1 Introduction of Intellectual Property (Kimberly Gautreaux)

"Intellectual property pertains to any original creation of the human intellect such as artistic, literary, technical, or scientific creation” (Sasha & Bhattacharya 2011). These rights are enforced to protect the individual on their innovations for a specific stretch of time. It is very important that these properties are in place because the knowledge of the inventors needs to be protected, including their time and money.

The Journal of Advanced Pharmaceutical Technology & Research provided types of intellectual properties:

1. Patents

2. Industrial designs relates to features of any shape, configuration, surface pattern, composition of lines and colors applied to an article whether 2-D, e.g., textile, or 3-D, e.g., toothbrush

3. Trademarks relate to any mark, name or logo under which trade is conducted for any product or service and by which the manufacturer or the service provider is identified. Trademarks can be bought, sold, and licensed. Trademark has no existence apart from the goodwill of the product or service it symbolizes

4. Copyright relates to expression of ideas in material form and includes literary, musical, dramatic, artistic, cinematography work, audio tapes, and computer software

The history of IP started in Europe and permitted patents in the fourteenth century. Venice was where all the legalities started including laws and systems.  “Intellectual properties enhances technology advancement in it provides a mechanism of handling infringement, piracy, and unauthorized use and provides a pool of information to the general public since all forms of IP are published except in case of trade secrets”(Abbott 2001).

In today’s world with the progressively expanded trade, pharmaceutical patents are essential for the obtainability and inexpensive medicines that are needed. Countries are benefited from intellectual properties to yield inventions and to keep prices down. The availability of these medicines is also vital in countries where their resources are inadequate. This has also been imperative for individuals living with HIV/AIDS in countries that do not have access to medicine.

2 Intellectual Property in Pharmaceuticals (Gina Goad)

Intellectual property impacts the industry of pharmaceuticals in two ways. First, IPs are involved in the issue of pricing and access, exclusion of competitors and the availability and pricing of new medications (Cockburn). Secondly, IPs provide opportunities for companies to make pharmacological discoveries, develop and market new drugs and the IPs effect drug allocation across diseases, countries and organizations (Cockburn). Pharmaceutical companies invest years of research and development in new products. The costs are further driven up by expensive clinical trials and lengthy regulatory approval processes. Basically, IPs protect pharmaceutical companies by providing investors opportunity and time to recoup their costs (Stone). To decrease competition, pharmaceutical patent holders often obtain exclusivity extensions that postpone generic forms of their drug from hitting the market by one to three years (Stone). Another way to delay generic competition is by patent infringement suits against generic manufacturers. However, there is a distinct benefit to consumers when a patent has expired. Once a generic drug is on the market, the monopoly of the patent holder is removed, which results in competition and a significant drop in the drugs cost (Mandal, 2014). 

3 Intellectual Property of Electronic Health Records ( Amanda Hudgins)

3.1 Electronic Health Record

Modern technology has infiltrated the healthcare industry in the past two decades. One of the major advances in technology is the implementation of electronic health records (EHR).  Healthcare facilities, physicians, pharmacies, payers, and patients are able to store and retrieved viable patient information and health records electronically to promote public health (Rolnick, 2013). According to HealthIT.gov (2014), electronic health records are real-time, patient-centered records which allow information available instantly, whenever and wherever, by providing a central location for the patient’s health records. The EHR can be created, managed, and consulted by providers and medical professionals across the nation by bringing together past medical providers, pharmacies, clinics, schools, diagnostic imaging, and medical facilities visits (HealthIT, 2014).

4 Health Information Ownership

Electronic health records have created much confusion when it comes to the control and ownership of the data due to the uncertainty of several state laws. In addition to EMR ownership barriers, there the entire healthcare system has failed interconnect EMRs. There are many different systems and software available to physicians, hospitals and pharmacies to use and implement stored patient data (Hall, 2010). There is notable intellectual property rights deemed to the creators and owners of software templates and programs. However, even though the Department of Health and Human Services (2014) states the Health Insurance Portability and Accountability 1996 (HIPAA) provides federal law protection of identifiable health information held by covered entities, a property law for the medical information is in great demand to determine ownership of the medical information since it is unique to the individual’s record (Hall, 2010). The following provisions acknowledged by Hall (2010) provides a guide for patient ownership of medical information:

1. People should be able themselves, or through their agents, to  authorize access to and use of their medical information for  financial rewards, and these licenses should be transferable.

2. Default rules should be set with some degree of paternalism  toward protecting patients’ interests, in order to take account of  the cognitive and other limitations on consent involving vital  medical information.

3. Some rights or protections should be nonwaivable (or  inalienable) and should follow the information regardless of  agreement or provenance.

4. Patients’ rights to control or sell access to their medical  information should be limited to data that can be linked to them  personally. (p. 660-661)

5 Intellectual Property of Healthcare Software (Caleb Swisher)

Health care software includes the software that runs devices like MRI machines, X-Ray Machines and other devices. The Intellectual property rights each company has, is or can be specific to each device that they manufacture. One example is GE making a MRI machine that is ultra-quiet while maintaining image quality (GE Silent Scan). The idea or copyright to this technology gives these companies rights to earn money from their products for certain number of years before another company and use the same ideas to improve on or change.

Healthcare software can even include the software in your smartphone that tracks how many steps that you have taken, lets you input how many calories that you have eaten and other daily activities. There are many different devices that do similar tasks, yet each company has a different idea or intellectual right to their idea and way of implementing these devices (Gholipour). Some devices strictly monitor while other devices can alert or prompt you to become active throughout the day. The software that runs these devices can change all of these features depending on what ideas each company comes up with and can infringe on intellectual property by overlapping some features.

6 Intellectual Property of Medical Devices (Stephanie Miller)

Intellectual property (IP­) of medical devices are made up of several different aspects that one has to ensure is properly completed in order to protect their ideas and interventions, especially in the medical field. Medical devices can be any sort of medical equipment that can be used by patients at home, the hospital, a nursing home, and/or rescue squads, such as anything from a walker to ventilator machine (How To Protect Your Medical Device Intellectual Property, 2014).  

Several key concepts that make up IP on medical devices are copyrights, patents, trademarks, trade secrets, and industrial design rights as discussed previously. Under these laws, they are able to provide some sort of exclusive rights are provided to the owner. However, if the maker does not take part and have correct knowledge of these laws, there are many ways one must look into how they wish to protect their investment especially since FDA approval is not easy or cheap.  In fact, it takes tons of time, large funding, and careful planning to obtain approval. Often times as one is struggling and obtaining approval, a fellow company may be lurking in the background, creating a very similar machine only to steal the original company’s thunder. Figure 1 is a chart which shows the percentage of startup holding in U.S. patents and applications. As one can tell for medical devices, it shows that 76% occur in overall population of companies, but when companies join with venture capital companies that invest money into high potential, early stage, new businesses, there is an increase to 94% (Kesler & Lateef, 2012).

Have you ever looked at an electrocardiogram monitor and thought I should have come up with that? If you don’t know what that is, it is a monitor that shows an image of a heart’s electrical pattern to figure out if any issues arise.  A picture is shown below of a portable example of such a devise.   There is an image of a vital sign machine which is commonly used in doctor’s office, hospitals, nursing homes, and sometimes schools. These machines have every instrument attached to it to complete a full set of vital signs except the respiration rate, must be obtained through observation, but they are capable of obtaining temperatures, blood pressures, heart rates, and oxygen saturation levels.  They are even capable of storing such vitals and being able to print them.                                                                  

As one can tell, there are many aspects to both of these machines. You have the sensors, sensor probes, user interference, and the signal processer for the ECG alone, and that is not including the software. There are many more included in the vital sign machine, for example you have the thermometer, the thermometer protectors, the blood pressure cuff, the cords, the printer, the ink, etc. The creator of these devices looked into what would make them the most money, whether it would be the sensors or the cords (Kesler, 2012).  The Welch Allyn Spot Vital Sign Monitor LXi backed with venture capital companies. If one was to take a look at the user manual, they would see the different patents, but not all is labeled Welch Allyn Spot, for the each component is broken down. Masimo own the patents for the cables and Nellcor are responsible for their patents on the oxygen saturation sensor technology (Welch Allyn Spot Vital Signs LXi Service Manual, n.d.). Therefore, when creating new invention one may be able to benefit by using their technology to earn IP, but also combine their aspects with other machines. This will reduce the chances of there being similar technology used in medical devices.

7 Intellectual Property of Medical Research (Terry Brown)

Intellectual property as defined by the World Intellectual Property Organization (WIPO) is, “creations of the mind, such as inventions; literary and artistic works; designs; and symbols, names and images used in commerce” (Patino, 2009). For medical research, this provides a layer to balance medical innovations to the public.  There is rationale behind intellectual property and medical research (Krattiger, 2013). The purveying belief is providing public and private organizations a mechanism for open disclosure.  WIPO reports that patents forces innovators to provide detail of their technologies or solutions, which provides the public the availability to utilize the product (Krattiger, 2013).

As stated before, the standard practice for intellectual property for medical research is the same as other technologies, which employ patents, trademarks, copy rights, trade secrets, and agreements to secure ownership and use rights (Patino, 2009). There are definitions and timelines associated with the each method of IP requirements as listed below: