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India denies revoking Roche cancer drug patent

India on Monday denied revoking additional patents related to Roche Holding's breast cancer drug Herceptin, saying the Swiss pharma failed to follow legal procedures so the applications lapsed.

India denies revoking Roche cancer drug patent
Roche headquarters in Basel. Photo: Roche

India granted Herceptin a patent in April 2007 but said the company failed to protect its intellectual property rights for three other patents related to the best-selling drug.

The Kolkata Patent Office said Roche, which still holds an Indian patent on its main Herceptin invention, failed to turn up for hearings for the additional patents and filed incorrect paperwork.

 "Before the patent controllers issued their decisions, the applicants (Roche) were given due opportunity of being heard but the applicants have chosen not to attend," the office said in a statement.

The Kolkata Patent Office objected to Roche's patent problems, reported at the weekend, being portrayed by foreign media as the latest in a string of intellectual property setbacks for multinational pharmaceutical firms in India's $13-billion drug market.

The patent office said in the case of Roche, it was following "due course of the principle of natural justice, gave the applicant the opportunity of being heard and then only finally disposed of the matter".

The Herceptin additional patents had "not been revoked" but the request for them was treated as "withdrawn" due to failure to follow prescribed steps, the patent office said.

The government does not normally comment at such length on patent issues but it has been under fire from the international drug industry and the United States over its series of rejections of patents accepted in other nations.

The country has been smarting from accusations it fails to uphold intellectual property rights – charges it strongly denies.

India's patent laws are, however, tougher than those in many other countries as part of its attempt to make medicines more affordable for its vast poor population.

It insists drugs must stand the "test of innovation" to be granted patents and refuses to allow so-called "evergreening" – the awarding of a patent for a small improvement to an existing medicine to extend the patent's shelf life.

Once drugs go off patent, they can be sold much more  cheaply.

India, known as the "pharmacy to the world", has a huge generics industry that turns out cheaper copycat versions of life-saving branded drugs for poor patients in developing nations.

Roche spokesman Daniel Grotzky told AFP that the company could "confirm that the Assistant Controller of Patents at the Kolkata Patent Office has refused" Herceptin the additional patents.

"We are now considering the further course of action," he said in an email, adding he could not immediately comment on the Indian account of events.

Roche's drug, Herceptin, has become one of its most successful medicines, blocking the action of a protein that spurs tumour growth.

"The applicant may explore further legal possibilities, as they so desire," the Kolkata Patent Office said in its statement late Monday, without elaborating.

The Roche controversy comes after the Intellectual Property Appellate Board in India last week revoked a local patent granted to Britain's GlaxoSmithKline for breast cancer drug Tykerb, calling it an incremental improvement on anearlier drug.

The Roche patents were rejected for procedural problems rather than for intellectual property reasons.

Western drug-makers are seeking to win a larger part of India's rapidly expanding drugs market to compensate for slowing sales in advanced markets.

India earlier did not grant drug patents but changed the law in 2005 to allow them as part of a World Trade Organization agreement.

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ROCHE

Swiss-American antibody drug ‘effective at preventing Covid infection’

US biotech firm Regeneron and its Swiss partner Roche unveiled promising clinical trial results Monday indicating that an antibody treatment used to treat Covid-19 patients also helps prevent infections.

Swiss-American antibody drug 'effective at preventing Covid infection'
Photo: Fabrice COFFRINI / AFP

The results of the Phase 3 trial showed that the combination of the antibodies casirivimab and imdevimab dramatically reduced the risk of symptomatic infection among people living with Covid-19 patients, Roche said in a statement.

The trial entailed injecting 1,505 people not infected with the SARS-CoV-2 virus but living in households with people carrying the virus with the Regeneron antibody cocktail or a placebo.

READ MORE: Why are vaccination appointments still vacant in Zurich?

The trial, which was conducted in cooperation with the National Institute of Allergy and Infectious Diseases, showed that those who received the antibody cocktail saw their risk of symptomatic infection reduced by 81 percent, the companies said.

It also indicated that those treated with casirivimab and imdevimab who did experience symptomatic infection on average saw their symptoms clear within one week — far faster than the three-week average for those who received the placebo.

In a separate part of the study, 204 people who had recently tested positive for Covid-19 but showed no symptoms received either a dose of the antibody cocktail or a placebo.

Those who received the cocktail saw their risk of developing symptoms reduced by 31 percent compared to the placebo group, the companies said.

“Today’s data confirm the potential dual value of casirivimab and imdevimab to reduce household Covid-19 infections and to decrease the disease burden in those who do become infected, when given as a subcutaneous option,” Levi Garraway, Roche’s chief medical officer said in a statement.

“Although vaccinations are increasing globally, there remains a critical unmet need worldwide to prevent infections and provide immediate protection from Covid-19 between close contacts,” he said.

EXPLAINED: How Switzerland is speeding up its vaccination programme

Regeneron president and chief scientist George Yancopoulos agreed, pointing out that in the United States alone, 60,000 people are being diagnosed with Covid-19 every day.

The antibody cocktail “may help provide immediate protection to unvaccinated people who are exposed to the virus”, he said in a statement, adding that it could also potentially “provide ongoing protection for immunocompromised patients who may not respond well to vaccines”.

Regeneron said it would present the data to the US Food and Drug Administration and request it clear the Covid antibody cocktail for use as a preventative treatment.

The companies said they would share the new data with health regulators worldwide.

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