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: The patent agent should never become the inventor but should strive to have the clearest grasp of the invention needed to obtain a patent with the broadest claims allowed by law. Discuss.

Answer & Explanation:

In order to obtain patent protection in any country, a patent application has to be filed in the patent office. From preparing a patent application for submission, negotiating with the patent examiners for its grant, and appearing before the administrative tribunals within the office the patent professionals play an important role. Preparing a patent application and navigating the proceedings before the patent office requires an understanding of statutory provisions governing the patents, and familiarity of the scientific and technical details of the invention. As the scale of knowledge grows, it becomes increasingly difficult for any one person to stay on top of details and developments across a field, and specialization represents something of a natural division of labour. Patent system is no exception to this role. The primary role of a patent agent is to help any inventor or applicant secure legal protection for his or her invention by filing a patent application and prosecuting the same toward its grant. Any matter or proceeding before the Patent Offices can be represented by a patent agent. They can communicate on behalf of the applicant and represent them at all attendances before the Patent Office. In order to make a good representation in a competent manner, a patent agent must have the ability to understand an invention and its technical aspects. Expertise in the field assists a patent agent to better understand the invention and draft a technically sound patent application. A patent agent at first may have to take instructions concerning the invention. Details regarding the nature and field of the invention are comprehended for understanding the invention. The patent agent must also establish what the inventors believe is new about his or her invention, how the invention is different from and advantageous over earlier prior art. Other details include information regarding the problem that the invention intended to solve, details with respect to inventor or entitlement with respect to filing the application. Adding to this, it is also essential to determine whether the invention meets the criteria of patentability in the country in which the patent is deemed to be protected. If the inventors do not have enough information about the field of invention, patent agent may be required to perform searches to get an overall idea of the invention. In general, a patent agent must identify the essential idea or concept that the patent application should seek to protect and reduce the essential features of the invention to writing in a legal document called a Specification with one or more claims. Claims define the scope and extent of the legal protection conferred by the patent and their object is to provide the owner of the patent with a legal right to exclude others from making, using, selling or offering for sale the subject matter of the patent in the territory in which the patent is registered. The Patent Agent is required therefore to write the patent application and especially the claims in a clear and concise manner that can withstand. Also, they must possess sufficient knowledge to be able to review and advise the people whom they represent of the merit of any objections raised by the Patent Office, submit oral or written responses to the Patent Office that overcome the objections or amend the patent application so as to allow the application to proceed to grant. Hence, the right patent professional (patent agent) with appropriate experience can remarkably add value to patent application. The patent agent provides maximum possible protection for your invention since the drafting of the patent is done from a technical as well as legal perspective. The patent application is written such that it provides the broadest possible protection for your invention. Following things will be considered by patent agent while drafting patent: The claims are written in such a way that they provide maximum protection All possible embodiment and variants are covered Each claim finds its support in the detailed description in the specification Use of specific words in description and claims that has a specific meaning in patent law. Thus, the patent agent must not assume the role of the inventor but should have the clearest grasp and understanding of the invention in order to properly execute his role as a patent agent to obtain a patent with the broadest claims allowed by law.

Topics: Patents

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