INTRODUCTION:
Medical Innovation has transformed the perspective of healthcare and continues to be a ray of hope for people worldwide. Intellectual Property plays a critical role in maintaining the quality and affordability of medicines and other medical products. IPR has helped the medical sphere by advancing patient care, pioneering new frontiers by finding solutions to age-old diseases, economic benefits, tackling global health issues, and long-term sustainability. There are seven types of Intellectual Property Rights (IPR) but patents, copyrights, and trademarks play a pivotal role in medical innovation. [1]
Patents are granted for the inventions, it is an exclusive right of the inventor that excludes others from making, selling, and using the invention for a certain period (usually 20 years). Patents are important for protecting new medical technologies like drugs, machines used in the treatment of different diseases, and other medical devices.[2]
Copyright is granted to the original art, literary, and intellectual work. Copyright includes books, articles, music, paintings, etc. The expression of ideas is protected under copyright rather than the ideas themselves. In medical innovation, copyrights are granted mainly to medical literature, educational materials, research papers, etc. It includes textbooks, medical software solutions, research papers, etc.[3]
A trademark is a unique symbol, sign, name, or phrase used by a company or industry for branding their product that helps consumer distinguish their goods and services from others. A well-recognized trademark in the medical field ingrains confidence in patients and other customers.[4] Trademarks are essential for promoting pharmaceutical products, medical services, and other equipment.
The historical context of the role of IPR in medical innovation is a sophisticated narrative that has evolved with time. Earlier, people used to share medical knowledge as much as possible. There was limited or no protection for medical discoveries. The 19th and 20th centuries witnessed tremendous development in the field of science and technology. The medical field also witnessed the development of new vaccines, antibiotics, and various medical devices. During the 20th century, medical industries saw excellent growth which had a profound impact on public health. In the 21st century, the outburst of various diseases like malaria, dengue, and COVID-19 brought attention to global health concerns and the need for affordable access to essential medicines.
ROLE OF IPR IN INCENTIVISING MEDICAL INNOVATIONS:
Medical innovation is a powerful fight against global health challenges. Innovation of various vaccines, drugs, diagnostics, etc plays a pivotal role in defeating pandemics and other neglected diseases. IPR plays a significant role in incentivizing medical innovation making it affordable and accessible to patients and other consumers worldwide. IPR brings exclusivity in the market, promotes investment and encourages risk-taking, fosters competition, recoups costs, encourages innovation, etc.[5] There are numerous advantages to the medical field granted by the IPR. IPR provides exclusive rights to the owner of the innovation for a certain period (usually for 20 years). It ensures that one should not copy and market the idea, technology, or invention of the owner who enjoys the competitive advantage. IPR provides an incentive for investments in the medical field by attracting individuals and organizations. This incentivizes the creation of new drugs, medical technologies, etc. The creation of innovative medicines, and other medical technologies involves considerable investments and years of research. IP rights allow innovators to charge premium prices on their products to recover their expenses invested in research and development. Experiencing these advantages of IPR motivates scientists to explore new areas, take risks, and development of new therapies and medications. IPR allows companies to share or sell their innovation in exchange for royalties and compensations.
Numerous successful innovations like vaccines have been protected by IPR including patents, copyrights, trademarks, etc. Fredrick Banting, Charles Best and JJR Macleod discovered Insulin in 1921 that regulates blood sugar levels in the body. They sold their patent to the
The University of Toronto for $1 to ensure widespread access to Insulin[6]. One of the most effective vaccines is the Polio vaccine invented by Dr. Jonas Salk and Dr. Abert Sabin in the mid-20th century. Dr. Salk invented the Inactivated Polio Vaccine (IPV) and made it available freely without patent to the general public[7]. Dr. Sabin invented the Oral Polio Vaccine (OPV) and made it available with a trademark to protect the manufacturing process to ensure the broadest access.[8]
DRAWBACKS OF IPR IN MEDICAL INNOVATION:
While IPR is essential in incentivizing medical innovation there are some drawbacks and challenges, particularly in the access to healthcare. High drug prices, monopolies in the medical market, evergreening, research misallocation, barriers to competition, etc. are some drawbacks of IP rights.[9] Particularly patents in IP rights allow innovators to charge premium prices on drugs which is the challenge in affordability and accessibility of various life-saving drugs. High drug prices allowed by IP rights give rise to monopolies and dominance of few companies in the market resulting in an arbitrary increase in prices furthermore. To extend patent protection, companies use the method of evergreening by making some minute changes to existing drugs and other pharmaceutical techniques. Companies often focus on research into those diseases that give more profit due to strong IP rights protection and neglect the miserable life-challenging diseases.
IPR plays a multifaceted role in medical innovation as it is advantageous and sometimes challenging. One of the popular examples of challenges faced due to IP rights is the case of EpiPen Controversy. A company named Mylan created the drug EpiPen used to prevent the allergic reaction of anaphylaxis[10]. The company raised the prices of the drug which made it difficult for middle and low income to afford it. Critics claimed that patent protection by IP Rights allowed the monopoly of the company to arbitrarily raise the prices.
CASES:
India has seen notable IPR cases in the medical field and it has been an important player of IPR in medical innovations. Novartis v. Union of India[11] is the most important case where Novartis invented a drug for the treatment of cancer and applied for its patent under section 3(d) of the Indian Patents Act. The application was rejected by the Indian Patent Office and Madras High Court as it failed to provide evidence of enhanced efficacy. Section 3(d) of the Indian Patent Act protects the grant of a patent unless the an enhancement of efficacy. The apex court upheld the decision of the Madras High Court and rejected the plea of Novartis as it failed to provide evidence for enhancement criteria under the act. This landmark case clarified the scope of the Indian Patent Act making the protection under IP rights stronger.
Roche v. Cipla[12] is another significant judgment that enshrined the scope of IPR in medical innovations. Roche a Swiss company sued Cipla for marketing and manufacturing the generic version of Erlotinib of which Roche was the patent holder. Delhi High Court ruled in favour of Cipla and contended that it is allowed to market and manufacture the generic version of Erlotinib. The court stated that Roche’s patent was invalid under Indian Patent Law as it lacked intensive steps. The case addressed the issue of patent validity and infringement in India.
CONCLUSION:
The blog illustrated the dual nature of IPR in medical innovation. While there are many advantages of IPR protection to medical innovation, there are some drawbacks as well. There is a need for a balanced approach to IPR. The right equilibrium between IPR and Medical Innovations can be achieved through measures like compulsory licensing, patent pools, and collaborations that prioritize public health. The responsibility to maintain the balance and ensure accessibility and affordability lies with the government, international organizations, pharmaceutical companies, scientists, and researchers. They must work to foster medical innovation and ensure its worldwide access.
Author(s) Name: Mahi Jaiswal (ILS Law College)
References:
[1] Chandra Nath Saha and Sanjip Bhattacharya, ‘Intellectual Property Rights: An Overview and Implications in Pharmaceutical Industry’ (National Instituite of Biotechnology Information, April 2011) <https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3217699/> accessed on November 15, 2023
[2] Anthony Walker, ‘Pharmaceutical Patent, An Overview’ (Alacrita,) <https://www.alacrita.com/blog/pharmaceutical-patents-an-overview> accessed on November 15, 2023
[3] Partick Kilbride, ‘High- Value Economy Needs Protection of Intellectual Property’ (The Times of India, 20 June 2023
<https://timesofindia.indiatimes.com/blogs/voices/high-value-economy-needs-protection-of-intellectual-property/> accessed on November 15, 2023
[4] Priyanka Nimje, ‘The Need for Trademark in Pharmaceutical Industry’ (Sagacious IP) <https://sagaciousresearch.com/blog/the-need-for-trademark-in-pharmaceutical-industry/> accessed on November 15, 2023
[5] Patrick Kilbride, ‘Intellectual Property Rights are a Driver of Innovation in Healthcare Sector’ (ET Healthworld 3 July 2022) <https://health.economictimes.indiatimes.com/news/industry/intellectual-property-rights-are-a-driver-of-innovation-in-the-healthcare-sector/92629667> accessed on November 15, 2023
[6] Julia Belluz,‘The Absurdly High Cost of Insulin, Explained’ (VOX, 7 November, 2019) <https://www.vox.com/2019/4/3/18293950/why-is-insulin-so-expensive> accessed on November 15, 2023
[7] Siang Yong Tan and Nate Ponstein, ‘Jonas Salk (1914-1995): A Vaccine Against Polio’ (National Library of Medicine, January 2019) <https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6351694/#:~:text=There%20is%20no%20patent> accessed on Novembr 15, 2023
[8] Angus Stewart, ‘Medicine Makers of History: Salk and Sabin’ (The Medicine Maker, 9 May, 2022) <https://themedicinemaker.com/manufacture/could-you-patent-the-sun-jonas-salk-albert-sabin-and-the-polio-vaccine> accessed on November 15, 2023
[9] Chandra Nath Saha and Sanjip Bhattacharya, ‘Intellectual Property Rights: An Overview and Implications in Pharmaceutical Industry’ (National Instituite of Biotechnology Information, April 2011) <https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3217699/>
[10] Michael Rosen, ‘The EpiPen Debacle: Are IP Issues to Blame’ (American Enterprise Institute, 6 September 2016) < https://www.aei.org/technology-and-innovation/epipen-debacle-ip-issues-blame/ > accessed on November 16, 2023
[11] Novartis Ag. v Union of India [2013] 3 SCC Civ 227, SC 271.
[12] F Hoffmann- La Roche Ltd. & Anr. v Cipla Ltd. [2015], 4 Civ LT 500.
