Planned reforms to patenting ‘out of sync with global approach’, says US pharmaceutical giant
The multinational, which employs 3,500 people in Ireland, is one of Ireland’s biggest exporters of pharmaceuticals due to the success of its weight-loss drug Zepbound and diabetes treatment Mounjaro.
Last year it announced a $1bn (€860m) expansion of its manufacturing site in Limerick, in order to increase production of the active ingredients for an Alzheimer’s disease treatment.
Records released under the Freedom of Information Act show that its global vice-president of IP strategy sought a meeting with the department last May to make the case that planned EU changes around intellectual property (IP) are “out of sync with the global approach”.
“The process as currently set out would undermine patent rights, as it has the potential to allow generic [medicines] to market when patent protection applies,” Eli Lilly said, according to a minute of the meeting.
The EU’s current regime for allowing generic medicines into the market has been criticised because member states have been interpreting it in different ways.
Attempts are under way – known as the Article 85 process – to allow manufacturers to test, trial, prepare and store generic medicines while patents are still in force, so they are ready for market entry immediately after a patent expires.
A strong and predictable intellectual property framework is essential to create new medicines for patients
The idea is to promote the EU as a base for the research and development of new medicines.
Pharma companies argue that investment into treatments for difficult diseases such as Alzheimer’s relies on strong and predictable IP regimes. Expanding the exemptions for generic medicines too widely could undermine this.
At its meeting with the Department of Enterprise, including senior official John Newham, Eli Lily said it is “pivotal” to ensure that the revised regulations “leave no room for diverging interpretations in different EU member states, and provide clear, unequivocal provisions removing any grey area or legal uncertainty that may allow the use of ‘patent linkage’ to delay competition”.
Patent linkage is the process of connecting the granting of market approval for a generic medicine with the status of the patent for the original product.
Asked whether they still have concerns about the planned changes, an Eli Lilly spokesperson said: “A strong and predictable intellectual property framework is essential to create new medicines for patients. In order to be a globally competitive hub for the biopharmaceutical industry and attract future investments into research and development, Europe needs to strengthen the current IP framework through the general pharmaceutical legislation package, not reduce it and add conditions.”
Eli Lilly also raised the question of Ireland joining the United Patent Court (UPC), which is to be the final arbiter in disputes about IP. A constitutional referendum is needed, and was due to be held in June 2024, but was postponed.
Eli Lilly said it was “overall in favour” of Ireland joining, “but would prefer a wait-and-see approach of about two years”.
It said there’s a fear the UPC’s case load will lead to a fragmentation of cases, with preliminary hearings about EU-wide injunctions possibly being overturned in litigation cases between innovators.
source