In the closing days of March, the US District Court for the Southern District of New York handed down a ruling that helps clear up the emerging area of genetic patents. Their solution? You can't have them. Composition claims on isolated DNA sequences and method claims on the use of those sequences for diagnosing breast and ovarian cancer fail to qualify as patentable subject matter under 35 U.S.C. 101.

The court, in good form, avoided the topic of First Amendment Law that the plaintiff alleged was breached when the USPTO granted a patent regarding two genes used for Breast Cancer screening. Judge Sweet was persuaded that an “isolated” gene is no different from a gene in its natural environment of the body.In Diamond v. Chakrabarty, the Court held that products of nature can be patentable if the inventor makes a change to that product of nature such that it becomes markedly different.

The Court found that DNA possesses unique characteristics that distinguish it from traditional chemical compounds that change readily when isolated and purified.   Those unique qualities, both structural and functional, are identifiable in DNA’s naturally occurring state and do not change into something markedly different when DNA is removed from the body, according to the Court. If that was the case, the DNA would serve the same utility for testing.

It should be noted that this is just the first court of impression and that a number of appeals will likely follow, however Judge Sweet made a good decision (his idea of writing a 156 page opinion however, is terrible). We toe a dangerous line when we try to patent certain portions of DNA. The DNA itself is naturally existing - we're born with it - perhaps not the exact copy but one similar enough to provide a similar function. The USPTO has granted patents before that isolated certain naturally existing compounds, but only because the invention took steps to transform and isolate this chemical into a pure form.

DNA inside the body, and DNA outside the body are exactly the same - nothing occurs that makes them markedly different. Not only was this decision sound patent law, but smart policy as well. To hold a lengthy monopoly on the very material that provides instructions to the human body seems offensive.

The ruling seems to have had a negligible result on the biotechnology market. One article from the New York Times stated:

But the industry is already moving to a period of somewhat less dependence on DNA patents for its sustenance. Diagnostic laboratories, for instance, are shifting from testing individual genes to testing multiple genes or even a person’s entire genome. When hundreds or thousands of genes are being tested at once, patents on each individual gene can become a hindrance to innovation rather than a spur. 

It seems that other industries are competing very well without the benefit of a patent.

There is thriving competition in areas like testing for mutations that cause cystic fibrosis or Huntington’s disease, even though no company has exclusivity. “It’s quite demonstrable that in the diagnostic area, one does not need gene patents in order to see robust development of these tests,” [Dr. Evans] said.

The cure for the whole industry (and our better health) might be to take two aspirin and call in the morning. It seems the industry can thrive and continue to enable generativity without the crutch of a DNA patents.

As for that call in the morning, lawyers are anxiously waiting upon the court to resolve In re Bilski (which Judge Sweet relied on heavily) to see how it will apply to this case.