Pharmaceutical and Medical Diagnostics Innovation and Patents under the TRIPS and Indian Patent Law 

Pharmaceutical and Medical Diagnostics Innovation and Patents under the TRIPS and Indian Patent Law 

Patent regime

To protect the inventions, patents are issued. A patent is an exclusive right given to the inventor for the invention by the government. An inventor or anyone else appointed by the inventor may apply for a patent. It is the right to exclude others from unauthorised manufacture, use, offer for sale, sale, or import. The patent is a negative right that does not have a right to make, use or sell the invention, but rather a right that empowers the patentee (patent proprietor) without his/her consent to prevent or stop the use of the patent’s invention by third parties. The patent includes the right to authorise others for the invention to be produced, used, or sold. A patent is an agreement between the applicant/inventor and the government in which the government grants the right of the invention to be protected for a limited period after the applicant/inventor has made full disclosure. Patenting, therefore, provides a strategic approach to protecting inventions without confidentiality

A patent provides a technical solution to the technical problem. Only inventions that meet certain conditions known as the patentability criteria are granted a patent. Patents shall have a maximum period of 20 years from the date of the issuance of the patent. Patents are sovereign rights, but only in the nation in which they are issued are enforceable..

The Impact of Indian Patent Law on the Local Pharmaceutical Industry

 Rejection of Product Patent

The Report on the Revision of the Patent Law submitted by the Patent Law Amendment Commission in 1959, which was led by Shri Justice N. Rajagopala Ayyangar, pointed out that at that time foreigners held 80% to 90% of India’s patents, of which 90% of the patented products were not manufactured in the Indian territory. Foreign companies could block the production of their patented drugs in India, causing the stagnation of the Indian domestic pharmaceutical industry. Thus, the Commission believed that the patent system had been used by multinational corporations to monopolise the market, especially in the food, pharmaceutical, and chemical industries. Market monopolies also led to high product prices. Therefore, the Commission recommended that only methods or processes in the abovementioned fields be patentable, as opposed to the Indian Patents and Designs Act of 1911, which granted patents to both product and process inventions in the pharmaceutical sector.

Also Read: Glenmark Pharmaceuticals Ltd. v. Curetech Skincare and Galpha Laboratories Ltd.

This suggestion was adopted by the Patents Act of 1970, which has laid the foundation for the boom in India’s generic drug industry. According to the Patents Act of 1970, no patent shall be granted in respect of claims for substances intended for use or capable of being used as medicine or drug or relating to substances prepared or produced by chemical processes. The reason that the Patents Act of 1970 only grants method patents in the fields of pharmaceuticals and chemicals is because product patents have an inhibitory effect on other related research, as they can prevent others from obtaining the same products through different methods. Once product patents are granted to drugs, patentees can control the production of patented drugs and thereby unreasonably raise the prices of essential medicines.

Thus, the rejection of the drug product patents guaranteed that India’s generic companies could produce drugs with the same or similar composition through reverse engineering and avoid being accused of infringement. India denied product patents in the pharmaceutical sector until the expiration of the transition period of the TRIPS Agreement on January 1, 2005. The rejection of product patents in the pharmaceutical sector for more than 30 years has created an opportunity for the development of the generic drug industry in India.

After comparing drug prices among India, the United Kingdom, Malaysia, and Nigeria, before and after the Indian Patents Act of 1970, R.B. Saxena, consultant at the Indian Council for Research on International Economic Relations, found  that the prices of pharmaceutical products in India were highest before the enactment of the Patents Act of 1970 and that in 1987 the prices in India for commonly used drugs, such as analgin tablets, doxycycline capsules, diazepam tablets, and metronidazole tablets, were low compared to those of other countries. The research also found that some of the important new drugs could be introduced into India with a time lag ranging between only 4 and 6 years. Thus, Saxena pointed out that the changes relating to process patenting incorporated in the Indian Patents Act of 1970 had benefited Indian consumers in terms of prices paid for drugs and medicines and, meanwhile, it also became possible to produce many new pharmaceutical products in India much faster than what could have been otherwise.

TRIPS

India was an early signatory to the General Agreement on Tariffs and Trade (GATT).

However, it is evident that GATT was more inclined toward developed countries than developing ones. Some developing countries, especially Brazil and India, have proposed during the Uruguay Round negotiations that GATT has no business dealing with the issues of intellectual property protection, which should be discussed at the World Intellectual Property Organisation (WIPO); the United Nations Educational, Scientific, and Cultural Organisation (UNESCO); and the United Nations Conference on Trade and Development (UNCTAD). During the negotiations, notwithstanding pointing out that countries at different levels of development should have their own right to decide whether to grant patent rights to certain products, India decided to join the nascent World Trade Organisation (WTO).

Medical Innovation

Isabel Van de Keere: Rehab in virtual reality

Immersive Rehab have been using virtual reality since 2016 to help provide a more comprehensive and efficient solution for patients undergoing physical and neurological rehabilitation. To date, the social enterprise has worked with more than 40 patients, with their customised approach to rehab resulting in increased engagement and mobility, a greater reach of motion and an increased concentration span.

3D-printed devices: Lower-cost and highly customized medical technology products that can be tailored to suit the physiological needs of individual patients

The latest annual report from IFI CLAIMS Patent Services has identified 3D printing as the ninth fastest growing technology of 2020, based on US Patent and Trademark Office data.

The report compiles the enterprises, technologies, and countries that have received the most patents over the past year. Throughout 2020, patent grants declined less than one percent from 2019 to 352,013, despite the global Covid-19 pandemic, while patent applications rose almost five percent, continuing an upward trend seen for the past four years.

Innovative Use Cases for 3D Printing in Medicine

Patient-Specific Surgical Models

3D printed anatomical models from patient scan data are becoming increasingly useful tools in today’s practice of personalised, precision medicine. As cases become more complex and operating room efficiency becomes more important for routine cases, visual and tactile reference models can enhance understanding and communication within OR teams and with patients.

Affordable Prostheses

Each year hundreds of thousands of people lose a limb, but only a subset of them get access to a prosthesis to recover its function.

Corrective Insoles and Orthoses

Many of the same high financial barriers to treatment seen in prosthetics are also native to fields such as orthoses and insoles. Like many other patient-specific medical devices, custom orthoses are often inaccessible due to their high cost and take weeks or months to get manufactured. With 3D printing, that no longer needs to be the case.

Bioprinting, Tissue Engineering, 3D Printed Organs and Beyond

The conventional means of treating patients with grave organ failures currently involve using autografts, a graft of tissue from one point to another of the same individual’s body, or organ transplants from a donor. Researchers in the fields of bioprinting and tissue engineering are hoping to soon change that and be able to create tissues, blood vessels, and organs on demand.

3D bioprinting refers to the use of additive manufacturing processes to deposit materials known as bioinks to create tissue-like structures that can be used in medical fields. Tissue engineering refers to the various evolving technologies, including bioprinting, to grow replacement tissues and organs in the laboratory for use in treating injury and disease. 

Written by – Himanshu Singh (IPR Club Intern)

Email – hsingh.him@gmail.com

References

• https://www.dovepress.com/intellectual-property-protection-in-india-and-implications-for-health–peer-reviewed-fulltext-article-IEH
• https://link.springer.com/chapter/10.1007/978-981-13-8102-7_11
• https://www2.deloitte.com/us/en/pages/life-sciences-and-health-care/articles/top-10-health-care-innovations.html
• https://www.rbi.org.in/scripts/bs_viewcontent.aspx?Id=2028
• https://formlabs.com/asia/blog/3d-printing-in-medicine-healthcare/
• https://www.sciencedirect.com/topics/engineering/wearable-device
• https://blog.ipleaders.in/patent-right-healthcare-india/
• https://3dprintingindustry.com/news/patent-data-puts-3d-printing-in-top-10-fastest-growing-technologies-of-2020-182477/