What Bilski Means For Biotech Patents

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."

Comments

Feh

[Pojut]

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

Re:Feh

[h4rr4r]

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

[Pojut]

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

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

[h4rr4r]

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.

Re:Feh

[zx-15]

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

[Grond]

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

[Daniel Dvorkin]

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:Feh

[Pojut]

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:Feh

[zx-15]

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.

Re:Feh

[nacturation]

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 asking a question with having a particular belief.

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?

Re:Feh

[Grond]

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).

Re:Feh

[Daniel Dvorkin]

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 (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, and the court probably should have made its decision a lot more clear.

Re:Feh

[blackraven14250]

Hey, cases in front of the supreme court decide on the meanings of laws. 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.

Re:Feh

[Daniel Dvorkin]

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.

Re:Feh

[kwbauer]

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 First Amendment does not permit laws that force speakers to retain a campaign finance attorney, conduct demographic marketing re-search, or seek declaratory rulings before discussing the most salient political issues of our day." pg 7 "While some means of communication may be less effective than others at influencing the public in different contexts, any effort by the Judiciary to decide which means of communications are to be preferred for the particular type of message and speaker would raise questions as to the courts’ own lawful authority. Substantial questions would arise if courts were to begin saying what means of speech should be preferred or disfavored. And in all events, those differentiations might soon prove to be irrelevant or outdated by technologies that are in rapid flux." pg 9 "First Amendment standards, however, 'must give the benefit of any doubt to protecting rather than stifling speech.'" pg 10 "If the First Amendment has any force, it prohibits Congress from fining or jailing citizens, or associations of citizens, for simply engaging in political speech. If the antidistortion rationale were to be accepted, however, it would permit Government to ban political speech simply because the speaker is an association that has taken on the corporate form." pg 33 The majority opinion also points out the absurdity of treating some corporations as special (GE, Disney, Newscorp, etc.) because they consider themselves to be media corporations (or members of THE PRESS). The majority opinion of the court is simply that a corporation is a corporation and if they had ruled that Citizens United enjoyed no First Amendment protections, then neither did ABC (Disney), NBC, MSNBC, CNBC (GE) or even Simon & Schuster, etc. So, if you don't want corporations to have the right to make political speech, please don't support any corporation that does so. No more Huffpo, MoveOn, Slate, Mother Jones, Chris Matthews, et al on the air, etc. No more SNL doing political skits. No more discussion of Climate Change on any commercial venue. No more hearing from the ACLU or the Free Software groups.

In that case...

[swanzilla]

...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.

Re:In that case...

[Pojut]

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.

Re:In that case...

[Monkeedude1212]

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

A Mickey of Captain Morgan's.

Re:In that case...

[Pojut]

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

Huh?

[pushing-robot]

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?

[Grond]

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 (of Diamond v. Chakrabarty fame) in the Bilski case.

Re:Huh?

[king neckbeard]

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.

Re:Huh?

[Grond]

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; they just didn't want to pay Prometheus for it.

People sometimes invent this boogeyman of the greedy inventor or company patenting something then refusing to license or practice the invention. After all, why would a company invest in R&D, then invest between tens of thousands and millions in patenting the invention in the US (and likely abroad), and further invest potentially millions in litigation to prevent others from using the invention? This essentially never happens.

And remember, of course, that the US government has 'march-in rights' to any NIH-funded invention. And that the US government can always infringe any patent and only pay the patentee a reasonable royalty (the government has immunity from injunctions to prevent patent infringement). And finally the government can always take a patent outright, in the worst case. There is really no danger that life-saving cures will sit on the shelf. To the extent they ever do, the most likely culprit is that the regulatory regime makes bringing the product or service to market more expensive than it's worth, not that a patent is the problem.

Re:Huh?

[theshowmecanuck]

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 determines whether the levels of T4 and T3 are high enough or not. If not, the pituitary releases TSH (thyroid stimulating hormone) to tell the thyroid to product more T4. If the thyroid cannot produce enough because of say Hashimoto's, the TSH level goes up. The same if the levothyroxine prescribed is not high enough. So the doctors give medicine, the body transforms the medicine, and the doctors then take blood samples which are measured for these derivative chemicals (hormones). Sounds like there is prior art for this patent. No?

Re:Huh?

[HungryHobo]

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.

Re:Huh?

[king neckbeard]

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:Huh?

[Grond]

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:Huh?

[Grond]

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, the automatic waffle maker could still be patented separately, but the automatic waffle maker company would need a license from the method patentee before they could sell their product. So in the end, the public gets automatic waffle makers and the inventor of waffles gets a royalty for his or her (indirect) contribution to the invention of the automatic waffle maker. What, exactly, is the issue?

Second, you seem to be suggesting that a patent claiming a machine that carries out a method is okay whereas a more general patent claiming only the method is not. Why should it matter whether a doctor performs the diagnostic method or a machine analyzes a sample then prints out the new dose to be given?

Furthermore, what about the case where a person can actually perform the test more easily and cheaply than machines? Or when a machine cannot (yet) perform the task at all? For example, the sex of baby chickens is still determined by hand in most cases because machines are not yet capable of doing it, or at least not efficiently. Should we grant patents on methods unless a machine could do it? What if a machine can probably do it soon (i.e. within the lifetime of the patent)? Where and how is the PTO supposed to draw the line?

Re:Huh?

[a_n_d_e_r_s]

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 a high price then letting lots of people that really need it get it for a price they all can afford.

So no, its often more profitable to sell a medicine to a select few and let the rest die.

The technical term is the supply and demand curve in micro economics. (google it)

Re:Huh?

[theshowmecanuck]

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 chemicals (I agree the chemicals should be patentable (as they are now), as long as they are not chemicals produced by the body, like hormones). As well, most of the research to come up with these new tests are conducted in universities, much with government grants. Given all of the above, then I would have to agree with the other poster and say this seems like a case where granting a patent on something like this would go against the best interests of society. And I really do think allowing patents on something like this would be terrible for society.

Finally... what is the difference between hormones and vitamins? If you can make a hormone, you don't need vitamins. Good night.

Re:Huh?

[drew30319]

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 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

Frankly I don't understand why trade secret protection isn't sought in these instances more often; don't reveal which gene triggers treatment with foo, which with bar, etc. If it was adequately protected (e.g. the Coke formula!) it's protected far longer than the 20 years from a patent.

Re:Huh?

[HungryHobo]

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.

This is literally patenting making sandwitches rather than patenting sandwitch making machines.(I seem to remember an old slashdot story where much outrage was had until someone pointed out that McDonalds had patented the latter, not the former)

With a machine what it does generally isn't patentable, merely how it does it.
What you want to do is patent the "what" which is absurd.

If you find the gene responsible for some disease is there any possible way for someone to innovate around your patent if they want to test for the gene causing that disease?

If machines are not capable of doing something and you want a patent on it then get off your arse and design a machine which can.
Until then it should be no more patentable than a cake recipe.

The line?
easy.
Novel, non-obvious inventions.

not vague ideas, not spreadsheets, not cake recipes.

Ideas are easy.

I actually have little problem with software patents as long as they include full unobfusticated source code.

What about Hell and Paradise?

[stanlyb]

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??

Impact on Medical Testing

[PPH]

I guess this means the aliens are going to take their probes and find another planet populated by meatbags.

SCALIA: My work here is done! Write it up, Thomas!

[MillionthMonkey]

"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.

Bilski Is Necessary, but Deliberately Vague

[krsmav]

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.

Re:Bilski Is Necessary, but Deliberately Vague

[BitterOak]

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 innovation.

I also disagree with your assessment of SCOTUS's role in this. The lower courts had decided Bilski in a more radical way, one which would have, in effect, eliminated software patents. While SCOTUS upheld the result in Bilski, it did so in a much more careful way, leaving the door still open on software patents. (I actually wish SCOTUS had upheld the reasoning of the lower courts, as I think on balance, software patents are not a good thing.)

Re:IANAL

[nacturation]

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.

Re:IANAL

[MillionthMonkey]

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.

The flaw in your reasoning

[IBitOBear]

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 important questions like "should software even be patentable".

So yea, a heck of a lot more stoneware needs to be smashed under bovine hooves before we are likely to have restored any rationality to the world of patents.