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Apr 15, 2014

A Common Sense Discussion of Patenting Medical Diagnostics

Methods such as breakthrough diagnostic tests should be patentable, but the courts may disagree.

A Common Sense Discussion of Patenting Medical Diagnostics

The Ariosa decision could have a chilling effect on diagnostic research. [© rare - Fotolia.com]

  • A woman learns she is pregnant. After the excitement subsides, she wonders: “Will my child be healthy?” or “Will the baby have a birth defect?” Her husband, parents, and siblings also wonder. One or more prayers may be offered. Indeed, if a history of genetic anomalies exists, concerns are exacerbated. During pregnancy, if certain physical observations indicate that the child may have, e.g., Down syndrome, or other possible problems, what should she do? The options were limited. Prenatal screening is possible. But this only estimates the chance that a child will have Down syndrome, the most common birth defect in the United States. It is hardly definitive in providing results to the parents to allay their concerns. Diagnostic tests are also a possibility. While the results of amniocentesis or chorionic villus sampling are more definitive, the tests are particularly invasive and can result in the spontaneous termination of the pregnancy, i.e., a miscarriage. These were essentially the only options available to the future parents.

    Recently, however, a new blood test offers pregnant women a safe and much more accurate way to screen for, inter alia, Down syndrome. A confirmatory amniocentesis may still be required in certain cases, but the new test would send far fewer women for that risky procedure. As a result, miscarriages would be reduced. In addition, pregnant women will not suffer the anxiety from false positives that are much more common with existing tests. Indeed, data from one medical center demonstrate that the “positive predictive value” of the new test is ten times greater than standard tests. Another well-known research organization has called the test a “major advance.”

    One might think that the new test with its numerous benefits “promote[s] the Progress of Science and Useful Arts” and therefore, that this “Discover[y]” is worthy of “exclusive right[s]” under the U.S. Constitution, i.e., a patent. Not so, at least for now.

  • Patentable Subject Matter: The Troll Problem

    In Ariosa Diagnostics, Inc. v Sequenom, Inc., 2013 WL 5863022 (N.D. Cal. 2013), the District Court for the Northern District of California granted Ariosa’s motion for summary judgment and held, as a matter of law, that the asserted claims in Sequenom’s ‘540 patent were invalid; more specifically, they were not patent-eligible under section 101. We'll return to the Ariosa case below, but for a moment let’s step back and consider the question of patentable subject matter.

    When most people think of inventions they think of a “eureka” moment, where a previously challenging problem met its match in a clever and novel solution. But judicially created exceptions to the requirements for patentability exist, such that the discovery of a law of nature is not patentable. One of the most famous examples is that Einstein's “E=mc2” equation is not patentable. The law on what discoveries qualify for patents, i.e., are “patentable subject matter,” is found in 35 U.S.C. §101. That section of the patent laws has been the subject of extensive litigation and Supreme Court attention in recent years. Some commentators believe that the Supreme Court is using that section to tackle an unrelated problem: the prevalence and abuse of abstract or overbroad patents by patent assertion entities (a.k.a., “patent trolls”). Unfortunately, by using section 101 as a vehicle for reform, important diagnostic patents could inadvertently become collateral damage.

    While the troll problem is real, it thus far has mostly impacted technology companies and tends to involve software patents; however, the problem appears to be expanding to nontechnological retail and restaurant businesses. The debate over how and even if software inventions should be patentable is vigorous, and indeed, even the NY Times recently weighed in with an editorial against the patenting of such inventions. But truly problem-solving and detailed inventive methods—such as breakthrough diagnostic tests—should be patentable, even if a swath of other patents, from software to unmodified DNA or a “law of nature,” do not necessarily qualify. Whatever one's thoughts on patent trolls and software patents, it is important that one does not throw out the baby with the bath water. Unfortunately that appears to be what is happening, as can be seen in the Ariosa decision discussed below. 

  • Ariosa

    Returning to Ariosa and as previously noted, conventional prenatal diagnostic tests such as amniocentesis and chorionic villus sampling were invasive procedures with risks to both the mother and the fetus. Noninvasive DNA tests focused on detecting fetal cells in a mother’s blood because the presence of cell-free fetal DNA (“cffDNA”) was not known. The ‘540 patent was based on the inventors’ discovery that cffDNA is detectable in maternal serum or plasma. To put this discovery in context, Chief Judge Rader of the Federal Circuit Court of Appeals, in an earlier related opinion, stated that “the ‘540 patent discloses methods to identify fetal genetic defects by analyzing the fluid that had commonly been discarded as medical wastes…” and that the patented methods present “fewer risks” and  are “more dependable” than existing methods.

    In Ariosa, the parties agreed that neither cffDNA nor the discovery of cffDNA in maternal plasma or serum was patentable. Regardless, Sequenom contended that the claims were patentable because they covered the novel use of a natural phenomenon, rather than covering the phenomenon itself. In response, Ariosa argued that the claims did not cover patent-eligible subject matter because inherited cffDNA is a natural phenomenon, and the methods of processing that DNA were routine. 

    In its decision, the court pondered whether the claims added enough to the basic science such that they qualified as patent eligible under Supreme Court precedent. The court then parsed the claims into individual parts and queried whether that the additional elements added to the claims reflected an “inventive concept.” The court concluded that appending conventional processing steps to natural phenomena did not render the processes of the ‘540 patent patentable. Only an innovative use of a natural phenomenon would be patentable. Accordingly, after discussing various Supreme Court decisions focusing on section 101, the court held the claims invalid.

    The court’s decision is based on the combined effect of recent Supreme Court decisions. Without a further analysis of these decisions (there have been many), the Ariosa decision prompts two simple questions: Does the district court’s decision and its underlying reasoning promote the progress of science and useful arts? Did the inventors of the ‘540 patent make a discovery worthy of patent protection? One must conclude that the type of research, analysis and, most importantly, the results of the ‘540 inventors should be encouraged. It would appear, however, that this type of research is disincentivized by the court’s decision.

    Simply put, for commercial institutions, will the lack of patent protection for such discoveries influence their areas of medical research? Moreover, since many academic institutions receive research funds by licensing the resulting patents, will court decisions like Ariosa influence their areas of scientific endeavor?

    In view of the Ariosa decision, is it time to step back and analyze how recent court decisions will affect ongoing medical research and the possibility of future discoveries like the one embodied in the ‘540 patent?  Has the law gone too far in paying homage to the law of nature rule such that the progress of science and useful arts is jeopardized? The invalidation of clearly inventive diagnostic patents hurts everyone. Moreover, the public needs a solution to the collateral damage that will occur as a result of section 101 jurisprudence.

    The best opportunity may be with the U.S. Senate, which is now considering the Innovation Act, passed late last year by the House of Representatives. The provisions of this legislation are designed to discourage patent assertion entity (troll) activities. The legislation could be amended to make to make it clear that diagnostic patents, in appropriate circumstances, are patentable subject matter under section 101 of the patent laws. The two concepts have nothing to do with each other, but patent-related legislation is always politically thorny, so this opportunity should be seized. This addition to the legislation would not impact any of the efforts against patent trolls, nor would it impact the “gene patent” debate. Rather, it would alleviate some of the collateral damage to diagnostic patents that will be caused by the Supreme Court's recent approach to section 101.

    It is likely that the Senate would go along with this change because, as in the case of prenatal diagnostics, the cost to the public of disincentivizing discovery is real and immediate. The Senate, as it considers the Innovation Act, has an opportunity to bring some much needed clarity.



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