- Brendan Shaw
Goodbye to Gila: 2020 patent expiries and the product cycle of life
I admit that I sometimes get a bit nostalgic when I look through the lists of medicines that are set to lose patent expiry.
This year's list of medicines that are expected to lose patent protection in 2020 is no exception.
It reminds me of the policy and pricing arguments that accompanied some of these medicines when they first became available to patients years ago.
Maybe it shows my age more than anything else.
I’ve spent years of my life sitting around committee tables, looking at spreadsheets, talking to companies, speaking at public forums, doing media interviews and copping abuse from people over some of these medicines.
I confess that to see them now lose patent protection and potentially become generics makes me come over all wistful, like watching your kids grow up and leave home.
The new, young medicines have all grown up and gone out on their own.
But back to the economics ……
Patents and technology development
The classic pattern of technological development in many industries, including life sciences, is that new technologies get developed, they get commercialised and come to the market with patent protection.
Patent protection doesn't mean that the owner of the patent 'owns' the technology, but it does mean they have the say on who can commercialise it.
It provides the person, company or laboratory who developed the technology exclusive rights to make a commercial return from the technology.
Once the patent expires the technology essentially becomes a public good that others can use and exploit.
Pharmaceuticals receive at least 20 years of patent protection in recognition that it typically takes 10-15 years to develop a medicine from when it first is discovered in the lab to when it is first used in patients.
Its the product life cycle where new technologies are often initially expensive, expand through growth and maturity before being overtaken by newer, better technologies.
If you're really into this stuff you can read about Vernon's product life cycle theory or even Kondratiev's and Schumpeter's work on long waves and technological innovation theory.
The pattern you see in industries as diverse as vacuum cleaners, electronics and computers you also see in pharmaceuticals and life sciences.
Waves of biotech innovation
Source: Fernald, K. 2015. The Waves of Biotechnological Innovation, Erasmus Research Institute of Management, p. 13, https://core.ac.uk/reader/43308028, accessed 13/2/2020.
What’s new is old …. again
And this year is no exception.
Depending on which country you're in, 2020 will see the start of patent expiry of several important medicines that once upon a time were expensive, new-fangled treatments but will soon become run-of-the-mill, cheaper medicines that are just accepted as the norm.
Pharmaceuticals and biologics with patents expiring in 2020
Source: Shawview Consulting table. Data: Dearment, A. 2020. “These drug patents are expected to expire in 2020”, MedCity News, 31 January, https://medcitynews.com/2020/01/these-drugs-have-patents-expected-to-expire-in-2020-and-some-will-face-generic-competitors/, accessed 13/2/2020. Note: Cosentyx (secukinumab) excluded because could not be corroborated independently.
Medicines that once upon a time came to market in a flurry of expectation, scientific amazement, argument and sometimes controversy will this year start to become, well …. boring.
While soon to be boring, when they were launched there were often arguments about their cost, about whether patients had access to them, about whether their safety profile justified their listing and about whether budgets could afford them.
Sound familiar .... ?
And now many of these medicines are likely to become cheap, old generics and biosimilars that are just taken for granted the same as other old medicines like statins for cholesterol and AIIRAs for blood pressure before them.
This year’s patent expiries
A review of the list of 2020 patent expiries finds some interesting stories behind some of them.
Exenatide– sold as Bydureon by AstraZeneca. Used to manage diabetes, exenatide is a synthetic version of a substance discovered in the saliva of the Gila Monster which inhabits the deserts of south-western United States and north-western Mexico. A great story about the scientific discovery of new medicines by looking in nature, this formerly breakthrough scientific research will start to see its patents expire allowing others to manufacture it.
Memantine - originally developed by Eli Lilly in the 1960s as an anti-diabetic medicine but proving ineffective in lowering blood sugar levels, it was later discovered to help relieve some symptoms of Alzheimer's Disease. While sold by various companies through its history as a treatment for symptoms, memantine doesn't cure the disease. It was a medicine that sometimes got caught up in policy arguments about value to the payer versus value to the patient and is a reminder that we still have a long way to go in this disease to find a real cure.
Ranibizumab– marketed as Lucentis by Novartis who developed it, this is a treatment for wet macular degeneration, a condition that leads to blindness in millions of people. Ranibizumab was accompanied by arguments about its price relative with alternative treatments with studies showing varying results . Many a discussion was had with health officials over its cost but it is expected to soon to become a generic.
Varenicline – developed by Pfizer and marketed under the Chantix/Champix brands, this was ground breaking smoking cessation treatment to help people stop smoking. The medicine wasn’t without some controversy, due to its alleged side effects, but was deemed safe and helped millions of people kick the habit with the obvious health benefits.
A range of leading cancer therapies – there are several innovative, biologic therapies that are game changers in cancer treatment in the list for this year. Many of them were also the subject of hours of argument and criticism as part of the ‘cancer drugs are too expensive’ debate that has only gained momentum in recent years. But medicines such as axitinib to treat kidney cancer, dasatinib to treat leukaemia and lapatinib to treat breast cancer are all expected to start losing their patent protection this year.
There are more medicines on the list each with their own story of how they got here, how they benefited patients and how the community argued and fought about their price and value.
Now their patents will start to expire and see their price fall in many cases - perhaps precipitously.
The product cycle of life
While there are times when the process produces bad examples of inequity, inefficiency and mistreatment that need addressing, ultimately it does good by developing medical technologies for the world to use.
The fact that today we have thousands of new medicines developed over the last century or so to treat many diseases is testament to that.
How we pay for these and how we judge what’s good value is a whole other debate that will continue in the future as more new breakthrough treatments become available to the market.
But it is worth stopping for a moment and remembering that these new-fangled, expensive treatments we argue about today do become cheap commodity medicines one day.
And this generation's new treatments were developed out of the profits earned from previous generations' older medicines that are now genericised.
Cheap, old, commodity medicines that no one thinks of as breakthrough anymore.
Such is the product cycle of life in life sciences.