Innovative biologicals development must be preserved

INICIO/Noticias Farmacéuticas | Posted 26/01/2010 post-comment0 Post your comment

As reported by Gene Quinn on, for many months we have been hearing about the US government attempts to “reform” health care in the United States, and in the first weekend of December 2009 the US Senate was actually working, as the contentious debate continues. Even a relatively rare Presidential visit to Capitol Hill was scheduled for the afternoon of 6 December 2009, presumably so President Obama can rally the troops for whatever lies ahead. While patent policy has not taken centre stage in these debates, it is hard to ignore the under current that rages through the debates. Health care costs too much, so costs need to be contained. Of course, market initiatives like a national heath insurance market, which would lower premiums for everyone overnight, are not being considered.


Likewise, attempts to prevent those without insurance from clogging up emergency rooms for simple matters like runny noses, sprains, colds and a litany of other ailments is not on the table either, so rather than discussing health insurance premium reform and government sponsored clinics in areas where there is the highest density of uninsured, we are debating a host of other things and trying to squeeze the private sector.

Mr Quinn has long wondered why there has been such an all-out patent war against pharmaceutical and biotechnology companies, but the American Civil Liberties Union (ACLU) patent challenge against Myriad Genetics and the assault on biologicals from some corners of government has him thinking that the preferred way to control costs in the minds of some politicians is to either stop or dramatically slow medical technology progress through revised patent and innovation policy.

“That is a mistake, an enormous mistake. We enjoy an ever increasing life span and higher-quality medical care than anywhere in the world because of technology and innovative advances in an array of disciplines and that MUST be preserved”, he argues. “Did you know that on average, it takes an investment of more than US$1 billion over ten years to develop a biotech medicine?”

Mr Quinn explains there are typically multiple companies making this sort of investment and ultimately bringing to market products to treat the same or similar conditions, which then compete with one another. All of these competing innovator products go through similar lengthy and costly processes to bring their products to market, which means making them available to patients like you and me. This marketplace competition among innovators has always existed. “There is, however, another kind of competition that up to now has not been possible – competition from biosimilar manufacturers who seek a scientific and regulatory shortcut to bring their products to market. Unlike innovators who undertake their own costly research and development programmes to independently prove the safety and efficacy of their medical biotechnology products to secure FDA approval, biosimilar manufacturers seek product approval through an abbreviated process that allows them to rely on an innovator’s data to secure approval. Conceptually this is similar to how generic drug manufacturers seek to undercut brand-name pharmaceuticals”. (see also 12 years exclusivity workable for patients; not anticompetitive, Data exclusivity is not the same as market exclusivity and Minimal 12 years of biologicals data exclusivity required)


Gene Quinn. Fact vs. Fiction: The Truth on Biologics and Biosimilars. IP Watchdog. 2009 December 6.

Source: IP Watchdog

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