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Biotech Businesses Medicine Patents The Courts Science

What Bilski Means For Biotech Patents 47

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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  • Re:Feh (Score:5, Informative)

    by Pojut ( 1027544 ) on Friday July 02, 2010 @03:41PM (#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:Huh? (Score:5, Informative)

    by Grond ( 15515 ) on Friday July 02, 2010 @04:08PM (#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.

  • Re:Feh (Score:3, Informative)

    by Grond ( 15515 ) on Friday July 02, 2010 @04:18PM (#32778930) Homepage

    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 method patents than it did, but it wasn't so much because of the way oral argument went. Because of the way the Federal Circuit works (as opposed to the regional circuits), the Supreme Court rarely grants certiorari simply to affirm the Federal Circuit, so it seemed likely that the Court would reverse, and if it were to reverse it seemed likely that it would impose a stricter rule, not a looser one, as lately the Supreme Court has typically weakened patents rather than strengthened them (see, e.g., the eBay and KSR cases). And of course virtually no one thought that the Court would actually say that the application-in-question (i.e., the Bilski & Warsaw application) claimed patentable subject matter, and it would be very difficult to announce an expansive subject matter rule that nonetheless excluded the Bilski application, so a narrow rule or test seemed likely for that reason as well.

    In sum: reading oral argument tea leaves won't get you very far, but the result was indeed still surprising given the Court's recent history of weakening patents and willingness to create new rules rather than defer to the Federal Circuit.

  • Re:Feh (Score:5, Informative)

    by Daniel Dvorkin ( 106857 ) * on Friday July 02, 2010 @04:28PM (#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.

  • Re:Huh? (Score:3, Informative)

    by Grond ( 15515 ) on Friday July 02, 2010 @05:12PM (#32779742) Homepage

    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 all the right words, they're not in a useful order. Clearly the method you describe would not anticipate another therapeutic method unless it was either identical to or a subset of the method you've described.

    The other prior art-based invalidation is obviousness, which allows the combination of multiple pieces of prior art that would each by themselves be incomplete. Since the KSR decision, obviousness can also be based on a certain degree of common sense or common ingenuity rather than explicit teachings documented in evidence. So, the method you describe might be a part of a larger body of prior art that could establish the obviousness of a similar therapeutic method. For example, it could be combined with prior art describing a drug similar to levothyroxine to make obvious a method that was the same except for substituting that other drug for levothyroxine. After all, a doctor or researcher having ordinary skill in the art would probably find it obvious that a drug with a similar pharmacokinetic profile to levothyroxine could have its dosage optimized in the same way.

    What it would not do, however, is make obvious all therapeutic methods based on measuring a substance, observing the level, and adjusting treatment because the nonobvious part is discovering exactly what the critical levels are and what the appropriate dose response is. Nothing about the method you described would suggest what the optimal level of, say, azathioprine is for someone with rheumatoid arthritis or how much to adjust the dose by given a certain level of azathioprine or its metabolites in the blood.

  • Re:Feh (Score:4, Informative)

    by Daniel Dvorkin ( 106857 ) * on Friday July 02, 2010 @05:23PM (#32779914) Homepage Journal

    You need the law that was interpreted during Santa Clara County v Southern Pacific Railroad to mean corporations were people in order to find where the whole thing originates.

    The law in question was the 14th Amendment, which says nothing about corporations, and was clearly written to refer to individuals. The corporate intepretation was made up out of whole cloth. It was a mistake, and one which the SC could easily correct.

"The pathology is to want control, not that you ever get it, because of course you never do." -- Gregory Bateson