The ACLU v. Myriad Genetics Suit: Legitimate Challenge or Publicity Stunt?
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.
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[...] Office, et al. reopens the age old debate on patentability of human genetic material, but unlike other federal circuit cases which attacked the breadth and vast scope of rights granted to the holders of these patents, it [...]
Seems to me the ACLU has a good argument. The idea that isolated genes are an invention rather than a discovery seems about as plausible as the idea that newly discovered prime numbers are an invention and patentable for use in encryption.
Methods for discovering and using prime numbers should be patentable, but prime numbers themselves should not be. Methods for discovering and using genes should be patentable, gene sequences themselves should not be unless they are novel, artificially-constructed sequences with some utility.
If a company owns the gene “lock stock and barrel ” including any mutation, use of and research of then they are responsible for it and should be sued if that gene does you harm, If the can profit from it then they can be held responsible for it.
I think a class action suit from those affected adversely would allow the pharmaceutical companies to re think how much the want to own, just processing, testing, equipment and techniques. or the gene itself.
If a company owns the gene “lock stock and barrel ” including any mutation, use of and research of then they are responsible for it and should be sued if that gene does you harm, If they can profit from it then they can be held responsible for it.
I think a class action suit from those affected adversely would allow the pharmaceutical companies to re think how much the want to own, just processing, testing, equipment and techniques. or the gene itself.
Isn’t it quite sad that Myriad Labs is really more about the money than helping those of us with Breast Ca or our families. As soon as their patent expires, I just bet we might see BRCA3 and 4—strategic timing, don’t you think?? Who knows how long it may take me to pay off my bill from Myriad!! (and who really cares?) Thanks for the opportunity to vent.
Having come from a family inundated with a mutation to our BRCA 1 gene, and as a breast cancer survivor, there are numerous things about Myriad’s patent that are disturbing. One of the most alarming is the fact that they have collected data on over 400,000 people who tested for a BRCA 1 or BRCA 2 mutation. If only that data was shared with the rest of the medical community as well as those of us so anxious for answers, imagine the difference it might make. Several years ago, testing for a BRCA mutation was well over $3,000 for the first person in the family. Well before that, Myriad indicated that the cost of testing would come down. Instead, it is more expensive now than ever before. Myriad also supports direct to consumer marketing-in other words, rather than acknowledging that patients seek genetic counseling first before they test…..sell them the test, give the results, and let them wonder what to do next.
For sure, this is not a good thing. If a company is allowed to “own” a gene under patent, that means that they alone would have the ability to test and treat you. You wouldn’t even be able to get a second opinion. So, without a system of checks and balances, how honest do you think this company is going to be? They would have a complete monopoly in this area. The thought of it makes my skin crawl and my teeth grind.
I wish more people were interested in sciences in the USA. Myriad got a patent on a method to test for BRCA-1 and BRCA-2, genes that indicate a predisposition to get breast cancer.
It costs MONEY to get a PhD in bio sciences, and it takes long, hard work to get there. Yes, the test costs approx. $5000, but the people working to develop this test spent their youth studying to achieve this.
I am sick and tired of people feeling entitled to getting food stamps, free housing, free cell phones (the $10 Universal charge), etc., and now testing for cancer!!!!!!!!!!!!!!!!!!!!!!!
Where does it stop??????????????
What am I — a SLAVE who got a MS to pay for these expenses?
And who will do further bio research on cancer, Aids, etc. without MONEY????