Indian Patent Office Rejects AbbVie Patents for Rinvoq and Maviret, Clearing Path for Generic Competition
核心洞察
The Indian Patent Office rejected AbbVie (搜索)'s patent applications for two blockbuster drugs, Rinvoq (upadacitinib) for immunology conditions and Maviret for Hepatitis C (搜索), citing lack of inventive step and abandonment respectively.
The Rinvoq patent rejection under Section 3(d) of the Indian Patent Act prevents "evergreening" of pharmaceutical patents, similar to the landmark Novartis Glivec case in 2013.
These decisions will enable affordable generic versions to enter the Indian market, benefiting millions of patients with rheumatoid arthritis (搜索), autoimmune diseases (搜索), and Hepatitis C (搜索).
The Indian Patent Office has delivered two significant blows to pharmaceutical giant AbbVie (搜索), rejecting patent applications for its blockbuster immunology drug Rinvoq and Hepatitis C (搜索) treatment Maviret. These decisions will pave the way for affordable generic versions to enter the domestic market, potentially benefiting millions of patients across India.
Rinvoq Patent Rejected Under Anti-Evergreening Provision
In a recent hearing, the Delhi Patent Office refused AbbVie (搜索)'s patent application for Rinvoq (upadacitinib), determining that the claimed invention was "obvious" and lacked inventive step. The rejection was made under Section 3(d) of the Indian Patent Act, a crucial safeguard that bars patents on new forms of known substances unless they demonstrate significant enhancement in therapeutic efficacy.
The application, filed in 2012, faced pre-grant opposition from generic drug makers including MSN Labs (搜索) and Natco, with hearings stretching over nearly a year. Rinvoq, used for treating rheumatoid arthritis (搜索) and several autoimmune diseases (搜索), represents AbbVie (搜索)'s second best-selling drug behind Skyrizi, generating approximately $10 billion in sales globally.
S Majumdar from law firm S Majumdar & Co, who represented Natco, stated: "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."
Maviret Application Abandoned After Opposition
In a separate case, the Indian Patent Office refused to grant a secondary patent for AbbVie (搜索)'s Hepatitis C (搜索) drug combination glecaprevir/pibrentasvir, marketed globally as Maviret. The order, dated May 7, 2026, came after AbbVie failed to contest pre-grant oppositions and subsequently informed the Patent Office of its intention to abandon the application.
The patent application, filed in 2018, sought protection for a specific bilayer tablet formulation of the pan-genotypic Hepatitis C (搜索) treatment. This secondary patent, if granted, would have extended AbbVie (搜索)'s patent monopoly by five years beyond the original patent protection.
Opposition Groups Challenge Patent Applications
Both the Third World Network (TWN) and Delhi Network of Positive People filed pre-grant oppositions against the Maviret application under Section 25(1) of the Patents Act. Despite being formally notified of both oppositions in November 2025, AbbVie (搜索) chose not to file any reply or evidence in response.
When a hearing was scheduled for May 4, 2026, AbbVie (搜索)'s agent informed the Patent Office that the company wished to formally abandon the application and would not attend. The Patent Office subsequently refused the application under Section 15 of the Act, finding that AbbVie had failed to address the raised objections.
Implications for Patient Access
KM Gopakumar, senior researcher and legal advisor at Third World Network, emphasized the significance of the Maviret decision: "This decision is significant as refusal of the patent application means that AbbVie (搜索) has not been able to obtain secondary patent for the composition of glecaprevir/pibrentasvir, which if granted would have extended AbbVie's patent monopoly by five years."
The rejection follows the precedent set by the landmark 2013 case where Swiss firm Novartis lost its patent on blockbuster cancer drug Glivec under the same Section 3(d) provision, which aims at preventing "evergreening" of pharmaceutical patents.
Market Impact and Treatment Access
Hepatitis C (搜索) affects an estimated 35 million people in India and can lead to cirrhosis and liver cancer if left untreated. While effective treatments exist, affordability remains a decisive factor in patient access to these therapies.
AbbVie (搜索) had previously entered into a voluntary licensing agreement with the Medicines Patent Pool (MPP) for Maviret, but India was excluded as a sales territory. Under this arrangement, Indian manufacturers were permitted to produce the generic medicine but were barred from selling it to Indian patients.
Sources indicate that AbbVie (搜索) has yet to launch Rinvoq in India and has sought regulatory approval to introduce it for atopic dermatitis (搜索) treatment. The patent rejections now clear the path for generic manufacturers to develop and market affordable versions of both treatments in the Indian market.