Diagnostic Patents Suffer Another Setback In US As Supreme Court Refuses To Hear Sequenom Appeal

from the outbreak-of-good-sense dept

In recent years, there have been a couple of really important US Supreme Court decisions in the biotech field. One is the 2013 judgment striking down gene patents. The other is a ruling from 2012 that rejected the patenting of basic medical diagnostics, in a case involving Mayo Collaborative Services and Prometheus Labs. The resultant loss for biotech companies in terms of devalued patent portfolios, and their reduced ability to control the market using intellectual monopolies, has been so serious that it is no surprise that there are periodic attempts to get these decisions mitigated through subsequent court rulings.

For this reason, the industry has been watching with great interest a case involving Sequenom, and its patent on a non-invasive pre-natal diagnosis test using the fact that fetal DNA is present in the blood plasma of expectant mothers. A lower court invalidated that patent on the basis of the Mayo decision, and Sequenom appealed to the Supreme Court to review the ruling. But a statement from the company has now dashed the biotech industry’s hopes:

The Supreme Court of the United States denied [Sequenom’s] petition to review decisions by lower Federal courts that the claims of Sequenom’s U.S. Patent No. 6,258,540 (“‘540 Patent”) are not patent eligible under the patent eligibility criteria established by the Supreme Court’s Mayo Collaborative Services v. Prometheus Laboratories decision. In the petition, Sequenom urged the Court to hear the case because the Court is uniquely suited to reconcile and interpret the patent eligibility criteria established in its Mayo decision. Sequenom will pursue no further appeal opportunities for review of the ‘540 Patent.

Although the industry will doubtless whine about how there is no incentive to produce new diagnostic tests, there’s no evidence that research and development in this area has ground to a halt in the US since the Supreme Court ruling on Mayo. All that has happened is that obvious applications of natural biological phenomena have been removed from patentability. Given the inherent reasonableness of that, we can probably hope that further challenges to Mayo will also fail.

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Companies: sequenom

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Comments on “Diagnostic Patents Suffer Another Setback In US As Supreme Court Refuses To Hear Sequenom Appeal”

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Re: Throwing the baby out with the bathwater...

That kind of thinking only works for Viagra and other mass market products. For the more sophisticated drugs for diseases none of your doctors have heard of, this kind of kindergarten thinking won’t work. Someone has to pay the piper. You don’t work for free, so why should you expect anyone else to?

While there are some obvious abuses, seeking to destroy all economic incentives is shortsighted.

This isn’t just some meaningless entertainment product.

Ninja (profile) says:

Re: Re: Throwing the baby out with the bathwater...

Remember Daraprim? Turing Pharmaceuticals?

I agree with you and that’s why I think the Government should support its citizens and bear the price of these uncommon, insanely expensive drugs IF their price is really justified. We both know this is not always the case.

I know some chemicals are insanely complex to produce, being a chemical engineer I see your reasoning and understand it but I don’t think it’s quite right to profit 10.000% over something that cost pennies to manufacture like it happens many times. You do have R&D costs involved but again we also know that the companies often inflate these costs a lot.

Remember Brazil simply broke the patents because the pharmas were abusing their control over certain HIV meds and we managed to bring it under some control quite quickly. The meds still cost thousands and the Government still needs to shoulder the financial burden but it’s way more sensible than it was before.

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