In a significant development for patients in India, the Indian Patent Office has refused to grant a patent to multinational pharmaceutical company AbbVie for its blockbuster immunology therapy Rinvoq (upadacitinib). This decision paves the way for affordable generic versions of the drug to enter the domestic market, potentially reducing treatment costs for patients suffering from rheumatoid arthritis and other autoimmune diseases.
Patent Rejection Details
The Delhi Patent Office, in a recent hearing, ruled that the claimed invention was "obvious" and lacked an inventive step, violating Section 3(d) of the Indian Patent Act. Legal experts confirmed this to TOI. Section 3(d) is a crucial provision in Indian patent law that prevents the patenting of new forms of known substances unless they demonstrate a significant enhancement in therapeutic efficacy. This provision is designed to curb "evergreening" of pharmaceutical patents, a practice where companies extend patent protection by making minor modifications to existing drugs.
Under Section 3(d), Swiss firm Novartis lost its patent on the cancer drug Glivec in 2013, a landmark case that reinforced India's stance on preventing evergreening. The rejection of AbbVie's patent application for Rinvoq follows a similar rationale.
Application and Opposition
AbbVie filed the patent application for Rinvoq in 2012. The application faced pre-grant opposition from generic drug manufacturers, including MSN Labs and Natco Pharma. The hearings stretched over nearly a year before the final decision was made. S. Majumdar, from the law firm S. Majumdar & Co., which represented Natco, commented: "This decision provides important clarity on core patent law concepts, particularly obviousness and technical advance - especially in situations involving common inventors between prior art and patent application - along with evergreening and extent of disclosure required to sustain a priority claim."
Significance of Rinvoq
Rinvoq (upadacitinib) is used to treat rheumatoid arthritis and several autoimmune diseases. It is AbbVie's second best-selling drug, following Skyrizi, with global sales of approximately $10 billion. Despite its commercial success, AbbVie has not yet launched Rinvoq in India. The company has sought approval from Indian regulators to introduce the drug for atopic dermatitis, but the patent rejection may impact its market strategy.
Impact on Patients and Market
The refusal of the patent is expected to benefit patients by enabling the entry of lower-cost generic versions of Rinvoq. This aligns with India's public health priorities, ensuring access to affordable medicines. The decision also reinforces the robustness of India's patent examination system in preventing unjustified monopolies on essential drugs.
Sources indicate that AbbVie is yet to launch Rinvoq in India and has sought regulatory approval for its use in atopic dermatitis. The company may face challenges in securing patent protection for the drug in the country, given the recent ruling.
