On January 13th, AMP et al. filed a 59 page brief contended that human DNA, including DNA fragments, RNA and cDNA, should not be considered patent-eligible under 35 USC s. 101. There is a lot to read here, much of it argued and re-argued in past reviews, but a few points stand out—way out.
Petitioners’ arguments rely on three primary propositions. The first is that DNA is a natural product that is not “markedly changed” by isolation from the body, because it is “foremost an informational molecule.” But this argument is undercut by their argument that “[i]solation is a necessary step in any serious study, research, clinical or commercial use” and “it is currently not possible to use genes, including looking at or sequencing them, without removing or ‘isolating them’”. Brief at pages 41 and 5. Doesn’t that compel the conclusion of a change of some sort from the gene as it exists in vivo? Also, in conflating the sequence (…ATTAGGAA…) with the actual isolated molecule, AMP ignores a long line of precedent that holds that, e.g., MeCO2H, may contain information about the structure of acetic acid but it is not acetic acid – that a claim to a compound is directed to both its formula and its properties.
The second proposition, repeated tirelessly, is that the claims are disgracefully overbroad, given the disclosure in the specification, and encompass “millions and millions” of genes and gene fragments, most of which Myriad did not isolate. But this is an argument that the claim is invalid as broader than the enabling disclosure and belongs in an analysis of patentability under s. 112(1), not under s. 101. The argument also undercuts the later argument that “another entity cannot invent a gene that embodies a person’s BRCA1 and BRCA2 genetic information.” Brief at 44. No mention is made of inventions of selection. Also, we patent attorneys should be offended by AMP’s reading of a “consisting of” claim to a specific DNA sequence –claim 2 of the ‘282 patent—to include “all versions of the nucleotide sequence (and more).” Brief at 14.
And this leads into the heart of the Brief, which is that the patent claims preempt, without exception, all future research involving any use of the claimed DNA for any purpose; “These patents preclude using the DNA for the development of drugs, instruments, and treatment methods [including] the potential applications of isolated DNA in new therapeutics, biomedical devices and instruments, and sequencing technologies.” The Brief makes one indirect reference to the common law research exemption from infringement liability on page 56, where the authors distinguish permissible investigations of a patented carburetor, which can be examined to see how it works and improved upon, from DNA: “[o]nce a human gene is patented, nobody can invent a new human gene, and nobody can access that particular genetic information.” Brief at 56.
Apart from the fact that the scope of the common law research exemption is far from settled, for some reason, the authors fail to distinguish the Supreme Court’s holding in Merck v. Integra, 545 US 193 (2005), in which infringement of research on patented peptides comprising a naturally-occurring peptide motif (the RGD peptides), was found to be well within the “safe harbor” of 271(e)(1), and thus exempt from infringement liability. Furthermore, while disclaiming any holding on the permissible use of “research tools”, the Court stated that the use of the peptides to make antibodies that might have therapeutic utility and the use of the peptides as positive controls in screening for small molecule anti-cancer agents was also within the safe harbor.
Perhaps the final irony of the Brief’s argumentation and constant citation of the Prometheus decision (“passim”) is that “[t]hrough its patents, Myriad not only commands the law of nature that is embodied by the BRCA genes, but also laws of nature… [A]s to how the genes might be linked to diseases other than breast and ovarian cancer – key scientific insights required for the development of personalized medicine.” Well, it is well and good to speak out for the freedom for researchers to have “key scientific insights” that would advance personalized medicine– just don’t try to patent any of them.