The Public Policy

Is Chunky Monkey an Obvious Combination?

Perhaps unwittingly, the Supreme Court has moved to stifle innovation in modern medicine.

By 5.23.07

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Earlier this month, the U.S. Supreme Court unanimously ruled to make it more difficult to invalidate a patent. Essentially, the court decided that "obvious" combinations of previous inventions do not warrant protection under U.S. patent law.

The case before the high court was KSR International Co. v. Teleflex Inc. The dispute was over a patent for gas pedals. Teleflex had combined two existing inventions -- an electronic throttle control and an adjustable pedal. The Court ruled that this was too obvious a combination to warrant protection under a new patent.

Unfortunately, the court's ruling will have implications that go far beyond gas pedals. Namely, it will stifle innovation in the pharmaceutical industry -- which, ultimately, will have a negative impact on the future of public health.

According to Justice Anthony Kennedy, who wrote the majority opinion, "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 or utility."

At first glance, that seems to be somewhat reasonable -- for things like gas pedals. The problem is, 21st century medicine has very little in common with automobile parts.

In medical innovation today, there are precious few "Eureka!" moments. Progress is made step-by-step, one incremental innovation at a time. Those advances require extensive research. And they're terrifically expensive. On average, it takes nearly a billion dollars to bring a new drug to market.

But this slow, steady progress is how today's medical advances are made -- not through Hollywood-style "Aha!" moments so popular with politicians and pundits.

NEVERTHELESS, GENERIC DRUG MAKERS routinely challenge the patents of name-brand drug makers in court, claiming that they're too obvious to warrant patent protection.

It's far cheaper for generic companies to wage these legal battles than invent the drugs themselves. If they win, they can reap the benefits of the hundreds of millions worth of research that a name-brand company spent developing the drug. If the drug is denied patent protection, generic companies move in to reproduce low-cost copies of the same molecular combinations.

The downside, of course, is that the name-brand companies cannot recoup their R&D costs if their patents aren't upheld. As a result, they will have less incentive to invest in developing new drugs in the future.

The high court's ruling will make pharmaceutical innovation more difficult by reducing the incentive for companies to make small steps forward. If the courts don't recognize the concept of incremental innovation as worthy of patent protection, investors simply won't pay for it.

And if investors won't pay because there's no profit motive, name-brand companies will be unable to pursue incremental advances.

If the current system collapses, what's the alternative? Who will pay drug companies to invent new drugs?

DISTURBINGLY, SOME FOLKS ARE now advocating a "prize" system where there are no drug patents. Instead, the government would pay a drug maker a lump sum for its innovation, and then the new drug would immediately be placed in the public domain.

This is unlikely to work. The government "prize" model has already been used in the past -- in the old Soviet Union. And it was a spectacular disaster. The Soviet experience was characterized by low levels of monetary compensation and poor innovative performance.

There's also the problematic issue of how such a sum would be determined.

The United States government does not have a good track record when it comes to rewarding inventors.

For example, the federal government paid Robert Goddard -- "the father of American rocketry" -- $1 million as compensation for his basic liquid rocket patents. That was hardly a fair price given that during the remaining life of those patents, U.S. expenditures on liquid-propelled rockets amounted to around $10 billion.

Even though the "prize" system is widely acknowledged to be a crackpot idea, it has a frightening number of supporters in high places -- including the U.S. Senate.

In fact, Sen. Bernie Sanders is introducing federal legislation to create a prize system for medical innovations. Leave it to the senator from Vermont to come up with a Ben & Jerry's-style solution.

If only inventing the cure for cancer were as easy as dreaming up a new flavor of ice cream.

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About the Author

Peter Pitts is partner/director of global health at Porter Novelli, a senior fellow at the Center for Medicine in the Public Interest, and a former FDA associate commissioner.