Novartis has changed a lot recently. The Switzerland-based pharmaceutical company announced this year that it has formed a five-year artificial intelligence alliance with Microsoft to help improve its drug development process.
The business’s CEO, Vas Narasimhan, has also overhauled the company’s culture to establish an ‘unbossed’ environment that encourages innovation from the bottom up and promotes openness, trust and transparency throughout the business.
It seems that Novartis is fast becoming a radical force for technological and managerial progress; but it is by no means just the boardroom-level business leaders who are driving this change.
Galit Gonen-Cohen, who moved from Teva in 2017 to become Novartis’s global head of pharma IP, has been an integral figure in encouraging Novartis patent attorneys to think outside the box when formulating protection strategies – particularly when it comes to gene and cell therapies.
“Cell and gene therapeutics development represents a hugely exciting area for Novartis,” she says. “But when it comes to IP in this space, we need to think outside the box and consider new approaches because it is not always possible to protect cell and gene therapies in the same ways as small molecule products or even biologics.”
“The question then is always: ‘what is the best form of protection for these products?’ Patents are just one form of protection and can be very specific, so it becomes a matter of asking whether we pursue platform patents, for example, or take a different route and look at regulatory exclusivities. that might open up the way for similar products.
"If we are looking at orphan indications and the competition comes more from other originators, specific patents might not be relevant. But this may change as we start to develop cell and gene therapies for broader indications, which will probably attract biosimilars."
She adds that as well as reforming its own approaches to IP, Novartis is working to drive reform in the IP system itself. “Legal systems must adapt to new technologies such as gene therapies and make sure there are robust incentives in place that will continue to enable their development.
“This is high on my and the company's IP agenda and it is one of the most exciting things I have worked towards in my career.”
Gonen-Cohen is also driving use of digital IP tools in her department to help support the business’s patent strategy. These tools, she says, are useful for communicating otherwise-complicated IP-related information to business leaders and getting them on board with what the IP department wants to achieve.
“If you share information that business stakeholders can understand, it becomes easier to manage IP affairs because you have the support of the partners behind you.”
She tells Patent Strategy that she is also keenly aware of the challenges surrounding access to medicine, and reveals the insights she has gained from working in the generics and innovator sectors.
How has your experience been moving from Teva to Novartis?
Well, first, it is important to note that the industry is changing and there is no longer such a clear line between generics and innovators. Traditional innovators are producing biosimilars and more and more companies, including Novartis and Sandoz, have both generic and innovator arms. There is also an increasing amount of innovator v innovator litigation in the industry now.
When I was at Teva, I was responsible for the generics side of the portfolio but also the innovative products. My time was split between the two and so the move to Novartis, an innovator business, was not as big a change as some might think.
The models, strategies and concerns of innovative and generics drug businesses are very different, though, and I think working in both made me more rounded as a lawyer. I would highly recommend that other lawyers get experience in both sides if they have a chance.
I also say that because, when we look at the industry, there is a need to get a good balance between the needs of generics and innovators, because both are important players in sustaining the viability of the healthcare system.
Innovators lead the way in innovation and open the way for future generics. If innovators stop developing new drugs, generic companies will not have new products to launch in the future. So without innovation, the generic industry cannot function. Understanding both sides, I think, has enabled me to take a position that is fair and perhaps more trustworthy.
Apart from the work, what do you like about Novartis?
The new culture. Not everyone knows this, but Novartis is on a cultural journey right now, and it has been a huge privilege to experience such a massive cultural change in a company that I am a leader in.
Novartis is moving from a hierarchical culture to one that is more inspired, curious and empowered. The CEO, Vas Narasimhan, defined this as an 'unbossed' culture, where innovation can come up from the bottom.
The change is effected and cascaded from the top down. We are encouraged to work towards these values every day in some way. Trust and transparency are key values in the organisation; even when it comes to HR matters, which traditionally have been very confidential, you can see this change bringing more transparency.
In my opinion, the change has been implemented with great kindness, caring and humility, and it all comes from the CEO, and is embraced, developed and practiced through the company. We are all on board with the process and we think it is amazing. There is a bright future for the company and for IP and innovation because the changes ensure that the R&D pipeline is maintained.
Why did you get into IP in the first place?
First I did a pharmacy degree, which is a full degree of four years plus a year working, at the Hebrew University, Jerusalem. My parents own a community pharmacy in Israel and their dream was that I would one day work in the pharmacy with them.
Then I decided to study law as well, which was another five years. So after 10 years of university, I had the right background for IP, which is the perfect mix of science and law.
I love the strategy side of things, and pharma in particular because it is an interesting industry that gives a lot to society. And I have big personal pride in working at a company that every day has new stories of changing someone's life. There is nothing more rewarding.
What else is high on your agenda?
Drug exclusivity and pricing, which has come to the forefront of the access to medicines debate recently. It is a very important topic for us.
We have to make sure we work with stakeholders and policy makers to maintain our ability to invent and bring innovative products to the market, while helping governments address the inefficiencies and budget challenges that the healthcare system faces.
Beyond that, we must make sure that we do our day jobs properly to guarantee freedom to operate for all products and maintain sufficient exclusivity for truly innovative inventions. That exclusivity is important because we must sustain our business model, which enables us to invent, develop and deliver innovative medicines.
It is also important, as part of these day-to-day roles, to work with complementary systems that provide regulatory data protection or exclusivity. These systems offer additional forms of protection for products in situations where patents are not optimal.
We try and ensure the right exclusivities are available across the world, which we use to sustain an essentially global R&D system. In some markets, we are actively trying to get regulatory data protection recognised to help sustain our business to benefit society and patients.
Could you expand on the challenges surrounding IP protection for gene and cell therapies?
Yes. One of the challenges, more with cell therapy than gene therapy, is “compounding” which is called “hospital exemption” in Europe for these products. What do you do if a hospital prepares cell therapies itself for its own patients? Is this an exemption from patent law? It might not require a marketing authorisation in certain circumstances so it could be done before expiry of regulatory data protection.
It is important that we find a good balance here. On the one side, there is the matter of respecting patient safety and IP. On the other, we need to look at access to these very innovative, curative and often life-saving medicines.
This balance also has to be considered on a national level. Each country has different prescribing and dispensing practices and different national laws, and that factor makes this process even more complicated.
Another issue when it comes to cell and gene therapies is orphan exclusivity, when these products are used to treat rare (orphan) diseases. Orphan exclusivity in Europe generally incentivises research in rare diseases by providing protection against other products which are the same or similar from obtaining a marketing authorisation in the same indication.
If you develop a gene therapy and a competitor is developing something similar, in the same orphan indication, it becomes a race between the two companies to get their marketing authorisation first. If one therapy gets its marketing authorisation granted before the other, the other may be blocked because of orphan exclusivity, which is a real loss for the company because of all the research that has gone into it, and is hard to predict in advance and plan for.
There is also the matter of how you define “sameness” or 'similarity' in this context, because these products are not chemicals, where the understanding of this concept is better developed.
And then there are the new market dynamics we are seeing in this space. The area of gene and cell therapies does not follow the traditional innovator versus generics competitive model. At this point, it is more about innovator against innovator in this space – as we also see in the biologics space. It is a new era of IP in many ways.
