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DOJ Gets Confused About Patent Law

November 9, 2010

The DOJ has recently submitted an amicus brief in AMP v. Myriad (Fed. Cir. 2010) arguing that isolated genes are ineligible patentable subject matter under 35 U.S.C. §101. The DOJ does advocate that human engineered genes should be patent eligible, and focus their argument on naturally occurring isolated DNA sequences. In so doing, the DOJ jumbles together 35 U.S.C. §§101, 102, and 103, confusing the issues of patent eligibility with patentability. Moreover, the brief fails to understand the policy concerns and implications of their position.

The DOJ argues that isolated genes are unpatentable because they are a “product of nature.” In so arguing, the DOJ jumbles statutory sections, and bases its position on novelty (35 U.S.C. §102) and obviousness (35 U.S.C. §103) rationale.

Naturally occurring chemicals, claimed in isolated form, are patentable. Schering v. Geneva 339 F. 3d 1373 (2003). DNA, as a chemical, is no different from other naturally occurring chemicals. All bioactive chemicals do something, just because DNA provides the starting point for the production of another molecule should have no bearing on its patent eligibility.

In Schering, the Federal Circuit held that a naturally occurring metabolite of a drug was unpatentable under §102, because it was inherently anticipated when produced by the human body. However, the court noted that if the metabolite were claimed in isolated or purified form, it would be patentable. No §101 issue was raised, because, as in Myriad, it is not an appropriate argument.

For another example, it is common and appropriate for chemicals from plants to be isolated or purified and then patented. It is inappropriate to draw a distinction between DNA and other chemicals. These chemicals, along with isolated DNA are new, useful compositions of matter, or at least improvements thereof, and as such are patent eligible subject matter under §101.

The DOJ uses §102 novelty reasoning when it argues that isolated DNA is not patent eligible subject matter, stating that because the “basic natural relationships” between the molecule that the DNA codes for, and the molecule itself is a “natural phenomena”. This argument is analogous to the chemical-metabolite inherent anticipation fact pattern in Schering. Like DNA transcription, a natural phenomena causes the drug in Schering to be transformed into the metabolite at issue. The Federal Circuit correctly ruled that the metabolite is not novel under §102, but not that it is entirely patent ineligible.

The DOJ further confuses §101 with §103 obviousness when it argues: “Isolation does not transform a product of nature into a man-made invention.” In other words, the DOJ is arguing that there is no “inventive step” involved in the isolation of DNA. Those familiar with foreign patent law will recognize that “inventive step” is analogous to obviousness in other jurisdictions. Therefore, the “transformative” argument has no place in §101, but rather §103.

 

When analyzing policy considerations of DNA patent eligibility, it is clear that to further progress in genetic research, isolated DNA sequences should be patentable. Patents are vital to progress in the medical field because of the tremendous investment required, and the ease with which innovation can be copied. To promote progress in genetic research, broad patent eligible subject matter is required.

Those opposing patents on isolated DNA shortsightedly argue that it is unfair that some women are unable to afford the patented breast cancer screening tests, and this lack of access should bear on patent eligibility. Removing isolated DNA from patent eligibility may give a few people low-cost treatment in the very short-term, but would kill innovation in the field, preventing society as a whole from benefiting. While it is a tragedy that some are unable to pay for cutting edge cancer screening, or any other cutting edge medicine, a greater tragedy still would be if everyone were to be denied new treatments. Without patents, medical innovation would slow drastically because of a lack of funding, preventing society as a whole from access to medical progress. Thus, the policy argument against patent eligibility is shortsighted, progress in the field is clearly driven by the patent system, and therefore policy favors isolated DNA patent eligibility.

In arguing against the patent eligibility of isolated DNA the DOJ sets forth novelty and obviousness reasoning thinly veiled to use patent eligibility language. Further, the DOJ fails to appreciate the patent policy implications of their position. There may be strong arguments that this particular isolated DNA is not novel under §102, or that it is obvious under §103, but eliminating the entire field of DNA research from patent eligibility is too extreme a measure. Hopefully, the Federal Circuit will see through the DOJ’s reasoning, and hold isolated DNA to be patentable by overruling the district court decision.

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2 Comments leave one →
  1. April 23, 2011 2:34 pm

    After listening to the Myriad oral arguments, I was struck at how complex and sometimes even confusing the government’s argument was. It felt like they were trying to force a complicated rule to 101, but I agree with you that there is no need because the other rules do a pretty good job (102, 103, 112).

  2. July 28, 2011 7:02 pm

    In this thread David Connaughton, Jr. confuses the gov’s argument with the gov arguing section 102/103.

    Gj David.

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