DDP 2020 and Informa Passport Events Poster
The Value of Intellectual Property (IP) for Connected Drug Delivery NOW
While it's clear that there is heightened interest in developing medication telemanagement solutions, much of what's still out there today in the mHealth marketplace consists mainly of "take your medicine" reminders, "refill your prescription" alerts, and self-tracking diaries. While these are helpful to promote adherence, the mMed patent portfolio relates to technology that not only supports greater adherence, but also provides foundations for platforms and business systems addressing a fuller, much richer scope of medication telemanagement issues.
Granted claims cover providing vital information that could be made immediately available not only to patients, but also to their medical professionals and caregivers. Algorithms in a communications device or elsewhere, in combination with sensed medication and patient information, provide stakeholders with decision tools. A central facility could perform analyses, make remote diagnoses and take actions as necessary.
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Besides providing reminders to take the medication or prompts to initiate the replenishment process, an advanced mobile medication management system using technology protected by the mMed patent portfolio could do much more.
Besides providing reminders to take the medication or prompts to initiate the replenishment process, an advanced medication management system enabled by the mMed patent portfolio could also:
The technology protected by the mMed portfolio of patents could enable breakthrough wireless services to deliver essential medical information not communicated today, in ways not in use today.
All the U.S. patents in the mMed patent portfolio extend the concepts of medication telemanagement to different inventions. In some, sensors are primarily in a device containing the drug. In others, sensors are primarily in a medication carrying case for such a device. While the patents cover all dosage forms, there is exceptional strength in inventions for management of injectable dosage forms. See Purchasing/Licensing
The mMed patent portfolio protects inventions for advanced mobile medication telemanagement. Generally, the inventions involve a medication container or a case for a medication container communicating in various ways. The communication can be with a central facility, sometimes via a mobile device having a location sensor, or to a caregiver or to the party who is supposed to carry the medication container.
The mMed portfolio includes five U.S. patents granted between July 2010 and July 2012, and corresponding Israeli and Australian patents. The granted U.S. patents have 21 independent and 191 dependent claims.
New Directions Technology Consulting Managing Director Napoleon Monroe is the sole inventor of the patents.
Product Information Management System: Method of processing product-related shipment and usage information to understand the cause of an abnormal event after the product has been distributed. This allows a flow of information to and from patients and mitigation of risks once products are in patients' hands.
Injection Device with Reporting Ability: Means for showing that a drug-containing injector is not being carried by the designated person.
Claim 1 of 15 claims
An injector with a location sensor sends a signal to a central facility that the injector is not being carried. The central facility retrieves a data record associated with the injector and sends a reminder message to the indicated person to carry the injector.
Injection Device and Case with Reporting Ability: Means for including one or multiple medications and dosage forms in cases and communicating added information.
Claim 1 of 96 claims
A container includes a location sensor and at least two of (i) a product sensor, (ii) a container sensor, and (iii) a patient sensor. A communication signal is sent to a central facility, including a central facility access code, a container ID code, sensor readings and the location of the container.
The claims in this patent apply primarily to securing usage information for medication and other healthcare products "in the wild"; that is, in the hands of patients, away from physical locations of medical professionals. This patent anticipated before the passage of legislation and formulation of regulations defining such current standardized systems as barcoding for medical devices and serialization for pharmaceuticals. These standardized systems enable important information flow from "the wild" in such situations as care transitions, treatment of chronic and acute diseases at home, and medical emergencies.
Claim 11 of 96 claims
Similar to claim 1 of the 8,044,778 patent, except the container has a usage indicator and lacks a location sensor. The communication signal is sent to a mobile device that includes a location sensor. The mobile device then sends the communication signal to the central facility.
Central Facility that Communicates with Portable Container via Mobile Device: Covers means to incorporate monitoring facilities into medication management. A central monitoring facility staffed with medical professionals can facilitate medical treatment. This could be important from a regulatory perspective.
Claim 1 of 30 claims
A portable container having a usage sensor sends usage information to a mobile device having an environmental sensor and a patient sensor. The mobile device sends the usage information, along with environmental and patient information, to a central facility.
The central facility has a situational rule that determines data sent to the mobile device and has a notification rule that determines a notice sent to a third party.
Product Container for Use with Device Capable of Long-Range and Short-Range Communications: Covers further claims on devices with short-range and long-range capabilities, such as smartphones.
A medication container or a case for a medication container that communicates with a communications device having both long- and short-range communications capability.
|Sensors that can be in medication container or in a case for a medication container.|
|Sensors to determine whether the medication is with the patient.|
Cameras that capture images (still, video, or thermal); microphones that capture audio signals; sensors that monitor temperature, humidity, and vibration.
|Providing information to a monitoring facility.|
|Ability to integrate medication information with information from other apps.|
|Use of a product tag, such as a 2D barcode to help control product in the patient's hands.|
|A case for a medication container that could contain multiple medications.|
|These and other features when incorporated in medication telemanagement devices and systems provide numerous benefits to many different stakeholders. They combine to encourage adherence, provide real-time information and training possibilities, and allow supply-chain management to the patient level.|
Systems based on the mMed patent portfolio offer numerous benefits to all healthcare stakeholders.
Benefits for purchasing or licensing patents include: (i) competitive barrier against others providing similar/same service, and (ii) ability to control who competes in your market via licensing. Benefits accrue to patent owners and licensors.
Pharma is being asked to demonstrate product value, evidence-based outcomes, and improvement in quality of life. With mobility being crucial to quality of life, there is a strong rationale for a Pharma emphasis on mHealth. Service beyond the script and mHealth/medication telemanagement are now key parts of pharmaceutical companies' strategies to gain and retain patients. This is ever more important in a healthcare environment in which patients, practitioners and others, assess the value of pharma products.
mHealth/medication telemanagement can provide real-time information to permit Pharma to manage the medications they provide. Such information can be of significant predictive value, as well.
This can be particularly important when it comes to often-expensive specialty pharma products, including those used to treat such complex diseases as multiple sclerosis, rheumatoid arthritis, hepatitis C and cancer. Some are fragile and administered parenterally (to withstand first-pass metabolism or otherwise to enhance bioavailability), and injectable products pose special compliance and disposal issues.
The specialty pharma market is growing far faster than the overall market for pharmaceutical companies. More products are being compounded or engineered for specific patients or patient groups. Pharma has invested billions in the specialty-drug market primarily through the purchase, development and marketing of biotech products.
According to some studies, specialty pharmaceuticals now account for 25 percent of healthcare costs and represent a rapidly growing area of spending in healthcare. By 2019 some expect that specialty drugs will represent 50 percent of overall Rx drug spending. Many of the new drugs filed for marketing in the United States by the FDA are specialty pharmaceuticals.
Home administration offers significant savings opportunities.
Market differentiation / competitive positioning
Generics/biosimilars pose major threats to branded pharma. So, to enhance the competitive posture of branded products vs. generics/biosimilars, branded pharma can differentiate products and add value—and revenue—by providing related services using mHealth technologies.
In addition to the benefits for specialty pharma and competitive positioning, mHealth technologies offer opportunities to make more effective a risk evaluation and mitigation (REMS) program to ensure the safety of products, to foster concordance among healthcare stakeholders, and to help improve Pharma's overall public image.
Pharma often partners with device manufacturers, which are now also driven to embrace a service model. When the patent owner/licensor sells products, services or systems practicing the inventions in the portfolio to support your pharma products their stakeholder partners also benefit.
For healthcare payers, the benefit is clear:
The use of mobile medication management systems can improve patient outcomes and avoid re-hospitalizations and emergency-room visits. This complements pay-for-performance models, such as accountable care organizations (ACOs) and evolving CMS mHealth reimbursement programs.
Payers — patients, caregivers, employers, insurers, government and taxpayers — are working toward solutions that both improve outcomes and reduce patient use of expensive medical services, including emergency rooms and batteries of tests. Solutions that increase adherence to medication regimens help achieve these goals, resulting in decreased overall costs.
Smart application of automated identity and data capture (AIDC) technology can have broad-reaching advantages to all stakeholders. Manufacturers that track their products to the patient will be able to add value by providing direct-to-patient services, not only helping to improve outcomes, but also gaining real-world data to prove drug benefits to payers.
Legislation and regulations are now in place for the digitization of healthcare.
There also is great potential for enabling the tracking and tracing of medical devices and pharmaceuticals using AIDC, an umbrella term for collecting data electronically. AIDC is widely used in industries other than healthcare.
The mMed patent portfolio has claims that are enabled by 2013 final Unique Device Identifier FDA rulemaking and the Drug Supply Chain and Security Act. Until late 2013, other than a minimally informative, linear National Drug Control barcode requirement for Rx pharmaceutical products, there were no regulations requiring standardized systems for AIDC on healthcare products in the United States.FDA final rulemaking and legislation in 2013 moved toward defining standards for AIDC for medical devices. Legislation on prescription pharma products followed. These facilitate tracking healthcare products "into the wild" and will lead to better understanding patient outcomes related to the use of those products. For information on serialization see PDA Letter Napoleon Monroe bylined articles. For more on track and trace, see Pharmalot article and FDA.gov.
Greater patient engagement using medication telemanagement can result in better health outcomes and reduced costs. Medication telemanagement also presents huge opportunities for Pharma and other stakeholders at the technology forefront of the evolving healthcare market.
Prior to the licensing announcement in January 2018, New Directions Technology Consulting was the exclusive market developer for the mMed portfolio. The portfolio has claims relating to medication and medical products telemanagement, and information in these and related areas.
The technology protected by the five granted U.S. patents in the mMed portfolio provides foundational tools to help patients outside institutional settings take the actions required to make and keep themselves well.
New Directions is available to discuss opportunities for partnering to develop telemanagement systems, including those based on the patent portfolio. New Directions Managing Director Napoleon Monroe is the sole inventor of all the patents in the mMed portfolio.
In addition to the current granted U.S. patents, Israel and Australia have issued patents extending protection of some allowed claims from the United States to those countries. Healthcare systems in those two countries are well positioned to benefit from mobile medication management.
More about the medication management and healthcare information market opportunities
P&S Market Research:
The global medication adherence market is expected to grow with 17.5% CAGR during 2016 – 2022.
The global medication management market is estimated to grow at a CAGR of 14% from an estimated $845.1 million in 2014 during the forecast period of 2014–2019. (read report)
The global market for mHealth services will reach $26 billion by 2017.
The mHealth app market will grow by 15% to reach $31 billion by 2020. (read more)
Contact Napoleon Monroe, New Directions managing director
The Value of Intellectual Property (IP) for Connected Drug Delivery NOW
Connectivity Using Consumer Technology To Create Real ValueFor Patients (1-28-2019)View PDF
Note: Resources generated prior to January 2018 might include outdated market developer and/or assignee information.
Aterica Inc. (1-24-2018)View PDF
Connected Combination Products (1-23-2018)View PDF
Patent Portfolio (1-15-2014)View PDF
Medication Telemanagement Systems for Drug Delivery Devices (4-06-2016)View PDF
Monitoring of Advanced Injection Devices (2-21-2014)More
Licensing to Create Value (1-15-2015)More
Improve Threat Responses and Casualty Outcomes Using Pharmacomedical Telemanagement (7-25-2016)More
Benefits of IP Partnering for Drug Delivery Telelmanagement (presented at Drug Delivery Partnerships conference, 1-20-2016)More
The Roles of Connected Combination Products in the Creative Reconstruction of Pharma (presented at Drug Delivery Partnerships conference, 2-07-2017)More
University of Pennsylvania Senior and Emeritus Faculty (presented at Penn, 11-17-2016)More
CEWIT 2013, Stony Brook University, N.Y.More
The Universe of Pre-filled Syringes and Injection Devices, Vienna, Austria (11-2015)More