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Artemis Law Associates
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A medical device and IPR

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Introduction

A medical device is any instrument, apparatus, implement, machine, appliance, implant, reagent for in vitro use, software, material, or other similar or related product intended by the manufacturer to be used for a medical purpose, either alone or in combination. Thus, medical devices encompass a wide range of items that can be protected and monopolized in the market through various Intellectual Property Rights as and when they are developed.

It’s crucial to get the finest protection possible for each component of the device and to choose the kind of protection most appropriate for a particular device. Choosing one type of IP protection does not restrict the concurrent or subsequent use of another type of protection. A tiered approach may be necessary to maximize medical device protection. Medical device development and introduction in any market necessitate stringent regulatory compliance as well as Intellectual Property (IP) approval and ownership. The following are different IP rights that can attribute to the protection of the medical device.

Trademarks – Trademarks for medical devices can be put to a variety of uses. First, the device’s brand name, as well as any logo or tagline that is used on or in conjunction with it to denote its origins, may be protected. Second, it might be possible to use a “trade dress” to defend the product’s visual appeal or “look and feel.” The term “trade dress” refers to the overall appearance of a product, which may include attributes like “size, form, colour, or colour combinations, texture, graphics, or even specific sales approaches.” A device’s shape or colour may be able to be protected as trade dress if they are simply aesthetic and have no practical or utilitarian function. Only the design’s nonfunctional elements are eligible for trade dress protection.

Patents – Utility patents and Design patents can be considered for medical devices. Any “novel and useful process, machine, manufacturing, or composition of matter” is eligible for a utility patent. If a medical device is new, inventive, and beneficial, it may be covered by a utility patent. The validity of issued patents is presumed in legal procedures, and they can be a significant source of income because the rights to use the invention may be licensed to others or retained for competitive advantage. Design patents safeguard a patented design’s novel ornamental elements. For e.g., many surgical and orthopedic equipment have specialized designs to increase compatibility for usage with other devices. Therefore, obtaining a design patent can be used to protect a medical device’s specific design. Protection under a design patent is valid for 15 years after issuance.

Copyrights – As you already know copyright protects artistic novelty. You might wonder how the medical device can be protected under copyright. An idea is not protected by copyright; rather, it merely safeguards how it is expressed or implemented. A medical imaging gadget, for instance, can have several features that are copyright protected. These elements include the software that controls the gadget and the user interface’s appearance and feel. However, there is a delicate line between practical “industrial design,” which is not copyrightable, and “applied arts,” which are. If the curves used to hold an implantable medical device in the body were also designed to be aesthetically pleasing, the features might not be protected by copyright. The idea behind this is that the design elements for which copyright protection is requested, namely the device’s curves, have practical use. These aesthetic qualities of the item cannot be distinguished or exist separately from its functional qualities.

Trade secret  – As the term implies, if the device or its information has an economic value from being “kept secret” is protected by trade secret legislation. Source code, business plans, client lists, marketing schemes, and process-related inventions are a few examples of trade secrets. Examples: The process for producing a specific alloy that is utilized in an implanted device could be kept a trade secret by the device’s manufacturer. The list of doctors and hospitals the firm serves as a trade secret could likewise be kept private.

It is possible that a product’s various features will satisfy the requirements for some, all, or even all the above-discussed types of IP protection. Which form, if any, will be best for protecting the concerned assets then becomes the question.

The good news is that courts have repeatedly ruled that “a product’s various qualities can be protected simultaneously, or successively, by more than one of the statutory means for the protection of intellectual property.” In the end, merely weighing the advantages and disadvantages of each form of IP protection won’t tell you which one is ideal for your device.The value of the device and its intended longevity, foreseeable design changes, and even the intention to license the device or the underlying IP should all be carefully and strategically considered in light of short- and long-term objectives.

If the device works in a market where brand recognition offers competitive advantages and trademark protection for the name and logo may be advised. If the technology of the gadget offers a competitive advantage, a utility patent should be taken into account. If the technology employed in the device is hard to reverse-engineer and can be kept a secret, trade secret protection might be sufficient. If the device has a unique and recognizable appearance, it may be essential to protect the design through trade dress, copyright, and design patent protection.

It is necessary to simultaneously safeguard and develop IPR (intellectual property rights) for medical device development in order to comprehend and take into consideration the different legal issues that can come up during the protection and commercialization of inventions. To prevent future lawsuits, the main legal considerations taken into account during creation include defining competition, using prior art, and freedom to operate. Maintaining a competitive advantage requires carefully considering IP issues at every stage of a medical device’s life cycle.

Strict confidentiality should be upheld at the prototype stage in order to preserve any prototypes that are created. If a third party is enlisted to help with the creation of the prototypes, certain procedures including the execution of non-disclosure agreements (NDAs) should be followed.

The patentability of medical devices should be examined during pre-clinical and clinical stages. The most crucial thing is to find out if anyone else holds legal patents that one’s new invention might violate. White space research should be used to plan an alternative design in the event that any similar earlier arts are found. Once again, it is ideal to have a unique brand name for the medical equipment that helps customers and healthcare professionals to recognize the source of your goods. Protected trademarks include distinctive brand names and logos.

We advise copyright protection for medical device content during manufacturing. The text and images on packaging that serve as trade dress, instructions, or advertisements are probably covered by copyright laws. The medical gadget should go through a product and intellectual property valuation at the marketing stage. An investor is constantly turned off by spurious claims, therefore a proper valuation aids an innovator in commercialising their inventions.

You must do a thorough search for existing previous artworks in order to prove your IP rights in this field. We at Artemis Law Associates promise to defend your originality by assisting you throughout the full intellectual property protection process.

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