Roche won’t contest Hetero Drug’s tocilizumab copy

Roche has decided that it won’t pursue any legal dispute with manufacturers such as Hetero over patent rights against the use of tocilizumab, which Roche produces under its brand name Actemra/RoActemra. In an email statement to Mint, Roche said that its decision not to enforce patents was “tailored to the exceptional circumstances that certain (low- and middle-income) countries faced during the pandemic, and given the unprecedented surge in demand for Actemra/RoActemra worldwide."

“Following our decision to not assert any patent rights against the use of Actemra/RoActemra to treat covid-19 in low- and middle-income countries during the current pandemic, manufacturers who are ready and able to produce the medicine can do so without the delay of licensing negotiations or legal uncertainty in relation to our (Roche and Chugai) patent rights," a spokesperson for Roche told Mint.

Hetero’s EUA to manufacture a non-comparable biologic (a drug that cannot be seen as an exact copy of Roche’s brand of tocilizumab) of its drug will provide an additional option for patients and further expand access to tocilizumab.

Shortage of tocilizumab has been a problem across the world during the first and second wave of the covid-19 pandemic. In a press event earlier this month Roche chief executive officer Bill Anderson said the shortage was a global supply chain issue and yet the company has delivered 60% of its manufacturing capacity to low- and middle-income countries.

Roche’s move not to enforce its patent for this drug has also opened the doors for other manufacturers in India to develop a biosimilar version of Acetemra, according to experts. Intas, Biocon and Zydus Cadila are some of the Indian drug makers who have expertise in manufacturing such biosimilar drugs.

Roche’s decision not to enforce its patent rights coincides with ongoing negotiations at the World Trade Organization (WTO) where countries such as India and South Africa are leading an appeal to waive certain provisions of the Trade-Related Intellectual Property Rights (TRIPS) for covid-19 therapies, diagnostics and vaccines. More than 100 countries have backed the waiver proposal amid vaccine inequity and a shortage of key drugs to treat covid-19.

“The patent waiver by Roche will really benefit patients in India and other low- and middle-income countries if the price of tocilizumab is cut and Roche shares the technology so that biosimilar makers can seek WHO pre-qualification for exports in low- and middle-income countries," said Leena Menghaney, global IP adviser, MSF Access Campaign, which is the campaign for access to essential medicines undertaken by Médecins Sans Frontières, or Doctors Without Borders.

Price still remains one of the key barriers for patients to access drugs such as tocilizumab, Menghaney said. In India, one vial of tocilizumab costs between ₹45,000 and ₹60,000. Activists fear that once a high price point is set by an innovator company, the entry of a single biosimilar maker will not drastically change the pricing.

Hetero did not respond to a query by Mint on the price at which it was planning to sell its biosimilar.

Big pharma has been under pressure to share technology to expand the manufacturing of vaccines and covid-19 treatment.

Besides Roche, companies such as Eli Lilly, Merck and Gilead have shared the technology for repurposed drugs that have been used in the treatment of moderate to severe covid-19 patients. US drugmaker Gilead has shared the technology for its anti-viral drug remdesevir with 10 generic drug makers, most of them in India, while Eli Lily has decided not to enforce a patent on baricitinib, another repurposed drug for covid-19. Merck has given voluntary licences to six Indian generic makers for its antiviral drug molnupiravir.