Legal Swords Sharpened In Kenya-Manchester Cancer Drug Rights Dispute

NAIROBI, Kenya — A dispute between Kenyan researchers and the University of Manchester, United Kingdom, over ownership of a cancer discovered after successful clinical trials in Kenya finally seems headed to courts.

Lawyers working for Kenyatta National Hospital (KNH) in Kenya and the University of Manchester (UoM) patent office attorney are now handling the dispute after both parties failed to agree on what claims the Kenyans had in the discovery of the drug lopimune, said to have high efficacy in treatment of cervical cancer.

The dispute arose in February after the university partnered with New Zealand pharmaceutical company Douglas Pharmaceuticals to register intellectual property rights to the invention in exclusion of the Kenyan researchers who include four medical scientists, the KNH and the University of Nairobi despite their role in trials conducted in Kenya.

The New Zealand drugs firm has been granted rights to manufacture the drug which after trials of more than 800 women in Kenya in 2014 was found to have efficacy of up 90 percent in fighting cervical cancer cells.

At the heart of the breakthrough is British couple Ian and Lynne Hampson, both researchers at UoM, who led the invention and will benefit from the discovery in IP terms, and their Kenyan doctorate student Innocent Maranga the lead Kenyan partner during the trials, but who is not sharing any rights with the couple.

The university has registered ownership of the patent, awarding the couple rights to the invention, while Douglas Pharmaceuticals will enjoy exclusive rights to produce the drug, a combination between lopinavir and ritonavir, two drugs widely used to treat HIV.

“The IP is the sole property of the University of Manchester in essence, the Kenyan team tested an invention already conceived by the Manchester team and the patent covers that invention,” the university said in response to a query from Intellectual Property Watch.

“Under patent law, only those individuals that conceived the invention can be named as inventors and this was confirmed by our patent attorney when we filed the patent,” the UK university asserted.

In 2014, when the news of the breakthrough was announced to the media in Nairobi, Kenyan professor Peter Gichangi who participated in the trials had exuded confidence that the local team and institutions were part of the whole discovery, and would be enjoined in any rights registered.

Further, he had claimed that documents existed to show that the Kenyan university plus KNH, the largest public hospital in the East African region, were part of the discovery.

“We are in this together with the UK. In fact, KNH and the University of Nairobi are enjoined patenting the treatment, we have documentation with us today to prove this,” he was quoted saying at the time.

The row as reported in Kenyan media, for example here.

But it would appear that no such document ever existed and if it did, then it not address or enjoin the local partners into IP rights.

According Joel Ochieng, a biotechnology researcher at the University of Nairobi, a memorandum of understanding (MOU) must be signed before any such joint initiative is undertaken, spelling out the rights, privileges and roles of parties participating in such a project.

He told Intellectual Property Watch that a second more detailed document anchored on the MOU should be drafted by legal teams, detailing such things as dispute resolutions mechanisms to be used in the event of a misunderstanding arising.

“It is also important to note that for any party to be enjoined in rights emanating from research breakthrough, they must be part of the entire process right from drafting of a proposal, design of project as well as fundraising for the same,” said Ochieng.

It is not clear if Maranga, a student of the Hampsons at the time, and who requested the couple to conduct trials at KNH where he worked as a gynaecologist and colleagues, had signed any such documents with the university.

When reached for comment, the doctor refused to delve into the matter, only referring us to the hospital’s legal department which he said is now handling the matter.

“This issue is being handled by the hospital (KNH) legal team and therefore not at liberty to respond, I’ve therefore hereby copied in the legal team,” he wrote in an indication that he feared prejudicing the legal process.

For now, it seems the Kenyan researchers and the country will not share in the windfall that will come from the invention irrespective of the roles played, save for a mention in the peer-reviewed journal, PLOS One, where the four of them are mentioned.

That aside, the Kenyans had registered a trust called the Cancer Research Trust Kenya, which the study recognised as one of its funding agents.

“It is noteworthy, however, that there is a related peer-reviewed publication whereby the Kenyan triallists are named,” says UoM.

“Publications can recognise the broader contribution of both inventors and triallists. You will note that there are many contributors from both Kenyan and British Universities whose broader contribution is not deemed inventive and cannot be recognised within the patent,” UoM further stated.

There is no role envisaged in the specific research agreement for the Kenyan entities, the UK university asserts, adding that that there were only two parties, – the University of Manchester and Douglas Pharmaceuticals.

The university added that the Kenyans only tested an invention conceived by UoM and therefore had no legitimate claim to any rights.

Further and final trials on the therapy are due to be conducted later this year this time involving a bigger sample of 5,000 women in a country to be picked by the initiators.