Dishonest Roll Call Editorial on Follow on Biologics

Earlier today James Love and James Glassman published what can only be described as an intellectually dishonest op-ed piece on  The two James either simply do not understand patent law, the biologics legislation they detest or have an agenda that requires lying and obscuring the truth using scare tactics and falsehoods.  I don’t really know whether they are as clueless as their op-ed makes them appear, of if this is an orchestrated effort to persuade public opinion using obviously incorrect conclusions that are thrown about as if they were objective fact.  To be perfectly honest, I couldn’t care less whether they are malicious, misinformed or just stupid.  What I do care about is that their opinions are completely and utterly wrong, the supposed facts they rely on are false and those of us who understand patent law and this particular piece of legislation must do whatever is necessary to prevent to commandeering of patent policy to achieve whatever ill-conceived social agenda they seek to promote.  The cause du jour cannot and must not lead us to make bad innovation policy that will unravel the Constitutional mandate to foster innovation.

The two James start their op-ed piece by proclaiming that they rarely if ever agree, leading the reader to presumably conclude for themselves that when they do agree they must be right.  Immediately I was suspicious because whenever anyone needs to resort to subjective, irrational and politically correct niceties to start an argument my experience teaches that is because there is little or no substance to what is about to come.  In the wake of no substance debate tactics and persuasion is all there is to rely on, and when that is the case someone needs to stand up and shout that the emperor actually is not wearing any clothes!  It wasn’t long before my suspicions were confirmed, and I am hear to tell you that if the two James were emperors they would be standing naked.

The second paragraph of the op-ed, which is really the second and third sentences of the op-ed, says:

At a time of deep concern about rising health care costs, Senate and House committees last month voted to make it difficult, if not impossible, for generic drugs to compete with biologics, even after patents have expired. If the measure becomes law, it has the potential to harm millions of sick people, in the United States and beyond.

First, when are allegedly sophisticated individuals going to learn that  sentence is not a paragraph?  If you are writing for dramatic effect and or to persuade in a legal document there will be times this violation of basic rule could be warranted, but what has happened to writing in paragraphs with a topic sentence, support and a conclusion?  But I digress.

Putting the writing style aside, the content of the first sentence of the second paragraph is absurd on its face.  The legislation pending before Congress will really make it difficult if not impossible for generics to compete with patented biologics?  Simply not true.  Anyone who knows anything about patent law and anything specifically about this legislation should immediately understand that this statement is incorrect, made to persuade public sentiment using scare tactics and false information.  Nothing in the pending legislation would make it either difficult or impossible for follow on biologics, which are NOT generic drugs by the way, to compete with patented biologics.  The two James are simply wrong on the law, and wrong on the facts.

The sticking point for the two James is that they preferred the 5 years of exclusivity the original legislation presented provided for patent biologics.  The biotechnology industry lobbied for 12 to 14 years.  The Federal Trade Commission, in the most absurd, illogical and ridiculous conclusion any government body has ever made, said that 0 years of exclusivity was plenty fine to encourage and massive (i.e., hundreds of billions of dollars) that need to be invested by innovative companies to bring biologics to the market.  President Obama wanted 7 years.  Howard Dean, who can hardly be characterized as a conservative on any issue, said that Obama was wrong, the original Congressional proposals were wrong and the FTC was completely wrong.  He didn’t really say those things directly, but what he did say was that 12 years is what should be provided in terms of exclusivity, and that is what Congress as a whole has said to date as well.  So it seems that plenty of Democrats, plenty of Republicans, the entire biotechnology sector and ever staunch liberals like Dean who understand the science involved agree that the industry is correct and Henry Waxman, President Obama and the FTC are wrong.

It is ridiculous on every level to suggest that 0 years of exclusivity should be the reward for putting hundreds of billions of dollars are risk to innovate.  So we can easily dismiss with the FTC position.  The FTC position was obviously political, presented to off-set the industry proposal of 12-14 years and make the “Obama compromise” of 7 years look reasonable.  The trouble is that there are actually some people in Congress who understand patent law, understand innovation and understand that no one in their right mind would put hundreds of billions of dollars at risk without the prospects of recouping and making a reasonable return given the amount invested and the overall risk involved.  The reality is the biotech industry, like the pharmaceutical industry, has to pay for the many things that fail and never make it to market, and the return has to be real and substantial to entice such overwhelming risk.

The position of the two James that 12 years of exclusivity will make it difficult or impossible for follow on biologics to exist is simply false and internally illogical.  If 12 years makes it impossible, then 5 years of exclusivity would as well.  The truth is that the difference between 5 and 12 and 7 and 12 is 7 and 5, respectively.  If follow on biologics would enter the market and be able to compete after 5 years (the original Congressional time frame) or after 7 years (the Obama time frame) then they will be able to compete after 12 years.  That is obvious, and the fact that the two James thought no one would see through their illogical rouse tells me all I need to know about them.  People who read and can think for themselves are not stupid, and cannot be lead around by the nose, as has been demonstrated over the last month or so in town halls across the country.  You can say whatever you want, but those who read and understand know when they are being fed a line of crap!

The reality is that 12 years is likely the right length of protection.  If Congress wanted to back that down to 10 years I would support that as well.  A little pain from both sides would evidence that the deal is exactly where it should be, if you ask me.  But to conclude that 0 to 5 is right and Congress is selling out sick people by giving 12 years is unfair and the exact type of inside the beltway intellectual dishonesty that has the rest of the country upset and invigorated like never before.


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5 comments so far.

  • [Avatar for Gene Quinn]
    Gene Quinn
    September 10, 2009 05:34 pm


    Thanks for the suggestion. I like it! Yes, I seem to be more and more preoccupied with those clueless soles who have an agenda and could potentially sway public opinion.

    Thanks for reading


  • [Avatar for Steve Miller]
    Steve Miller
    September 10, 2009 05:30 pm

    Gene said, “To be perfectly honest, I couldn’t care less whether they are malicious, misinformed or just stupid.”

    Hey Gene, you should trademark this for your “patent commentary services”, or at least make it your catchphrase. It captures the essence of a lot of your posts.

  • [Avatar for Adam]
    September 9, 2009 07:17 pm

    Oops, I meant “generic biologic”, not “biological generic”. Mea culpa.

  • [Avatar for Adam]
    September 9, 2009 07:15 pm

    Despite the rhetorical sloppiness of the op-ed, I found this to be one of the more interesting parts:
    “Bill Marth, the North American CEO of Teva Pharmaceuticals, the world’s largest maker of generics, recently told Reuters that, if the changes stand, his company does not see a way to enter the biogenerics market.”

    Do you think he’s lying through his teeth? If not, what do you think he’s worried about? Obviously, as you point out, the exclusion period wouldn’t keep his company from entering the market for most biologics, it would just make them enter later.

    By the way, “biogeneric” and “biological generic” seem to be synonyms of Follow-On Biologic:

  • [Avatar for EG]
    September 9, 2009 01:03 pm


    The length of “data exclusivity” has certainly been the “hot spot” in the follow-on biologic (FOB) debate. But there’s a more significant issue the two “Jims” didn’t address which is how do you determine if the FOB drug is truly “biosimilar” to the original NDA-approved biologic drug. Kevin Noonan at Patent Docs has already alerted us to this glaring and potentially alarming issue in the FOB legislation originally proposed. In fact the EU has already sufftered their FOB version of the “thalidomide tragedy” where several patients died from pure red cell aplasia in 2001 after taking a form of the biotech drug erythropoietin that they suffered an autoimmune reaction to. This overweaing concern with lower biologic drug costs has masked some very serious “safety” issues if the bar for “biosimilarity” is too low. Talk about the “potential to harm millions of sick people,” if you don’t make the “biosimilarity” standard sufficiently stringent, you’re truly “playing with fire,” including potentially causing a FOB drug-induced health “disaster.”