Justice Anthony Kennedy wrote.
"Granting patent protection to advances that would occur in the ordinary course without real innovation retards progress and may ... deprive prior inventions of their value."
The case in front of the high court was KSR International Co. v. Teleflex Inc. The issue -- a patent for adjustable gas pedals.
The issue, needless to say, transcends this particular innovation.
To again quote the AP, â€œThe legal test at issue in the Teleflex lawsuit has been criticized by the Bush administration as leading to an unwarranted extension of patent protection to claimed inventions that are obvious. Critics of the test say it results in less competition and stifles innovation.â€
Adjustable gas pedals are one thing. 21st century medicines are something else entirely â€“ something else with important implications for the future of the public health.
And itâ€™s not good news.
Hereâ€™s the rub â€“ whatâ€™s â€œreal innovation?â€ What does â€œobviousâ€ mean? And what does it mean when one considers the concept of pharmaceutical incremental innovation.
All of a sudden itâ€™s not so obvious.
Letâ€™s face it; there are precious few â€œEureka!â€ occasions in healthcare. Progress is made step-by-step, one incremental innovation at a time. And those incremental innovations require extensive research and are expensive. But, boy, are the important. Why? Because thatâ€™s how health care progress is made â€“ not through Hollywood-style â€œAha!â€ moments so popular with politicians and pundits. Obvious? Hardly.
The reason the high courtâ€™s ruling is so profoundly disturbing to the future of pharmaceutical innovation is because now it becomes not a leap but a small step to mindless support for healthcare technology assessment aka evidence-based medicine aka comparative effectiveness. After all, if we donâ€™t recognize the concept of incremental innovation as â€œobviousâ€ â€“ as progress worthy of patent protection â€“ why should we pay for it?
Indeed, why even pursue it? Yikes.
And whatâ€™s the alternative -- Jamie Loveâ€™s concept of replacing pharmaceutical patents with a â€œprizeâ€ system wherein the government pays an innovator a lump sum amount for its innovation (based on some measurement of the newfangledness) that is then placed in the public domain?
And what might such a measure be? Most likely comparative effectiveness information that misuses and misrepresents data derived from RCTs.
The â€œprizeâ€ model has been used in the past â€“ in the old Soviet Union. It didnâ€™t work. The Soviet experience was characterized by low levels of monetary compensation and poor innovative performance. The US experience isnâ€™t much better. The federal government paid Robert Goddard (â€œthe father of American rocketryâ€) $1 million as compensation for his basic liquid rocket patents. A fair price? Not when you consider that during the remaining life of those patents, US expenditures on liquid-propelled rockets amounted to around $10 billion.
One wonders if the new Supreme Court ruling would allow that Dr. Goddardâ€™s patent reached the level of â€œobviousâ€ innovation. But we'll leave the alternative history lesson for another day.
Now consider the fact that Mr. Loveâ€™s idea is going to be introduced in federal legislation by the new Socialist Senator from Ben & Jerryâ€™s, Bernie Sanders. Frighteningly, not so fantastical after all.
As Joe DiMasi (Tufts University) and Henry Grabowski (Duke University) presciently observed in 2004, â€œThe main beneficiaries in the short-term would be private insurers and public sector purchaser of pharmaceuticals â€¦ Governments and insurers are focused myopically on managing health care costs. They are not likely to be strong advocates for funding new drug development that can increase individual quality of life and productivity."
To again quote DiMasi and Grabowski, â€œThe dynamic benefits created by patents on pharmaceuticals can, and almost surely do, swamp in significance their short-run inefficiencies.â€
Obvious? Obviously not.