04 March 2015

Me First, Me First

For, basically, forever the US had a first-to-invent patent rule; some claim that the Constitution makes that explicit. That meant, if one kept true records, then your discovery/invention had precedence over filers in front of you. The result of this was that, sometimes, a Big Corp would apply for, and even get, a patent on a Special Widget only to discover that Some Scienceguy had earlier made such a Special Widget. Discovery was primary, not filing. Eventually, Big Corps got tired of being left out, so lobbied Congress to change the law, asserting that the EU did it right (how often does that happen? Socialist scum that they are?) with a first-to-file law.

Some studies have shown what one might expect from such a change in incentive: Big Corps have a leg up on the patent process and patent grants flow to Big Corps since the change. Another anomaly may have emerged in the last few days. A biopharma, Orexigen, has one of three newish weight loss drugs, named Contrave, (the other two companies are Arena and Vivus) on the market. The three companies have been in competition to get FDA approval (which they all managed) and now sales.

The Arena drug was new, while Orexigen and Vivus built new recipes using existing compounds. For reasons not entirely clear, only Orexigen was required to conduct pre-approval heart studies. A post-approval study has been in process for some time. In the course of such studies the sponsors are supposed to be blinded to ongoing results, although interim analyses can be defined to the study. Such analyses are supposed to be done by third-party monitoring boards; only the recommendation is supposed to be communicated to the sponsor. Generally, the recommendation is just: stop for futility, continue, or stop for superior effect. Both futility and superior effect numbers will be specified in the trial design.

Orexigen got the details of the analysis, and promptly applied for a patent. It seems that, with ¼ of the patients tested, not only did the drug not cause heart issues, but lowered incidence of heart issues. Now, keep in mind that FDA ordered the study because one of the components is known to have some issues. Mixed with another component, viola, lowered heart issues.

Here's the problem: by unblinding the data, the conduct of the trial is blown up. To smithereens. While I've not seen it admitted yet, the need to file-first is likely the motivation. The individual compounds in the drug are public, so any bench chemist could make it and claim the heart benefits. Orexigen might well be able to fight such an application based on its pre-existing IP on the drug, but it would be a hassle, to say the least. So, blow the study to protect what might be enormous profits. "Contrave: lose those ugly pounds and save your ticker at the same time!!" Or such. Orexigen can't make that claim in promoting Contrave until FDA says it's a really proven fact, still having a patent claim first can't hurt.

What cynics call unintended consequences.

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