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Biotech Businesses Medicine Patents The Courts Science

What Bilski Means For Biotech Patents 47

Posted by Soulskill
from the reply-hazy-try-again dept.
eldavojohn writes "Patents aren't just a software thing, and while Bilski's dismissal didn't shake the ground for software, it's certainly making waves in the biotech community. You may recall Prometheus v. Mayo, in which doctors fought a biotech startup's methodology patents. Well, medical method patents are now being reconsidered by order of the Supreme Court. Stocks of biotech startups jumped as this news broke, but questions remain on how the lower Federal Circuit court will rule when it reconsiders these cases of medical testing. It's clear the Supreme Court has 'ruled that judges should be more flexible in determining if methods, rather than objects, are eligible for patents, citing emerging technologies such as medical testing.' So Bilski may result in dire news for medical methods and testing patents."
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What Bilski Means For Biotech Patents

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  • Feh (Score:4, Interesting)

    by Pojut (1027544) on Friday July 02, 2010 @02:32PM (#32778348) Homepage

    The SCOTUS really screwed the pooch here. Considering how the oral arguments went, I was very surprised at the opinion they ended up releasing.

    • by h4rr4r (612664)

      Really?
      I am surprised they did not hold up methods patents 100%. These judges are as much corporate whores as the rest of our government, see their other recent rulings for evidence.

      • Re:Feh (Score:5, Informative)

        by Pojut (1027544) on Friday July 02, 2010 @02:41PM (#32778462) Homepage

        Um...did you listen to/read the oral arguments from last November? They fucking CRUCIFIED method patents. For some reason, the link I had saved from the Supreme Court website isn't working, but Patently-O did a fine job of picking out the relevant passages:

        http://patentlyo.com/patent/2009/11/bilski-v-kappos-supreme-court-arguments.html [patentlyo.com]

        Here are some samples from the oral arguments:

        JUSTICE BREYER: You know, I have a great, wonderful, really original method of teaching antitrust law, and it kept 80 percent of the students awake. ... And I could probably have reduced it to a set of steps and other teachers could have followed it. That you are going to say is patentable, too?

        JUSTICE SCALIA: . . . Let's take training horses. Don't you think that -- that some people, horse whisperers or others, had some, you know, some insights into the best way to train horses? And that should have been patentable on your theory.

        JUSTICE SOTOMAYOR: So how do we limit it to something that is reasonable? Meaning, if we don't limit it to inventions or to technology, as some amici have, or to some tie or tether, borrowing the Solicitor General's phraseology, to the sciences, to the useful arts, then why not patent the method of speed dating?

        JUSTICE SOTOMAYOR: But a patent limits the free flow of information. It requires licensing fees and other steps, legal steps. So you can't argue that your definition is improving the free flow of information.

        Like I said. Fucking. Crucified.

        • Re:Feh (Score:4, Insightful)

          by h4rr4r (612664) on Friday July 02, 2010 @03:02PM (#32778710)

          I realize they said that, and it surprised the hell out of me. These are the same folks who decided corporations could donate as much as they wanted. They made bribery legal.

          • by zx-15 (926808)

            It is not as if supreme court judges can do whatever they want. The law that legally makes corporation into a person caused that decision and should be stricken down, then even a conservative judge woudn't be able to argue for such nonsense.

            • Re:Feh (Score:5, Informative)

              by Daniel Dvorkin (106857) * on Friday July 02, 2010 @03:28PM (#32779082) Homepage Journal

              It is not as if supreme court judges can do whatever they want. The law that legally makes corporation into a person caused that decision and should be stricken down, then even a conservative judge woudn't be able to argue for such nonsense.

              AFAIK, corporate personhood in US law comes from Santa Clara County v. Southern Pacific Railroad, and has never been codified into law. What the Supreme Court did, it can undo.

              • by zx-15 (926808)

                Sorry for using broad terms, but then how did we end up with corporation legally being a person? I read somewhere that a legal clerk messed up something citing judges "Corporation is in no way a person" to "Corporation is a person", I'm assuming that carries some weight.

                • I read somewhere that a legal clerk messed up something citing judges "Corporation is in no way a person" to "Corporation is a person", I'm assuming that carries some weight.

                  That appears to be a myth, although as with many such, it has some origin in truth. Apparently a court reporter put corporate personhood into the writeup of the case [wikipedia.org] (as opposed to reversing the meaning, as the myth would have it) and did in fact get the Chief Justice's kinda-sorta approval for doing so. But the reporter in question may have had some personal reasons for what he did [wikipedia.org], and the court probably should have made its decision a lot more clear.

          • "These are the same folks"? Of the above quoted justices, only Scalia is a member of the Roberts-Alito-Scalia-Thomas bloc that always hands down 4 unanimous predictable votes for bareknuckled justice.

            As for Kennedy, the fifth vote for the majority opinion in Citizens United- he's the "Butters" of the group.
          • by kwbauer (1677400)
            If you are referring to Citizens United, then you are truly flame-baiting. The Citizens United decision does not allow unrestricted corporate donations to political campaigns. The majority opinion contains much detail about why restricting independent expenditures violates the First Amendment.
            The majority opinion was all about defending the First Amendment and the liberal establishment is actually opposed to it. Just imagine, the liberal left in America being opposed to First Amendment freedoms. "The Fir
        • Re: (Score:3, Informative)

          by Grond (15515)

          Um...did you listen to/read the oral arguments from last November? They fucking CRUCIFIED method patents.

          The Supreme Court Justices often push very hard against all sides. It's very difficult to try to guess at the outcome based on a line of questioning. The Court is loath to revisit cases, so it tries to get the result correct the first time, and that requires being critical even of the side the Justices might agree with.

          Now, to be sure, most observers felt the Court would come down harder on business me

          • by Pojut (1027544)

            Normally, I wouldn't have put so much weight into the oral arguments...but let's be honest here: they went balls to the wall with some of the comments during oral arguments in November of 2009.

        • Re: (Score:3, Interesting)

          by nacturation (646836) *

          Um...did you listen to/read the oral arguments from last November? They fucking CRUCIFIED method patents.

          I read the entire transcript and the sense that I got was that the justices were testing the soundness of the arguments by throwing out absurd scenarios that stretch credibility in order to see whether or not it is applicable. This is a common method employed to gauge the applicability of a law to a specific situation. While I'm sure the justices have an opinion on what is and isn't patentable, their job is to explore the limits of the law and the mechanism they use is through questioning. Don't confuse

          • by Grond (15515)

            I'd be interested in actually hearing the audio of the arguments so that I could know the tone in which those questions were raised. Anyone have a link handy?

            The audio recordings of the oral arguments in Bilski have not been released yet. They will probably be released at the beginning of the next term (i.e., in late September or early October).

          • IANAL (Score:1, Troll)

            I read the entire transcript and the sense that I got was that the justices were testing the soundness of the arguments by throwing out absurd scenarios that stretch credibility in order to see whether or not it is applicable.

            OK, let's say you're the judge, and you don't think your scenario is absurd. But you have to render an opinion in a court on the surface of the moon with its attendant jurisdictional and respiratory issues in which the plaintiff may not have standing- she may be kneeling, and administering oral sex to justices under the bench. Meanwhile defendants are traveling by at almost the speed of light and experiencing time dilation that interferes with scheduled court appearances. Upon completion of a happy ending,

            • I read the entire transcript and the sense that I got was that the justices were testing the soundness of the arguments by throwing out absurd scenarios that stretch credibility in order to see whether or not it is applicable.

              OK, let's say you're the judge, and you don't think your scenario is absurd. But you have to render an opinion in a court on the surface of the moon with its attendant jurisdictional and respiratory issues in which the plaintiff may not have standing- she may be kneeling, and administering oral sex to justices under the bench. Meanwhile defendants are traveling by at almost the speed of light and experiencing time dilation that interferes with scheduled court appearances. Upon completion of a happy ending, shall defendants be cited for failing to appear with summary judgment granted to the plaintiff, or given the indeterminate simultaneity dependent upon which party's reference frame is considered, toss the case back to lower courts on Earth requiring clarification on whether the court's proper frame must be used? Would the same findings hold if the ending were say, not happy?

              In your moon scenario, the goatse guy would show up and everyone would see the light at the end of the tunnel after firsthand experience of a significant amount of dilation thereby collapsing the quantum wave function and Schrodinger's cat would leap out. In the end, that's all that matters.

              • Ah but if the cat were shorter from head to tail than the Planck length, that line of reasoning would not be applicable and the verdict's hybrid quantum state will collapse in favor of goatse guy in all jurisdictions except the State of Texas.
  • ...I'll let you in on my method to cure the common hangover. Four ibuprofen washed down with a can of sugar-free Red Bull. You're welcome.
    • by Pojut (1027544)

      Even better, how about a method to prevent the common hangover:

      Every three beers or three shots, drink a glass of water. Before going to sleep (assuming you don't pass out), drink a glass of water. You will wake up hangover free, I guarantee it.

      Source: never once had a hangover in my entire life when following that advice.

    • I'll let you in on MY method to cure the common hangover:

      A Mickey of Captain Morgan's.

      • by Pojut (1027544)

        For a second, just a second, I thought you wrote "Captain Morgan's Mickey". Time for me to lay off the sauce, jeebus.

  • I thought that a patent was still permitted if (1) it is tied to a particular machine or apparatus, or (2) it transforms a particular article into a different state or thing. It's hard to believe that a drug or gene couldn't meet those qualifications if a piece of software can.

    Not to say that I'm in favor of these patents, mind you.

    • Re:Huh? (Score:5, Informative)

      by Grond (15515) on Friday July 02, 2010 @03:08PM (#32778788) Homepage

      I thought that a patent was still permitted if (1) it is tied to a particular machine or apparatus, or (2) it transforms a particular article into a different state or thing. It's hard to believe that a drug or gene couldn't meet those qualifications if a piece of software can.

      Well, first, the Supreme Court held that the machine-or-transformation test, which you recited, is only a tool or clue to the patentability of a method, not the sole test. Second, the diagnostic patents being discussed here generally take this form:

      "A method for treating disease X, comprising performing test A, observing the result, and administering treatment foo, bar, or baz depending on the result."

      The issue here is that in many of these patents test A and treatments foo, bar, and baz are all known in the art. The invention is the discovery of the association or correlation between test results and the optimal treatment (e.g., if you have a certain gene then you get this drug, but if you lack it you should get this other drug). The Federal Circuit has hinted that it is the observing or correlating step that must pass the machine-or-transformation test; (possibly) the testing and (more likely) the treatment steps are merely 'insignificant postsolution activity' that can't rescue the patent from unpatentability.

      In my opinion, however, such patents should be granted so long as they are new, useful, nonobvious, and adequately specified in the patent. Subject matter is too crude a tool to filter out undesirable patents. As a society we want investment into new diagnostic methods and personalized medicine. For example, the availability of fast, inexpensive genetic testing has opened up new doors to making sure that people are given the best drug at the best dose, but determining which genes match which drugs and doses will require significant studies. We can encourage investment in those kinds of studies by offering patent protection to the resulting diagnostic and therapeutic methods.

      Full Disclosure: I worked with the team that wrote the amicus brief for Dr. Ananda Chakrabarty [abanet.org] (of Diamond v. Chakrabarty [wikipedia.org] fame) in the Bilski case.

      • But do the incentives for investment added outweigh the costs to society of other doctors or hospitals not being able to use these methods for 20 years? The drug used for the treatment would be patentable, and a more effective usage of that drug is arguably in the benefit of the patent holder, at least if they want to compete with other drugs.
        • by Grond (15515)

          But do the incentives for investment added outweigh the costs to society of other doctors or hospitals not being able to use these methods for 20 years?

          Why do you think the methods would be unavailable to 'other doctors or hospitals?' The patent holders would want to maximize revenue by making the methods available to as many licensees as possible. The Prometheus v. Mayo Clinic case, for example, was not about doctors at Mayo being unable to use the diagnostic method or patients not having access to it; t

          • Re: (Score:2, Insightful)

            Why do you think the methods would be unavailable to 'other doctors or hospitals?' The patent holders would want to maximize revenue by making the methods available to as many licensees as possible.

            The number of hospitals willing to pay the licensing fee will probably be lower than the number of hospitals that would practice these methods if they weren't patented.

            And remember, of course, that the US government has 'march-in rights' to any NIH-funded invention

            Which only applies if the NIH funds it. My personal opinion is that nothing that has significant government funding should be eligible for a patent.

          • Re: (Score:3, Interesting)

            by a_n_d_e_r_s (136412)

            Why do you think the methods would be unavailable to 'other doctors or hospitals?' The patent holders would want to maximize revenue by making the methods available to as many licensees as possible.

            Licensing to as many as possoble may very vell be less profitable then licensing to a few who can pay really good. Thats why 7 miljon people in Africa don't get the medicine against AIDS that they need - they can't afford it.

            The pharmaceuticals are making more money selling the AIDS medicine to those that can pay

      • So I have Hashimoto's Thyroiditis. I have to take almost as much levothyroxine every day as someone who has had their thyroid removed. Levothyroxine is synthetic thyroxine hormone commonly known as T4. The body breaks down some of the T4 into T3 (triiodothyronine). One of the diagnostic tests is to measure the levels of these two hormones. However, the primary test for thyroid function, or whether the levels of T4 and T3 in the blood are normal is to measure TSH levels. The body via the pituitary gland dete
        • Re: (Score:3, Informative)

          by Grond (15515)

          Sounds like there is prior art for this patent. No?

          There are (basically) two ways to invalidate a patent based on prior art: anticipation and obviousness. Anticipation requires that a single piece of prior art (e.g., another patent, a paper in a journal, a web page, etc) describe each and every element of the claimed invention. The prior art must also enable someone to use the invention, which is why a dictionary isn't prior art for every invention imaginable; although a dictionary technically contains al

          • The way you put it, it sounds like you advocate that all diagnostic tests be patented. We would see doctors have to pay royalties in order to do a physical on a patient, or just to examine a sick patient. That would drive up the costs of medicine far worse than is happening now. And really, for using techniques and methods that have been used for years. Most of these therapeutic methods are based on past practice and experience (such as measuring for functioning thyroid glands) albeit modified for new chemi

      • If I want a better breakfast do I let people patent the steps in making waffles or do I let them patent an automatic waffle maker.

        I see little advantage in the first over the second except that it lets them be lazier and not bother designing a machine to do it automatically.

        • by Grond (15515)

          If I want a better breakfast do I let people patent the steps in making waffles or do I let them patent an automatic waffle maker.

          I see little advantage in the first over the second except that it lets them be lazier and not bother designing a machine to do it automatically.

          First, a well written patent on a method for making waffles would actually read on an automatic waffle maker because it would only describe the essential steps of making waffles and not claim specifics like mixing by hand. Of course, th

          • Patents are supposed to be on inventions not ideas.

            I see only a barrier to the company doing something productive by trying to build a machine to do the task- especially since the method patent owners wouldn't likely be happy to invite competition and are perfectly free to tell the real productive company to fuck off and not compete with them and the method they charge people a lot of money to do by hand and turning it into a faster and easier test with a machine would only drive down the percieved value.

            Th

      • by drew30319 (828970)

        Subject matter is too crude a tool to filter out undesirable patents.

        I agree that we would not want subject matter to be the only test but that's fortunately not the case. I think that it makes sense that subject matter be used as an initial hurdle however. I read the Bilski ruling as indicating a general reluctance by SCOTUS to patent processes but they wanted to avoid a bright-line ruling to allow for processes in unanticipated technologies that are more appropriate candidates.

        The issue here is that in

  • Since, this is obviously something new, and very original idea, do you have to pay a fee to go to Paradise? Or even Hell? Or even talking about??
  • I guess this means the aliens are going to take their probes and find another planet populated by meatbags.
  • by krsmav (1410223) on Friday July 02, 2010 @04:04PM (#32779646)
    IAAL. When SCOTUS takes a patent case, they're like a bull in a china shop. They're not engineers or patent lawyers, so they undo a lot of stuff that has been carefully worked out by the Patent Office and special patent courts. That said, the area of non-device patents has grown enormously over the last few years, and there was a great need to set some ground-rules to cut back on overreaching claims while giving people with new ideas a chance to make a profit from their innovations. In my view, Bilski is a monster (and necessary) bitch slap for methodology patents, which had gotten out of bounds. (IMO, the next one will come on copyright overreaching.) The Supremes deliberately left the opinion vague to let the experts work out the details.
    • by BitterOak (537666)

      IAAL. When SCOTUS takes a patent case, they're like a bull in a china shop. They're not engineers or patent lawyers, so they undo a lot of stuff that has been carefully worked out by the Patent Office and special patent courts.

      Just because that "stuff" has been carefully worked out by the Patent Office and Patent courts doesn't mean the results are in the best interests of the population as a whole. Remember, that the Patent Office's "customers" are the people applying for patents, but patent law should strike a balance between those interests and the rest of the population (including others who want to innovate). Some patent protection is necessary to promote potentially costly research and development, but too much can stifle

    • Nothing, as near as I can tell, has been "carefully worked out" by the courts or the Patent Office. The PAtent office is a patent granting machine because it has become a profit center for the government instead of a cost center executing an expensive but necessary regulatory action. The patent courts likewise have not worked anything out "carefully" because a court can not "think" it can only "rule on the questions before it" and none of the litigants with enough money to see it through have asked the impo

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