Vaccine Patent Politics and The Swine Flu

It would appear as if the swine flu virus, known in the scientific community as the H1N1 virus (so named because of the surface proteins), is not going to be as virulent as some feared it could be. According to Peter Palese, the Chairman of the Department of Microbiology at Mount Sinai School of Medicine, who wrote an article in the Wall Street Journal Weekend Edition, the swine flu virus is likely not any more virulent than other seasonal flu strains because “it lacks an important molecular signature (the protein PB1-F2) which was present in the 1918 virus and in the highly lethal h5N1 chicken viruses.”  Any time there  are deaths involved as a result of a virus or transmittable infection, it is of little solace to those who have lost loved ones to hear that  it will not be as bad as it could have otherwise been.  So while we have dodged a bullet, every sympathy must and should be extended to those affected by this virus.

It is broadly believed that it is only a matter of time before we are faced with a widely deadly influenza virus that will rival or even surpass the 1918 pandemic virus, which killed more than 50 million people across the globe.  Given the ease of travel and speed with which the relatively benign swine virus spread from Mexico to all parts of the world, we all should be mindful that it was not so long ago in the course of human history that the black death took the lives of nearly one-third of the population of Europe.  When compared to the plague, the 1918 pandemic pales in comparison.  It is almost unthinkable that a pandemic virus were to claim one-third of the population of world, or even just the United States, but such a possibility may not be so far off.  Experts are claiming that we are well overdue for such a pandemic, which is a scary thought indeed.

So what does this have to do with intellectual property?  Everything really.  While none of us like the thought of having to pay what seems like exorbitant prices for drugs, we all like the fact that when we are sick there are drugs available to treat whatever we are suffering from.  Many of us also like the fact that we can get vaccinated for various ailments, ranging from the common flu to measles, mumps, rubella, polio, hepatitis and a range of other viruses.  The reality is that there is not a lot of money in vaccines, at least not when compared to other activities those that could produce vaccines could engage in.  So what we need to be doing as part of a national and international health strategy is provide companies incentives to engage in research and development to produce vaccines and continually learn more about the human response to viruses.  New viruses are being discovered constantly, so with mother nature continuing to evolve we ought not slow down our pursuit of treatments and preventative measures.

In an interview aired Saturday on “The Journal Editorial Report” on FOX News, Paul Gigot, the editorial page editor and vice president of The Wall Street Journal, asked Scott Gottlieb, former deputy commissioner of the Food and Drug Administration and current resident fellow at the American Enterprise Institute, about swine flu and the production of vaccines. It was news to me to learn that Congressman Henry Waxman has introduced a bill that would limit the length of patent protection for vaccines to as little as 5 years. Here is a portion of the Gigot – Gottlieb exchange:

Gottlieb: The other thing that’s happening on Capitol Hill is a piece of legislation that’s going forward by Congressman Waxman that would limit the patent protection on biologics to as little as five years. And there’s no carve-out for vaccines. Vaccines are a form of biologics, and so they would be swept into this bill. And if you limit patent protection, you really reduce the incentives to invest in this space. The investments are enormous in vaccines.

Gigot: They really are enormous in vaccines, as large as in other drugs like for statins, for blood pressure, that sort of thing, or for–

Gottlieb: Much more so. The amount of capital costs involved in developing vaccines is enormous, and the margins, the payoff, isn’t as big. So, for example, on flu vaccine, it costs about $3 to make a shot, and the manufacturers get back around $10 to $12. It costs $600 million to invest in a facility that can only produce 40 million doses of vaccines. So when you do the math, it’s an enormous upfront cost.

Several days before this interview Gottlieb wrote an article for Forbes magazine saying:

Preparing for future threats requires a broad armamentarium and the residual capacity to create new things quickly. We are better prepared to respond to swine flu as a consequence of these lessons. But this strategic capacity doesn’t come cheap, and we need to strike a careful balance between policies that enable better access to today’s medicines and incentives that invest in tomorrow’s. As the biology of threats like swine flu grow more complex, it’s not a sure thing our medical industry will be robust enough to keep pace with it.

So why then has Congressman Henry Waxman introduced legislation that would clearly provide less incentives for drug companies to engage in the research and development of vaccines?  Why has Senator Charles Schumer (D-NY) submitted legislation in the Senate similar to the legislation introduced by Congressman Waxman?

According to Palese:

Our government has intiated major advances to develop new and improved manufacturing processes.  Exciting new vaccines and antiviral approaches are also in the pipeline, and they show primise of tipping the balance in favor of humans against a devious virus.  Universal influenza vaccines (one long-lasting vaccine against all strains) and broadband antivirals (comparable to broadly effective antibiotics) are being developed in academic laboratories and in innovative small biotech companies.

At a time when experts are telling us that we are heading for a repeat of the 1918 pandemic, or perhaps even worse, it is irresponsible to do anything that may have the effect of making us more at risk.  Even if there is some “chicken-little” in these warnings, we know that viruses are deadly.  We know that the common flu virus kills an average of 36,000 Americans every year.  We know that there have been incredibly virulent and deadly viruses throughout recorded history. So why then would anyone in government want to make it less likely that drug companies would develop vaccines?  I realize that I don’t know a lot about politics, because to me problems have solutions and things that have never worked should not be pursued, while things that have worked in the past should be pursued.  That aside, I find it impossible to understand how and why an anti-vaccine bill makes any sense.  Even a politician should understand that, right?


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Join the Discussion

6 comments so far.

  • [Avatar for Gabriella Adams]
    Gabriella Adams
    April 26, 2010 10:55 am

    Swine flu is not as dangerous as Dengue Fever but we should still take precautions to avoid spreading and contracting this disease.

  • [Avatar for how to prevent flu]
    how to prevent flu
    August 4, 2009 02:13 pm

    I think they should spend more time educating people on preventative measures while also preparing for the worse case scenario.

  • [Avatar for anonymous]
    May 7, 2009 11:17 am

    The patents for the biosimilars is like the orange book. It is HR 1427 by Waxman. Read the bill. There is very little difference between it and the current ANDA rules for small molecules. The patents are public so there is nothing confidential that is being turned over. Pharma keeps trade secrets all the time for manufacturing processes. The bill that BIO wants passed gives 12 years exclusivity regardless of any patents and 2 years for an extra indication– that would be a total of 14 years. Therefore, there would be almost no need for a patent given how long prosecution can take–how does that promote the progress?

  • [Avatar for far cold north]
    far cold north
    May 7, 2009 09:40 am

    Given the push to eliminate patent protectin on biologics, I do see Pharma going the trade secret route. Suppose Pharma simply ignores patents for innovative large-molecule biopharmaceutical products. For the most part, these biologics generally exhibit high molecular stereo-specific complexity, and may be quite sensitive to manufacturing process changes. A follow-on manufacturer would not have access to the originator’s molecular clone and original cell bank, nor to the exact fermentation and purification process. Finally, nearly undetectable differences in impurities and/or breakdown products could have serious health implications. In short, invoke state trade secret laws, and reveal NOTHING except the letter of the law to the FDA. Pharma always has many drugs in the FDA approval cycle and, as nobody is clairvoyant, it is a guessing game as to which drugs will be eventually approved. This buys time. However, most importantly, without patent preferred embodiments to guide them, the biosimilar companies will have to introduce a NEW drug, which means they will have to conduct separate clinical trials. This should give Pharma at least as much time protection as a utility patent, and who knows, maybe more. Under the current four biosimilars bills in Congress, everything revolves around the exchange of patent information. If there are no patents, then there is no exchange of information. Even if the biosimilars have samples of the final drug, complex molecules are difficult to reverse engineer and even if one were successful in duplicating it, it would have to be treated as a NEW drug. Is the FDA going to take the word of a biosimilar that their new drug is the same as one that is already in the market? What’s wrong with this scenario?

  • [Avatar for Gene Quinn]
    Gene Quinn
    May 4, 2009 02:20 pm

    I am not sure that is exactly right. As I understand it, this bill would force innovators to turn over patent information to generics. The generics could then seek approval of bio-equivalents. This would then effectively cut into the term of patent protection. So while there is talk of exclusivity, I think this does dig into the protection already afforded to innovators. More to come.

  • [Avatar for anonymous]
    May 4, 2009 01:40 pm

    I don’t think the bill limits patent protection to 5 years it gives automatic exclusivity regardless of patent protection to 5 years. If you want more than 5 years you need a patent. This is exactly the same as Hatch-Waxman for pharmaceuticals.