Medical procedures and patent policies: an overview

The patentability of medical procedures is a topic that has been subject to debate since several years. Ethical and economic issues concerning the same have led fueled discussions surrounding the patentability of medical procedures, particularly in the last 40 years. In order to provide validation and incentives to medical experts who invent innovative medical procedures, they were often granted patents over the years. In her paper titled "Patent Policy and Medical Procedures: The Case for Statutory Exclusion from Patentability", Wendy Yang has underlined the fact that approximately 15 medical procedures were patented every week in the United States, thus proving that medical procedures were patentable subject matters. Essentially, a medical procedure patent can be defined as patents that protect the rights over innovative procedural steps in a medical procedure. It is pertinent to note that the patent does not extend to the protection of any medical devices that are a part of the medical procedure. However, recent years have observed a general distrust on the patentability of medical procedures. Several stakeholders of the medical fraternity, activist organizations and international organizations have time and again criticized the patenting of medical procedures as an unjustifiable means to incentivize the inventors. This led to the diminishment of the scope of patent protect that subsists on such medical procedures. For instance, surgical and therapeutic methods were excluded from patent protection and only diagnostic models were permitted to be patentable subject matter.  Proponents who advocated against patent protection for medical procedures contends that the patenting of medical procedures can be a hindrance to the equal distribution of knowledge and information regarding new procedures that are lifesaving. Moreover, it is also argued that the patenting of medical procedures would only go against the philanthropic nature of ethics carried by medical professionals.

The importance of patenting medical procedures

There are various reasons as to why medical procedures are patented. Initially, medical procedures were patented in order to facilitate productive efficiency. Essentially, it was believed that productive efficiency would positively impact public interests. This was because, through patenting, inventors were monetarily incentivized for inventing medical procedures. Such monetary rewards, in turn, would fuel further research and development which is imperative to develop innovative medical procedures. From an economic perspective, it was considered that if medical procedures are not legally protected through patents, the competition in the market may reduce prices to the point that the innovator has no incentive and only the opportunity cost is repaid. This may eventually result in a loss of innovation which would negatively impact the general public. The demand-supply rule had also significantly impacted the frequency at which medical procedures were patented. In the past, medical procedures were patented if the demand for the medical procedure exceeded the cost of invention. Lastly, medical procedure patents also help sustain monopoly pertaining to a particular product. Essentially, patenting a medical procedure would restrict other organizations or inventors from replicating the procedure and obtaining commercial benefits from it. This would translate the inventor's monopolization into profitability.

Disadvantages of patenting medical procedures

One of the biggest disadvantages associated with the patenting of medical procedures is the licensing of the same. Licensing fees and royalties significantly increase the costs of the procedures. This would act as a hindrance to accessible healthcare for all. Moreover, transaction costs related to the medicine may also make it incredibly difficult to enforce such medical procedure patents. Several proponents who are against the patenting of medical procedures argue that the right to health of the general public should be prioritized over the economic benefits one may derive from medical procedure patents. It is contended that the quality of public health must be given importance by making medical procedures more accessible. To make medical procedures more accessible, it would be important to not patent them. Lastly, from an ethical perspective, several have argued that the patenting of medical procedures may potentially tamper the physician-patient relationship. This roots from the fact that due to patents, a physician's choice of an appropriate diagnostic and therapeutic method for the patient is quite limited. In sum, the patenting of medical procedures can often be a hindrance to accessible healthcare for all.

US Laws pertaining to the patenting of medical procedures

Currently, US laws do accommodate the patenting of medical procedures. US laws do not explicitly exclude the patenting of medical procedures. However, US legislations does not specify any remedy in case an infringement arises. The USPTO permits the patenting of medical use claims if the steps are recited. This essentially implies that an applicant would be expected to explain and recite every step that is involved in the creation or manufacturing of that particular medical procedure. Generally, the patentability of a particular medical procedure depends on certain pre-requisites that must be satisfied. These requirements include novelty, non-obviousness and the presence of an inventive step.

Indian laws pertaining to the patenting of medical procedures

Currently, India excludes the patenting of surgical, therapeutic and diagnostic methods that are used to treat human beings or animals. Section 3(i) of the Patents Act, 1970 states that the following cannot be considered an invention within the meaning of the Act:

Any process for the medicinal, surgical, curative, prophylactic 23 [diagnostic, therapeutic] or other treatment of human beings or any process for a similar treatment of animals 24 [***] to render them free of disease or to increase their economic value or that of their products.

This change was implemented following the TRIPS Agreement. Medical procedures were excluded from being patentable due to the fact that it did not have any industrial applicability. It is imperative for a procedure to have an industrial applicability in order to be patentable. Nevertheless, as per patent regimes in India, procedures that are used to treat external tissues or fluids are considered to be patentable. The Indian patent regime, however, has created exceptions for certain medical devices or products as well as the manufacturing of the same. These products may include artificial limbs, ocular prosthesis, and arm prosthetics. The processes and devices that are used to produce such medical products are also patentable under the Indian patent regime.

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