“Apparently, [opponents of Bayh-Dole] I thought the 4th time was the charm. Now they know better. And this time, the NIH has dealt a subtle but fatal blow to any attempt to retrace this path. ”
Perhaps Bayh-Dole critics have learned a painful lesson after their favorite theories were blown at every turn over the past two decades. Their carefully constructed claim that the law contains hidden provisions that allow governments to successfully set prices for products that have been commercialized has been criticized by every Democratic or Republican administration that considered it. It was rejected immediately.
They say the definition of insanity is repeating the same thing while expecting different results. No. Again, the National Institutes of Health (NIH) has rejected calls to “march” under laws banning the prostate cancer drug Xtandi.
Apparently, petitioners thought the fourth time would be a charm. Now they know better. And this time, the NIH has dealt a subtle but fatal blow to any attempt to retrace this path.
NIH: No March-Ins for You
Once again, on Tuesday, March 21, the NIH found that the legal standard is whether a product based on a federally funded invention has been successfully commercialized. Nothing gives the government the power to “march” to force university patent holders to license other companies just because someone doesn’t like the price of their product.
Below is the NIH statement, highlighting the key phrases.
An NIH analysis at the request of the petition found Xtandi to be widely available on the market. Additionally, given the remaining patent life and lengthy administrative process associated with the march-in procedure, the NIH does not believe that the use of march-in authority will be an effective means of lowering drug prices. For these reasons, the NIH has determined that initiation of march-in proceedings is not warranted in this case.
The decision is consistent with a 2016 NIH decision in which KEI and the Affordable Cancer Care Coalition invited the NIH and the Department of Defense to participate based on the price of Xtandi, but each declined. In response to the 2016 request for introduction of Xtandi, the NIH agreed that, consistent with the decision to introduce Cell Pro (1997), Norvir (2004, 2013), and Xalatan (2004), commercialization was defined as “manufacturing, implementation, and operation. ”, and “public availability and use …” of the invention.
Xtandi’s maker, Astellas, estimates that more than 200,000 patients were treated with Xtandi between 2012 and 2021.Accordingly, the patent owner, University of California, Because Xtandi is manufactured and marketed like any other prescription drug, there is no shortage of requirements to make Xtandi viable. (emphasis added). NIH has reviewed information submitted by current petitioners that is substantially identical to that submitted in 2016 and has concluded that Xtandi is still widely available as a prescription drug.
Note that the NIH said that the patent owner, the University of California, and not the developer, Astellas, met the requirements to commercialize the invention. That’s the key difference.
As we have pointed out many times before, unlike the other three march-in triggers, the first march-in trigger demonstrates a good faith effort to achieve practical application of the invention. Applies only to patent owners, not licensees.
Part of “commercialization” is defined as making sure that the invention is “available to the public on reasonable terms.” Twenty years after its enactment, critics took “reasonable terms” to mean “reasonable prices” and launched a series of petitions to governments against some drugs because they didn’t like the prices. I submitted the form, but it was unsuccessful. All such requests were properly denied.
If the intent of the law was to include “reasonable pricing,” this clause would have included licensees setting prices, as with other triggers. What this language actually refers to is the requirement that academic patent owners license on reasonable terms and monitor the efforts of licensees to put their inventions into practice.
NIH is a term often overlooked by the casual reader, and it does so elegantly and correctly emphasizes the meaning of the statute. But it’s a dagger to the heart of the critic’s treasured theory.
What made the NIH decision even more painful for those seeking to undermine the Bayh-Dole Act was the decision by Senator Bernie Sanders, despite the petition’s march to be pending for more than a year. The ruling comes just before the long-awaited hearing on the lawmakers’ health. The Education, Labor, and Pensions (HELP) Commission is designed to beat Moderna on the price of her COVID vaccine in commercial sales.
It was expected that Sanders would threaten to enforce his rights against Moderna. Instead, Republican senators’ only mention of the Bayh-Dole Act was to praise its contribution to the response to a devastating nationwide pandemic. Whether or not the NIH decision blew the wind out of Sanders’ efforts is uncertain, but the hearing wasted most of the expected drama.
potential battles to come
The NIH decision was a crushing victory for the Bayh-Dole system, but a single storm cloud appeared on the horizon. In announcing the decision, the Department of Health and Human Services announced the formation of a “government-wide” interagency working group for Bayh-Dole, along with the Department of Commerce, which oversees Bayh-Dole. Implementation of march-in clauses that clearly outline the guidelines and processes for making decisions when various factors, including price, may be considered in agency valuations. ”
who knows what that means. But the bottom line is that Bayh-Dole survived another important test. No doubt more battles await, but take a moment to savor the decisive victory.
Don’t forget to thank the stubborn people at the NIH who defied incredible political pressure to keep a very important law up.
Image Source: Deposit PHotos
Image ID: 202135568
Author: Pasta Seven Seven
