Kevin, M.D. - Medical Weblog

I studied economics before going to med school and while I've always been at least slightly troubled by some of the consequences of current medical IP legal frameworks, I've been even more annoyed by the folks proposing radical solutions and lambasting big pharma for spending money on marketing and/or being profitable.

To my mind there are two separate issues here: one is whether patents as a general legal construction are a good idea, the other is the specific application of patents to certain classes of discovery.

Anyone arguing, in the US at least, against the general principle of patents is wasting their breath. First of all the principle of patents simply matches the general political mood of the US much better than state sponsored prizes or a socialist utopian collective common IP pool. Second of all, patents do work in many fields (including, to a certain extent in medicine). Abolishing patents outright and replacing them with prizes is about as appealing to America as abolishing copyright and suggesting that the government pay artists and writers. The first amendment would be meaningless overnight.

I think that arguments against patents are on much stronger ground when they attack the constitutional/philosophical underpinings and practical application of patent law to specific classes of 'discovery'.

Some cases:

1) Obvious combination formulations (as opposed to novel combinations which are genuine discoveries). If it is well known in the medical literature that taking 2 antiretrovirals together, on the same or a very similar schedule, is part of a good HAART regime, then a patent on a formulation of a combination dose didn't require a significant outlay in expenditure and it shouldn't be patent protected (or its protection should be for much shorter than the protection for truly novel innovation which is what patents are supposed to encourage).

2) Gene sequence patenting. Every gene sequence of value already exists in nature (that is why it has value to humans). Testing methods and devices clearly qualify as innovation that can be patented, but the current scope of gene patents is more analogous to granting someone the rights to prevent the sale of gold or some other naturally occurring element.

3) 'Me too' drugs that everyone seems so fixated upon. You'd probably get more traction arguing that since patents exist to simultaneously provide a return on investment for drug development and provide social value and that since the development costs of 'me too' drugs are lower and their social value is lower than truly novel compounds, the patent protection afforded such compounds should be less (not zero since there IS a development cost and these compounds, while offering marginal benefits over existing compounds, have a non-zero marginal therapeutic value).
 

You make several good points. First, I'm also constantly frustrated by people who hate profit whether it be doctors, big pharm, or anyone. We life in a capitalistic society, if you don't like it, go to Cuba and see how good life is w/o profit.

Second, you're right on as far as the patent system never changing, but i can understand your concerns for "soft" patents that are equivalent to patenting breathing, or cardiac rhythms :). That being said, in my opinion nearly every other patent should be protected. Regardless of the cost/development of a me-too drug, it still meets the qualifications for a patent and deserves it. I don't think you want to start down the slippery slope of granting patents based on cost of R&D, or 'social value'.
 

Ala esomeprazole..........
Losec , but purple and pricey.
Excellent post anonymous!
 

Oh, how convenient to say that restricting the use of intellectual property (IP) is "inefficient" (now I know he's talking like an economist) because it costs nothing for another person to use it, neatly ignoring the cost of creating it. Joe, IP laws exist to promote the creative processes leading to useful products. They promote the process by protecting the result.

Eliminating IP rights would be tantamount to eliminating the motivation to create useful things like movies, books, & pharmaceuticals.

Besides, patent rights aren't quite the monopoly Stiglitz makes them out to be. Patents run 20 years from filing, which sounds like a long time but really isn't. Why? Because simply filing an application doesn't equate with enforceable rights -- it's only after the application issues as a patent that rights are enforceable, and that usually takes years. For example, the sections of the Patent Office that deal with biological inventions are swamped with applications, and it can take YEARS to get around to looking at an application. Then, with the back-and-forth between Examiner and Applicant, it can take years more before a patent issues. Yes, there can be some give-back to the Applicant to account for the time lost pursuing the application process, but it ain't much.

What do we, the taxpaying public, get in return? We get full disclosure of the invention such that one skilled in the art can take that patent specification and re-create the invention (at least in theory!). Believe me: when I used to do research, I looked at published patent applications.

Without the 20 year patent monopoly, what do you think would happen? Everything of commercial consequence would remain a "trade secret," of course. No one could learn how to make recombinant erythropoetin, or any chemical cousins, or how to improve on them because its creators would never tell how they were made or how they functioned. Knowledge would be fractured into thousands of pieces, hoarded by those with money and power enough to hold the fragments and keep them secret.

At least now we have a tit-for-tat exchange between the inventing entities and the public. The patent system is the worst form of exchanging commercially valuable information, except for all those other forms that have been tried from time to time.

My views on copyright, though, are quite different. Congress has mucked that up terribly, especially with the Sonny Bono Copyright Term Extension Act and the Digital Millennium Copyright Act (DMCA). As Congress continues regularly to lengthen the term of copyright, it makes a farce of the Constitution, which says the right shall be secured for "limited times to authors...." And the DMCA seems a naked attempt to circumvent the common law exception of "fair use."

But I digress....

Sure. Let's have a medical prize fund. And an authors' prize fund. And a movie-directors' prize fund. And then let's all sing Kumbayah around the campfire. But I get to run the prize funds.