Ontario company seeks licence to make generic Johnson and Johnson COVID vaccine for developing countries

Tom Smith

Breadcrumb Trail Links News Canadian Politics Canada A compulsory licence can be granted when a company demonstrates a clear need for generic versions of patented medicine Author of the article: Ryan Tumilty Publishing date: Mar 24, 2021  •  March 25, 2021  •  4 minute read  •  14 Comments Biolyse Pharma, […]

A compulsory licence can be granted when a company demonstrates a clear need for generic versions of patented medicine

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OTTAWA — A St. Catharines, Ont., company that says it could have played a role vaccinating Canadians against COVID-19 but was passed over, now wants the federal government’s help to vaccinate the developing world.

The company is hoping to tap a rarely used regulation to obtain a compulsory licence to manufacture Johnson and Johnson’s vaccine, overriding the company’s patent in an effort to rush more doses to developing countries.

When the pandemic struck, Biolyse Pharma, a maker of generic cancer drugs, was expanding into monoclonal antibody treatments. The manufacturing process for those treatments involves bio-reactors the company says could have been repurposed.

Brigitte Kiecken, Biolyse’s president and CEO, said with the right investment, the company could have been part of the effort to make vaccines for Canadians.

“The equipment was there in the bio-reactors, and everything else, so we thought we were in a good position to bring that help forward,” she said.

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In addition to the bio-reactors, the company has a new fill and finish line sitting idle, but capable of filling 400,000 glass vials per week. It initially proposed simply being part of the final step, taking vaccines manufactured in bulk and putting them through the fill and finish line, but expanded that request last summer and proposed manufacturing vaccines at its facility as well.

Biolyse has never made a vaccine before, but it asked for $4 million from the federal government to finish the installation of the equipment and train staff, an effort Kiecken estimates would have taken six months.

The company says it would have been able to make AstraZeneca or Johnson and Johnson’s vaccine at a rate of about 20 million doses per year, but it would have needed the support of those companies and permission to use their intellectual property.

Canada anticipates having enough doses to vaccinate every Canadian by the end of September, but the developing world is not expected to be able to vaccinate everyone until at least 2022 and possibly much later.

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Kiecken said she believes with the federal money Biolyse could have helped with the effort.

“We would like to participate in the war against COVID, like a lot of other businesses, and we were in a position to offer the production of vaccines at our facility,” she said.

The federal Liberals have said repeatedly they gave information to all of the companies with vaccine purchase agreements on the manufacturing facilities available in Canada. Biolyse was contacted early in the pandemic about its capabilities but all of the major vaccine makers passed on manufacturing here and are making vaccines in Europe, India or the United States, creating barriers to Canadian deliveries.

Novavax intends to make its vaccine at the National Research Council’s facility in Montreal, but it is not expected to start producing doses there until the end of this year and its first shipments to Canada will come from abroad.

The investment at the NRC facility is part of hundreds of millions of dollars the government has invested in drug makers across the country.

Medicago, a Quebec City-based firm, will make its COVID-19 vaccine in Canada when it finishes construction on a facility, but that is not expected until next year. The first doses of the company’s vaccine, which is now in the final stage of trials, will be manufactured in the U.S.

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Having been passed over in the effort to vaccinate Canadians, Biolyse is now seeking a compulsory licence to manufacture Johnson and Johnson’s vaccine for the developing world. A compulsory licence can be granted when a company demonstrates a clear need for generic versions of patented medicine. The patent holder is paid a set licensing fee and can’t sue a firm for breaching its patent.

Biolyse sought a compulsory licence before, for the influenza drug Tamiflu during the H5N1 scare, after seven months they were halfway through the process, but the flu had largely run its course. Compulsory licences were issued to generic drug giant Apotex to send AIDS medications to Rwanda.

Since the legislation came in in the early 2000s the process has been rarely used because of the complexity. Any country receiving vaccines produced in Canada under a compulsory licence also has to bring in a compulsory licence in their country.

John Fulton, a consultant working with Biolyse, said the COVID-19 pandemic is the exact sort of health crisis that compulsory licences were designed for.

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“If you can’t use a compulsory licence now, you can’t use Canada’s access to medicines regime now, then what’s the use?”

The company has started the effort, which begins with discussions with Johnson and Johnson about a licence. If Johnson and Johnson turns down that request, then the company can ask the federal government to issue the compulsory licence.

Fulton said they’re hopeful even the threat of a compulsory licence could get the major pharmaceutical companies to consider working with Biolyse.

Even with that licence, Johnson and Johnson would not be under any obligation to help Biolyse manufacture the vaccine, it just would have no recourse to stop it under patent law.

John Power, a spokesman for Industry Minister François-Philippe Champagne, said the government is aware of the effort and is in favour of companies working together if the end result is more vaccines.

“Licensing arrangements that facilitate industry collaboration will be crucial in this regard and the government welcomes the agreements that have already been struck and encourages further collaboration to identify and use manufacturing capacity to increase the production of COVID-19 vaccines.”

Power reiterated that the government put all of the country’s bio-manufacturing facilities in front of the major vaccine makers, but they were simply too small.

“Canadian biomanufacturing assets were of a scale which was not of interest to these firms,” he said.

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