Posts Tagged: "myriad genetics"

Federal Circuit Panel Rehears ACLU, Myriad Gene Patent Case

Although predictions on the outcome of an unusual case such as this are probably worthless, I think that it is most likely that this panel will rule in 2012 the same way that it ruled in 2011. It is probably safe to presume that the judges are fairly entrenched in their positions. In my view, no arguments were presented which show that Mayo was a game-changer with respect to the isolated DNA claims and the screening method claim. In particular, AMP’s main point about the relevance of Mayo—the preemption argument—was harshly criticized by Judge Moore. Among the three members of the panel, Judge Moore would appear to be the most likely to change sides, and I do not see this happening. Thus, I expect the same outcome as last year. However, the long-term outcome is much murkier, with an en banc hearing and/or a Supreme Court appeal almost certain.

Debunking the Gene Patent Mythology: Professor Holman’s Supplemental Brief in the AMP Remand*

Professor Holman not only teaches patent law at UMKC, but has a Ph.D. in biochemistry and molecular biology, as well as well as some post-doctoral drug discovery research experience. In other words, Professor Holman speaks as one who understands both the patent law and the technology involved in the AMP case. And what Professor Holman’s supplemental brief does is debunk the “gene patent mythology” fabricated by ACLU, PubPat, (and others), as well as “ a number of assumptions regarding the nature of the claimed subject matter” made by the original Federal Circuit panel which he characterizes as “unsupported at best, and in some instances clearly mistaken.”

Chakrabarty Controls on Isolated DNA Sequences, not Mayo*

Unfortunately this unspecific remand by the Supreme Court in AMP vacates as well the two-to-one ruling by this same Federal Circuit panel (Judges Lourie and Moore in the majority, Judge Bryson in dissent) that the claimed isolated DNA sequences were also patent-eligible under 35 U.S.C. § 101. What, pray tell, does Mayo Collaborative Services change with regard to that ruling in the original AMP decision? For those, like the plaintiffs in AMP (including the ACLU), who would like to upset this “applecart,” they’re likely to be very disappointed. I can describe what should be the impact of the ruling (and reasoning) in Mayo Collaborative Services on the claimed isolated DNA sequences in three short monosyllabic words: NONE AT ALL. And the Federal Circuit can (and should) say likewise, perhaps in far more words.

The Prometheus Decision: No Worries, No Problem

Unlike many in the biotech community I do not think the Prometheus decision will break the biotech industry or even seriously affect it. Much like the car mechanic in a small Caribbean island told me when my engine light came on in my rental car, “no worries, no problem!” I believe the holding in Prometheus prevents what could be a future legal quagmire, where overly-broad patents could serve to block entire fields of practice and create an enforcement nightmare in which ghosts of legal uncertainty and licensing ambiguities would haunt hospital hallways, R&D labs, boardrooms, and investment entities throughout the country. If the Prometheus decision would have gone the other way, it would not have been status quo, but rather been fairly harmful to future innovation.

Myriad: Isolated DNA claims from “ball bats in trees,” and “kidneys” to “magic microscopes.”

The basic argument in Myriad is whether DNA that is isolated from the chromosomes is statutory subject matter, or whether it is a product of nature. The stakes are high in the Myriad case, since the isolated DNA claimed by Myriad encodes mutated BRCA1 and BRCA2 proteins that can be used to detect breast cancer. Myriad has the only test offered in the United States because of its aggressive enforcement of its several patents. The numerous plaintiffs in the case speak to the core of the patent versus non-patent debate: whether patents actually “promote the progress of science and useful arts” as required in the U.S. Constitution. Myriad and other companies heavily reliant on biotechnology patents, would support the argument that strong patent enforcement allows companies which have invested millions or billions in assay or drug development for clinical use to recoup their investment and provide a return for investors. The plaintiffs would argue that such patents not only hinder the useful arts, but also endanger lives and/or drives up the cost of providing potentially life-saving testing and treatment.