Context: Current pre-grant opposition provisions in the Patents Act allow anyone to file objections against patent grants before they are finalized.

• Proposed changes in draft patent amendment rules, 2023 aim to alter the process and criteria for pre-grant opposition.

Draft Patent Amendment Rules: Key takeaways

• Financial Burden: A notable modification is the introduction of variable fees for filing pre-grant oppositions, potentially placing a substantial financial burden on civil society organizations and patient groups.

• Maintainability Decision: Of particular concern is the provision granting the controller the authority to determine the maintainability of representation by individuals or civil society organizations seeking to file pre-grant oppositions.

Impact on Public Health Safeguards

• Key Public Health Safeguard: Pre-grant opposition serves as a crucial public health safeguard against practices like patent evergreening and the granting of unwarranted monopolies. It ensures continued accessibility to quality-assured and affordable generic medicines.

• Lobbying for Weakened Safeguards: The draft amendment rules have raised concerns that they may undermine these safeguards and potentially extend patent protection on frivolous grounds. Big pharmaceutical companies have long lobbied to remove critical safeguards from India’s patent laws.

Proposed Changes and Concerns

• Draft rules introduce variable fees for opposition.

• Grant controller gains the power to decide opposition maintainability.

• Weakened safeguards against patent evergreening, and higher drug prices.

• Lack of clear guidelines for maintainability decisions.

• Proposed fees pose financial challenges for smaller groups.

Champions Against Evergreening

• Nandita Venkatesh (India), Phumeza Tisile (South Africa) thwarted Johnson & Johnson’s Bedaquiline patent extension.

• Both individuals, TB survivors themselves, filed the pre-grant opposition along with the Network of Maharashtra people living with HIV (NMP+), with support from Médecins Sans Frontières.

About Patents

• Patents are government-issued exclusive rights that grant inventors or assignees the sole authority to utilize, make, sell, or license their invention for a limited period, typically 20 years.

• Patents are granted for new and useful inventions and are intended to encourage innovation by providing legal protection and exclusive rights to inventors.

• Granted by: Controller General of Patents, Designs and Trade Marks (CGPDTM) under the DPIIT (Ministry of Commerce & Industry)

• Patents in India are governed by “The Patent Act 1970,” which was amended in 2005 to comply with TRIPS (Trade-Related Aspects of Intellectual Property Rights).

Criteria for issuing patents in India include

• Novelty: The invention must be new and not previously published or publicly known or used in India.

• Non-Obviousness: It should involve an inventive step, representing a technical advancement compared to existing knowledge, and not obvious to a person skilled in the relevant field.

• Industrial Use: The invention should be capable of industrial application.

Unique Provision and Its Importance

• Pre-grant opposition is distinct in the Indian Patent Act.

• Section 25(1) of the Indian Patent Act allows any person to file a pre-grant opposition against a patent application before it is granted.

• Prevents unjust patent protection extensions.

• Vital for affordable generic drug access.

Failed Evergreening Attempts Stopped by Opposition

• Patents for Tenofovir disoproxil fumarate (TDF), Boehringer Ingelheim’s pediatric form of the anti-AIDS drug Nevirapine, Glivec (imatinib mesylate), Zidovudine/Lamivudine (first-line HIV medicines), and Lopinavir/Ritonavir (second-line HIV medicines).

Indian Patents Act, 1970

• Primary legislation governing patents in India.

• Novelty and Non-Obviousness: Patents require new and non-obvious ideas.

• Industrial Application: Inventions must be usable in industry.

• Exclusions: Some inventions, like those related to atomic energy, are not patentable.

• Term of Patent: Patents last for 20 years from the filing date.

• Opposition: Third parties can oppose a patent within a set time frame.

• Compulsory Licensing: Under specific conditions, third parties can use a patented invention.

Evergreening

• Evergreening is the practice of companies filing for an extension of a patent with minor process or product modifications just before the original patent expires at the end of 20 years.

• Patents offer their owners market exclusivity for a limited period of time–For medicines, this exclusivity should last as long as the primary patent — which relates to the active pharmaceutical ingredient (API) of the medicine is in effect, typically 20 years.

• The end of patent exclusivity will reduce the drug prices drastically.

• The threat of this steep fall in profits urges pharmaceutical companies to find new ways to postpone their exclusivity.

• Companies use a process known as secondary patenting or evergreening to keep generic companies out of the market

• Secondary patenting or evergreening is achieved by seeking extra patents on modifications of the original drug: new forms of release, new dosages, new combinations or new forms.

Indian Patent Act and evergreening

• The basic principle of the Patent Law in our country is that a patent is granted only for an invention which must be new and useful.

• Section 3(d) of India’s patent law forbids patenting of incremental innovations—or evergreening.

• Section 3(d) of The Patents Act, 1970 –“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 unless such known process results in a new product or employs at least one new reactant is not patentable”.

• This clause was also upheld by the Supreme Court in 2013 when it turned down Swiss drugmaker Novartis’ plea for patenting its cancer drug Glivec.

• Section 3(d) necessitates a demonstration of improvement in its therapeutic efficacy. The provision also bars patents for new uses and new properties of known substances.

• In the case of Novartis, Glivec was just a new form of a known substance, imatinib, and therefore the patent for Glivec was rejected under section 3(d) of the Patents Act.

• Section 2(1)(ja) -the product in question must feature a technical advance over what came before that’s not obvious to a skilled person.

• Section 3(e) ensures that patents for combinations of known substances are allowed only if there is synergistic effect.

• Section 3(i) ensures that no exclusivity can be claimed over methods of treatment.

Potential Ramifications

• Global Implications: The proposed changes could disproportionately impact patients in India and the global South, who heavily rely on India’s production of affordable generic drugs and vaccines.

• Threat to Access: Weakening pre-grant opposition may impede access to essential medicines, putting patients at risk and affecting the generic drug industry.

• Concerns Raised: Experts emphasize that any erosion of this provision within the Indian Patent Act would be a significant change, jeopardizing patients’ ability to access affordable medications and enabling pharmaceutical corporations to exert greater control over the market.

Conclusion

• The draft patent amendment rules have sparked concerns that they may undermine essential safeguards, potentially benefiting pharmaceutical giants while posing a threat to patients’ access to affordable medicines.

• The pivotal role of pre-grant opposition in safeguarding public health interests is at risk, raising questions about the impact on patients in India and beyond.