Patent policy in medical terms | Understanding the Relationship Between Medical Procedures and Patent Policy – Intellectual Property

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Understand the relationship between medical procedures and patent policy in medical terms. For many years, medical processes and their patentability have been debated. In practice, the patentability of medical processes has become increasingly important over the past 40 years. According to legal experts in the United States, approximately 15 medical processes are patented per week. Medical specialists needed to be validated to invent and innovate new techniques all of a sudden. A medical procedure patent was a patent that granted rights to mere procedural steps rather than the development of any medical device. However, this trend peaked and then quickly faded. Major medical institutions quickly banded together to condemn the practice of issuing patents for medical operations as unwarranted. As a result, more than 80 countries are wary of the patentability of medical procedures, whether surgical, diagnostic or therapeutic, and some only allow patents on diagnostic designs. It has been interpreted as a threat to the dissemination of new knowledge and procedural information, as well as a violation of the philanthropic nature of health professional ethics.

Questions relating to the patenting of medical procedures/techniques

“The patenting of methods of medical treatment of human beings is a complicated issue because it is not only based on patent law but also on medical law. The Hippocratic Oath is the foundation of medical legislation, and the purpose is preserve human life. Patent law differs from medical law in that it aims to foster innovation by rewarding inventors. Therefore, there is a public policy issue that physicians should always be free in their treatment choices in order to provide the best possible health care. The blog clearly highlights the many facets of the patent regime, as well as the idea of ​​exclusions for medical, surgical and therapeutic treatments. patentability has profound socio-economic, medical, ethical and other implications.The issue becomes multi-dimensional when considering exclusivity. on medical, diagnostic and therapeutic methods of patentability. The TRIPS Agreement specifically mentions exceptions and exclusions in its terms; the goal to be achieved is important. However, the non-uniform enforcement of the TRIPS Agreement, as well as the absence of stricter and more stringent means of interpreting the TRIPS Agreement’s disclaimer, have led to a myriad of problems. at the application and implementation levels. Detailed research on the pros and cons of patent exclusions, particularly for medical, diagnostic and therapeutic approaches, has not gone very far.

The concept of exempting medical, surgical and therapeutic methods from patentability is based on human rights considerations. A person’s fundamental right to life must be given the highest priority. From the outset, a person’s right to receive adequate and appropriate treatment becomes a fundamental human right of every human being. The purpose of excluding medical methods from patentability is to ensure that patents do not impede or restrict the ability of physicians to fulfill their responsibilities to patients, which is essential for the medical profession and the general public. public. However, due to a misperception of the ideology underlying such exclusivity of patentability, as well as a pro-capitalist outlook, many industrialized countries have strayed from the well-defined path of patenting medical, diagnostic, and therapeutics. The balance between the right of the inventor and the benefit for society seems compromised. The principle of investor gain seems to obscure the humanitarian implications of patent exclusions.

The legal framework in India

Under Section 3(i) of the Indian Patents Act 1970, India excludes surgical, therapeutic and diagnostic methods of treatment for humans and animals from the scope of patentable subject matter in because of the TRIPS Agreement. [Trade-Related Aspects of
Intellectual Property Rights ] OK. Previously this included plants, but with the passage of the Patents (Amendment) Act 2002 this has changed. The non-industrial application of medical procedures was one of the main reasons for their exclusion from patenting, which is an important criterion for the examination and granting of patents. A specific way of delivering medication, diagnosing a medical condition, or performing surgery are all examples of medical procedures. An incision without stitches for cataract surgery, for example, cannot be copyrighted. Diagnostic procedures for external tissues or fluids, on the other hand, may be patentable. Furthermore, in the case of Lalit Mahajan’s [Patent
Application No. 693/KOL/2007 decided on 11.01.2010
] patent application relating to a “device for detecting anti-HIV antibodies and HIV1 p24 antigen in human serum or plasma”, the gray area between patentability of a device and diagnostic/therapeutic method has been clarified . Opponents argued that because the device in question lacked diagnostic features, it was not patentable under Section 3(i). The patent examiner acknowledged the inventive step, but pointed out that the invention was an apparatus rather than a diagnostic technique. Likewise, the question in Ms. Ars Holding Applied Research Systems, Netherlands [2003. ] was whether a “kit for the treatment of infertility in women with multiple doses of FSH”21 can be excluded under section 3(i) of the Act. Since the product was only used as a medical procedure, the decision was affirmative. While the first application did not meet the method requirements for industrial application, the second did.

Legal framework in the United States

Any process, machine, manufacture or composition of matter is patentable if it is innovative and beneficial, in accordance with the law. While inventors are free to obtain patents for medical processes, they have no recourse in the event of infringement, as the law does not provide for specific exclusions. This means that while they may have a standalone monopoly, there is no way to enforce it. After a sequence of three cases – Ex parte Brinkerhoff, Ex parte Scherer, and finally the Pallin case in 1992 – the question of whether a medical procedure patent could be claimed was clarified. The first two cases in the controversial Pallin case, in which a surgeon sued colleagues for patent infringement of a surgical method of cataract removal, have been overturned by US courts. Following the first infringement case, the U.S. Supreme Court for the first time adopted a concept of excluding medical, surgical, and therapeutic processes from patentability, assuming a greater obligation to balance the equation between public health and social benefits.

Conclusion

The exclusions of medical operations, such as medicinal, surgical and diagnostic methods, remain a difficult notion to apprehend in the field of patentability. There are so many different interpretations and reasons for inclusion and exclusion that the topic causes more confusion than it solves. On the international level, it is high time to provide some clarifications so that a unified position can be taken. Clearly, the arguments against incorporating medical processes into patentability outweigh the benefits, and most governments have already done so. The gaps need to be filled by creating a model based on TRIPS and WMA [ full form] meetings, so that an effective mechanism can be established and Member States can effectively balance public health and the social benefits of inventors on an equal footing.

Patent policy in medical terms | Understand the relationship between medical procedures and patent policy

The content of this article is intended to provide a general guide on the subject. Specialist advice should be sought regarding your particular situation.

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