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Sandoz: EU Stakeholders Must Stand Up For Proper Competition Behavior

Company’s Legal Head Also Calls For EPO TO Further Leverage Capabilities

Executive Summary

Sandoz and Teva were among representatives discussing intellectual property and other legal challenges during the first day of Medicines for Europe’s 2022 annual conference. The European Commission’s Directorate-General for Competition director, Paul Csiszár, added his insight on legal issues.

Addressing intellectual property challenges, providing greater incentives for industry, and continuing to promote education were areas named by Sandoz as those needing closer monitoring and improvement to foster greater competition for biosimilars during off-patent industry association Medicines for Europe’s 2022 annual conference.

Addressing delegates to the conference in Sitges, Barcelona, last week, Sandoz’s general counsel and global legal head, Ingrid Sollerer, observed that while the future “looks bright and there are a lot of opportunities out there for us,” issues in the three areas were holding back the potential of biosimilars.

“We see the originators trying to protect their molecules through very complex patent landscapes,” Sollerer commented, speaking during a dedicated intellectual property session.

“What we have seen so far,” she acknowledged, “is that we do have a very strong opposition system at the European Patent Office. So, we would really encourage the EPO to further leverage their capabilities and even strengthen their opposition proceedings to give us a quicker way to get clarity around patents.”

It was “super important,” Sollerer insisted, that “when it comes to disputes and this probably cannot be avoided, to get really quick solutions also from the local courts. We need highly-skilled, well-staffed working court systems to get the clarity that we need in this industry,” she underlined.

In a broader swipe at legal issues for industry, Sandoz and other industry players were “seeing and experiencing unfair behavior on the market. Be it through misleading promotion, be it through false claims, we see this over and over again, including with anticompetitive activities like predatory pricing, exclusionary contracting.”

“We try to take action,” Sollerer said, “but it’s challenging because sometimes it’s really hard to get the right evidence, it’s costly and time consuming. We don’t get to a conclusion very quickly. I think this is a very strong call to action for all of us playing in the market…for stakeholders to stand up for the kind of behavior we want to see in the market.”

On this point, the European Commission’s Directorate-General for Competition director, Paul Csiszár, had commented beforehand, “I think we are doing our best in DG Comp. We have a number of people, a number of resources. We can take half-a-dozen cases max at a given time and consider them…and I think no extra resources are expected. So, if you think, and I think you do think, that there are systemic problems here: competition law cannot be a silver bullet.”

“We need to find tailwinds. The circle has to be bigger,” Csiszár noted. “Politicians have to understand people who are in charge of budgets [and politicians need to be told] ‘Hey, something can be done and should be done. You’re going to be a hero if you fix this’.”

Industry was enthusiastic with certain efforts to tackle IP issues, Sollerer commented, in particular the supplementary protection certificate manufacturing waiver that became operational on 1 July, allowing companies to start manufacturing in Europe for export and stockpiling for day-one launch in Europe. (Also see "Industry Prepares For Advent Of SPC Manufacturing Waiver" - Generics Bulletin, 28 Jun, 2019.)

“Definitely for us [the SPC waiver] is going in the right direction. However,” Sollerer maintained, “looking at biosimilars, the six-month term for stockpiling in Europe is not long enough. That’s a nice start but we would really like to see more.”

Teva: Tenders Create Imbalance

The increasing use of tender systems for procurement across Europe was a further challenge for Sandoz, Sollerer added, and was proving a something of a disincentive for manufacturers.

“As long as tenders are focusing on the lowest price, and the ‘winner takes it all,’ that’s a challenge. That’s not an incentive to invest in the long and costly process of biosimilar development.”

Teva’s general counsel for Europe, Bibianne Bon, concurred. “Combined with strict price regulation and austerity measures, they create an imbalance,” she insisted “All measures are at cutting costs. Governments want lower, lower, lower prices. But that comes at a cost.”

“We need to move away from cost-based models to value-based models,” Bon underlined. And “to ensure the right R&D investments, we need to have a strong, balanced IP framework in Europe.”

Sollerer also rallied against biosimilar misinformation. “This is sometimes getting supported by other players in the market. We need to do even more to educate stakeholders, particularly in therapeutic areas where there is more reluctance or hesitation to switch to biosimilars,” she stated.

While these challenges remained, Sollerer was also positive about the impact of biosimilar competition to date. “Here in Europe, [we have seen] €6bn ($6.2bn) savings from biosimilars, which I think is a really very impressive number.”

Moreover, Sollerer commented, biosimilars were a “huge engine for driving innovation in terms of being a booster for the next generation of biologics. We really energize the market to go to the next level. And by driving competition what we’ve also seen is that the service level for patients has improved so that the value that comes from treatments increases.”

Looking to the future, “there is a lot coming our way. When we look at losses of exclusivity, in the next ten years, we’re expecting more than 100 biologic molecules losing exclusivity, which is a huge opportunity.”

“If you look back at what we have achieved with relatively fewer biologics…you can probably imagine the opportunities that we have ahead of us in the next ten years…and how we can close the equity gaps that we still see across Europe,” Sollerer suggested.

Adrian van den Hoven, the director general for Medicines for Europe, who moderated the IP panel session, asked Sollerer if there was a business case for a century of molecules?

“I think there should be,” Sollerer responded. “There is a lot we still need to do to make sure it stays attractive and is doable from a business perspective. There are still actions we can take…but we need to solve the challenges that are out there.”

 

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