Justice Department Files Brief Arguing that Isolated Genes are Not Patentable

In March, Judge Robert Sweet invalidated a number of patent claims directed to isolated gene sequences and methods of comparing or analyzing the sequences.  This case is now on appeal at the Federal Circuit.  The consensus is that the case will be reversed.  In a rather strange move, the Department of Justice has filed an amicus brief arguing that Judge Sweet’s opinion should be affirmed, at least with respect to isolated DNA.  No member of the Patent Office or Department of Commerce is listed on the brief.  It appears to have been written strictly by DOJ lawyers.

The brief begins with the argument that this case is about the distinction between human-made inventions and products of nature.  Engineered DNA molecules are human made and are thus eligible for patent protection.  Molecules that are engineered by humans or are manipulated by scientists and do not occur in nature are patent eligible.

The brief next goes on with the argument that isolated genomic DNA is not a human-made invention and is not eligible for patenting.  The DOJ does suggest that methods of identifying, isolating, or manipulating DNA sequences may be patented, but genomic DNA itself is a product of nature.

The DOJ acknowledges that this position is contrary to the PTO’s policy and the practice of the NIH and other government agencies.  Judge Sweet’s opinion in this case, however, was so persuasive that the DOJ needed to reevaluate its policy on these issues. 

The argument is that there are many items that are found in nature in only non-isolated forms that would not be patent eligible.  For example, coal beneath the earth, cotton fibers mixed with cotton seeds, and stigmas of the saffron flower are not found in their isolated forms.  Simply isolating them from the surrounding environment does not make them man-made inventions.  Similarly, there are many highly reactive elements on the periodic table that do not occur in nature in their separated elemental form, but only as chemical compounds.  These are also still products of nature. 

The argument is that the isolated product must be “different in kind” from the naturally occuring product to warrant patent protection.  In this case, isolated DNA is not different in kind from DNA in the human body.

Unfortunately, the DOJ relies heavily on a 1948 Supreme Court case that deals with obviousness rather than patent eligibility, Funk Bros. Seed Co. v. Kalo Inoculant Co., 333 U.S. 127 (1948).  This case dealt with the pre-1952 Patent Act standard of obviousness, rather than patent eligibility under § 101.  The case involved a new mixture of bacteria that were each individually old.  Thus, the question was whether the new combination was obvious over the known individual bacteria.  The Court ruled that it was obvious and thus the mixture could not be patented.

Justice Stevens made the same mistake in Parker v. Flook where he confused the arguments of patent eligibility and non-obviousness.  These are completely separate inquiries.  An invention may very well be eligible for patent protection, but not receive a patent because it is an obvious combination of what is known in the art.


It still seems likely that this case will end up at the Supreme Court.  It is not completely clear what will happen before that Court.  The Federal Circuit, however, will likely still reverse the district court’s decision.  Although Judge Dyk expounded his view this summer in a completely unrelated case that isolated DNA is not patent eligible, it is likely the other members of the court would stick to the precedent and history of granting such patents.

Why did the DOJ file this brief?  Where are the members of the Department of Commerce and the Patent Office who would presumably have expertise in this area?  This brief takes a position contrary to that taken by the US Chamber of Commerce where it argues that the plaintiff’s lack standing to bring this suit.

Most likely, the Commerce Department and the PTO do not agree with the position taken in this brief by the DOJ.  It is not surprising that the current administration is aligning itself with the position of the ACLU.  Both have now taken extreme positions in this case.

It is possible that the Federal Circuit will simply agree that the plaintiffs do not have standing to bring this suit because there is simply no threat of enforcement against them and no case or controversy between the parties.  The plaintiffs would then be required to appeal that ruling to the Supreme Court.  Given the expansive reading by the court of the MedImmune decision, that is unlikely.

This case just keeps getting more interesting.

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4 Responses to “Justice Department Files Brief Arguing that Isolated Genes are Not Patentable”

  1. Download Software » Blog Archive » Download Software | Niche Podcasting – Step-By-Step How To Podcast Guide & Videos Says:

    [...] Justice Department Files Brief Arguing that Isolated Genes are Not … [...]

  2. Researchers develop morpholino oligonucleotides that can turn off specific genes | Optimal Health Journey Says:

    [...] Justice Department Files Brief Arguing that Isolated Genes are Not Patentable « INVENTIVE STEP [...]

  3. Pharma & Biotech Global Week in Review 3 Nov 2010 from IP Think Tank Says:

    [...] DoJ amicus brief in Myriad says no to patentability of genomic DNA: AMP v USPTO (IPBiz) (Inventive Step) (Patently-O) (Patent Docs) (Holman’s Biotech IP [...]

  4. Federal Circuit Reverses District Court in Gene Patent Case « INVENTIVE STEP Says:

    [...] so holding, the court rejected the government’s view that isolated DNA should not be patentable, pejoratively referring to the government’s [...]

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