Skip to main content

By Sandra S. Park,  Staff Attorney, ACLU Women's Rights Project

Last week, federal district court Judge Robert Sweet made  history by issuing the first  ruling ever that human genes can't be patented. The ruling was in a case brought by the ACLU and the Public Patent Foundation (PUBPAT) challenging patents granted by the U.S. Patent and Trademark Office (PTO) to Myriad Genetics on two human genes — specifically, the BRCA1 and BRCA2 genes, which are associated with breast and ovarian cancer. The lawsuit was filed on behalf of breast cancer and women's health groups, individual women, geneticists, and scientific associations representing approximately 150,000 researchers, pathologists and laboratory professionals.  

The ACLU believes gene patenting raises serious civil  liberties concerns because the government is essentially giving  patent-holders a monopoly over the patented genes and all of the information contained within them. Patent-holders have the right to prevent anyone else from testing, studying, or even examining the genes. Under patent law, if you or your doctor were to remove your genes from your cells in order to look at them, you potentially could be sued by the patent-holder for committing patent infringement. Thus, when Myriad obtained its patents, it was able to shut down other labs that were providing testing — not because those labs were using a particular kind of test developed and patented by Myriad, but because Myriad controlled the genes themselves. (For a discussion of the legal background and arguments we made in the case, see our earlier post.)

In his decision, Judge Sweet declared that all  15 patent claims that we challenged are invalid, because they cover  products of nature and abstract ideas.

The judge ruled that Myriad's argument — that the "isolation" of the BRCA genes from the surrounding DNA and cellular material makes them into something distinct and patentable — is fundamentally flawed and nothing more than semantics:

Many, however, including scientists in the field of molecular biology and genomics, have considered this practice a "lawyer's trick" that circumvents the prohibitions on the direct patenting of the DNA in our bodies but which, in practice, reaches the  same result.

His decision recognized that patents on genes — like patents on chemically-treated fruit, a combination of species of bacteria, and purified tungsten that have been rejected by the courts — are not authorized by the Patent Act. Myriad did not invent the biological information embodied by genes.  

The resolution of these motions is based upon long recognized principles of molecular biology and genetics: DNA represents the physical embodiment of biological information, distinct in its essential characteristics from any other chemical found in nature. It is concluded that DNA's existence in an "isolated" form alters neither  this fundamental quality of DNA as it exists in the body nor the information it encodes. Therefore, the patents at issue directed to "isolated DNA" containing sequences found in nature are unsustainable as a matter of law and  are deemed unpatentable subject matter under 35 U.S.C. § 101.

Judge Sweet also concluded that all of the so-called "method" claims that were challenged are unpatentable because they cover abstract ideas — the simple mental process of comparing the sequence of one person's BRCA1 gene with the normal BRCA1 genetic sequence. Myriad's claims are not limited to any particular method of comparing sequences and are not tied to the use of a particular machine. They are so broad as to prohibit anyone from taking two genetic sequences and comparing them, side-by-side, letter-by-letter.

Because Judge Sweet found that all of the challenged patent  claims are invalid, he chose to dismiss without prejudice the claims brought  against the PTO because it was unnecessary to decide the constitutional  questions. He noted that:

[A] decision by the Federal  Circuit or the Supreme Court affirming the holding set forth above would apply to both the issued patents as well as patent holders and applicants, as well as the USPTO….the USPTO would conform its examination policies to avoid issuing  patents directed to isolated DNA or the comparison or analysis of DNA sequences.

The ruling is a significant step forward for women's health and scientific freedom. If this decision is upheld, it will mean that clinicians and researchers across the country — thousands of whom have the ability to conduct BRCA testing — will no longer be prohibited from providing  genetic test results to women.

Myriad has announced that it will appeal the decision. But Judge Sweet's ruling is only the latest pronouncement rejecting gene patents.  

Francis Collins, the Director of the National Institutes of  Health, wrote in his recent book, called "The Language of Life:  DNA and the Revolution in Personalized Medicine":

The information contained in our shared instruction book is so fundamental, and requires so much further research to understand its utility, that patenting it at the earliest stage is like putting up a whole lot of unnecessary toll booths on the road to discovery.

And in February, an advisory committee to the Secretary of  Health and Human Services issued a report (PDF) concluding that gene patents are not needed to incentivize the development of genetic testing. It recommended that the law be amended so that gene patents do not stand in the way of research and women's access to their own genetic information.

(This was originally published on ACSblog.)

Originally posted to ACLU on Thu Apr 08, 2010 at 08:18 AM PDT.

Your Email has been sent.
You must add at least one tag to this diary before publishing it.

Add keywords that describe this diary. Separate multiple keywords with commas.
Tagging tips - Search For Tags - Browse For Tags


More Tagging tips:

A tag is a way to search for this diary. If someone is searching for "Barack Obama," is this a diary they'd be trying to find?

Use a person's full name, without any title. Senator Obama may become President Obama, and Michelle Obama might run for office.

If your diary covers an election or elected official, use election tags, which are generally the state abbreviation followed by the office. CA-01 is the first district House seat. CA-Sen covers both senate races. NY-GOV covers the New York governor's race.

Tags do not compound: that is, "education reform" is a completely different tag from "education". A tag like "reform" alone is probably not meaningful.

Consider if one or more of these tags fits your diary: Civil Rights, Community, Congress, Culture, Economy, Education, Elections, Energy, Environment, Health Care, International, Labor, Law, Media, Meta, National Security, Science, Transportation, or White House. If your diary is specific to a state, consider adding the state (California, Texas, etc). Keep in mind, though, that there are many wonderful and important diaries that don't fit in any of these tags. Don't worry if yours doesn't.

You can add a private note to this diary when hotlisting it:
Are you sure you want to remove this diary from your hotlist?
Are you sure you want to remove your recommendation? You can only recommend a diary once, so you will not be able to re-recommend it afterwards.
Rescue this diary, and add a note:
Are you sure you want to remove this diary from Rescue?
Choose where to republish this diary. The diary will be added to the queue for that group. Publish it from the queue to make it appear.

You must be a member of a group to use this feature.

Add a quick update to your diary without changing the diary itself:
Are you sure you want to remove this diary?
(The diary will be removed from the site and returned to your drafts for further editing.)
(The diary will be removed.)
Are you sure you want to save these changes to the published diary?

Comment Preferences

Grassroots Mom, JekyllnHyde, Aexia, Alumbrados, ogre, teacherken, Trendar, Ivan, Gooserock, shurley, Powered Grace, mem from somerville, mattman, jethropalerobber, TechBob, Shockwave, LynChi, genethefiend, KateG, Swampfoot, gjohnsit, mataliandy, givmeliberty, erinmblair, agoldnyc, jackspace, opinionated, bronte17, TracieLynn, lippythelion69, KMc, Xapulin, boadicea, pedrito, taonow, garbo, Cedwyn, Chrisfs, OutOfManyOne, Eddie C, danthrax, MA Liberal, alivingston, JimWilson, churchylafemme, mnguitar, Pennsylvanian, Pohjola, dkmich, Oaktown Girl, AllisonInSeattle, Silverbird, mungley, Virginia Liberal, Schwede, Daddy Bartholomew, demandcaring, Timroff, TekBoss, My Philosophy, julifolo, rapala, John3, Skennet Boch, G2geek, A Citizen, tovan, bloomer 101, radarlady, Kewalo, klamothe, Shrew in Shrewsbury, PBen, sap, Alien Abductee, grimjc, Luetta, ajsuited, RequestedUsername, ChemBob, Laurence Lewis, Gary Norton, eru, SaraBeth, Frank Palmer, jimstaro, Sara R, Sandino, noemie maxwell, bently, martini, LeftOverAmerica, Showman, SoniaS, Sanuk, keeplaughing, Job52, Clytemnestra, BlueInARedState, Dvalkure, martyc35, smokeymonkey, fromer, Son of a Cat, mystery2me, hideinplainsight, triv33, TalkieToaster, StrayCat, imabluemerkin, Preston S, doinaheckuvanutjob, engine17, Cenobyte, breakingranks, Dreaming of Better Days, kurt, Bill O Rights, shaharazade, Picot verde, Johnathan Ivan, Temmoku, mapman, Nulwee, AntKat, sephius1, J Royce, FoundingFatherDAR, Cocker Mom, moodyinsavannah, ColoTim, gloriana, aravir, Outrider, edsbrooklyn, gustynpip, Jimdotz, Calvin Jones and the 13th Apostle, sfbob, Strabo, bnasley, FeingoldWarner08, Newzie, millwood, Moderation, pioneer111, JML9999, Terra Mystica, MKinTN, martydd, mayrose, revm3up, mconvente, jack 1966, VelvetElvis, Devsd, Justus, B VT, ShadowSD, ScottyUrb, Lujane, tofumagoo, pamelabrown, MsWings, Kathy S, petulans, luckylizard, joy sinha, ekyprogressive, Simply Agrestic, rhutcheson, statsone, squarewheel, ZhenRen, maggiejean, SciMathGuy, McGahee220, El Yoss, greengemini, Magick Maven, DynamicUno, iowaworker, An Affirming Flame, jaf49, Stranded Wind, TehWondahkitty, Rabbithead, more liberal than you, Norm in Chicago, Partisan Progressive, velvet blasphemy, Daily Activist, dRefractor, zbbrox, UnaSpenser, asym, IreGyre, sfarkash, louisprandtl, nancat357, KS Rose, Hunter Huxley, hillgiant, Jampacked, pyegar, 1000 Points of Fright, The Free Agent, legalchic, Marja E, Mariken, DrFitz, Funkygal, Texnance, Betty Pinson, elengul, MsGrin, Otteray Scribe, Actbriniel, BrowniesAreGood, renbear, Colorado is the Shiznit, allenjo, Oldowan, agito, yesdevkmem, DoubleT, anyname, Cintimcmomma, BlueJessamine, m00finsan, The Clevelander, InRainShadow, Aranfell, Engaged, Lorikeet, tier1express, chira2, dibsa, Aquagranny911, StateOfGrace, Brimi, blackjackal, weisja4, KingofSpades, Regina in a Sears Kit House, aerie star, Left in NY, PrometheusUnbound, Rejoinder, Patric Juillet, James Robinson, Prairie D, Flying Goat, FireBird1, OHknighty, Williston Barrett, catlover9, Green Sauce

Subscribe or Donate to support Daily Kos.

Click here for the mobile view of the site