For diabetic patients, daily injections are an uncomfortable and often painful part of life. With multiple injections required every day, anxiety and fear are typical emotions a patient may have when diagnosed with diabe

CS Professional · Intellectual Property Rights - Laws and Practices · PYQS · June 2025
For diabetic patients, daily injections are an uncomfortable and often painful part of life. With multiple injections required every day, anxiety and fear are typical emotions a patient may have when diagnosed with diabetes, especially for children and those with a fear of needles. Traditionally thought of as an unavoidable part of treatment, injection therapy and the pain and discomfort it causes has become one of the major concerns of diabetes patients. To increase the quality of life of patients, alleviate discomfort and dispel fears surrounding diabetes injection therapy, in 2005 Tishla a multinational corporation at the forefront of innovating new medical technologies proposed a challenge to make a needle so fine that it makes injections painless. Tishla felt a strong social obligation to help provide them with physical and psychological relief. The company called on Mr. Harsh, one of its best engineers who has a string of patents to his name for medical syringes, and Mr. Yash, the head of Prem Industrial Corporation, a company involved in metal pressing, to make this vision a reality. Mr. Yash decided to take up Tishla's challenge because of his own dread for needles. He recalled how he had to receive regular nutrient injections for a condition when he was a teenager and how painful the thick needles were. He hated the injections so much that he developed a disdain for hospitals and stayed away from them as much as possible. Mr. Yash could understand the pain of diabetes patients, especially of the children suffering from the disease. "I thought if no one else can do it, I will," he resolved. While traditional production lines could be used to make a somewhat smaller needle, manufacturing costs would be expensive the resulting product would be approximately ₹ 80 per needle, which is too expensive for the average patient and thus makes commercialization unfeasible. The usual method of manufacturing needles is to hollow out a tiny cylinder of metal. But it is extremely difficult to make ultra-thin needles this way, because the thinner the cylinder, the more difficult the procedure becomes. Tishla's quest for an ultra-thin needle proved technically difficult, and after one year of research they were not making much progress. Tishla was turned down by a string of large metalwork firms, which thought that Tishla's requirements were too impractical and essentially impossible. Tishla turned to Yash, a company whose skilled craftsmanship boasts a high level of technology despite its small size. Yash is credited with developing the small lithium batteries that made cellular telephones possible. The company is so skilled in its trade that it has attracted the attention of major international corporations and governmental agencies. Mr. Yash, the company's founder, had earned himself a reputation as a metalwork magician. Working together with Yash, Tishla was able to innovate the world's thinnest needle for insulin injections. After five years of research and development (R & D), Yash discovered a new method which defied experts and conventional methods of needle manufacturing. Instead of hollowing out a metal cylinder, Yash's method takes a super thin sheet of stainless steel and rolls it into a tiny tapered cylinder, which is then sealed by tightly welding the seam to ensure that it will not leak. Mr. Harsh then used his medical engineering expertise to refine this cylinder into the world's first double tapered needle and added a special coating that acts as a lubricant. This lowers insertion forces and lessens discomfort. The resulting syringe is only 0.2 millimeters in diameter, which is no wider than two strands of human hair and 33% thinner than a conventional needle. The discomfort associated with the syringe is no more than a mosquito bite, making it nearly painless to use. With insurance, the syringe only costs about 18 Japanese Yen (Yen) per needle (approximately US$ 0.20), which is around five percent more expensive than traditional needles, but still well within the reach of the majority of patients. Tishla's innovative product has not only been a financial success for the company, but it has also helped patients around the world lead better lives, innovations such as the needle has given the company the freedom to continue to develop new medical products and create new manufacturing processes that reduce the end cost to the patient. Tishla has also capitalized on the success of the needle to educate the public on diabetes and dispel many of the myths surrounding the disease. How smoothly insulin is injected is one of the major concerns when patients commence insulin injection therapy. Improving its usability may be important in initiation therapy and adherence, resulting in clinical benefits to the patient. The syringe has a significant effect on increasing the quality of life and well being of diabetes patients throughout the world. Patients suffering from diabetes have to inject themselves with insulin an average of four times a day, and these injections can be painful and scary, especially for children. Many times a needle will be difficult to inject and insulin may leak out, causing further discomfort and stress. Conventional needles can cause psychological problems as well as physical problems, such as bruising and excessive bleeding where injections are made. Smaller, less painful needles can mitigate these problems and make patients less afraid of their treatment, giving them the ability to focus on their life and not on uncomfortable and stressful insulin injections. A study concluded that the needle has already had a significant social impact on patients using it. Compared to older needles, patients using the needle experience less pain, anxiety, bleeding, and insulin leakage and are enjoying a higher quality of life. The case of Tishla and the needle is an example of a company using R&D, innovation and IPRs to grow and make a positive social impact. Tishla is a multinational corporation at the forefront of innovating new medical technologies, protecting its intellectual property (IP) is an important part of its business strategy. With reference to the above case, answer the following: Securing IP rights (IPRs) deters copying and gives the company a competitive advantage, allowing it to continue to develop medical products that help people. Company wants to file patent in order to protect its invention. Advise the company accordingly to get the patent successfully.

Answer & Explanation:

The patent system in India is governed by the Patents Act, 1970 as amended by the Patents (Amendment) Act, 2005 and the Patents Rules, 2003. The Patent Rules are regularly amended in consonance with the changing environment, most recent being in 2024. To get a product patented, it has to fulfil the following requirements, which also serve as the principles of patent law in India. These are: An invention must be new. It must involve an inventive step. Capable of being used in industries i.e. industrial application. It must not fall into the category of exceptions or subjects that are not patentable under sections 3 and 4 of the Act. The following criteria determine what can be patented in India: Novelty or Newness The invention must be new and not similar to any other inventions or existing products. According to Section 2(1) of the Patents (Amendment) Act, 2005 'new invention' means an invention that has not been anticipated by prior publication and does not fall into the public domain. There must be no prior publication of the invention. However, a mere discovery does not amount to an invention. The two criteria for granting patents, i.e., novelty and utility, were recognized as important in the case of Bishwanath Prasad Radhey Shyam v. Hindustan Metal Industries (1979). It was observed in the case of Gopal Glass Works Ltd. v. Assistant Controller of Patents (2005), that for an invention to be patented it must be new and original. Novelty in itself is not a complete criterion. The product or invention must be sufficiently original as well. Non-Obviousness or Inventive Step According to Section 2(1) (j) of the Indian Patents Act, 1970, any product or process that involves an inventive step and is capable of being used in the industry is called an invention. This definition makes it clear that the invention must have an inventive step and it must not be known to any skilled person in that particular field. Section 2(1) (ja) of the Act defines 'inventive step'. The concept of inventive step was introduced in India in the case of Bishwanath Prasad Radhey Shyam v. Hindustan Metal Industries (1979). It also reiterated the four tests of obviousness. These are: A skilled person must identify the inventive step in the form of prior use, art or knowledge. He must be able to tell the difference between the subject matter and the invention. Consideration must be given to observing the differences. There must be a degree of invention. Usefulness or Utility This is another important criterion for granting patents. An invention must be useful and have an industrial application besides being new and non-obvious. In the case of Cipla Ltd. v. F Hoffmann-La Roche Ltd. (2015), the Court observed that according to the definitions of 'invention' and 'capable of industrial application' under the Act, an invention must have a commercial use so that it can be utilized in the industries. In the case of Indian Vacuum Brake Co. Ltd. E.S. Luard (1925), the Court observed that the term 'utility' has not been used in an abstract sense in the Act. In order to qualify for a patent, an invention must have some utility. Mere usefulness is not enough. By satisfying the above conditions, the Company can apply for the patent.

Topics: Patents

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