The practicalities of patenting a gene

The following contribution to our gene patenting symposium comes from Charles Rothfeld, Special Counsel at Mayer Brown in Washington, DC.

The question in Association for Molecular Pathology v. Myriad Genetics may strike a patent lawyer very differently than it does the generalist. The majority on the Federal Circuit approached the question as patent lawyers, looking at it from a technical perspective. That doubtless explains their counter-intuitive holding that a gene is patentable.

But that conclusion strikes most non-experts as very odd.  In fact, the very question – is it possible for someone to patent a human gene? – seems like something out of Brave New World. And that is bad news for Myriad.

The Justices are unlikely to have the same perspective as did the Federal Circuit. They are not patent lawyers, and they can be expected to approach the question in Myriad just as they did the very similar one in last Term’s Mayo Collaborative Services v. Prometheus Laboratories.  There they took a common-sense approach to the equally unlikely suggestion that it was possible to patent the correlation between the concentration of a particular drug in the bloodstream and the likelihood that a given dosage of the drug would or would not be harmful – a claim not much different from an attempt to patent the idea that a bowl of chicken soup is good for a cold. The Federal Circuit upheld that patent, too, but a unanimous Supreme Court had no difficulty holding the correlation patent invalid.

Justice Breyer’s opinion for the Court in Mayo focused on one consideration in particular that will have considerable salience in Myriad and that is likely to move the generalist Justices – the idea, “repeatedly emphasized” by the Court, “that patent law not inhibit further discovery by improperly tying up the future use of laws of nature.” That is a theme to which Justice Breyer, the Court’s resident patent authority, has returned with some frequency: his “tenure piece” as a young professor at Harvard declared that “a heavy burden of persuasion should be placed upon those who would extend [patent] protection.”

Is it likely that the Court will find a patent on a gene (a gene “isolated” by Myriad, to be sure, but one that at least two of the Federal Circuit judges believed to be materially identical to that same gene in its natural state) more defensible than a patent on a dosage correlation for administering drugs?  Almost certainly not, for two very practical reasons.

On the first side of the patent equation, it seems undeniable that allowing a single company to patent genes will retard innovation and increase costs. This reality has significant real-world consequences. The holder of such a patent on a scientific principle or correlation – or a gene – “may be able to use it to threaten litigation and to bully competitors,” as Justice Stevens put it in his Bilski decision. Extensive academic commentary, from scholars who will get some attention from the Justices, confirms that patents like Myriad’s choke off research. It could hardly be otherwise.

It does not take much imagination to see how exactly how such patents inhibit innovation and limit patient care. The academic research shows that it is not possible to “invent around” patents like these; after all, patenting a gene, by definition, gives the patent bolder monopoly control over the gene that extends to research and diagnostic uses.

The Court will see, both from the application of common sense and from a plethora of amicus briefs, that these concerns are not theoretical.  The HHS Secretary’s Advisory Committee on Genetics, Health, and Society found that patents on genes are discouraging follow-on research, hindering development of genetic tests, and discouraging laboratories from reporting medically significant results for fear of generating patent infringement liability. The American Medical Association and other medical groups – whose views the Court takes seriously – made this argument forcefully in Mayo, and has done so again in Myriad.

It also is impossible to deny that patents like Myriad’s, and the many other gene patents that would be sure to follow it if Myriad’s is upheld, will have an adverse effect on patient care, increasing the cost and reducing the availability of medical service. Allowing a single patent holder to control the use that is made of a gene prevents clinical testing by other labs, makes it impossible for patients to get second opinions, and keeps other labs from offering competing tests at a lower price. And this, effect, too, is plainly visible.

A Court that cares about the practicalities when thinking about patents can’t be happy with these obvious effects of a patent like Myriad’s.

What of the second side of the patent equation? That asks whether a patent is essential to encourage innovation – where, it will be recalled, then-Prof. Breyer would impose “a heavy burden of persuasion” on the would-be holder of intellectual property. And here, as well, what the Court already has said suggests that Myriad will not get much sympathy.

Basic medical research – as opposed, for example, to the development of particular pharmaceuticals – may be an area where common sense tells the Justices that patent protection is uniquely unnecessary. One would expect academic researchers and physicians to investigate the causes of breast and ovarian cancer without the promise of a patent at the end, as the AMA and academics have promised the Court. Academic researchers typically have many motivations – advancing knowledge, getting tenure, doing good – but profiting from a patent on the results of their basic research generally isn’t one of them. Much of this research, after all, is funded directly by the federal government, and will take place whether or not anyone sees the prospect of getting a patent at the end.

And the common sense is again backed up here by empirical evidence. The HHS Secretary’s Advisory Committee looked specifically at genetic research and found no case in which possession of exclusive rights was necessary either to encourage the development of a particular genetic test or resulted in faster test development.

This all puts Myriad in a very tough spot. The Court’s doctrine invites it to add up the pluses and minuses of the patent: does it do more good than harm? The context here would seem to make that an easy calculation. On the minus side: documented higher prices and less help for women who fear breast or ovarian cancer; less research; and fewer scientific advances – effects that would be felt widely as other genes are patented. On the plus side: not much. A Court that began its most recent patent decision by worrying about patents that “would risk disproportionately tying up the use of the underlying natural laws” is unlikely to find this a difficult decision.