INTRODUCTION
Innovations in medicine have the power to revolutionise healthcare in the dynamic pharmaceutical sector. However, by forming complex networks of overlapping patents, a controversial technique known as patent thicketing has surfaced that can obstruct progress. This approach delays the delivery of life-saving medications to individuals in need while simultaneously impeding competition. A "patent thicket" is a complex web of overlapping patents held by several different parties that makes it difficult to manage intellectual property rights. New entrants incur substantial legal and financial risks when identical or related technology are covered by a large number of patents. Research and development (R&D) may be slowed down and innovation may be discouraged as startups and businesses traverse these complications, which frequently result in significant expenses . The complexity of overlapping patents creates significant barriers for small innovators, who may find themselves entangled in expensive legal disputes. Furthermore, by limiting prospects for new companies and deterring investment in ground-breaking discoveries, patent thickets lessen market competition. Public health is impacted by these obstacles in the pharmaceutical sector, which postpone the release of reasonably priced generic medications. Patents are meant to safeguard innovation, but when they are abused through patent thicketing, big pharmaceutical corporations benefit at the price of competition, creativity, and the welfare of consumers.
Patent Thicketing in India
In India, patent thicketing has delayed access to necessary pharmaceuticals rather than fostering innovation. Instead of encouraging competition, it maintains a fictitious monopoly that disadvantages patients in need of life-saving medications while favouring big pharmaceutical companies. This strategy increases the financial burden on consumers and healthcare systems by delaying the launch of generic alternatives. Patents in India are granted on the basis of inventiveness, uniqueness, and industrial usefulness. Patent thicketing, on the other hand, happens when businesses submit several applications for slight changes to already-approved medications, making it challenging for rivals to create substitutes.
One important type of patent thicketing is evergreening, which prolongs the life of a medicine patent by making minor adjustments to the medication or its formulation as opposed to making significant breakthroughs. This tactic is used by pharmaceutical firms to postpone generic competition and preserve market exclusivity. Even though these changes might satisfy patent requirements, they frequently don't offer any appreciable therapeutic or clinical advantages. A good example is the case of Novartis and their cancer medication Glivec, in which the business tried to extend its patent by making little adjustments, which finally raised moral and legal questions. Pharmaceutical firms can use evergreening strategies to fictitiously prolong monopolies, preventing generic competition even after the original patent has expired. Pharmaceutical firms can use evergreening strategies to fictitiously prolong monopolies, preventing generic competition even after the original patent has expired. This results in increased prescription costs and limited access to reasonably priced pharmaceuticals, especially in nations with low and intermediate incomes.
Impact of Evergreening on Public Health
The detrimental effects of evergreening on public health and the availability of medications are among its most important side effects. Pharmaceutical firms keep drug prices high long after patents should have expired by postponing the release of generic alternatives. Because patented drugs can be unaffordable in developing countries, this problem is particularly pressing there. The cost difference between branded and generic medications can have a significant impact on a patient's survival in situations involving life-threatening conditions like HIV/AIDS or cancer. Access to necessary medications is restricted when patent protection is extended by evergreening, which delays the timely arrival of reasonably priced generics. Additionally, when governments and insurance companies foot the bill for expensive patented medications, evergreening puts more financial strain on healthcare systems. This lowers overall public health outcomes by limiting financing for other healthcare activities and necessary treatments. Companies that monopolise drug patents limit competition, which hinders price reductions and the availability of reasonably priced drugs. Stronger laws against evergreening are necessary since these actions jeopardise the viability of healthcare systems.
Abuse of Patent Rights
Companies frequently misuse patent rights when they unduly restrict competition, stifle innovation, or undermine the public interest. Although patents are meant to encourage innovation, monopolies that abuse them have negative effects on customers and market competition. One such misuse is patent trolling, in which businesses get patents to demand settlements from real innovators rather than for innovative purposes. Instead of creating goods, patent trolls manage vast portfolios and file infringement lawsuits to demand monetary settlements. Evergreening is another common misuse, where businesses make little changes to already-approved medications in order to perpetually renew their patents. This keeps medicine prices high by preventing generic alternatives from accessing the market. Furthermore, even when the original patent is about to expire, dominating corporations exploit it to prevent competitors from entering the market and limit the sale of less expensive alternatives. Such measures raise consumer costs, hinder innovation, and restrict competition. By generating intricate networks of patents, patent thicketing exacerbates the problem and makes it challenging for smaller businesses to manage intellectual property rights without running the danger of legal repercussions. Many nations have responded by enacting legislation to stop patent abuse, including India. In order to ensure that intellectual property laws fulfil their intended function of encouraging true innovation, courts frequently step in to invalidate pointless patents.
Impact of Patent Thicketing in India
A major problem in India is patent thicketing, especially in the pharmaceutical sector. India is a key player in the global healthcare system as a significant provider of reasonably priced generic medications. However, patent thicketing is a tactic used by global pharmaceutical corporations to erect financial and legal obstacles in the way of Indian generic producers, which delays or stops them from creating affordable substitutes.
Limiting the development of generic drugs, which is essential for lowering the cost of medications, is one of the main effects. Patent thicketing keeps drug prices artificially high and restricts access to reasonably priced medications by preventing generic manufacturers from joining the market. In India, where a sizable section of the populace depends on generic medications for therapy, the effects are more acute. Competition is hampered by patent thicketing, which delays the release of life-saving drugs and lowers the affordability of healthcare as a whole.
Legal and Regulatory Challenges
Public Interest and Patent Law
With the introduction of Section 3(d) of the Patents Act, 1970, India has taken important action to combat patent thicketing. By limiting patents for small changes unless they show improved efficacy, this clause stops evergreening. Nevertheless, patent thicketing makes it more difficult to challenge several patents covering various facets of a medication collectively. Long-running legal disputes between multinational pharmaceutical firms and Indian generic producers raise litigation costs and postpone the release of more reasonably priced medications. The growing volume of patent applications and court cases places a greater regulatory strain on the Indian Patent Office and judiciary. This complicates matters further and delays the patent clearance process by posing administrative hurdles.
India’s legal framework prioritizes public health over corporate monopolies, as demonstrated in the landmark case Novartis v. Union of India . The Supreme Court’s ruling reinforced the importance of Section 3(d) in preventing evergreening and ensuring that patents are granted only for substantial innovations. Moving forward, India should promote greater competition by enforcing stricter patent scrutiny and utilizing compulsory licensing when necessary. Regular revisions to patent laws are crucial in maintaining a balance between encouraging innovation and safeguarding public health. By strengthening regulations and increasing patent transparency, India can continue to combat patent thicketing and ensure access to affordable medicines for all. A well-regulated patent system will foster innovation while preventing monopolistic practices that hinder competition and public welfare.
Conclusion
A strong legal framework that strikes a balance between public health needs and intellectual property protection must be put in place in India in order to effectively prevent patent thicketing and provide fair access to necessary medications. Evergreening can be avoided and the issuing of pointless patents can be curbed by strengthening Section 3(d) of the Patents Act, 1970, by providing more precise criteria on what qualifies as an "enhanced efficacy" claim. Further discouraging pharmaceutical companies from misusing the system to prolong monopolies can be achieved by speeding up patent inspections and tightening surveillance of secondary patents. Improving the function of mandatory licensing, as allowed by the TRIPS Agreement, will guarantee that life-saving medications continue to be available when market monopolies jeopardise cost.
Additionally, needless litigation delays can be avoided by promoting an open opposition system that allows public health advocates and generic manufacturers to contest weak patents prior to their issuance. In order to ensure that patents promote true innovation rather than stifle competition, India must also penalise businesses that engage in anti-competitive patenting tactics. The judiciary and regulatory bodies should collaborate closely to expedite dispute resolution procedures and cut down on drawn-out court cases that impede the prompt launch of generic medications. India's rules can be brought into line with international best practices by improving collaboration between the Indian Patent Office and international patent organisations. By incorporating these legal remedies, India may continue to lead the world in providing reasonably priced generic medications while avoiding abusive patenting practices that stifle competition, innovation, and the general public's access to necessary medical treatment.
© 2025 Business Consultant & Law Firm - Legacy Partners. All Rights Reserved.
Designed by Nuewelle Digital Solutions LLP
Legacy Partners
We typically reply in a few minutes
