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Medicine Patents Science

Supreme Court Legitimizing Medical Patents? 251

RobinEggs writes "A case before the U.S. Supreme Court Wednesday addressed the legality of medical patents. From the article: 'The case focuses on a patent that covers the concept of adjusting the dosage of a drug, thiopurine, based on the concentration of a particular chemical (called a metabolite) in the patient's blood. The patent does not cover the drug itself—that patent expired years ago—nor does it cover any specific machine or procedure for measuring the metabolite level. Rather, it covers the idea that particular levels of the chemical "indicate a need" to raise or lower the drug dosage. The patent holder, Prometheus Labs, offers a thiopurine testing product. It sued the Mayo Clinic when the latter announced it would offer its own, competing thiopurine test. But Prometheus claims much more than its specific testing process. It claims a physician administering thiopurine to a patient can infringe its patent merely by being aware of the scientific correlation disclosed in the patent—even if the doctor doesn't act on the patent's recommendations.'"
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Supreme Court Legitimizing Medical Patents?

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  • by Theaetetus ( 590071 ) <theaetetus@slashdot.gmail@com> on Thursday December 08, 2011 @09:26AM (#38302028) Homepage Journal

    Sorry Mr. Patient. While I know exactly what's wrong with you, the Medi-Jackass Inc. will sue me into oblivion if I prescribe the proper treatment to you! No, I can't tell you either. They'd sue me into oblivion TWICE, then go after you too.

    Un-fucking believable.

    35 USC 287(c)(1): With respect to a medical practitioner's performance of a medical activity that constitutes an infringement under section 271(a) or (b) of this title, the provisions of sections 281, 283, 284, and 285 of this title shall not apply against the medical practitioner or against a related health care entity with respect to such medical activity.

    There are no damages for infringement by a medical practitioner of a medical activity. No one's going to sue doctors. Stop the FUD.

  • Generic version (Score:5, Informative)

    by ZombieBraintrust ( 1685608 ) on Thursday December 08, 2011 @09:43AM (#38302170)
    No, this is about if a generic version of the drug can be sold as long as the label doesn't instruct the physician about the patented use. The holder of the patent wants to ban generics even though the patent on the drug itself has expired.
  • Not really, not yet (Score:5, Informative)

    by Dachannien ( 617929 ) on Thursday December 08, 2011 @09:44AM (#38302174)

    I read the transcript [supremecourt.gov] of the arguments, and it wasn't really clear to me what way they were leaning. Sotomayor seemed mostly in favor of the patentee, while Breyer especially was critical of the patentee. But these are oral arguments, and justices can take devil's advocate positions during these in order to tease out certain details of the case. Figuring out how the court will swing based on the oral arguments is like reading tea leaves, especially when it comes to patent law.

    As for the correctness of the headline: This case is in the Supreme Court because an early summary judgment motion in the district court was granted, ruling that the patent is invalid. The case was appealed to the Federal Circuit, which reversed the ruling, and then Mayo appealed to the Supreme Court.

    This case only focuses on the question of patentable subject matter under 35 USC 101, i.e., what kinds of claims should be patentable. In particular, the question here is whether the claims are directed to an application of a law of nature (the metabolism of a certain drug administered to a patient) or to the law of nature itself. Laws of nature are not patentable in and of themselves, but applications of a law of nature can be, as long as the entire law of nature is not "pre-empted" by the claim. In other words, matter-energy equivalence, E = mc^2, is a law of nature. Particular applications of that principle can be patentable, but if the claims are written such that every conceivable application of the principle is covered by the patent, then the principle is pre-empted by the claim (i.e., they might as well have claimed that entire law of nature, because the claims effectively cover it entirely).

    Prometheus, and the federal government, both argue that the arguments that Mayo is making are better addressed when considering the claims against the prior art (i.e., under 35 USC 102 and 103). (This is in part because Mayo is doing a hamfisted job of arguing their case, probably because they don't want to sabotage some of their own medical treatment patents.) The issue is that prior art considerations require a time-consuming process called a Markman hearing, where the court decides how to construe the various terms recited in the claims, and usually thereafter, a jury decides whether the prior art covers the claims, which makes the process extremely uncertain. It's Mayo's hope that patents like this can be killed early on in the process by a judge, rather than putting all their money on double-zero and giving it a spin with a jury.

    TLDR version: Nobody really knows what SCOTUS was thinking during oral arguments. This isn't the end of the road for this case, even if Mayo loses, because prior art still has to be considered.

  • Comment removed (Score:5, Informative)

    by account_deleted ( 4530225 ) on Thursday December 08, 2011 @10:11AM (#38302420)
    Comment removed based on user account deletion
  • Re:Legal fees (Score:3, Informative)

    by Grond ( 15515 ) on Thursday December 08, 2011 @10:31AM (#38302598) Homepage

    The Monsanto cases typically involved farmers who intentionally harvested and planted GMO seeds, not accidental pollination. The most famous such case occurred in Canada, by the way, not the US [wikipedia.org].

  • Re:Legal fees (Score:3, Informative)

    by wienerschnizzel ( 1409447 ) on Thursday December 08, 2011 @10:57AM (#38302836)

    You are probably refering to Monsanto v. Schmeiser case [wikipedia.org]. Correct me if I'm wrong but there were no other cases like that.

    There is no-one sued just for having his crops pollinated with Monsanto's Roundup wheat. The farmer was sued because he knowingly planted Monsanto's seeds. On the other hand the judge also ruled against any financial compensation to Monsanto as the farmer did not gain anything by his actions.

    It still sucks that the farmer ended up paying a fortune for legal aid while not doing anything wrong, on the other hand the judges made a correct decision - it's not their fault that the legislature is what it is.

    From the ruling:

    93 Inventions in the field of agriculture may give rise to concerns not raised in other fields -- moral concerns about whether it is right to manipulate genes in order to obtain better weed control or higher yields. It is open to Parliament to consider these concerns and amend the Patent Act should it find them persuasive.

    94 Our task, however, is to interpret and apply the Patent Act as it stands, in accordance with settled principles. Under the present Act, an invention in the domain of agriculture is as deserving of protection as an invention in the domain of mechanical science. Where Parliament has not seen fit to distinguish between inventions concerning plants and other inventions, neither should the courts.

  • by DJ Jones ( 997846 ) on Thursday December 08, 2011 @11:02AM (#38302888) Homepage
    Exactly. A similar example of this is the drug Propecia - the hair loss drug. Propecia is a 1mg dosage of Finasteride that goes for over $2 a pill and is patented so there's no generic option. The thing is, Finasteride isn't new, it has been around since the 60's in a 4mg dosage to treat prostate enlargement and hormonal issues, it isn't under patent anymore and costs about $.02 a pill. Merck came along a few years ago and claimed to invent the same damn drug for a different purpose and got an 8 year patent on it allowing them to jack the price for no good reason.
  • Re:Legal fees (Score:5, Informative)

    by jonwil ( 467024 ) on Thursday December 08, 2011 @11:30AM (#38303238)

    There is a story (mentioned in the documentary Food Inc IIRC) about someone who owned a machine for cleaning soybean seeds so they could be re-planted. Monsanto went after him and basically said "unless you can prove that not a single Monsanto GM seed went through your machine, we will sue you"

  • Re:Legal fees (Score:2, Informative)

    by the eric conspiracy ( 20178 ) on Thursday December 08, 2011 @11:44AM (#38303462)

    Complete BULLSHIT. The cases where Monsanto sued farmers all involve instances where farmers intentionally planted seed which they knew contained unlicensed genetic material. There has never been a case including the famous Monsanto vs Schmeiser where accidental pollination was the sole event.

  • Re:Legal fees (Score:5, Informative)

    by rtfa-troll ( 1340807 ) on Thursday December 08, 2011 @01:12PM (#38304626)

    farmers intentionally planted seed which they knew contained unlicensed genetic material

    Lets parse that a little shall we.

    The farmer had a field next to a GMO field. The plants in the farmers own field got contaminated. Yes the farmer "knew about it" but it wasn't his fault and there was nothing he could do to stop it. There certainly weren't Monsanto reps running around offering to filter his seeds for free to identify which ones were GMO contaminated and which ones weren't.

    Now when you say "intentionally planted"; what you mean is that the farmer took his only seeds; the ones which were contaminated; and then planted them. So in the end, if the farmer wanted to use his own seeds from his own field he had no choice apart from "intentionally" planting seeds which had been knowingly contaminated by Monsatnto.

    Blaming the farmer is deeply disingenuous here. If Monsanto wants control of it's own genes then it should be responsible for ensuring that they don't contaminate other people's crops.

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