[Ip-health] Do Pharmaceutical Firms Invest More Heavily in Countries with Data Exclusivity?"

Biotech. Info. Inst. biotech at biopharma.com
Thu May 16 10:07:01 PDT 2013

I am just reporting quantitative data, which happen to show that shortening data exclusivities for U.S. biologics will have negligible impact on improving access to biosimilars.  As such, I am the bearer of unwelcome news, particularly, for those strongly opposed to pharmaceutical exclusivities/monopolies of any type.  As you note, my reporting did not include commentary regarding whether patents or biopharmaceutical products are good or bad, cause HARM or not, cost too much, etc., which appears to be an ethical lapse on my part from your perspective.  

But other than finding data exclusivity lacking in utility, don't my findings support your presumptions and world view?  Why not consider my findings as evidence fully supporting views that biopharmaceutical patents are bad for society; preventing access to biosimilars, competition and cheaper products?   Here, inherently monopolistic patents are even acting against the will-of-the-people - eliminating the utility of the biologics data exclusivity periods intended by Congress to hasten access to biosimilars.

Otherwise, so far, here and in other, mostly biopharmaceutical industry, venues where I've reported my preliminary findings, not a single person has questioned the veracity of my data or conclusions.  I welcome anyone with similar or contrary data contacting me, including pointing out any currently marketed biopharmaceuticals where relevant U.S. patents expire before regulatory approval-conferred exclusivities.

Thank you.

Ronald A. Rader
President / Author & Publisher of BIOPHARMA:  Biopharmaceutical Products in the U.S. and European Markets
Biotechnology Information Institute
1700 Rockville Pike, Suite 400
Rockville, MD 20852
Phone:  301-424-0255
E-mail:  biotech at biopharma.com
Web sites:  www.biopharma.com; www.bioinfo.com; 
    www.biosimilars.com; www.biopharmacopeia.com

On May 16, 2013, at 8:46 AM, George Carter wrote:

> What you don't seem to get is the notion that patents, the way they are employed, are HARMING science, medicine, discovery and human life. You simply would rather hang out with your numbers and pretend they mean something useful--and the only thing they're good for is profiting.
> In fact, let's take your example of TNF-antibodies. These are produced naturally by our bodies--this is a discovery, NOT an invention. They're not manufactured except by our B-cells. The patent, 6,090,382, is absurdly over-broad, calling on all kinds of bits and pieces of antigen and antibody and anything these guys could dream up to cover in the patent. 
> Then, they push this thing on the market as infliximab or humira. What do we get for the outrageous cost? A drug that a third of people develop antibodies to, in the case of humira. Not to mention particular harms, which the pharmaceutical companies have been assiduous in suppressing data on as it impacts profits negatively. For example, in the case you bring up to defend your position, see, e.g., http://www.sokolovelaw.com/newsroom/blog/2012/07/31/abbott-labs-sued-over-humira 
> What if that was your sister? Or you?
> Other efforts to thwart TNF have led to death (e.g., pentoxifylline). But there are a number of more natural ways to reduce not just TNF but other inflammatory cytokines, like IL1 and IL6. These are problematic in a number of conditions and infections when their expression is prolonged or sustained. Potential agents range from L-carnitine to combinations of agents like alpha lipoid, NAC, fish oil….we need studies that reflect MEDICINE done in a SCIENTIFIC way that help HUMANS FIRST, not profits.
> What we lack is more robust data because the model of patent medicines and profit stymies such studies. 
> That's why I get angry. I think that petty, small-minded "accountancy" of putative suffering by pharma because there is some perceived lack of "protection" for biologics--or any drugs--is fundamentally and at root a kind of psychosis.
> I stand with the de-linking of profit approach. This will allow discovery to be unimpeded, discoverers to share in a reward (the incentive) and low-cost means of production and access will assure we, as patients, will have a shot at something that actually works, rather than something that just makes some executives craploads of cash while denying patients access to medicines or exposing those that can access them to often unnecessary and/or absurd risks.
> George M. Carter

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