By now everyone has heard of the ACLU-instigated suit against Myriad’s patents on the breast cancer susceptibility genes BRCA1 and BRCA2 (read: ACLU release; the complaint). These patents emerged from research at the University of Utah and were assigned to Myriad, a private spinoff. The broadest product claims cover “an isolated DNA coding for a BRCA1 [or 2] polypeptide [protein], said polypeptide having the amino acid sequence” listed in the patent. Related patents also challenged in the suit cover methods for screening for genetic mutations. As a result of these patents, research and diagnostic testing involving BRCA1/2 must be done by or with the approval of Myriad, usually at some cost.
The ACLU has assembled a broad coalition of authoritative and sympathetic plaintiff. They include medical and scientific organizations, individual researchers and physicians, the women’s health cooperative that publishes Our Bodies, Ourselves, and cancer patients who allege that they need but cannot afford (and cannot get their insurers to pay for) BRCA1/2 testing. The defendants are Myriad, the U.S. Patent and Trademark Office, and several directors of the University of Utah Research Foundation.
The suit comes against the background of some recent decisions that nibble around the edges of gene patentability. Earlier this year, in In re Kubin, 561 F.3d 1351 (Fed. Cir. 2009), the Federal Circuit affirmed the PTO’s obviousness rejection of a patent on polynucleotides that encode natural killer cell activation proteins (the NK cells help fight infections and cancer). The holding was that it would have been obvious to try to isolate these nucleotide sequences in light of existing knowledge of the proteins in question and the sequencing methods. Back in 1995, in In re Deuel, the Federal Circuit had had rejected this “obvious to try” objection to a generally comparable gene patent. But now the same court took the view that the Deuel had been “discredited” by the Supreme Court’s 2007 obviousness decision, KSR International v. Teleflex.
Also this year, in Ariad v. Eli Lilly, 560 F.3d 1366 (Fed. Cir. 2009), the Federal Circuit invalidated a Harvard patent on a method to treat disease by reducing the activity of a “messenger” protein that regulates gene expression in cells for failure to comply with the written description requirement of section 112 of the Patent Act. The court clearly intended to send a strong message of concern about the “vast scope of generic claims.”
The ACLU suit, by contrast, is a frontal attack on the patentability of genes-and a highly unusual one at that. The plaintiffs characterize-or perhaps caricature-Myriad’s product patents as “claims on natural human genes,” on the scientifically plausible theory that isolated genes are of interest precisely, and only, because they perform the same function and contain the same information as their natural counterparts. All of the Myriad patents are said to violate the products of nature/laws of nature limitation that the Supreme Court has read into the patentable subject matter statute (section 101 of the Patent Act) as well as Article I, Section 8 of the Constitution, which authorizes Congress to grant patents to “inventors” on their “discoveries.” The patent method claims (caricatured as claims on “thought or abstract ideas”) are also attacked as violating the First Amendment.
The whole biotechnology industry would be turned upside-down if the courts were to agree with the ACLU that isolated genes do not constitute patentable subject matter. So does this attack on gene patents have any realistic prospects for success? Given the state of the precedent, the district court in New York will have no basis for throwing out the product claims, although it might narrow some of the methods patents. The Federal Circuit has the authority to reinterpret or reverse its own cases (most importantly, Amgen back in 1992), but is far more likely to continue on its current course of limiting gene patents at the margins.
Should the Myriad case get to the Supreme Court, though, all bets would be off. In the 1996 case of Laboratory Corp. v. Metabolite Labs, the Court came out of left field and ordered briefing on the question of whether a medical biotechnology patent violated the laws of nature doctrine. Then, equally unexpectedly, it dismissed the case without deciding it. Justices Breyer, Stevens, and Souter wrote a strong dissent from the dismissal in which they said that the patentees had “simply described the natural law at issue in the abstract language of a ‘process.'” So there is some concern on the Supreme Court that biotech patents have gone too far. In a couple of years we may finally find out just how deeply that concern runs.