Howard Dean Supports Strong Protection for Biologics

Last week, on July 8, 2009, former Presidential Candidate, former Vermont Governor and former Chair of the Democratic National Committee, Howard Dean stepped into the health reform debate, discussing in an Op-ed piece published by TheHill.com. It is not surprising that Dean, who is a Medical Doctor and politician, would attempt to let his positions on health reform be known. What is perhaps surprising is that Dean decided to discuss patent reform, rather than keeping with the larger policy matters swirling around the debate. What is downright shocking is that I agree with Howard Dean.  To my knowledge this is the first time I have ever agreed with Dean, although I have always liked him because I feel (perhaps naively) that he is a man of principle. I would prefer elected officials to be straight forward and real, and Dean is certainly both of those things. As it turns out, Dean is also right on the issue of patent reform, at least insofar as biosimilars (sometimes call “follow on biologics) are concerned, which clearly need longer protection than President Obama wants to provide.

Dean’s position on patent reform associated with biosimilar legislation, which is circulating through the halls of Congress, is not only coherent and thoughtful, but also dead on accurate. It is also contrary to President Obama’s stance on the issue. It seems that Howard Dean supports strong intellectual property protections that would guarantee research, development and foster innovation. President Obama and others pushing for short exclusivity for biosimilars would do well to listen to Dean.

In part, Dean wrote:

The Congress is now developing a regulatory pathway for the approval of biosimilars — medicines that are similar to, but not the same as, breakthrough biologics. Some inaccurately suggest that biosimilars are essentially generic versions of traditional pharmaceutical drugs. Biologics are actually much more complex than traditional drugs and cannot be copied using existing science. By expanding market competition, biosimilars can expand access to and reduce the cost of these cutting-edge drugs. But if the initial breakthroughs are not supported by adequate patent protection, innovation in America will die.

As I was reading this I started to get ready to disagree with him, because when he started explaining that biosimilars are not equivalent to generic drugs, I thought he was setting up an argument similar to those made by the Federal Trade Commission when they concluded that because biosimilars are expensive to make there would be little competition even after patent protection expires for the underlying biologic. This, of course, ignores the certain advancement that will occur over the coming years, which can only logically be expected to ever decrease the cost and process for creating biosimilars. But Dean is right. Biosimilars can be analogized to generics in some important ways, but the science is not the same and the technical realities are indeed quite different.

When I read Dean write that without “adequate patent protection, innovation in America will die,” I was skeptical that he really meant that, and was perhaps giving lip service to a fundamentally American trait – the ability to innovate. But then my skepticism turned into admiration, because Dean was not just paying lip service, but seems to really believe in the importance of patent protection and the role it plays in innovation. Dean wrote:

A commonsense and fair approach, similar to the process and timeline currently in place for generic versions of chemical-based medicines, would allow the original developer of the biologic to protect the proprietary data used to develop the medicine for at least 12 years. A shorter exclusivity period would prematurely rob biotech innovators of their intellectual property and destroy incentives to develop new cures. Most firms would be unable to recoup their investments in new medicines, which ordinarily top $1 billion and involve 15 years of research and development. If we discourage investment, we jeopardize the development of the next generation of breakthrough medicines and cures.

Dean then went on to later say that he believes that patent life should “begin running at the time of FDA approval, not at the time of application.”

It is hard to know the politics behind Dean’s op-ed piece, but it is clear that he disagrees with President Obama. According to the President only 7 years of exclusivity is necessary and would strike the appropriate balance between protecting innovators and the public. Dean’s stance is far more in line with the proposals of biotech and pharmaceutical industries, who are urging Congress for 12 to 14 years of exclusivity for biologics. The cynical observer, or political realist depending on your view, would say that Dean is starting the journey to separate himself from the President and courting a powerful industry that might wish to support future Presidential Candidate Dean in 2012. I don’t know if that is the case, but it wouldn’t surprise me at all, and if he is patent friendly that would be a good thing indeed. I suspect there will be many Republicans lining up at a run for the White House, and I also suspect there will be many Democrats doing the same, particularly given the path the Obama Administration is taking presently.

Regardless of whether Howard Dean wrote this op-ed piece to foster a divide between himself and the President, or whether it is simply because he believes the President is wrong and Congress needs to do the right thing if we want revolutionary medical advances, you have to acknowledge that he is dead on accurate. The question here is whether we want revolutionary medical advances or we do not want revolutionary medical advances, it really is that simple. There are many who make a “greater good” argument, falling on the side of little or no patent protection relating to genetic innovations, biotechnologies and pharmaceuticals. The “greater good,” however, is clearly on the side of more patent protection, not less. Beginning with the Framers of the U.S. Constitution we have always desired to foster innovation and provide protections to innovators in order to give appropriate incentives to encourage consistent and extraordinary levels of revolutionary advancement. As cruel as it is for those who need exceptionally expensive treatments and drugs in order to survive, the greater good to society is to err on the side of more patent protection, rather than less, even if many are unable to afford the treatment or drugs during the life of the patent.

To put this into a pop-culture context, there is a scene at the end of Star Trek II where Mr. Spock exposes himself to an enormous dose of radiation in order to fix the engines of the Enterprise, thereby allowing the ship and her crew to escape certain death as a result of an explosion in a nearby star ship. Captain Kirk wants to save Spock, and he cannot. They share a universal moment together knowing that Spock will die. Spock explains that the good of the few, or one, cannot outweigh the good of the many. I don’t want to get campy about this, or bring down the level of debate by referencing science fiction, but this scene capture so much human emotion, and provides such a useful lesson. Spock, as the result of a truly noble act will die. The good of the many dictated that he, or someone, undertake just such an act. Because of this act the ship and the crew will live. We live in a harsh and unfair world where some do not enjoy the benefits that others will.

I know no way to ensure that revolutionary medical advances will be made, which will benefit millions and billions, other than to provide patent protection long enough to guarantee such advancements will occur in large numbers. It is intellectually dishonest to focus on the few who will not be able to afford treatment and drugs when making decisions that impact society at large. The critics will no doubt say it is not “a few” who are and will be denied, but that argument is simply incorrect. The number of people denied during the life of a patent is indeed very small compared to the number of people who will enjoy the benefits of the generics (or biosimilars) once the underlying patent protection is lost.

Make no mistake, we are not talking about helping those who cannot afford drugs and treatments. Without adequate incentives we will not have those revolutionary advances to offer anyone, including those who could not afford them during the patent term. So, for those who dislike this reality it is time to be intellectually honest and cease trying to steal the debate with lies and mischaracterizations. There is nothing noble about foreclosing revolutionary medical advances because of some socialistic ideal that suggest that drugs and treatments must be available for everyone equally, or not available to anyone. Such a position, which is held by many, is cold hearted and flat out stupid. We should not allow “cut off your nose to spite your face” policy to become law.