In-house counsel from European pharma innovators say Nordic countries and the Netherlands have the best regulatory systems to help prevent against second medical use patent infringement.
These countries stand in contrast to the UK where generic companies are obliged to carve out the protected indication from their label and leaflet in what is known as ‘skinny labelling’. While this method protects generic drug manufacturers from directly infringing the product, pharma innovators say this is not enough to keep their medicines safe from infringement.
Innovators point to Denmark and Norway as possible solutions. In these countries, doctors are allowed to write prescriptions noting the patient’s indication instead of the international nonproprietary name number or drug molecule. Pharmacists can then fill the prescription with the patent-protected product instead of the generic substitute.
“Denmark has the perfect solution because, on prescriptions, every patient’s electronic prescription is denoted with the indication for which the medication is being prescribed,” says the assistant general counsel at a European pharma innovator company.
“Denmark is a very pro-IP country; it is very high-tech and innovative. Their medical system is the same, and very socialised, so that – quite unusually compared to other countries – the prescription includes the indication for which the drug is prescribed.”
She says that allowing the prescription to be written in an efficient way with the indication clearly marked is key to protecting the second medical use patent for a given indication.
“So if the medicine is approved for neuropathic pain, the doctor will write what they are prescribing,” she says.
The senior patent counsel for a Swiss pharma innovator tells Patent Strategy that an ideal way to protect second medical use would involve a regulatory system that differentiates between indications, and that the current system in the UK is set up in a way that makes it difficult for generic companies to respect the on-label patent.
“In Norway there are prescriptions for non-hospital medicines that use coding. The coding is used by the pharmacist and in the Norwegian system you inform the authorities of your protection – you are encouraged to do this – and this is taken into account,” he says.
“This is a step up from Denmark,” he argues. “In Norway you don’t have the indication on the prescription, so from the confidentiality perspective this is better because you have a code. But in other countries the information isn’t there for confidentiality reasons and then typically you get the prescription for the generic name.”
The Netherlands provides another option by giving drug makers protection that is more thorough. The country’s Supreme Court ruled in Merck Sharpe & Dome v Teva (2017) that a generic drug manufacturer can infringe a patent if they deliberately give the off-patented drug to medical professionals who have no licence to administer the patented indication. Simply having a skinny label is not enough to ensure against infringement.
The assistant managing counsel of a European pharma innovator says the Dutch have a better system than in the UK because they take a much broader view of infringement.
“The problem with the UK is that they have three different court decisions and they are not consistent. The Dutch look if they would prescribe the medication for a second use or if it in any way, shape or form could be used for a second medical use.
“They look at the intentions of the generic company and what the physicians would think. This is good for patients because it incentivises research,” he says.
Forget getting skinnyThe proposed Unified Patent Court (UPC) could offer harmonisation across Europe on how to enforce second medical use patents. Even though innovators would risk huge losses if the courts ruled against their core patents, rulings could offer the advantage of granting clarity to generic companies on how they can best avoid infringement.
The assistant managing counsel says: “At this point in time we have varied case law in Europe. Clearly if you have the UPC there will be an opportunity to get the position of second medical use settled. If the ruling went the right way, if they gave protected power, I would say that would be good for patients and general healthcare.
“My expectation is the courts would perform very well, and as a result of that pharma companies would change their attitude and see good decisions, and see it as a good court to litigate in.”
Although the UPC could offer harmonised legal guidance, it has no power to change the prescribing system in any country. The assistant general counsel says that while she would welcome a favourable court ruling, she is sceptical it would do much to protect against infringement unless the prescription laws across Europe are changed.
“The thing about enforcement is that how you get on very much depends on the national environment. The UPC won’t change prescribing and dispensing. If you had a good judgment they can rule whether or not the patent is valid, but how you enforce that is very much dependent on local characteristics,” she says.
“You have very different prescribing and reimbursement conventions and practices and rulings ranging from Denmark to other countries. They all have very different practices.”
Conducting research on secondary indications for already-approved medications has several advantages for pharma companies. For one, the innovators already know the medication is safe and do not have to run the safety trials they would otherwise have to for a newly-invented molecule.
But bringing a medication to market for a second medical use can still cost companies millions of dollars in research. Exploring a product that is off-patent can be a difficult decision for innovators if they are not sure whether they will see a return on investment.
“There’s nothing wrong in theory with second medical use claims; the EPO is very good at granting them, and that’s well established law. The issue is enforcing them,” says the assistant general counsel.
“In theory the idea is that there are a number of medicines out there where there are suggestions that they could be used to treat other medicines. It is because you know they are safe that you have a leg up getting them approved. The issue is that you still need to do clinical trials, which of course still cost a lot of money and may fail.”
The head of patent affairs for a European innovator and generic company tells Patent Strategy it is an absolute certainty that drug makers would research secondary indications more if they felt their inventions would receive adequate protection.
“For second medical use it is very unclear what the risks are; we cannot guarantee a return on our investment, and that is a burden for us and people who need this drug. It would be great if these patients could be helped, but if you spend $10 million there needs to be a kind of insurance that you can get this back. This stops investors from investing,” he says.
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