Comparative Obviousness

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  • 05/01/2007
The Associated Press reports that. “In a unanimous ruling, the justices said a federal appeals court has gone too far in embracing a standard that addresses one of the most basic issues in patent law: whether a claimed invention is obvious and therefore unworthy of patent protection.”

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, “The 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.”

Adjustable gas pedals are one thing. 21st century medicines are something else entirely – something else with important implications for the future of the public health.

And it’s not good news.

Here’s the rub – what’s “real innovation?” What does “obvious” mean? And what does it mean when one considers the concept of pharmaceutical incremental innovation.

All of a sudden it’s not so obvious.

Let’s face it; there are precious few “Eureka!” 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 that’s how health care progress is made – not through Hollywood-style “Aha!” moments so popular with politicians and pundits. Obvious? Hardly.

The reason the high court’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 don’t recognize the concept of incremental innovation as “obvious” – as progress worthy of patent protection – why should we pay for it?
Indeed, why even pursue it? Yikes.

And what’s the alternative -- Jamie Love’s concept of replacing pharmaceutical patents with a “prize” 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 “prize” model has been used in the past – in the old Soviet Union. It didn’t work. The Soviet experience was characterized by low levels of monetary compensation and poor innovative performance. The US experience isn’t much better. The federal government paid Robert Goddard (“the father of American rocketry”) $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. Goddard’s patent reached the level of “obvious” innovation. But we'll leave the alternative history lesson for another day.

Now consider the fact that Mr. Love’s idea is going to be introduced in federal legislation by the new Socialist Senator from Ben & Jerry’s, Bernie Sanders. Frighteningly, not so fantastical after all.

As Joe DiMasi (Tufts University) and Henry Grabowski (Duke University) presciently observed in 2004, “The main beneficiaries in the short-term would be private insurers and public sector purchaser of pharmaceuticals … 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."

Sound familiar?

To again quote DiMasi and Grabowski, “The dynamic benefits created by patents on pharmaceuticals can, and almost surely do, swamp in significance their short-run inefficiencies.”

Obvious? Obviously not.

Center for Medicine in the Public Interest is a nonprofit, non-partisan organization promoting innovative solutions that advance medical progress, reduce health disparities, extend life and make health care more affordable, preventive and patient-centered. CMPI also provides the public, policymakers and the media a reliable source of independent scientific analysis on issues ranging from personalized medicine, food and drug safety, health care reform and comparative effectiveness.

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