CRE Problem 6

UG VI Semester
Law of IPR
Date of CRE: 3rd April, 2024
Date of Release of CRE Problem:28th March, 2024

During the COVID-19 pandemic, several drug manufacturers engaged in pharmaceutical

drug innovation. The existing drugs used for treatment of other indications also came to use
in the treatment of COVID-19 Symptoms. One such drug was Baricitinib, which was initially
used for treating rheumatoid arthritis (RA) in adults whose disease was not well controlled by
tumor necrosis factor (TNF) inhibitors. It acted as an inhibitor of Janus kinase (JAK),
blocking the subtypes JAK1 and JAK2. The said drug also served as a useful drug for treating
COVID-19 Patients.
Baricitinib has been used in combination with Remdesivir to effectively treat Covid-19
patients. Baricitinib inhibits the intracellular signalling pathway of cytokines such as IL-2,
IL-6, IL-10, interferon-γ, and granulocyte macrophage colony-stimulating factor, thereby
improving the lymphocyte count and preventing entry of the coronavirus into the cell.
However, the drug was in extensive demand during the second wave of COVID-19 pandemic
in the year 2022. The drug was protected under a patent granted in India to Mreck Sharp &
Dohme Corporation (a US based multinational pharmaceutical company). The patent was
granted on 1st December, 2021 and was due to expire only in 2035. The commercialisation
rights for the same were transferred to AbbVie Inc. (another US Based pharmaceutical
company) through an “exclusive license arrangement”, with a liberty to further sub-license
the rights.
Due to shortage of drug supply and increased demand of the drug from March, 2022, the
Indian generic pharmaceutical companies explored opportunity to manufacture the drug. For
the same, Cipla Ltd. approached AbbVie Inc. on 5 th April, 2022, seeking the grant of a
Voluntary license for the drug, permitting Cipla to manufacture the drug in India through an
email communication. However, AbbVie Inc. refused the same through their email
communication made on 10th April, 2022.
Considering the backdrop of the second wave of COVID in India and the unmet demand for
the drug, Cipla Ltd. makes an application for the grant of a Compulsory License on 20 th
April, 2022 before the Controller of Patents. Cipla Ltd. pleaded that:
 the drug was in immediate requirement.
 The demand for the drug had surpassed the manufacturing capability of the patentee/
exclusive licensee in India.
 Due to shortage in drug supply, the drug is available at inflated/higher prices.
 The pandemic has posed a national emergency implicit from the total number of
deaths reported per day.
 The Exclusive licensee has refused to offer a voluntary license of mutually agreed
terms.
Upon reviewing the application, the Controller of Patents rejects the application through a
speaking order holding that the company AbbVie Inc. had already granted voluntary
licenses to two other generic Indian Manufacturers, namely – Sun Pharma Ltd. and
Alkem Laboratories on 15th April, 2022. Thus, a third license shall not be required until
the two licensees fail in meeting the market demand.

Cipla Ltd. prefers an appeal against the Assistant Controller of Patents before the High
Court against the decision of the Assistant Controller refusing the grant of Compulsory
license claiming the circumstances of “national emergency” in India.

Argue on behalf of Cipla (Appellant) and Assistant Controller of Patents (Respondent),

respectively.