PATENT POLICY AND MEDICAL PROCEDURES

ABSTRACT 

‘‘No one has advanced a just and logical reason why the reward for service to the public should be extended to the inventor of a mechanical toy and denied to the genius whose patience, foresight, and effort have given a valuable new [discovery] to mankind’’.

The medical community is indeed serving a noble job. The medical procedures have only biological impacts and not as such any commercial impacts. Medical procedures encourage innovation, being a part of the scientific world, but still, they are considered non-patentable. Patents for pharmaceuticals, medical equipment, and aesthetic treatments of the human body are allowed under various laws. In certain nations, however, patentability for a technique of treating the same body is disallowed for numerous public policy reasons. Medical procedures and their patentability have been the subject of debate for a number of years. It was necessary to validate medical professionals for developing novel methods. Medical procedure patenting has been outlawed in many countries as a result of the growing conflict over individual claims to medical processes.

KEYWORDS : Medical Procedures, Patents, Pharmaceuticals, Doctors, Technique

INTRODUCTION

New inventions are legally protected under patent law once they have been patented by their creators. A patent is a limited privilege provided to the licensee in exchange for public disclosure of the invention. The patent system favors both the public and the innovator. The inventor gains while being capable of preventing everyone else from utilizing the innovation for twenty years, while society has advantages since the product is freely accessible for everybody to utilize once the patent expires.

Medical procedure patentability has gained significant importance over the past four to five decades. A patent that only granted rights to procedural steps and not to the creation of medical equipment was referred to as a "medical procedure patent."This trend reached its peak before quickly waning. The practice of issuing patents for medical operations was then condemned as unjustified by significant medical institutions. As a result, the patentability of medical procedures, whether surgical or diagnostic, has been questioned by over 80 nations. Patents on diagnostic models are allowed in some states, but not others. It was interpreted as a violation of the charitable nature ethics of medical professionals and as a threat to the dissemination of new process knowledge and information. 

PATENT POLICY AND MEDICAL PROCEDURES 

Medical treatments have been a touchy subject since the beginning of patent law. Because patent law grants inventors a legal monopoly that is not subject to any restrictions, the basic question seems to be whether doctors who reveal their ideas should be safeguarded. Patents in medical practices were only admissible because they boosted productivity efficiency for the two basic reasons of invention and innovation. This was undertaken in the "public interest," with the belief that patenting novel methods, ideas, and approaches would provide a financial incentive to investors. 

Health professionals would be more likely to follow a method if they knew they would be granted a patent for it. An additional aspect of it was the platform's economy. It was agreed that if such a safeguard is not in place, awarded to the creator, the competitive environment may push prices so down that there is no inducement to innovate. The investor bears the risk, and only the opportunity cost is recouped. There could be penalties as a result of this. Overall, there will be a deficit of invention or innovation. If the availability of healthcare techniques surpassed the expense of inventions, patents on those techniques were promoted. It seemed reasonable to place the former on the latter because both patent policy and medical practices were still in their infancy. Innovating new procedures come at a reasonable price. Therefore there was a growing interest in a hefty price since health professionals were willing to pay the extra price. To obtain the patent If the contrary is correct, medical procedure patents are in short supply due to a lack of want for a reduction in patentability. Even though some contend that patent costs have no bearing on their utilization, this appears to be inaccurate.

Autonomy over techniques implied that innovators may use and commercialize their innovation in any way they wanted in the economy. They profit both socioeconomically as a consequence of the shortage of limitations. Health is among the goods of living towards which everybody has a right, as Henry Sigerist properly observed it; in every situation, wherever the notion is applied, the rationale is that all steps for safeguarding and promoting health are provided free of cost. It means that if basic operations such as cardiac procedures were to be patented and patents for these kinds of treatments were limited, thousands of citizens could suffer and their healthcare would be jeopardized.

MEDICAL PROCEDURES: NON-PATENTABLE 

In the medical community and among all the peer groups it has become a topic of debate regarding granting patents to medical procedures. Medical techniques are considered non-patentable due to various moral and sociological reasons affecting a mass group of people. It is considered in the various public policies that patenting medical procedures directly violates human rights. Medical procedures have a biological effect on the human body thus it is considered a doctor's ethical responsibility to not place the rank of patentability above the life of a person. The various points which favor the non-patentability of medical procedures are explained as follows:

• ETHICAL RESPONSIBILITY:  Due to various public policies, governments of several nations deny the patentability of medical procedures. Even though there are scientific and industrial aspects favoring the patentability of medical procedures, medical practitioners are expected not to prioritize commercial gains. The most concerning reason for granting patents to medical techniques is that most people cannot afford them easily. Since Hippocrates' era, without any aspiration for any kind of monetary worth, medical practitioners have tried their best to share all the innovative ideas related to all medical technology. This all has direct consequences of swift dissemination and adoption of technological advancements in the medical field with consecutive testing. Thus, commercial interests do not come in the way of the welfare of the whole community. For the good of the public at large and with the motive to make all the latest innovative and easier ways of practicing accessible all over the world, it becomes essential to consider this aspect of moral responsibility to take into account while debating or deciding regarding the patentability of the medical procedures.

• SOCIETAL CONCERNS: All people are well aware that medical practices have a direct impact on the human bodies and thus directly affect society at large. This has resulted in the grave effects of the patents on the medical world as compared to all other professions. Patents result in the restricted use of the registered products and methods as many can't afford these and some confusion regarding disputed products remains intact. Patentability also leads to the nonavailability of innovations and inventions in medical technology to be available publicly. But for the welfare of the society in which a man is surviving, instant revealing and practicing of all the latest developments are required.

• LICENSING: Patenting a product includes huge licensing costs which just results in financial strain. The processing charges make the whole process difficult in several cases. In some situations, the outcome might be biased or also too adverse. The money-making mindset of the investors encourages them to earn huge profits from such people, leading the latter to face various obstacles in the form of monetary expenses. Thus, the direct analysis claims that for several people it becomes unaffordable, making the whole process of patenting their product extremely difficult.

• HUMAN RIGHTS ASPECT: The right to health is a basic human right that in no sense should be restricted or violated by any individual all over the world. The right to health is available in the statutory provisions or as a constitutional right in a large number of nations. The health of a person should be prioritized over patent laws and commercial benefits gained from these. Availability of innovative medical procedures without the restrictions imposed by patent laws will put a lot in the welfare of the medical world.  People can meet their health demands thanks to the continual advancement of current scientific and technological advances, thus we may say that the creation of new equipment is a significant aspect of their regional and worldwide right to health.

INDIA'S SITUATION 

The Indian medical sector is a burgeoning high-tech sector that has shown consistent expansion over the last thirty years. Due to reasons such as supportive state regulations and a low degree of global competition, various private Indian enterprises are actively competing in the sector and have taken a significant portion of the local pharmaceutical industry. India is being forced to reconsider its long-term objectives and business practices as it exposes its industries to international trade. As the need to protect important pieces in research and innovation has grown, factors such as intellectual property have become highly significant. 

India is attempting to address issues with the inapplicability of current intellectual property laws, and the Indian government is seeking to establish a patent framework that promotes technological growth while also adhering to its international obligations. Since India joined the Doha Declaration on Trade-Related Aspects of Intellectual Property Rights and the Public Health Agreement in 2001, the question of access to treatment has gained focus. Protecting the well-being of our nation's millions of vulnerable individuals has indeed been one of the big hurdles.

TRIPS (Trade-related Aspects of Intellectual Property Rights), which was signed in 1995, in a World Trade Organization( WTO). Countries could exclude diagnostic, therapeutic, and surgical techniques for the therapy of humans or animals from the range of patentable subject material under paragraph 3 of Article 27 of the Agreement on Trade Related Aspects of Intellectual Property Rights (TRIPS).

CONCLUSION

Exclusions of medical procedures, such as medicinal, surgical, and diagnostic methods, still is a difficult notion to grasp in the patentable arena. The topic is so complex, with several different interpretations and grounds for inclusion and exclusion, that it causes greater complexity than it resolves. On the global stage, it's past time for some consistency so that a unified stance can be taken. The arguments against including medical processes in patentability outnumber the arguments for their inclusion, and most nations have already done so. The gap must be bridged by creating a model based on the TRIPS agreement and WMA meetings so that an accurate simulation can be established and member countries may effectively manage community welfare and medical benefit of inventors on an equal footing. The medical sector's compliance with the TRIPS Agreement will have a significant impact on India's health service destiny. 'Local patent activity' refers to the development of a patented product or application of a patented process in the local market. The inventive stage can contribute to creativity, which can result in technical advancement, and urban and technological prosperity, that could only be achieved through the local operation of patented inventions. Innovation and patenting are opposite sides of the same coin. Patents must not be solely to earn profits, and innovations must be in the best service of mankind, particularly in the healthcare profession.

AUTHOR - ABJOT KAUR