citizen Petition with the FDA just months before a potential generic competitor from Teva was set to launch. The petition raised last-minute design concerns about the generic device, a move plaintiffs argued was not a legitimate safety concern but a tactic designed purely to abuse the regulatory process and cause further delay.51
The Outcome and the Sobering Lesson
Facing years of litigation and immense public and political pressure, the defendants chose to settle. Pfizer agreed to a $345 million settlement in 2021, and Mylan followed with a $264 million settlement in 2022, for a combined total of $609 million, all without admitting wrongdoing.50
The EpiPen saga is a stark and powerful warning that a company’s patent and lifecycle management strategy does not exist in a legal vacuum. While an individual action—filing a patent on a device improvement, offering a commercial rebate, changing product packaging—might be perfectly legal in isolation, the calculus changes when these actions are viewed together as part of a broader scheme to unlawfully maintain a monopoly. The critical lesson for business leaders is that IP strategy, commercial strategy, and regulatory strategy must all be vetted through an antitrust lens. The question for a company with a dominant market position is not just “Can we legally obtain this patent?” but “How will we use this patent and our market power in a way that does not unlawfully harm competition?” The EpiPen case demonstrates that the failure to ask and correctly answer that second question can have staggering financial consequences.
Section 6: A Global Perspective: Harmonizing Patent Strategy Across the USPTO, EPO, and JPO
For any company with global ambitions, a successful patent strategy cannot be confined to a single jurisdiction. The three largest and most important patent offices in the world—the United States Patent and Trademark Office (USPTO), the European Patent Office (EPO), and the Japan Patent Office (JPO)—each have their own distinct laws, examination guidelines, and legal precedents. Crafting a patent application that can survive scrutiny and provide meaningful protection in all three jurisdictions is a highly sophisticated art. It requires a deep understanding of their key differences and the ability to draft a single, foundational patent specification that can support three different strategic arguments.
While all three offices require an invention to be non-obvious or possess an “inventive step,” the analytical framework they use to make this determination varies significantly.
USPTO: The Flexible, Post-KSR Approach: As discussed in Section 3, the U.S. employs a flexible, common-sense approach following the KSR decision. An examiner can put forth any number of rationales to combine prior art references, such as combining known elements to yield predictable results, substituting one known element for another, or pursuing an “obvious to try” solution from a finite set of options. To overcome this, the applicant’s argument must focus on demonstrating unexpected results, solving a long-felt need, or showing that the prior art teaches away from the invention. The approach is holistic and evidence-based.
EPO: The Structured “Problem-Solution Approach”: The EPO uses a much more structured and formalistic methodology known as the “problem-solution approach”. This is a three-step process:
Determine the “closest prior art,” which is the single prior art reference that represents the most promising starting point for arriving at the invention.
Establish the “objective technical problem” that the invention solves over this closest prior art. This problem is formulated based on the technical effect or advantage provided by the features that distinguish the invention from the prior art.
Consider whether a PHOSITA, starting from the closest prior art and faced with the objective technical problem, would have arrived at the claimed invention in an obvious way.This structured approach means that arguments at the EPO must be framed in a very specific way, focusing on identifying a technical problem and presenting the invention as the non-obvious solution.
JPO: The Emphasis on “Advantageous Effects”: The JPO’s examination guidelines also involve identifying the closest prior art and analyzing the differences. However, a key and often decisive factor in the JPO’s inventive step analysis is the presence of “advantageous effects” that are superior to the prior art.59 If an invention demonstrates an effect that is of a different nature or is significantly and unexpectedly better than what was known, this is considered strong evidence supporting the existence of an inventive step. Therefore, patent applications in Japan often benefit greatly from including clear, quantitative, comparative data that demonstrates the superiority of the invention over the prior art.
This divergence in analytical frameworks means that the concept of a single, “one-size-fits-all” global patent application is a myth. To succeed, the core technical disclosure must be drafted with enough breadth and detail to support three distinct narratives. For the USPTO, the story might emphasize the unexpected clinical data and how it solved a long-standing market need. For the EPO, the same data must be framed as the solution to a specific objective technical problem. And for the JPO, that data must be presented as clear evidence of a superior, advantageous effect. Drafting a single specification that can effectively support all three arguments from day one is the hallmark of a sophisticated global patent strategy.
Disclosure Requirements and the Use of Post-Filing Data
Another critical difference that has profound strategic implications is how each office treats data that is generated after the patent application has been filed.
USPTO: The U.S. is generally more lenient in this regard. An applicant can often submit post-filing data during patent prosecution (for example, in response to an office action) to provide evidence that the invention is enabled or that it possesses unexpected properties that make it non-obvious.
EPO & JPO: These offices are significantly stricter. The patent application as originally filed must contain enough information to make the invention plausible and credible across the full scope of the claims. Post-filing data can sometimes be used to confirm an effect that was already made plausible in the original application, but it generally cannot be used to remedy a fundamental deficiency in the initial disclosure. If the original application does not provide a credible basis for the invention, no amount of subsequent data can save it.
This procedural difference creates a critical strategic tension, particularly for early-stage companies. There is a strong incentive to file a patent application as early as possible to secure a priority date. In the U.S., a company can file a provisional application with preliminary data and use the following year to generate more robust data to support the application. This is a common and effective strategy.
However, a global company must be more cautious. If it files a global (PCT) application based on only preliminary data and then enters the national phase in Europe and Japan, it runs a serious risk of receiving fatal rejections for lack of sufficiency or inventive step that cannot be fixed with later-generated data. The optimal global strategy often involves a more patient approach: using the one-year priority period to generate the robust, comparative, and quantitative data needed to satisfy the stricter disclosure requirements of the EPO and JPO before filing the comprehensive international application. This requires a disciplined and forward-looking alignment of R&D planning with global IP strategy.
Section 7: The Future Is Combined: Emerging Trends and the Next Generation of Patents
The world of drug/device combination products is not static. It is a field of relentless innovation, driven by rapid advances in digital technology, data science, and personalized medicine. As we look to the horizon, it’s clear that the very definition of a combination product is expanding, creating a new generation of therapeutic systems that will bring with them a host of novel patenting challenges and opportunities. The companies that will lead the next decade will be those that anticipate these trends and build the IP strategies needed to protect these highly complex, integrated innovations.
The Digital Revolution: Software, AI, and Connected Devices
The most significant trend reshaping the industry is the integration of digital technology. The “smart” devices we see today, like connected inhalers and insulin pumps, are just the beginning. We are entering an era where software is not just an accessory to a therapy but is the therapy itself, or at least an indispensable part of it.
The Rise of SaMD and Digital Therapeutics: The concept of Software as a Medical Device (SaMD) is creating entirely new classes of combination products. A therapeutic might consist of a standard drug paired with a sophisticated smartphone app that uses cognitive behavioral therapy to improve patient outcomes. An even more integrated product might be an “electroceutical” that combines a drug with an implantable device that delivers targeted electrical stimulation, all controlled by an AI algorithm.
New Patenting Frontiers: This digital convergence opens up vast new territories for patent protection. Innovators can and should seek patents on the software algorithms that personalize dosing, the machine learning models that predict adverse events from sensor data, the unique graphical user interfaces that improve patient engagement, and the secure methods of transmitting and analyzing health data.2
New and Intensified Challenges: This trend will also amplify the patenting challenges we’ve already discussed. The problem of divided infringement will become the default scenario for any therapy involving a patient, a device, a smartphone, and a cloud server. Furthermore, innovators will have to navigate the complex and still-evolving legal standards for patent eligibility of software and abstract ideas, particularly under 35 U.S.C. § 101 in the United States, which has been a source of significant uncertainty for technology patents.
The Era of Personalization: Companion Diagnostics and Bespoke Therapies
The second major trend is the move away from “one-size-fits-all” medicine toward highly personalized therapies tailored to an individual’s unique genetic makeup or disease characteristics.
Companion Diagnostics: A growing number of targeted cancer therapies are approved for use only in patients whose tumors express a specific biomarker. These therapies are inextricably linked with a companion diagnostic test used to identify eligible patients. This creates a cross-labeled combination product where the drug and the diagnostic are co-dependent.
Bespoke and “N-of-1” Therapies: Advances in technologies like 3D printing are making it possible to create truly customized medical products. One can envision a future where a surgeon designs a patient-specific, 3D-printed bone scaffold that is then impregnated with a specific cocktail of antibiotics and growth factors tailored to that patient’s needs. This is the ultimate “N-of-1” combination product.
A Shift in Patent Strategy: This trend will likely necessitate a shift in patenting philosophy. The blockbuster model, which relied on extremely broad patents covering a single molecule for a wide population, may give way to portfolios of narrower, but highly defensible, patents. These patents might cover the use of a drug in a specific, biomarker-defined patient subpopulation, or claim a system for designing and manufacturing customized, patient-matched implants.
Ultimately, the future of combination products lies at the intersection of these two powerful trends. The next revolutionary therapy may be a fully integrated, closed-loop system: a wearable or implantable biosensor (device) continuously monitors a patient’s unique biological state in real-time; a sophisticated AI algorithm (software) hosted on their smartphone analyzes this data stream and calculates a precise, personalized dose of a targeted therapy (drug); and this dose is then administered on-demand by a smart delivery system like a wearable pump (device).
Protecting such a system will be the ultimate test of a company’s IP strategy. It will require a masterful “picket fence” of patents covering the biologic, the sensor hardware, the AI algorithm, the data security protocols, the delivery mechanism, and the overarching system architecture. The enforcement challenges will be immense, with divided infringement being a constant threat involving the manufacturer, the patient, the cloud service provider, and the physician monitoring the data. The companies that succeed in this future will be those that master not only the science but also the incredibly complex, interwoven patent and regulatory strategies required to protect and commercialize these revolutionary therapies.
Conclusion: From Complexity to Competitive Edge
The landscape of drug/device combination products is a domain of immense opportunity, but it is not for the faint of heart. It is a world defined by a convergence of disciplines—pharmaceutical science, bioengineering, software development, and data analytics—and governed by a parallel convergence of complex legal and regulatory frameworks. As we have seen, the path from a novel concept to a market-leading product is fraught with challenges, from navigating the philosophical differences between the FDA and EMA to overcoming the high legal bars of non-obviousness and enablement, and designing patent claims that can withstand the enforcement nightmare of divided infringement.
Yet, for all its complexity, the central message of this report is one of opportunity. The very hurdles that make this field so challenging are also what create the potential for building deep, durable, and long-lasting competitive advantage. In the world of simple small-molecule drugs, the path for generic competition is often straightforward. In the world of complex combination products, a well-executed, integrated strategy can create barriers to entry that last for decades.
Success in this arena is not the result of a single brilliant invention or a single perfectly drafted patent. It is the result of a sustained, proactive, and holistic strategic vision. It requires breaking down the traditional silos between R&D, regulatory affairs, legal, and commercial teams. It demands that patent strategy inform R&D from day one, ensuring that the right data is generated not just for regulators, but to prove an inventive step to patent examiners. It requires that regulatory strategy be crafted with a global mindset, anticipating the different questions and requirements of major world health authorities. And it demands that commercial and legal strategies be vetted through an antitrust lens, ensuring that the hard-won power of a dominant market position is not squandered through anticompetitive conduct.
The future of medicine is combined. The therapies that will transform patient care in the coming decades will be smarter, more personalized, and more integrated. For the companies developing these innovations, mastering the dual challenges of patent law and regulation is not just a necessary evil; it is the fundamental basis of value creation. Those who treat this complexity as a checklist to be completed will struggle. Those who embrace it as a strategic landscape to be mastered will not only succeed but will define the future of healthcare.
Key Takeaways
Regulatory Philosophy Dictates Strategy: The U.S. FDA’s categorical approach (“What is it?”) and the EU EMA’s functional approach (“What does it do?”) are fundamentally different. A successful global strategy requires tailoring your product’s narrative and evidence package for each jurisdiction from the earliest stages of development.
PMOA is the U.S. Gatekeeper; NBOp is the EU Hurdle: In the U.S., determining the Primary Mode of Action (PMOA) is the most critical step, as it assigns your product to a single lead review center (CDER, CDRH, or CBER). In the EU, securing a Notified Body Opinion (NBOp) on the device component is a mandatory, parallel process that can be a major bottleneck if not managed proactively.
Non-Obviousness is About Functional Invention, Not Structural Novelty: In the post-KSR era, simply combining known elements is not enough to secure a patent. You must prove an unexpected synergistic effect or that your product solves a long-felt but unresolved need. R&D must be designed to generate the data that tells this inventive story.
Build a “Picket Fence” Patent Portfolio: Do not rely on a single patent. Protect every aspect of your combination product—the drug, the device’s mechanical and design features, the drug-device interaction, methods of use, and manufacturing processes—to create a multi-layered fortress that is difficult for competitors to circumvent.
Align Patent and Regulatory Clocks for Lifecycle Management: Use the “picket fence” strategy to file patents on incremental device improvements over time. This can extend market protection for years after the core drug patent and initial regulatory exclusivities have expired, a powerful tool for lifecycle management.
Design Claims to Avoid Divided Infringement: For interactive or connected devices, prioritize “system” or “apparatus” claims that can be enforced against a single entity (the manufacturer). User-centric “method” claims are often unenforceable due to the single-entity rule for direct infringement.
Antitrust is the Third Rail: An aggressive patent and commercial strategy, especially for a market-leading product, can attract antitrust scrutiny. Seemingly legal individual actions (e.g., patenting, rebating) can be viewed as part of an illegal monopolistic scheme, as seen in the EpiPen litigation. All strategies must be vetted for antitrust risk.
Frequently Asked Questions (FAQ)
1. We have a novel drug and plan to launch it in a standard, off-the-shelf delivery device. Is it worth the time and expense to patent the device component?
Absolutely. This is one of the most common strategic mistakes companies make. While the initial device may be off-the-shelf, your lifecycle management strategy should include developing and patenting next-generation versions of that device. As demonstrated by numerous successful products like the EpiPen, patents on incremental device improvements (e.g., a better safety mechanism, improved ergonomics, connectivity features) can become your most valuable assets for extending market exclusivity long after the patent on the novel drug has expired.46 Failing to build this “picket fence” around your device is leaving years of potential revenue on the table.
2. Our combination product has a clear drug PMOA in the U.S. How much attention do we really need to pay to the device regulations under CDRH?
A great deal. Even though CDER is the lead review center, they will formally consult with CDRH to review all device-related aspects of your NDA or BLA submission. CDRH will scrutinize your device design controls, risk analysis (as per ISO 14971), biocompatibility data, and human factors/usability studies with the same rigor they would apply to a standalone device. A deficiency in your device data package can lead to a Complete Response Letter (CRL) for the entire combination product, delaying your launch. Underestimating the importance of the consulting center’s review is a frequent and costly error.
3. What is the single biggest difference in patent drafting strategy between the U.S. and Europe for a combination product?
The treatment of post-filing data. The USPTO is relatively permissive, often allowing you to submit new data during prosecution to support arguments of non-obviousness or enablement. The EPO is far stricter; the application as filed must contain enough data to make the claimed invention plausible across its full scope. This means a U.S.-centric strategy of filing early with minimal data can be fatal in Europe. A global patent application must be drafted from day one with the EPO’s higher “plausibility” standard in mind, which often means delaying filing until more robust, comparative data is available.
4. Our new product involves a patient using a smartphone app to control a drug delivery pump. How do we patent this without our claims being unenforceable due to divided infringement?
This is the central patent enforcement challenge for digital health. The key is to shift your claims’ focus from the user’s actions to the manufacturer’s product. Instead of claiming a method like “a method of delivering a drug, comprising the steps of a patient inputting a command on an app and a pump administering the drug,” you should claim the system that enables this action. For example: “A system for drug delivery, comprising: a pump; and a non-transitory computer-readable medium (the app) with instructions that, when executed by a processor (the phone), cause the system to receive a user command and actuate the pump.” The company that makes and sells the pump and provides the app for download can be sued for directly infringing this system claim, neatly avoiding the divided infringement problem.
5. We are partnering with another company to develop a combination product; they are providing the drug and we are providing the device. How should we handle the IP ownership?
This must be addressed with extreme clarity in your collaboration agreement before any significant joint work begins. There are several potential structures, but ambiguity is your enemy. Key questions to resolve are: Who owns the pre-existing “background” IP for the drug and the device? Who will own the “foreground” IP created jointly during the collaboration—specifically, patents on the integrated combination product? Will ownership be joint, or will one party assign their rights to the other in exchange for licensing fees or royalties? What are the rights of each party to use the joint IP if the collaboration terminates? Establishing these rights at the outset is crucial to avoiding costly and potentially relationship-ending disputes down the line.
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