Saturday, January 20, 2007

Hacking Meds to Make a, eerr, New Drugs!

Scientists find way to slash cost of drugs by reverse engineering existing molecular structure and tweaking it to form a technically new and patent free drug

In other news: Porsche dealers project shortage due to meteoric rise in 2007 patent attorney fees

A couple of scientists at Imperial College have devised a way to analyze and recreate the molecular structure of a new drug, tweak it and make it into a "different" drug---thereby skirting the rights of the original patent holder, releasing into the world, and saving lives.

That's the general gist of the story, as reported by The Guardian this week. How I undertand, it's making generics out of proprietary drugs before their 20 year patent reign. This is possible because they are essentially a different compound.

We like a good hack just as the next person, but there's some issues with the approach:

  1. We're not hacking the Colonel Sanders KFC's 11 secret herbs and spices to yummy fried chicken. These are drugs and they involve clinical trials. Last I checked, clinical trials still matter when you're talking about new drugs.

  2. Yes, they can argue that these are generics, which may be eligible for fast track approval (505(b)(2). Wait, if they are generics, then how does that differentiate them from the original drug in terms of patent law? I'm not a lawyer, but I can see a good one arguing this. If it walks like Lipitor, smells like Lipitor, tastes like Lipitor (wait what is that I see under the microscope? Lipitor-like strucuture?) shouldn't it be Lipitor? No, judge, that's Lypytore, Lipitor's estranged half brother.

  3. The drug companies probably saw this coming a while back. There's an interesting company in Australia called iCeutica who's doing some reverse engineering of their own on behalf of drug companies. The idea is that they can shrink the formulation of the compounds to nanosizes, which affects how it gets absorbed in the body. Since it's a new type of formulation, that makes it a new drug (sound familiar?) In this case, the strategy extends the lifetime of the patent another 20 years. Watch for nanosized Aleve that gets absorbed a lot faster than the generic naproxen right besides it.

There's good coverage of the story at the THD blog and some compelling arguments about collaborative innovation versus reverse engineering at the New Paradign Innovation Blog.

Update: Perhaps this is like the perfume knock-offs that cost $10 instead of $45. Sometimes you really can't tell the difference. Although, I'm told the knock offs don't last as long. Again, an argument for #1 here.

No comments: