Biotech Values

[DewDiligence]

[OT] Esperion, patents, and journalists:

[From Derek Lowe’s blog at www.corante.com –no not that Derek Lowe]:

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Tuesday, November 11, 2003

To The Editors of the New York Times

Your recent editorial on the Apo-A1 Milano therapy for atherosclerosis is strong stuff. For example, you say that ". . .infusing H.D.L. cholesterol directly into the body, was shown effective in animals more than a decade ago, but the industry never really pursued it. One reason was that companies saw little economic incentive in using a normal body protein for therapeutic purposes, since it would be hard to gain patent protection. A medicine that could be made and sold by anybody had little potential for profit."

There's a lot to argue with here. A "medicine that could be made and sold by anybody" is a good definition of a generic drug, for example, and generic drug companies can actually make plenty of profit. Of course, that only happens after the major R&D costs were incurred by someone else. You came very close to realizing this useful point, but pulled up at the last moment - did you realize that you were about to make an argument for recouping research costs through patent rights?

But the entire piece is an oversimplification, as a little extra thought might have shown. How, by your reasoning, did Eli Lilly ever realize any profit from insulin? It's just another "normal body protein" whose medical use was already known, after all. How did Genentech ever make any money from human growth hormone? We could go on.

HDL therapy has actually had plenty of money thrown at it. You don't seem to have taken the time to find out that human trials of normal Apo-A1 protein for atherosclerosis were attempted several times during the 1990s by at least two biotech companies. They would scarcely have been interested were the financial incentives as low as you picture them. The trials were not conclusive, unfortunately, not least because Apo-A1 is an extremely difficult protein to produce, isolate, or purify. Different preparations of the protein can have completely different qualities - it's a major difficulty in interpreting the scientific literature on the topic.

So you're wrong on that count, too: it cannot be "made and sold by anybody." It's more accurate to say that it can be made and sold by nobody. And I can only imagine the outraged editorial comments your editorial page would have made about rising health care costs if it had come to market. Doubtless you would have favored reimporting it from the cheapest source that could be found.

Moving right along, your understanding of the patent system is also incomplete. Patents are issued for many kinds of inventions. Chemical matter (such as the protein itself) is patentable, as are new or improved methods of producing such materials, as well as new uses for them. A good method for economical large-scale production of Apo-A1 would be a very lucrative patent indeed. In fact, a number of applications and issued patents from the pharmaceutical industry have addressed this exact problem, seeking the potential for profit that you claim does not exist.

Apo-A1 Milano is being pursued not because it is patentable, but because it has already been shown to be remarkably beneficial in the humans who express it. It clearly has very different and desirable properties, compared to the normal protein. As you may recall, this is what caught the attention of the medical research world in the first place. Thanks to the Italian carriers of the gene, key clinical data in humans is already in hand, which is a rare situation indeed in drug development. It's a wonderful opportunity. Now, whether this protein can also be made in sufficient quantities, I don't know. But this topic is, as you may be able to guess by now, the subject of still more patent claims.

So, your editorial bungles its key scientific and legal points. Then you follow that up by lecturing academic and industrial researchers who actually know what they're talking about - here we go: "But the fact that such a promising treatment was widely ignored because there was no immediate profit potential is disturbing. . .This story makes one wonder how many similar gaps exist in the vaunted American research establishment."

Well, speaking as a member of the vaunted American research establishment, I find it irritating to be harangued by the New York Times about a subject you've clearly made little attempt to understand. Spend an hour reading the medical literature before you load up the cannons again - it'll be worth it, trust me. Fill in your own gaps, and then we'll talk.

(For readers who want to take a look at the patents I mentioned, here are some good starting points: Recombinant Apo-A1 production is in US 5643757, and a purification of ApoA and its subsequent uses are claimed in US 5990081. Modified forms of Apo-A1 are claimed in US application 20020156007 and US 6630450, which has an excellent prior art section giving the background in that area. Apo-A1 Milano is covered by US 5876968 and US 6617134. And if any of you guys at the Times use these, let me know so I can bill you for the research.)
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