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28 November 2014Big Pharma

University of Manchester IP: walk the line

When it comes to developing and marketing drugs, it is fair to say universities are in a precarious position. Unlike pharmaceutical and biotechnology companies, universities are responsible to research councils and their taxpayer masters to be open about their research.

This can put a strain on protecting research with IP. By having to facilitate public access to the work being done, universities face the challenge of maintaining a balance between transparency and IP protection.

But things have moved beyond basic government demands that research be published and put in the public domain. Now, says Dr Rich Ferrie, head of the University of Manchester IP (UMIP), “research councils that are funding this research want to see that translated into some societal benefit”.

A commitment to knowledge transfer is embodied in the university’s history of scientific achievements. An illustrious list lays claim to splitting the atom in 1917 and building the first computer in 1948. It boasts 25 Nobel Prize winners, with the most recent in 2010, and it was the academic home for mathematicians Ludwig Wittgenstein and Alan Turing.

In 2004, the University of Manchester Institute of Science and Technology merged with the Victoria University to create the University of Manchester, the second largest university in the UK by student population (ignoring the Open University). In the merger it outlined its three priorities as research, teaching, and knowledge transfer, which are “all worthy academic pursuits”, notes Ferrie.

The university employs 3,500 academic staff, half of whom work in the bio/medical research departments. “We’re really fortunate,” Ferrie says, “because around half of the research spend is in the life sciences field”.

So what is UMIP’s role? Ferrie states that 400-plus inventions come from the university every year, but “we typically only file patents on 25 of those”. “We have very strict criteria,” he adds.

Spinning out

Research can go down two routes: IP can be directly licensed with companies in industry, or academics can opt to form a ‘spin-out’ company. Spin-out companies allow academics to take their research further and commercialise their IP with a degree of independence, but with the university remaining as a stakeholder.

Although this is rare, Ferrie says, he expects between four and eight companies to be formed by enthusiastic academics every year. “Because the university owns IP that has been conceived by its academic researchers, the university assigns that IP to the new company in exchange for owning equity in that new company.

“Essentially, you end up with three shareholders in the company: the university, the academic founder and the incoming manager. Then, typically, what happens is that a business plan is drafted and we look to raise finance from an investor on securing that finance and the investor becomes an owner of equity in the company,” he explains.

“The idea is then to develop the technology or the IP further within the context of the company,” he adds.

An example of a spin-out company is C4X which, Ferrie says, was listed on the London Stock Exchange in October. Founded by resident academics Andrew Almond and Charles Blundell, C4X provides a “way of discovering new therapeutic entities and new drugs. It is a way in which you can understand how drug molecules interact in real time, with their intended biological targets”.

Phagenesis is another spin-out company, founded by academic Shahid Hamdy. It produces a medical device that “helps people regain the ability to swallow after they have had a stroke”. The device is a “new iteration of the feeding tube, with a stimulator attached to it. That stimulator re-trains your brain to control your swallowing function”.

Ferrie says: “These really are at an arm’s length from the university. Our only real connection is by virtue of the equity. We have an incubator facility here, where those companies can take residence if that makes sense for them to do so. It allows our academics to remain within the university and still get connected to their research.”

Despite only a small portion of its inventions reaching patent stage, the university is very conscious about what information it puts out for potential investors.

“The biggest issue we have as an academic institute is one of confidentiality. Our academic researchers will see it as a normal academic duty to publish their research and we need to have a mechanism that allows us to patent or protect by other means before it is published and is no longer novel.”

One of these mechanisms is a provision in the licensing agreements that grants the university the right to audit the way a company is monetising its IP.

Ferrie says: “We have the right to audit those companies and look at what is happening with the IP and what revenues have been attributed to it. We can check the company’s books and make sure that they’re in compliance with the licensing agreements.

“Because we do that quite effectively, things don’t get to the stage where we fall out substantially,” he adds.

At the centre of this is developing an open dialogue with the companies the university is licensing its IP to. A testament to UMIP’s success at developing such relationships is that the university has so far not been involved in any IP disputes.

However, Ferrie is not aware of any patent infringement lawsuits filed by UK universities. It is perhaps odd, given that in the US litigation is far more common, that the UK has not had its own case similar to Stanford v Roche. The California-based university filed a patent infringement lawsuit against the pharmaceutical company over patents covering diagnostic tests for HIV, in 2009. Ferrie, however, is unsure why such disputes happen across the Atlantic and not in the UK.

"we need to have a mechanism that allows us to patent or protect by other means before it is published and is no longer novel.”

The US is a very important place for UMIP to register its IP. “It is impossible to not contemplate filing life sciences IP in the US,” Ferrie says. “Most of the major markets are international ones and we always file in the UK first, but typically we then go international after that.”

UMIP also casts its eye beyond US borders. Ferrie says the BRIC (Brazil, Russia, India and China) countries offer additional avenues of commercial exploitation. He stresses that its IP strategy is adaptable. “We don’t just have a one-size-fits-all strategy. We look to where the IP has the most commercial opportunity,” he says.

Research hubs

Ultimately, for Ferrie, the role of patents and trademarks within life sciences research at the university is about further integration into the pharma industry. The university is fortunate to be part of a cluster of research institutions that has the Central Manchester Healthcare Trust at its centre.

The latest product in development is the smartphone app ClinTouch, which helps people suffering from psychosis to record the occurrence of symptoms. Designed to help doctors make accurate diagnoses, the app has received funding from the Medical Research Council and a trademark application for its name has been filed. It is listed on UMIP’s portfolio page and at the time of writing it is seeking an industry partner to help commercialise the product.

ClinTouch is just the latest product in an assembly line of scientific research at the university that dates back to physicist Sir Ernest Rutherford.

But as the demands for greater public access to the research increase, so does the challenge for the “modestly sized office”, as Ferrie calls UMIP. The advantage to this modest size, however, is that Ferrie and his team are able to be more careful in selecting which research is monetised.

“This university is a long way from having a blanket around all of its IP. What we do is protect it when it makes sense and we always make sure that when we protect the IP the academic still has an opportunity to publish it.”

As Wittgenstein noted, “knowledge is in the end based on acknowledgement”. Whether that acknowledgement results in a patent application or direct societal impact, the challenge for Ferrie is to make sure the development of such research maintains the balance between protection and transparency.