Patenting the Building Blocks of Life

by Michelle Meyer, Bioethics Program Faculty

Imagine a world in which useful inventions, such as drugs, are immediately freely available to all. This world may seem attractive, but the process of invention is often costly and fraught with risk of failure. If everyone else could free ride off of the hard work of the inventor, no inventor might have sufficient incentive to engage in innovation in the first place, and then no one would have the benefit of the invention.

Now imagine a polar opposite world in which inventions are forever the exclusive property of the inventor. Someone invents, say, a saw for cutting down trees, and if you want to cut down trees, you need to either pay the inventor for a license to use his saw or invent your own, different mechanism for cutting down trees. In this world, inventors who collect licensing fees would have ample incentive to invent, but as monopolies, they would hold their inventions hostage to any price they chose to charge.

The centuries-old U.S. patent system is designed to strike a balance between these two worlds, with maximal innovation its goal. By giving inventors property rights in their inventions, the patent system creates incentives to engage in useful innovation that will improve human welfare. And by limiting those property rights to 20 years and requiring the inventor to adequately describe the details of their invention, the patent system ensures that others may use and build on it.

The U.S. Patent and Trademark Office (PTO) issues patents to purported inventors for things (“compositions of matter”), methods for making things, or methods for using things. But disputes often arise over the validity of patents between purported inventors and third parties, which disputes courts often must ultimately resolve, setting precedent for other patents in the process. To be valid, the subject matter of the patent must be novel, useful, and non-obvious. But an even more basic requirement is that the inventor’s claims must concern patentable subject matter. The scope of patentable subject matter is quite broad, encompassing “anything under the sun that is made by man,” according to the legislative history of the 1952 Patent Act, except for (according to past Supreme Court cases) abstract ideas, laws of nature, and natural phenomena.

On April 15, the U.S. Supreme Court heard oral arguments in Association for Molecular Pathology v. Myriad Genetics, a case that will test just how broad the scope of patentable subject matter is by answering question: Are human genes patentable? At issue in the case is the validity of Myriad’s patents on isolated DNA from two human genes, known as BRCA1 and BRCA2. Women who have mutations in one or both of those genes, as most readers know, have a significantly higher chance of developing breast or ovarian cancer, and perhaps other kinds of cancers as well. No one disputes that both the method by which Myriad isolates DNA fragments from human blood is patentable (although Myriad did not invent this method, which has long been ubiquitous in molecular biology and is off-patent). Nor does anyone dispute that the use to which Myriad puts the isolated DNA — a particular disease risk prediction test — is patentable.

But are the isolated DNA fragments themselves patentable subject matter? All inventions are ultimately derived from nature. No one disputes that although a naturally occurring tree is not patentable, a wooden baseball bat made from that tree is, for instance. But how closely may a purported invention resemble nature and still be patentable?

The ACLU, patients at risk for breast and ovarian cancer, and various medical associations have asked the federal courts to declare that neither isolated DNA nor so-called cDNA — synthetic DNA that is complementary to and built off of naturally-occurring RNA — is patentable but are instead simply natural phenomena. Isolating fragments of DNA, they say, simply involves removing from the body a portion of naturally occurring DNA. Just as sawing off the branch of a tree does not entitle the sawer to a patent on either the tree or the branch, they say, removing a fragment of DNA does not entitle Myriad to a patent on either the isolated fragment or the embodied gene.

Turning to the innovation policy behind the patent system, the challengers argue that Myriad’s patents have prevented standard clinical testing of the BRCA genes, inhibited research on these genes, and prevented patients from accessing their own genetic information. They further argue that Myriad’s real contribution wasn’t any invention at all, but, rather, discovering the natural correlation that exists between cancer and specific gene mutations. They say that there are sufficient incentives for academics and others to pursue this kind of knowledge without the promise of a composition patent on genes. Those incentives include recognition and acclaim as well as process and use patents. Justices from both the “conservative” and “liberal” wings of the Court were clearly concerned about the effects on innovation of invalidating Myriad’s patents, and they seemed to find the latter, but not the former, incentives a compelling reason to think that these kinds of important discoveries would continue to be made.

Myriad, of course, disputes each of these points — as do half of the judges who have previously ruled on this case. The Supreme Court has not issued an opinion on what constitutes patentable subject matter in a composition patent in over thirty years, and this older jurisprudence itself is less than clear. In the absence of clarity, when determining whether a purported invention is sufficient different from natural phenomena to be patentable, some judges look to differences in structure, while others look to differences in function. The district court in this case, for instance, held that neither DNA nor cDNA is patentable since the function of both is the same, whether it exists inside or outside of the body. At the appellate level, one Federal Circuit judge, looking solely to structure, argued that DNA is patentable because isolating the DNA from the body necessarily changes its chemical structure. Another judge, arguing that the structural changes here occur only by virtue of the fact of Myriad possessing the DNA outside of the body, concluded that Myriad’s patents must fail. (Challengers in the case similarly note that the very utility of the isolated BRCA genes in predicting disease is that they are in fact identical, in all relevant respects, to the genes as they naturally occur in the proband’s body). Finally, the third Federal Circuit judge argued that both structure and function are relevant and found that Myriad’s patents passed muster on both counts, primarily because this position was consistent with PTO precedent.

On the matter of innovation policy, Myriad notes that it spent some $500m on developing its patents, and that invalidating those patents is likely to set a precendent that will stifle innovation throughout the biotech industry. Some scholars also argue that it is mere “myth” that 20% of the human genome has been patented, and that claims that “gene patents” have impeded medical research and practice are “wildly exaggerated.”

The Supreme Court permitted the federal government to appear during oral arguments. There, it took a middle approach that a majority of Justices seemed to find palatable during Monday’s arguments. Under this theory, although mere isolated DNA fragments are simply natural phenomena and hence not patentable, cDNA, which is man-made, is. Deciding whether an isolated gene fragment (or cDNA) is sufficiently different from that gene as it exists in its natural state ultimately involves making a choice to draw a line somewhere along a continuum marked by the tree at one end and the baseball bat at the other. Rather than allowing such metaphysics to rule the day, the Court may well lean on the purpose that patent law was designed to serve and look to the likely consequences on innovation of its decision. Although the scientific reality is a bit more complex than the DNA/cDNA distinction would suggest, some have argued that the distinction does have the significant benefit of roughly tracking important innovation policy concerns.

The Supreme Court’s ruling is expected in June.

[This blog entry is an original contribution by Prof. Meyer. Its contents are solely the responsibility of the author alone and do not represent the views of the Bioethics Program or Union Graduate College.]