India is considered one of the emerging players in the medical device industry. It is one of the top 20 markets for medical devices globally. The medical device industry in India is currently valued at $ 5.2 billion and has about 800 medical manufacturers in the country with an annual turnover of ₹ 500 million. According to reports, the medical device industry has the potential to grow at 28% annually and reach to $50 billion by 2025. India has increasingly been focusing on protecting the Intellectual Property rights of medical device owners and has subsequently also increased the regulatory requirements pertaining to the medical device industry in the country. In this blog, we will discuss IP Strategies for Medical Devices.
The protection of IP or Intellectual Property in relation to medical devices is a crucial part of any development process of the life cycle of medical devices. Timely measures and adequate IP protection can help entrepreneurs and startups to gain a competitive advantage over their competitors and attract investments. It also enables them to secure marketing tie ups and future acquisitions by more prominent players in the market. This article aims to delineate various strategies required for adequate IP protection of medical devices during different stages of development to aid medical device innovators in honing the IP potential of their medical devices. It can also help them effectively commercialise their product and gain financial rewards while also obtaining a competitive edge over other players in the market.
What are Medical Devices?
The term “medical device” covers a myriad of products and substances like diagnostic devices, surgical implants, and drug delivery systems. Some of the standard medical devices include imaging devices, analytical tools, sensors, prostheses, and implantable devices, among other things.
The term “Medical Devices” is defined under the Medical Device Rules of 2017 as “
- Substances which are used as surgical dressings, in vitro diagnosis, surgical bandages, surgical sutures, surgical staples, ligatures, blood collection bag, and collection bag for blood component which is without or with an anticoagulant.
- It also includes substances which include medical contraceptives like intrauterine devices, condoms, tubal rings, various insecticides and disinfectants, as notified in the Official Gazette.
- And various other devices which shall be notified from time to time in as per the provisions of the Medical Device Act.
The WHO defines medical devices as:
“medical device means any instrument, apparatus, implant, implement, machine, appliance, reagent for in vitro use, software, material or other similar or related article Internet manufacturer to be used either alone or in combination for human beings for one/more specific medical purposes of:
- Diagnosis, prevention, monitoring, treatment/alleviation of disease.
- Diagnosis, prevention, monitoring, cure or mitigation of or compensation for injury.
- The investigation, replacement, modification/support of the anatomy/of a physiological process.
- Supporting/sustaining life.
- Control of conception.
- Infection of medical devices.
- Providing information by means of in vitro examination of specimens derived from the human body.
And does not achieve its primary introduction by pharmacological, immunological/metabolic means in/on the human body, but which may be intended function by such means. “
Thus, the term medical device under the Medical Devices Rules of 2017 shall include devices and substances both under its ambit.
The medical devices in India have been classified in accordance with the global harmonisation task force practice into different categories based on the risk factors. Class A includes low risk medical devices, Class B includes low to moderate risk medical devices, Class C has moderate to high risk medical devices and Class D includes high risk medical devices.
Types of Intellectual Property for Medical Devices – IP Strategies for Medical Devices
Medical devices have many protections available that help protect many components of the device, including the idea. It is essential to develop and implement appropriate measures to safeguard rights provided under the below mentioned to adequately commercialise one’s products and unlock their IP potential efficaciously. There are many categories of protections available to medical devices (IP Strategies for Medical Devices) and they are as follows:
- Trademark Protection
Trademark protects distinct words, symbols, design, representation or combination of any of them together and which can represent the goods or services of one brand from another’s. Even if the design of the product changes over a period of time, the trademark must remain constant to receive protection.
- Patent
In an industry that churns out new devices frequently, utility patents aid in keeping the identity of the product intact. If an invention is novel, includes an inventive step or is not obvious and is capable of industrial application, it is eligible to receive protection under Patent Law. The rights and safety granted under a patent are valid for up to a period of 20 years.
- Design Patent
Design Patent shall provide protection to the design of the medical device. Design patent grants the patent holder monopoly over the design and does not allow anyone else to commercialise it or a design similar or identical to the patent owner’s design unless without the consent of the patent holder or through a license.
- Trade Dress Protection
Trade dress refers to the whole look and feel of the medical device. For it to receive protection, a trade dress must have identifiable characteristics. Trade dress shall include the shape, size, colour and colour combinations which are aligned with the identity of the product.
- Trade Secret Protection
Trade secrets shall include business plans, source code, marketing strategies, customer lists and process related inventions. These require protection as these help a product achieve distinctiveness and success in the market. They are protected under the Trade Secrets Act.
There are often specific exclusions when it comes to the patentability of a medical device which every innovator must be aware of and keep in mind while filing applications for a grant of patent. Medical devices are patentable in most jurisdictions. However, there are certain exceptions when it comes to specific subject matters pertaining to medical devices. For instance, the method of treatment using a medical device is a subject matter for a patent in the USA, while it is excluded from such patentability in Europe and India.
Medical Devices and Intellectual Property – IP Strategies for Medical Devices
There is increased focus on intellectual property pertaining to medical devices in India as the market for the same is vast, which also opens up ways to IP infringement[1]. Since medical devices can be monopolised through various intellectual property rights, the protection of these rights is highly critical.
The development of medical devices and deployment in the market requires meeting requisite regulatory compliance and obtaining IP protection and clearance. Medical device development often requires the development and protection of IPR simultaneously at various stages of development. This is important to understand the many legal challenges which may eventually arise during the commercialisation or protection of the inventions. The key factors which need to be considered include outlining competition and conducting prior art searches to avoid any litigations in the future. It is highly imperative to analyse these IP matters during various stages of the life cycle of medical devices and how to maintain a strategic edge over multiple manufacturers in the market.
Along with adhering to regulatory requirements, the protection of intellectual property rights, especially patent rights, is increasingly becoming an essential aspect of the development of medical devices. This is in sync with the global trend of increasing the number of patent applications which are filed in order to protect the IP associated with medical devices. For the years from 2015 to 2018, the most significant number of patent applications was filed in the domain of medical devices and healthcare from India in the US. India, being a signature to the Trade related aspects of Intellectual Property Rights or the TRIPS agreement, has made necessary amendments to the Patent Act of 1970 to have it conform with the obligations of the TRIPS Agreement, including granting of product patents for various fields, including medical devices and pharmaceuticals.
Article 27, Clause 3(a) of the TRIPS agreement says that a member state is allowed to exclude therapeutic, surgical and diagnostic methods of treating animals or humans from the school subject matters which can be patented. There is a twofold reason for excluding treatment methods from patentability. Firstly, the whole process of removing the pathological condition from the body was not considered something which can be said to have an “industrial application”. The second and the most prevalent reason just keep a medical professional can provide the best treatment available to an individual without the constant fear of infringing another’s patent. However, it is of vital importance to mention that the above mentioned exclusion is not directory but discretionary, and members can choose to keep treatment methods as a subject matter for patentability in their jurisdiction.
The United States is an example offer a member state which chooses to retain treatment methods as patentable. Medical devices, as well as medical treatment methods, are patentable in the United States. Furthermore, unlike the European patent law, the US law does not differentiate between diagnostic and various other treatment methods when it comes to enforceability or patentability. Every medical method of treatment is considered patentable. However, in order to keep the reason for the exclusion of the treatment method, patents for the treatment method shall not be enforced against licensed medical professionals or any medical entity. It is also important to note that this immunity shall not be extended to companies and technicians who are involved in the domain of diagnostics during medical treatment. When a medical device is granted a patent, neither can it be manufactured nor can it be sold without the consent of the patentee in a free market. However, the performance of a medical activity by a medical professional shall not amount to infringement. Article 53 Clause 3 of the European Patent Convention excludes diagnostic, surgical therapeutic methods of treatment from patentability.
Section 3(i) of the Patents Act of 1970 is often considered an objection against the patentability of medical devices along with the process or method of operation of such devices. The jurisprudence and interpretation pertaining to this particular provision in India are at a nascent stage, with there being limited case laws on the subject. Patent offices and courts have often granted protection or any other relief to a patent in cases pertaining to diagnostic devices, syringes, inhalers and other similar medical devices on the reasoning that it does not pertain to the process for medical treatment. However, this particular area may soon become extremely contentious in the future in patent litigations because of the rising number of patent applications in relation to medical devices and the increased use of artificial intelligence or robotics and performing varied functions in the field of medical treatment.
The regulations in relation to medical devices in India have transitioned to a mature stage after the introduction of the Medical Devices Rules of 2017, which is further backed by pattern protection which is TRIPS compliant. After the introduction of the new regulatory regime, the focus is more on the ease of doing business and the quality of medical devices by developing an Indian standard which is at par with many global counterparts. Institutions like the Bureau of Indian Standards set standards which are at an equal level to the International Organization of Standardization and IEC. By introducing organisations like these, the government has significantly reduced the cost of obtaining certification for products.
A robust system of regulations pertaining to medical devices in India is also backed by a strong IPR system where cases related to IPR are now regarded as commercial disputes and thus have strict procedures and timelines what happened put in place by the legislature. This was brought about after the Commercial Courts Act of 2015 was enacted. While there is still a dearth of solid jurisprudence and precedents in relation to the patentability of medical devices, most of the Indian laws are essentially compliant with the TRIPS agreement and with other jurisdictions like Europe and the USA along with requisite legal remedies which are available to an inventor.
Intellectual Property at Various Stages of Medical Device Development – IP Strategies for Medical Devices
The life cycle of the medical device comprises of the following stages:
- Concept Stage
- Prototype Stage
- Preclinical & Clinical Stage
- Manufacturing Stage
- Marketing Stage
Intellectual property rights are created during various of the above mentioned stages, and it is essential to identify and protect the assets under these rights in order to commercialise them better and develop anticounterfeiting measures.
Concept Stage – IP Strategies for Medical Devices
It is essential for those involved in the concept stage of the project to understand that they are required to meet required levels of confidentiality to protect the concept, design drawings, documents created, and technical details which can reveal the shape, operation and configuration of the medical device.
The idea related to the medical device, its components and the mechanism of generally working a subject matter of patent effect qualifies the three requirements of patentability, namely, novelty, inventive step or non-obviousness and capability of industrial application.
IP sensitisation is extremely important for all the inventors and members of the project to understand the need for secrecy. At this stage, a provisional patent for the concepts pertaining to the medical device must also be followed.
Prototype Stage – IP Strategies for Medical Devices
At the prototype stage, it is vital to protect any prototypes that are created, and strict confidentiality must be maintained. If a 3rd party is involved in the development of the prototypes, various legal safeguards like executing a non-disclosure agreement or an NDA must be followed.
Pre-clinical and clinical stage – IP Strategies for Medical Devices
At the pre-clinical and clinical stages, the very first step is to check the patentability of the medical device. One is also required to check whether their medical device is infringing any previously owned valid patents. If any similar prior arts are found in an in-depth analysis should be taken in order to make their product not infringe an existing patent. It is also desirable to develop a distinctive brand name for one’s medical device, which shall allow healthcare professionals and consumers to clearly identify the origins of the medical device. Unique brand names and logos are clearly protected under the trademark act.
Before proceeding to file a patent application for a medical device, it is imperative for the inventor to conduct a comprehensive prior art search to evaluate whether the invention is novel or not. Prior art search involves looking through the technical information which exists before one files for a patent. This includes conducting a detailed search in literature which is both patent and other non-patent, including conference papers, publications, marketing brochures, devices, and products, among other things. Performing a patentability assessment and carrying out a prior art search before filing for a patent helps in ensuring the novelty of the invention and also avoids future patent litigations. It also helps in drafting sufficient claims with respect to the prior art, which consequently helps speed up the process of prosecution. It also helps in strategically planning the time and funds to be invested based on whether the domain has limited or no prior arts. It is also imperative to carry out a competitor analysis to assess the IP of the competitor products. This can help the inventor gain an edge by making requisite changes in the technology of her creations over other existing options. For a well drafted patent application, it is imperative to articulately identify the unique features with respect to a particular technology before filing the patent application.
Manufacturing stage – IP Strategies for Medical Devices
At this stage, it is suggested to protect the copyright associated with one’s medical device. Any texts or an artwork on the packaging of the medical device can be protected as trade dress, advertising and instruction leaflets are likely to receive protection under copyright.
Marketing Stage – IP Strategies for Medical Devices
During this stage, it is good practice to contact an IP and product valuation on one’s medical device. Moreover, conducting a reasonable valuation of all the medical devices can help the inventor adequately commercialise her inventions, as investors can often be wary of frivolous claims.
Inventors must always conduct detailed market research to find out different theoretical differentiators by scouring the patent literature as well as the non-patent literature. After conducting due market research, the inventors must learn from the market feedback simultaneously into that product and IPR. They must make sure that there are no private or public conferences or paper disclosures turned in before the provisional filing of the patent. Inventors seeking to predict market strategies and trends must keep a close watch on competitors’ products and their IPR filings. Inventors must judiciously use timelines granted to build the IPR by the patent offices.
Conclusion
Medical devices cover a myriad of products and substances, like diagnostic devices, surgical implants, and drug delivery systems. Timely measures and adequate IP protection can help entrepreneurs and startups gain a competitive advantage over their competitors and attract investments. It also enables them secure marketing tie ups and future acquisitions by more significant players in the market. There are many categories of protections available to medical devices like Trademark Protection, Patent, Design Patent, Trade Dress Protection and Trade Secret Protection. Intellectual property rights are created during various stages development of a medical device, and it is essential to identify and protect the assets under these rights in order to implement adequate measures to commercialise one’s product and put anti-counterfeiting measures in place. Inventors must always conduct detailed market research to find out different theoretical differentiators by scouring the patent literature as well as the non-patent literature. After conducting due market research, the inventors must learn from the market feedback simultaneously into that product and IPR. Developing and implementing effective IP strategies can help inventors unlock the real IP potential of their medical devices.
Read Our Article: An Overview Of Patent For Medical Devices In India
