Now patenting ... you
By Jennifer J. Foster
I was never much of a science geek in school. A regular geek, sure, but that geekiness kept mostly to English and Social Studies.
SIDEBAR: Don’t ever ask me to do math for you. END SIDEBAR
But there’s an important story on the wires today that demonstrates why a basic understanding of science is so critical to being a good citizen.
Patents on two human genes linked to breast and ovarian cancers are being challenged in court by the American Civil Liberties Union, which argues that patenting pure genes is unconstitutional and hinders research for a cancer cure.
“Knowledge about our own bodies and the ability to make decisions about our health care are some of our most personal and fundamental rights,“ said ACLU Executive Director Anthony D. Romero. “The government should not be granting private entities control over something as personal and basic to who we are as our genes.“
The ACLU, joined by Yeshiva University’s law school, filed the lawsuit Tuesday in U.S. District Court in southern New York against the U.S. Patent and Trademark Office, Utah-based Myriad Genetics and the University of Utah Research Foundation.
Did you know that the U.S. Patent Office is trademarking human genes?
We’re not talking about replicas here. These are the real things, baby:
Myriad and the research foundation hold patents on the pair of genes—known as BRCA1 and BRCA2—that are responsible for many cases of hereditary breast and ovarian cancers.
The ACLU contends that patenting the genes limits research and the free flow of information, and as a result violates the First Amendment. The lawsuit also challenges genetic patenting in general, noting that about 20 percent of all human genes are patented—including genes associated with Alzheimer’s disease, muscular dystrophy and asthma.
Holy science fiction, Batman!
This is wrong on so many levels. For proof, let us don our tweed sport coats and spectacles and grab our pipe (isn’t that what inventor-scientist-types do?) and review the helpful explanatory language about patents provided to us by the ... United States Patent and Trademark Office.
First, class, what can be patented?
In the language of the statute, any person who “invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent,” subject to the conditions and requirements of the law. The word “process” is defined by law as a process, act or method, and primarily includes industrial or technical processes. The term “machine” used in the statute needs no explanation. The term “manufacture” refers to articles that are made, and includes all manufactured articles. The term “composition of matter” relates to chemical compositions and may include mixtures of ingredients as well as new chemical compounds. These classes of subject matter taken together include practically everything that is made by man and the processes for making the products.
The patent law specifies that the subject matter must be “useful.” The term “useful” in this connection refers to the condition that the subject matter has a useful purpose and also includes operativeness, that is, a machine which will not operate to perform the intended purpose would not be called useful, and therefore would not be granted a patent.
Interpretations of the statute by the courts have defined the limits of the field of subject matter that can be patented, thus it has been held that the laws of nature, physical phenomena, and abstract ideas are not patentable subject matter.
Human genes: Useful and operative? Check, and check.
But they are not processes, though they can be isolated and examined using processes that are patentable (patentable? Go with me here, people). Neither are they machines or manufactures. They exist in nature, which probably means they can be classified as “physical phenomena.”
But let’s give them the benefit of the doubt and grant them that “discovers any … composition of matter” phrase. What type of patent could we receive?
There are three types of patents from which to choose, class:
1) Utility patents may be granted to anyone who invents or discovers any new and useful process, machine, article of manufacture, or composition of matter, or any new and useful improvement thereof;
2) Design patents may be granted to anyone who invents a new, original, and ornamental design for an article of manufacture; and
3) Plant patents may be granted to anyone who invents or discovers and asexually reproduces any distinct and new variety of plant.
Which group do you think the folks at the patent office assume human genes belong in?
I guess, for the sake of argument, we’ll go with the utility patent.
That brings us to the the purpose of a patent itself:
A patent for an invention is the grant of a property right to the inventor, issued by the United States Patent and Trademark Office ... The right conferred by the patent grant is, in the language of the statute and of the grant itself, “the right to exclude others from making, using, offering for sale, or selling” the invention in the United States or “importing” the invention into the United States. What is granted is not the right to make, use, offer for sale, sell or import, but the right to exclude others from making, using, offering for sale, selling or importing the invention. Once a patent is issued, the patentee must enforce the patent without aid of the USPTO.
Um … wait a minute: We were able to procure the patent because we “discovered … composition of matter” – i.e., genes. We didn’t produce anything ourselves; we just discovered them. So our new patent gives us “the right to exclude others from making, using, offering for sale, selling or importing” human genes ... but not “discovering” them, which is all we did.
??????????
If I translated this into an argument my kids were having, this is what it would sound like: You can’t see it! I saw it first! Uncle SAAAAAAAMMMMMMM!!!!!!
If your eyes are glazing over, I’m with you. Good thing we have Dan Ravicher, executive director of the Public Patent Foundation and a patent law professor at Yeshiva University’s Benjamin N. Cardozo School of Law (which is a plaintiff in the suit), to spell it out for us:
Ravicher offered an analogy to describe the plaintiffs’ argument, saying, “It’s like saying if someone removes your eyeball ... just because you remove the eyeball and wash it off, that doesn’t make the eyeball patentable.
“Now, if they create another eyeball out of plastic or metal, then you can patent that.“
OK. I’m with them. But isn’t this just an isolated case? There can’t be that many patents for human genes, right?
Wrong. The story doesn’t say how many patents exist on human genes, but Ravicher says that with this lawsuit, the plaintiffs intend to render invalid “patents on many other genes.”
SIDEBAR: For extra credit, how many genes are in the human genome? No Googling. END SIDEBAR
And what kind of practical impact can such a seemingly boring case have in and on the real world?
Its impact on you depends on whether you or anyone you love has ever had, has or may ever develop breast cancer. From the CNN story:
More than 192,000 U.S. women are diagnosed with breast cancer each year—about 5 to 10 percent of those cases have a hereditary form of the disease, according to the National Cancer Institute. Mutation in the genes called BRCA1 and BRCA2—short for breast cancer 1 and breast cancer 2—are involved in many cases of hereditary breast and ovarian cancers, the institute said …
Myriad’s patents give it exclusive right to perform diagnostic tests on the genes—forcing other researchers to request permission from the company before they can take a look at BRCA1 and BRCA2, the ACLU said. The patents also give the company the rights to future mutations on the BRCA2 gene and the power to exclude others from providing genetic testing.
The company also charged $3,000 a test, possibly keeping some women from seeking preventive genetic testing, the ACLU says.
Nice, huh?
And one more thing: Some legal experts believe that the plaintiffs would be better off trying to get the patents reversed rather than challenge their constitutionalitty, according to CNN.
It seems that some patent experts think the government was wrong to grant the patents in the first place … something about them not actually creating the genes, but just discovering “something that already existed.”
“You can’t patent things that are publicly available, that anyone can find. You have to create something, make something, do something with the thing.“
That sounds familiar.
Take care of yourself. You – or, certain parts of you, anyway – are property protected by the U.S. government.
P.S. Check your own papers on the extra credit ... the answer is ~23,299; no one knows the exact number for sure. Read more about the human genome project here.
