Can Companies Patent Human Genes? A Myriad of Problems with the Court’s Answer

by Bryan Suchenski (3L Class of 2014)
March 28, 2014

Last June was a busy time for the Supreme Court, and amidst a flurry of important decisions, it was easy to let opinions slide through the news cycle without a careful analysis. So when the Supreme Court announced its decision in Association for Molecular Pathology v. Myriad Genetics (Myriad), unequivocal victory was declared for the public interest. The New York Times headline read “Justices, 9-0, Bar Patenting Human Genes” and the ACLU’s blog nearly shouted, “VICTORY! Supreme Court Decides: Our Genes Belong to Us, Not Companies.”

One month later, Myriad, the same company that had lost its case before the Court, filed patent infringement suits against two smaller companies concerning the same genes that were the subject of the June decision. How is that possible? A closer reading of Myriad reveals a problematic opinion that simply fails to address the core issues at stake in the gene patent debate.

The Decision

What was this case about? Myriad Genetics owned patents on “isolated DNA molecule[s]”, including BRCA1 and BRCA2, which can indicate a predisposition to breast cancer. The company then built its business on offering an exclusive test on the isolated gene, and suing anyone else who attempted to offer breast cancer screenings based on the same gene. This resulted in both a heightened price for clinical tests, and a potential roadblock for other researchers, leading the Association for Molecular Pathology, several universities, and several patient advocacy groups to go to court in order to have the Myriad patents invalidated.

The case made its way up to the Supreme Court, which rendered a unanimous decision on June 13th, 2013. The Court invalidated Myriad’s patents on isolated genes, on the basis of the fact that a DNA sequence found in humans “is a product of nature and not patent eligible merely because it has been isolated.” However, there was a second variety of patent at issue in the case – patents on complementary DNA, or cDNA. A cDNA molecule is made by copying all of the protein-coding portions of a particular gene, and thus contains the same code as the naturally occurring gene, except that excess non-coding segments (called introns) have been removed. The Court held that cDNA, since it was prepared in a laboratory, could be patented.

This distinction drawn between cDNA and naturally-occuring DNA, or gDNA, is at the heart of the logic of the Court’s opinion. What the opinion notably does not rest on is the competing interests of those who invest in patents and the public at large.

The Public Interest

There is a great deal of popular interest in the question of patentability of human genes. Patents on genes can make not only tests, but potential treatment options for many patients expensive or simply unavailable, while independent researchers may run into roadblocks in trying to progress knowledge because making any use of a patented molecule is an infringement of a patent owner’s intellectual property rights. On a more basic emotional level, however, many individuals simply feel that it is wrong for a private company to “own” a DNA sequence that naturally occurs in human bodies.

At first glance, the Court’s decision does seem like a victory for the public interest because it declares naturally occuring genes ineligible for patent protection. However, isolating a gene is only the first step in most clinical or research applications of gDNA, and the second step in many of these applications is to create a copy of the exons – cDNA. As a result, many important avenues of research that involve an isolated gene sequence are still blocked by cDNA patents. Even the narrow situation presented in the Myriad case, diagnostic tests of BRCA1/2 to assess a woman’s risk of breast cancer, expose clinicians to potential lawsuits because of the surviving cDNA patents .

This is particularly troubling because as with gDNA, a company that patents a cDNA sequence does not invent the genetic sequence, which leads one to ask – what is the patent office incentivizing by granting such patents? The patentee does not have to discover a new specific new use for the cDNA sequence, nor a new method of creating it. The patent for a sequence can theoretically go to the first company that happens to produce cDNA in a lab even if the gene in question is already understood, and the patent, once granted, prevents any and all use of that genetic sequence in cDNA.

One response is to point out that the Supreme Court only ruled on subject matter eligibility – a patent on cDNA can still be denied by the USPTO for other reasons, namely lack of utility or obviousness. The utility requirement does place some barrier in the way of a research firm patenting huge swathes of DNA without rhyme or reason, but it is a small barrier, because the existence of any single known use for a particular gene allows a patent holder to monopolize all future uses, known and unknown (including uses that will be left undiscovered because of the effect the patent has on research).

The obviousness criterion could potentially be a very important tool for filtering out inappropriate patents, because the process of creating cDNA is “well understood,” to use the Court’s language, and it should be a obvious step to anyone studying a particular gene. However, technically the patent act only invalidates a patent if it obvious relative to other patents or published discoveries and inventions (called “prior art,” see 35 USC 103). Even though human genes are “naturally occurring,” an invention based upon them is not obvious unless that gene has been described in a patent or publication, and since the Supreme Court just invalidated patents on isolated genes, it is now even less likely that any such publication will preempt future applications for patents on cDNA (though there are other ways to find a patent application on a gene obvious – see In re Kubin). In short, the patentability of cDNA provides research firms powerful patent tools nearly as extensive as they would have had if the Supreme Court came out differently in Myriad.

Patent Applicants

So if the above is all correct, should patent applicants be happy about the Myriad opinion? The answer is still no, because the Court’s logic is far more broad than it admits. The distinction the Court relies upon, between substances that are “naturally occuring” and those that are not, buries a century-old line of cases that defined when “extracts” or “purified” forms of naturally-occurring substances can be patent-eligible, starting with Learned Hand’s 1911 decision granting a patent on extracted adrenaline. Although the Court claimed that it’s holding was limited to isolated genes, it’s emphasis on “naturally-occurring” substances, if taken seriously, could entirely eliminate discovered compositions from patentability (in spite of the language of 35 USC 101, which provides that patents can be given to “anyone who invents or discovers any new and useful process, machine, manufacture, or composition of matter”).

The question of policy again rears its head. If the purpose of patent law is to incentivize new inventions and discoveries, then why does it matter that a discovered substance is naturally occurring if it has never been available to public previously? Perfectly good answers could be given to this question – perhaps the protection available from patents on particular uses of discovered substances are sufficient to incentivize discovery without unduly restricting public access to the substance. The Court, however, fails to even raise that question, and provides no reason to believe that the line between “naturally occurring” and artificial compositions is the line that actually promotes the most good.

The Point: Balance of Interests

The point is that the Court’s opinion in Myriad attempts to address an important issue by reference to an irrelevant distinction. Even if the outcome – providing broader access to testing for breast cancer – seems good, in practice the Court has left the plaintiffs in nearly the same situation they were in before, and potentially confused the debate about the proper scope of eligibility for patents on genes by focusing on the wrong issues. The confusion surrounding the decision is made even more clear by Scalia’s concurrence, in which he joins the entire opinion except “portions…going into fine details of molecular biology.” By his own admission, he doesn’t understand the science well enough to have a valid opinion on the matter.

What we need is an opinion that actually wrestles with the core issue in debate – the balance between the need to incentivize research and the need to protect the public’s access to their own genetic information. This is far from the last we’ll hear on the issue.