The history of medical patenting varies by country. However, it is generally acknowledged that medical patenting was non-existent until the 18th and 19th centuries. Particularly in the 18th and 19th centuries, medicinal compounds marketed with attractive names and even catchier offers came to be known as "patent medicines." Such medications were once known as nostrum re-medium, or "our remedy," thus the term "nostrum." These mixtures, often known as proprietary medications, were, for the most part, medicines that were trademarked but not patented. One of the first significant product categories that the advertising industry pushed was patent medications. In the 18th century, these medications were brought from England to America as private drugs produced under grants, or "patents of royal favour," to individuals who supplied healthcare to the Royal Family. Some of the first English patent medications to go to North America with the early immigrants were Dr Bateman's Pectoral Drops, John Hooper's Female Pills, and Daffy's Elixir Salutis for "colic and griping." Business owners and small shopkeepers sold the medications. The production of medicines had grown significantly in importance in America by the middle of the 19th century.When discussing the situation in India, one discovers that the British introduced patenting. Act VI of 1856 was the first patent-related piece of law in India. This regulation aimed to foster the development of novel and practical products as well as to persuade inventors to divulge their innovations' trade secrets. As a result of being passed without the British Crown's consent, the Act was subsequently revoked by Act IX of 1857. Act XV of 1859, new legislation established new rules for granting "exclusive privileges." In 1911, the Indian Patents and Designs Act II superseded all earlier laws. The Act was thought to be failing to achieve its goal after Independence. Comprehensive patent legislation was deemed desirable due to the country's significant changes in political and economic realities. To guarantee that the patent system is advantageous to the country's interests, the Government of India established a committee in 1949, which was headed by a retired judge from the Lahore High Court, Justice (Dr.) Bakshi Tek Chand. The government did, however, enact the New Patents Act in 1970, which disqualified agrochemicals and medicines from being eligible for patents. It allowed only process patents for the production of low-cost generic versions of existing patented medicines and was instrumental in the development of an indigenous pharmaceutical industry. Essentially a “process patent” refers to the granting of a patent on the chemical process resulting in the manufacture of a particular medicine but not on the product per se.
Following India's ratification of the TRIPS (Trade-Related Aspects of Intellectual Property Rights) Agreement in 1995, the country's patent laws underwent substantial changes. In 2005, India moved to a “product patent” system, to align with its obligations under the TRIPS (Trade Related Intellectual Property Rights) agreement. This involved the transition to a “product patent” regime under which firms with discovery are granted patents on the final product, for 20 years from the date of filing the patent application to all innovations, regardless of category. The patent system offers adequate incentives to engage in R&D. Technological advancements have opened up new avenues for the treatment of illnesses, and there is an increase in both the demand for drugs globally and healthcare spending. The pharmaceutical industry's innovation has not kept up with the rate of demand for new treatments to meet unmet medical needs.
Companies are frequently rebranding and reusing old medications through patent evergreening or patent thickening rather than developing brand-new ones. Humira’s manufacturer, AbbVie, has been granted over 130 patents, resulting in a market exclusivity period stretching from launch in 2002 until 2023. Humira, the market leader, is currently the highest-grossing product globally and has retained exclusivity since its launch in 2002.The Center for Drug Evaluation and Research authorized 50 new medications in 2021(CDER). A little over 20 unique pharmaceuticals were presented in 2016, while approximately 60 new goods were approved in 2018. In 2021, 50 new medicines received approval. However, a new drug's development can take up to 15 years and cost roughly 2.6 billion dollars.
The pharmaceutical industry spends more on R&D than many other businesses in proportion to revenue. According to an OECD study on Pharmaceutical Innovation and Access to Medicines, only a small percentage of approved treatments are successful commercially. Half of the 466 novel active compounds introduced in the US between 1991 and 2009 had lifetime sales of less than USD 1.5 billion, and just around 10% had sales of USD 10 billion or more. Further reducing the innovation potential is the habit of major pharmaceutical corporations using share buybacks to raise share prices (and stock options for management). A Reuters Special Report pointed out that during the previous ten years, Pfizer, a manufacturer of medicines, spent just $82 billion on research and development and $139 billion on dividends and share buybacks.
Another factor in the loss of pharmaceutical innovation is the complexity of pricing rules. Reduced medication prices may result in lessened profits, which might lower the exorbitant acquisition costs that major manufacturers are now paying to acquire inventions created by smaller companies. Big firms to escape innovation competition often use mergers in pharmaceuticals. This also results in greater bargaining power, more market power, and thus to a greater influence on prices. Even though several factors are slowing down innovation in the market, the pharmaceutical ecosystem will continue to prosper as long as those who innovate are given the resources to do so and those who play other roles in bringing new drugs to market are fairly compensated for those contributions. Regulators might focus on harmonizing approval criteria, expediting and simplifying assessment procedures, enabling information and data exchange, and other issues while companies are constantly looking to improve the efficiency of their R&D operations.Reforms in the past have focused on a range of issues, including patent systems, price regulation and public procurement systems for medicines.
Indian pharmaceuticals sector has historically emphasized access to and affordability of medicines. Increased accessibility to affordable drugs has been one of the key enablers in lowering the disease burden in India.Public Health in India faces many challenges, such as a gradual decrease in the share of mortality due to communicable diseases and an increase due to Non-communicable Diseases in India. Given the impact on public health and the issue of the safety of human lives, the world over the pharmaceutical sector is a highly regulated sector, and India is no exception to it. The Indian pharmaceutical sector makes a valuable contribution to improving public health by developing, producing, distributing, and marketing the needed drugs or pharmaceutical products. The Indian pharmaceutical industry has played a key role in driving better health outcomes across the world through its affordable and high-quality generic drugs. India accounts for 60 per cent of global vaccine production, contributing 40 to 70 per cent of the WHO demand for Diphtheria, Tetanus and Pertussis (DPT) and Bacillus Calmette–Guérin (BCG) vaccines, and 90 per cent of the WHO demand the measles vaccine. The industry has also helped in bringing down the treatment costs of life-threatening diseases such as Chronic Myeloid Leukaemia and Hepatitis C, to less than five per cent of the original cost.Since the early 1970s with the introduction of new patent legislation and the adoption of drug policy (1978), technological capability-building processes have been the focus of policymakers in the Indian pharmaceutical industry.
During the 1980s, several domestic firms entered the local market using process technologies developed both in-house and in public research laboratories for compounds manufactured for different diseases. India has eradicated diseases such as poliomyelitis, leprosy, and neonatal tetanus as a result of strong collaboration among vaccine manufacturers, healthcare providers, the government and development organisations. In the first two phases, especially during 1965-1994, priority was assigned to Type I lifestyle diseases (cancer, obesity, diabetes, cardiovascular diseases, and hepatitis). In publicly financed innovation, the focus earlier was on diseases that were considered national priorities, in areas where all over the world public finance drives innovation (such as contraception, tuberculosis, malaria, and filariasis). However, some infectious diseases under control have returned or developed resistance to drugs, such as dengue fever, viral hepatitis, tuberculosis, malaria, and pneumonia. In 2003, 5.1 million Indians were living with HIV/AIDS, and over 3 million had tuberculosis. Approximately 32 million Indians were diabetic in 2000, and the number has come to around 77 million in 2022. The cases of dengue, for instance, have increased to 1.5 lakhs and 1.09 million had malaria in 2017 that serious problem in the tribal-dominated regions of Central and North East India. Cases of Japanese encephalitis and kala-azar in India also show the potential burden of the disease.
Currently, the disease burden in India indicates the predominant focus of drug development on NCDs such as cancer, hypertension and cardiovascular diseases as compared to communicable diseases and even other important causes of disease burden within NCDs like respiratory diseases, diabetes, and digestive and genitourinary diseases. CDSCO gave details on the generics and biosimilars developed showing that out of 1,635 new drugs approved for marketing between 2000 and 2017, 87% were for non-communicable diseases (NCDs) but only 6% of the new drugs that came to market were for communicable diseases. Within NCDs, the highest number of new drugs that came into the market was for cardiovascular diseases and hypertension (228), followed by neurological diseases (220), cancer (153), dermatology and hygiene (131), ophthalmology (120), immunology and rheumatology (111), gastrointestinal (106), and respiratory diseases (105). Diseases related to the kidneys received the least focus, followed by urology, psychiatric, endocrine and metabolic diseases, and infectious diseases.“India has a great tradition and technical capacity for drug innovation. However, drug development for its health priorities is limited. Historically, Indian companies have been the principal providers of medicines and vaccines for the Indian population, enabled by domestic talent and patent laws that protected processes but not products. Inevitably, local competition was reduced to pricing wars that eroded the capacity of established companies to self-funded proprietary R&D and discouraged the formation and capitalization of innovative new biotech companies. Now, introducing a new vaccine in a developing country like India faces several financial and logistical challenges. Global challenges include the fact that newer-generation vaccines are often too expensive to be introduced in developing countries. Several vaccines that were previously used both in developed and developing countries are being replaced with newer generation vaccines in the developed world (e.g., whole-cell pertussis vaccine being replaced by acellular pertussis vaccine due to its fewer adverse reactions) but continue to be used in developing countries due to their low cost. Major global vaccine manufacturers tailor their selection of vaccines to the needs of the developed world only such as NCDs in the developed world. Because. there is little incentive for them to develop vaccines for diseases largely prevalent in the developing countries alone (e.g., Japanese Encephalitis, Dengue, Cholera, Tuberculosis, Malaria, etc). While malaria and Tuberculosis have attracted some attention, however, no drugs exist for diseases such as African trypanosomiasis, leishmaniasis and Chagas diseases (the ‘most neglected’ diseases).