This Article is Written by Tanishq Alandkar, Manikchand Pahade Law College,3rd year Student during an internship at LeDroit India.

KEYWORDS:

• Patents
• Evergreening
• Patents Act
• Litigation

INTRODUCTION:

Patent Evergreening refers to the process where companies seek to renew or extend their patents by making incremental modifications to an existing product, and then filing new patent applications for these modifications. Patent Evergreening is a strategy used by companies, primarily in the pharmaceutical industry, to extend the life of a patent beyond its original expiration date. This practice can lead to the prolonged exclusivity of a product, delaying generic competition and potentially keeping prices higher for consumers. While the concept of evergreening has supporters who argue it

fosters continuous innovation, it also has critics who believe it hampers competition and limits access to affordable products.

Examples of Evergreening Strategies:

• Minor Modifications: Changing the formulation of a drug (e.g., from a tablet to a gel) or altering its dosage.
• New Uses: Patenting a new use for an existing product.
• Combination Patents: Combining an existing drug with another substance and filing a new patent.
• Dosage Changes: Altering the dosage form or release mechanism, such as moving from a standard release to an extended-release format.

How Does Evergreening Work?

Evergreening works by filing additional patents related to the original patent. This allows patent holders to extend the life of their inventions and protect them from competitors for longer periods of time. The process typically involves filing multiple follow-up patents that build off of the original patent in order to provide further protection for the invention. The goal is usually to ensure that there are no loopholes that competitors can use to bypass the original patent and create a competing product or service without infringing on it.

In India, patents are given out for 20 years after annual fees are paid. Once the patent period for an invention is over, it goes into the public domain, which means that any company, firm, or person can make, sell, or import it. But sometimes the patent holders, which are usually pharmaceutical companies, try to keep their monopoly on the invention even after the patent expires. They do this by filing a new patent on minor modifications to the original invention so that no other company can make or sell the invention.

Indian Patent Act and Evergreening

• The fundamental tenet of our nation’s patent law is that a patent can only be  issued  for  an  invention  that  is  both  novel  and  useful. Patenting incremental advances, sometimes known as “Evergreening,” is prohibited by Section 3(d) of India’s patent legislation.

• According to The Patents Act of 1970’s Section 3(d), “the mere discovery of a new form of a known substance or the discovery of any new property or new use for a known substance or of the use of a known process, machine, or apparatus is not patentable” unless the known process produces a new product or uses at least one new reactant.

Indian Patents Act, 1970

• This primary statute for India’s patenting system went into effect in 1972. It took the place of the Indian Patents and Designs Act of 1911.
  • The Patents (Amendment) Act of 2005 revised the Act by extending product patents to all disciplines of technology, including food, medicines, chemicals, and microbes.
  • The laws relating to Exclusive Marketing Rights (EMRs) have been deleted as a result of the modification, and a clause allowing the award of compulsory licenses has been established.
  • Pre-grant and post-grant objection provisions have also been implemented.

Patents (Amendment) Rules, 2021

Certain amendments were made in 2021 and a new set of rules was added. The changes were as follows.

LOWER PATENT FEES FOR EDUCATIONAL INSTITUTIONS

• Educational institutions conduct a wide range of research activities in which professors, teachers, and students develop new technologies that must be patented to be commercialized.
  • When filing for patents, innovators must apply in the name of institutions, which must pay costs for large applicants, which are quite high and so act as a disincentive.
  • To encourage greater participation by educational institutions, the Patents (Amendment) Rules, 2021 decreased the official fees charged by them in respect of several acts under the Patents Rules, 2003.
  • All educational institutions are now eligible for the 80% fee reduction for patent                                            filing                               and                               prosecution. Previously, this benefit was available to all government-owned recognized educational institutions.

EXPANSION OF THE EXPEDITED EXAMINING SYSTEM

• The fastest-issued patent is one that was granted 41 days after the request was filed. This Accelerated Examination system capability was initially available for patent applications filed by startups.
  • SMEs (Small and Medium Businesses), Female applicants, Government Departments, Institutions created by a Central, Provincial, or State Act, Government Corporations, an Institutions completely or largely sponsored by the Government, and applicants under the Patents Prosecution Highway are now included.
  • The Patent Prosecution Highway (PPH) is a collection of activities designed to speed up patent prosecution by sharing information among patent offices.

Benefits of Evergreening Patents

• Extended life of patents: It provides increased protection for inventions over an extended period of time. This is especially beneficial for companies who have invested heavily in research and development and want to protect their investments from competitors as long as possible.
  • Maintain profitability: Evergreening can also help companies maintain market share by preventing competitors from entering the market with similar products or services.
  • Lawful protection: Evergreening can also provide other legal benefits such as increased damages in infringement cases or a decrease in licensing fees due to increased protection.

Drawbacks of Evergreening Patents

• Expensive procedure: Evergreening can be an expensive process since each additional patent requires significant legal fees and research costs.
  • Promotes unfair competition: Filing too many follow-up patents may lead to overcrowded markets which can make it difficult for new entrants into a particular area or industry since they will have difficulty competing with established players who have secured numerous patents on various

aspects of a product or service they offer. overly broad interpretations of existing patents may lead to litigation if a company’s competitor feels that they are infringing on their intellectual property rights even though they are not technically breaking any laws or regulations.

• Costly Litigation: Evergreening patents can lead to lengthy and costly legal battles between patent holders and competitors. These legal disputes can drain resources and divert funds away from research and development.
  • Monopolistic Practices: Evergreening patents can create monopolies, where a single company has exclusive control over the production and sale of a product. This can lead to high prices, reduced competition, and limited consumer choice.

The Novartis case: Why does the Indian judiciary discourage the Evergreening of Patents?

The recent ruling by India’s Supreme Court on the Novartis case has brought attention to the issue of Evergreening of patents. Novartis, a Swiss drug company, sought to obtain a patent for a new version of its cancer drug Gleevec, claiming that it was more effective in fighting leukemia. However, India’s patent law, specifically Section 3(d) of the Patents Act of 1970, prohibits Evergreening by preventing the grant of patents for minor modifications of existing patents.

Novartis challenged the validity of Section 3(d) in court, arguing that it breached international agreements such as the TRIPS (Trade-Related Aspects of Intellectual Property Rights) agreement and Article 14 of the Indian Constitution. The case went through various stages, including the Madras High Court and the Intellectual Property Appellate Board, before reaching the Supreme Court of India. The two-judge bench of the Supreme Court rejected Novartis’ appeal, stating that there was no proven newness in their patent application after a thorough comparison with the existing patent, and thus no new patent could be granted to prevent Evergreening.

The Supreme Court’s ruling has been hailed as a godsend for individuals who cannot afford life-saving treatments due to exorbitant costs charged by pharmaceutical companies. Evergreening allows existing patent holders to

make minor changes to their patented drugs and claim them as new inventions, thus extending their market monopoly. This practice is often seen as a way to avoid investing in expensive research and development (R&D) for genuinely new drugs after the patent expires. R&D for existing drugs costs significantly less, around 10% of the expense required for developing a completely new drug. However, this approach also carries risks, as seen with recent failures in clinical trials of new drugs, such as with COVID-19 vaccinations.

The Supreme Court’s ruling against the evergreening of patents is a significant step in preventing the abuse of patent monopolies and promoting genuine innovation in the pharmaceutical industry. It upholds the intent of the Patent Law of 1970, which aims to ensure that patents are granted only for truly novel and non-obvious inventions, and not for minor tweaks to existing patented products. This decision has far-reaching implications, as it helps protect access to affordable medicines for those in need, encourages genuine innovation, and safeguards the public interest in the field of healthcare

CONCLUSION

Patent Evergreening remains a controversial topic. While companies argue that it enables them to fund ongoing research and make incremental improvements, the practice often results in delayed competition and higher costs for consumers. A balanced approach, ensuring both innovation incentives and public access to affordable medicines, is crucial. Policymakers around the world continue to grapple with this issue, seeking to find a regulatory framework that adequately protects the interests of both innovators and the public.