OxyContin(ues)- The FDA gets it right4/17/13

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Josh Bloom, Medical Progress Today, 4/17/13 "OxyContin(ues)- The FDA gets it right"

The age-old debate about pharmaceutical patents, novelty, and money will probably never end.

While some people want to abolish pharmaceutical patents altogether (and good luck ever seeing a new drug again), most other pharma critics are at least somewhat rational. Yet, many still maintain that drug companies overuse patent protection as a tool to maximize profits, while providing no real innovation.

The first opinion is, of course nonsense--without patents to protect their inventions, no drug company in its right mind would spend a billion dollars to develop something that other companies (that incurred none of these costs) could sell for a fraction of the price.

And although the second opinion is frequently misguided--this is not always so.

There is a gray area where the concepts of novelty and advantage are blurry and can be open to a wide range of interpretation-- issues that are frequently fought in court.

Operating within this gray area are line extensions and "copycat" drugs--those with just enough difference to get a patent, while providing little or no real benefit to patients (Prilosec vs. Nexium is probably the best example of this). Additionally, new patents can be obtained for older drugs by simply tweaking the formulation, which may offer an advantage (sometimes small) relative to the old pill. It is this type of case where criticism is the most persuasive...[Read more].