impact Archives – THINK Magazine

To patent or not to patent?

As universities and research institutions look to protect the knowledge they develop, András Havasi questions time frames, limited resources, and associated risks.

The last decade has seen the number of patent applications worldwide grow exponentially. Today’s innovation- and knowledge-driven economy certainly has a role to play in this.

With over 21,000 European and around 8,000 US patent applications in 2018, the fields of medical technologies and pharmaceuticals—healthcare industries—are leading the pack.

Why do we need all these patents?

A patent grants its owner the right to exclude others from making, using, selling, and importing an invention for a limited time period of 20 years. What this means is market exclusivity should the invention be commercialised within this period. If the product sells, the owner will benefit financially. The moral of the story? A patent is but one early piece of the puzzle in a much longer, more arduous journey towards success.

Following a patent application, an invention usually needs years of development for it to reach its final product stage. And there are many ‘ifs’ and ‘buts’ along the way to launching a product in a market; only at this point can a patent finally start delivering the financial benefits of exclusivity.

Product development is a race against time. The longer the development phase, the shorter the effective market exclusivity a product will have, leaving less time to make a return on the development and protection costs. If this remaining time is not long enough, and the overall balance stays in the negative, the invention could turn into a financial failure.

Some industries are more challenging than others. The IT sector is infamous for its blink-and-you-miss-it evolution. The average product life cycle on software has been reduced from three–five years to six–12 months. However, more traditional sectors cannot move that quickly.

The health sector is one example. Research, development, and regulatory approval takes much longer, spanning an average of 12–13 years from a drug’s inception to it being released on the market, leaving only seven to eight years for commercial exploitation.

So the real value of a patent is the effective length of market exclusivity, factored in with the size of the market potential. Can exclusivity in the market give a stronger position and increase profits to make a sufficient return on investment? All this makes patenting risky, irrespective of the technological content—it is a business decision first and foremost.

Companies see the opportunity in this investment and are happy to take the associated risks. But why does a university bother with patents at all and what are its aims in this ‘game’?

Universities are hubs of knowledge creation and today’s economy sees the value in that. As a result, research institutions intend to use and commercialise their know-how. And patenting is an essential part of that journey.

The ultimate goal and value of a patent remains the same, however, it serves a different purpose for universities. Patents enable them to legally protect their rights to inventions they helped nurture and claim financial compensation if the invention is lucrative. At the same time, patent protection allows the researchers to freely publish their results without jeopardising the commercial exploitation of the invention. It’s a win-win situation. Researchers can advance their careers, while the university can do its best to exploit the output of their work, bolster its social impact, and eventually reinvest the benefits into its core activity: research.

At what price?

Patenting may start at a few hundred or thousand euros, but the costs can easily accumulate to tens or even hundreds of thousands over the years. However, this investment carries more risk for universities than for companies.

Risks have two main sources. Firstly, universities’ financial capabilities are usually more limited when compared to those of businesses. Secondly, universities are not the direct sellers of the invention’s eventual final product. For that, they need to find their commercial counterpart, a company that sees the invention’s value and commercial potential.

This partner needs to be someone who is ready to invest in the product’s development. This is the technology transfer process, where the invention leaves the university and enters the industry. This is the greatest challenge for university inventions. Again, here the issue of time raises its head. The process of finding suitable commercial partners further shortens the effective period of market exclusivity.

A unique strategy is clearly needed here. Time and cost are top priorities. All potential inventions deserve a chance, but risks and potential losses need to be minimised. It is the knowledge transfer office’s duty to manage this.

We minimise risks and losses by finding (or trying to find) the sweet spot of time frames with a commercial partner, all while balancing commercial potential and realistic expectations. The answer boils down to: do we have enough time to take this to market and can we justify the cost?

Using cost-optimised patenting strategy, we can postpone the first big jump in the costs to two and a half years. After this point, the costs start increasing significantly. The rule of thumb is that about five years into a patent’s lifetime the likelihood of licensing drops to a minimum. So on a practical level, a university invention needs to be commercialised very quickly.

Maintaining a patent beyond these initial years can become unfeasible, because even the most excellent research doesn’t justify the high patenting costs if the product is not wanted by industry. And the same applies for all inventions. Even in the health sector, despite product development cycles being longer, if a product isn’t picked up patents can be a huge waste of money.

Patenting is a critical tool for research commercialisation. And universities should protect inventions and find the resources to file patent applications. However, the opportunities’ limited lifetime cannot be ignored. A university cannot fall into the trap of turning an interesting opportunity into a black hole of slowly expiring hopes. It must be diligent and level-headed, always keeping an ear on the ground for the golden goose that will make it all worth it.

#drug #research Andras Havasi commercial development exploit health impact innovation knowledge KTO market medicine patent patent application price product regulation risk social technology transfer

Beneath the Glow

In Malta, fireworks are the harbingers of summer, joy, and celebration. But news that their chemical leftovers are harming our environment and health cannot be blatantly pushed aside. How do we find the happy medium between heritage and safety? Gail Sant writes.

A child laughs with glee as she skips along a narrow rubble wall. Her mother raises an eyebrow—’Tilgħabx man-nar,’ she calls out. Translated, the saying that warns against ‘tempting fate’ also literally means ‘don’t play with fire’, ironic when one of Malta’s national pastimes is literally fire play—logħob tan-nar. Fireworks.

With around 35 known firework factories peppering Malta and Gozo, the tradition can be traced back to the Knights of St John. They used fireworks to celebrate important occasions such as the election of a new Pope or Grand Master, and so the display became rooted in our past and more recent history, evolving with time to become the complex artform that today wins Malta acclaim the world over. But there is more to the story.

Studies have shown that there’s a dark side to this flashy spectacle. Some of the chemicals used to create fireworks are harmful, and as a result, each festa leaves behind residue which may be more dangerous than we think.

To get a better idea of the situation, we interviewed two people on opposite ends of the fireworks operation: Mr Karl Rueth, a firework crafter, and Prof. Alfred Vella, an environmental chemist who has studied some of the effects fireworks leave behind after the party is over.

Fireworks and identity

Rueth is a Dingli, born and raised. Brought up in a village that celebrates one of the most widely recognised patrons on the island, the feast of St Mary, he grew up fascinated by the annual summer bonanzas. The fact that his friends and family were involved helped too. It surprised no one when he eventually picked up pyrotechnics as a pastime. It’s been three years now, and the novelty has not worn off.

‘It’s an art form. It helps you express yourself, bringing out your unique ideas’, says Rueth.

The techniques involved, from developing specific colours to altering the shape of the blast, create a myriad of opportunities for self-expression. That said, Rueth swiftly adds, there’s much more to it: ‘It’s part of our culture. And not just for the village feasts. Every activity you care to mention involves fireworks.’

Think of events like Valletta 2018 or Isle of MTV; all of them make use of these colourful bombs to add energy and charm. ‘We advertise our island with imagery of fireworks,’ Rueth notes. And yes, a lot of press related to tourism and travel to Malta features fireworks. They create spectacles, ones which tourists appreciate and enjoy, and with tourism being one of our most important economic drivers, a glowing skyline and a free show does add value to our little island beyond the sun and sand.

The issue Rueth points out himself is the one with noise. ‘Nowadays many people see fireworks as a nuisance. It’s a reality we can’t escape,’ he says, also admitting that unfortunately, there is no real solution for this. Many within the fireworks community believe the bang is as important as the colours. However, ‘it’s all about balance,’ says Rueth.

The other side of the coin

‘If I had to live through a summer where not a single bang would be heard, Malta would have truly lost a part of its identity,’ says Vella the minute we sit down to talk about the phenomenon of fireworks on the island.

Thinking back to his time living in the US, Vella laughs, remembering how it felt a little ‘too quiet’.

Much like Sunday School’s bells, a firework’s distant boom is something we’ve grown accustomed to, a background noise. However, the comfort that comes with those chimes, flashes, and bangs hasn’t blinded him to their negative side-effects.

Vella says that one of the biggest environmental impacts fireworks have is the sheer amount of dust they leave behind. This particulate matter in the air causes many health problems, including respiratory issues such as lung inflammation, while exacerbating others like asthma. Respiratory diseases account for 1 in every 10 deaths in Malta, placing them as one of our biggest killers.

Not only does this dust fall in excessive quantity, it also contains chemicals which are either toxic or which, though initially inert, become toxic once they’re burned. ‘What we were putting in those explosives was remaining around unexploded or in the form of its products,’ Vella emphasises.

Antimony, the chemical used to create a glitter effect, changes into antimony oxide, a known carcinogen, when burned in air. Heavy metals that are used to add colour to the explosion include barium. Accumulation of barium in the body can lead to muscle paralysis, gastrointestinal hemorrhage, and even death.

Finally, Vella moves on to the main player in his research—potassium perchlorate. This chemical is a key ingredient for successful blasts. His studies suggest that a significant amount of perchlorate remains unused after the explosion, settling on our island, both outdoors and indoors. His findings show that the amount of perchlorate dust found indoors is almost twice the amount of China’s indoor dust. China. The pioneering country that invented fireworks back in the ninth century is also the country that banned their use in its capital city during the 2018 new year celebrations in an attempt to fight off air pollution.

Related research has also shown that perchlorate can interfere with thyroid function. Currently, there aren’t any studies which link the two together locally, but knowing that there’s an excessive amount of this chemical all over our environment isn’t great news. ‘Why should we have to live side by side with a chemical which is totally alien to our environment?’ Vella asks.

Finding balance

Although Rueth and Vella have different ideas of what fireworks mean to them, they both agree that some sort of compromise is needed.

‘You need to understand where people are coming from’, says Rueth, adding that for some, noise pollution lasts the whole summer, not just a week. As for their chemical effects, he’s ‘sure that some harm is caused.’ However, he also believes that more research would be beneficial, helping us to understand the topic better. To him, this is not a matter of ‘us against them,’ but about finding a way to make fireworks safe and enjoyable for everyone.

On that note of safety, Vella thinks that ‘it’s high time that we control fireworks through making perchlorate a controlled chemical.’ At the moment, of the three main oxidising agents used to make fireworks, perchlorate is the only one which doesn’t require permits.

Despite bad media framing, Vella takes a moment to emphasise that he doesn’t want an outright ban on fireworks. ‘For better or for worse, it is part of who we are’.

At the end of the day, few people can deny that the visuals fireworks give us are mesmerising. But we also need to acknowledge the science. ‘Much like alcohol consumption, a little of it is probably not all that damaging. We can tolerate a small impact of fireworks because of the benefits they give us,’ says Vella. But we cannot go through life drunk. Just like everything else, moderation is key.