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

Biotech. Info. Inst. biotech at biopharma.com
Fri May 17 05:52:19 PDT 2013


Yes, simply stated, my "data can be interpreted merely to mean that data exclusivity is of negligible value added to IP monopoly on the narrow range of biologics...analyzed, and thus data exclusivity can be abandoned."   More specifically, BPCIA-conferred 12 years of post-BLA data exclusivity will be of negligible value, including to reference/innovator product and biosimilar companies and consumers, with U.S. patent coverage nearly always extending beyond data exclusivity (and of course, shorter orphan/market exclusivity), with this data based on 119 current biopharmaceutical products, nearly all facing biosimilar competition this decade, with ≥90% being mainstream recombinant proteins and monoclonal antibodies (vaccines and blood/plasma products excluded).  Yes, data exclusivity could be abandoned with negligible impact on biopharmaceutical products and their upcoming biosimilars throughout at least the rest of this decade.  

But data exclusivity could well be important to protect future reference/innovator products from biosimilar competition.  I'm thinking of products such as individualized cellular therapies that have no patent protection; some "new" technologies now coming off-patent after languishing for decades, such as gene therapies and antisense; etc.  And data exclusivity remains an issue worth pursuing.  From any rational, even a broad (not confined to innovators) industry-biased, perspective, indiscriminately handing out over a decade of any type of exclusivity to every product simply because they receive approval is crude and bad policy, including being too easily gamed (something critics seemingly do not address).  

So efforts to shorten biologics data exclusivity should continue and could well have significant future impact (hasten biosimilar competition).  But just realize that even its total elimination will likely not have much, if any, real impact on the market this decade.  

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 6:13 PM, George Carter wrote:

> Shortening data exclusivity is not the point: eliminating it IS. Along with fundamental and profound reform on what IP means, discovery and so forth. And even to the point of whether patents should be granted upon living processes like DNA or antibodies. So I am questioning the fundamental premise of IP for these kinds of discoveries, not questioning your data. 
> 
> Tho with agents like HPV vaccines, one wonders if this analysis would hold up? Let alone with the projections of patient-centered development of tailored biologics or small molecules on an individualized basis...but that's another kettle of fish...and one where we need more public investment to figure out how this kind of technology can be developed and made available to humans who need it. Like - http://www.ncbi.nlm.nih.gov/pubmed/19183853 -- (apologies for the tangent, except that it may impact on the pertinence of biologics development).  Let alone our understanding of what a "biosimilar" actually is and/or if it is effective. (Alpha interferon springs to mind....horrible drug in pretty much any variation on the theme...)
> 
> I was challenging the implications of your data--but I will entertain the unsurprising notion that I may have been hasty. I'm hotheaded because I'm tired of the assiduous embrace of the bankrupt "pharma" perversions of IP and their corrupt and destructive "business model" that results in economic genocide for literally millions of men, women and children, living with HIV, hep C, TB, malaria and a slew of tropical and other diseases, let alone cancers.
> 
> But allow me to add that my "presumptions" and "worldviews" are not merely idle opinions. They are supported by a great deal of data. Much of it has been collected in Goldacre's Bad Pharma, which I would hope you may have read.
> 
> The notion that a "negligible impact" of data exclusivity should be some kind of support for the ideas I'm raising here doesn't really strike me as an argument I'm inclined to embrace, as I'm not sure what it means. It initially sounded to me like a defense: "hey, it's no big deal, just ignore it for biologics." However, if your data can be interpreted merely to mean that data exclusivity is of negligible value added to IP monopoly on the narrow range of biologics you analyzed, and thus data exclusivity can be abandoned, that is less egregious than I initially believed but begs the question of patent life with or without data exclusivity having anything but a deleterious impact on discovery. But is that what you're saying?
> 
> If that's exactly what you are saying and I was too dense to see it, then I would hastily add my sincerest apologies if I've misunderstood those implications of your data.
> 
> But I look forward to your clarifications, in any event.
> george
> 
> On May 16, 2013, at 1:07 PM, Biotech. Info. Inst. wrote:
> 
>> 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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