Tough road ahead for Remdesivir to win the race against COVID-19?

Overview        

In just a few weeks, Remdesivir, an anti-viral medication, has gone from a racked, unsuccessful treatment to the center of a national effort to treat patients infected with COVID-19. The Drug Controller General of India (DCGI) has given the approval to Remdesivir for "restricted emergency use" on severely ill, hospitalized, coronavirus patients amid COVID-19 pandemic.

Remdesivir is a broad-spectrum anti-viral medication developed by the US based pharmaceutical company Gilead Sciences, Inc. Remdesivir was originally developed as a general antiviral useful for 'filoviridae virus infections' and to treat Ebola virus, Marburg virus and Cueva virus. It was later tried on Ebola patients; however, the drug was ineffective for these viral contaminations.

After undergoing clinical trials on patients infected with COVID-19, Remdesivir received an emergency use approval in USA and South Korea, and full approval in Japan for individuals with extreme and severe symptoms of the COVID-19. Currently, Remdesivir's significance has developed exponentially and it is being considered as fundamental for COVID-19 patients with co-morbidities, such as, but not limited to, cancer or diabetes.

The US Food and Drug Administration (USFDA) issued a crisis use authorization for the utilization of Remdesivir to treat patients with extreme COVID-19, after a study indicated positive preliminary results. It may be noted that an emergency use approval is lower than full FDA approval. Preliminary data from a trial run by the National Institute of Allergy and Infectious Diseases (NIAID) indicated that Remdesivir had a "clear-cut, significant, positive effect in diminishing the time to recovery" in COVID-19 patients thus, improving recovery time for patients infected with COVID-19 from 15 days to 11 days.

Concerns of Cancer Patients Aid Association (CPAA)

The drug, Remdesivir enjoys negative monopoly under patent protection laws in India as the Gilead's patent application for Remdesivir filed in India in 2015 and was granted a patent on 18th February 2020. In the wake of perceiving the same, Cancer Patients Aid Association (CPAA), a charitable organization, sought for the revocation of the patent granted to Remdesivir in India to guarantee that the medication is accessible to those in need at reasonable costs and furthermore, with the intent that generic alternatives of the same are manufactured, thereby increasing the availability of the drug. On 9th April 2020, CPAA wrote to the Health Ministry and Pharma Ministry soliciting for the revocation of patent allowed to Remdesivir under Section 66 of the Patents Act, 1970 on the ground of public interest and Section 64 of the Act on the ground of non-patentability of the patented medication. CPAA made just a representation to the Health Ministry and no legal plan of action has been searched out yet.

As per the Patents Act, 1970, section 64 states that a patent, whether granted before or after the commencement of this Act, may, be revoked on a petition of any person interested or of the Central Government by the Appellate Board or on a counter-claim in a suit for infringement of the patent by the High Court on numerous grounds such as non-patentability. The request set forth by CPAA intends to set up that the patent application for Remdesivir was for a salt of a known compound, therefore inadequate with regards to patentability and prohibited by Section 3(d) of the Patents Act which states that a new form of a known substance such as salts, esters, etc., that does not result in enhanced efficacy cannot be patented. Further, the plea by CPAA claimed that the patent lacks the novelty and inventive step and the current patent has been granted for minor anticipated modifications of the compounds already disclosed in prior patent applications for compounds similar to Remdesivir which are obvious to a person skilled in the art. On these two grounds, CPAA questioned the grant of the patent.

Section 66 of the Patents Act, 1970, states that where the Central Government is of opinion that a patent or the mode in which it is exercised is mischievous to the State or generally prejudicial to the public, it may, after giving the patentee an opportunity to be heard, make a declaration to that effect in the Official Gazette and thereupon the patent shall be deemed to be revoked. Depending on the fact that the Right to Life under Article 21 of the Indian Constitution also encloses the Right to Health, CPAA concentrated on the requirement for the accessibility of Remdesivir at affordable prices and the production of generic alternatives for the same by applying for revocation of Gilead's Remdesivir on the ground of public interest.

Licensing deal

It appears that in view of the impact of the above, Gilead has signed non-exclusive voluntary licensing agreements with generic pharmaceutical manufacturers based in Egypt, India and Pakistan i.e. Cipla Ltd.; Dr. Reddy's Laboratories Ltd.; Eva Pharma; Ferozsons Laboratories; Hetero Labs Ltd.; Jubilant Lifesciences; Mylan; Syngene, a Biocon company; and Zydus Cadila Healthcare Ltd. for manufacturing and distributing Remdesivir at affordable prices in 127 countries. These licenses are royalty-free until the World Health Organization (WHO) declares the end of the public health emergency regarding COVID-19, or until a medication other than Remdesivir or a vaccine is approved to treat or prevent COVID-19, whichever is earlier.

As per the recent reports, Cipla has launched Remdesivir under the brand name Cipremi (Remdesivir lyophilised powder for injection 100 mg) which has been approved for adult and paediatric patients hospitalized with suspected/laboratory confirmed COVID-19 infection, in particular, for those on oxygen support. Similarly, Hetero Pharma has launched the generic version of Remdesivir under the brand name Covifor (100 mg injectable vials) for treating COVID-19 infection.

In view of the above, the most important drug in the current scenario of COVID-19 pandemic has become the need of the hour after facing numerous challenges and all that the common man of India desires is a solution to deal with the pandemic in an affordable way.