Prescription reform needed to avoid second medical use infringement

Secret

Generic and innovator in-house lawyers agree that serious reform to the way medications are prescribed is needed to avoid patent infringement on secondary uses, and that they will need to work together to make that change

Fixing the problem of second medical use patent infringement would involve a major reform of medical prescription systems, say in-house counsel from generics and innovator drug companies.

Under most health care systems, pharmacists are unaware of patients’ medical indications and fill prescriptions with the cheapest available drug. In many situations, the pharmacist has no way of knowing if the medication they are giving is protected by a second medical use patent.

Requiring doctors to write the trademarked name of a drug is one way sources suggest to avoid patent infringement.

“The best way to fix this problem is by creating more sophisticated ways to write prescriptions,” says the IP director of a UK innovator drug company.

He points out that second medical use infringement isn’t a problem in every jurisdiction because the doctor can relay a request using the brand name rather than the international non-proprietary name (INN).

The chief patent counsel for an innovator drug company in the UK adds that Denmark may be a good example of how the prescription system could be changed to avoid infringement.

“There is willingness on both the generic and originator sides to avoid infringement but the way to get around this problem is fully integrated systems like Denmark where one system contains all the health indications and prescriptions of the patient,” he says.

With all the patient’s information stored in a central database and shared between pharmacies and doctors, a pharmacist could fill a prescription without infringing a patent.

Senior legal counsel for a UK generics company tells Patent Strategy: “Innovators have asked the generic companies to write to physicians, pharmacists and the NHS in the UK to make it clear that the product is still protected by the patent and therefore cannot be prescribed for that specific indication.”

He says despite letters written by judges and pharma marketing executives advising doctors to write the full trademarked name of a drug, many doctors are reluctant to do so out of habit or principle.

With a growing number of medications used for second indications, he believes the pressure to honour innovators’ patents will eventually result in the UK updating its system so doctors can write more detailed prescriptions using the trademarked name for protected second indications and the INN name for non-protected primary uses.

 “My view is that by the time a drug launches in 2022, the NHS will be updated so that infringement of second medical use patents isn’t an issue anymore,” he explains.

The chief patent counsel for an innovator drug company argues the consequence of the intentional or accidental infringement of second medical use patents is less innovation in the pharmaceutical industry.

“This infringement disincentives the repurposing of medications,” he explains. “We have all these drugs on the shelves but who knows what they can do? Who is going to do the research, go through the regulatory process, do the clinical trials, and invest billions of dollars only to find there is no market because the product is going to be cross labelled?”

Judge a product by its label

Part of the approval process for any generic medication includes submitting product information to the relevant regulatory institution that is identical to that of the originator, including information on dosage and indication.

In the recent Walter-Lambert v Generics case, the UK Supreme Court attempted to grapple with the question of how far should generic companies be expected to go to avoid infringing a second medical use patent.

But generics companies that comply with the court’s decisions not to include the second medical use in their leaflets say they are still getting a push from innovators to do more to avoid infringement.

“Quite honestly, a generic or biosimilar company only wants his product used for the approved indications on the label,” says the global head of patents for a generic drug company.

“Sometimes what we can actually do to affect how a drug is prescribed is quite limited. This is more of a regulatory and proscribing issue, and depending on the jurisdiction there is little we can do to change things.”

For some generics companies, placing the burden on them to inform doctors and pharmacists of their products off-patented indications creates too much uncertainty and the potential risk of infringement.

The patent manager for a generics drug company in Turkey says: “It’s a burden to let the doctors know what kind of drugs can be used for second illnesses.”

He adds that even if generic companies are proactively informing doctors not to prescribe patented drugs, convincing them can be difficult because doctors naturally want to use all available means of treatment to help their patients.

“It is not the generics companies’ problem to make sure pharmacists are prescribing the correct drug. We aren’t going to run campaigns on what is and is not allowed,” he says.

The UK Supreme Court rejected the “objective intention” test in Walter-Lambert v Generics set out by the Court of Appeal that would have obligated generics companies to actively inform doctors and pharmacists to only prescribe their medications for the intended off-patent use.

In a split decision, the court proposed an outward presentation test, otherwise known as ‘skinny labelling’, that would only require generics companies to properly label their medication in the leaflet for the drug’s specified purposes to avoid infringement.

Common knowledge

Should innovator and generics companies work together to inform doctors how to prescribe medication, there is still little they can do to control doctors’ or pharmacists’ behaviour.

 “You can’t sue a doctor for prescribing off label,” says the senior patent counsel for a Swedish innovator drug company. “A doctor never infringes, and that’s a weakness of the second medical use patent if everybody knows you can cure several illnesses with one drug.

“Everybody knows you can treat acne with birth control.”

In some jurisdictions, such as Sweden, pharmacists are required by law always to prescribe the cheapest drug. In these instances, correctly labelling the medication provides little assurance that the second medical use patent won’t be infringed.

The IP director for a UK pharma innovator suggests innovators and generics companies work together to make sure all products are labelled accurately and ensure that more sophisticated prescribing systems are established.

“To a large extent, generics companies are cooperating, but there are a few still flooding the market.  More rulings to provide better clarity would help to be sure each side labels their products fairly, but the best way to reform the system is more sophistication writing prescriptions.”

Combatting second medical use infringement is a problem for the time being. Many second uses are as well known as baking soda’s ability to absorb smell or brandy’s use as a disinfectant.

Generics and innovators will need to put their differences aside to reform prescription systems and raise the value of second medical use patents.