BioPharm Executive: Patent Threats, and the Cheap Cost of R&D

Published: Aug 30, 2012

Patent Threats, and the Cheap Cost of R&D

Myriad Genetics won the latest battle in its long-fought struggle to maintain its patents on BRCA genes and related diagnostic tests. The case has been closely watched ever since a surprising court decision threw the patentability of genes--long assumed but never confirmed--into question.

Here's a quick recap of events: Back in March 2010, Federal District Court Judge Robert Sweet ruled in summary judgment that Myriad's patents on its BRCA tests were invalid because they described the mere isolation of natural DNA--something which "alters neither [the] fundamental quality of DNA as it exists in the body nor the information it encodes." Never mind that isolating DNA involves the exacting use of restriction enzymes to achieve a molecule that never existed before in nature; Sweet concluded that genes are natural and therefore unpatentable.

In July 2011, the Court of Appeals for the Federal Circuit (CAFC) overturned the more sweeping parts of that decision, leading the way to a Supreme Court appeal by the American Civil Liberties Union. Then, in March of this year, the High Court vacated the Circuit court decision and told them to reconsider it in light of another case it had just ruled on, Mayo Collaborative Services v. Prometheus Laboratories. That decision held that a diagnostic method relying on merely observing natural correlations in the body was unpatentable.

That catches us up to the present. With the ball back in its court, the CAFC on August 17 reaffirmed much of its original decision, leaving isolated genes as patentable inventions--at least for the time being. In recognition of Prometheus, the court did throw out parts of Myriad's patents relating to the comparison of isolated DNA samples to reference samples--the kind of abstract observation the High Court had rejected. But for the most part, the judges decided Prometheus was irrelevant to the issue at hand.

As Judge Alan Lourie but it in the majority decision, "Everything and everyone comes from nature, following its laws, but the compositions here are not natural products. They are the products of man, albeit following, as all materials do, laws of nature."

This probably isn't over yet--the case could be appealed yet again to the Supreme Court. While it probably won't have much direct impact on companies developing therapeutics, the outcome could matter very much to diagnostics companies. The Supreme Court decisions in Prometheus and another case, In re Bilski, suggest that the Justice aren't very friendly to the notion that abstract methods of observation, no matter how innovative or clever, can be patented.

On the one hand, Bilski stresses the importance of a "machine or transformation" being necessary for invention. In other words, an inventor must have come up with a unique device or otherwise transform matter to gain a patent. A theoretical diagnostic that uses well-established methods to observe the interaction of a patient sample against a panel of genetic markers might not count as an invention--particularly if those isolated markers are themselves ultimately determined to be unpatentable. The difficulty of finding and validating those markers may not be sufficient, and without patent protection, companies would be unlikely to undertake the expense or effort.

On the other hand, the court left a lot of wiggle room in Bilski, overturning a lower court finding that the machine-or-transformation test was all that mattered. It is this corner of the life sciences that will likely be looking most closely at what comes next. But with the growing importance of personalized medicine and companion diagnostics, everyone interested in the advancement of health care should be watching closely.

On another point altogether, I have to mention that Donald Light and friends are back again, and this time they've gotten the British Medical Journal to publish their fumbling thoughts on how "the widely touted 'innovation crisis' in pharmaceuticals is a myth." I had a go at Light last year when he and Rebecca Wharton published their original estimate that the "real" cost of developing a new drug is about $43 million. I'd be tempted to have a reprise, but I certainly wouldn't be able to match Derek Lowe's takedown at In the Pipeline, which is highly recommended reading. But honestly, I'm more concerned about the standards over at BMJ.

-Karl Thiel

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